DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 412, 413, 422, and 495

CMS-0033-F

RIN 0938-AP78

Medicare and Medicaid Programs; Electronic Health Record Incentive Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule.

SUMMARY: This final rule implements the provisions of the American Recovery and

Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) that provide incentive payments to eligible

professionals (EPs), eligible hospitals and critical access hospitals (CAHs) participating in

Medicare and Medicaid programs that adopt and successfully demonstrate meaningful use of

certified electronic health record (EHR) technology. This final rule specifies—the initial criteria

EPs, eligible hospitals, and CAHs must meet in order to qualify for an incentive payment;

calculation of the incentive payment amounts; payment adjustments under Medicare for covered

professional services and inpatient hospital services provided by EPs, eligible hospitals and

CAHs failing to demonstrate meaningful use of certified EHR technology; and other program

participation requirements. Also, the Office of the National Coordinator for Health Information

Technology (ONC) will be issuing a closely related final rule that specifies the Secretary’s

adoption of an initial set of standards, implementation, specifications, and certification criteria

for electronic health records. ONC has also issued a separate final rule on the establishment of

certification programs for health information technology.

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EFFECTIVE DATE: These regulations are effective on [insert 60 days after the date of

publication in the Federal Register].

FOR FURTHER INFORMATION CONTACT:

Elizabeth Holland, (410) 786-1309, EHR incentive program issues.

Edward Gendron, (410) 786-1064, Medicaid incentive payment issues.

Jim Hart, (410) 786-9520, Medicare fee for service payment issues.

Bob Kuhl or Susan Burris, (410) 786-5594, Medicare CAH payment and charity care issues.

Frank Szeflinski, (303) 844-7119, Medicare Advantage issues.

SUPPLEMENTARY INFORMATION:

Acronyms

ARRA American Recovery and Reinvestment Act of 2009

AAC Average Allowable Cost (of certified EHR technology)

AIU Adopt, Implement, Upgrade (certified EHR technology)

CAH Critical Access Hospital

CAHPS Consumer Assessment of Healthcare Providers and Systems

CCN CMS Certification Number

CFR Code of Federal Regulations

CHIP Children’s Health Insurance Program

CHIPRA Children's Health Insurance Program Reauthorization Act of 2009

CMS Centers for Medicare & Medicaid Services

CPOE Computerized Physician Order Entry

CY Calendar Year

EHR Electronic Health Record

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EP Eligible Professional

EPO Exclusive Provider Organization

FACA Federal Advisory Committee Act

FFP Federal Financial Participation

FFY Federal Fiscal Year

FFS Fee-For-Service

FQHC Federally Qualified Health Center

FTE Full-Time Equivalent

FY Fiscal Year

HEDIS Healthcare Effectiveness Data and Information Set

HHS Department of Health and Human Services

HIE Health Information Exchange

HIT Health Information Technology

HIPAA Health Insurance Portability and Accountability Act of 1996

HITECH Health Information Technology for Economic and Clinical Health Act

HMO Health Maintenance Organization

HOS Health Outcomes Survey

HPSA Health Professional Shortage Area

HRSA Health Resource and Services Administration

IAPD Implementation Advance Planning Document

ICR Information Collection Requirement

IHS Indian Health Service

IPA Independent Practice Association

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IT Information Technology

MA Medicare Advantage

MAC Medicare Administrative Contractor

MAO Medicare Advantage Organization

MCO Managed Care Organization

MITA Medicaid Information Technology Architecture

MMIS Medicaid Management Information Systems

MSA Medical Savings Account

NAAC Net Average Allowable Cost (of certified EHR technology)

NCQA National Committee for Quality Assurance

NCVHS National Committee on Vital and Health Statistics

NPI National Provider Identifier

NPRM Notice of Proposed Rulemaking

ONC Office of the National Coordinator for Health Information Technology

PAHP Prepaid Ambulatory Health Plan

PAPD Planning Advance Planning Document

PFFS Private Fee-For-Service

PHO Physician Hospital Organization

PHS Public Health Service

PHSA Public Health Service Act

PIHP Prepaid Inpatient Health Plan

POS Place of Service

PPO Preferred Provider Organization

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PQRI Physician Quality Reporting Initiative

PSO Provider Sponsored Organization

RHC Rural Health Clinic

RHQDAPU Reporting Hospital Quality Data for Annual Payment Update

RPPO Regional Preferred Provider Organization

SMHP State Medicaid Health Information Technology Plan

TIN Tax Identification Number

Table of Contents

I. Background

A. Overview of the HITECH Programs Created by the American Recovery and

Reinvestment Act of 2009

B. Statutory Basis for the Medicare & Medicaid EHR Incentive Programs

II. Provisions of the Proposed Regulations and Response and Analysis of Comments

A. Definitions Across the Medicare FFS, Medicare Advantage, and Medicaid Programs

1. Definitions

a. Certified Electronic Health Record (EHR) Technology

b. Qualified Electronic Health Record

c. Payment Year

d. First, Second, Third, Fourth, Fifth and Sixth Payment Year

e. EHR Reporting Period

f. Meaningful EHR User

2. Definition of Meaningful Use

a. Considerations in Defining Meaningful Use

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b. Common Definition of Meaningful Use under Medicare and Medicaid

c. Stage 1 Criteria for Meaningful Use

3. Sections 4101(a) and 4102(a)(1) of HITECH Act: Reporting on Clinical Quality

Measures Using EHR by EPs, Eligible Hospitals and CAHs

a. General

b. Requirements for the Submission of Clinical Quality Measures by EPs, Eligible

Hospitals and CAHs

c. Statutory Requirements and Other Considerations for the Selection of Clinical Quality

Measures for Electronic Submission by EPs, Eligible Hospitals and CAHs

(1) Statutory Requirements for the Selection of Clinical Quality Measures for Electronic

Submission by EPs, Eligible Hospitals and CAHs

(2) Other Considerations for the Selection of Clinical Quality Measures for Electronic

Submission by EPs, Eligible Hospitals and CAHs

d. Clinical Quality Measures for EPs

e. Clinical Quality Measures Reporting Criteria for EPs

f. Clinical Quality Measures for Electronic Submission by Eligible Hospitals

g. Potential Measures for EPs, Eligible Hospitals and CAHs in Stage 2 and Subsequent

Years

h. Reporting Method for Clinical Quality Measures for 2011 and Beginning with the

2012 Payment Years

(1) Reporting Method for 2011 Payment Year

(2) Reporting Method Beginning in 2012

i. Alternative Reporting Methods for Clinical Quality Measures

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j. Reporting Period for Reporting Clinical Quality Measures

4. Demonstration of Meaningful Use

a. Common Methods of Demonstration in Medicare and Medicaid

b. Methods for Demonstration of the Stage 1 Criteria of Meaningful Use

5. Data Collection for Online Posting, Program Coordination, and Accurate Payments

a. Online Posting

b. Program Election between Medicare FFS/MA and Medicaid for EPs

c. Data to be Collected

6. Hospital-based Eligible Professionals

7. Interaction with other Programs

B. Medicare Fee-for-Service Incentives

1. Incentive Payments for Eligible Professionals

a. Definitions

b. Incentive Payment Limits

c. Increase in Incentive Payment for EPs who Predominantly Furnish Services in a

Geographic Health Professional Shortage Area

d. Form and Timing of Payment

e. Payment Adjustment Effective in CY 2015 and Subsequent Years for EPs who are not

Meaningful Users of Certified EHR Technology

2. Incentive Payments for Hospitals

a. Definition of Eligible Hospital for Medicare

b. Incentive Payment Calculation for Eligible Hospitals

c. Medicare Share
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d. Charity Care

e. Transition Factor

f. Duration and Timing of Incentive Payments

g. Incentive Payment Adjustment Effective in Federal FY 2015 and Subsequent Years

for Eligible Hospitals who are not Meaningful EHR Users

3. Incentive Payments for Critical Access Hospitals

a. Definition of CAHs for Medicare

b. Current Medicare Payment of Reasonable Cost for CAHs

c. Changes made by the HITECH Act

d. Incentive Payment Calculation for CAHs

e. Reduction of Reasonable Cost Payment in FY 2015 and Subsequent Years for CAHs

that are not Meaningful EHR Users

4. Process for Making Incentive Payments under the Medicare FFS Program

a. Incentive Payments to EPs

b. Incentive Payments to Eligible Hospitals

c. Incentive Payments to CAHs

d. Payment Accounting under Medicare

C. Medicare Advantage Organization Incentive Payments

1. Definitions

a. Qualifying MA Organization

b. Qualifying MA Eligible Professional

c. Qualifying MA-Affiliated Eligible Hospital

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2. Identification of Qualifying MA Organizations, MA EPs, and MA-Affiliated Eligible

Hospitals

3. Computation of Incentives to Qualifying MA Organizations for MA EPs and

Hospitals

4. Timeframe for Payment

5. Avoiding Duplicate Payment

6. Meaningful User Attestation

7. Posting Information on the CMS Website

8. Limitation on Review

9. Conforming Changes

10. Payment Adjustment and Future Rulemaking

D. Medicaid Incentives

1. Overview of Health Information Technology in Medicaid

2. General Medicaid Provisions

3. Identification of Qualifying Medicaid EPs and Eligible Hospitals

a. Overview

b. Program Participation

1. Acute Care Hospitals

2. Children’s Hospitals

c. Medicaid Professionals Program Eligibility

d. Calculating Patient Volume Requirements

e. Entities Promoting the Adoption of Certified EHR Technology

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4. Computation of Amount Payable to Qualifying Medicaid EPs and Eligible Hospitals

a. Payment Methodology for EPs

(1) General Overview

(2) Average Allowable Costs

(3) Net Average Allowable Costs

(4) Payments for Medicaid Eligible Professionals

(5) Basis for Medicaid EHR Incentive Program First Payment Year and Subsequent

Payment Years

(i) Medicaid EP Who Begins Adopting, Implementing or Upgrading Certified EHR

Technology in the First Year

(ii) Medicaid EP who has Already Adopted, Implemented or Upgraded Certified EHR

Technology and Meaningfully Uses EHR Technology

b. Payment Methodology for Eligible Hospitals

c. Alternative and Optional Early State Implementation to Make Incentive Payments for

Adopting, Implementing or Upgrading Certified EHR Technology

d. Process for Making and Receiving Medicaid Incentive Payments

e. Avoiding Duplicate Payment

f. Flexibility to Alternate Between Medicare and Medicaid EHR Incentive Programs One

Time

g. One State Selection

5. Single Provider Election Repository and State Data Collection

6. Collection of Information Related to the Eligible Professional's National Provider

Identifier (NPI) and the Tax Identification Number (TIN)

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7. Activities Required to Receive Incentive Payments

a. General Overview

b. Definitions Related to Certified EHR Technology and Adopting, Implementing or

Upgrading Such Technology

(1) Certified EHR Technology

(2) Adopting, Implementing or Upgrading

c. Other General Terminology

d. Quality Measures

8. Overview of Conditions for States to Receive Federal Financial Participation (FFP)

for Incentive Payments and Implementation Funding

9. Financial Oversight, Program Integrity and Provider Appeals

III. Collection of Information Requirements

A. ICRs Regarding Demonstration of Meaningful Use Criteria (§495.8)

B. ICRs Regarding Participation Requirements for EPs, Eligible Hospitals, and

Qualifying CAHs (§495.10)

C. ICRs Regarding Identification of Qualifying MA Organizations, MA-EPs and MA-

affiliated Eligible Hospitals (§495.202)

D. ICRs Regarding Incentive Payments to Qualifying MA Organizations for MA-EPs

and Hospitals (§495.204)

E. ICRs Regarding Meaningful User Attestation (§495.210)

F. ICRs Regarding Incentive payments to qualifying MA organizations for MA-eligible

Professionals and Hospitals (§495.220)

G. ICRs Regarding Process for Payments (§495.312)

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H. ICRs Regarding Activities Required to Receive an Incentive Payment (§495.314)

I. ICRs Regarding State Monitoring and Reporting Regarding Activities Required to

Receive an Incentive Payment (§495.316)

J. ICRs Regarding State Responsibilities for Receiving FFP (§495.318)

K. ICRs Regarding Prior Approval Conditions (§495.324)

L. ICRs Regarding Termination of Federal Financial Participation (FFP) for Failure to

Provide Access to Information (§495.330)

M. ICRs Regarding State Medicaid Agency and Medicaid EP and Hospital Activities

(§495.332 through §495.338)

N. ICRs Regarding Access to Systems and Records (§495.342)

O. ICRs Regarding Procurement Standards (§495.344)

P. ICRs Regarding State Medicaid Agency Attestations (§495.346)

Q. ICRs Regarding Reporting Requirements (§495.348)

R. ICRs Regarding Retroactive Approval of FFP with an Effective Date of February 18,

2009 (§495.358)

S. ICRs Regarding Financial Oversight and Monitoring Expenditures (§495.362)

T. ICRs Regarding Appeals Process for a Medicaid Provider Receiving Electronic

Health Record Incentive Payments (§495.366)

IV. Regulatory Impact Analysis

A. Overall Impact

B. Regulatory Flexibility Analysis

C. Small Rural Hospitals

D. Unfunded Mandates Reform Act

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E. Federalism

F. Anticipated Effects

G. HITECH Impact Analysis

H. Accounting Statement

I. Background

A. Overview of the HITECH Programs Created by the American Recovery and Reinvestment

Act of 2009

The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) was

enacted on February 17, 2009. Title IV of Division B of ARRA amends Titles XVIII and XIX of

the Social Security Act (the Act) by establishing incentive payments to eligible professionals

(EPs), eligible hospitals, and critical access hospitals (CAHs), and Medicare Advantage

Organizations to promote the adoption and meaningful use of interoperable health information

technology (HIT) and qualified electronic health records (EHRs). These provisions, together

with Title XIII of Division A of ARRA, may be cited as the “Health Information Technology for

Economic and Clinical Health Act” or the “HITECH Act.” These incentive payments are part of

a broader effort under the HITECH Act to accelerate the adoption of HIT and utilization of

qualified EHRs.

On January 13, 2010 we published a proposed rule (75 FR 1844), entitled “Medicare and

Medicaid Programs; Electronic Health Record Incentive Program” to implement the provisions

of ARRA that provide incentive payments to EPs, eligible hospitals, and CAHs participating in

Medicare and Medicaid programs that adopt and successfully demonstrate meaningful use of

“certified EHR technology,” and incentive payments to certain Medicare Advantage

Organizations for their affiliated EPs and eligible hospitals that meaningfully use certified EHR
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technology. Through this final rule, we are developing the incentive programs which are

outlined in Division B, Title IV of the HITECH Act. This final rule sets forth the definition of

“meaningful use of certified EHR technology.”

Section 13101 of the HITECH Act adds a new section 3000 to the Public Health Service

Act (PHSA), which defines “certified EHR technology” as a qualified EHR that has been

properly certified as meeting standards adopted under section 3004 of the PHSA. CMS and

ONC have been working closely to ensure that the definition of meaningful use of certified EHR

technology and the standards for certified EHR technology are coordinated. In the interim final

rule published on January 13, 2010 (75 FR 2014) entitled “Health Information Technology:

Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic

Health Record Technology,” ONC defined the term “certified EHR technology,” identified the

initial set of standards and implementation specifications that such EHR technology would need

to support the achievement of the proposed meaningful use Stage 1, as well as the certification

criteria that will be used to certify EHR technology. ONC is also issuing a final rule on the

standards, implementation specifications, and certification criteria elsewhere in this issue of the

Federal Register.

In a related proposed rule published on March 10, 2010, (75 FR 11328) entitled

“Proposed Establishment of Certification Programs for Health Information Technology” ONC

proposed the establishment of two certification programs for purpose of testing and certifying

health information technology. In the June 24, 2010 Federal Register (75 FR 36157), ONC

published a final rule to establish a temporary certification program whereby the National

Coordinator would authorize organizations to test and certify complete EHRs and EHR Modules,

and plans to issue a separate final rule to establish a permanent certification program to replace
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the temporary certification program. Specifically, this final rule will ensure that the definition of

meaningful use of certified EHR technology does not require EPs, eligible hospitals, and CAHs

to perform functions for which standards have not been recognized or established. Similarly, the

functionality of certified EHR technology should enable and advance the definition of

meaningful use.

We urge those interested in this final rule to also review the ONC interim final rule on

standards and implementation specifications for certified EHR technology and the related final

rule as well as the final rule on the establishment of a temporary certification program. Readers

may also visit http://healthit.hhs.gov and

http://www.cms.hhs.gov/Recovery/11_HealthIT.asp#TopOfPage for more information on the

efforts at the Department of Health and Human Services (HHS) to advance HIT initiatives.

B. Statutory Basis for the Medicare & Medicaid EHR Incentive Programs

Section 4101(a) of the HITECH Act adds a new subsection (o) to section 1848 of the Act.

Section 1848(o) of the Act establishes incentive payments for demonstration of meaningful use

of certified EHR technology by EPs participating in the original Medicare program (hereinafter

referred to as the Medicare Fee-for-Service (FFS) program) beginning in calendar year (CY)

2011. Section 4101(b) of the HITECH Act also adds a new paragraph (7) to section 1848(a) of

the Act. Section 1848(a)(7) of the Act provides that beginning in CY 2015, EPs who do not

demonstrate that they are meaningful users of certified EHR technology will receive an

adjustment to their fee schedule for their professional services of 99 percent for 2015 (or, in the

case of an eligible professional who was subject to the application of the payment adjustment

under section 1848(a)(5) of the Act, 98 percent for 2014), 98 percent for 2016, and 97 percent for

2017 and each subsequent years. Section 4101(c) of the HITECH Act adds a new subsection (l)
CMS-0033-F 16

to section 1853 of the Act to provide incentive payments to certain Medicare Advantage (MA)

organizations for their affiliated EPs who meaningfully use certified EHR technology and meet

certain other requirements, and requires a downward adjustment to Medicare payments to certain

MA organizations for professional services provided by any of their affiliated EPs who are not

meaningful users of certified EHR technology, beginning in 2015. Section 1853(l) of the Act

also requires us to establish a process that ensures that there are no duplicate payments made to

MA organizations under section 1853(l) of the Act and to their affiliated EPs under the FFS EHR

incentive program established under section 1848(o)(1)(A) of the Act.

Section 4102(a) of the HITECH Act adds a new subsection (n) to section 1886 of the Act.

Section 1886(n) of the Act establishes incentives payments for demonstration of meaningful use

of certified EHR technology by subsection (d) hospitals, as defined under section 1886(d)(1)(B)

of the Act, participating in the Medicare FFS program beginning in Federal fiscal year (FFY)

2011. Section 4102(b)(1) of the HITECH Act amends section 1886(b)(3)(B) of the Act to

provide that, beginning in FY 2015, subsection (d) hospitals that are not meaningful users of

certified EHR technology will receive a reduced annual payment update for their inpatient

hospital services. Section 4102(a)(2) of the HITECH Act amends section 1814(l) of the Act to

provide an incentive payment to critical access hospitals (CAHs) who meaningfully use certified

EHR technology based on the hospitals’ reasonable costs for the purchase of certified EHR

technology beginning in FY 2011. In addition, section 4102(b)(2) of the HITECH Act amends

section 1814(l) of the Act to provide for a downward payment adjustment for hospital services

provided by CAHs that are not meaningful users of certified EHR technology for cost reporting

periods beginning in FY 2015. Section 4102(c) of the HITECH Act adds a new subsection (m)

to section 1853 of the Act to provide incentive payments to qualifying MA organizations for
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certain affiliated hospitals that meaningfully use certified EHR technology to make a downward

adjustment to payments to certain MA organizations for inpatient hospital services provided by

its affiliated hospitals that are not meaningful users of certified EHR technology beginning in

FY 2015. Section 1853(m) of the Act also requires us to establish a process that ensures that

there are no duplicate payments made to MA organizations under section 1853(m) of the Act and

to their affiliated hospitals under the FFS EHR incentive program established under section

1886(n) of the Act.

Section 4103 of the HITECH Act provides for implementation funding for the EHR

incentives program under Medicare.

Section 4201 of the HITECH Act amends section 1903 of the Act to provide 100 percent

Federal financial participation (FFP) to States for incentive payments to certain eligible providers

participating in the Medicaid program to purchase, implement, operate (including support

services and training for staff) and meaningfully use certified EHR technology and 90 percent

FFP for State administrative expenses related to the program outlined in 1903(t) of the Act.

Section 4201(a)(2) of the HITECH Act adds a new subsection (t) to section 1903 of the Act to

establish a program with input from the States to provide incentives for the adoption and

subsequent meaningful use of certified EHR technology for providers participating in the

Medicaid program.

II. Provisions of the Proposed Rule and Analysis of and Responses to Public Comments

We proposed to add a new part 495 to title 42 of the Code of Federal Regulations to

implement the provisions of Title IV of Division B of ARRA providing for incentive payments

to EPs, eligible hospitals, CAHs and certain Medicare Advantage organizations for the adoption
CMS-0033-F 18

and demonstration of meaningful use of certified EHR technology under the Medicare program

or the Medicaid program.

The HITECH Act creates incentives under the Medicare Fee-for-Service (FFS), Medicare

Advantage (MA), and Medicaid programs for EPs, eligible hospitals and CAHs to adopt and

demonstrate meaningful use of certified EHR technology, and payment adjustments under the

Medicare FFS and MA programs for EPs, eligible hospitals, and CAHs who fail to adopt and

demonstrate meaningful use of certified EHR technology. The three incentive programs contain

many common elements and certain provisions of the HITECH Act encourage avoiding

duplication of payments, reporting, and other requirements, particularly in the area of

demonstration meaningful use of certified EHR technology. Eligible hospitals and CAHs may

participate in both the Medicare program and the Medicaid program, assuming they meet each

program’s eligibility requirements, which vary across the two programs. In certain cases, the

HITECH Act has used nearly identical or identical language in defining terms that are used in the

Medicare FFS, MA, and Medicaid programs, including such terms as ‘‘hospital-based EPs’’ and

‘‘certified EHR technology.’’ For these reasons, we seek to create as much commonality

between the three programs as possible and have structured this final rule, as we did the

proposed rule, based on the premise by beginning with those provisions that cut across the three

programs before moving on to discuss the provisions specific to Medicare FFS, MA and

Medicaid.

A. Definitions across the Medicare FFS, MA, and Medicaid Programs

Title IV, Division B of ARRA establishes incentive payments under the Medicare and

Medicaid programs for certain professionals and hospitals that meaningfully use certified EHR

technology, and for certain MA organizations whose affiliated EPs and hospitals meaningfully
CMS-0033-F 19

use certified EHR technology. We refer to the incentive payments made under the original

Medicare program to EPs, eligible hospitals, and CAHs as the Medicare FFS EHR incentive

program, the incentive payments made to qualifying MA organizations as the MA EHR incentive

program, and the incentive payments made under Medicaid to eligible professionals and eligible

hospitals as the Medicaid EHR incentive program. When referring to the Medicare EHR

incentive program, we are generally referring to both the Medicare FFS EHR and the MA EHR

incentive programs.

1. Definitions

Sections 4101, 4102, and 4201 of the HITECH Act use many identical or similar terms.

In this section of the preamble, we discuss terms for which we are finalizing uniform definitions

for the Medicare FFS, MA, and Medicaid EHR incentive programs. These definitions are set

forth in part 495 subpart A of the regulations. For definitions specific to an individual program,

the definition is set forth and discussed in the applicable EHR incentive program section.

The incentive payments are available to EPs which are non-hospital-based physicians, as

defined in section 1861(r) of the Act, who either receive reimbursement for services under the

Medicare FFS program or have an employment or contractual relationship with a qualifying MA

organization meeting the criteria under section 1853(l)(2) of the Act; or healthcare professionals

meeting the definition of “eligible professional” under section 1903(t)(3)(B) of the Act as well as

the patient-volume and non-hospital-based criteria of section 1903(t)(2)(A) of the Act) and

eligible hospitals which are subsection (d) hospitals as defined under subsection 1886(d)(1)(B) of

the Act that either receive reimbursement for services under the Medicare FFS program or are

affiliated with a qualifying MA organization as described in section 1853(m)(2) of the Act;

critical access hospitals (CAHs); or acute care or children's hospitals described under section
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1903(t)(2)(B) of the Act).

a. Certified Electronic Health Record (EHR) Technology

Under all three EHR incentive programs, EPs, eligible hospitals, and CAHs must utilize

“certified EHR technology” if they are to be considered eligible for the incentive payments. In

the Medicare FFS EHR incentive program this requirement for EPs is found in section

1848(o)(2)(A)(i) of the Act, and for eligible hospitals and CAHs in section 1886(n)(3)(A)(i) of

the Act. In the MA EHR incentive program this requirement for EPs is found in section

1853(l)(1) of the Act, and for eligible hospitals and CAHs, in section 1853(m)(1) of the Act. In

the Medicaid EHR incentive program this requirement for EPs and Medicaid eligible hospitals is

found throughout section 1903(t) of the Act, including in section 1903(t)(6)(C) of the Act.

Certified EHR technology is a critical component of the EHR incentive programs, and the

Secretary has charged ONC, under the authority given to her in the HITECH Act, with

developing the criteria and mechanisms for certification of EHR technology. Therefore, we

finalize our proposal to use the definition of certified EHR technology adopted by ONC. ONC

issued an interim final rule with comment for the standards and certification criteria for certified

EHR technology at the same time our proposed rule was issued. After reviewing the comments

they received and to address changes made in this final rule, ONC will be issuing a final rule in

conjunction with this final rule. When we refer to the ONC final rule, we are referring to this

final rule titled “Health Information Technology: Initial Set of Standards, Implementation

Specifications, and Certification Criteria for Electronic Health Record Technology. When we

refer to the ONC IFR, we are referring to the interim final rule with comment period published in

the Federal Register on January 13, 2010.

Comment: Several commenters asked for clarification on the definition of certified EHR
CMS-0033-F 21

technology. Currently, hospitals utilize multiple systems to operate electronically. For example,

some electronic operating systems feed EHR data and some systems pull EHR data. Data from

the two systems are then extracted and manipulated to create a quality measure calculation. The

commenters’ inquired as to how these systems can continue to be utilized even though,

independently, these systems will not meet all certification standards. Some commenters

expressed concern the ONC IFR did not include generation of the data needed to demonstrate

meaningful use as a certification requirement and that certified EHR technology requirements

should also include compliance with HIPAA standards as well as all relevant state statutes for

the state or states where it is installed. Commenters recommended various approaches to

defining certified technology especially in the early stages of the program. Some suggestions

included, grandfathering existing systems for a period of three years as long as the provider

could meet specific meaningful use objectives while requiring all upgrades to existing systems to

be certified, allowing all EHR products certified by the Certification Commission for Health

Information Technology (CCHIT) at the criteria established for 2008 or later be deemed as

meeting Stage 1 certification requirements or alternatively CMS provide a process that can verify

compliance of required features at no cost to providers or vendors as is done now with Enterprise

Data Interchange (EDI) claims processing. Some commenters also offered other thoughts on

potential unintended consequences of defining the EHR certification software process to include

certifying agencies that charge for the process. The commenters believed this could result in

continued new and revised requirements to justify the certifying entities’ existence and increase

its revenue.

Response: We have referred those comments to ONC who addresses them in their final

rule.
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We are adopting the ONC definition of certified EHR technology at 45 CFR 170.102 in

this final rule.

b. Qualified Electronic Health Record

In order for an EHR technology to be eligible for certification, it must first meet the

definition of a Qualified Electronic Health Record. This term was defined by ONC in its in its

IFR and finalized by ONC in their final rule, and we are finalizing our proposal to use the

definition of qualified electronic health record adopted by ONC in their final rule to be published

concurrently with this rule.

Comment: We received a few comments on the definition of qualified EHR technology.

Commenters expressed concerns regarding perceived gaps in defining an EHR as qualified such

as a lack of the requirement for a narrative text for physicians (also known as progress note).

Another comment requested further clarification regarding the requirement for a qualified EHR

to “capture and query information relevant to health care quality” and “exchange electronic

health information with and integrate such information from other sources.” For example, some

might believe that these requirements apply strictly to information contained within the EHR or

closed proprietary hospital systems and not to information that would have to be obtained from

outside the four walls of the practice or the extended (but closed) system.

Response: We have referred those comments to ONC who addresses them in their final

rule.

We are adopting the ONC definition of Qualified Electronic Health Record at45 CFR 170.102.

c. Payment Year

As discussed in the proposed rule, under section 1848(o)(1)(A)(i) of the Act the Medicare

FFS EHR incentive payment is available to EPs for a “payment year.” Section 1848(o)(1)(E) of
CMS-0033-F 23

the Act defines the term “payment year” as a year beginning with 2011. While the Act does not

use the term, “payment year,” for the Medicaid EHR incentive program, it does use the term

“year of payment” throughout section 1903(t) of the Act, for example, at sections 1903(t)(3)(C),

1903(t)(4)(A), and 1903(t)(6)(C) of the Act. For all EPs in the Medicare and Medicaid EHR

incentive programs, we are proposing a common definition for both “payment year” and “year of

payment,” as “any calendar year beginning with 2011” at §495.4. In the proposed rule, we

explained that this definition, which is consistent with the statutory definition of “payment year”

under Medicare FFS, would simplify the EHR incentive programs for EPs. As discussed later in

this preamble, EPs will have the opportunity to participate in either the Medicare or Medicaid

incentive programs, and once an EP has selected a program, they are permitted to make a one-

time switch from one program to the other. A common definition will allow EPs to more easily

understand both incentive programs, and inform their decisions regarding participation in either

program.

Under section 1886(n)(1) of the Act, the Medicare FFS EHR incentive payment is

available to eligible hospitals and CAHs for a “payment year.” Section 1886(n)(2)(G) of the Act

defines the term “payment year” as a fiscal year beginning in 2011. As hospitals are paid based

on the 12-month Federal fiscal year, we interpret the reference to a “fiscal year” means the fiscal

year beginning on October 1 of the prior calendar year and extending to September 30 of the

relevant year. Again, for the Medicaid EHR incentive program, the HITECH Act uses the term,

“year of payment” (see section 1903)(t)(5)(D)(ii) of the Act), rather than “payment year.” For

the same reasons expressed in the proposed rule and summarized above for proposing a common

definition of “payment year” for EPs, and because hospitals will have the opportunity to
CMS-0033-F 24

simultaneously participate in both the Medicare and Medicaid EHR incentive programs, we

propose a common definition of “payment year” and “year of payment” for both programs.

For purposes of the incentive payments made to eligible hospitals and CAHs under the

Medicare FFS, MA and Medicaid EHR incentive programs, we proposed to define payment year

and year of payment at §495.4, consistent with the statutory definition, as “any fiscal year

beginning with 2011.”

Comment: A commenter asked CMS to identify the first possible payment year for EPs,

and hospitals and CAHs.

Response: The first payment year for EPs is any calendar year (CY) beginning with

CY 2011 and for eligible hospitals and CAHs is any fiscal year (FY) beginning with 2011.

Comment: The majority of commenters favored our definition of “payment year” based

on the different existing fiscal periods for eligible professionals and hospitals. Additional

support was received from some commenters whom explained that they participated in

performance-based initiatives, which define a payment year the same as the proposed rule.

Response: After consideration of the public comments received, we are adopting our

proposed definition of “payment year” in the Medicare and Medicaid EHR incentive programs as

described above.

Comment: The majority of comments received regarding the definition of a payment

year asked whether payment years must be consecutive for an EP or eligible hospital to receive

all years of incentive payments.

Response: In the proposed rule, we defined the second, third, fourth, fifth, and sixth

payment year, respectively, to mean "the second, third, fourth, fifth, and sixth calendar or

Federal fiscal year, respectively, for which an EP or eligible hospital receives an incentive
CMS-0033-F 25

payment." However, section 1848(o)(1)(E) of Act defines the second through fifth payment

years for an EP as each successive year immediately following the first payment year for such

professional for the Medicare FFS and MA EHR incentive programs. Similarly, section

1886(n)(2)(G)(ii) of the Act defines the second through fourth payment years for an eligible

hospital or CAH as requiring the years to be "successive" and "immediately following" the prior

year. This requirement, that each payment year "immediately follow" the prior year, means that

every year subsequent to the first payment year is a payment year regardless of whether an

incentive payment is received by the EP, eligible hospital or CAH. For example, if a Medicare

EP receives an incentive in CY 2011, but does not successfully demonstrate meaningful use or

otherwise fails to qualify for the incentive in CY 2012, CY 2012 still counts as one of the EP's

five payment years and they would only be able to receive an incentive under the Medicare EHR

incentive program for three more years as CY 2013 would be there third payment year. In this

example, the maximum incentive payment that would apply for this Medicare EP not practicing

predominately in a health professional shortage area (HPSA) would be $18,000 in 2011, and

$8,000 in 2013 as outlined in section 1848(o)(1)(B) of the Act. The EP would have qualified for

a maximum incentive payment of $12,000 in 2012, but did not qualify as a meaningful user for

this year. No incentives may be made under the Medicare EHR incentive program after 2016.

The same rule, however, does not apply to the Medicaid EHR incentive program. For

that program, payments may generally be non-consecutive. If an EP or eligible hospital does not

receive an incentive payment for a given CY or FY then that year would not constitute a

payment year. For example, if a Medicaid EP receives incentives in CY 2011 and CY 2012, but

fails to qualify for an incentive in CY 2013, they would still be eligible to receive incentives for

an additional four payment years. For hospitals, however, starting with FY 2017 payments must
CMS-0033-F 26

be consecutive. This rule is required by section 1903(t)(5)(D) of the Act, which states that after

2016, no Medicaid incentive payment may be made to an eligible hospital unless "the provider

has been provided payment . . . for the previous year." As a result, Medicaid eligible hospitals

must receive an incentive in FY 2016 to receive an incentive in FY 2017 and later years.

Starting in FY 2016, incentive payments must be made every year in order to continue

participation in the program. In no case may any Medicaid EP or eligible hospital receive an

incentive after 2021. We have revised our regulations at §495.4 to incorporate these statutory

requirements.

Comment: Some commenters requested that CMS clarify the impact on EPs when they

change practices in the middle of the incentive payment program; in other words, if an EP leaves

a practice in year two of the incentive payment program and goes to another practice, does that

EP forfeit the ability to continue collecting incentive payments for years 3 through 5?

Response: A qualifying EP that leaves one practice for another may still be eligible to

receive subsequent incentive payments if the EP is a meaningful EHR user in the new practice.

The incentive payment is tied to the individual EP, and not to his or her place of practice.

d. First, Second, Third, Fourth, Fifth, and Sixth Payment Year

In accordance with sections 1848(o)(1)(A)(ii), 1886(n)(2)(E), 1814(l)(3)(A),

1903(t)(4)(B), and 1903(t)(5)(A) of the Act, for EPs, eligible hospitals, and CAHs that qualify

for EHR incentive payments in a payment year, the amount of the payment will depend in part

on whether the EP or hospital previously received an incentive payment and, if so (for the

Medicare EHR incentive program) when the EP or hospital received his or her first payment.

We proposed to define the first payment year to mean the first CY or Federal fiscal year (FY) for

which an EP, eligible hospital, or CAH receives an incentive payment. Likewise, we proposed
CMS-0033-F 27

to define the second, third, fourth, fifth ,and sixth payment year, respectively, to mean the

second, third, fourth, fifth, and sixth CY or FY, respectively, for which an EP, eligible hospital,

or CAH receives an incentive payment.

Comment: As stated above, many commenters requested clarification on non-

consecutive payment.

Response: This comment is addressed above.

Comment: A commenter requested CMS to clarify the consequences for a hospital that

originally qualified and received incentive payments the first year, but in a subsequent year

failed to qualify as a meaningful user of certified EHR technology.

Response: Meaningful use will be assessed on a year-by-year basis as we establish

different Stages of meaningful use criteria for different years. If an EP or an eligible hospital

including a CAH has failed to demonstrate meaningful use of certified EHR technology for a

certain payment year, the EP, eligible hospital, or CAH will not be qualified for incentive

payments for that payment year. However, upon successful demonstration as a meaningful EHR

user in subsequent years, an EP, eligible hospital or CAH may be eligible to receive an incentive

payment. As discussed above, however, for the Medicare program, the failure of the eligible

hospital or CAH to demonstrate meaningful use in the subsequent year, will affect the total

payments that hospital is eligible to receive, as, pursuant to the statute, the hospital is treated as

skipping a payment year. Payment adjustments apply to Medicare providers who are unable to

demonstrate meaningful use starting in 2015.

Comment: One commenter asked if CMS could apply the same Medicaid EP’s first year

incentive eligibility requirements of adopting, implementing or upgrading to certified EHR

technology to Medicare physicians instead of demonstration of meaningful use.

CMS-0033-F 28

Response: The HITECH Act allows Medicaid EPs and eligible hospitals to receive an

incentive for the adoption, implementation, or upgrade of certified EHR technology in their first

participation year. In subsequent years, these EPs and eligible hospitals must demonstrate that

they are meaningful users. There are no parallel provisions under the Medicare EHR incentive

program that would authorize us to make payments to Medicare EPs, eligible hospitals, and

CAHs for the adoption, implementation or upgrade of certified EHR technology. Rather, in

accordance with sections 1848(o)(2), 1886(n)(3)(A), and 1814(l)(3)(A) of the Act, Medicare

incentive payments are only made to EPs, eligible hospitals, and CAHs for the demonstration of

meaningful use of certified EHR technology.

After consideration of the public comments received, we are finalizing the definitions of

First payment year as proposed. For the Medicare EHR incentive programs, we are modifying

the definitions of second, third, fourth, fifth payment year to make clear that these years are

“each successive year following the first payment year.” For the Medicaid EHR incentive

program, we included definitions of first, second, third, fourth, fifth and sixth payment year that

make clear that these are the years for which payment is received. The regulations can now be

found at §495.4 of our regulations.

e. EHR Reporting Period

In the proposed rule, we proposed a definition of EHR Reporting Period for purposes of

the Medicare and Medicaid incentive payments under sections 1848(o), 1853(l)(3), 1886(n),

1853(m)(3), 1814(l) and 1903(t) of the Act. For these sections, we proposed that the EHR

reporting period would be any continuous 90-day period within the first payment year and the

entire payment year for all subsequent payment years. In our proposed rule, we did not make

any proposals regarding the reporting period that will be used for purposes of the payment
CMS-0033-F 29

adjustments that begin in 2015. We intend to address this issue in future rulemaking, for

purposes of Medicare incentive payment adjustments under sections 1848(a)(7), 1853(l)(4),

1886(b)(3)(B)(ix), 1853(m)(4), and 1814(l)(4) of the Act.

For the first payment year only, we proposed to define the term EHR reporting period at

§495.4 of our regulations to mean any continuous 90-day period within a payment year in which

an EP, eligible hospital or CAH successfully demonstrates meaningful use of certified EHR

technology. The EHR reporting period therefore could be any continuous period beginning and

ending within the relevant payment year. Starting with the second payment year and any

subsequent payment years for a given EP, eligible hospital or CAH, we proposed to define the

term EHR reporting period at §495.4 to mean the entire payment year. In our discussion of

considerations in defining meaningful use later in this section we discuss how this policy may be

affected by subsequent revisions to the definition of meaningful use.

For the first payment year, we stated in the proposed rule our belief that giving EPs,

eligible hospitals and CAHs flexibility as to the start date of the EHR reporting period is

important, as unforeseen circumstances, such as delays in implementation, higher than expected

training needs and other unexpected hindrances, may cause an EP, eligible hospital, or CAH to

potentially miss a target start date.

Comment: Some commenters supported the 90-day reporting period proposed for the

first payment year. One commenter requested that exceptions, per the provider request, be

considered individually in cases of compliance for less than the 90 days (for example, 85 days).

Commenters preferred the 90-day reporting period overall and many suggested it be used for

subsequent years as well. We also received comments questioning why Medicaid providers

would need to conform to the 90-day reporting period in order to adopt, implement or upgrade
CMS-0033-F 30

certified EHR technology.

Response: We do believe that for program integrity it is crucial to maintain a consistent

reporting period. Basing the incentive payments on meaningful use implies a minimum level of

use in order to receive the incentive payment. The timeframe is part of the determination of

whether use is meaningful and therefore requires a minimum as well. Given the short time period

as compared to the entire year, we do not believe an exception process is needed. However, we

agree with commenters that an EHR reporting period for demonstrating adoption,

implementation or upgrading certified EHR technology by Medicaid EPs and eligible hospitals is

unnecessary and are removing it for the final rule in this instance. Similarly, Medicaid EPs and

eligible hospitals who are demonstrating meaningful use for the first time in their second

payment year, will have a 90-day reporting period to maintain parity with Medicare providers’

first meaningful use payment year. We do not believe that after successfully demonstrating

meaningful use, a 90-day period is appropriate for subsequent years. The reasons for using the

90-day period instead of the full year are based on potential delays in implementing certifying

EHR technology. Once certified EHR technology is implemented these are no longer applicable.

After consideration of the public comments received and with the clarification described

above for adopting, implementing or upgrading, we are finalizing the 90-day reporting period for

the first payment year based on meaningful use as proposed for Medicare EPs, eligible hospitals

and CAHs and full year EHR reporting periods for subsequent payment years. For Medicaid EPs

and eligible hospitals, the EHR reporting period will be a 90-day period for the first year a

Medicaid EP or eligible hospital demonstrates meaningful use and full year EHR reporting

periods for subsequent payment years.

f. Meaningful EHR User

CMS-0033-F 31

Section 1848(o)(1)(A)(i) of the Act, limits incentive payments under the Medicare FFS

EHR incentive program to an EP who is a “meaningful EHR user.” Similarly, section 1886(n)(1)

and 1814(l) of the Act, limits incentive payments under the Medicare FFS EHR incentive

program to an eligible hospital or CAH, respectively, who is a “meaningful EHR user.” Section

1903(t)(6)(C)(i)(II) of the Act limits incentive payments for payment years other than the first

payment year to a Medicaid EP or eligible hospital who “demonstrates meaningful use of

certified EHR technology.” We proposed to define at §495.4 the term “meaningful EHR user”

as an EP, eligible hospital, or CAH who, for an EHR reporting period for a payment year,

demonstrates meaningful use of certified EHR technology in the form and manner consistent

with our standards (discussed below).

Comment: Several commenters indicated there is a need to align measures and programs,

to avoid having to report similar measure standards to different federal, state and other entities.

Response: We concur with the goal of alignment to avoid redundant and duplicative

reporting and seek to accomplish this to the extent possible now and in future rulemaking.

Comment: Several commenters suggested that CMS considers EPs, eligible hospitals,

and CAHs who are participating in certain existing programs as meaningful EHR users. The

commenters contended that the standards followed by participants in these programs are

equivalent to those we proposed to adopt for purposes of demonstrating meaningful use. The

programs recommended by commenters are--

• Qualified Health Information Exchange Networks; and

• Medicare Electronic Health Record Demonstration Program.

Response: We do not agree that participation in these programs would be the equivalent

to demonstrating meaningful use in accordance with the criteria under the EHR incentive
CMS-0033-F 32

programs. Most of these programs place a heavy focus on one of the five priorities of

meaningful use discussed in the next section such as reporting clinical quality measures or the

exchange of health information, tailored to the individual program’s goals. For example, the

goal of the Medicare Electronic Health Record Demonstration Program, for example, which was

started in 2009 and pre-dates passage of the HITECH Act, is to reward delivery of high-quality

care supported by the adoption and use of electronic health records in physician small to

medium-size primary care practices. The purpose of this program is to encourage adoption and

increasingly sophisticated use of EHRs by small to medium-sized primary care practices. While

this goal is similar to the overall objective of the HITECH Act, the requirements for the

demonstration are not as broad-based as that of the HITECH Act, and payment incentives are

based on the level of use over the duration of the program, which will vary by practice.

Therefore, it is not appropriate to deem practices participating in the EHR Demonstration as

meaningful users for purposes of the HITECH Act. The HITECH Act also requires use certified

EHR technology as defined by ONC to qualify for incentive payments. While CCHIT has

certified EHR technology in the past, the ONC regulation “Establishment of the Temporary

Certification Program for Health Information Technology; Final Rule” (see 75 FR 36157) which

establishes a temporary certifying body has yet to be established. Where possible, we have

aligned the criteria required to demonstrate meaningful use with existing programs like PQRI

and RHQDAPU as discussed in section II.A.3 of this final rule. After consideration of the public

comments received, we are finalizing our definition of a meaningful EHR user as proposed.
CMS-0033-F 33

2. Definition of Meaningful Use

a. Considerations in Defining Meaningful Use

In sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act, the Congress identified the broad

goal of expanding the use of EHRs through the term meaningful use. In section 1903(t)(6)(C) of

the Act, Congress applies the definition of meaningful use to Medicaid eligible professionals and

eligible hospitals as well. Certified EHR technology used in a meaningful way is one piece of a

broader HIT infrastructure needed to reform the health care system and improve health care

quality, efficiency, and patient safety. HHS believes this ultimate vision of reforming the health

care system and improving health care quality, efficiency and patient safety should drive the

definition of meaningful use consistent with the applicable provisions of Medicare and Medicaid

law.

In the proposed rule we explained that in defining meaningful use we sought to balance

the sometimes competing considerations of improving health care quality, encouraging

widespread EHR adoption, promoting innovation, and avoiding imposing excessive or

unnecessary burdens on health care providers, while at the same time recognizing the short time-

frame available under the HITECH Act for providers to begin using certified EHR technology.

Based on public and stakeholder input received prior to publishing the proposed rule, we

consider a phased approach to be most appropriate. Such a phased approach encompasses

reasonable criteria for meaningful use based on currently available technology capabilities and

provider practice experience, and builds up to a more robust definition of meaningful use, based

on anticipated technology and capabilities development. The HITECH Act acknowledges the

need for this balance by granting the Secretary the discretion to require more stringent measures

of meaningful use over time. Ultimately, consistent with other provisions of law, meaningful use
CMS-0033-F 34

of certified EHR technology should result in health care that is patient centered, evidence-based,

prevention-oriented, efficient, and equitable.

Under this phased approach to meaningful use, we intend to update the criteria of

meaningful use through future rulemaking. We refer to the initial meaningful use criteria as

“Stage 1.” We currently anticipate two additional updates, which we refer to as Stage 2 and

Stage 3, respectively. We expect to update the meaningful use criteria on a biennial basis, with

the Stage 2 criteria by the end of 2011 and the Stage 3 criteria by the end of 2013. The stages

represent an initial graduated approach to arriving at the ultimate goal.

• Stage 1: The Stage 1 meaningful use criteria, consistent with other provisions of

Medicare and Medicaid law, focuses on electronically capturing health information in a

structured format; using that information to track key clinical conditions and communicating that

information for care coordination purposes (whether that information is structured or

unstructured, but in structured format whenever feasible); implementing clinical decision support

tools to facilitate disease and medication management; using EHRs to engage patients and

families and reporting clinical quality measures and public health information. Stage 1 focuses

heavily on establishing the functionalities in certified EHR technology that will allow for

continuous quality improvement and ease of information exchange. By having these

functionalities in certified EHR technology at the onset of the program and requiring that the EP,

eligible hospital or CAH become familiar with them through the varying levels of engagement

required by Stage 1, we believe we will create a strong foundation to build on in later years.

Though some functionalities are optional in Stage 1, as outlined in discussions later in this rule,

all of the functionalities are considered crucial to maximize the value to the health care system

provided by certified EHR technology. We encourage all EPs, eligible hospitals and CAHs to be
CMS-0033-F 35

proactive in implementing all of the functionalities of Stage 1 in order to prepare for later stages

of meaningful use, particularly functionalities that improve patient care, the efficiency of the

health care system and public and population health. The specific criteria for Stage 1 of

meaningful use are discussed at section II.2.c of this final rule.

• Stage 2: Our goals for the Stage 2 meaningful use criteria, consistent with other

provisions of Medicare and Medicaid law, expand upon the Stage 1 criteria to encourage the use

of health IT for continuous quality improvement at the point of care and the exchange of

information in the most structured format possible, such as the electronic transmission of orders

entered using computerized provider order entry (CPOE) and the electronic transmission of

diagnostic test results (such as blood tests, microbiology, urinalysis, pathology tests, radiology,

cardiac imaging, nuclear medicine tests, pulmonary function tests, genetic tests, genomic tests

and other such data needed to diagnose and treat disease). For the final rule, we elaborate on our

plans for Stage 2. We expect that stage two meaningful use requirements will include rigorous

expectations for health information exchange, including more demanding requirements for

e-prescribing and incorporating structured laboratory results and the expectation that providers

will electronically transmit patient care summaries to support transitions in care across

unaffiliated providers, settings and EHR systems. Increasingly robust expectations for health

information exchange in stage two and stage three will support and make real the goal that

information follows the patient. We expect that Stage 2 will build upon Stage 1 by both altering

the expectations of the functionalities in Stage 1 and likely adding new functionalities which are

not yet ready for inclusion in Stage 1, but whose provision is necessary to maximize the potential

of EHR technology. As discussed later in this final rule, we are making some objectives of the

Stage 1 of meaningful use optional and other required. We will consider every objective that is
CMS-0033-F 36

optional for Stage 1 to be required in Stage 2 as well as revaluate the thresholds and exclusions

of all the measures both percentage based and those currently a yes/no attestation. Additionally,

we may consider applying the criteria more broadly to all outpatient hospital settings (not just the

emergency department).

• Stage 3: Our goals for the Stage 3 meaningful use criteria are, consistent with other

provisions of Medicare and Medicaid law, to focus on promoting improvements in quality, safety

and efficiency leading to improved health outcomes, focusing on decision support for national

high priority conditions, patient access to self management tools, access to comprehensive

patient data through robust, patient-centered health information exchange and improving

population health.

We did not include regulatory provisions for Stage 2 or Stage 3 in our proposal and with

one exception discussed under the CPOE objective, we are not finalizing Stage 2 or Stage 3

requirements at this time. However, we plan to build upon Stage 1 by increasing the

expectations of the functionalities in Stage 1 and adding new objectives for Stage 2. In our next

rulemaking, we currently intend to propose that every objective in the menu set for Stage 1 (as

described later in this section) be included in Stage 2 as part of the core set. While allowing

providers flexibility in setting priorities for EHR implementation takes into account their unique

circumstances, we maintain that all the objectives are crucial to building a strong foundation for

health IT and to meeting the statutory objectives of the Act. In addition, as indicated in our

proposed rule, we anticipate raising the threshold for these objectives in both Stage 2 and 3 as the

capabilities of HIT infrastructure increases. For Stage 2, we intend to review the thresholds and

measures associated with all Stage 1 objectives considering advances in technology, changes in
CMS-0033-F 37

standard practice, and changes in the marketplace (for example, wider adoption of information

technology by pharmacies) and propose, as appropriate, increases in these requirements.

We recognize that the thresholds included in the final regulation are ambitious for the

current state of technology and standards of care. However, we expect the delivery of health

care to evolve through the inception of the HITECH incentive programs and implementation of

the Affordable Care Act prior to finalizing Stage 2. Furthermore, data collected from the initial

attestations of meaningful use will be used to ensure that the thresholds of the measures that

accompany the objectives in Stage 2 are continue to aggressively advance the use of certified

EHR technology. Finally, we continue to anticipate redefining our objectives to include not only

the capturing of data in electronic format but also the exchange (both transmission and receipt)

of that data in increasingly structured formats. As appropriate, we intend to propose the addition

of new objectives to capture new functions that are necessary to maximize the potential of EHR

technology, but were not ready for Stage 1. For instance, we would consider adding measures

related to CPOE orders for services beyond medication orders. The intent and policy goal for

raising these thresholds and expectations is to ensure that meaningful use encourages patient-

centric, interoperable health information exchange across provider organizations.

We will continue to evaluate the progression of the meaningful use definition for

consistency with the HITECH ACT and any future statutory requirements relating to quality

measurement and administrative simplification. As the purpose of these incentives is to

encourage the adoption and meaningful use of certified EHR technology, we believe it is

desirable to account for whether an EP, eligible hospital or CAH is in their first, second, third,

fourth, fifth, or sixth payment year when deciding which definition of meaningful use to apply in

the beginning years of the program. The HIT Policy Committee in its public meeting on
CMS-0033-F 38

July 16, 2009 also voiced its approval of this approach. However, such considerations are

dependent on future rulemaking, so for this final rule Stage 1 criteria for meaningful use are

valid for all payments years until updated by future rulemaking.

We proposed that Medicare EPs, eligible hospitals, and CAHs whose first payment year

is 2011 must satisfy the requirements of the Stage 1 criteria of meaningful use in their first and

second payment years (2011 and 2012) to receive the incentive payments. We anticipate

updating the criteria of meaningful use to Stage 2 in time for the 2013 payment year and

therefore anticipate for their third and fourth payment years (2013 and 2014), an EP, eligible

hospital, or CAH whose first payment year is 2011 would have to satisfy the Stage 2 criteria of

meaningful use to receive the incentive payments. We proposed that Medicare EPs, eligible

hospitals, and CAHs whose first payment year is 2012 must satisfy the Stage 1 criteria of

meaningful use in their first and second payment years (2012 and 2013) to receive the incentive

payments. We anticipate updating the criteria of meaningful use to Stage 2 in time for the 2013

payment year and anticipate for their third payment year (2014), an EP, eligible hospital, or CAH

whose first payment year is 2012 would have to satisfy the Stage 2 criteria of meaningful use to

receive the incentive payments. We discussed in the proposed rule that Medicare EPs, eligible

hospitals, and CAHs whose first payment year is 2013 must satisfy the Stage 1 criteria of

meaningful use in their first payment year (2013) to receive the incentive payments. We

anticipate updating the criteria of meaningful use to Stage 2 in time for the 2013 payment year

and therefore anticipate for their second payment year (2014), an EP, eligible hospital, or CAH

whose first payment year is 2013 would have to satisfy the Stage 2 criteria of meaningful use to

receive the incentive payments. We discussed in the proposed rule that Medicare EPs, eligible

hospitals, and CAHs whose first payment year is 2014 must satisfy the Stage 1 criteria of
CMS-0033-F 39

meaningful use in their first payment year (2014) to receive the incentive payments. In the

proposed rule, we discussed the idea that alignment of stage of meaningful use and payment year

should synchronize for all providers in 2015, and requested comment on the need to create such

alignment. After reviewing public comment on this issue, our goal remains to align the stages of

meaningful use across all providers in 2015. However, we acknowledge the concerns regarding

the different Medicare and Medicaid incentive timelines, as well as concerns about whether

Stage 3 would be appropriate for an EP’s, eligible hospital’s or CAH’s first payment year at any

point in the future and believe the issue needs additional review and discussion before we lay out

a clear path forward for 2015 and beyond. Therefore, we have decided to remove language in

the final rule discussing our possible directions for any year beyond 2014. We will address the

years beyond 2014 in later rulemaking. Table 1 outlines how we anticipate applying the

respective criteria of meaningful use in the first years of the program, and how we anticipate

applying such criteria for subsequent payment years, through 2014. Please note that nothing in

this discussion restricts us from requiring additional stages of meaningful use (beyond stage 3)

through future rulemaking. In addition, as we expect to engage in rulemaking to adopt the

criteria that will accompany Stages 2 and 3 of meaningful use, stakeholders should wait for those

rulemakings to determine what will be required for those Stages and should not view the

discussions in this preamble or final rule as binding the agency to any specific definition for

those future stages.

TABLE 1: Stage of Meaningful Use Criteria by Payment Year

First Payment Year

Payment Year 2011 2012 2013 2014 2015
2011 Stage 1 Stage 1 Stage 2 Stage 2 TBD
2012 Stage 1 Stage 1 Stage 2 TBD
2013 Stage 1 Stage 1 TBD
2014 Stage 1 TBD
CMS-0033-F 40

Please note that each of the EHR incentive programs has different rules regarding the

number of payment years available, the last year for which incentives may be received, and the

last payment year that can be the first payment year for an EP, eligible hospital, or CAH. The

applicable payment years and the incentive payments available for each program are also

discussed in section II.C. of this final rule for the Medicare FFS EHR incentive program, in

section II.D. of this final rule for the MA EHR incentive program, and in section II.E. of this

final rule for the Medicaid EHR incentive program.

Comment: Numerous commenters noted that it is inappropriate to align the Medicaid

EHR incentive payment program with the Medicare program due to the lack of penalties in the

Medicaid program and due to the option for Medicaid providers to participate in their first year

by adopting, implementing, or upgrading certified EHR technology.

Response: This was not the only reason for having all EPs, eligible hospitals, and CAHs

align by 2015. However, as we are not addressing stages of meaningful use beyond 2014 in this

final rule, potential alignment is not discussed. We will reconsider this comment in future

rulemaking.

The stages of criteria of meaningful use and how they are demonstrated are described

further in this final rule and will be updated in subsequent rulemaking to reflect advances in HIT

products and infrastructure. We note that such future rulemaking might also include updates to

the Stage 1 criteria.

We invited comment on our alignment between payment year and the criteria of

meaningful use particularly in regards to the need to create alignment across all EPs, eligible

hospitals, and CAHs in all EHR incentive programs in 2015.

Comment: Many commenters requested that if there continued to be a year where all
CMS-0033-F 41

EPs, eligible hospitals and CAHs must meet the same stage of meaningful use that that year be

2017, rather than 2015 as we had discussed in the proposed rule. These commenters asserted

that EPs, eligible hospitals, and CAHs whose first payment year is after 2011 might not have

sufficient time to reach the Stage 3 of meaningful use criteria by 2015. Some commenters

pointed out that while the HITECH Act states that 2015 is the first year of payment adjustments,

it provides for escalation of the payment adjustments so that they do not reach their full levels

until 2017.

Response: As we explained in the proposed rule, equity in the level of meaningful use

across all EPs, eligible hospitals, and CAHs subject to the payment adjustment was not the only

reason for our plan that all EPs, eligible hospitals, and CAHs satisfy the Stage 3 criteria for either

the Medicare or Medicaid EHR incentive programs. The achievement of many of the ultimate

goals of meaningful use of certified EHR technology are dependent on a critical mass of EPs,

eligible hospitals, and CAHs all being meaningful EHR users. Exchange of health information is

most valuable when it is so robust that it can be relied upon to provide a complete or nearly

complete picture of a patient’s health. For example, robust Stage 3 meaningful use by an EP does

not assist that EP in avoiding ordering a duplicative test, if the EP with information on the

original test is only a Stage 1 meaningful EHR user and is not yet exchanging that information.

This dependency is key to the need to get to Stage 3 for all providers. Another reason for

alignment at Stage 3 in 2015 is that many of the barriers to functionalities of EHRs that exist

today as may no longer exist in 2015. The existence of these barriers today is one of the primary

reasons for having a staged approach as opposed to requiring more robust meaningful use at the

beginning of the program. Providers, developers of EHRs, government and non -governmental

organizations are all working to remove these barriers. We believe it is likely there will be
CMS-0033-F 42

success in removing many of these barriers, which would make many of the compromises made

in Stage 1 no longer necessary by 2015. However, due to the many comments on alignment

starting in 2015 and our plan to engage in additional more rounds of rulemaking, we are

removing discussion of actual alignment between the first payment year of an EP, eligible

hospital, or CAH and the Stage of meaningful use they will be expected to meet for all years

after 2014. Our policies for 2015 and subsequent years will be determined through future

rulemaking.

Comment: Several commenters requested that CMS base the payment adjustments on

Stage 1 of meaningful use regardless of the EP, eligible hospital, or CAH’s prior participation in

the incentive program.

Response: We thank commenters for the thoughtful comments received, and will take

their input into consideration when in future rulemaking when we consider whether to require

that EPs, eligible hospitals, and CAHs satisfy the stage 3 definition of meaningful use in order to

avoid reduced payments under Medicare for their professional services and inpatient hospital

services beginning 2015. We reiterate, however, that in this final rule we are only adopting

criteria that we expect will apply in 2011 and 2012. We have also outlined the expected

progression of stages of meaningful use criteria until 2014. However, we are not in this rule

finalizing regulations that address the meaningful use standards that apply in 2015 and thereafter.

Comment: Numerous commenters requested that we specifically propose objectives and

measures for Stage 2 and 3. We also received recommendations on what those objectives and, in

rare cases, measures should be. We discussed some of these objectives in the proposed rule and

discuss them again in this final rule in section II.d. Others are highly related to existing

objectives, while still others were not discussed in any way in the proposed rule. The suggested
CMS-0033-F 43

objectives and measures for Stages 2 and 3 include the following:

• Use of evidence-based order sets

• Electronic medication administration record (eMAR)

• Bedside medication administration support (barcode/RFID)

• Record nursing assessment in EHR

• Record nursing plan of care in EHR

• Record physician assessment in EHR

• Record physician notes in EHR

• Multimedia/Imaging integration

• Generate permissible discharge prescriptions electronically

• Contribute data to a PHR

• Record patient preferences (language, etc)

• Provide electronic access to patient-specific educational resources

• Asking patients about their experience of care

Response: With one exception discussed under the CPOE objective, we continue to

believe that finalizing specific objectives and measures for later stages is inappropriate. One of

the greatest benefits of the phased stage approach is the ability to consider the impact and lessons

of the prior stage when formulating a new stage. Many commenters supported our discussion of

later stages for this very reason. In addition, we do not believe it is appropriate to finalize

objectives for any stage of meaningful use that were not specifically discussed in the proposed

rule, as doing so would deprive the public the opportunity to comment on the objective in

question. Nevertheless, we thank commenters for the thoughtful comments received, and expect
CMS-0033-F 44

to take their input into consideration when in future rulemaking we consider additional or revised

criteria and measures to adopt for the stage 2 and stage 3 definitions of meaningful use.

Comment: A commenter indicated that attestation is an insufficient means to hold

providers accountable for the expenditure of public funds and to protect against fraud and abuse.

Response: We likewise are concerned with the potential fraud and abuse. However,

Congress for the HITECH Act specifically authorized submission of information as to

meaningful use through attestation. CMS is developing an audit strategy to ameliorate and

address the risk of fraud and abuse.

b. Common Definition of Meaningful Use under Medicare and Medicaid

Under sections 1848(o)(1)(A)(i), 1814(l)(3)(A), and 1886(n)(1) of the Act, an EP,

eligible hospital or CAH must be a meaningful EHR user for the relevant EHR reporting period

in order to qualify for the incentive payment for a payment year in the Medicare FFS EHR

incentive program. Sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act provide that an EP and

an eligible hospital shall be considered a meaningful EHR user for an EHR reporting period for a

payment year if they meet the following three requirements: (1) demonstrates use of certified

EHR technology in a meaningful manner; (2) demonstrates to the satisfaction of the Secretary

that certified EHR technology is connected in a manner that provides for the electronic exchange

of health information to improve the quality of health care such as promoting care coordination,

in accordance with all laws and standards applicable to the exchange of information; and (3)

using its certified EHR technology, submits to the Secretary, in a form and manner specified by

the Secretary, information on clinical quality measures and other measures specified by the

Secretary. The HITECH Act requires that to receive a Medicaid incentive payment in the initial

year of payment, an EP or eligible hospital may demonstrate that they have engaged in efforts to
CMS-0033-F 45

“adopt, implement, or upgrade certified EHR technology.” Details, including special timeframes,

on how we define and implement “adopt, implement, and upgrade” are in section II.D.7.b.2 of

this final rule. For subsequent payment years, or the first payment year if an EP or eligible

hospital chooses, section 1903(t)(6)(C)(i)(II) of the Act, prohibits receipt of an incentive

payment, unless “the Medicaid provider demonstrates meaningful use of certified EHR

technology through a means that is approved by the State and acceptable to the Secretary, and

that may be based upon the methodologies applied under section 1848(o) or 1886(n).” (Sections

1848(o) and 1886(n) of the Act refer to the Medicare EHR incentive programs for EPs and

eligible hospitals/CAHs respectively.) Under section 1903(t)(8) of the Act to the maximum

extent practicable, we are directed to avoid duplicative requirements from Federal and State

governments to demonstrate meaningful use of certified EHR technology. Provisions included at

section 1848(o)(1)(D)(iii) of the Act also contain a Congressional mandate to avoid duplicative

requirements for meaningful use, to the extent practicable. Finally, section 1903(t)(8) of the Act

allows the Secretary to deem satisfaction of the requirements for meaningful use of certified

EHR technology for a payment year under Medicare to qualify as meaningful use under

Medicaid.

We stated in the proposed rule that we believe that given the strong level of interaction on

meaningful use encouraged by the HITECH Act, there would need to be a compelling reason to

create separate definitions for Medicare and Medicaid. We declared in the proposed rule that we

had found no such reasons for disparate definitions in our internal or external discussions. To

the contrary, stakeholders have expressed strong preferences to link the Medicare and Medicaid

EHR incentive programs wherever possible. Hospitals are entitled to participate in both

programs, and we proposed to offer EPs an opportunity to switch between the Medicare and
CMS-0033-F 46

Medicaid EHR incentive programs. Therefore, we proposed to create a common definition of

meaningful use that would serve as the definition for EPs, eligible hospitals and CAHs

participating in the Medicare FFS and MA EHR incentive program, and the minimum standard

for EPs and eligible hospitals participating in the Medicaid EHR incentive program. We

clarified that under Medicaid this proposed common definition would be the minimum standard.

We proposed to allow States to add additional objectives to the definition of meaningful use or

modify how the existing objectives are measured; the Secretary would not accept any State

alternative that does not further promote the use of EHRs and healthcare quality or that would

require additional functionality beyond that of certified EHR technology. See section II.D.8. of

this final rule for further details.

For hospitals, we proposed to exercise the option granted under section 1903(t)(8) of the

Act and deem any Medicare eligible hospital or CAH who is a meaningful EHR user under the

Medicare EHR incentive program and is otherwise eligible for the Medicaid incentive payment

to be classified as a meaningful EHR user under the Medicaid EHR incentive program. This is

applicable only to eligible hospitals and CAHs, as EPs cannot simultaneously receive an

incentive payment under both Medicare and Medicaid.

We solicited comments as to whether there are compelling reasons to give the States

additional flexibility in creating disparate definitions beyond what was proposed. In addition, if

commenting in favor of such disparate definitions, we also asked interested parties to comment

on whether the proposal of deeming meeting the Medicare definition as sufficient for meeting the

Medicaid definition remains appropriate under the disparate definitions. This is applicable only

to hospitals eligible for both the Medicare and Medicaid incentive programs. Furthermore, if a

State has CMS-approved additional meaningful use requirements, hospitals deemed as

CMS-0033-F 47

meaningful users by Medicare would not have to meet the State-specific additional meaningful

use requirements in order to qualify for the Medicaid incentive payment.

Comment: Most commenters believe that States should not be allowed the option to add

to or change the meaningful use requirements for the Medicaid EHR incentive program. The

commenters’ main reason for standardizing the meaningful use requirements for both Medicare

and Medicaid is to eliminate administrative burden on both providers and EHR vendors to

accommodate programming and reporting using different technical specifications for the same or

similar measures.

Response: After consideration of the comments received, we are finalizing the

provisions regarding possible differences in the definition of meaningful use between Medicare

and Medicaid with the following revisions. We believe that over time the option to add to or

change the floor definition of meaningful use might represent an important policy tool for States

and therefore CMS plans to review and adjudicate these requests over the duration of the

program. For Stage 1 of meaningful use, we have revised the definition of meaningful use in

response to the many comments and are requiring an overall lower bar and an approach that is

more flexible. On the other hand, we wish to support the ability for States to reinforce their

public health priorities and goals based upon their existing public health infrastructure and

maturity. For that reason, we, for Stage 1, will only entertain States' requests to tailor the Stage 1

meaningful use definition as it pertains specifically to public health objectives and data registries.

For purposes of the Medicaid EHR incentive program during Stage 1 of meaningful use, these

are limited to:

Objective: Generate lists of patients by specific conditions to use for quality improvement,

reduction of disparities, research, or outreach.

CMS-0033-F 48

Measure: Generate at least one report listing patients of the EP or eligible hospital with a

specific condition.

Example: Generate lists of patients with the following conditions: depression, diabetes,

obesity, etc. This would not be for reporting to the State but to draw EPs’ or eligible

hospitals’ attention in order to better manage their patient population. States would also

be permitted to request CMS approval to include this in the core set for all EPs and/or

eligible hospitals.

Objective: Capability to submit electronic data to immunization registries of

Immunization Information Systems and actual submission in accordance with applicable

law and practice.

Measure: Performed at least one test of certified EHR technology's capacity to submit

electronic data to immunization registries and follow up submission if the test is

successful (unless none of the immunization registries to which the EP or eligible

hospital submits such information have the capacity to received the information

electronically).

Example: State could point to a specific immunization registry that supports standards-

based transmission of data and dictate how that information is transmitted. States would

also be permitted to request CMS approval to include this objective in the core list for all

EPs and eligible hospitals. The justification for this request in their State Medicaid HIT

Plan, should address any potential barriers for providers in achieving this objective.
CMS-0033-F 49

Objective: Capability to submit electronic data on reportable (as required by state or local law)

lab results to public health agencies and actual submission in accordance with applicable law and

practice.

Measure: Performed at least one test of certified EHR technology's capacity to submit electronic

data on reportable lab results to public health agencies and follow-up submission if the test is

successful (unless none of the public health agencies to which an eligible hospital submits such

information have the capacity to receive the information electronically).

Example: State could specify the standards-based means of transmission and/or the destination

of this data. States would also be permitted to request CMS approval to include this objective in

the core list for all and eligible hospitals. The justification for this request in their State

Medicaid HIT Plan, should address any potential barriers for providers in achieving this

objective.

Objective: Capability to submit electronic syndromic surveillance data to public health agencies

and actual transmission according to applicable law and practice.

Measure: Performed at least one test of certified EHR technology's capacity to submit electronic

syndromic surveillance data to public health agencies and follow-up submission if the test is

successful (unless none of the public health agencies to which an EP or eligible hospital submits

such information have the capacity to receive the information electronically).

Example: State could specify the standards-based means of transmission and/or the destination

of this data. States would also be permitted to request CMS approval to include this objective in

the core list for all EPs and eligible hospitals. The justification for this request in their State

Medicaid HIT Plan, should address any potential barriers for providers in achieving this

objective.
CMS-0033-F 50

We reiterate that we will not approve any requests that would require EHR functionality

above and beyond that included in the ONC EHR certification criteria as finalized for Stage 1 of

meaningful use.

Comment: Several commenters requested that CMS affirm the ability of States to require

additional meaningful use criteria for all eligible professionals and hospitals (pursuant to

§§495.316(a), 495.316(d)(2)), regardless of whether those entities were deemed eligible through

Medicare.

Response: Section 1903(t)(8) provides authority for the Secretary to “deem satisfaction

of requirements for . . . meaningful use for a payment year under title XVIII to be sufficient to

qualify as meaningful use under [1903(t)].” We continue to believe that allowing deeming

ensures that hospitals eligible for both programs are able to focus on only one set of measures,

without requiring duplication of effort or confusion regarding meaningful use standards. Thus,

hospitals eligible for both Medicare and Medicaid incentive payments will be deemed for

Medicaid if they have met the meaningful use definition through Medicare, even if a State has an

approved State-specific definition of meaningful use. States cannot withhold a Medicaid EHR

incentive payment from dually eligible hospitals if they have met all the eligibility criteria for

Medicaid, and have met the Medicare definition for meaningful use.

Because of this comment, we are revising section §495.4 of our regulations to indicate

that eligible hospitals who are meaningful users under the Medicare EHR incentive payment

program are deemed as meaningful users under the Medicaid EHR incentive payment program,

and need not meet additional criteria imposed by the State. While this is not a new requirement,

it was not previously listed in regulations.

CMS-0033-F 51

Comment: A commenter asked that CMS adopt and affirm the deeming approach in its

final rule and ensure that the regulatory language reflects this approach.

Response: We agree and have included in the final rule regulation language that

hospitals that are meaningful users under the Medicare EHR Incentive Program are deemed

meaningful users under the Medicaid EHR Program.

Comment: Several commenters requested that CMS not deem hospitals having met the

meaningful use requirements for the Medicare EHR Incentive Payment, as having fulfilled the

meaningful use requirements for the State’s Medicaid EHR Incentive Payment. The commenters

noted that if a State sought for acute care hospitals to participate in their statewide health

information exchange and yet those hospitals did not have to do so in order to qualify for both

the Medicare and Medicaid EHR Incentive Payments, then they would have no motivation to do

so. The commenters would like acute care hospitals eligible for both the Medicare and Medicaid

EHR Incentive Program to have to comply with any State-specific meaningful use requirements,

in addition to the Medicare floor definition.

Response: In consideration of the comments received, CMS adopts its proposed

preamble language about deeming hospitals and adds the corresponding regulation text. This is

necessary for Stage 1 of meaningful use in particular, where we believe it is crucial to prevent

additional burden on providers and foster eligible hospitals’ path to successful EHR adoption and

meaningful use. In addition, as already noted, for Stage 1, we will not entertain States’ requests

to alter the floor definition of meaningful use as codified in this final rule except for specific

public health objectives. That thereby reduces the possible differences between the Medicare

and Medicaid definitions of meaningful use. As part of Stage 2 of meaningful use, CMS might

consider States requests to tailor meaningful use as it pertains to health information exchange,
CMS-0033-F 52

for example. Further details about this policy option will be included in future rulemaking and

subject to public comment.

c. Stage 1 Criteria for Meaningful Use

In the proposed rule we proposed that to qualify as a meaningful EHR user for 2011, EPs,

eligible hospitals or CAHs must demonstrate that they meet all of the objectives and their

associated measures as set forth in proposed §495.6. We further proposed and finalize in this

final rule that except where otherwise indicated, each objective and its associated measure must

be satisfied by an individual EP as determined by unique National Provider Identifiers (NPIs)

and an individual hospital as determined by unique CMS certification numbers (CCN).

Discussion of whether an EP, eligible hospital or CAH must meet all Stage 1 Meaningful

Use Objectives and their Associated Measures

Comment: Commenters almost unanimously said that requiring an EP, eligible hospital

or CAH to meet all of the objectives and their associated measures in order to qualify as a

meaningful EHR user was too ambitious given the current state of EHR technology, adoption

levels, the timeline for certification of EHR technologies, the realities of implementing EHR

technology and the timeline proposed for Stage 1 of meaningful use in our proposed rule.

Most of the commenters suggested alternatives that they believed would support the

health care policy priorities of Stage 1. Several different alternatives were proposed. The first

alternative would be to require a specified percentage of the Stage 1 meaningful use objectives

and associated measures, with an EP, eligible hospital or CAH free to select which of the

objectives and associated measures it would satisfy. For example under our proposed objectives

and associated measures, if an EP were required to meet 20 percent, then an EP would be

considered a meaningful EHR user if he or she satisfied any five of the proposed twenty–five
CMS-0033-F 53

objectives and associated measures. Most commenters suggesting this alternative envisioned

that later stages of meaningful use would require that EPs, eligible hospitals, and CAHs satisfy a

higher of the percentage of the objectives and associated measures. For example if 20 percent of

the objectives and associated measures were required for Stage 1, then 50 percent might be

required in Stage 2.

After a fixed percentage, the suggestion next favored by commenters, including the HIT

Policy Committee and MedPAC, was to divide the meaningful use objectives into two

categories, a “core set” of objectives and “menu set” of objectives. To be a considered a

meaningful user under this approach, an EP, eligible hospital, or CAH would be required to

satisfy (1) all core set of objectives, and (2) a specified percentage of the menu set of objectives,

with the EP, eligible hospital, or CAH free to select which of the menu set of objectives it would

satisfy. For example, if five objectives were in the core set all EPs, eligible hospitals, and CAHs

would have to meet those objectives. If twenty objectives were in the menu set, then EPs,

eligible hospitals, and CAHs would not have to meet one or more of those objectives.

Commenters varied widely as to which objectives should be included in the core set of

objectives, as well as the percentage of menu set objectives an EP, eligible hospital, or CAH

must satisfy.

Some commenters suggested that we simply reduce the number of objectives required for

Stage 1 of meaningful use. Recommendations in this regard varied from reducing the required

objectives to only just a few (the lowest number being three), limiting the required objectives to

only to those objectives that affect health outcomes of individual patients, to targeted elimination

of a few objectives.

Finally, some commenters suggested that we eliminate all of the measures associated
CMS-0033-F 54

with the Stage 1 meaningful use objectives and only require that EPs, eligible hospitals, and

CAHs attest that they have attempted to meet each of the objectives.

Response: After reviewing the comments, we agree that requiring that EPs, eligible

hospitals, and CAHs satisfy all of the objectives and their associated measures in order to be

considered a meaningful EHR user would impose too great a burden and would result in an

unacceptably low number of EPs, eligible hospitals, and CAHs being able to qualify as

meaningful EHR users in the first two years of the program. In considering an alternative

approach, we have sought to develop an alternative that is responsive to some degree to all the

concerns raised by the commenters. We have tried to reduce the requirements both in number

required and in the thresholds of the associated measures and provide some flexibility as well.

At the same time, however, we must be mindful of the relevant statutory requirements. Sections

1848 (o)(2)(A) and 1886(n)(3) of the Act, specify three requirements for meaningful use: (1) use

of certified EHR technology in a meaningful manner (for example, electronic prescribing); (2)

that the certified EHR technology is connected in a manner that provides for the electronic

exchange of health information to improve the quality of care; and (3) that, in using certified

EHR technology, the provider submits to the Secretary information on clinical quality measures

and such other measures selected by the Secretary. We believe that each EP, eligible hospital,

and CAH must meet at least one objective within each of the three requirements for meaningful

use. We are concerned that if we were to give EPs, eligible hospitals, and CAHs full discretion

to select which meaningful use objectives they will satisfy, some providers would not choose one

or more objectives within each of the three statutory requirements for meaningful use.

Furthermore, we are concerned that affording EPs, eligible hospitals, and CAHs such flexibility

as to which meaningful use objectives to meet would delay many of the goals outlined for
CMS-0033-F 55

meaningful use in section II.a.2. of this final rule. If in choosing what objectives to defer, one

provider chooses to focus on improving processes to improve healthcare quality, another chooses

to focus on being able to exchange health information and yet another on engaging patients and

families it is possible that we would fail to accomplish any of these goals at a population level.

For these reasons, we do not believe it would be appropriate to afford providers the unlimited

flexibility to select which of the meaningful use objectives they will meet. Rather, as explained

below, we believe providers at a minimum should have to satisfy a core set of objectives in order

to qualify as meaningful EHR users.

Similarly, while we agree that merely reducing the number of objectives would make

meaningful use easier to achieve for most providers, we believe that this reduction does not

affords the same flexibility to all providers to account for their individual difficulties in meeting

meaningful use that some of the other alternatives do as allowing a provider to choose certain

objectives to defer. Due to any number of circumstances such as EHR adoption level,

availability of health information exchange network, size of practice or hospital, etc, an objective

that is easy for one EP to achieve might be very difficult for another EP. Under this alternative,

no allowance is made for those differences. Finally, we disagree that meaningful use should be

limited to improving the health outcomes of individual patients. There are significant gains that

meaningful use can achieve in the areas of public health, privacy and security, engagement of

patients and their families and efficiency of care that may not improve health outcomes, but have

significant other benefits such as engaging patients more fully in decisions affecting their health

and reducing costs through increased efficiency of care. We believe that all of these have a

significant impact on health outcome priorities. Therefore, we do not categorically reduce the

number of objectives for Stage 1 definition of meaningful use. We consider requests to defer an
CMS-0033-F 56

objective to later stages of the meaningful use criteria or eliminate a specific objective below in

our discussion of each objective.

Comment: Another alternative that was recommended by a significant number of

commenters was that we base the incentive payment amount on the number of stage 1

meaningful use objectives satisfied by an EP or eligible hospital, with those satisfying more

objectives eligible for a higher incentive payment amount. While some commenters varied in

the specifics or did not provide specifics, generally we take this to mean that if an EP, eligible

hospital, or CAH met half of the objectives then they would receive half of the incentive

payment they would have received had they met all the objectives.

Response: The HITECH Act does not give us the authority to award partial payments.

As discussed elsewhere in this final rule, sections 1848(o)(1)(A) of the Act specifies the payment

incentive amount to which an EP who is a meaningful EHR user is entitled. Similarly, section

1886(n)(2) of the Act sets forth a formula for calculation of incentive payment amount to which

an eligible hospital that is a meaningful EHR user is entitled. Similarly, section 1814(l)(3)(A) of

the Act sets forth a formula for calculation of incentive payment amount to which an eligible

hospital that is a meaningful EHR user is entitled. Similarly, section 1903(t)(4)(B) of the Act

sets parameters for determining the Medicaid EHR incentive for Medicaid EP. None of these

parameters are related to meaningful use. Similarly, section 1903(t)(5)(A) of the Act sets forth a

formula for calculation of the incentive payment amount to which a Medicaid eligible hospital is

entitled. As we do not have the authority to alter these statutory formulas for calculating the

incentive payment amounts under Medicare and Medicaid, we cannot pro rate the incentive

payment amount based on the number of meaningful use objectives satisfied by an EP, eligible

hospital, or CAH.
CMS-0033-F 57

After consideration of the public comments received, we are establishing a core set of

objectives with associated measures and a menu set of objectives with associated measures. In

order to qualify as a meaningful EHR user, an EP, eligible hospital, or CAH must successfully

meet the measure for each objective in the core set and all but five of the objectives in the menu

set. With one limitation, an EP, eligible hospital, or CAH may select any five objectives from

the menu set to be removed from consideration for the determination of qualifying as a

meaningful EHR user. Further discussion of the objectives, including additional details about

their inclusion in the core set, can be found at each objective.

We believe that establishing both a core and a menu set adds flexibility and allows the

minimum statutory set to be met. In determining the objectives to include in the core set, we

looked at all comments, especially those of the HIT Policy Committee and other commenters

who recommended some required and optional elements. The HITECH Act requires the use of

health information technology in improving the quality of health care, reducing medical errors,

reducing health disparities, increasing prevention and improving the continuity of care among

health care settings. In defining the core set of meaningful use objective, we believe the most

crucial aspect to consider is meeting the three statutory guidelines provided in the HITECH Act

and discussed in section II.A.2.a of this final rule. Second is to identify those objectives that are

most crucial to laying the foundation for obtaining value from meaningful use of certified EHR

technology. Third, we believe that meaningful use should be patient-centered so we focus on

getting the most value to the patient. We believe the recommendation of the HIT Policy

Committee accomplishes third criteria, but falls short of the first and second. To accomplish the

first criteria, we add the objective of submitting clinical quality measures to CMS or the States

and the objective of exchanging key clinical information among providers of care and patient
CMS-0033-F 58

authorized entities. To accomplish the second, we add several additional objectives to the core

set of measures as critical elements pertinent to the management of patients. We have received a

number of comments in support of these particular measures as critical to the management of

patients (maintaining an up-to-date problem list, active medication list, active allergy list,

smoking history and incorporate clinical lab tests into EHR as structured data) in comparison to

other requirements. The addition of two other functional objectives (drug-drug and drug-allergy

features) as core measures are for improved patient-safety. All of the listed elements are integral

to the initial or on-going management of a patient’s current or future healthcare. While each

element is important in the management of patients in and of itself, the aggregate of the elements

elevates the importance of clinical information to not only the primary provider but for all

members of the interdisciplinary team involved in the patient’s care. The HITECH Act

statutorily requires the use of health information technology in improving the quality of health

care, reducing medical errors, reducing health disparities, increasing prevention, and improving

the continuity of care among health care settings. These core set of measures are also

foundational and aligned with each other. For example, electronic copies of health information

given to patient will be useless if it does not contain basic information such as a problem list,

medication list or allergy list. Exchange of information to other members of the health care team

across settings will depend on having structured data of these elements. Therefore, in support of

the HITECH Act in meeting the statutory requirements, we have expanded the core set of

measures include these fundamental elements to improve patient care. Below we list the

objectives included in the core set of meaningful use objectives.

- Use CPOE

- Implement drug to drug and drug allergy interaction checks

CMS-0033-F 59

- E-Prescribing (EP only)

- Record demographics

- Maintain an up-to-date problem list

- Maintain active medication list

- Maintain active medication allergy list

- Record and chart changes in vital signs

- Record smoking status

- Implement one clinical decision support rule

- Report CQM as specified by the Secretary

- Electronically exchange key clinical information

- Provide patients with an electronic copy of their health information

- Provide patients with an electronic copy of their discharge instructions (Eligible

Hospital/CAH Only)

- Provide clinical summaries for patients for each office visit (EP Only)

- Protect electronic health information created or maintained by certified EHR

In addition, achieving Stage 1 meaningful use means demonstration of progress in each of the

five healthcare outcome priorities outlined in the proposed rule and discussed again later in this

section. Only one of these priorities is not represented in the core set, population and public

health. As we have discussed in this section we do not want any priority to be overlooked due to

the flexibility we have added to Stage 1 of meaningful use; therefore, all EPs and hospitals must

choose at least one of the population and public health measures to demonstrate as part of the

menu set. This is the only limitation placed on which five objectives can be deferred from the

menu set.
CMS-0033-F 60

Discussion on whether certain EP, eligible hospital or CAH can meet all Stage 1 meaningful

use objectives given established scopes of practice

In the proposed rule, we specifically encouraged comments on whether certain providers may

have difficulty meeting one or more of the objectives due to their provider type or chosen

specialties

Comment: We received many comments, both general and specific, that certain

providers or specialists may not be able to comply with certain objectives because they are

beyond the scope of their licensing authority or because they are outside the scope of their

standard of practice. For example, chiropractors do not have prescribing authority and thus may

not make use of an EHR technology’s e-prescribing function and rheumatologists may not

require information on vital signs. While comments on this potential non-applicability primarily

focused on EPs, we did receive comments that some objectives may not be relevant to smaller or

specialized eligible hospitals as well.

Response: We believe the division of the meaningful use objectives into a core set and a

menu set may minimize the impact of including among the meaningful use objectives one or

more objectives that certain providers or specialists may be unable to satisfy as the EP, eligible

hospital, or CAH can defer five objectives from the menu set. However, if the EP, eligible

hospital or CAH has an insurmountable barrier to meeting an objective in the core set or a

significant number in the menu set then the problem remains. For example, without any

consideration on an EP, eligible hospital or CAH’s capability to meet the measure associated

with a core objective any EP that could not order medications requiring a prescription would not

be able to become a meaningful EHR user as e-prescribing is a core set objective. Similarly, any

eligible hospital or CAH that did not have any requests for electronic copy of discharge
CMS-0033-F 61

instructions would not be able to become a meaningful EHR user. In addition, if this were to

occur for a significant number of menu set objectives, the flexibility for the EP, eligible hospital,

or CAH to use the five objectives to account for other concerns such as implementation struggles

or workflow process redesign would be curtailed. To account for this possibility, we have

modified each objective and measure to indicate when there is an option for an EP, eligible

hospital, or CAH to report that the objective/measure is inapplicable to them, because they have

no patients or no or insufficient number of actions that would allow calculation of the

meaningful use measure. This will allow an EP, eligible hospital, or CAH to qualify as a

meaningful EHR user without being required to meet objectives we have specified as potentially

inapplicable. We note that the exclusions to meaningful use objectives/measures are specific to

each objective/measure. In our discussion of each specific objective/measure (which occurs later

in this preamble), we have identified specific exclusions where they exist. Providers wishing to

claim that an objective/measure is inapplicable to them would need to meet the criteria of such

an exception.

After consideration of the public comments received, we have identified, for each

meaningful use objective, whether the EP, eligible hospital, or CAH may attest that they did not

have any patients or insufficient actions on which to base a measurement of a meaningful use for

the EHR reporting period. For objectives in the core set, such an attestation would remove the

objective from consideration when determining whether an EP, eligible hospital, or CAH is a

meaningful EHR user. In other words, the EP, eligible hospital, or CAH could satisfy the core

set objectives by satisfying all remaining objectives included in the core set. For objectives in

the menu set, such an attestation would also remove the objective from consideration when

determining whether an EP, eligible hospital, or CAH is a meaningful EHR user. For example, if
CMS-0033-F 62

for one objective included in the menu set an EP attests that he or she did not have any patients

or insufficient actions during the EHR reporting period on which to base a measurement of a

meaningful use objective, rather than satisfy 5 of the 10 meaningful use objectives included in

the menu set for EPs, the EP need only satisfy 4 of the 9 remaining meaningful use objectives

included in the menu set for EPs

EPs practicing in multiple practices

Another situation where flexibility may be needed in order for an EP to become a

meaningful EHR user is the situation where an EP may provide care in multiple practices or

multiple locations. We proposed a policy to account for EPs practicing in multiple practices and

settings. We discussed in the proposed rule that we believe it is unlikely for an EP to use one

record keeping system for one patient population and another system for another patient

population at one location. We are concerned about the application of the measures associated

with the meaningful use objectives for EPs who see patients in multiple practices or multiple

locations. If an EP does not have certified EHR technology available at each location/practice

where they see patients it could become impossible for the EP to successfully become a

meaningful EHR user based on the measures associated with the meaningful use objectives. We

do not seek to exclude EPs who meaningfully use certified EHR technology when it is available

because they also provide care in another practice where certified EHR technology is not

available. Therefore, we proposed that all measures be limited to actions taken at

practices/locations equipped with certified EHR technology. A practice is equipped if certified

EHR technology is available at the beginning of the EHR reporting period for a given geographic

location. Equipped does not mean the certified EHR technology is functioning on any given day

during the EHR reporting period. Allowances for downtime and other technical issues with
CMS-0033-F 63

certified EHR technology are made on an objective-by-objective basis as discussed later in this

section. We are concerned that seeing a patient without certified EHR technology available does

not advance the health care policy priorities of the definition of meaningful use. We are also

concerned about possible inequality of different EPs receiving the same incentive, but using

certified EHR technology for different proportions of their patient population. We believe that

an EP would have the greatest control of whether certified EHR technology is available in the

practice in which they see the greatest proportion of their patients. We proposed that to be a

meaningful EHR user an EP must have 50 percent or more of their patient encounters during the

EHR reporting period at a practice/location or practices/locations equipped with certified EHR

technology. An EP for who does not conduct 50 percent of their patient encounters in any one

practice/location would have to meet the 50 percent threshold through a combination of

practices/locations equipped with certified EHR technology. For example, if the EP practices at

both a Federally Qualified Health Center (FQHC) and within his or her individual practice, we

would include in our review both of these locations and certified EHR technology would have to

be available at the location where the EP has at least 50 percent of their patient encounters.

Comment: Some commenters recommended that 50 percent or more of the patient

encounters must occur at the practice location that receives the incentive payment.

Response: As discussed in section II.A.4 of this final rule, an EP may assign their

incentive payment to other practices. We do not believe that limiting practices and EPs to only

considering the location that receives an incentive payment provides advantages to the program.

The requirement suggested by commenters would potentially cause some EPs not to meet the

50 percent threshold even if through a combination of practices they may use certified EHR

technology for far more than 50 percent of their patient encounters.

CMS-0033-F 64

Comment: Some commenters requested clarification of our proposed statement

“Therefore, we proposed that all measures be limited to actions taken at practices/locations

equipped with certified EHR technology”

Response: We mean this statement to be that as long as an EP has certified EHR

technology available for 50 percent or more of their patient encounters during the EHR reporting

period they only have to include those encounters where certified EHR technology is available at

the start of the EHR reporting period. We discuss the measures later in this section of the final

rule, but an illustrative example would be the objective of maintain an up-to-date problem list.

The measure associated with this objective is “More than 80% of all unique patients seen by the

EP or admitted to the eligible hospital’s or CAH’s inpatient or emergency department (POS 21

or 23) have at least one entry or an indication that no problems are known for the patient

recorded as structured data.” Therefore, if an EP only practices at one location or has certified

EHR technology available at all practice locations then the denominator would be all unique

patients seen during the EHR reporting period. However, if an EP practices at multiple locations

and only has certified EHR technology for 80 percent of their patient encounters, then the

denominator is only those unique patients seen at locations where certified EHR technology is

available. We reiterate that this is not to account for certified EHR technology downtime,

Certified EHR technology is available at a location if it is available at the start of the EHR

reporting period regardless of its actual availability for any given day during the EHR reporting

period.

After consideration of the comments received, we are finalizing this requirement as

proposed.
CMS-0033-F 65

Discussion of the Burden Created by the Measures associated with the Stage 1 Meaningful

Use Objectives

Comment: Many commenters expressed concerns about the difficulties of capturing the

denominators for the measures that are expressed as percentages. They pointed out that the

formulas in the proposed rule would require providers to conduct labor-intensive counts of paper

documents such as prescriptions or laboratory results in order to compute the denominators of

the percentage based measures. Some commenters suggested that we adopt alternative

measurement mechanisms, for example establishing simple counts of electronic occurrences,

while others proposed that denominators be computed utilizing only data collected in the

certified EHR technology.

Response: We acknowledge that the percentage-based measures, as expressed in the

proposed rule, would create a reporting burden for EPs, eligible hospitals, and CAHs, and we

examined a number of alternatives that potentially reduce the burden of reporting.

In the proposed rule, we discussed the option of counts instead of percentages and due to

comments received have reassessed this option in the final rule. This approach clearly has the

advantage of simplifying the process. For example, rather than counting the number of

prescriptions transmitted electronically and then dividing by the total number of prescriptions,

the EP would simply need to count the number of electronically transmitted prescriptions until a

benchmark number is passed. If the benchmark number is exceeded, then the provider meets the

measure. However, there are several shortcomings to this approach. First, we received little

input from commenters as to where the benchmark numbers for the various objectives should be

set and any benchmark set now would not benefit from public comment without significantly

delaying the Medicare and Medicaid EHR incentive programs. (One exception was that a
CMS-0033-F 66

number of commenters suggested using the PQRI measure for e-prescribing, which is the

generation of at least one eRx associated with a patient visit on 25 or more unique events during

the reporting period.) Setting the limit too high would disadvantage small providers, since they

would have smaller patient populations, while setting the limit too low would create

requirements for larger providers that would be so limited as to be meaningless. A larger

provider could implement the functionality for a much shorter period than the EHR reporting

period and meet the count. In either case, it would be difficult to establish a trajectory in later

stages that would result in meaningful progress being made by both small and large providers.

We then assessed the option of limiting the occurrences counted in the denominator to

those included in the provider’s certified EHR technology. As an example, if an EP captures

1,000 prescriptions as structured data in certified EHR technology, and electronically transmits

500 of these prescriptions, the EP’s certified EHR technology generated score would be

50 percent. This approach does simplify the computation process, since this approach does not

have to take into account whether some prescriptions were not included or included as

unstructured data in the certified EHR technology. However, it does not demonstrate the extent

to which the provider has used the certified EHR technology. For example, a provider that has

captured only 10 prescriptions in the certified EHR technology as structured data, but writes

1,000 prescriptions because the provider achieved only a limited use of their certified EHR

technology would also score 50 percent by electronically transmitting only 5 prescriptions

according to an automatic report from the certified EHR technology. Again, this methodology

does not lead providers toward an upward trajectory of both certified EHR technology

deployment and accomplishment of meaningful use.

We selected a third option, which we believe addresses the shortcomings of the second
CMS-0033-F 67

option while still preserving much of the simplicity of that approach. In our approach, we focus

on those measures whose denominator is not based on all patients, but rather a subset of patients

or actions such as the ordering of a lab test or the recording of a patient’s request for an

electronic copy of their discharge instructions. We believe that it is reasonable to require an EP,

eligible hospital, or CAH to know how many unique patients they care for in the EHR reporting

period and therefore maintain that denominator where it applies. The maintenance of measures

using the patient as the denominator as encompassing all patients ensures a certain level of

utilization of certified EHR technology by the EP, eligible hospital, or CAH. If a measure

encompassing all patients has a threshold of 80 percent, then at least 80 percent of the patients’

records must be maintained using certified EHR technology otherwise the EP, eligible hospital or

CAH could not possibly meet the threshold. We note a number of measures included in the core

set (such as “Record Demographics” and “Maintain an Up-to-Date Problem List”) require an

analysis of all unique patients, and not just patients whose records are maintained in certified

EHR technology As discussed later the thresholds for maintaining an up-to-date problem list,

medication list and medication allergy list are set at 80 percent. We believe these thresholds will

create a baseline that ensures that EPs, eligible hospitals and CAHS are maintain a minimum

percentage of patient records in certified EHR technology, and allows the provider community to

advance toward the longer-term objective of capturing all patient data in certified EHR

technology. For those measures that focus on the recording of actions or subset of patients to

generate the denominator, we limit the measures to the information for patients whose records

are maintained in certified EHR technology. We offer the following examples that relate to the

e-prescribing and the provision of electronic copy of a patient’s health information:

E-Prescribing Example: An EP orders 1,000 prescriptions for patients whose records are
CMS-0033-F 68

maintained in their certified EHR technology and 500 of those are transmitted electronically.

The EP’s denominator is 1,000 prescriptions, the numerator is 500 prescriptions, and their score

is 50 percent. If the EP captures all 1,000 prescriptions as structured data the calculation could

be automated by the certified EHR technology. If the EP does not capture all 1,000 prescriptions

as structured data than more manual review may be required. We would define “records

maintained in the certified EHR technology” to include any patient for which sufficient data was

entered in the certified EHR technology to allow the record to be saved, and not rejected due to

incomplete data. This may be a more limited set of data, but an EP, eligible hospital, or CAH

would still have to have sufficient information in certified EHR technology to meet the measures

associated with Stage 1 of meaningful use. For example, an EP might be able to save a record

with just a patient’s name, but as the record would lack any information this patient would count

in the denominator, but not the numerator for many objectives. Electronic Copy of a Patient’s

Health Information Provided upon Request Example: An EP maintains 1,000 patient records in

their certified EHR technology. Of those patients, fifty make requests for electronic copies of

their health information. The EP provides all of the electronic copies within three business days.

The denominator is 50, the numerator is 50, and the EP’s percentage is 100 percent. If the EP

captures requests for information as structured data, the calculation could be automated by the

certified EHR technology. If the EP does not capture all the requests as structured data then more

manual review may be required. We will likely revisit the methodology in Stage 2, where we

would expect that at least basic EHR functionality has been implemented throughout the

provider enterprise.

After consideration of public comments, we are limiting the following objectives and

their associated measures to patients whose records are maintained using certified EHR
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technology. Specific information on how to determine inclusion in the denominator and

numerator is discussed in the full discussion of each objective later in this final rule.

• Use CPOE

• Generate and transmit permissible prescriptions electronically (eRx)

• Record and chart changes in vital signs

• Record smoking status for patients 13 years old or older

• Record advance directives for patients 65 years old or older

• Incorporate clinical lab-test results into certified EHR technology as structured data

• Provide patients with an electronic copy of their health information (including diagnostic

test results, problem list, medication lists, medication allergies), upon request

• Provide patients with an electronic copy of their discharge instructions at time of

discharge, upon request

• Provide clinical summaries for patients for each office visit

• Send reminders to patients per patient preference for preventive/follow-up care

• Perform medication reconciliation at relevant encounters and each transition of care

• Provide summary care record for each transition of care and referral

Discussion on Meaningful Use Relationship to Certified EHR Technology

Comment: We received several comments requesting more specific information of how

certified EHR technology will accomplish meaningful use. Some commenters expressed

concern that patient clinical outcome measurement and improvement was not addressed

explicitly in the requirements of certified EHR technology, but rather the requirements focused

data entry and provision of data electronically.

CMS-0033-F 70

Response: One of the main purposes of certifying EHR technology is to provide the EP,

eligible hospital, or CAH with confidence that the technology will not be the limiting factor in

the achievement of meaningful use. As such, all questions of how or will certified EHR

technology be able to accomplish meaningful use broadly or at a specific objective level are best

answered by ONC. CMS and ONC have worked closely since the enactment of the HITECH Act

to ensure certification fully supports meaningful use. We explicitly link each meaningful use

objective to certification criteria for certified EHR technology. The capabilities and standards

that are certified are those that are used to meet the Stage 1 objectives of meaningful use. This

way we ensure that certified EHR technology can accomplish meaningful use and meaningful

use has the intended consequences of improving the healthcare priorities that make up

meaningful use.

Discussion on the Relationship between a Stage 1 Meaningful Use Objective and its

Associated Measure

Comment: Many commenters pointed out gaps between what they believed were the

anticipated results from an objective and the results that are measured by the associated measure.

A particular concern of some of these commenters is cases where the certification criteria

supports the measure, but in their view fell short of supporting the objective.

Response: In the proposed rule, we attempted to draw a clear distinction between the

objective and the associated measure. The objectives represent a wide range of activities some of

which are commonplace for EPs, eligible hospitals, and CAHs using EHRs today, while others

are ambitious goals even for the most sophisticated EHR user of today. For some objectives, all

aspects of the objective are within the control of the EP, eligible hospital, or CAH. Other

objectives rely on electronic exchange with partners or external infrastructure over which EPs,
CMS-0033-F 71

eligible hospitals and CAHs may have little influence and no control. We have attempted to

accommodate these differences when we select the Stage 1 measure for a given objective. The

measure more accurately reflects our view of what is feasible for Stage 1 than the objective

itself. The certification criteria necessarily reflect more on the measure than the objective, as full

compliance with an objective is beyond the scope of what can be accomplished for a significant

number of EPs, eligible hospitals or CAHs in our timeframe for Stage 1. This rationale was our

assertion in the proposed rule as the justification for measures that represent less than full

achievement of their objective. This is further supported by some of the comments received

although for any given objective the comments addressing that objective were a small fraction of

the total number of comments received and views on how much a measure should allow for less

than full achievement varied widely among those commenting. Although we received over

2,000 public comments, the number of specific comments addressing an individual objective

were relatively small ranging from 40 to 200. We reviewed those comments and made specific

changes to measures in the discussion of each objective. We reiterate that achievement of the

measure always equates to achievement of the objective for Stage 1 of meaningful use. We also

reiterate that certified EHR technology will always be able to support achievement of the

measure by including the necessary functionalities. However, as with any technology, certified

EHR technology is only as good as the information it contains and getting information into

certified EHR technology is heavily dependent on processes developed by the EP, eligible

hospital, or CAH. It is for this reason that all measures, even those for objective whose aspects

are fully under the control of the EP, eligible hospital, or CAH, represent less than full

fulfillment of the objective to varying degrees. As stated, for demonstrating meaningful use and

any follow up review by CMS or the States, successfully meeting the associated measure always
CMS-0033-F 72

equates to successfully meeting the objective. Updated information on the associated measures

including the numerator, denominator, thresholds and exclusions are as discussed in the

following section. More detailed specifications and guidance on calculating the measures will be

issued soon after the publication of this final rule.

As we described in the proposed rule, in discussing the objectives that constitute the

Stage 1 criteria of meaningful use, we adopted a structure derived from recommendations of the

HIT Policy Committee of grouping the objectives under care goals, which are in turn grouped

under health outcomes policy priorities. We believe this structural grouping provides context to

the individual objectives; however, the grouping is not itself an aspect of meaningful use. The

criteria for meaningful use are based on the objectives and their associated measures.

We will now review the comments for each objective and measure and make changes to

our original proposal or finalize as proposed.

(1) Objectives and Their Associated Measures

The HIT Policy Committee identified as its first health outcomes policy priority

improving quality, safety, efficiency and reducing health disparities. The HIT Policy Committee

also identified the following care goals to address this priority:

● Provide access to comprehensive patient health data for patient's healthcare team

● Use evidence-based order sets and CPOE.

● Apply clinical decision support at the point of care.

● Generate lists of patients who need care and use them to reach out to those patients.

● Report information for quality improvement and public reporting

As we explained in the proposed rule, for the last care goal, the HIT Policy Committee proposed

the goal as “Report to patient registries for quality improvement, public reporting, etc.” We have
CMS-0033-F 73

modified this care goal, because we believe that patient registries are too narrow a reporting

requirement to accomplish the goals of quality improvement and public reporting. We note that

the HIT Policy Committee's recommended objectives include the reporting of quality measures

to CMS. We do not believe that CMS would normally be considered a “patient registry”. We

also removed the phrase “etc.” We believe that the level of ambiguity created by “etc” is not

appropriate for Federal regulations.

NPRM EP Objective: Use CPOE

NPRM Eligible Hospital Objective: Use CPOE for orders (any type) directly entered by the

authorizing provider (for example, MD, DO, RN, PA, NP).

In the proposed rule, we described CPOE as entailing the provider's use of computer

assistance to directly enter medical orders (for example, medications, consultations with other

providers, laboratory services, imaging studies, and other auxiliary services) from a computer or

mobile device. The order is also documented or captured in a digital, structured, and computable

format for use in improving safety and organization. We said that for Stage 1 criteria, it will not

include the electronic transmittal of that order to the pharmacy, laboratory, or diagnostic imaging

center.

Comment: A majority of commenters recommended that EPs, eligible hospitals, and

CAHs be allowed to defer CPOE for varying lengths of time ranging from 2012 to 2017. The

commenters cited various reasons for deferment including that CPOE is an advanced clinical

function that typically is the last process to be implemented due to the need to build the entire

infrastructure to support the CPOE process. Other commenters noted an increased burden as if

the orders cannot be transmitted, then duplicate paper orders will have to be produced which can

lead to patient safety risks. Commenters also noted that CPOE appears in the latter stages of the
CMS-0033-F 74

Certification Commission for Healthcare Information Technology (CCHIT) EHR

implementation process. A minority, but significant number of comments encouraged CMS to

maintain CPOE for 2011. Those commenters in favor of retaining CPOE in 2011 believed that

CPOE is a basic EHR feature that should be a standard offering of a certified EHR technology

and is critical to improving quality of care through audit trails and alerting of delinquent order

and/or delinquent deferred orders.

Response: We have determined that CPOE should be included in the core set of

measures for Stage 1 in order to advance meaningful use. CPOE is a foundational element to

many of the other objectives of meaningful use including exchange of information and clinical

decision support. Many commenters, including several physician associations, the HIT Policy

Committee and members of Congress through their endorsement of the HIT Policy Committee’s

recommendation, recommended that CPOE be required in Stage 1. CPOE has been a major

initiative of US hospitals for over a decade and is a foundational functionality to many of the

activities that further the health care policy priorities of meaningful use. For example, entering a

medication order using CPOE allows the EHR to provide feedback on whether the medication

may have adverse reactions with other medications the patient is taking. Another benefit of

CPOE is that greatly simplifies the workflow process of inputting information into certified EHR

technology in a structured way to populate the patient record.

Comment: Several commenters asked that we further specify who could enter the order

using CPOE. Some commenters stated that only the ordering provider should be permitted to

enter the order. These commenters stated that the ordering professional needs to be presented

with clinical decision support at the time of entry and that the relay of an order to another

individual is a source of potential error. Other commenters recommended that any licensed
CMS-0033-F 75

healthcare professional or indeed any individual (licensed or not) who receives the order from

the ordering provider be permitted to perform the CPOE. The most common argument presented

by these commenters is that this is currently how CPOE is handled in practice and a shift to entry

by only the ordering provider would be too disruptive to workflow.

Response: We agree with those commenters who recommend allowing any licensed

healthcare professional to enter orders using CPOE. We further refine this recommendation to

be that any licensed healthcare professional can enter orders into the medical record per state,

local and professional guidelines. While we understand that this policy may decrease

opportunities for clinical decision support and adverse interaction, we believe it balances the

potential workflow implications of requiring the ordering provider to enter every order directly,

especially in the hospital setting. We disagree with commenters that anyone should be allowed

to enter orders using CPOE. This potentially removes the possibility of clinical decision support

and advance interaction alerts being presented to someone with clinical judgment, which negates

many of the benefits of CPOE.

Comment: We received requests for clarification of this objective and what types of

orders would meet this requirement.

Response: Our intent in the proposed rule was to capture orders for medications,

laboratory or diagnostic imaging.

However, after careful consideration of the comments, we are adopting an incremental

approach by only requiring medication orders for Stage 1. First, this supports the objectives of e-

prescribing, drug-drug and drug-allergy checks. Second, this requirement will improve patient-

safety because of the alignment of ordering medications in a structured data format will enable

providers to create registries of patients for potential medical recalls, participate in surveillance
CMS-0033-F 76

for potential sentinel events and life-threatening side effects of new medications. Third, other

measures involving transitions of care documents and summary of care document will require

the entry of an active medication list. After consideration of the public comments received, we

are finalizing the meaningful use objective for EPs at 495.6(d)(1)(i) and for eligible hospitals,

and CAHs at 495.6(f)(1)(i) as “Use CPOE for medication orders directly entered by any licensed

healthcare professional who can enter orders into the medical record per state, local and

professional guidelines”.

NPRM EP Measure: CPOE is used for at least 80 percent of all orders

NPRM Eligible Hospital or CAH Measure: For eligible hospitals, CPOE is used for 10

percent of all orders

In the proposed rule under CPOE, we discussed several concepts related to any associated

measure of any objective that relies on a percentage calculation. These are the use of a

percentage versus a count; setting a threshold for measures not requiring the electronic exchange

of information; EPs practicing in multiple locations, some of which may not have certified EHR

technology available, and the patient population to which the measure would apply. All except

the last of these received extensive comments and are addressed in comment and response

sections earlier in this section. In the proposed rule, we said that we would base the measures

associated with the objectives on both the Medicare/Medicaid patient population and all other

patients as well. We said that we believe it is unlikely that an EP would use one record keeping

system for one patient population and another system for another patient population at one

location and that requiring reporting differences based on payers would actually increase the

burden of meeting meaningful use. We received very few comments on this aspect of our

proposed rule and those that were received were generally supportive of this proposal.
CMS-0033-F 77

Therefore, we are finalizing the policy that all meaningful use measures be calculated based on

the eligible provider’s entire patient population (except where otherwise noted).

Comment: Nearly every commenter who commented on CPOE objected to our proposal

to limit this measure to the inpatient department (Place of Service Code 21) for the eligible

hospital or CAH. Commenters stated that this limitation was inappropriate given the manner in

which hospitals use EHR technology. To account for current practice, the commenters

recommended the measures be expanded to include the emergency department (ED) (POS 23).

Other reasons cited by commenters were that orders begin in the ED and remain open as the

patient transitions to inpatient (for example, infusions), transitioning from paper documentation

in the ED to electronic for subsequent care is unsafe as it can result in missed information, and/or

transcription errors as the initial allergies and medications are entered into the system, significant

data collection occurs in the ED that would not be included in the system, the exclusion of the

ED creates disincentives to adoption and that the ED is a hybrid of temporal and functional

services that are neither purely ambulatory nor inpatient.

Response: We agree with the commenters, and therefore are expanding this objective

and its associated measure to the emergency room (POS 23). More information on place of

service codes is available at http://www.cms.gov/PlaceofServiceCodes/. Furthermore, given the

revision to the HITECH Act that changed hospital based eligible professionals to include only

the setting of inpatient and emergency departments and all of the benefits of integration of these

two departments spelled out by commenters we will adopt both departments when considering

the measure of eligible hospitals or CAHs unless we find there are unique circumstances of a

objective and its associated measure that would preclude the inclusion of the emergency

department for meaningful use. This change does not affect the incentive payment calculation
CMS-0033-F 78

described in section II.B. of this final rule

Comment: We received several recommendations from commenters that the requirement

of a percentage measurement for determining whether an EP, eligible hospital or CAH meets this

objective should be replaced with a numerical count for CPOE and many other measures

associated with percentage thresholds. The two main reasons given for switching to numerical

counts are the burden of calculating the percentage if it cannot be done automatically using

certified EHR technology and the assertion that if an EP, eligible hospital, or CAH does

something a specific number of times it can be assumed that it is done often enough to constitute

meeting the objective for Stage 1 of meaningful use.

Response: We have previously discussed the merits of a percentage based measure over

a count based measure earlier in this section under the discussion of the burden created by the

measures associated with the Stage 1 meaningful use objectives. However, we do try to seek a

balance reducing the burden on providers while still ensuring the progression of meaningful use

of certified EHR technology. In the next comment/response, we discuss changes to this measure

that respond to concerns regarding burden.

Comment: Many commenters representing EPs as well as other commenters

recommended lowering the CPOE threshold for EPs. Those commenters representing EPs

generally recommended parity with eligible hospitals at 10 percent, while other commenters

recommending a reduction generally recommended 50 percent.

Response: With CPOE, we had a unique situation of disparate thresholds between EPs

and hospitals. This was due to recommendations prior to the proposed rule by the HIT Policy

Committee. Eligible hospitals were granted an even lower threshold for this particular

requirement. The reason given for this recommendation was that CPOE is one of the last
CMS-0033-F 79

functionalities to be implemented in the hospital setting. Commenters point out that holds true

for EPs as well. As discussed above, given the limitations we are placing on the numerator and

denominator for calculating the CPOE percentage, we e no longer see a compelling reason to

maintain disparate thresholds for the EPs and the eligible hospital/CAH.

Comment: Commenters have suggested that our proposal to count an action per unique

patients could be applied to the measure for CPOE as well through a revised measure of “[a]t

least 10% of unique patients seen by the EP or admitted to the eligible hospital or CAH have at

least one order entered using CPOE.” Commenters also pointed to CPOE as an example of a

case where adequate lead time is necessary to implement certified EHR technology.

Response: At the heart of this new basis for this measure is the assumption that every

patient would have at least one order that could be entered using CPOE. We believe this is a

reasonable assumption for EPs, eligible hospitals and CAHs. According to analysis of 25,665

office-based visits in the 2005 National Ambulatory Medical Care Survey, 31 percent of visits

included a new medication order, and 44 percent included at least one refill; 66 percent had any

type of medication order. However, whether a medication order is appropriate for every practice

could vary significantly by scope of practice; therefore, for the final rule, we are further limiting

the denominator to patients with at least one medication listed in their medication list. We

believe that this limitation will reduce providers’ burden as compared to accounting for all

orders. To further reduce the burden on providers, we also will limit the numerator to unique

patients with at least one medication order entered using CPOE. Because we have reduced

provider burden by limiting the denominator and numerator as discussed above, we believe that a

corresponding increase in the CPOE threshold is appropriate for hospitals and CAHs. For stage

1, we are finalizing a threshold for CPOE of 30 percent for EPs, eligible hospitals, and CAHS.
CMS-0033-F 80

We believe this relatively low threshold, in combination with the limitation to only medication

orders, will allow hospitals and EPs to gain experience with CPOE. However, as providers gain

greater experience with CPOE, we believe it is reasonable to expect greater use of the function.

As explained above, we also believe CPOE is foundational to many other objectives of

meaningful use. For these reasons, we believe it is reasonable to expect providers to move to a

60 percent threshold at Stage 2 of meaningful use. Thus, for this measure, we are finalizing, for

Stage 2 of meaningful use, that EPs, eligible hospitals and CAHs must meet a 60 percent

threshold for CPOE. Therefore, we are finalizing a Stage 2 measure for CPOE at §495.6(h) for

EPs and §495.6(i) for eligible hospitals and CAHs as “More than 60 percent of all unique

patients with at least one medication in their medication list seen by the EP or admitted to the

eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) during the EHR

reporting period have at least medication one order entered using CPOE”.

Comment: We received several comments asking for clarification of the term unique

patient in response to various objectives.

Response: In the proposed rule, we state, “the reason we propose to base the measure on

unique patients as opposed to every patient encounter, is that a problem list would not

necessarily have to be updated at every visit.” To further describe the concept of “unique

patient” we mean that if a patient is seen by an EP or admitted to an eligible hospital’s or CAH’s

inpatient or emergency department (POS 21 or 23) more than once during the EHR reporting

period then for purposes of measurement they only count once in the denominator for the

measure. All the measures relying on the term “unique patient” relate to what is contained in the

patient’s medical record. Not all of this information will need to be updated or even be needed by

the provider at every patient encounter. This is especially true for patients whose encounter
CMS-0033-F 81

frequency is such that they would see the same provider multiple times in the same EHR

reporting period. Measuring by every patient encounter places an undue burden on the EPs,

eligible hospitals and CAHs and may have unintended consequences of affecting the provision of

care to patients merely to comply with meaningful use. Given the emphasis placed on the

reporting burden by commenters as described in the beginning of this section, we believe that our

concerns about the burden of measurement were well founded. We also continue to believe that

the use of patient encounters could have unintended consequences on the provision of care by

providers.

Comment: Some commenters asked whether the CPOE objective and associated measure

require transmission of the order. Most of these commenters were opposed to such transmission

in Stage 1 for various reasons such as the cost of developing interfaces between EHRs and

laboratory and radiology service providers, the volume of transmissions would outpace the

capacity to connect, HIE infrastructure is not yet mature enough and the lack of the requirement

for non-eligible entities to participate (for example, laboratory vendors, pharmacies). Some

commenters supported the inclusion of the transmission of the order as they believed this would

provide better outcomes than if the transmission was not required.

Response: In the proposed rule, we stated, “For Stage 1 criteria, we propose that it will

not include the electronic transmittal of that order to the pharmacy, laboratory, or diagnostic

imaging center.” While a few commenters recommended that this objective be changed to

require transmission, given the large opposition to the objective and measure as proposed and

the reasons commenters presented against transmission, it would not be responsive to the vast

majority of commenters to expand this objective beyond our proposal. We agree with the

commenters that said the HIE infrastructure is still being developed in most parts of the country.
CMS-0033-F 82

Furthermore, we note that in the hospital setting, most medication orders would not require

transmission outside of the certified EHR technology of the hospital. For EPs, we already

address transmission of the medication order in a separate objective for e-prescribing.

Therefore, we finalize the proposal that the transmission of the order is not included in the

objective or the associated measure for Stage 1.

After consideration of the public comments received, we are modifying the meaningful

use measure for EPs at 495.6(d)(1)(ii) of our regulations and for eligible hospitals, and CAHs at

§495.6(f)(1)(ii) of our regulations to “More than 30 percent of all unique patients with at least

one medication in their medication list seen by the EP or admitted to the eligible hospital’s or

CAH’s inpatient or emergency department (POS 21 or 23) during the EHR reporting period have

at least medication one order entered using CPOE”.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.304(a) for EPs and 45 CF170.306(a) for eligible hospitals and CAHs.

The ability to calculate the measure is included in certified EHR technology. Thus, for example,

an EP, eligible hospital or CAH must use a certified functionality in entering the medication

order, and could not use a functionality that has been added by the EHR vendor, but that is

outside the scope of the certification. We believe this rule is necessary to ensure that the EP,

eligible hospital, or CAH is actually making meaningful use of “certified” EHR technology, and

is not using non-certified technology. In addition, requiring providers to use functionalities that

are certified will ensure the interoperability of information maintained in the EHR as providers

will be able to operate according to consistent standards. We believe this standardization and

consistency is key to realizing the goal of using EHR technology to improve health care.
CMS-0033-F 83

As noted previously in this section under our discussion of the burden created by the

measures associated with the Stage 1 meaningful use objectives, the only patients that are

included in the denominator are those patients whose records are maintained using certified EHR

technology.

To calculate the percentage, CMS and ONC have worked together to define the following for

this objective:

• Denominator: Number of unique patients with at least one medication in their medication

list seen by the EP or admitted to an eligible hospital’s or CAH’s inpatient or emergency

department (POS 21 or 23) during the EHR reporting period

• Numerator: The number of patients in the denominator that have at least one medication

order entered using CPOE.

• Threshold: The resulting percentage must be more than 30 percent in order for an EP,

eligible hospital or CAH to meet this measure.

Exclusion: If an EP’s writes fewer than one hundred prescriptions during the EHR reporting

period they would be excluded from this requirement as described previously in this section in

our discussion whether certain EP, eligible hospital or CAH can meet all Stage 1 meaningful use

objectives given established scopes of practices. We do not believe that any eligible hospital or

CAH would have less than one hundred prescriptions written for patients admitted to their

inpatient and emergency departments during the EHR reporting period.

NPRM EP/Eligible Hospital Objective: Implement drug-drug, drug-allergy, drug-formulary

checks

In the proposed rule, we did not elaborate on this objective.

CMS-0033-F 84

Comment: Many commenters requested clarification as to what formulary the checks

would be conducted against.

Response: Ideally, this check would be performed against any formulary that may affect

the patient’s welfare, inform the provider as to the best drug to prescribe or provide the patient

and provider information on the drug’s cost to both the patient and any third party payer. We

recognize, however, that not every available third party payer, pharmacy benefit management,

preferred drug list is standardized and made available for query through certified EHR

technology. As we cannot through this regulation impose such a requirement on every developer

of a formulary, we do not require that an EP/eligible hospital/CAH would have to accommodate

every formulary in their implementation. However, at a minimum an EP/eligible hospital/CAH

must have at least one formulary that can be queried. This may be an internally developed

formulary or an external formulary. The formularies should be relevant for patient care during

the prescribing process. To further address this, we expect that this measure will be expanded to

be counted on a transactional basis for future stages.

Comment: Commenters suggested separating the objective into one objective for the

clinical checks (drug-drug and drug-allergy) and a second objective for the administrative check

(drug-formulary). The rationale stated for the division was that clinical measures are focused on

preventing medication errors versus encouraging consideration of cost when prescribing

medications. In addition, the two types involve connections to different kinds of resources (drug

safety information versus formulary information).

Response: We agree that these should be separate objectives for the reasons stated by the

commenters and split them accordingly.

CMS-0033-F 85

Comment: We received comments that these functions were really part of CPOE and

electronic prescribing. Commenters most commonly noted that the drug formulary is part of

electronic prescribing, as is currently the case under the Medicare e-Prescribing program.

Response: While we agree that the drug-drug, drug-allergy, drug-formulary checks,

CPOE, e-prescribing meaningful use objectives all serve the same broader goal of ensuring

accurate ordering and prescribing that takes into account all available information about the

patient the functions and their readiness for Stage 1 of meaningful use are distinct. In terms of

functions, CPOE and e-prescribing could be performed without the drug to drug, drug-allergy or

drug formulary checks. Similarly, it is not necessary for CPOE or e-Prescribing to take place in

order for a drug to drug allergy check to occur. In terms of readiness and ability to measure

progress for Stage 1 of meaningful use, CPOE and e-prescribing both are percentage based

measures of a distinct activity that creates a record even in today’s EHR’s and paper patient

records. The viewing and consideration of information presented to the provider on possible

drug interactions is not a similarly distinct activity and does not currently create a record. So

while the goal of these functionalities is similar, we believe drug-drug, drug-allergy, drug-

formulary checks create unique concerns for implementation and demonstration of meaningful

use, and therefore we maintain them as separate objectives.

Comments: Several commenters expressed concern of “alert fatigue” occurring with

drug-drug interaction checks. Alert fatigue or otherwise known as “pop-up” fatigue is a

commonly perceived occurrence with electronic medical records and clinical decision support

tools in which alerts are presented to the user when a potential safety issue is identified by the

system (for example, drug to drug interaction). The alerts, while beneficial in some cases, can

result in a type of "fatigue" whereby the provider, after receiving too many alerts, begins to
CMS-0033-F 86

ignore and/or override the alerts. Receiving too many alerts can result in slowing the provider

down rendering the alert useless. Commenters recommended some changes to the objective and

associated measure to mitigate the risk of “alert fatigue” such as limiting the checks for

interactions to only the most critical medications or allowing for adjustment of risk levels rather

than an on/off functionality.

Response: We recognize “alert fatigue” is a potential occurrence with drug-drug and

drug-allergy checks. However, meaningful use seeks to utilize the capabilities of certified EHR

technology and any means to address alert fatigue requires a critical evaluation of each alert. We

believe this is beyond the scope of the definition of meaningful use. We believe these checks are

valuable and improve patient care and therefore do not remove them to address alert fatigue.

Comment: Commenters recommended food allergies be included in the drug-allergy

check as some drugs contain ingredients that are contraindicated in individuals with certain

allergies.

Response: We certainly agree that some allergies other than drug can interact with drugs;

however, as we stated under our discussion of the objective “Medication Allergy List”, the

ability to identify other types of allergies in a useful way are not yet available to the extent

necessary to require them in Stage 1 of meaningful use. This certainly does not preclude any EP,

eligible hospital, or CAH from working with the designers of their certified EHR technology to

include this functionality.

Comment: A commenter requested clarification as to whether the drug-drug, drug-

allergy and drug-formulary checks are required for contrast media and imaging agents used by

radiologists.
CMS-0033-F 87

Response: We do not link the checks to specific drugs or agents. However, we note that

is common practice in radiology to identify a patient’s past drug and food allergies and take

appropriate interventions if necessary. Therefore, the drug-drug, drug-allergy and drug-

formulary checks would be appropriate prior to administration of contrast media and imaging

agents to patients.

After consideration of the public comments received, we are finalizing the meaningful

use objective for EPs at §495.6(d)(2)(i) and for eligible hospitals and CAHs at §495.6(f)(2)(i) as

“Implement drug-drug and drug-allergy checks.” We include this objective in the core set as it is

integral to the initial or on-going management of a patient's current or future healthcare and

would give providers the necessary information to make informed clinical decisions for

improved delivery of patient care.

In addition, we are finalizing the meaningful use objective at for EPs at §495.6(e)(1)(i)

and for eligible hospitals and CAHs at §495.6(g)(1)(i) of our regulations as “Implement drug-

formulary checks.”

NPRM EP/Eligible Hospital Measure: The EP/eligible hospital/CAH has enabled the drug-

drug, drug-allergy, and drug-formulary check functionality

In the proposed rule we discussed that the capability of conducting automated drug-drug,

drug-allergy, and drug-formulary checks is included in the certification criteria for certified EHR

technology. This automated check provides information to advise the EP, eligible hospital, or

CAH's decisions in prescribing drugs to a patient. The only action taken by the EP, eligible

hospital, or CAH is to consider this information. Many current EHR technologies have the

option to disable these checks and the certification process does not require the removal of this

option. Therefore, in order to meet this objective, an EP, eligible hospital, or CAH would be
CMS-0033-F 88

required to enable this functionality and ensure they have access to at least one drug formulary.

While this does not ensure that an EP, eligible hospital or CAH is considering the information

provided by the check, it does ensure that the information is available.

After consideration of the public comments received on the objective, we believe the

measure as proposed requires more clarity on the length of time for which the functionality must

be enabled, which we clarify to be the entire EHR reporting period. Therefore, we are modifying

the meaningful use measure for “Implement drug-drug and drug-allergy checks for the entire

EHR reporting period” for EPs at §495.6(d)(2)(ii) and for eligible hospitals and CAHs at

§495.6(f)(2)(ii) of our regulations to “The EP/eligible hospital/CAH has enabled this

functionality for the entire EHR reporting period.”

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.302(a). The ability to calculate the measure is included in certified

EHR technology.

As this objective only requires that functionalities of certified EHR technology be

enabled, we do not believe that any EP, eligible hospital or CAH would need an exclusion for

this objective and its associated measure.

After consideration of the public comments received on the objective, we are modifying

the meaningful use measure for “Implement drug-formulary checks” at for EPs at

§495.6(e)(1)(ii) and for eligible hospitals and CAHs at §495.6(g)(1)(ii) of our regulations to

“The EP/eligible hospital/CAH has enabled this functionality and has access to at least one

internal or external formulary for the entire EHR reporting period.”

CMS-0033-F 89

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.302(b). The ability to calculate the measure is included in certified

EHR technology.

The consideration of whether a drug is in a formulary or not only applies when

considering what drug to prescribe. Therefore, we believe that any EP who writes fewer than

one hundred prescriptions during the EHR reporting period should be excluded from this

objective and associated measure as described previously in our discussion of whether certain

EP, eligible hospital or CAH can meet all Stage 1 meaningful use objectives given established

scopes of practices.

NPRM EP/Eligible Hospital Objective: Maintain an up-to-date problem list of current and

active diagnoses based on ICD-9-CM-CM or SNOMED CT®

In the proposed rule, we described the term “problem list” as a list of current and active

diagnoses as well as past diagnoses relevant to the current care of the patient.

Comment: Several commenters noted that the coding of problem lists at the point of care

is outside the normal workflow process and would be disruptive.

Response: We did not and do not intend that coding of the diagnosis be done at the point

of care. This coding could be done later and by individuals other than the diagnosing provider.

Comment: Commenters suggested including ICD-10-CM, the Diagnostic and Statistical

Manual of Mental Disorders and explicitly allowing subsets of SNOMED CT®.

Response: We have removed the references to specific standards, as we believe

specifying the relevant standards falls within the purview of ONC. For ONC’s discussion of this
CMS-0033-F 90

functionality and the relevant standards including response to the above comment, we refer

readers to ONC’s final rule.

After consideration of the public comments received, we are modifying the meaningful

use objective for EPs at §495.6(d)(3)(i) and for eligible hospitals at §495.6(f)(3)(i) of our

regulations to “Maintain an up-to-date problem list of current and active diagnoses”.

We include this objective in the core set as it is integral to the initial or on-going

management of a patient's current or future healthcare and would give providers the necessary

information to make informed clinical decisions for improved delivery of patient care.

NPRM EP/Eligible Hospital Measure: At least 80 percent of all unique patients seen by the

EP or admitted to the eligible hospital or CAH have at least one entry or an indication of none

recorded as structured data.

In the proposed rule, we introduced the concept of “unique patients” in the discussion of

this objective. We received many comments requesting clarification of this term and address

those in the comment and response section under our discussion of the CPOE measure.

Comment: A few commenters stated that “None” is not a clinically relevant term and

should be replaced with no known problem or no problem.

Response: Our intent is not to dictate the exact wording of the specific value. Rather we

are focused on the overall goal of making a distinction between a blank list because a patient

does not have known problems and a blank list because either no inquiry of the patient has been

made, or problems have been recorded through other means. As long as the indication

accomplishes this goal and is structured data, we do not believe it is necessary to prescribe the

exact terminology, thus leaving that level of detail to the designers and users of certified EHR

technology.
CMS-0033-F 91

Comment: Commenters requested clarification of the term “up-to-date”.

Response: The term “up-to-date” means the list is populated with the most recent

diagnosis known by the EP, eligible hospital, or CAH. This knowledge could be ascertained

from previous records, transfer of information from other providers, or querying the patient.

However, not every EP has direct contact with the patient and therefore has the opportunity to

update the list. Nor do we believe that an EP, eligible hospital, or CAH should be required

through meaningful use to update the list at every contact with the patient. There is also the

consideration of the burden that reporting places on the EP, eligible hospital, or CAH. The

measure, as finalized, ensures the EP, eligible hospital, or CAH has a problem list for patients

seen during the EHR reporting period, and that at least one piece of information is presented to

the EP, eligible hospital, or CAH. The EP, eligible hospital, or CAH can then use their judgment

in deciding what further probing or updating may be required given the clinical circumstances.

Comment: Commenters stated that this measure should be replaced with either a simple

attestation of yes, the problem list exists or the percentage of the measure should be replaced

with a count. Alternatively, that the percentage should be maintained, but that the threshold

should be lowered. Commenters generally supported this lowering of the threshold for one or all

of the following reasons: it may require a change in traditional workflow; implementation and

rollout of certified EHR technology creates unforeseeable system downtimes, complications, and

the required clinical classification systems are not geared toward clinical information.

Response: For reasons discussed earlier in this section under our discussion of the

burden created by the measures associated with the Stage 1 meaningful use objectives, we

believe a percentage is a more appropriate measure than those suggested by comments. As this

objective relies solely on a capability included as part of certified EHR technology and is not, for
CMS-0033-F 92

purposes of Stage 1 criteria, reliant on the electronic exchange of information, we believe it is

appropriate to set a high percentage threshold. In the proposed rule, we set the percentage

required for successful demonstration at 80 percent. Though full compliance (that is, 100

percent) is the ultimate goal, 80 percent seemed an appropriate standard for Stage 1 meaningful

use as it creates a high standard, while still allowing room for technical hindrances and other

barriers to reaching full compliance.” We proposed 80 percent for every measure with a

percentage that met the criteria of relying solely on a capability included as part of certified EHR

technology and are not, for purposes of Stage 1 meaningful use criteria, reliant on the electronic

exchange of information. Commenters generally agreed with this alignment; however, they

disagreed that 80 percent sufficiently allows for “technical hindrances and other barriers”.

Commenters have highlighted numerous barriers towards successfully meeting an 80 percent

threshold including technical barriers, barriers to implementation, applicability to all patients and

all provider types eligible for the EHR incentives, patient requested exclusions and others. We

address some of these with specific exclusions from the measure as discussed previously in this

section under our discussion of whether certain EP, eligible hospital or CAH can meet all Stage 1

meaningful use objectives given established scopes of practices. Although some technical issues

exist, recording an up-to-date problem list remains largely within the individual provider’s

control and does not rely to a large degree on some external sender or receiver of structured

electronic health data. In addition, there is a standard of practice for collecting the elements

required for an up-to-date problem list. Although the commenters may be right that some

clinical workflow needs to change, that is an integral part of meaningful use of EHRs. Although

we do not expect all clinical workflow to adapt in Stage 1, there is an expectation that the clinical

workflow necessary to support the Stage 1 priority of data capture and sharing will be in place in
CMS-0033-F 93

order to effectively advance meaningful use of EHRs. In addition, given the wide range of

activities that must occur for meaningful use, we believe that most EPs, eligible hospitals and

CAHs will have fully rolled out the capabilities required by this objective and the others with an

80 percent threshold prior to the start of the EHR reporting period thereby reducing the

likelihood of unexpected system downtime and other implementation complications.

For situations in which there is an existing standard of practice and complying is

fundamentally within the provider’s control and where the objective relies solely on a capability

included as part of certified EHR technology and is not, for purposes of Stage 1 criteria, reliant

on the electronic exchange of information, for the final rule, we adopt, the reasonably high

threshold of 80 percent. We believe existing infrastructure and expectations support this

relatively high target. This foundational step of structured data capture is a prerequisite for many

of the more advanced functionalities (for example, clinical decision support, clinical quality

measurement, etc.) for which a solid evidence base exists for improved quality, safety and

efficiency of care. Without having most of a provider’s up-to-date problem lists in structured,

electronic data, that provider will have major challenges in building more advanced clinical

processes going forward.

For other situations, where the objective may not be fundamentally within the provider’s

control and is not an existing standard of practice, but where objective continues to rely solely on

a capability that is included as part of certified EHR technology and is not reliant on electronic

exchange of information, we are setting the percentage at 50 percent. This was the most

commonly recommended percentage for these objectives that rely solely on a capability included

as part of certified EHR technology and do not rely on the electronic exchange of information.
CMS-0033-F 94

After consideration of the public comments received, we are modifying the meaningful

use measure for EPs at §495.6(d)(3)(i) and for eligible hospitals at §495.6(f)(3)(i) of our

regulations to “More than 80 percent of all unique patients seen by the EP or admitted to the

eligible hospital’s or CAH’s inpatient or emergency departments (POS 21 or 23) have at least

one entry or an indication that no problems are known for the patient recorded as structured

data”.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.302(c). The ability to calculate the measure is included in certified EHR

technology.

To calculate the percentage, CMS and ONC have worked together to define the following for

this objective:

• Denominator: Number of unique patients seen by the EP or admitted to an eligible hospital’s

or CAH’s inpatient or emergency department (POS 21 or 23) during the EHR reporting

period.

• Numerator: The number of patients in the denominator who have at least one entry or an

indication that no problems are known for the patient recorded as structured data in their

problem list.

• Threshold: The resulting percentage must be more than 80 percent in order for an EP,

eligible hospital, or CAH to meet this measure.

We do not believe that any EP, eligible hospital, or CAH would be in a situation where they

would not need to know at least one active diagnosis for a patient they are seeing or admitting to
CMS-0033-F 95

their hospital. Therefore, there are no exclusions for this objective and its associated measure.

NPRM EP Objective: Generate and transmit permissible prescriptions electronically (eRx).

Comment: Some commenters requested clarification of the term “permissible

prescription.”

Response: As discussed in the proposed rule the concept of only permissible

prescriptions refers to the current restrictions established by the Department of Justice on

electronic prescribing for controlled substances in Schedule II. (The substances in Schedule II

can be found at http://www.deadiversion.usdoj.gov/schedules/orangebook/e_cs_sched.pdf).

Any prescription not subject to these restrictions would be permissible. We note that the

Department of Justice recently released a notice of proposed rulemaking that would allow the

electronic prescribing of these substances; however, given the already tight timeframe for Stage

1 of meaningful use we are unable to incorporate any final changes that may result from that

proposed rule. Therefore, the determination of whether a prescription is a “permissible

prescription” for purposes of the eRx meaningful use objective should be made based on the

guidelines for prescribing Schedule II controlled substances in effect when the notice of

proposed rulemaking was published on January 13, 2010. We define a prescription as the

authorization by an EP to a pharmacist to dispense a drug that the pharmacist would not dispense

to the patient without such authorization. We do not include authorizations for items such as

durable medical equipment or other items and services that may require EP authorization before

the patient could receive them. These are excluded from the numerator and the denominator of

the measure.
CMS-0033-F 96

Comment: Some commenters recommended combining this objective and measure with

other meaningful use objectives such as CPOE or the drug-drug, drug-allergy, drug-formulary

checks

Response: We addressed these comments under our discussion of the CPOE objective.

After consideration of the public comments received, we are finalizing the meaningful

use objective at 495.6(d)(4)(i) as proposed.

We have also included this objective in the core set. Section 1848 (o)(2)(A)(i) of the Act

specifically includes electronic prescribing in meaningful use for eligible professionals. This

function is the most widely adopted form of electronic exchange occurring and has been proven

to reduce medication errors. We included this objective in the core set based on the combination

of the maturity of this objective, the proven benefits and its specific mention as the only example

provided in the HITECH Act for what is meaningfully using certified EHR technology.

NPRM EP Measure: At least 75 percent of all permissible prescriptions written by the EP are

transmitted electronically using certified EHR technology.

In the proposed rule, we said that while this measure does rely on the electronic exchange

of information based on the public input previously discussed and our own experiences with

e-prescribing programs, we believe this is the most robust electronic exchange currently

occurring and proposed 75 percent as an achievable threshold for the Stage 1 criteria of

meaningful use. Though full compliance (that is, 100 percent) is the ultimate goal, 75 percent

seemed an appropriate standard for Stage 1 meaningful use as it creates a high standard, while

still allowing room for technical hindrances and other barriers to reaching full compliance.

Comment: A majority of commenters commenting on this measure believe the

75 percent threshold is too high. Several issues were raised to explain why the commenters
CMS-0033-F 97

believe the threshold is too high. The first is that barriers to e-prescribing exist at the pharmacies

and they must be brought into the process to ensure compliance on the receiving end. The second

represents the most common barrier cited by commenters and that is patient preference for a

paper prescription over e-prescribing. A patient could have this preference for any number of

reasons cited by commenters such as the desire to shop for the best price (especially for patients

in the Part D “donut hole”), the ability to obtain medications through the VA, lack of finances,

indecision to have the prescription filled locally or by mail order and desire to use a

manufacturer coupon to obtain a discount. Other barriers mentioned by individual commenters

were the limited functionality of current e prescribing systems such as the inability to distinguish

refills from new orders. Suggestions for addressing these difficulties were either to lower the

threshold (alternatives recommended ranged from ten to fifty percent) or replacing the

percentage with a numerical count of 25 to align with the 2010 Medicare e-Prescribing program.

Of the comments received that requested a specific lower threshold, about half of them suggested

a 50 percent threshold, and about half suggested a threshold of 25 percent to 30 percent.

Response: We are finalizing the use of a percentage threshold for the reasons discussed

previously in this section under our discussion of the burden created by the measures associated

with the Stage 1 meaningful use objectives. In the proposed rule, we pointed out that we “believe

this is the most robust electronic exchange currently occurring” to justify a high threshold of 75

percent given that this objective relies on electronic exchange. While we continue to believe this

is the case, two particular issues raised by commenters caused us to reconsider our threshold.

The first is the argument to include pharmacies in the Medicare and Medicaid EHR incentive

programs to ensure compliance on the receiving end. Non-participation by pharmacies was

presented by commenters as a major barrier to e-Prescribing. The second is patient preference for
CMS-0033-F 98

a paper prescription. In regards to the first argument, we do not have the ability to impose

requirements on pharmacies through the HITECH legislation. However, prescriptions

transmitted electronically have been growing at an exponential rate. The number of prescriptions

sent electronically increased by 181 percent from 2007 to 2008 according to comments received.

The number of pharmacies is also increasing rapidly. Yet this growth in uneven across the

country and we wish to accommodate all EPs and do lower the threshold based on this argument.

In regards to the second argument, we also have neither the ability nor the desire to limit patient

preference. We considered allowing an EP to exclude from the denominator those instances

where a patient requested a paper prescription. However, the burden of tracking when this

occurs, the disincentive it would create for EPs to work with patients on establishing a

relationship with a pharmacy and the hindrance to moving forward with e-prescribing, lead us to

address this through further reduction of the threshold as opposed to an exclusion. To address

these concerns we are lowering the threshold for the e-prescribing measure to 40 percent. As

pointed out by commenters, e-prescribing it is not yet standard of practice and there may be

important external barriers beyond the provider’s control. In particular, for e-prescribing,

providers are dependent upon an external receiver of electronic health data, and there are

significant variations depending on where the provider practices.

After consideration of the public comments received, we are modifying the meaningful

use measure at §495.6(d)(4)(ii) of our regulations to “More than 40 percent of all permissible

prescriptions written by the EP are transmitted electronically using certified EHR technology”.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
CMS-0033-F 99

standards at 45 CFR 170.304(b). The ability to calculate the measure is included in certified

EHR technology.

As noted previously in this section under our discussion of the burden created by the

measures associated with the Stage 1 meaningful use objectives, the prescriptions in the

denominator are only those for patients whose records are maintained using certified EHR

technology.

To calculate the percentage, CMS and ONC have worked together to define the following for

this objective:

• Denominator: Number of prescriptions written for drugs requiring a prescription in order

to be dispensed other than controlled substances during the EHR reporting period.

• Numerator: The number of prescriptions in the denominator generated and transmitted

electronically.

• Threshold: The resulting percentage must be more than 40 percent in order for an EP,

eligible hospital, or CAH to meet this measure.

As addressed in other objectives and in comment response, this objective and associated measure

do not apply to any EP who writes fewer than one hundred prescriptions during the EHR

reporting period, as described previously in this section under our discussion of whether certain

EP, eligible hospital or CAH can meet all Stage 1 meaningful use objectives given established

scopes of practices.

NPRM EP/Eligible Hospital Objective: Maintain active medication list.

Comment: Commenters requested clarification of the term “active medication list.”

Response: We define an active medication list as a list of medications that a given

patient is currently taking.

CMS-0033-F 100

After consideration of the public comments received, we are finalizing this objective for

EPs at §495.6(d)(5)(i) and for eligible hospitals and CAHs at §495.6(f)(4)(i) of our regulations as

proposed.

We include this objective in the core set as it is integral to the initial or on-going

management of a patient's current or future healthcare and would give providers the necessary

information to make informed clinical decisions for improved delivery of patient care.

NPRM EP/Eligible Hospital Measure: At least 80 percent of all unique patients seen by the

EP or admitted by the eligible hospital have at least one entry (or an indication of “none” if the

patient is not currently prescribed any medication) recorded as structured data.

As with the objective of maintaining a problem list, we clarify that the indication of

“none” should distinguish between a blank list that is blank because a patient is not on any

known medications and a blank list because no inquiry of the patient has been made. As long as

the indication accomplishes this goal and is structured data, we do not believe it is necessary to

prescribe the exact terminology preferring to leave that level of detail to the designers and users

of certified EHR technology.

Comment: Commenters stated that the measure should be replaced with a numerical

count or attestation and that the threshold was too high for reasons including the lack of current

electronic exchange of information, difficulty capturing information as structured data and lack

of readiness of HIE infrastructure.

Response: We are finalizing the use of a percentage for the reasons discussed previously

in this section under our discussion of the burden created by the measures associated with the

Stage 1 meaningful use objectives. For the same reasons we explained under the discussion of

up-to-date problem list, medication list is a functionality for which there is an existing standard
CMS-0033-F 101

of practice, it is foundational data capture function to make more advanced clinical processes

possible, and complying is fundamentally within the provider’s control. Therefore, we maintain

the reasonably high threshold of 80 percent because the existing infrastructure and expectations

support this target.

Comment: Commenters requested clarification as to whether the measure is limited to

patients seen during the EHR reporting period.

Response: Yes, the measure applies to all unique patients seen by the EP or admitted to

the eligible hospital’s or CAH’s inpatient or emergency departments (POS 21 or 23) during the

EHR reporting period.

Comment: A few commenters expressed concern regarding the requirement that the

entry must be recorded as “structured data.” The commenters state that there may not be a code

for over the counter, homeopathic or herbal products and that would penalize the provider even

though the data is collected and recorded.

Response: The distinction between structured data and unstructured data applies to all

types of information. Structured data is not fully dependent on an established standard.

Established standards facilitate the exchange of the information across providers by ensuring

data is structured in the same way. However, structured data within certified EHR technology

merely requires the system to be able to identify the data as providing specific information. This

is commonly accomplished by creating fixed fields within a record or file, but not solely

accomplished in this manner. For example, in this case for it to be structured, if the patient is on

aspirin, then that information should be in the system so that it can be automatically identified as

a medication and not as an order, note, or anything else. An example of unstructured data would

be the word aspirin, but no ability of the system to identify it as a medication.

CMS-0033-F 102

Comment: A few commenters pointed out their current health information system vendor

does not utilize RxNorm as its standard.

Response: This is a certification issue best addressed in the ONC final rule. We therefore

have referred these comments to ONC for their consideration.

Comment: We received comments suggesting that this requirement could create

additional privacy/security concerns for patients who do not want all physicians and their clinical

staff to have access to their entire medication history. Examples provided included

antidepressant, antipsychotic or erectile dysfunction medications.

Response: We are only concerned with medications that are known to the provider

through querying the patient, their own records and the transfer of records from other providers.

Meaningful use cannot address situations where the information is withheld from the EP, eligible

hospital, or CAH by the patient or by other providers. We understand that some patients would

prefer not to have their entire medical history available to all physicians and clinical staff. We

also understand that laws in some states restrict the use and disclosure of information (including

that related to medication) that may reveal that a patient has a specific health condition (for

example, HIV). Recording data in a structured manner will facilitate the implementation of these

preferences and policies in an electronic environment. It is easier to identify and potentially

withhold specific data elements that have been recorded in a structured format than information

recorded as free text.

After consideration of the public comments received, we are modifying the meaningful

use measure for EPs at §495.6(d)(5)(ii) and for eligible hospitals at §495.6(f)(4(ii) of our

regulations to “More than 80 percent of all unique patients seen by the EP or admitted to the

eligible hospital’s or CAH’s inpatient or emergency departments (POS 21 or 23) have at least
CMS-0033-F 103

one entry (or an indication that the patient is not currently prescribed any medication) recorded

as structured data”.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.302(d). The ability to calculate the measure is included in certified

EHR technology.

To calculate the percentage, CMS and ONC have worked together to define the following for

this objective:

• Denominator: Number of unique patients seen by the EP or admitted to an eligible

hospital’s or CAH’s inpatient or emergency departments (POS 21 or 23) during the EHR

reporting period. A definition of unique patient is discussed under the objective of CPOE.

• Numerator: The number of patients in the denominator who have a medication (or an

indication that the patient is not currently prescribed any medication) recorded as structured data.

• Threshold: The resulting percentage must be more than 80 percent in order for an EP,

eligible hospital, or CAH to meet this measure. Detailed discussion of the more than 80 percent

threshold can be found under the objective of maintaining an up-to-date problem list.

We do not believe that any EP, eligible hospital or CAH would be in a situation where they

would not need to know whether their patients are taking any medications. Therefore, there are

no exclusions for this objective and its associated measure.

NPRM EP/Eligible Hospital Objective: Maintain active medication allergy list.

Comment: We received comments that limiting this list to medication allergies instead of

all allergies was not consistent with efficient workflow and that all allergies should be housed in
CMS-0033-F 104

the same location within the EHR. Commenters also highlighted that lack of knowledge of other

allergies such as latex and food allergies could lead to significant harm to the patient.

Response: We agree that information on all allergies, including non-medication allergies,

provide relevant clinical quality data. However, while we agree that collecting all allergies would

be an improvement, current medication allergy standards exists in a structured data format that

may be implemented in Stage 1. We hope to expand this measurement to include all allergies as

the standards evolve and expand to include non-medication allergies. We believe EP/eligible

hospitals/CAHs should continue to document all allergies, regardless of origin, consistent with

standard of care practice for that EP/eligible hospital/CAH. We encourage them to work with the

designers of their certified EHR technology to make this documentation as efficient and

structured as possible.

Comment: A commenter inquired why the Substance Registration System Unique

Ingredient Identifier (UNII) was not indicated for use until 2013 yet the measure requires the

information to be recorded as structured data.

Response: Any standards for the structured vocabulary for medication allergies or other

aspects of meaningful use are included in ONC final rule. Structured data does not require an

established standard as discussed under the objective of maintaining a medication list.

Comment: We received a few comments requesting a definition of “allergy.”

Response: We adopt the commonly held definition of an allergy as an exaggerated

immune response or reaction to substances that are generally not harmful. The definition is

derived from Medline Plus, a service of the U.S. National Library of Medicine and the National

Institutes of Health.
CMS-0033-F 105

After consideration of the public comments received, we are finalizing the meaningful

use objective for EPs at 495.6(d)(6)(i) and for eligible hospitals and CAHs at 495.6(f)(5)(i)as

proposed.

We include this objective in the core set as it is integral to the initial or on-going

management of a patient's current or future healthcare and would give providers the necessary

information to make informed clinical decisions for improved delivery of patient care.

NPRM EP/Eligible Hospital Measure: At least 80 percent of all unique patients seen by the

EP or admitted to the eligible hospital have at least one entry (or an indication of “none” if the

patient has no medication allergies) recorded as structured data.

Comment: Multiple commenters noted that “none” is not a typical value to describe the

absence of allergies in medical documentation and should be replaced with “no known allergies

(NKA),” “no known drug allergies (NKDA)” or “no known medication allergies (NKMA).”

Response: Our intent is not to dictate the exact wording of the specific value. Rather we

are focused on the overall goal of making a distinction between a blank list that is blank because

a patient does not have known allergies and a blank list because no inquiry of the patient has

been made or no information is available from other sources. As long as the indication

accomplishes this goal and is structured data, we do not believe it is necessary to prescribe the

exact terminology, preferring to leave that level of detail to the designers and users of certified

EHR technology.

Comment: Given that the measure is only a one time check for a single entry, one

commenter questioned whether this measure truly constitutes maintenance of an “active” list.

Response: We agree that this measure does not ensure that every patient under the care

of every EP, eligible hospital, or CAH has an active or up-to-date medication list. However, not
CMS-0033-F 106

every EP comes in contact with the patient, and therefore has the opportunity to update the list.

Nor do we believe that an EP, eligible hospital, or CAH should be required through meaningful

use to update the list at every contact with the patient. There is also the consideration of the

burden that reporting places on the EP, eligible hospital, or CAH. The measure as finalized

ensures that the EP, eligible hospital, or CAH has not ignored having a medication allergy list for

patients seen during the EHR reporting period and that at least one piece of information on

medication allergies is presented to the EP, eligible hospital, or CAH. The EP, eligible hospital,

or CAH can then use their judgment in deciding what further probing or updating may be

required given the clinical circumstances at hand. Therefore, we are maintaining the measure of a

onetime check for a single entry.

Comment: Several commenters recommended eliminating the percentage measurement

and allowing the provider to attest that active medication lists are maintained in the certified

EHR technology.

Response: We are retaining a percentage for the reasons discussed previously in this

section under our discussion of the burden created by the measures associated with the Stage 1

meaningful use objectives. For the same reasons we explained under the discussion of up-to-

date problem list, medication-allergy list is a functionality for which there is an existing standard

of practice, it is foundational data capture function to make more advanced clinical processes

possible, and complying is fundamentally within the provider’s control. Therefore, we maintain

the reasonably high threshold of 80 percent because the existing infrastructure and expectations

support this target.

After consideration of the public comments received, we are modifying the meaningful

use measure for EPs at §495.6(d)(6)(ii) and for eligible hospitals at §495.6(f)(5)(ii) of our
CMS-0033-F 107

regulations to “More than 80 percent of all unique patients seen by the EP or admitted to the

eligible hospital’s or CAH’s inpatient or emergency departments (POS 21 or 23) have at least

one entry (or an indication that the patient has no known medication allergies) recorded as

structured data”.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.302(e). The ability to calculate the measure is included in certified EHR

technology.

To calculate the percentage, CMS and ONC have worked together to define the following for

this objective:

• Denominator: Number of unique patients seen by the EP or admitted to an eligible

hospital’s or CAH’s inpatient or emergency departments (POS 21 or 23) during the EHR

reporting period. The definition of “a unique patient” is provided under the objective of CPOE.

• Numerator: The number of unique patients in the denominator who have at least one

entry (or an indication that the patient has no known medication allergies) recorded as structured

data in their medication allergy list

• Threshold: The percentage must be more than 80 percent in order for an EP, eligible

hospital, or CAH to meet this measure. Detailed discussion of the rationale more than 80 percent

threshold can be found at under the objective of maintain an up-to-date problem list.

We do not believe that any EP, eligible hospital or CAH would be in a situation where they

would not need to know whether their patients have medication allergies and therefore do not

establish an exclusion for this measure.

CMS-0033-F 108

NPRM EP Objective: Record the following demographics: preferred language, insurance type,

gender, race and ethnicity, and date of birth.

NPRM Eligible Hospital Objective: Record the following demographics: preferred language,

insurance type, gender, race and ethnicity, date of birth, and date and cause of death in the event

of mortality.

In the proposed rule, we noted that race and ethnicity codes should follow current federal

standards published by the Office of Management and Budget

(http://www.whitehouse.gov/omb/inforeg_statpolicy/#dr). We maintain that proposal for the

final rule.

Comment: Some commenters requested clarification of whether all of the demographics

are required and under what circumstances no indication might be acceptable. Examples of

acceptable circumstances from commenters include patient unwillingness to report, language

barriers, and requirement to report ethnicity and/or race contrary to some state laws.

Response: In general, we do require that all demographic elements that are listed in the

objective be included in a patient’s record in certified EHR technology. However, we do not

desire, nor could we require, that a patient provide this information if they are otherwise

unwilling to do so. Similarly, we do not seek to preempt any state laws prohibiting EPs, eligible

hospitals, or CAHs from collecting information on a patient’s ethnicity and race. Therefore if a

patient declines to provide the information or if capturing a patient’s ethnicity or race is

prohibited by state law, such a notation entered as structured data would count as an entry for

purposes of meeting the measure.

Comment: Several commenters asked for clarity on the definition of preferred language.

Commenters also indicated that standards are in development (ISO 639 and ANSIX12N
CMS-0033-F 109

Claim/Reporting Transaction). Some commenters also requested that we include the

requirement that the EP, eligible hospital or CAH also communicate with the patient in their

preferred language.

Response: Preferred language is the language by which the patient prefers to

communicate. This is just a record of the preference. We do not have the authority under the

HITECH Act to require providers to actually communicate with the patient in his or her

preferred language, and thus do not require EPs, eligible hospitals, and CAHs to do so in order to

qualify as a meaningful EHR user as suggested by some commenters. In regards to standards,

those would be adopted under the ONC final rule.

Comment: Some commenters also requested clarity on the definition of race and

ethnicity. Some commenters noted an Institute of Medicine report entitled “Race, Ethnicity and

Language Data: Standardization for Health Care Quality Improvement”, which makes

recommendations for how to ask questions to collect information and builds on the OMB

Standards for language, race and ethnicity. Some commenters were also concerned about

situations where the available choices were not granular enough, did not properly account for

mixed race and ethnicity, and when the patient did not know their ethnicity.

Response: In the proposed rule, we said that EPs, eligible hospitals and CAHs, should

use the race and ethnicity codes that follow current federal standards published by the Office of

Management and Budget (http://www.whitehouse.gov/omb/inforeg_statpolicy/#dr). We

continue to believe that these standards should be applied for purposes of implementing the

Stage 1 meaningful use objectives, but will consider whether alternative standards or additional

clarification would be appropriate for future stages of meaningful use criteria. We believe it is

beyond the scope of the definition of meaningful use to provide additional definitions for race
CMS-0033-F 110

and ethnicity beyond what is established by OMB. In regards to patients who do not know their

ethnicity, EPs, eligible hospitals, and CAHs should treat these patients the same way as patients

who decline to provide the race or ethnicity, that is, they should identify in the patient record that

the patient declined to provide this information.

Comment: Some commenters requested additional clarity on insurance type and others

recommended the elimination of insurance type due to the complexity of insurance coverage, the

function of the EHR as a medical tool and not a financial one, the volatility of this information

due to patients frequently changing plans and concerns that information on a patient’s insurance

status will have a possible behavioral influence on the providers if this information were

presented.

Response: Classifying insurance involves two distinctions – the source of coverage and

insurance design. Source of coverage refers to the type of funding, such as public, private or self-

pay. The design of the insurance program, such as health maintenance program (HMO),

preferred provider organization (PPO), high-deductible consumer directed plan, fee-for-service,

etc. Although not specified in the proposed rule, by insurance type we were referring to the first

distinction -- the source of funding for the insurance. We found two initiatives that could provide

clarity on type. The first is the “Source of Payment Typology” developed by the Public Health

Data Standards Consortium (http://www.phdsc.org/standards/payer-typology.asp). The

consortium is currently in the process of working with States to implement this typology. The

other initiative is established in the Uniform Data Set (UDS) collected by HRSA

(http://www.hrsa.gov/data-statistics/health-center-data/index.html). The information in the UDS

contains several caveats, however, that make it difficult to be used by all EPs, eligible hospitals

and CAHs, and it does not accommodate patients with multiple types of insurance such as those
CMS-0033-F 111

dually eligible for Medicare and Medicaid or who those with both Medicare and MediGap

coverage. Many EHRs that currently report on HRSA UDS Insurance Type standards account

for multiple types of insurance by maintaining separate Reporting Insurance Groups and deriving

the Insurance Type data from the primary insurance company on the encounter and mappings to

that Insurance Type Reporting Group. This information is documented at the patient

demographic level or the patient encounter/progress note. Given the complexity of defining

insurance type and attributing it to patients in an agreed upon way, we are eliminating “insurance

type” from this meaningful use objective.

Comment: A minority of commenters commenting on this objective recommended that

CMS remove cause of death from the objective for eligible hospitals. The most common

rationale is that the coroner or medical examiner officially determines cause of death when the

case is referred to them. By law, the hospital cannot declare a cause of death in these cases.

Response: When a patient expires, in the routine hospital workflow, a clinician evaluates

the patient to pronounce the patient’s death. The clinician typically documents in the patient’s

chart, the sequence of events leading to the patient’s death, conducts the physical exam and

makes a preliminary assessment of the cause of death. We are requiring that eligible hospitals

record in the patient’s EHR the clinical impression and preliminary assessment of the cause of

death, and not the cause of death as stated in any death certificate issued by the Department of

Health or the coroner’s office.

Comment: A few commenters requested inclusion of Advanced Directives under this

objective as recommended by the HIT Policy Committee.

Response: We discuss advance directives separately in this final rule under its own

objective.
CMS-0033-F 112

Comment: Several commenters recommended requiring the submission of the

demographic data to CMS.

Response: Stage 1 of meaningful use seeks to ensure certified EHR technology has the

capability to record demographic information and that those capabilities are utilized. We believe

the information recorded for this measure is for provider use in the treatment and care of their

patients and therefore should not be submitted to CMS at this time.

Comment: Commenters suggested requiring the use of the demographic data from this

measure to stratify clinical quality measure reporting and the generation of reports for patient

outreach and quality initiatives.

Response: While we encourage all providers and EHR developers to work together to

develop reporting from the EHR system for use in the improvement of population and public

health, for purposes of becoming a meaningful EHR user in Stage 1, we only require the

recording of the specified demographics.

After consideration of the public comments received, we are modifying meaningful use

objective at §495.6(d)(7)(i) of our regulations for EPs to “Record the following demographics:

preferred language, gender, race and ethnicity, and date of birth”.

After consideration of the public comments received, we are modifying meaningful use

objective at §495.6(f)(6)(i) of our regulations for eligible hospitals and CAHs to “Record the

following demographics: preferred language, gender, race and ethnicity, date of birth, and date

and preliminary cause of death in the event of mortality in the eligible hospital or CAH”.

We include this objective in the core set as it is integral to the initial or on-going

management of a patient's current or future healthcare, recommended by the HIT Policy

CMS-0033-F 113

Committee and would give providers the necessary information to make informed clinical

decisions for improved delivery of patient care.

NPRM EP/Eligible Hospital Measure: At least 80 percent of all unique patients seen by the

EP or admitted to the eligible hospital have demographics recorded as structured data

Comment: Commenters said that this should be replaced with a count or attestation or

alternatively that the threshold was too high.

Response: We are maintaining a percentage for the reasons discussed previously in this

section under our discussion of the burden created by the measures associated with the Stage 1

meaningful use objectives. However, we do reduce the threshold to over 50 percent as this

objective meets the criteria of relying solely on a capability included as part of certified EHR

technology and is not, for purposes of Stage 1 criteria, reliant on the electronic exchange of

information In contrast to our discussion of maintaining an up-to-date problem list/medication

list/medication allergy list, we believe that some demographic elements (especially race,

ethnicity and language) are not as straightforward to collect as objective data elements and

therefore the standard of practice for demographic data is still evolving. As we believe this

measure may not be within current standard of practice, we are adopting the lower threshold of

50 percent (rather than 80 percent).

After consideration of the public comments received, we are modifying the meaningful

use measure for EPs at §495.6(d)(7)(ii) and for eligible hospitals at §495.6(f)(6)(ii) of our

regulations to “More than 50 percent of all unique patients seen by the EP or admitted to the

eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) have

demographics recorded as structured data”.

CMS-0033-F 114

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.304(c) for EPs and 45 CFR 170.304(b) for eligible hospitals and CAHs.

The ability to calculate the measure is included in certified EHR technology.

To calculate the percentage, CMS and ONC have worked together to define the following for

this objective:

• Denominator: Number of unique patients seen by the EP or admitted to an eligible

hospital’s or CAH’s inpatient or emergency departments (POS 21 or 23) during the EHR

reporting period. A unique patient is discussed under the objective of CPOE.

• Numerator: The number of patients in the denominator who have all the elements of

demographics (or a specific exclusion if the patient declined to provide one or more elements or

if recording an element is contrary to state law) recorded as structured data.

• Threshold: The resulting percentage must be more than 50 percent in order for an EP,

eligible hospital or CAH to meet this measure. Most EPs and all eligible hospitals and CAHs

would have access to this information through direct patient access. Some EPs without direct

patient access would have this information communicated as part of the referral from the EP

who identified the service as needed by the patient. Therefore, we did not include an exclusion

for this objective and associated measure.

NPRM EP/Eligible Hospital Objective: Record and chart changes in the following vital signs:

height, weight and blood pressure and calculate and display body mass index (BMI) for ages 2

and over; plot and display growth charts for children 2 - 20 years, including BMI.

In the proposed rule, we described why we included growth charts in this objective. The

reason given was that BMI was not a sufficient marker for younger children.
CMS-0033-F 115

Comment: Over two thirds of the commenters commenting on this objective expressed

concern about the applicability of the listed vital signs to all provider types and care settings.

Response: While this objective could be met by receiving this information from other

providers or non-provider data sources, we recognize that the only guaranteed way for a provider

to obtain this information is through direct patient interaction and that this information is not

always routinely provided from the EP ordering a service because of a direct patient interaction.

EPs who do not see patients 2 years or older would be excluded from this requirement as

described previously in this section under our discussion of whether certain EP, eligible hospital

or CAH can meet all Stage 1 meaningful use objectives given established scopes of practices.

We would also allow an EP who believes that measuring and recording height, weight and blood

pressure of their patients has no relevance to their scope of practice to so attest and be excluded.

Comment: Several commenters stated this objective should be removed in favor of

clinical quality measures addressing BMI and blood pressure as these measures serve the same

purpose and to require both is to require duplicative reporting.

Response: We disagree that these two measures serve the same purpose and therefore

that the measure should be eliminated in favor of clinical quality measures addressing BMI and

blood pressure. The objective included here seeks to ensure that information on height, weight

and blood pressure and the extractions based on them are included in the patient’s record.

Furthermore, the objective seeks to ensure that the data is stored in a structured format so that it

can be automatically identified by certified EHR technology for possible reporting or

exchanging. We also note that the clinical quality measure focuses on a smaller subset of the

patient population.
CMS-0033-F 116

After consideration of the public comments received, we are finalizing the objective for

EPs at 495.6(d)(8)(i) and for eligible hospitals and CAHs at 495.6(f)(7)(i)as proposed.

We include this objective in the core set as it is integral to the initial or on-going

management of a patient's current or future healthcare and would give providers the necessary

information to make informed clinical decisions for improved delivery of patient care.

NPRM EP/Eligible Hospital Measure: For at least 80 percent of all unique patients age 2 and

over seen by the EP or admitted to the eligible hospital, record blood pressure and BMI;

additionally, plot growth chart for children age 2 to 20.

Comment: Commenters suggested replacement of the percentage measurement with a

count or attestation or alternatively that that the threshold was too high.

Response: We are retaining a percentage for the reasons discussed previously in this

section under our discussion of the burden created by the measures associated with the Stage 1

meaningful use objectives. However, we did reduce the threshold from 80 percent to greater

than 50 percent as this objective meets the criteria of relying solely on a capability included as

part of certified EHR technology and is not, for purposes of Stage 1 criteria, reliant on the

electronic exchange of information. In addition, in contrast to the measures associated with

maintaining an up-to-date problem list, an active medication list, and an active medication-

allergy list, we believe that for many specialties, the current practice on vital signs may not be as

well-established. We believe there may not be the same level of consensus regarding the

relevance to patient care of vital signs for many specialties and the frequency with which such

vital signs should be collected. Thus, for this measure, we adopt a percentage of 50 percent,

rather than 80 percent.

CMS-0033-F 117

Comment: Commenters requested clarification of the frequency and methods of

recording the vital signs included in the measure.

Response: As discussed in the objective, the EP/eligible hospital/CAH is responsible for

height, weight and blood pressure so we will focus our discussion on those items. First, we do

not believe that all three must be updated by a provider at every patient encounter nor even once

per patient seen during the EHR reporting period. For this objective we are primarily concerned

that some information is available to the EP/eligible hospital/CAH, who can then make the

determination based on the patient’s individual circumstances as to whether height, weight and

blood pressure needs to be updated. The information can get into the patient’s medical record as

structured data in a number of ways. Some examples include entry by the EP/eligible

hospital/CAH, entry by someone on the EP/eligible hospital/CAH’s staff, transfer of the

information electronically or otherwise from another provider or entered directly by the patient

through a portal or other means. The measure hinges on access of the information. Therefore,

any EP/eligible hospital/CAH that sees/admits the patient and has access to height, weight and

blood pressure information on the patient can put that patient in the numerator.

Comment: Some commenters requested clarification regarding the role of both the

EP/eligible hospital/CAH and the certified EHR technology for the calculation of BMI and the

plotting and displaying of growth charts. Other commenters recommended the exclusion of

growth charts for certain patients and care settings. Another commenter also expressed the

desire for the exclusion of growth charts for patients over the age of 18, inpatient care settings

and more specifically, non-pediatric inpatient care settings.

Response: We believe a clarification is in order about which of the listed vital signs are

data inputs to be collected by the EP/eligible hospital/CAH and which are calculations made by
CMS-0033-F 118

the certified EHR technology. The only information required to be inputted by the provider is

the height, weight and blood pressure of the patient. The certified EHR technology will calculate

BMI and the growth chart if applicable to patient based on age. As this requirement imposes no

duty or action on the provider, we see no reason to limit its availability to any EP, eligible

hospital, or CAH based on setting or other consideration. Concerns on presentation and interface

are best left to designers of certified EHR technology and users. Finally, as certified EHR

technology is able to automatically generate BMI and the growth chart if height and weight are

entered as structured data we see no reason to include BMI and growth chart in the measure. We

therefore will limit the final measure to data requiring provider data entry points.

Comment: A few commenters suggested that “reported height” by the patient should be

acceptable when measurement is not appropriate such as in the case of severe illness.

Response: We agree and would allow height self-reported by the patient to be used.

After consideration of the public comments received, we are modifying the meaningful

use measure for EPs at 495.6(d)(8)(ii) and for eligible hospitals §495.6(f)(7)(ii) of our

regulations to “For more than 50 percent of all unique patients age 2 and over seen by the EP or

admitted to eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23),

height, weight and blood pressure are recorded as structured data”.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.302(f). The ability to calculate the measure is included in certified EHR

technology..
CMS-0033-F 119

As noted previously in this section under our discussion of the burden created by the

measures associated with the Stage 1 meaningful use objectives, the percentage is based on

patient records that are maintained using certified EHR technology.

To calculate the percentage, CMS and ONC have worked together to define the following for

this objective:

• Denominator: Number of unique patients age 2 or over seen by the EP or admitted to an

eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) during the EHR

reporting period. A unique patient is discussed under the objective of CPOE.

• Numerator: The number of patients in the denominator who have at least one entry of

their height, weight and blood pressure are recorded as structure data.

• Threshold: The resulting percentage must be more than 50 percent in order for an EP,

eligible hospital, or CAH to meet this measure. As addressed in other objectives and in comment

response, an EP who sees no patients 2 years old or younger would be excluded from this

requirement as described previously in this section under our discussion of whether certain EP,

eligible hospital or CAH can meet all Stage 1 meaningful use objectives given established scopes

of practices. We would also allow an EP who believes that all three vital signs of height, weight

and blood pressure have no relevance to their scope of practice to so attest and be excluded.

However, we believe this attestation and exclusion from recording height, weight, and blood

pressure does not hold for other patient specific information collection objectives, like

maintaining an active medication allergy list. We do not believe that any EP would encounter a

situation where the patient's active medication and allergy list is not pertinent to care and

therefore would be outside of the scope of work for an EP. We believe the exclusion based on

EP determination of their scope of practice for the record vital signs objective, as written in
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Stage 1, should be studied for relevance in further stages. We do not believe eligible hospitals or

CAHs would ever only have a patient population for patients 2 years old or younger or that these

vital signs would have no relevance to their scope of practice. Therefore, we do not include an

exclusion for eligible hospitals or CAHs.

NPRM EP/Eligible Hospital Objective: Record smoking status for patients 13 years old or

older

In the proposed rule, we explained that we believe it is necessary to add an age restriction

to this objective as we do not believe this objective is applicable to patients of all ages and there

is no consensus in the health care community as to what the appropriate cut off age may be. We

encouraged comments on whether this age limit should be lowered or raised. We received many

comments on the age limit and address them below.

Comment: Several commenters requested a different age limitation. Commenters

suggested ages anywhere between 5 years old up to 18 years old.

Response: For the purposes of this objective and for meaningful use, our interest is

focused on when a record of smoking status should be in every patient’s medical record.

Recording smoking status for younger patients is certainly not precluded. We do believe there

would be situations where an EP/eligible hospital/CAH’s knowledge about other risk factors

would indicate that they should inquire about smoking status if it is unknown for patients under

13 years old. However, in order to accurately measure and thereby assure meaningful use, for

this objective we believe that the age limit needs to be high enough so that the inquiry is

appropriate for all patients. Therefore, we are maintaining the age limitation at 13 years old or

older.
CMS-0033-F 121

Comment: Some commenters suggested expanding smoking status to any type of

tobacco use.

Response: While we agree that an extended list covering other types of tobacco use may

provide valuable insight for clinical care for certified EHR technology ONC has adopted the

CDC's NHIS standard recodes for smoking status. This will provide a standard set of questions

across providers and standardize the data. The extended list does not make the collection of

multiple survey questions clear. For example, a patient may be a current tobacco user as well as

a smoker. For these reason in Stage 1 we will use the standards adopted by ONC for certified

EHR technology at 45 CFR 170.302(g). For future stages, we will review this measure for

possible inclusion of other questions. This is a minimum set. We do not intend to limit

developers of EHR technology from creating more specific fields or to limit EPs/eligible

hospitals/CAHs from recording more specific information.

Comment: We also received comments requesting that second-hand smoking be

included in the objective for children and adolescents.

Response: Including second-hand smoking introduces much more variability into the

objective as to what constitutes a level of exposure and difficulty in measuring it successfully

with different age limits to different aspects. For instance, how much exposure is acceptable for

a given age and how is such exposure determined? How would these differing requirements be

accounted for by certified EHR technology? As with the change from smoking status to tobacco

use, we believe this introduces an unacceptable level of complexity for Stage 1 of meaningful

use. For Stage 1 of meaningful use we are not adding second hand smoke exposure to this

objective. However, we remind EPs, eligible hospitals and CAHs that nothing about the criteria

for meaningful use prevents them from working with their EHR developer to ensure that their
CMS-0033-F 122

EHR system meets their needs and the needs of their patient population. We encourage all EPs,

eligible hospitals and CAHs to critically review their implementation in light of their current and

future needs both to maximize their own value and to prepare for future stages of meaningful

use.

Comment: We received comments asking at what frequency the information must be

recorded and whether the information can be collected by support staff.

Response: We clarify that this is a check of the medical record for patients 13 years old

or older. If this information is already in the medical record available through certified EHR

technology, we do not intend that an inquiry be made every time a provider sees a patient 13

years old or older. The frequency of updating this information is left to the provider and

guidance is provided already from several sources in the medical community. The information

could be collected by any member of the medical staff.

Comment: We received a number of comments recommending either removing this

objective to record smoking status from the HIT functionality objectives or removing the

smoking measure from the core clinical quality measures as these measures serve the same

purpose and to require both is to require duplicative reporting.

Response: We disagree that these two measures serve the same purpose and therefore

only one should be included. The objective included here seeks to ensure that information on

smoking status is included in the patient’s record. Furthermore, that the information is stored in

a structured format so that it can automatically be identified by certified EHR technology as

smoking status for possible reporting or exchanging. We also note that the clinical quality

measure only focuses on patients 18 years or older, while the objective focuses on patients

13 years or older. In addition, many quality measures related to smoking are coupled with
CMS-0033-F 123

follow-up actions by the provider such as counseling. We consider those follow-up actions to be

beyond the scope of what we hope to achieve for this objective for Stage 1 of meaningful use.

After consideration of the public comments received, we are finalizing the meaningful

use objective for EPs at §495.6(d)(9)(i) and for eligible hospitals at §495.6(f)(8)(i) of our

regulations as proposed.

We include this objective in the core set as it is integral to the initial or on-going

management of a patient's current or future healthcare and would give providers the necessary

information to make informed clinical decisions for improved delivery of patient care.

NPRM EP/Eligible Hospital Measure: At least 80 percent of all unique patients 13 years old or

older seen by the EP or admitted to the eligible hospital have “smoking status” recorded

In the proposed rule, discussion of this measure referenced other sections exclusively.

Comment: We received comments recommending alternative thresholds for this

measure. Commenters provided thresholds ranging from anything greater than zero to 60 percent

in stage 1.

Response: In the proposed rule, we established a consistent threshold for measures not

requiring the exchange of information. For the final rule, (other than up-to-date problem list,

active medication list and active medication-allergy list), we have lowered the threshold

associated with these measures to 50 percent. In our discussion of the objective, we noted many

concerns by commenters over the appropriate age at which to inquire about smoking status.

There were also considerable differences among commenters as to what the appropriate inquiry

is and what it should include. Due to these concerns, we do not believe this objective and

measure fit into the threshold category described under up-to-date problem lists and therefore we

adopt a 50 percent (rather than an 80 percent) threshold for this measure. After consideration of
CMS-0033-F 124

the public comments received, we are modifying the meaningful use measure for EPs at

§495.6(d)(9)(ii) and for eligible hospitals at §495.6(f)(8)(ii) of our regulations to “More than 50

percent of all unique patients 13 years old or older seen by the EP or admitted to the eligible

hospital’s or CAH’s inpatient or emergency departments (POS 21 or 23) have smoking status

recorded as structured data”.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.302(g). The ability to calculate the measure is included in certified

EHR technology.

As noted previously in this section under our discussion of the burden created by the

measures associated with the Stage 1 meaningful use objectives, the percentage is based on

patient records that are maintained using certified EHR technology.

To calculate the percentage, CMS and ONC have worked together to define the following for

this objective:

• Denominator: Number of unique patients age 13 or older seen by the EP or admitted to

an eligible hospital’s or CAH’s inpatient or emergency departments (POS 21 or 23) during the

EHR reporting period. A unique patient is discussed under the objective of maintaining an up-

to-date problem list.

• Numerator: The number of patients in the denominator with smoking status recorded as

structured data.

• Threshold: The resulting percentage must be more than 50 percent in order for an EP,

eligible hospital, or CAH to meet this measure. As addressed in other objectives, EPs, eligible

hospitals or CAHs who see no patients 13 years or older would be excluded from this
CMS-0033-F 125

requirement as described previously in this section under our discussion of whether certain EP,

eligible hospital or CAH can meet all Stage 1 meaningful use objectives given established scopes

of practices. Most EPs and all eligible hospitals and CAHs would have access to this

information through direct patient access. Some EPs without direct patient access would have

this information communicated as part of the referral from the EP who identified the service as

needed by the patient. Therefore, we did not include an exclusion based on applicability to scope

of practice or access to the information for this objective and associated measure.

NPRM EP/Eligible Hospital Objective: Record advance directives

In the proposed rule, we discussed this objective, but did not propose it as a requirement

for demonstrating meaningful use, for a number of reasons, including: (1) it was unclear whether

the objective would be met by indicating that an advance directive exists or by including the

contents of the advance directive; (2) the objective seems relevant only to a limited and

undefined patient population when compared to the patient populations to which other objectives

of Stage 1 of meaningful use apply; and (3) we believe that many EPs would not record this

information under current standards of practice. Dentists, pediatricians, optometrists,

chiropractors, dermatologists, and radiologists are just a few examples of EPs who would require

information about a patient's advance directive only in rare circumstances.

Comment: We received several comments including a comment from the HIT Policy

Committee that we should include advance directives in the final rule. The HIT Policy

Committee clarified that this would be an indication of whether a patient has an advanced

directive. Furthermore, they recommend limiting this measure to patients 65 and older. We

received other comments that said this should be a requirement for eligible hospitals. Other

commenters reported that having this information available for the patient would allow eligible
CMS-0033-F 126

hospitals to make decisions that were better aligned with the patient’s expressed wishes.

Response: In the proposed rule, we said that confusion as to whether this objective

would require an indication of the existence of an advanced directive or the contents of the

advance directive itself would be included in certified EHR technology was one of the reasons

for not including the objective in Stage 1 of meaningful use. We expressed concerns that the

latter would not be permissible in some states under existing state law. As commenters have

clarified that advance directives should be just an indication of existence of an advance directive

and recommended a population to apply the measure to, we reinstate this objective for eligible

hospitals and CAHs. We believe that the concern over potential conflicts with state law are

alleviated by limiting this to just an indication. We also believe that a restriction to a more at

risk population is appropriate for this measure. By restricting the population to those 65 years

old and older, we believe we focus this objective appropriately on a population likely to most

benefit from compliance with this objective and its measure. This objective is in the menu set so

if an eligible hospital or CAH finds they are unable to meet it then can defer it. However, we

believe many EPs would not record this information under current standards of practice.

Dentists, pediatricians, optometrists, chiropractors, dermatologists, and radiologists are just a few

examples of EPs who would only require information about a patient's advance directive in rare

circumstances. For other meaningful use objectives, we have focused our exclusions on rare

situations, which would not be the case for this objective. Therefore, we do not include this

objective for EPs.

After consideration of the public comments received, we are including this meaningful

use objective for eligible hospitals and CAHs at §495.6(g)(2)(i) of our regulations as “Record

whether a patient 65 years old or older has an advanced directive as structured data ”.
CMS-0033-F 127

NPRM EP/Eligible Hospital Measure: N/A

While we did not receive specific percentage recommendations from commenters, this

objective is the recording of a specific data element as structured data in the patient record. This

is identical to other objectives with established measures such as, recording vital signs, recording

demographics and recording smoking status. Therefore, we adopt the measure format and the

lower threshold (50 percent) from those objectives. We also believe that this information is a

level of detail that is not practical to collect on every patient admitted to the eligible hospital’s or

CAH’s emergency department, and therefore, have limited this measure only to the inpatient

department of the hospital.

In the final rule, this meaningful use measure for eligible hospitals at §495.6(g)(2)(ii) of

our regulations: “More than 50 percent of all unique patients 65 years old or older admitted to

the eligible hospital’s or CAH’s inpatient department (POS 21) have an indication of an advance

directive status recorded as structured data”.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.306(h). The ability to calculate the measure is included in certified

EHR technology.

As noted previously in this section under our discussion of the burden created by the

measures associated with the Stage 1 meaningful use objectives, the percentage is based on

patient records that are maintained using certified EHR technology.

To calculate the percentage, CMS and ONC have worked together to define the following for

this objective:
CMS-0033-F 128

• Denominator: Number of unique patients age 65 or older admitted to an eligible

hospital’s or CAH’s inpatient department (POS 21) during the EHR reporting period. A unique

patient is discussed under the objective of CPOE.

• Numerator: The number of patients in the denominator with an indication of an advanced

directive entered using structured data.

• Threshold: The resulting percentage must be more than 50 percent in order for eligible

hospital or CAH to meet this measure. An exclusion, as described previously in this section

under our discussion of whether certain EP, eligible hospital or CAH can meet all Stage 1

meaningful use objectives given established scopes of practices, would apply to an eligible

hospital or CAH who admits no patients 65 years old or older during the EHR reporting period.

NPRM EP/Eligible Hospital Objective: Incorporate clinical lab-test results into EHR as

structured data.

In the proposed rule, we defined structured data as data that has a specified data type and

response categories within an electronic record or file. We have revised that definition for the

final rule as discussed below.

Comment: Some commenters requested clarification on what constitutes structured data.

Response: The distinction between structured data and unstructured data applies to all

types of information. Structured data is not fully dependent on an established standard.

Established standards facilitate the exchange of the information across providers by ensuring

data is structured in the same way. However, structured data within certified EHR technology

merely requires the system to be able to identify the data as providing specific information. This

is commonly accomplished by creating fixed fields within a record or file, but not solely

accomplished in this manner.

CMS-0033-F 129

After consideration of the public comments received, we finalize the meaningful use

objective or EPs at §495.6(e)(2)(i) and eligible hospitals and CAHs at §495.6(g)(3)(i) as

proposed.

NPRM EP/ Eligible Hospital Measure: At least 50 percent of all clinical lab tests results

ordered by the EP or by an authorized provider of the eligible hospital during the EHR reporting

period whose results are either in a positive/negative or numerical format are incorporated in

certified EHR technology as structured data.

In the proposed rule, we identified this objective and associated measure as dependent on

electronic exchange and therefore requiring special consideration in establishing the threshold.

We said that we are cognizant that in most areas of the country, the infrastructure necessary to

support such exchange is still being developed. Therefore, we stated our belief that 80 percent is

too high a threshold for the Stage 1 criteria of meaningful use. As an alternative, we proposed

50 percent as the threshold based on our discussions with EHR vendors, current EHR users, and

laboratories. We then invited comment on whether 50 percent is feasible for the Stage 1 criteria

of meaningful use. Finally, we indicated that we anticipate raising the threshold in future stages

of meaningful use as the capabilities of HIT infrastructure increase. We received several

comments on the appropriateness of this 50 percent threshold and discuss them in the comment

and response section below.

Comment: Commenters requested clarification as to whether the measure includes only

electronic exchange of information with a laboratory or if it also includes manual entry.

Response: We encourage every EP, eligible hospital and CAH to utilize electronic

exchange of the results with the laboratory based on the certification and standards criteria in the

45 CFR 170.302(h). If results are not received in this manner, then they are presumably received
CMS-0033-F 130

in another form such as fax, telephone call, mail, etc. These results then must be incorporated

into the patient’s medical record in some way. We encourage that this way use structured data;

however, that raises the concerns about the possibility of recording the data twice; for example

scanning the results and then entering the results as structured data. Telephoned results could be

entered directly. We also recognize the risk of entry error, which is why we highly encourage

the electronic exchange of the results with the laboratory, instead of manual entry through

typing, option selecting, scanning or other means. Reducing the risk of entry error is one of the

primary reasons we lowered the measure threshold for Stage 1 during which providers are

changing their workflow processes to accurately incorporate information into EHRs through

either electronic exchange or manual entry. However, for this measure, we do not limit the EP,

eligible hospital or CAH to only counting structured data received via electronic exchange, but

count in the numerator all structured data. By entering these results into the patient’s medical

record as structured data, the EP, eligible hospital or CAH is accomplishing a task that must be

performed regardless of whether the provider is attempting to demonstrate meaningful use or not.

We believe that entering the data as structured data encourages future exchange of information.

Comment: A majority of commenters commenting on this measure believe the proposed

50 percent threshold is too high. Suggestions for alternative thresholds ranged from more than

zero to eighty percent. Some commenters suggested that the percentage calculation be replaced

with a numeric count.

Response: We are finalizing a percentage calculation for the reasons discussed

previously in this section under our discussion of the burden created by the measures associated

with the Stage 1 meaningful use objectives. We based the 50 percent threshold in the proposed

rule on our discussions with EHR vendors, current EHR users, and laboratories and specifically
CMS-0033-F 131

requested comment on whether the 50 percent threshold was feasible. While only a small

number of commenters commented on this objective, those that did were overwhelming in favor

of either a count or a lower threshold. EPs especially were concerned with our inability to

impose any requirements on laboratory vendors. Based on the comments received, we have

modified our assessment of the current environment for incorporating lab results into certified

EHR technology, and believe that a threshold lower than fifty percent is warranted. We want to

create a threshold that encourages, but does not require, the electronic exchange of this

information and commenters indicated that 50 percent was too high given the current state of

electronic exchange of lab results. Therefore, we lower the threshold to 40 percent.

Comment: Commenters requested clarification on what types of laboratories could

generate the lab results.

Response: The focus of this objective is to get as many lab results as possible into a

patient’s electronic health record as structured data. Limiting the objective to a specific type of

laboratory would not further this objective so therefore we leave it open to all lab tests and

laboratories.

Comment: Several commenters expressed concern regarding the financial burden of

establishing lab interfaces, especially for smaller hospitals and practices.

Response: The ability to exchange information is a critical capability of certified EHR

technology. Exchange between lab and provider and provider to provider of laboratory results

reduces errors in recording results and prevents the duplication of testing. Therefore, we

continue to include this objective within Stage 1 of meaningful use although as noted above the

measure does not rely on the electronic exchange of information between the lab and the

provider.
CMS-0033-F 132

Comment: We received comments requesting a listing of laboratory tests with results

that are in a numerical or positive/negative format.

Response: We consider it impractical to develop an exhaustive list of such tests.

Moreover, we believe further description of these tests is unnecessary. It should be self-evident

to providers when a test returns a positive or negative result or a result expressed in numeric

characters. In these case, the results should be incorporated into a patient’s EHR as structured

data.

Comment: Several commenters pointed out that many current EHR vendors do not

support the use of LOINC® codes and there is no federal regulatory requirement for labs to

transmit using this code set or for that matter, any structured code set.

Response: Standards such as LOINC® codes are included in the ONC final rule.

However, this measure requires incorporation of lab test results as structured data, but does not

include a requirement for transmission or electronic receipt of the results using certified EHR

technology.

After consideration of the public comments received, we are modifying the meaningful

use measure for EPs at §495.6(e)(2)(ii) and eligible hospitals at §495.6(g)(3)(ii) of our

regulations to “More than 40 percent of all clinical lab tests results ordered by the EP or by an

authorized provider of the eligible hospital or CAH for patients admitted to its inpatient or

emergency department (POS 21 or 23) during the EHR reporting period whose results are in

either in a positive/negative or numerical format are incorporated in certified EHR technology as

structured data”.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
CMS-0033-F 133

standards at 45 CFR 170.302(h). The ability to calculate the measure is included in certified

EHR technology.

As noted previously in this section under our discussion of whether certain EP, eligible

hospital or CAH can meet all Stage 1 meaningful use objectives given established scopes of

practices , the percentage is based on labs ordered for patients whose records are maintained

using certified EHR technology.

To calculate the percentage, CMS and ONC have worked together to define the following for

this objective:

• Denominator: Number of lab tests ordered during the EHR reporting period by the EP or

authorized providers of the eligible hospital or CAH for patients admitted to an eligible

hospital’s or CAH’s inpatient or emergency department (POS 21 & 23) whose results are

expressed in a positive or negative affirmation or as a number.

• Numerator: The number of lab test results whose results are expressed in a positive or

negative affirmation or as a number which are incorporated as structured data.

• Threshold: The resulting percentage must be more than 40 percent in order for an EP,

eligible hospital, or CAH to meet this measure.

If an EP orders no lab tests whose results are either in a positive/negative or numeric format

during the EHR reporting period they would be excluded from this requirement as described

previously in this section under our discussion of whether certain EP, eligible hospital or CAH

can meet all Stage 1 meaningful use objectives given established scopes of practices. We do not

believe any eligible hospital or CAH would order no lab tests whose results are either in a

positive/negative or numeric format during the EHR reporting period.

CMS-0033-F 134

NPRM EP/Eligible Hospital Objective: Generate lists of patients by specific conditions to use

for quality improvement, reduction of disparities, research, and outreach.

Comment: A few commenters recommended eliminating this requirement because they

believe it is redundant of clinical quality reporting.

Response: We disagree that this is redundant of clinical quality reporting. Clinical

quality reporting does not guarantee usability for all the purposes in the objective. One example

of such a use is a provider could not only generate list of patients with specific conditions, but

could stratify the output using other data elements in the certified EHR technology that are

entered as structured data. The lists could also be utilized at an aggregate level for purposes of

research into disparities, which could result in targeted outreach efforts.

Comment: Some commenters requested that if we finalize our proposal to only require

one report that we change the “and” in the objective to “or”.

Response: We are finalizing our measurement of only requiring one report for Stage 1 of

meaningful use and will change “and” to “or”. However, we note that all measures will be

reconsidered in later stages of meaningful use and multiple reports could be required in those

stages.

Comment: We received a few comments requesting the removal of the terms “reduction

of disparities” and “outreach” as there are no actionable items or measures associated with the

term. We also received comments that the measurement should include the requirement that the

lists be stratified by race, ethnicity, preferred language, and gender for initiatives targeted at

reducing disparities.

Response: We disagree that actions to reduce disparities or conduct outreach could not

be guided by this report, especially if stratified and aggregated reports of many providers are
CMS-0033-F 135

combined within large organizations or among organizations. While we do not require such

stratification or aggregation or specify specific uses, that does not preclude them.

Comment: Some commenters requested clarification of the term specific condition.

Response: Specific conditions are those conditions listed in the active patient problem

list.

After consideration of the public comments received, we are modifying the meaningful

use objective for EPs at §495.6(e)(3)(i) and for eligible hospitals at §495.6(g)(4)(i) of our

regulations to “Generate lists of patients by specific conditions to use for quality improvement,

reduction of disparities, research, or outreach”.

NPRM EP/Eligible Hospital Measure: Generate at least one report listing patients of the EP or

eligible hospital with a specific condition.

In the proposed rule, we said that an EP or eligible hospital is best positioned to

determine which reports are most useful to their care efforts. Therefore, we do not propose to

direct certain reports be created. However, in order to ensure the capability can be utilized we

proposed to require EPs and hospitals to attest to the ability of the EP or eligible hospital to

create a report listing patients by specific condition and to attest that they have actually done so

at least once. We received comments on this and address them and any revisions to the proposed

rule in the comment and response section below.

Comment: Commenters requested clarification that only one report per EHR reporting

period is required to meet the measure.

Response: Yes, only one report in required for any given EHR reporting period. The

report could cover every patient whose records are maintained using certified EHR technology or

a subset of those patients at the discretion of the EP, eligible hospital or CAH.
CMS-0033-F 136

Comment: A few commenters suggested the measure should be expanded to require

submission of the report to CMS or the States or to the local health department.

Response: Submission raises many questions about what types of information can be

sent to different entities, how the information is used, patient consent for sending the

information, and many of the issues, which add considerable complexity to this meaningful use

objective. Therefore, we are not requiring submission of the report to CMS, the States or local

health departments for Stage 1 of meaningful use. We do note that this is one of the objectives

for which a State can submit modifications to CMS for approval.

Comment: Several commenters requested a list of condition categories, a model report or

the core data elements required to satisfy the measure.

Response: As stated in the rule, we believe an EP, eligible hospital, or CAH is best

positioned to determine which reports are most useful to their care efforts. Therefore, we do not

propose to direct certain reports be created.

Comment: For eligible hospitals, commenters stated that the analysis of patient data is

derived from post-discharge coding of diagnosis and procedures and not problem lists.

Response: We do not specify that the list is limited to being generated from the data

problem list; rather, for the definition of conditions we refer providers to those conditions

contained in the problem list.

Comment: One commenter stated that for privacy and confidentiality reasons, patients

should be allowed to opt out of any provider outreach initiatives.

Response: Stage 1 of meaningful use does not require the submission of these reports to

other entities; rather, we require that the provider generate these reports for their own use. We

therefore do not believe the generation of such reports raises privacy and confidentiality
CMS-0033-F 137

concerns. We understand, however, that some patients may have concerns about such lists being

exchanged with others and will consider such concerns should future meaningful use

requirements focus on exchange of these reports.

After consideration of the public comments received, we are finalizing the meaningful

use measure for EPs at §495.6(e)(3)(ii) and for eligible hospitals and CAHs at §495.6(g)(4)(ii)

of our regulations as proposed.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.302(i). The ability to calculate the measure is included in certified

EHR technology.

As this measure relies on data contained in certified EHR technology the list would only

be required to include patients whose records are maintained using certified EHR technology as

discussed previously in this section under our discussion of the burden created by the measures

associated with the Stage 1 meaningful use objectives.

We do not believe anything included in this objective or measure limit any EP, eligible

hospital or CAH from completing the measure associated with this objective, therefore, we do

not include an exclusion.

NPRM EP Objective: Report ambulatory quality measures to CMS (or, for EPs seeking the

Medicaid incentive payment, the States).

Specific comments on the quality measures are discussed in section II.A.3 of this final rule.

We are finalizing this meaningful use objective at §495.6(d)(10)(i) of our regulations “Report

ambulatory clinical quality measures to CMS (or, for EPs seeking the Medicaid incentive

payment, the States)” to better align with the descriptions in section II.A.3.
CMS-0033-F 138

In response to our revised requirements for meeting meaningful use, we are including this

objective in the core set. Section 1848 (o)(2)(A)(iii) of the Act specifically includes submitting

clinical quality measures in meaningful use for EPs. Section 1903(t)(6)(D) of the Act also

anticipates that the demonstration of meaningful use may include quality reporting to the States

for the Medicaid program.

NPRM Eligible Hospital Objective: Report ambulatory quality measures to CMS (or, for

eligible hospitals seeking the Medicaid incentive payment, the States).

We make a technical correction to this objective from the proposed rule to ensure that it is clear

to the public that we were referring to hospital quality measures.

Specific comments on the quality measures are discussed in section II.A.3 of this final rule.

After consideration of the public comments received, we are finalizing this meaningful

use objective at §495.6(d)(9)(i) to account for our technical correction and to better align with

the descriptions in section II.A.3 as “Report hospital clinical quality measures to CMS (or, for

eligible hospitals seeking the Medicaid incentive payment, the States)”.

In response to our revised requirements for meeting meaningful use, we are including this

objective in the core set. Section 1886 (n)(3)(A)(iii) of the Act specifically includes submitting

clinical quality measures in meaningful use for eligible hospitals and CAHs. Section

1903(t)(6)(D) of the Act also anticipates that the demonstration of meaningful use may include

quality reporting to the States for the Medicaid program.

NPRM EP Measure: For 2011, an EP would provide the aggregate level data for the

numerator, denominator, and exclusions through attestation as discussed in section II.A.3 of this

final rule. For 2012, an EP would electronically submit the measures that are discussed in

section II.A.3. of this final rule.

CMS-0033-F 139

Specific comments on the quality measures themselves are discussed in section II.A.3 of this

final rule.

After consideration of the public comments received, we are finalizing this meaningful

use objective at §495.6(d)(10)(ii) as proposed.

NPRM Eligible Hospital Measure: For 2011, an eligible hospital or CAH would provide the

aggregate level data for the numerator, denominator, and exclusions through attestation as

discussed in section II.A.3 of this final rule. For 2012, an eligible hospital or CAH would

electronically submit the measures as discussed in section II.A.3. of this final rule.

Specific comments on the quality measures are discussed in section II.A.3 of this final rule.

After consideration of the public comments received, we are finalizing this meaningful use

objective at 495.6(f)(9)(ii) as proposed.

NPRM EP Objective: - Send reminders to patients per patient preference for

preventive/follow-up care.

In the proposed rule, we described patient preference as the patient’s choice between

internet based delivery or delivery not requiring internet access. We are revising that description

based on comments as discussed below.

Comment: Commenters have pointed out that requirements to accommodate reasonable

requests by individuals to receive communications by means other than the means preferred by

the provider already exist under HIPAA at 45 C.F.R. 164.522(b).

Response: As we stated in the proposed rule, patient preference refers to the patient’s

preferred means of transmission of the reminder from the provider to the patient, and not

inquiries by the provider as to whether the patient would like to receive reminders. In the

proposed rule, we had proposed that patient preference be limited to the choice between internet
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based or non-internet based. In order to avoid unnecessary confusion and duplication of

requirements, EPs meet the aspect of “per patient preference” of this objective if they are

accommodating reasonable requests as outlined in 45 C.F.R. 164.522(b), which are the guidance

established under HIPAA for accommodating patient requests.

After consideration of the public comments received, we are finalizing the meaningful

use objective at §495.6(e)(4)(i) of our regulations as proposed.

NPRM EP Measure: Reminder sent to at least 50 percent of all unique patients seen by the EP

or admitted to the eligible hospital that are 50 and over.

For the final rule, we are changing the measure to recognize that this is an EP only

objective. Therefore, we make the technical correction of striking “or admitted to the eligible

hospital”.

Comment: Commenters indicated that “practice management systems” or “patient

management systems” are commonly used for this function and that integrating them into

certified EHR technology would be expensive and time consuming for little value in return.

Response: While we disagree with commenters who suggest there is little to no value in

having information about reminders sent to patients available across all the systems used by the

provider, we do not assert that such integration of systems must be in place to meet this measure.

ONC provides for a modular approach that would allow these systems to be certified as part of

certified EHR technology.

Comment: Some commenters pointed out that many patients seen during an EHR

reporting period will not be sent a reminder during that same period. Commenters said this is

especially true for the 90-day EHR reporting period, but for some services could be true of the

full year EHR reporting period as well. Other commenters also pointed out that reminders are
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not limited to the older population and that children especially may require many reminders on

immunizations.

Response: We agree with commenters that many patients not seen during the EHR

reporting period would benefit from reminders. As the action in this objective is the sending of

reminders, we base the revised measure on that action. This focus is supported by numerous

public comments, including those by the HIT Policy Committee. Therefore, we are changing the

requirement to account for all patients whose records are maintained using certified EHR

technology regardless of whether they were seen by the EP during the EHR reporting period.

This greatly expanded denominator caused us to reconsider both our threshold and the age limit.

In order to increase the probability that a patient whose records are maintained in certified EHR

technology will be eligible for a reminder we change the age limit of the population to 65 years

old or older or 5 years old or under. We believe that older patient populations are more likely to

have health statuses that will indicate the need for reminders to be sent and this segment of the

population is have higher rates of chronic diseases which will require coordination in preventive

care such as vaccine reminders. Likewise, the 5 years old and under population will require a

multitude of childhood vaccinations such as influenza and will benefit from reminders.

However, we do not believe that changing the age limit of the affected population will result in

50 percent of every patient whose records maintained in certified EHR technology requiring a

reminder during the EHR reporting period. This is especially true for the first payment year

when the EHR reporting period is only 90 days. We are also concerned about the variability

among specialists’ scopes of practice that may affect the number of patients in the denominator

for which a reminder is appropriate. Therefore, we lower the threshold to 20 percent. The EP

has the discretion to determine the frequency, means of transmission and form of the reminder
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limited only by the requirements of 45 CFR 164.522(b) and any other applicable federal, state or

local regulations that apply to them. After consideration of the public comments received, we

are modifying the meaningful use measure at §495.6(e)(4)(ii) to “More than 20 percent of all

patients 65 years or older or 5 years old or younger were sent an appropriate reminder during the

EHR reporting period”.

We further specify that in order to meet this objective and measure, an EP must use the

capabilities Certified EHR Technology includes as specified and standards at 45 CFR

170.304(d). The ability to calculate the measure is included in certified EHR technology.

As noted previously in this section under our discussion of the burden created by the

measures associated with the Stage 1 meaningful use objectives, the denominator is based on

patients whose records are maintained using certified EHR technology.

To calculate the percentage, CMS and ONC have worked together to define the following for

this objective:

• Denominator: Number of unique patients 65 years old or older or 5 years older or

younger.

• Numerator: The number of patients in the denominator who were sent the appropriate

reminder.

• Threshold: The resulting percentage must be more than 20 percent in order for an EP to

meet this measure.

As addressed in other objectives and in comment responses, if an EP has no patients 65 years old

or older or 5 years old or younger with records maintained using certified EHR technology that

EP is excluded from this requirement as described previously in this section under our discussion
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of whether certain EP, eligible hospital or CAH can meet all Stage 1 meaningful use objectives

given established scopes of practices.

NPRM EP/Eligible Hospital Objective: Document a progress note for each encounter

In the proposed rule, we discussed this objective, but did not propose it for Stage 1 of meaningful

use. We noted our belief that documentation of progress notes is a medical-legal requirement

and a component of basic EHR functionality, and is not directly related to advanced processes of

care or improvements in quality, safety, or efficiency.

Comment: We received a limited number of comments regarding our decision not to

include documentation of progress notes as an objective. The commenters generally fell into

three categories: those who supported inclusion of this objective in the final rule, those who

supported its inclusion only if certain caveats are met and those who supported our proposal not

to include it as an objective for Stage 1 of meaningful use. Concerns raised by those supporting

the inclusion of this objective included the possibility that an EP may keep paper progress notes

in conjunction with use of certified EHR technology as prescribed by Stage 1 of meaningful use

and that such a choice by EPs would create the possibility of handwriting illegibility, loss of

information and reduced access to health information by both patients and other providers.

Another concern raised is that if the objective is not included in the criteria for the definition of

meaningful use designers of EHR technology will not include the function in their products. The

advocates in the second category agree with the above, but only support inclusion with certain

caveats. Some of these caveats include preserving the option of transcription, voice recognition

software, and direct entry by an EP or any combination of these. Another caveat is that progress

notes not be required to be entered as structured data. The third category supports exclusion of

progress notes as an objective for two fundamentally different reasons. Some commenters
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supported exclusion because they believe that the volume of objectives was already too high for

Stage 1 of meaningful use and therefore opposed anything that would increase the volume.

Other commenters agree with our proposal that progress notes is already a fundamental part of

current EHR products and did not represent a move that advances the use of EHRs.

Response: We predicated our discussion in the proposed rule on the assumption that

progress notes are a component of basic EHR functionality. We still believe this is the case and

have not received evidence to the contrary. However, we failed to clearly articulate the

ramifications of our belief. Our view continues to be that an EP who incorporates the use of

EHRs into a practice and complies with meaningful use criteria is unlikely to maintain separate

paper progress notes outside of the EHR system. We believe that the potential disruption in

workflow of the efforts to merge paper progress notes with the other records in certified EHR

technology in order to have a complete medical record far outweighs the burden of electronically

capturing progress notes. Moreover, we continue to believe this is a highly unlikely scenario.

As with any meaningful use objective, it is important to have clear, definitive definitions.

However, our observations of discussions held in public forums by the medical community and

review of literature have led us to conclude that it not possible to provider a clear, definitive

definition of a progress note at this time. We note that commenters recommending the

documentation of a progress note be included as an objective did not attempt to define the term.

Nor did commenters suggest an associated measure. We continue to believe that there is

insufficient need and upon review believe there is insufficient consensus regarding the term

progress note to include this objective for Stage 1 of meaningful use.

After consideration of the public comments received, we do not include this meaningful

use objective in the final rule.

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NPRM EP/Eligible Hospital Measure: N/A

NPRM EP Objective: Implement five clinical decision support rules relevant to specialty or

high clinical priority, including for diagnostic test ordering, along with the ability to track

compliance with those rules.

NPRM Eligible Hospital Objective: Implement 5 clinical decision support rules related to a

high priority hospital condition, including diagnostic test ordering, along with the ability to track

compliance with those rules.

First, we make a technical correction. On page 1856 of the proposed rule, we described

this objective for eligible hospitals as “Implement five clinical decision support rules relevant to

specialty or high clinical priority, including for diagnostic test ordering, along with the ability to

track compliance with those rules.” The underlined language was inappropriately carried over

from the EP objective in this instance and in the regulation text. The table contained our

intended language of “Implement 5 clinical decision support rules related to a high priority

hospital condition, including diagnostic test ordering, along with the ability to track compliance

with those rules.” Many commenters pointed this discrepancy out to us and we appreciate their

diligence.

Comment: Nearly half of the commenters mentioning clinical decision support suggested

that the term needed additional clarification. Some commenters said that the term was too vague

and open to interpretation while others said it was too specific. Other commenters provided

recommendations on what a clinical decision support rule should mean or which elements it

should include. These were evidence-based medicine templates, decision trees, reminders,

linked online resources, scientific evidence, and consensus.

CMS-0033-F 146

Response: In the proposed rule, we described clinical decision support as HIT

functionality that builds upon the foundation of an EHR to provide persons involved in care

processes with general and person-specific information, intelligently filtered and organized, at

appropriate times, to enhance health and health care. We purposefully used a description that

would allow a provider significant leeway in determining the clinical decision support rules that

are more relevant to their scope of practice and benefit their patients in the greatest way. In the

proposed rule, we asked providers to relate the rules they select to clinical priorities and

diagnostic test ordering. We do not believe that adding a more limiting description to the term

clinical decision support would increase the value of this objective. We believe that this

determination is best left to the provider taking into account their workflow and patient

population.

Comment: Several commenters objected to the requirement of five clinical decision

support rules when the HIT Policy Committee only recommended one. Others disagreed with

our proposed assertion that most EPs would report on at least five clinical quality measures from

section II.A.3 of the proposed rule and eligible hospitals will all report on at least five.

Response: We accept the argument that there is value in focusing initial CDS efforts on a

single CDS rule in order to get it right the first time and lay the foundation for future, broader

CDS implementation. This will help to prevent the unintended negative consequences associated

with poorly implemented CDS systems when providers have attempted to do too much too soon.

We agree that the appropriate balance is to require some degree of meaningful use of CDS in

Stage 1 without overburdening providers with too many areas to focus on at once. Since CDS is

one area of health IT in which significant evidence exists that it can have a substantial positive

impact on the quality, safety and efficiency of care delivery, it is important that it be included as
CMS-0033-F 147

a core objective with this more limited expectation. That requirement will assure that all

meaningful users have taken the first steps in CDS implementation but allow them to focus as

necessary on a single high-priority area at the outset in order to ensure that they can devote the

appropriate level of attention to their first CDS priority. We anticipate that this will set the

foundation for much more expansive CDS support in the near future.

Comment: A commenter inquired if modification of the clinical decision support tool

negates the EHR’s certification status.

Response: We believe this is a question on certification status and is outside of the scope

of this rule. ONC discusses what would affect Certified EHR Technology’s certified status in

their final rule (75 FR 36157) entitled "Establishment of the Temporary Certification Program

for Health Information Technology".

After consideration of the public comments received, we are modifying the meaningful

use objective for EPs at 495.6(d)(11)(i) to “Implement one clinical decision support rule relevant

to specialty or high clinical priority along with the ability to track compliance with that rule.”

After consideration of public comments received, we are modifying the meaningful use

objective for eligible hospitals and CAHs at §495.6(f)(10)(i) of our regulations as “Implement

one clinical decision support rule related to a high priority hospital condition along with the

ability to track compliance with that rule.”

We believe that clinical decision support is one of the most common tools that uses the

information collected as structured data included in the core set and therefore also include

clinical decision support in the core as the information needed to support it are already included

in the core set.

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NPRM EP/Eligible Hospital Measure: Implement five clinical decision support rules relevant

to the clinical quality metrics the EP/Eligible Hospital is responsible for as described further in

section II.A.3. of this final rule.

In the proposed rule, we said that clinical decision support at the point of care is a critical

aspect of improving quality, safety, and efficiency. Research has shown that decision support

must be targeted and actionable to be effective, and that “alert fatigue” must be avoided.

Establishing decision supports for a small set of high priority conditions, ideally linked to quality

measures being reported, is feasible and desirable. Meaningful use seeks to ensure that those

capabilities are utilized.

Comment: Commenters, both in the requests for clarification of the term clinical

decision support and explicitly in response to this measure, expressed concern about the linkage

to a particular quality measure.

Response: We agree that such linkage puts constraints on the provider and eliminates

many types of clinical decision support rules that may be beneficial. Therefore, we revise this

measure to require that at least one of the five rules be related to a clinical quality measure,

assuming the EP, eligible hospital or CAH has at least one clinical quality measure relevant to

their scope of practice. However, we strongly encourage EPs, eligible hospitals and CAHs to

consider the clinical quality measures as described in section II.A.3 when deciding which

additional rules to implement for this measure.

Comment: Several commenters, including the HIT Policy Committee, recommended that

we focus at least one clinical decision support rule on efficiency of care.

Response: In light of decision to limit the objective to one clinical decision support rule,

we do not believe that it is appropriate to further to link that rule to specific requirements and
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therefore give the EP, eligible hospital or CAH discretion on what to focus the clinical decision

support rule used to satisfy this measure.

Comment: A few commenters asked for clarification of how the “…with the ability to

track compliance with those rules” language of the proposed objective for clinical decision

support rules relates to the associated measures.

Response: While an integral part of the objective and certified EHR technology, we did

not include this aspect of the objective in the measure for Stage 1 of meaningful use. An EP,

eligible hospital, or CAH is not required to demonstrate to CMS or the States its compliance

efforts with the CDS recommendations or results for Stage 1 either at initial attestation or during

an subsequent review of that attestation.

After consideration of the public comments received, we are modifying the meaningful

use measure for EPs at §495.6(e)(11)(ii) and for eligible hospitals and CAHs at §495.6(g)(10)(ii)

to “Implement one clinical decision support rule.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.304(e) for EPs and 45 CFR 170.306(c). The ability to calculate the

measure is included in certified EHR technology.

Given the added flexibility added to this measure in the final rule, we do not believe that

any EP, eligible hospital, or CAH would be in a situation where they could not implement one

clinical decision support rules as described in the measure. Therefore, there are no exclusions for

this objective and its associated measure.

NPRM EP/Eligible Hospital Objective: Submit claims electronically to public and private

payers.
CMS-0033-F 150

Comment: Over three quarters of those commenting on this objective recommended that

it be eliminated for various reasons. The majority of the other commenters requested a

modification. Reasons given are:

- Electronic claims submission is already covered under HIPAA;

- Electronic claims submission is not part of traditional EHR technology;

- Billing systems would have to be certified adding to cost and burden of compliance with

meaningful use even though when electronic claims submission for Medicare is already

in place for all by the very smallest of providers;

- Electronic claims submission falls outside of the scope of the statutory mandate given by

Congress to implement the HITECH legislation to improve care delivery through broad

scale adoption and utilization of Electronic Health Record technologies. This function

does not impact the quality of care delivered and relies on product components that are

traditionally part of practice management systems;

- Private payers may customize the HIPAA-recognized standard transactions, which limits

the ability of practices to obtain accurate information prior to receiving an Explanation of

Benefits based on the actual services provided and negates many of the benefits of having

standardized transactions;

- Workers’ compensation and auto insurers do not accept electronic claims; and

- Many providers use clearinghouses and they requested that the burden of electronic

submission be shifted to the clearinghouse.

Response: In our proposed rule, we specifically cite that the existence of standard

transactions available under HIPAA for submitting claims as a reason for including this objective

as a meaningful use objective for Stage 1. We also disagree that this objective is outside the
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scope of meaningful use as defined by the HITECH legislation. The HITECH legislation states

the Secretary shall seek to improve not only health care quality, but also the use of electronic

health records. In addition, we note that sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act

provide that to be considered a meaningful EHR user, an EP, eligible hospital, or CAH must

demonstrate use of certified EHR technology in a meaningful manner as defined by the

Secretary. In the Medicaid context, any demonstration of meaningful use must be “acceptable to

the Secretary” under 1903(t)(6). We believe this language gives us broad discretion to require

the use of certified EHR technology in a manner that not only improves health care quality, but

results in gains in efficiency, patient engagement and enhances privacy and security. Under the

broad definition of electronic health record established by ONC in their final rule, electronic

exchange of eligibility information and claims submission could certainly improve the use of

electronic health records.

We believe that inclusion of administrative simplification in meaningful use is an

important long-term policy goal for several reasons. First, administrative simplification can

improve the efficiency and reduce unnecessary costs in the health care system as a whole; the

small percentage of paper claims submitted represent a disproportionate administrative cost for

health plans; the reconciliation of billing charges for services not eligible for payment creates a

significant burden for providers, health plans, and most significantly, for patients. Second, the

integration of administrative and clinical information systems is necessary to support effective

management and coordinated care in physician practices. The ability to leverage clinical

documentation in support of appropriate charge capture (for example, for preventive counseling,

or immunizations provided), the ability to link lists of patients needing clinical reminders with

patient contact information, the ability to stratify quality measures by patient demographic
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factors (for example, race/ethnicity) and insurer status (for example, Medicare beneficiaries), are

examples.

In addition, there are important benefits to the inclusion of administrative transactions in

criteria and standards for the certification of EHR technologies. The option of modular

certification provides an opportunity for eligible professionals and hospitals to use practice

management systems or clearinghouses that provide these functions as components of their

certified EHR technologies. However, we recognize there is not current agreement as to which

systems constitute an EHR and that many entities may view their billing system to be outside

their EHR and that the vendors of some practice management systems that provide these

functionalities in doctors’ offices today may not be prepared to seek certification for these legacy

products in 2010/ 2011. We also recognize that the introduction of the X12 5010 standards in

January 2012 would further complicate the certification process for stage 1. We also

acknowledge that we do not have the ability to impose additional requirements on third-party

payers or clearinghouses to participate in this exchange beyond what is required by HIPAA.

Based on these considerations, we are not including this objective in the final rule for Stage 1 of

meaningful use.

However, the introduction of these new X12 5010 standards, and the coming introduction

of ICD-10 in 2013 provides an opportunity for change in Stage 2 of meaningful use. In order to

meet these and other administrative simplification provisions, most providers will have to

upgrade their practice management systems or implement new ones. This provides an important

opportunity to achieve alignment of capabilities and standards for administrative transactions in

EHR technologies with the administrative simplification provisions that the Affordable Care Act

provides for health plans and health plan clearinghouses. We therefore intend to include
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administrative transactions as a part of Stage 2 of meaningful use, and expect providers and

vendors to take this into consideration in their decisions leading up to 2013.

Comment: Commenters focusing on how meaningful use would translate into the

Medicare Advantage program said that the measure of checking eligibility electronically and

submitting claims electronically for 80 percent of patients seen would not be possible. They

explained that for most of their visits, there is no insurance company with which to check, and

there is no insurance company to whom to submit claims. They described themselves as a

capitated system and for most of the patient visits, the concept of checking eligibility and

submitting claims in not relevant.

Response: This comment illustrates the difficulties in adopting FFS Medicare

meaningful use measures for qualifying MA organizations, MA-affiliated hospitals and MA EPs.

For purposes of determining meaningful use in a Medicare Advantage environment, we agree

that submitting claims electronically is not a useful standard in a capitated environment where

virtually all patients are members of the same insurance plan.

After consideration of the public comments received, we are not finalizing the objective

“Submit claims electronically to public and private payers”.

NPRM EP/Eligible Hospital Measure: At least 80 percent of all claims filed electronically by

the EP or the eligible hospital.

We received many comments on the difficulty in calculating this measure. However, as

all measures are tied to objectives and we do not finalize this objective we also do not finalize

the measure.

NPRM EP/Eligible Hospital Objective: Check insurance eligibility electronically from public

and private payers.

CMS-0033-F 154

Comment: Over three quarters of those commenting on this objective recommended that it

be eliminated for various reasons. Some of the most common reasons for elimination are:

- Electronic eligibility checks are already covered under HIPAA;

- Electronic eligibility checks are not part of traditional EHR technology;

- Billing and practice management systems that are used for electronic eligibility checks

would have to be certified as certified EHR technology adding to cost and burden;

- Electronic eligibility checks is outside of the scope of the mandate given by Congress to

implement the HITECH legislation in such a way as to improve care delivery through

broad scale adoption and utilization of Electronic Health Record technologies. This

function does not impact the quality of care delivered and relies on product components

that are traditionally part of practice management systems;

- Information returned on typical electronic eligibility checks is of little use to providers –

as responses are usually a yes/no answer on coverage, but not the specificity of coverage;

- The current poor adoption rate of the use of electronic eligibility verification is indicative

of the deficiencies in current methods;

- Once eligibility checking becomes easy to use and reliable, no incentive will be required

as providers will adopt the process readily;

- Payers do not guarantee their eligibility results;

- Many payers are still not in compliance with the HIPAA 270/271 electronic eligibility

standard. Therefore the objective should only be required if compliance with the standard

by health plans can be guaranteed; and

- Private payers may customize the HIPAA-recognized standard transactions, which limits

the ability of practices to obtain accurate information prior to receiving an Explanation of

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Benefits based on the actual services provided and negates many of the benefits of having

standardized transactions.

Response: In our proposed rule, we specifically cite the existence of the standard

transaction for eligibility checks available under HIPAA as an enabling factor for the inclusion

this objective. As with the electronic claims submission objective discussed above, we disagree

that this objective is outside the scope of meaningful use as defined by the HITECH legislation.

The HITECH legislation requires the Secretary to seek to improve not only health care quality,

but also the use of electronic health records. Under the broad definition of electronic health

record established by ONC in their final rule, electronic exchange of eligibility information could

certainly improve the use of electronic health records. However, we recognize there is not

current agreement as to which systems constitute an EHR and that many entities may view their

practice management system to be outside their EHR. We also acknowledge that we do not have

the ability to impose additional requirements on third-party payers to participate in this exchange

beyond what is required by HIPAA. Third-party payers can provide simple yes/no responses,

modify the standard transactions and do not have to guarantee their results. We agree with

commenters that this significantly devalues the results of this objective. However, we do believe

that as electronic records and exchange based on this and considerations that commenters nearly

universally considered this to not be a function of EHR, we are not including this objective in the

final rule for Stage 1 of meaningful use. However, we do believe that inclusion of a robust

system to check insurance eligibility electronically is an important long term policy goal for

meaningful use of certified EHR technology and we intend to include this objective as well as

electronic claims submission Stage 2.

CMS-0033-F 156

After consideration of the public comments received, we are not finalizing the objective

to “Check insurance eligibility electronically from public and private payers” or any

modification thereof. Given that we are not finalizing the objective, we also are not finalizing

the associated EP and eligible hospital/CAH measures.

The second health outcomes policy priority identified by the HIT Policy Committee is to

engage patients and families in their healthcare. The following care goal for meaningful use

addresses this priority:

● Provide patients and families with timely access to data, knowledge, and tools to make

informed decisions and to manage their health

As explained in the proposed rule, we do not intend to preempt any existing Federal or

State law regarding the disclosure of information to minors, their parents, or their guardians in

setting the requirements for meaningful use. For this reason, we defer to existing Federal and

State laws as to what is appropriate for disclosure to the patient or their family. For purposes of

all objectives of the Stage 1 criteria of meaningful use involving the disclosure of information to

a patient, a disclosure made to a family member or a patient's guardian consistent with Federal

and State law may substitute for a disclosure to the patient.

Comment: Several commenters requested that all objectives under the health care policy

priority be combined, as they are redundant.

Response: We disagree that they are redundant and believe each serves a unique

purpose. We will more fully describe those purposes in the discussion of each objective.

NPRM EP Objective: Provide patients with an electronic copy of their health information

(including diagnostics test results, problem list, medication lists, allergies) upon request.
CMS-0033-F 157

NPRM Eligible Hospital Objective: Provide patients with an electronic copy of their health

information (including diagnostic test results, problem list, medication lists, allergies, discharge

summary, procedures), upon request

The purpose of this objective is to provide a patient’s health information to them

electronically and in a human readable format and in accordance with the standards specified in

the ONC final rule subject to its availability to the provider electronically and any withholding

under regulations related to the HIPAA Privacy Act at 45 C.F.R. 164.524, Access of individuals

to protected health information.

In the proposed rule, we indicated that electronic copies may be provided through a

number of secure electronic methods (for example, personal health record (PHR), patient portal,

CD, USB drive). We have changed this description in response to comments to that when

responding to patient requests for information, the EP, eligible hospital, or CAH should

accommodate patient requests in accordance with 45 C.F.R. 164.524, Access of individuals to

protected health information. The objective provides additional criteria for meeting meaningful

use concerning the electronic copy or provision of information that the EP, eligible hospital or

CAH maintains in or can access from the certified EHR technology and is maintained by or on

behalf of the EP, eligible hospital or CAH.

Comment: We received requests for clarification that only information that the EP,

eligible hospital, or CAH has available electronically must be provided to the patient.

Response: Yes, we limit the information that must be provided electronically to that

information that exists electronically in or accessible from the certified EHR technology and is

maintained by or on behalf of the EP, eligible hospital or CAH. We believe it is impractical to

require information maintained on paper to be transmitted electronically. Furthermore, given the

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other criteria of Stage 1 of meaningful use, we believe sufficient information will be available

through certified EHR technology, especially given the inclusion of many of the foundational

objectives that were included in the core set.

Comment: Commenters pointed out that the HIPAA Privacy Rule permits licensed

healthcare professionals to withhold certain information if its disclosure would cause substantial

harm to the patient or another individual.

Response: As previously discussed for patient preference, we do not seek to conflict with

or override HIPAA through meaningful use requirements. Therefore, an EP, eligible hospital, or

CAH may withhold information from the electronic copy of a patient’s health information in

accordance with the regulations at 45 C.F.R. 164.524, Access of individuals to protected health

information.

Comment: Commenters requested clarification of the term “health information” or

alternatively a list of elements required to satisfy the objective.

Response: Subject to the withholding described above, an EP, eligible hospital, or CAH

should provide a patient with all of the health information they have available electronically. At

a minimum, this would include the elements listed in the ONC final rule at 45 CFR 170.304(f)

for EPs and 45 CFR 170.306 (d) for eligible hospitals and CAHs as required for EHR technology

to become certified.

Comment: Several commenters indicated that a provider should be allowed to charge a

fee for providing an electronic copy of a patient’s health information.

Response: We do not have the authority under the HITECH Act to regulate fees in this

manner. Rather, the charging of fees for this information is governed by the HIPAA Privacy

Rule at 45 C.F.R. 164.524(c)(4) (which only permits HIPAA covered entities to charge an
CMS-0033-F 159

individual a reasonable, cost-based fee for a copy of the individual’s health information). We

would expect these costs to be very minimal considering that the ability to generate the copy is

included in certified EHR technology. Additional clarification on the fee that a HIPAA covered

entity may impose on an individual for an electronic copy of the individual’s health information

will be addressed in upcoming rulemaking.

Comment: Commenters pointed out that the general term “allergies” is inconsistent with

other objectives of Stage 1 and with the capabilities mandated by certification under the ONC

IFR, which address only medication allergies.

Response: As we have stated on several other objectives, we encourage all EPs, eligible

hospitals, and CAHs to work with their EHR technology designers to make capabilities most

relevant to their individual practices of care. However, we have maintained that at a minimum

the capabilities that are part of certification should be included and those should be the basis for

meaningful use so we do modify this objective to medication allergies to align it with other

objectives and certification.

After consideration of the public comments received, we are modifying the meaningful

use objective for EPs at §495.6(d)(12)(i) of our regulations to “Provide patients with an

electronic copy of their health information (including diagnostics test results, problem list,

medication lists, medication allergies) upon request” and for eligible hospitals and CAHs at

§495.6(f)(11)(i) of our regulations to “Provide patients with an electronic copy of their health

information (including diagnostic test results, problem list, medication lists, medication allergies,

discharge summary, procedures), upon request”.

CMS-0033-F 160

We include this objective in the core set as it is integral to involving patients and their

families in their provision of care and was recommended by the HIT Policy Committee for

inclusion in the core set.

NPRM EP/Eligible Hospital Measure: At least 80 percent of all patients who request an

electronic copy of their health information are provided it within 48 hours.

In the proposed rule, we pointed out that all patients have a right under ARRA to an

electronic copy of their health information. We said that our purpose for including it in

meaningful use was to ensure that this requirement in met in a timely fashion. We also said that

providing patients with an electronic copy of their health information demonstrates one of the

many benefits health information technology can provide and we believe that it is an important

part of becoming a meaningful EHR user. We received requests for clarifications on what must

be provided and in what timeframe. We address those requests in the comment and response

section below. We note here that participation in the Medicare and Medicaid EHR incentive

programs is voluntary. Nothing in the Stage 1 criteria of meaningful use supersedes or exempts

an EP, eligible hospital or CAH from complying with otherwise applicable requirements to

provide patients with their health information.

Comment: An overwhelming majority of commenters commenting on this objective

indicated that the 48-hour time frame is too short and inconsistent with the HIPAA Privacy Rule.

Response: We discuss the reasoning for the time frame in the proposed rule. We state

that this measure seeks to ensure that a patient’s request is met in a timely fashion. Providing

patients with an electronic copy of their health information demonstrates one of the many

benefits health information technology can provide. We also believe that certified EHR

technology will provide EPs, eligible hospitals, and CAHs more efficient means of providing
CMS-0033-F 161

copies of health information to patients, which is why we proposed that a request for an

electronic copy be provided to the patient within 48 hours.

In the final rule, we further point out that this objective is limited to health information

maintained and provided electronically while HIPAA can require the retrieval, copying and

mailing of paper documents. For this reason, we do not believe the timeframes under this

meaningful use objective and the HIPAA Privacy Rule must be aligned. However, we appreciate

that the 48-hour timeframe may be burdensome for some providers, particularly for those

providers who do not operate 24/7. We therefore are lengthening the timeframe to three

business days. Business days are defined as Monday through Friday excluding federal or state

holidays on which the EP, eligible hospital, or CAH or their respective administrative staffs are

unavailable. As an example if a patient made a request for an electronic copy of their health

information on Monday then the EP, eligible hospital, or CAH would have until the same time

on Thursday to provide the information assuming there were no intervening holidays. If

provision of the copy involves the mailing of physical electronic media, then it would need to be

mailed on the Thursday.

Comment: Some commenters believed the 80 percent threshold was too high or

introduced examples of extraordinary circumstances such as natural disasters or system crashes

that would indicate a lower threshold is needed to accommodate them.

Response: We reduce the threshold to over 50 percent as this objective meets the criteria

of relying solely on a capability included as part of certified EHR technology and is not, for

purposes of Stage 1 criteria, reliant on the electronic exchange of information, as explained under

our discussion of the objective of maintain an up-to-date problem list. As this is a relatively new

capability that was not available to either providers or patients before the introduction of EHRs,
CMS-0033-F 162

we do not believe it meets the same standard of practice as maintaining an up-to-date problem

list and therefore adopt a threshold of 50 percent (rather than 80 percent).

Comment: We received comments that were concerned about the reporting burden of

this requirement.

Response: We believe that as long as the request by the patient is accurately recorded in

the certified EHR technology then the certified EHR technology should be able to calculate the

measure. Recording patient requests for certain actions should be part of the expectations of

meaningful use of certified EHR technology. If the EP, eligible hospital, or CAH records the

requests using certified EHR technology, certified EHR technology will be able to assist in

calculating both the numerator and denominator. If the requests are recorded by another means at

the choice of the provider, the provider would be responsible for determining the denominator.

Comment: Commenters inquired if third-party requests for information are included in

the denominator.

Response: Only specific third party requests for information are included in the

denominator. As we stated in the opening discussion for this health care priority, providing the

copy to a family member or patient’s authorized representative consistent with federal and state

law may substitute for a disclosure of the information to the patient and count in the numerator.

A request from the same would count in the denominator. All other third party requests are not

included in the numerator or the denominator.

Comment: Commenters inquired if asking the patient to register for their own personal

health record (PHR) satisfies the intent of the objective.

Response: EPs, eligible hospitals and CAHs are to provide the information pursuant to

the reasonable accommodations for patient preference under 45 CFR164.522(b). To be included

CMS-0033-F 163

in this measure, the patient has already requested an electronic method. While having a third

party PHR certainly would be one method, assuming the provider could populate the PHR with

all the information required to meet this objective. The provider should provide the same level

of assistance to the patient that would be provided as if they maintained their own patient portal.

Comments: Comments were received requesting the format and media for the provision

of the health information.

Response: As this is for use by the patient, the form and format should be human

readable and comply with the HIPAA Privacy Rule, as specified at 45 CFR 164.524(c). In

addition, efforts should be made to make it easily understandable to the patient. The media

could be any electronic form such as patient portal, PHR, CD, USB fob, etc. As stated in the

previous response, EPs, eligible hospitals and CAHs are expected to make reasonable

accommodations for patient preference as outlined in 45 CFR 164.522(b).

After consideration of the public comments received, we are modifying the meaningful

use measure for EPs at §495.6(d)(12)(i) and for eligible hospitals at §495.6(f)(11)(i) of our

regulations to “More than 50 percent of all patients of the EP or the inpatient or emergency

departments of the eligible hospital or CAH (POS 21 or 23) who request an electronic copy of

their health information are provided it within 3 business days”.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.304(f) for EPs and 45 CFR 170.306 (d) for eligible hospitals and

CAHs. The ability to calculate the measure is included in certified EHR technology.

As the provision of the electronic copy is limited to the information contained within

certified EHR technology, this measure is by definition limited to patients whose records are
CMS-0033-F 164

maintained using certified EHR technology as described previously in this section under our

discussion of the burden created by the measures associated with the Stage 1 meaningful use

objectives.

To calculate the percentage, CMS and ONC have worked together to define the following for

this objective:

• Denominator: The number of patients of the EP or eligible hospital’s or CAH’s inpatient

or emergency departments (POS 21 or 23) who request an electronic copy of their electronic

health information four business days prior to the end of the EHR reporting period.

• Numerator: The number of patients in the denominator who receive an electronic copy of

their electronic health information within three business days.

• Threshold: The resulting percentage must be more than 50 percent in order for an EP,

eligible hospital, or CAH to meet this measure. As addressed in other objectives and in comment

response, if the EP, eligible hospital, or CAH has no requests from patients or their agents for an

electronic copy of patient health information during the EHR reporting period they would be

excluded from this requirement as described previously in this section under our discussion of

whether certain EP, eligible hospital or CAH can meet all Stage 1 meaningful use objectives

given established scopes of practices.

NPRM Eligible Hospital Objective: Provide patients with an electronic copy of their discharge

instructions and procedures at time of discharge, upon request.

The purpose of this objective is to provide the option to patients to receive their discharge

instructions electronically. Discharge instructions would not necessarily be included in a copy of

health information and it is unlikely that a patient would request a copy of their health

information at every discharge. This objective is unique to eligible hospitals and CAHs.
CMS-0033-F 165

Comment: We received several comments suggesting that we eliminate or clarify the

term “procedures”.

Response: As we believe the terms "instructions" and "procedures" are interchangeable

as used in this objective, we are removing the term “procedures” from the objective. We left this

term in the provision of electronic copy of health information as the term “instructions” is not in

that objective. We clarify that the term “instructions” means any directions that the patient must

follow after discharge to attend to any residual conditions that need to be addressed personally

by the patient, home care attendants, and other clinicians on an outpatient basis.

Comment: Commenters pointed out that the HIPAA Privacy Rule permits licensed

healthcare professionals to withhold certain information if its disclosure would cause substantial

harm to the patient or another individual.

Response: We reiterate that it is not our intent for the meaningful use objectives to

conflict or override the HIPAA Privacy Rule through meaningful use requirements. Therefore

an EP, eligible hospital, or CAH may withhold information from the electronic copy to the extent

they are permitted or required to do so in accordance with the regulations at 45 CFR 164.524.

Comment: Some commenters recommended that hospitals should be required to either

provide every patient an electronic copy of their discharge instructions or at least inform them of

the option to receive it electronically.

Response: We believe it would be too burdensome to provide every patient an electronic

copy of his or her discharge instructions. Furthermore, we anticipate that many, if not most,

patients will prefer a paper copy during the years of Stage 1. While we certainly encourage

eligible hospitals to inform their patients of the option to receive their discharge instructions
CMS-0033-F 166

electronically, we do not see requiring this as within the scope of meaningful use of certified

EHR technology for Stage 1.

Comment: Comments were received requesting a clarification of the data that should be

included in the discharge instructions.

Response: This objective simply refers to the option of the electronic provision of

instructions that would be provided to the patient. We believe eligible hospitals are the

appropriate entity to determine the information that should be included in the discharge

instructions.

Comment: Comments were received requesting the format and media for the discharge

instructions.

Response: As this is for use by the patient, the form and format should be human

readable and comply with the HIPAA Privacy Rule, as specified at 45 CFR 164.524(c). In

addition, efforts should be made to make it easily understandable to the patient. The media could

be any electronic form such as patient portal, PHR, CD, USB fob, etc. EPs, eligible hospitals and

CAHs are expected to make reasonable accommodations for patient preference as outlined in 45

CFR 164.522(b).

After consideration of the public comments received, we are finalizing the objective at

495.6(f)(12)(i) of our regulations as proposed.

We include this objective in the core set as it is integral to involving patients and their

families in their provision of care and was recommended by the HIT Policy Committee for

inclusion in the core set.

CMS-0033-F 167

NPRM Eligible Hospital Measure: At least 80 percent of all patients who are discharged from

an eligible hospital and who request an electronic copy of their discharge instructions and

procedures are provided it.

Comment: Some commenters believed the 80 percent threshold was too high or

introduced examples of extraordinary circumstances that would indicate that a lower threshold is

needed to accommodate them.

Response: We reduce the threshold to over 50 percent as this objective meets the criteria

of relying solely on a capability included as part of certified EHR technology and is not, for

purposes of Stage 1 criteria, reliant on the electronic exchange of information. However, as this

is a relatively new capability that was not available to either providers or patients before the

introduction of EHRs we do not believe it meets the same standard of practice as maintaining an

up-to-date problem list and therefore adopt a threshold of50 percent (rather than 80 percent).

Comment: Some commenters expressed concern about the reporting burden imposed by

this requirement.

Response: We believe that as long as the request by the patient is accurately recorded in

the certified EHR technology then the certified EHR technology should be able to calculate the

measure. We believe that recording patient requests for certain actions that involve the use of

certified EHR technology should be part of EPs, eligible hospitals and CAHs standard practice.

If the eligible hospital or CAH records the requests using certified EHR technology, certified

EHR technology will be able to assist in calculating both the numerator and denominator. If the

requests are recorded by another means at the choice of the provider, the provider would be

responsible for determining the denominator.

CMS-0033-F 168

Comment: Several of the comments requested clarification of the timeframe in which the

discharge instructions should be provided to the patient.

Response: As discussed previously, this objective simply refers to the option of the

electronic provision of instructions that would be provided to the patient at the time of discharge.

Therefore, we believe for the information to be useful to the patient, the instructions themselves

or instructions on how to access them electronically should be furnished at the time of discharge

from the eligible hospital or CAH.

Comment: Some comments expressed concern that providing an electronic copy of

discharge instructions to the patient at the time of discharge would disrupt workflows and

lengthen the discharge process resulting in reduced bed turnover in emergency departments.

Response: As discussed previously, this objective simply refers to the option of the

electronic provision of instructions that would be provided to the patient at the time of discharge.

We do not believe the provision of an electronic copy of the discharge instructions, upon request,

at the time of discharge alters current workflow or lengthens the discharge process. A patient

could be provided instructions on how to access an internet website where they can get the

instructions or asked to provide an email address or simply be handed electronic media instead of

or in addition to a paper copy.

After consideration of the public comments received, we are modifying the meaningful

use measure at §495.6(f)(12)(ii) of our regulations to “More than 50 percent of all patients who

are discharged1 from an eligible hospital’s or CAH’s inpatient or emergency department (POS 21

or 23) and who request an electronic copy of their discharge instructions are provided it”.

1
Please note that although the final rule meaningful use measures refer to patients discharged from an emergency
department, such emergency room releases are not eligible hospital discharges for purpose of determining hospital
payment incentives under section 1886(n) of the Act. Section 1886(n) payments are only with respect to “inpatient”
hospital services pursuant to section 1886(n)(1)(A) of the Act.
CMS-0033-F 169

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.306(e). The ability to calculate the measure is included in certified EHR

technology.

As with the previous objective, the provision of the electronic copy of the discharge

summary is limited to the information contained within certified EHR technology; therefore this

measure is by definition limited to patients whose records are maintained using certified EHR

technology as described previously in this section under our discussion of the burden created by

the measures associated with the Stage 1 meaningful use objectives.

To calculate the percentage, CMS and ONC have worked together to define the following for

this objective:

• Denominator: Number of patients discharged from an eligible hospital’s or CAH’s inpatient

or emergency department (POS 21 or 23) who request an electronic copy of their discharge

instructions and procedures during the EHR reporting period.

• Numerator: The number of patients in the denominator who are provided an electronic copy

of discharge instructions.

• Threshold: The resulting percentage must be more than 50 percent in order for an EP, eligible

hospital, or CAH to meet this measure.

As addressed in other objectives and in comment response, if the eligible hospital or CAH has no

requests from patients or their agents for an electronic copy during the EHR reporting period

they would be excluded from this requirement as described previously in this section under our

discussion of whether certain EP, eligible hospital or CAH can meet all Stage 1 meaningful use

objectives given established scopes of practices..

CMS-0033-F 170

NPRM EP Objective: Provide patients with timely electronic access to their health information

(including lab results, problem list, medication lists, and allergies) within 96 hours of the

information being available to the EP.

In the proposed rule, we described timely as within 96 hours of the information being

available to the EP through either the receipt of final lab results or a patient interaction that

updates the EP's knowledge of the patient's health. We said we judged 96 hours to be a

reasonable amount of time to ensure that certified EHR technology is up to date and welcomed

comment on if a shorter or longer time is advantageous. We did receive comments on the time

frame and have revised it as discussed below in the comment and response section.

Comment: We received comments recommending that “access” be clarified to determine

whether this is online access as indicated in the ONC certification criteria for certified EHR

technology or just electronic access.

Response: We believe we inadvertently created confusion by listing the examples of

electronic media (CD or USB drive) in which this access could be provided. As many

commenters inferred, it was our intention that this be information that the patient could access on

demand such as through a patient portal or PHR. We did not intend for this to be another

objective for providing an electronic copy of health information upon request.

Comment: Several commenters requested that all objectives included in the health care

policy priority “engage patients and their families” be combined, as they are redundant.

Response: We disagree that they are redundant and believe each serves a unique

purpose. We regret any confusion created by the inclusion of CD or USB drive as examples of

electronic media caused in the intent of this measure. The difference between electronic access

and an electronic copy is that a patient with electronic access can access the information on
CMS-0033-F 171

demand at anytime while a patient must affirmatively request an electronic copy from the EP,

eligible hospital or CAH at a specific time and the information in the copy is current only as of

the time that the copy is transferred from the provider to the patient.

Comment: Some commenters asserted that some results and other sensitive information

are best communicated at a face-to-face encounter.

Response: We agree that there may be situations where a provider may decide that

electronic access of a portal or Personal Health Record is not the best forum to communicate

results. Within the confines of laws governing patient access to their medical records, we would

defer to EP’s, eligible hospital or CAH’s judgment as to whether to hold information back in

anticipation of an actual encounter between the provider and the patient. Furthermore just as in

the provision of electronic copy, an EP may withhold information from being accessible

electronically by the patient in accordance with regulations at 45 CFR 164.524. Any such

withholding would not affect the EP’s, eligible hospital’s or CAH’s ability to meet this objective

as that information would not be included. We do not believe there would be a circumstance

where all information about an encounter would be withheld from the patient and therefore no

information would be eligible for uploading for electronic access. If nothing else, the

information that the encounter occurred can be provided. Please note that providers must

comply with all applicable requirements under the HIPAA Privacy Rule, including 45 CFR

164.524.

Comment: We received several comments stating that the time frame of 96 hours is too

burdensome for EPs.

Response: While we believe that 96 hours is sufficient, most EPs do not operate 24/7.

Therefore, we will limit the timeframe to business days, in effect changing the timeframe from
CMS-0033-F 172

96 hours in the proposed rule to four business days. Business days are defined as Monday

through Friday excluding federal or state holidays on which the EP, eligible hospital or CAH or

their respective administrative staffs are unavailable.

Comment: Commenters pointed out that allergies is inconsistent with other objectives of

Stage 1 and with the capabilities mandated by certification under the ONC final rule.

Response: As we have stated on several other objectives, we encourage all EPs, eligible

hospitals, and CAHs to work with their EHR technology designers to make capabilities as

relevant to their individual practices of care as possible. However, we maintain that at a

minimum the capabilities that are part of certification should be included in certified EHR

technology so we do modify this objective to medication allergies to align it with other

objectives and certification.

After consideration of the public comments received, we are modifying the objective for

EPs at §495.6(d)(6)(i) of our regulations to “Provide patients with timely electronic access to

their health information (including lab results, problem list, medication lists, medication

allergies) within four business days of the information being available to the EP”.

NPRM EP Measure: At least 10 percent of all unique patients seen by the EP are provided

timely electronic access to their health information.

In the proposed rule, we said that we recognize that many patients may not have internet

access, may not be able or interested to use a patient portal. Health systems that have actively

promoted such technologies have been able to achieve active use by over 30 percent of their

patients, but this may not be realistic for many practices in the short term. We received

comments on this justification for the threshold and requests for clarification, which are

addressed in the comment and response section below.

CMS-0033-F 173

Comment: Some commenters expressed concern about the calculation of the percentage

and expressed the preference to use an absolute count instead of a percentage.

Response: We acknowledge there are unique concerns about calculating this percentage

as it involves determining the timeliness of the information. Certified EHR technology would be

able to ascertain the time from when the information was entered into its system to when the

information was available for electronic access. As certified EHR technology can provide the

access, any perceivable delay or requirement for affirmative action would be built in by the user

to allow for review of the information before posting. Certified EHR technology could not be

distinguish the difference in time when the information was available to the provider and when it

was entered into certified EHR technology. However, we see no reasonable way to track this

time frame that does not impose a heavy burden on the EP. Therefore, for the measure, we

define the four business days time frame as the time frame when the information is updated in

the certified EHR technology to when it is available electronically to the patient, unless the

provider indicates that the information should be withheld. It is acceptable for a provider to set

an automated withhold on certain information at their discretion. As we have discussed

previously in this section, we do not believe absolute counts are an adequate substitute for

percentage calculations.

Comment: We received comments requesting clarification on what data must be made

available.

Response: Certified EHR technology must be able to make certain data available

according to the ONC final rule. At a minimum, the data specified in the ONC final rule at 45

CFR 170.304(g) must be available subject to the ability of the provider to withhold it discussed

previously.
CMS-0033-F 174

Comment: Commenters suggested that some EPs might not have 10 percent of their

patient population who desire or could utilize such access.

Response: We agree that this is a possibility. We stated in the proposed rule that “we

recognize that many patients may not have internet access, may not be able or interested in the

use of a patient portal.” Health systems that have actively promoted such technologies have been

able to achieve active use by over 30 percent of their patients. However, this 30 percent

threshold may not be realistic for many practices in the short term and therefore serves

justification for the 10 percent threshold. However, the objective and measure focus on the

availability of the access and the timeliness of the data in it, not its utilization. Therefore, we

focus on the fact that more than 10 percent of unique patients seen during the EHR reporting

period could access it and that the information is timely. The EP is not responsible for ensuring

that 10 percent request access or have the means to access. However, we encourage EPs to make

the availability of electronic access known to their patients.

Comment: A commenter inquired about the provider’s liability versus the EHR

technology vendor for a security breach of the system.

Response: Depending on the facts surround the security breach, the provider may be

liable for a violation under the HIPAA Privacy and Security Rules, as well as under any other

applicable federal or state laws. Additionally, there may be circumstances where the EHR

technology vendor acted as a business associate and may potentially have liability under the

HIPAA Privacy and Security Rules. The issue of business associate liability under the HIPAA

Privacy and Security Rules will be addressed in upcoming rulemaking.

After consideration of the public comments received, we are modifying the meaningful

use measure for EPs at §495.6(d)(6)(ii) of our regulations to “At least 10 percent of all unique
CMS-0033-F 175

patients seen by the EP are provided timely (available to the patient within four business days of

being updated in the certified EHR technology) electronic access to their health information

subject to the EP’s discretion to withhold certain information”.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.304(g). The ability to calculate the measure is included in certified

EHR technology.

To calculate the percentage, CMS and ONC have worked together to define the following for

this objective:

• Denominator: Number of unique patients seen by the EP during the EHR reporting period.

A unique patient is discussed under the objective of CPOE.

• Numerator: The number of patients in the denominator who have timely (available to the

patient within four business days of being updated in the certified EHR technology)

electronic access to their health information online.

• Threshold: The resulting percentage must be at least 10 percent in order for an EP to meet

this measure.

As addressed in other objectives and in comment response, if an EP neither orders nor creates

any of the information listed in the ONC final rule 45 CFR 170.304(g) and therefore included in

the minimum data for this objective during the EHR reporting period they would be excluded

from this requirement as described previously in this section under our discussion of whether

certain EP, eligible hospital or CAH can meet all Stage 1 meaningful use objectives given

established scopes of practices.

NPRM EP Objective: Provide clinical summaries for patients for each office visit.
CMS-0033-F 176

In the proposed rule, we discussed why we were basing the objective on office visits

rather than encounters. We said that we did want encounter to be construed to mean every time a

provider interacts with the patient. We received comments requesting that we further define

office visit and address those in the comment and response section below. In discussing the

measure in the proposed rule, we also said that the clinical summary can be provided through a

PHR, patient portal on the web site, secure email, electronic media such as CD or USB fob, or

printed copy. The after-visit clinical summary contains an updated medication list, laboratory

and other diagnostic test orders, procedures and other instructions based on clinical discussions

that took place during the office visit.

Comment: We received requests for clarification as to what constitutes an “office visit”.

Response: An office visit is defined as any billable visit that includes: 1) Concurrent care

or transfer of care visits, 2) Consultant visits and 3) Prolonged Physician Service without Direct

(Face-To-Face) Patient Contact (tele-health). A consultant visit occurs when a provider is asked

to render an expert opinion/service for a specific condition or problem by a referring provider.

Comment: Some commenters believed the requirement for the provision of a clinical

summary at an office visit should be linked to the type or purpose of the office visit. Samples of

the suggested visits are--

- Level 4 or level 5 evaluation and management services;

- Visits conducted at the conclusion of an episode of care;

- Visits conducted at each transition of care;

- Visits relevant to specific conditions such as asthma; and

- Provider to patient face-to-face visits.

CMS-0033-F 177

Response: We believe that a clinical summary should be provided at all office visits

included in the definition of office visit as defined in this final rule. We believe all of the office

visits described in our definition result in the EP rendering a clinical judgment that should be

communicated to the patient.

Comment: Commenters requested CMS define “clinical summary” and offered several

specific data elements that should be included in the definition such as patient name, provider

name, date of visit, location of visit, reason for visit, updated medication list, laboratory orders,

diagnostic orders, patient instructions based on discussions with the provider and a nutrition care

management plan.

Response: After reviewing the comments we define clinical summary as an after-visit

summary that provides a patient with relevant and actionable information and instructions

containing, but not limited to, the patient name, provider’s office contact information, date and

location of visit, an updated medication list and summary of current medications, updated vitals,

reason(s) for visit, procedures and other instructions based on clinical discussions that took place

during the office visit, any updates to a problem list, immunizations or medications administered

during visit, summary of topics covered/considered during visit, time and location of next

appointment/testing if scheduled, or a recommended appointment time if not scheduled, list of

other appointments and testing patient needs to schedule with contact information, recommended

patient decision aids, laboratory and other diagnostic test orders, test/laboratory results (if

received before 24 hours after visit), and symptoms.

Comment: Commenters pointed out that the HIPAA Privacy Rule permits licensed

healthcare professionals to withhold certain information if its disclosure would cause substantial

harm to the patient or another individual.

CMS-0033-F 178

Response: As the EP is proactively providing this information to the patient,

45 CFR 164.524 of the HIPAA Privacy rule does not apply to this situation. However, we still

believe that an EP should be able to withhold information if its disclosure would cause

substantial harm to the patient or another individual. Therefore, if in their judgment substantial

harm may arise from the disclosure of particular information, an EP may choose to withhold that

particular information from the clinical summary

Comment: Most commenters noted that other than "at the time of the visit", there was no

specific time period given in which to comply with this objective. If CMS intended "at the time

of the visit" to mean before the patient leaves the building or upon the patient's request, neither

are possible due to workflow and review processes. Most commenters assumed we would

associate the 48 hours related to the 'copy' requirement or the 96 hours related to the 'access'

requirement to address this comment and stated that both were too short a period for a clinical

visit summary. Others recommended the 30-day timeframe for the provision information set

forth under the HIPAA Privacy Rule.

Response: We agree that our proposed objective lacked specificity about the time to

comply. To provide such specificity, we adopt the timeframe of three business days from our

objective of providing electronic health information to the patient. That is three business days

following the day of the visit excluding holidays as described in the providing electronic health

information to the patient objective.

Comment: Several commenters requested changes to the media through which this

information could be provided. Differing commenters recommended eliminating the paper

option, while others recommended only the paper option.

CMS-0033-F 179

Response: We believe that more options give the EP needed flexibility. The EP could

choose any of the listed means from the proposed rule of PHR, patient portal on a web site,

secure email, electronic media such as CD or USB fob, or printed copy. If the EP chooses an

electronic media, they would be required to provide the patient a paper copy upon request. Both

forms can be and should be produced by certified EHR technology.

Comment: Several commenters indicated that a provider should be allowed to charge a

fee for providing the copy.

Response: As this is a proactive requirement on the part of the EP and not a response to a

request from the patient, we do not believe it is appropriate to charge the patient a fee for this

copy. We note that we give that we give the EP considerable flexibility in the manner in which

the copy is provided including the provision of a paper copy. The only accommodation an EP is

required to make is the provision of a paper copy that can be automatically generated certified

EHR technology. We therefore believe that costs of this will be negligible.

Comment: A number of commenters expressed concern regarding whether the current

available technology could produce a summary of the required information in a standardized

format, the use of clinical nomenclature rather than lay terms and the fact that some providers

use multiple modules to document the care of the patient.

Response: We believe it is appropriate to leave the design of EHR technology systems

and their outputs to the system developers and the EHR technology users. However, we note

that the capability to meet this objective is included in the ONC final rule at 45 CFR 170.304(h)

as a criteria for certified EHR technology and we are confident that vendors will be able to

produce certified EHR technologies.

CMS-0033-F 180

After consideration of the public comments received, we are finalizing the objective for

EPs at §495.6(d)(13)(i) of our regulations to as proposed.

We include this objective in the core set as it is integral to involving patients and their

families in their provision of care and was recommended by the HIT Policy Committee for

inclusion in the core set.

NPRM EP Measure: Clinical summaries provided to patients for at least 80 percent of all

office visits.

Comment: Some commenters believed the threshold was too high or should be replaced

with a numerical count or attestation.

Response: We reduce the threshold to over 50 percent as this objective meets the criteria

of relying solely on a capability included as part of certified EHR technology and is not, for

purposes of Stage 1 criteria, reliant on the electronic exchange of information. Also, as this is a

relatively new capability that was not available to either providers or patients before the

introduction of EHRs, we do not believe it meets the same standard of practice as maintaining an

up-to-date problem list and therefore adopt a threshold of 50 percent (rather than 80 percent).

After consideration of the public comments received, we are modifying the meaningful

use measure for EPs at §495.6(d)(13)(ii) of our regulation to “Clinical summaries provided to

patients for more than 50 percent of all office visits within 3 business days”.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.304(h). The ability to calculate the measure is included in certified

EHR technology.
CMS-0033-F 181

As with the previous objective, the provision of the clinical summary is limited to the

information contained within certified EHR technology; therefore this measure is by definition

limited to patients whose records are maintained using certified EHR technology as described

previously in this section under our discussion of the burden created by the measures associated

with the Stage 1 meaningful use objectives.

To calculate the percentage, CMS and ONC have worked together to define the following for

this objective:

• Denominator: Number of unique patients seen by the EP for an office during the EHR

reporting period. A unique patient is discussed under the objective of using CPOE.

• Numerator: Number of patients in the denominator who are provided a clinical summary of

their visit within three business days.

• Threshold: The resulting percentage must be more than 50 percent in order for an EP,

eligible hospital, or CAH to meet this measure.

As addressed in other objectives, EPs who have no office visits during the EHR reporting period

would be excluded from this requirement as described previously in this section under our

discussion of whether certain EP, eligible hospital or CAH can meet all Stage 1 meaningful use

objectives given established scopes of practices.

NPRM EP/Eligible Hospital Objective: “Provide access to patient-specific education resources

upon request.”

In the proposed rule, we discussed this objective, but did not propose it. We stated that there was

a paucity of knowledge resources that are integrated with EHR, and that also are widely

available. We also noted that the ability to provide education resources in multiple languages
CMS-0033-F 182

might be limited. We stated our intent to further explore the objective in subsequent stages of

meaningful use.

Comment: We received many comments, including comments from both the HIT Policy

Committee and MedPAC, to include this measure in the final rule. These commenters disagreed

with our assertion in the proposed rule that “there is currently a paucity of knowledge resources

that are integrated within EHRs, that are widely available, and that meet these criteria,

particularly in multiple languages.” Specific examples of the availability of knowledge resources

integrated with current EHRs were provided. The HIT Policy Committee amended their

recommendation in their comments on the proposed rule to:

- EPs and hospitals should report on the percentage of patients for whom they use the EHR

to suggest patient-specific education resources.

Other recommended language for the objective includes

- Provide patients educational information that is specific to their health needs as identified

by information contained in their EHR technology such as diagnoses and demographic

data, and

- The original HIT Policy Committee objective of “Provide access to patient-specific

education resources upon request.”

Response: We are convinced by commenters that the availability of education resources

linked to EHRs is more widely available than we had indicated in the proposed rule. Therefore,

for the final rule we will include this objective for the Stage 1 of meaningful use.

We note that the new recommendation of the HIT Policy Committee is a hybrid of a measure and

an objective, whereas in developing the meaningful use criteria we consistently identify both an

objective and associated measure. However, we agree with the HIT Policy Committee and others
CMS-0033-F 183

that the objective and associated measure should make clear that the EP, eligible hospital or

CAH should utilize certified EHR technology in a manner where the technology suggests

patient-specific educational resources based on the information stored in the certified EHR

technology. Therefore, we are including a revised version of this objective in the final rule for

Stage 1 of meaningful use.

We also believe it is necessary to state what level of EP, eligible hospital and CAH

discretion is available when deciding whether to provide education resources identified by

certified EHR technology to the patient. Therefore, we include the phrase “if appropriate”,

which allows the EP or the authorized provider in the eligible hospital or CAH final decision on

whether the education resource is useful and relevant to a specific patient.

After consideration of the public comments received, we are including this meaningful

use objective for EPs at §495.6(e)(6)(i) and eligible hospitals and CAHs at §495.6(g)(5)(i) of our

regulations as “Use certified EHR technology to identify patient-specific education resources and

provide those resources to the patient if appropriate”.

NPRM EP/Eligible Hospital Measure: Not applicable

Comment: CMS received a comment requesting an 80 percent threshold of appropriate

patients and/or caregivers receiving patient-specific educational materials. In addition, the HIT

Policy Committee’s revised objective suggests a patient based percentage.

Response: As with the addition of the recording of advance directives, we are able to

relate this measure to one that is based on patients and can be accomplished solely using certified

EHR technology. As this objective requires more than just the recording of information in

certified EHR technology, we adopt a lower threshold of 10 percent.

CMS-0033-F 184

After consideration of the public comments received, we are including this meaningful

use measure for EPs at §495.6(e)(6)(ii) and eligible hospitals at §495.6(g)(5)(ii) of our

regulations as “More than 10 percent of all unique patients seen by the EP or admitted to the

eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) are provided

patient-specific education resources”.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.302(m). The ability to calculate the measure is included in certified

EHR technology.

To calculate the percentage, CMS and ONC have worked together to define the following for

this objective:

• Denominator: Number of unique patients seen by the EP or admitted to the eligible

hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) during the EHR

reporting period. A unique patient is discussed under the CPOE objective.

• Numerator: Number of patients in the denominator who are provided patient education

specific resources

• Threshold: The resulting percentage must be more than 10 percent in order for an EP,

eligible hospital, or CAH to meet this measure.

We do not believe that any EP, eligible hospital, or CAH will not have more than 10 percent of

their patients eligible to receive patient specific education resources and therefore do not believe

an exclusion is necessary for this objective.

CMS-0033-F 185

The third health outcomes policy priority identified by the HIT Policy Committee is to

improve care coordination. The HIT Policy Committee recommended the following care goals to

address this priority:

• Exchange meaningful clinical information among professional health care team.

NPRM EP Objective - Capability to exchange key clinical information (for example, problem

list, medication list, allergies, and diagnostic test results), among providers of care and patient

authorized entities electronically.

NPRM Eligible Hospital Objective - Capability to exchange key clinical information (for

example, discharge summary, procedures, problem list, medication list, allergies, diagnostic test

results), among providers of care and patient authorized entities electronically.

In the proposed rule, we defined the term “diagnostic test results “ as all data needed to

diagnose and treat disease, such as blood tests, microbiology, urinalysis, pathology tests,

radiology, cardiac imaging, nuclear medicine tests, and pulmonary function tests. We maintain

this description for the final rule. We said that when the information was available in a structured

format we expected that it be transferred in a structured format. However, if it was unavailable

in a structured format, that the transmission of unstructured data was permissible. We provide

additional information on structured data in the comment and response section, but maintain for

the final rule the concept that the exchange can be of structured or unstructured data.

Comment: Commenters requested clarification of the term “key clinical information.”

Response: By “clinical information”, we mean all data needed to diagnose and treat

disease, such as blood tests, microbiology, urinalysis, pathology tests, radiology, cardiac

imaging, nuclear medicine tests, and pulmonary function tests. We leave it to the provider's

clinical judgment as to identifying what clinical information is considered key clinical

CMS-0033-F 186

information for purposes of exchanging clinical information about a patient at a particular time

with other providers of care. The examples we provided in the proposed rule and the final rule

below are not intended to be exhaustive. ONC in their final rule provides a minimum set of

information that certified EHR technology must be able to exchange in order to be certified. A

provider’s determination of key clinical information could include some or all of this information

as well as information not included in the ONC final rule at 45 CFR 170.304(i) for EPs and 45

CFR 170.306(f) for eligible hospitals and CAHs.

Comment: Commenters requested clarification of the term “patient authorized entities.”

Response: By “patient authorized entities”, we mean any individual or organization to

which the patient has granted access to their clinical information. Examples would include an

insurance company that covers the patient, an entity facilitating health information exchange

among providers or a personal health record vendor identified by the patient. A patient would

have to affirmatively grant access to these entities.

Comment: Commenters requested clarification of the term “exchange.”

Response: We expect that this information, when exchanged electronically, would be

exchanged in structured electronic format when available (for example, drug and clinical lab

data). However, where the information is available only in unstructured electronic formats (for

example, free text and scanned images), we would allow the exchange of unstructured

information. We believe that the electronic exchange of information is most efficient when it is

exchanged from a provider’s certified EHR technology to another certified EHR technology

either directly or through an entity facilitating health information exchange using structured data

that can be automatically identified by the receiving system and integrated into the receiver’s
CMS-0033-F 187

records. However, we know that much information cannot currently be, and may never be,

transmitted in the way we just described.

Comment: Commenters requested clarification of the term “structured data.”

Response: This distinction between structured data and unstructured data applies to all

types of information. We have previously defined structured data in this section. To ensure that

certified EHR technology has a certain level of functionality, ONC at 45 CFR 170.304(i) for EPs

and 45 CFR 170.306(f) for eligible hospitals and CAHs specified certain types of information

that a certified EHR technology must be able to exchange to become certified. ONC also

provided standards to support this exchange. These standards do not preclude a vendor of EHR

technology from enabling its product to exchange additional types of information nor limit the

provider’s discretion (either in exchanging more or less) in deciding what information is key and

should be exchanged about a given patient at a given time.

Comment: Commenters expressed concern that the exchange of key clinical information

via certified EHR systems requires a unique or national patient identifier to ensure accurate

exchange.

Response: While such an identifier could facilitate an exchange, it need only be unique

to the parties involved in the exchange and need not be national in scope, nor is a specific unique

identifier necessary for successful exchanges. Many current health information exchanges have

had success identifying patients by a combination of several elements of information without a

separate independent identifier.

Comment: Commenters pointed out that the general term “allergies” is inconsistent with

other objectives of Stage 1 and with the capabilities mandated by certification under the ONC

final rule, which uses the term “medication allergies”.

CMS-0033-F 188

Response: As we have stated on several other objectives, we encourage all EPs, eligible

hospitals, and CAHs to work with their certified EHR technology designers to make capabilities

most relevant to their individual practices of care. However, we have maintained that at a

minimum the capabilities that are part of certification should be included so we modify the

example to change allergies to medication allergies to align it with other objectives and

certification.

After consideration of the public comments received, we are modifying the meaningful

use objective for EPs at §495.6(d)(14)(i) of our regulations to “Capability to exchange key

clinical information (for example, problem list, medication list, medication allergies, and

diagnostic test results), among providers of care and patient authorized entities electronically”

and for eligible hospitals and CAHs at §495.6(f)(13)(i) to “Capability to exchange key clinical

information (for example, discharge summary, procedures, problem list, medication list,

medication allergies, diagnostic test results), among providers of care and patient authorized

entities electronically”.

In response to our revised requirements for meeting meaningful use, we included this

objective in the core set. Section 1848 (o)(2)(A)(ii) of the Act specifically includes electronic

exchange of health information in meaningful use for eligible professionals.

NPRM EP/Eligible Hospital Measure - Performed at least one test of certified EHR

technology's capacity to electronically exchange key clinical information.

In the proposed rule, we identified this objective as reliant on the electronic exchange of

information. We said that we are aware that in most areas of the country, the infrastructure

necessary to support such exchange is still being developed. Therefore, for the Stage 1 criteria of

meaningful use we proposed that EPs and eligible hospitals test their ability to send such
CMS-0033-F 189

information at least once prior to the end of the EHR reporting period. We proposed that the

testing could occur prior to the beginning of the EHR reporting period. We also said that if

multiple EPs are using the same certified EHR technology in a shared physical setting, the

testing would only have to occur once for a given certified EHR technology, as we do not see

any value to running the same test multiple times just because multiple EPs use the same

certified EHR technology. Finally, we attempted to define an “exchange” as the clinical

information must be sent between different clinical entities with distinct certified EHR

technology and not between organizations that share a certified EHR. We received many

comments requesting further clarification on these concepts and we attempt to provide additional

information in the comment and response section below.

Comment: Commenters expressed concern that the receiving entities are not required to

have the same capabilities as meaningful users of certified EHR technology.

Response: The HITECH Act does not provide us the authority to require any entity

(medical provider or otherwise) to conform to certain standards and criteria unless they seek to

become a meaningful EHR user. The Act also limits the entities that are eligible to become

meaningful EHR users. In developing the associated measure for this objective, we have ensured

that eligible providers will be able to meet this objective as long as there is one other entity with

which they can test their capability. As electronic exchange is not constrained by distance, we

are confident that every provider seeking to test their system will be able to find another entity

with which to conduct such test.

Comment: Commenters asked whether the test needs to be “live” or if it could be a

“simulation.”
CMS-0033-F 190

Response: As specified in the proposed rule, this test must involve the actual submission

of information to another provider of care with distinct certified EHR technology or other system

capable of receiving the information.

Comment: Commenters asked whether the use of “test” or “dummy” data is permissible.

Response: While the use of test patient information may increase the risk that the system

will not be testing to its full capability, given the privacy and security concerns surrounding the

transmission of actual patient information we do not require it for the purposes of a test.

Therefore, the use of test information about a fictional patient that would be identical in form to

what would be sent about an actual patient would satisfy this objective.

Comment: Commenters suggested deferring the measure to a later stage due to the lack

of a mature HIE infrastructure and/or to emulate the Health Information and Management

System Society (HIMSS) EMR Adoption Model.

Response: We agree that many areas of the country currently lack the infrastructure to

support the electronic exchange of information. As the goal of this meaningful use objective is

to ensure that certified EHR technology has the capability to electronically exchange key clinical

information, we only require a single test.

After consideration of the public comments received, we are finalizing the meaningful

use measure at §495.6(d)(14)(ii) and §495.6(f)(13)(ii) of our regulations as proposed.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.304(i) for EPs and 45 CFR 170.306(f) for eligible hospitals and CAHs.

The ability to calculate the measure is included in certified EHR technology. EPs, eligible

hospitals, and CAHs should attempt to identify one other entity with whom to conduct a test of
CMS-0033-F 191

the submission of electronic data. This test must include the transfer of either actual or

“dummy” data to the chosen other entity. The testing could occur prior to the beginning of the

EHR reporting period, but must occur prior to the end of the EHR reporting period and every

payment year would require its own, unique test as infrastructure for health information

exchange is expected to mature over time. Therefore, if an eligible hospital or CAH were to

become a meaningful EHR user in 2011 for their first payment year, they would have to conduct

another, unique test to become a meaningful EHR user in 2012 for their second payment year. If

multiple EPs are using the same certified EHR technology in a shared physical setting, the

testing would only have to occur once for a given certified EHR technology, as we do not see

any value to running the same test multiple times just because multiple EPs use the same

certified EHR technology. To be considered an “exchange” for this objective and measure the

clinical information must be sent between different legal entities with distinct certified EHR

technology or other system that can accept the information and not between organizations that

share certified EHR technology. CMS will accept a yes/no attestation to verify all of the above

for EPs, eligible hospitals, and CAHs.

As the measure already accounts for the possibility of a failed test and we are confident

that everyone will be identify an entity with which to conduct a test, we do not believe an

exception is required for EPs, eligible hospitals or CAHs.

NPRM EP/Eligible Hospital Objective: Perform medication reconciliation at relevant

encounters and each transition of care.

In the proposed rule, we described “medication reconciliation” as the process of

identifying the most accurate list of all medications that the patient is taking, including name,

dosage, frequency and route, by comparing the medical record to an external list of medications
CMS-0033-F 192

obtained from a patient, hospital or other provider. We maintain this description for the final

rule. We also described “relevant encounter” and “transition of care”; however, as we received

comments requested additional clarification of these terms we address them in the comment and

response section below.

Comment: Several commenters requested that this objective be deferred until it can be

conducted using the exchange of electronic information between certified EHR technology.

Other commenters believed that the process is not one for avoiding medication errors, but a

human workflow process supported by the EHR, and not an automated EHR process.

Response: We certainly look forward to a time when most medication reconciliation

occurs as an automated process within the EHR reconciling information that has been

exchanged. However, it is unlikely that an automated process within the EHR will fully supplant

the medication reconciliation conducted between the provider and the patient. In order for this

automated reconciliation process to occur and be useful, the relevant structured data exchanged

needs to be as accurate as possible. Requiring medication reconciliation as part of meaningful

use in Stage 1 lays the groundwork for future reliable electronic exchange. We therefore do not

believe this objective should be deferred to a later stage.

Comment: Commenters requested additional clarity of the term “relevant encounter.”

Only a few suggestions on such clarity were provided by commenters. Two examples of

commenters’ recommendations are “when a prescription is generated” and “a significant change

in the patient’s condition that resulted in change in medication regimen which could include

significant change in dosing of more than 1 medication, identification of a new medical

condition, decline in functional status or change in advanced directive.”

CMS-0033-F 193

Response: We finalize our proposal by defining “relevant encounter” as an encounter

during which the EP, eligible hospital or CAH performs a medication reconciliation due to new

medication or long gaps in time between patient encounters or for other reasons determined

appropriate by the EP, eligible hospital or CAH. Essentially an encounter is relevant if the EP,

eligible hospital, or CAH judges it to be so. This flexibility has implications for the measure that

were not fully considered in the proposed rule. We will discuss those below in connection with

our discussion of the associated measure.

Comment: Commenters requested additional clarity of the term “transition of care.” A

few suggestions were provided by commenters including expanding the description to include all

transfers to different settings within a hospital or revising the definition to “the movement of a

patient from one setting of care (hospital, ambulatory primary care practice, ambulatory,

specialty care practice, long-term care, home health, rehabilitation facility) to another”.

Response: In the proposed rule we clarified “transition of care” as the transfer of a

patient from one clinical setting (inpatient, outpatient, physician office, home health, rehab, long-

term care facility, etc) to another or from one EP, eligible hospital, or CAH (as defined by CCN)

to another. We believe that different settings within one hospital using certified EHR technology

would have access to the same information so reconciliation would not be necessary. We modify

our clarification to account for some of the revisions provided. We clarify “transition of care” as

the movement of a patient from one setting of care (hospital, ambulatory primary care practice,

ambulatory, specialty care practice, long-term care, home health, rehabilitation facility) to

another. We also clarify that the receiving eligible hospital or EP would conduct the medication

reconciliation.
CMS-0033-F 194

Comment: Some commenters requested clarification on which EP, eligible hospital or

CAH would conduct the medication reconciliation. The one to whom the patient is transferred to

or the one who transfers the patient.

Response: When conducting medication reconciliation during a transfer of care, we

believe that it is the EP, eligible hospital or CAH that receives the patient into their care that

should conduct the medication reconciliation. It is for this provider that the information is most

crucial, as they will be making the future clinical judgments regarding the patient. Therefore, we

revise this objective and its associated measure to reflect this clarification.

Comment: Commenters requested a standard list be defined for the process including

prescription and non prescription medications, herbal products, dietary supplements, prescriber,

drug name, regimen and allergies.

Response: We believe the information included in the process of medication

reconciliation is appropriately determined by the provider and patient.

After consideration of the public comments received, we are modifying the meaningful

use objective for EPs at §495.6(e)(7)(i) and for eligible hospitals and CAHs at §495.6(g)(6)(i)

of our regulations to “The EP, eligible hospital or CAH who receives a patient from another

setting of care or provider of care or believes an encounter is relevant should perform medication

reconciliation”.

NPRM EP/Eligible Hospital Measure: Perform medication reconciliation for at least 80

percent of relevant encounters and transitions of care.

Comment: Commenters believed it was an unjustifiable burden to record, which

encounters were relevant and which were not given our flexible definition of "relevant

encounter".
CMS-0033-F 195

Response: We agree that the inclusion of relevant encounter creates a burden that one

commenter described as “non-value-added work”. We also believe that when the EP, eligible

hospital, or CAH identifies the encounter as relevant, it is unlikely that the EP, eligible hospital,

or CAH would then not carry out the medication reconciliation. For these reasons, we are

removing relevant encounters from the measure for this objective.

Comment: Commenters said the percent measurements should be replaced with a

numerical count or an attestation the objective has been met or the demonstration of the

capability by performing one test of certified EHR technology's capacity to present providers

with patient medication information that supports the reconciliation of medications at time of

admission and discharge. Other commenters stated the proposed 80 percent threshold was too

high.

Response: We are maintaining a percentage for the reasons discussed previously in this

section. However, we do reduce the threshold to over 50 percent as this objective meets the

criteria of relying solely on a capability included as part of certified EHR technology and while

not absolutely reliant on electronic exchange of information, it does involve the exchange of

information between providers and therefore we adopt a threshold of 50 percent (rather than

8 percent).

Comment: Commenters requested we align this objective with The Joint Commission

National Patient Safety Goal on medication reconciliation (Goal 8) in order to decrease

confusion, prevent the slowing of adoption of best practices and match current hospital

reconciliation processes.

Response: CMS understands the commenters’ concerns regarding possible confusion if

the meaningful use medication reconciliation requirement differs from The Joint Commission’s
CMS-0033-F 196

requirement for those facilities accredited by that organization. However, currently there is no

finalized Joint Commission standard as the Commission is currently in the process of re-

evaluating their National Patient Safety Goal 8 (Accurately and completely reconcile

medications across the continuum of care) given the difficulties that many organizations are

having in meeting the complex requirements. In the absence of a definitive Joint Commission

standard to take into consideration, this is not possible.

Comment: Some commenters expressed the desire to expand the scope of the measure to

include the clinical decision making and patient counseling and education by a pharmacist.

Response: We believe that is both beyond the scope of meaningful use as pharmacists

are not eligible professionals for the EHR incentive programs and that the provision of patient

counseling is more aligned with the objectives of clinical quality measures. Information from the

medication reconciliation could be used for the basis of clinical decision support rules, but is not

in and of itself a clinical decision.

After consideration of the public comments received, we are modifying the meaningful

use measure for EPs at §495.6(e)(7)(ii) and for eligible hospitals and CAHs at §495.6(g)(6)(ii)

of our regulations to “The EP, eligible hospital or CAH performs medication reconciliation for

more than 50 percent of transitions of care in which they patient is transitioned into the care of

the EP or admitted to the eligible hospital’s or CAH’s inpatient or emergency department (POS

21 or 23)”.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.302(j). The ability to calculate the measure is included in certified

EHR technology.
CMS-0033-F 197

As discussed previously in this section under our discussion of the burden created by the

measures associated with the Stage 1 meaningful use objectives, we only include in the

denominator transitions of care related to patients whose records are maintained using certified

EHR technology.

To calculate the percentage, CMS and ONC have worked together to define the following for

this objective:

• Denominator: Number of transitions of care during the EHR reporting period for which

the EP or eligible hospital’s or CAH’s inpatient or emergency department (POS 21 to 23) was

the receiving party of the transition.

• Numerator: The number of transitions of care in the denominator where medication

reconciliation was performed.

• Threshold: The resulting percentage must be more than 50 percent in order for an EP,

eligible hospital, or CAH to meet this measure.

If an EP was not on the receiving end of any transition of care during the EHR reporting period

they would be excluded as previously discussed in this section under our discussion of whether

certain EP, eligible hospital or CAH can meet all Stage 1 meaningful use objectives given

established scopes of practices. We do not believe that any eligible hospital or CAH would be in

a situation where they would not need to know the precise medications their patients are taking.

NPRM EP/Eligible Hospital Objective: Provide summary care record for each transition of

care or referral.

In the proposed rule, we pointed out that this objective was not explicitly included in the

HIT Policy Committee's recommended objectives, but that they did include a measure for the

“percent of transitions in care for which summary care record is shared. We said that we believe
CMS-0033-F 198

that in order for a measure to be relevant it must correspond to an objective in the definition of

meaningful use. Therefore, we proposed to add this objective in order to be able to include the

recommended measure. Furthermore, we add referrals because the sharing of the patient care

summary from one provider to another communicates important information that the patient may

not have been able to provide, and can significantly improve the quality and safety of referral

care, and reduce unnecessary and redundant testing. We received support for this inclusion from

commenters and include this objective in the final rule for the reasons outlined in the proposed

rule. We did receive comments requesting clarifications around this objective and address them

in the comment and response section below.

Comment: We received several comments that requested clarification as to the purpose

of this objective.

Response: The purpose of this objective is to ensure a summary of care record is

provided to the receiving provider when a patient is transitioning to a new provider or has been

referred to another provider while still remaining under the care of the referring provider. If the

provider to whom the referral is made or to whom the patient is transitioned to has access to the

medical record maintained by the referring provider then the summary of care record would not

need to be provided. The most common example cited by commenters was a referral during

which patient remains an inpatient of the hospital. Finally, unlike with medication

reconciliation, where the receiving party of the transfer conducts the action, the transferring party

would provide the summary care record to the receiving party.

Comment: Commenters requested additional clarity of the term “transition of care”. A

few suggestions were provided by the commenters including expanding the description to

include all transfers to different settings within a hospital or revising the definition to “the
CMS-0033-F 199

movement of a patient from one setting of care (hospital, ambulatory primary care practice,

ambulatory, specialty care practice, long-term care, home health, rehabilitation facility) to

another”.

Response: In the proposed rule we clarified that the term transition of care means a

transfer of a patient from one clinical setting (inpatient, outpatient, physician office, home health,

rehab, long-term care facility, etc) to another or from one EP, eligible hospital, or CAH (as

defined by CMS Certification Number (CCN) to another. We believe that different settings

within a hospital using certified EHR technology would have access to the same information so

providing a clinical care summary would not be necessary. We further clarify transition of care

as the movement of a patient from one setting of care (hospital, ambulatory primary care

practice, ambulatory, specialty care practice, long-term care, home health, rehabilitation facility)

to another.

Comment: Some commenters requested clarification on which EP, eligible hospital or

CAH should provide the summary of care document; the one to whom the patient is transferred

or referred or the one who transfers or refers the patient.

Response: We believe that it is the EP, eligible hospital or CAH that transfers or refers

the patient to another setting of care or provider that should provide the summary of care

document. It is for this provider that has the most recent information on the patient that maybe

crucial to the provider to whom the patient is transferred or referred. Therefore, we revise this

objective and its associated measure to reflect this clarification.

Comment: Commenters asked for clarification on how the summary of care record

should be transferred.
CMS-0033-F 200

Response: The goal is to get the summary care record into the next provider’s

possession. While we highly encourage all EPs, eligible hospitals, and CAHs to explore ways to

accomplish the transfer using electronic exchange, we realize that this capability is still in the

development stages. Therefore, an EP, eligible hospital, or CAH could send an electronic or

paper copy of the summary care record directly to the next provider or could provide it to the

patient to deliver to the next provider, if the patient can reasonably expected to do so. Certified

EHR technology would be used to generate the summary of care record and to document that it

was provided to the patient or receiving provider.

After consideration of the public comments received, we are modifying the meaningful

use objective for EPs at §495.6(e)(8)(i) and for eligible hospitals and CAHs at §495.6(g)(7)(i) of

our regulations to “ The EP, eligible hospital or CAH who transitions their patient to another

setting of care or provider of care or refers their patient to another provider of care should

provide summary care record for each transition of care or referral”.

NPRM EP/Eligible Hospital Measure: Provide summary of care record for at least 80 percent

of transitions of care and referrals.

Comment: Commenters said that this should be replaced with a count and that the

threshold was too high.

Response: We are maintaining a percentage for the reasons discussed previously in this

section. However, we do reduce the threshold to over 50 percent as this objective meets the

criteria of relying solely on a capability included as part of certified EHR technology and while

not absolutely reliant on electronic exchange of information, it does involve the exchange of

information between providers and therefore we adopt a threshold of 50 percent (rather than 80

percent).
CMS-0033-F 201

Comment: There were concerns about the ability of certified EHR technology to

calculate this measure. As long as an EP, eligible hospital, or CAH records the order for a

referral or transfer as structured data and a record is made that the summary care record was

provided then certified EHR technology will be able to calculate this measure.

After consideration of the public comments received, we are modifying the meaningful

use measure for EPs at §495.6(e)(8)(ii) and for eligible hospitals and CAHs at §495.6(g)(7)(ii)

of our regulations to “The EP, eligible hospital or CAH who transitions or refers their patient to

another setting of care or provider of care provides a summary of care record for more than

50 percent of transitions of care and referrals”.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.304(i) for EPs and 45 CFR 170.306(f) for eligible hospitals and CAHs.

The ability to calculate the measure is included in certified EHR technology.

As discussed previously in this section under our discussion of the burden created by the

measures associated with the Stage 1 meaningful use objectives, we only include in the

denominator transitions of care and referrals related to patients whose records that are

maintained using certified EHR technology.

To calculate the percentage, CMS and ONC have worked together to define the following for

this objective:

• Denominator: Number of transitions of care and referrals during the EHR reporting

period for which the EP or eligible hospital’s or CAH’s inpatient or emergency department (POS

21 to 23) was the transferring or referring provider.

CMS-0033-F 202

• Numerator: The number of transitions of care and referrals in the denominator where a

summary of care record was provided.

• Threshold: The percentage must be more than 50 percent in order for an EP, eligible

hospital, or CAH to meet this measure.

As addressed in other objectives and in comment response, if an EP does not transfer a

patient to another setting or refer a patient to another provider during the EHR reporting period

then they would have a situation of a null denominator as described would be excluded from this

requirement as described previously in this section under our discussion of whether certain EP,

eligible hospital or CAH can meet all Stage 1 meaningful use objectives given established scopes

of practices. We do not believe that any eligible hospital or CAH would be in a situation where

they would never transfer a patient to another care setting or make a referral to another provider.

The fourth health outcomes policy priority identified by the HIT Policy Committee is

improving population and public health. The HIT Policy Committee identified the following care

goal to address this priority:

● The patient's health care team communicates with public health agencies

The goal as recommended by the HIT Policy Committee is “communicate with public

health agencies.” In the proposed rule, we explained that we found this goal to be somewhat

ambiguous, as it does not specify who must communicate with public health agencies. We

propose to specify “the patient's health care team” as the individuals who would communicate

with public health agencies.

NPRM EP/Eligible Hospital Objective: Capability to submit electronic data to immunization

registries and actual submission where required and accepted.

In the proposed rule, we did not elaborate on this objective.

CMS-0033-F 203

Comment: Some commenters suggested out that not every EP, eligible hospital, or CAH

administers immunization. Therefore, as proposed, this objective and its associated measure

would require an EP, eligible hospital, or CAH to implement and test a capability that they

would not use.

Response: We acknowledge that this objective is not relevant to all EPs, eligible

hospitals or CAHs. Therefore, in this final rule, we clarify that this objective and its associated

measure apply only to EPs, eligible hospitals or CAHs that administer one or more

immunizations during the EHR reporting period.

Comment: Some commenters recommended revising the language of the immunization

objective to be consistent with the language of the syndromic surveillance objective by replacing

“where required and accepted” with “according to applicable law and practice.”

Response: First, we make a technical correction. The objective listed for EPs on page

1858 of the proposed rule listed this objective as “Capability to submit electronic data to

immunization registries and actual submission where possible and accepted.” The objective was

intended to be “Capability to submit electronic data to immunization registries and actual

submission where required and accepted” for EPs, eligible hospitals, and CAHs. It is written as

such in every other instance in the proposed rule including the regulation text. Second, in

response to the comment that “where required and accepted” be replaced with “according to

applicable law and practice”, we see little distinction between the two in terms of requirement as

applicable law and practice would be the things imposing a requirement. Therefore, we adopt

the proposed language, but modify the language slightly to “in accordance with applicable law

and practice”. We do note however, that applicable law and practice do not guarantee every

receiving entity will be able to accept it electronically. Our measure for meeting this objective is
CMS-0033-F 204

one test of electronic data submission and if the test is successful follow up submission to that

one entity. We do not seek to enforce through meaningful use every law and practice that may

require submission of immunization data. We also make another consistency change to the

objectives under the health care policy goal of improving population and public health. In this

objective, we describe the capability as submitting electronic data. In the other objectives under

this goal we describe the capability as providing electronic data. We believe that functionally

these terms are interchangeable, but to avoid any confusion we adopt the same term of “submit”

electronic data across all three objectives.

Comment: Some commenters suggested that the term “Immunization Information

Systems (IIS)” has replaced the term “registry” and is referred to as such by the Centers for

Disease Control (CDC).

Response: We modified the objective to account for both terms.

After consideration of the public comments received, we are modifying the meaningful use

objective for EPs at §495.6(e)(9)(i) and for eligible hospitals and CAHs at §495.6(g)(8)(i) of our

regulations to Capability to submit electronic data to immunization registries or Immunization

Information Systems and actual submission in accordance with to applicable law and practice.

NPRM EP/Eligible Hospital Measure: Performed at least one test of certified EHR

technology's capacity to submit electronic data to immunization registries (unless none of the

immunization registries to which the EP, eligible hospital, or CAH submits such information

have the capacity to receive the information electronically).

In the proposed rule, we identified this as an objective where more stringent requirements

may be established for EPs and hospitals under the Medicaid program in states where this

capability exists. This is just one example of a possible State proposed modification to
CMS-0033-F 205

meaningful use in the Medicaid EHR incentive program. This ability for the States is also

included in our final rule.

Comment: As with the objective of exchanging key clinical information, some

commenters asked whether the test needs to be “live” or if it could be a “simulation”. Some

commenters suggested that a simulation where the ability was tested without being transmitted to

another party should be sufficient. Others suggested that the test needs to include transmission

or difficulties in actual sending information might not be uncovered.

Response: As specified in the proposed rule, this test must involve the actual submission

of information to a registry or immunization information system, if one exists that will accept the

information.

Comment: Commenters asked whether the use of “test” or “dummy” data is permissible.

Response: While the use of test patient information may increase the risk that the system

will not be testing to its full capability, given the privacy and security concerns surrounding the

transmission of actual patient information we do not require it for the purposes of a test.

Therefore, the use of test information about a fictional patient that would be identical in form to

what would be sent about an actual patient would satisfy this objective. However, we note that

this is one of the objectives that a State may modify in accordance with the discussion in

II.A.2.c. of the proposed rule. Therefore, more stringent requirements may be established for

EPs and eligible hospitals under the Medicaid program in states where this capability exists.

Comment: Commenters expressed concern about the burden of multiple requirements for

submission from federal, state, and local government agencies or non-governmental registries.

They also raised the issue of lack of standardization of means and form of submission.
CMS-0033-F 206

Response: Standards for content exchange and vocabulary are established in the ONC

final rule at 45 CFR 170.302(k). As meaningful use seeks to utilize certified EHR technology

for purposes of the test and subsequent submission (if test was successful) these are the standards

that should be utilized. While we encourage all providers and registries to work together to

develop efficient, electronic submission of immunization information to all registries where it

can be used to improve population and public health, for purposes of becoming a meaningful

EHR user, we only require a single test and follow up submission if that test is successful.

Comment: Commenters suggested deferring the measure to a later stage due to the lack

of a mature HIE infrastructure.

Response: We agree that many areas of the country currently lack the infrastructure to

support the electronic exchange of information. As meaningful use seeks to ensure certified

EHR technology has the capability to submit electronic data to registries, we only require a

single test if a receiving entity is available and follow up submission only if that test is

successful. If none of the immunization registries to which the EP, eligible hospital or CAH

submits information has the capacity to receive the information electronically, then this objective

would not apply.

Comment: Commenters requested clarification whether on a failed attempted test

satisfies the criteria of this measure and whether EPs in a group setting using identical certified

EHR technology would only need to conduct a single test, not one test per EP.

Response: A failed attempt would meet the measure. We highly encourage EPs, eligible

hospitals, and CAHs to work with their vendor and the receiving entity with whom they tested to

identify the source of the failure and develop remedies, but for Stage 1 of meaningful use a failed

attempt would meet the requirements. We had indicated in the proposed rule that only one test is
CMS-0033-F 207

required for EPs practicing in a group setting that shares the same certified EHR technology. We

maintain that proposal for the final rule.

Comment: Commenters recommended the inclusion of electronically reporting to other

types of registries in addition to immunization registries such as disease-specific registries such

as the Cystic Fibrosis Registry.

Response: While we encourage all providers and registries to work together to develop

efficient, electronic submission of information to all registries where it can be used to improve

population and public health, for purposes of becoming a meaningful EHR user, we only require

a single test utilizing immunization data and follow up submission if that test is successful.

After consideration of the public comments received, we are modifying the meaningful

use measure for EPs at §495.6(e)(9)(ii) and for eligible hospitals and CAHs at §495.6(g)(8)(ii)

of our regulations to “Performed at least one test of certified EHR technology's capacity to

submit electronic data to immunization registries and follow up submission if the test is

successful (unless none of the immunization registries to which the EP, eligible hospital, or CAH

submits such information have the capacity to receive the information electronically)”.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.302(k). The ability to calculate the measure is included in certified

EHR technology. We require that an EP, eligible hospital, or CAH determine if they have given

any immunizations during the EHR reporting period. Those that have not given any

immunizations during the EHR reporting period are excluded from this measure according to the

discussion of whether certain EP, eligible hospital or CAH can meet all Stage 1 meaningful use

objectives given established scopes of practices. If they have given immunizations during the
CMS-0033-F 208

reporting period, they should then attempt to locate a registry or IIS with whom to conduct a test

of the submission of electronic data. This test must include the transfer of either actual or

“dummy” data to the chosen registry or IIS. The testing could occur prior to the beginning of the

EHR reporting period, but must occur prior to the end of the EHR reporting period. EPs in a

group setting using identical certified EHR technology would only need to conduct a single test,

not one test per EP. If the test is successful, then the EP, eligible hospital, or CAH should

institute regular reporting to that entity in accordance with applicable law and practice. CMS

will accept a yes/no attestation to verify all of the above for EPs, eligible hospitals or CAHs that

have administered immunizations during the EHR reporting period.

NPRM Eligible Hospital Objective: Capability to provide electronic submission of reportable

(as required by state or local law) lab results to public health agencies and actual submission

where it can be received.

In the proposed rule, we did not elaborate on this objective.

Comment: A few commenters requested this objective be applied to EPs as long as the

EHR Certification requirements are met. A commenter remarked that electronic submission of

reportable lab results should not put an additional burden on the providers as the EHR would be

able to automate this process.

Response: We based the limitation on the recommendation of the HIT Policy Committee

who in turn went through a considerable public development process. We do not believe that

burden of reporting was the only limiting factor in keeping this objective from being applied to

EPs; therefore, we maintain our proposal to limit this objective to eligible hospitals and CAHs.

EPs usually send out lab test to other organizations on which reporting burdens may fall.
CMS-0033-F 209

Comment: Commenters requested that the actual transmission of the information be

required.

Response: In the discussion of the reporting immunization data objective, we discussed

at length the need to align the language for the three objectives included under the health care

policy priority of improve population and public health, which is one of the five priorities of the

Stage 1 definition of meaningful use. Our interpretation is that the three phrases result in the

same outcome, but introduce confusion due to the varied wordings. As commenters strongly

preferred the phrase “according to applicable law and practice”, we will so modify this objective.

We do note however that applicable law and practice does not guarantee every receiving entity

will be able to accept it electronically. Our measure for meeting this objective is one test of

electronic data submission and if the test is successful, a follow up submission to that one entity.

We do not seek to enforce through meaningful use every law and practice that may require

submission of lab results.

After consideration of the public comments received, we are modifying the meaningful use

objective for eligible hospitals and CAHs at §495.6(g)(9)(i) of our regulations to “Capability to

submit electronic data on reportable (as required by state or local law) lab results to public health

agencies and actual submission in accordance with applicable law and practice”.

NPRM Eligible Hospital Measure: Performed at least one test of certified EHR technology

capacity to provide electronic submission of reportable lab results to public health agencies

(unless none of the public health agencies to which eligible hospital submits such information

have the capacity to receive the information electronically).

CMS-0033-F 210

In the proposed rule, we identified this as an objective where more stringent requirements

may be established for eligible hospitals under the Medicaid program in states where this

capability exists. This is just one example of a possible State proposed modification to

Comment: Commenters asked whether the test needs to be “live” or if it could be a

“simulation”.

Response: As specified in the proposed rule, this test must involve the actual submission

of information to a public health agency, if one exists that will accept the information.

Comment: Commenters asked whether the use of “test” or “dummy” data is permissible.

Response: While the use of test patient information may increase the risk that the system

will not be testing to its full capability, given the privacy and security concerns surrounding the

transmission of actual patient information we do not require it for the purposes of a test.

Therefore, the use of test information about a fictional patient that would be identical in form to

what would be sent about an actual patient would satisfy this objective. However, we note that

this is one of the objectives that a State may modify as discussed previously in this section.

Therefore, more stringent requirements may be established for EPs and eligible hospitals under

the Medicaid program in states where this capability exists.

Comment: Commenters requested that one national standard be established for reporting

lab results to public health agencies.

Response: Standards for content exchange and vocabulary are established in the ONC

final rule at 45 CFR 170.306(g). While we encourage all providers and public health agencies to

work together to develop efficient, electronic submission of reportable lab results to all public

health agencies, for purposes of becoming a meaningful EHR user, we only require a single test

and follow up submission if that test is successful.

CMS-0033-F 211

Comment: Commenters suggested deferring the measure to a later stage due to the lack

of a mature HIE infrastructure and lack of a clear standard for exchanging bio-surveillance data.

Response: We agree that many areas of the country currently lack the infrastructure to

support the electronic exchange of information. As meaningful use seeks to ensure certified

EHR technology has the capability to submit electronic data to public health agencies, we only

require a single test if a receiving entity is available and follow up submission only if that test is

successful.

After consideration of the public comments received, we are modifying the meaningful

use measure for eligible hospitals and CAHs at §495.6(g)(9)(ii) of our regulations to “Performed

at least one test of certified EHR technology’s capacity to provide electronic submission of

reportable lab results to public health agencies and follow-up submission if the test is successful

(unless none of the public health agencies to which eligible hospital or CAH submits such

information have the capacity to receive the information electronically)”.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.306(g). The ability to calculate the measure is included in certified

EHR technology. Eligible hospitals and CAHs should attempt to identify one public health

agency with whom to conduct a test of the submission of electronic data. This test must include

the transfer of either actual or “dummy” data to the chosen public health agency. The testing

could occur prior to the beginning of the EHR reporting period, but must occur prior to the end

of the EHR reporting period. If the test is successful, then the eligible hospital or CAH should

institute regular reporting to that entity according to applicable law and practice. CMS will

accept a yes/no attestation to verify all of the above for eligible hospitals and CAHs.
CMS-0033-F 212

NPRM EP/Eligible Hospital Objective: Capability to provide electronic syndromic

surveillance data to public health agencies and actual transmission according to applicable law

and practice.

In the proposed rule, we did not elaborate on this objective.

Comment: Half of the commenters commenting on this objective recommended that the

objective be deferred to Stage 2 or 3 as the objective is considered expensive, complex and

imposes significant administrative burdens on EPs, eligible hospitals and CAHs unless the

certified EHR technologies support the automate, electronic capture of the requisite data.

Response: The measure for this objective accounts for the possibility that such electronic

exchange of syndromic data is not possible. Standards and certification for certified EHR

technologies are covered under the ONC final rule and do support the automatic identification of

the requisite data and its electronic capture. This greatly limits the cost, complexity and burden

of this objective.

Comment: Commenters requested that an actual transmission be required.

Response: In discussing the reporting immunization data objective, we focused on the

need to align the language for the three objectives contained in under the health care policy

priority of improving population and public health. Our interpretation is that the three phrases

result in the same outcome, but introduce confusion with the current language. We adopted the

language from this objective for the others. We do note however that applicable law and practice

does not guarantee every receiving entity will be able to accept it electronically. Our measure

for meeting this objective is one test of electronic data submission and if the test is successful,

then follow up submission to that one entity based on the reporting requirements of that entity.
CMS-0033-F 213

We do not seek to enforce through meaningful use every law and practice that may require

submission of lab results.

Comment: Some commenters requested a clarification of the term “public health

agencies.”

Response: A public health agency is an entity under the jurisdiction of the U.S.

Department of Health and Human Services, tribal organization, State level and/or city/county

level administration that serves a public health function.

Comment: Some commenters recommended that providers be required to satisfy either

electronic submission to immunization registries or electronic submission of syndromic

surveillance data to a public health agency, but not both.

Response: We disagree. We believe these are fundamentally different types of

information. Each may impose unique requirements in terms of ability to exchange information

on both the EP, eligible hospital, or CAH and the receiving entity. Therefore, a test for one does

not prove or disprove the ability to exchange information for the other.

After consideration of the public comments received, we are modifying the meaningful

use objective for EPs at §495.6(e)(10)(i) and eligible hospitals and CAHs at §495.6(g)(10(i) of

our regulations to “Capability to submit electronic syndromic surveillance data to public health

agencies and actual submission in accordance with applicable law and practice.”

NPRM EP/Eligible Hospital Measure: Performed at least one test of certified EHR

technology's capacity to provide electronic syndromic surveillance data to public health agencies

(unless none of the public health agencies to which an EP, eligible hospital, or CAH submits

such information have the capacity to receive the information electronically).

CMS-0033-F 214

In the proposed rule, we identified this as an objective where more stringent requirements

may be established for EPs and hospitals under the Medicaid program in states where this

capability exists. This is just one example of a possible State proposed modification to

meaningful use.

First, a technical correction, in the proposed rule we incorrectly stated that the capability

to send electronic data to immunization registries was included in the certification standards for

certified EHR technology. We intended for this data to be sent to public health agencies and

ONC in their final rule at 45 CFR 170.304(l) correctly stated this capability as such.

Comment: Commenters asked whether the test needs to be “live” or if it could be a

“simulation”.

Response: As specified in the proposed rule, this test must involve the actual submission

of information to a public health agency, if one exists that will accept the information.

Comment: Commenters asked whether the use of “test” or “dummy” data is permissible.

Response: While the use of test patient information may increase the risk that the system

will not be testing to its full capability, given the privacy and security concerns surrounding the

transmission of actual patient information we do not require it for the purposes of a test.

Therefore, the use of test information about a fictional patient that would be identical in form to

what would be sent about an actual patient would satisfy this objective. However, we note that

this is one of the objectives that a State may modify in accordance with the discussion in

II.A.2.c. of the proposed rule. Therefore, more stringent requirements may be established for

EPs and eligible hospitals under the Medicaid program in states where this capability exists.

Comment: A few commenters expressed confusion as to the required frequency of the

test.
CMS-0033-F 215

Response: As stated in the proposed rule, the required frequency of a test in Stage 1 for

EPs, eligible hospitals, and CAHs is at least once prior to the end of the EHR reporting period.

We further clarify that each payment year would require it own unique test.

Comment: Commenters requested that one national standard be established for reporting

syndromic surveillance data to public health agencies.

Response: Standards for content exchange and vocabulary are established in the ONC

final rule. While we encourage all providers and public health agencies to work together to

develop efficient, electronic submission of syndromic surveillance data to all public health

agencies, for purposes of becoming a meaningful EHR user, we only require a single test and

follow up submission if that test is successful.

Comment: Commenters suggested deferring the measure to a later stage due to the lack

of a mature HIE infrastructure.

Response: We agree that many areas of the country currently lack the infrastructure to

support the electronic exchange of information. As meaningful use seeks to ensure certified

EHR technology has the capability to submit electronic data to public entities, we only require a

single test if a receiving entity is available and follow up submission only if that test is

successful. We note that this measure only applies if there is a public health agency with the

capacity to receive this information.

Comment: Commenters requested clarification on whether a failed attempted test

satisfies the measure and whether EPs in a group setting using identical certified EHR

technology would only need to conduct a single test, not one test per EP.

Response: A failed attempt would meet the measure. We highly encourage EPs, eligible

hospitals, and CAHs to work with their vendor and the receiving entity with whom they tested to
CMS-0033-F 216

identify the source of the failure and develop remedies, but for Stage 1 of meaningful use a failed

attempt would meet the requirements. We had indicated in the proposed rule that only on test is

required for EPs practicing in a group setting that shares the same certified EHR technology. We

maintain that proposal for the final rule.

After consideration of the public comments received, we are modifying the meaningful

use measure for EPs at §495.6(e)(10)(ii) and eligible hospitals and CAHs at §495.6(g)(10)(ii) of

our regulations to “Performed at least one test of certified EHR technology's capacity to provide

electronic syndromic surveillance data to public health agencies and follow-up submission if the

test is successful (unless none of the public health agencies to which an EP, eligible hospital, or

CAH submits such information have the capacity to receive the information electronically)”.

We further specify that in order to meet this objective and measure, an EP, eligible

hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and

standards at 45 CFR 170.302(l). The ability to calculate the measure is included in certified EHR

technology. EPs, eligible hospitals, and CAHs should attempt to identify one public health

agency with whom to conduct a test of the submission of electronic data. This test must include

the transfer of either actual or “dummy” data to the chosen public health agency. The testing

could occur prior to the beginning of the EHR reporting period, but must occur prior to the end

of the EHR reporting period. If the test is successful, then the EP, eligible hospital, or CAH

should institute regular reporting to that entity according to applicable law and practice. CMS

will accept a yes/no attestation to verify all of the above for eligible hospitals and CAHs.

If an EP does not collect any reportable syndromic information on their patients during

the EHR reporting period, then they are excluded from this measure according to the discussion
CMS-0033-F 217

of whether certain EP, eligible hospital or CAH can meet all Stage 1 meaningful use objectives

given established scopes of practices.

The fifth health outcomes policy priority is to ensure adequate privacy and security

protections for personal health information. The following care goals for meaningful use address

this priority:

● Ensure privacy and security protections for confidential information through operating

policies, procedures, and technologies and compliance with applicable law

● Provide transparency of data sharing to patient

NPRM EP/Eligible Hospital Objective: Protect electronic health information created or

maintained by the certified EHR technology through the implementation of appropriate technical

capabilities.

In the proposed rule, we discussed how we were relating the objectives presented by the

HIT Policy committee more tightly to the meaningful use of certified EHR technology as

opposed to the broader success of the EP, eligible hospital or CAH in ensuring privacy and

security. The primary reason we gave was that the proper vehicle for ensuring privacy and

security is the HIPAA Privacy and Security Act and that we sought with this objective to ensure

that certified EHR technology does not impede an EP’s, eligible hospital’s or CAH’s ability to

comply with HIPAA.

Comment: We received considerable support from many commenters who supported this

objective and measure as proposed.

Response: We appreciate the support of these commenters for our proposed objective

and measure.

Comment: Commenters requested clarification of appropriate technical capabilities.

CMS-0033-F 218

Response: The ONC final rule specifies certain capabilities that must be in certified EHR

technology. For the objective we simply mean that a technical capability would be appropriate if

it protected the electronic health information created or maintained by the certified EHR

technology. All of these capabilities could be part of the certified EHR technology or outside

systems and programs that support the privacy and security of certified EHR technology. We

could not develop an exhaustive list. Furthermore as we state in the proposed rule compliance

with HIPAA privacy and security rules is required for all covered entities, regardless of whether

or not they participate in the EHR incentive programs. Furthermore, compliance with the

HIPAA Privacy and Security Rules constitutes a wide range of activities, procedures and

infrastructure. We rephrased the objective to ensure that meaningful use of the certified EHR

technology supports compliance with the HIPAA Privacy and Security Rules and compliance

with fair sharing data practices outlined in the Nationwide Privacy and Security Framework

(http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_10731_848088_0_0_18/Nationwid

ePS_Framework-5.pdf), but do not believe meaningful use of certified EHR technology is the

appropriate regulatory tool to ensure such compliance with the HIPAA Privacy and Security

Rules.

Comment: Several commenters urged CMS not to finalized requirements for the fair data

sharing practices set forth in the Nationwide Privacy and Security Framework and to clarify the

policies to which CMS is referring.

Response: While we stated in the proposed rule we rephrased the objective to ensure

“compliance with fair sharing data practices outline in the Nationwide Privacy and Security

Framework,” we did not propose any practices or policies related to the Nationwide Privacy and

Security Framework and do not finalize any in this final rule.

CMS-0033-F 219

Comment: Several commenters requested the elimination of this objective as redundant

to HIPAA.

Response: We do not see meaningful use as an appropriate regulatory tool to impose

different, additional, and/or inconsistent privacy and security policy requirements from those

policies already required by HIPAA. With that said, we do feel it is crucial that EPs, eligible

hospitals, and CAHs evaluate the impact certified EHR technology has on their compliance with

HIPAA and the protection of health information in general. Therefore, we retain this objective

and measure for meaningful use in the final rule.

Comment: We received hundreds of comments that requested the cancelation of the

EHR incentive payment program due to the privacy and security risks imposed by the

implementation and use of certified EHR technology.

Response: We are required by the ARRA to implement the EHR incentive programs and

cannot cancel them. We seek to mitigate the risks to the security and privacy of patient

information by requiring EPs, eligible hospitals, and CAHs to conduct or review a security risk

analysis in accordance with the requirements under 45 CFR 164.308 (a)(1) and implement

security updates as necessary.

After consideration of the public comments received, we are finalizing the meaningful use

objective for EPs at §495.6(d)(15)(i) and eligible hospitals and CAHs at §495.6(f)(14)(i) of our

regulations as proposed.

We include this objective in the core set. We believe maintaining privacy and security is

crucial for every EP, eligible hospital or CAH that uses certified EHR technology and was

recommended by the HIT Policy Committee for inclusion in the core set.
CMS-0033-F 220

NPRM EP/Eligible Hospital Measure: Conduct or review a security risk analysis in accordance

with the requirements under 45 CFR 164.308 (a)(1) and implement security updates as

necessary.

In the proposed rule, we discussed the role of certified EHR technology in privacy and

security. We said that while certified EHR technology provides tools for protecting health

information, it is not a full protection solution. Processes and possibly tools outside the scope of

certified EHR technology are required. Therefore, for the Stage 1 criteria of meaningful use we

propose that EPs and eligible hospitals conduct or review a security risk analysis of certified

EHR technology and implement updates as necessary at least once prior to the end of the EHR

reporting period and attest to that conduct or review. The testing could occur prior to the

beginning of the EHR reporting period. This is to ensure that the certified EHR technology is

playing its role in the overall strategy of the EP or eligible hospital in protecting health

information. We have maintained this discussion for the final rule, but modified the measure to

account for requests discussed in the comment and response section below.

Comment: Some commenters requested clarification of the phrase “implement security

updates as necessary”.

Response: A security update would be required if any security deficiencies were

identified during the risk analysis. A security update could be updated software for certified

EHR technology to be implemented as soon as available, to changes in workflow processes, or

storage methods or any other necessary corrective action that needs to take place in order to

eliminate the security deficiency or deficiencies identified in the risk analysis. To provide better

clarity on this requirement, we are modifying the measure.

CMS-0033-F 221

After consideration of the public comments received, we are modifying the meaningful

use measure for EPs at §495.6(d)(15)(ii) and eligible hospitals and CAHs at §495.6(f)(14)(ii) of

our regulations “Conduct or review a security risk analysis per 45 CFR 164.308(a)(1) of the

certified EHR technology, and implement security updates and correct identified security

deficiencies as part of its risk management process”.

Table 2: Stage 1 Meaningful Use Objectives and Associated Measures Sorted by Core and

Menu Set

CORE SET
Health Stage 1 Objectives
Outcomes Policy Eligible Professionals Eligible Hospitals and CAHs Stage 1 Measures
Priority
Improving Use CPOE for medication Use CPOE for medication More than 30% of unique
quality, safety, orders directly entered by any orders directly entered by any patients with at least one
efficiency, and licensed healthcare licensed healthcare professional medication in their
reducing health professional who can enter who can enter orders into the medication list seen by the
disparities orders into the medical record medical record per state, local EP or admitted to the
per state, local and and professional guidelines eligible hospital’s or
professional guidelines CAH’s inpatient or
emergency department
(POS 21 or 23) have at
least one medication order
entered using CPOE
Implement drug-drug and Implement drug-drug and drug- The EP/eligible
drug-allergy interaction allergy interaction checks hospital/CAH has enabled
checks this functionality for the
entire EHR reporting
period
Generate and transmit More than 40% of all
permissible prescriptions permissible prescriptions
electronically (eRx) written by the EP are
transmitted electronically
using certified EHR
technology
Record demographics Record demographics More than 50% of all
o preferred language o preferred language unique patients seen by
the EP or admitted to the
o gender o gender eligible hospital’s or
o race o race CAH’s inpatient or
o ethnicity o ethnicity emergency department
(POS 21 or 23) have
o date of birth o date of birth
demographics recorded as
o date and preliminary cause structured data
of death in the event of
mortality in the eligible hospital
or CAH
CMS-0033-F 222

Maintain an up-to-date Maintain an up-to-date problem More than 80% of all

problem list of current and list of current and active unique patients seen by
active diagnoses diagnoses the EP or admitted to the
eligible hospital’s or
CAH’s inpatient or
emergency department
(POS 21 or 23) have at
least one entry or an
indication that no
problems are known for
the patient recorded as
structured data
Maintain active medication Maintain active medication list More than 80% of all
list unique patients seen by
the EP or admitted to the
eligible hospital’s or
CAH’s inpatient or
emergency department
(POS 21 or 23)have at
least one entry (or an
indication that the patient
is not currently prescribed
any medication) recorded
as structured data
Maintain active medication Maintain active medication More than 80% of all
allergy list allergy list unique patients seen by
the EP or admitted to the
eligible hospital’s or
CAH’s inpatient or
emergency department
(POS 21 or 23) have at
least one entry (or an
indication that the patient
has no known medication
allergies) recorded as
structured data
Record and chart changes in Record and chart changes in For more than 50% of all
vital signs: vital signs: unique patients age 2 and
o Height o Height over seen by the EP or
o Weight o Weight admitted to eligible
o Blood pressure o Blood pressure hospital’s or CAH’s
o Calculate and display o Calculate and display inpatient or emergency
BMI BMI department (POS 21 or
o Plot and display o Plot and display 23), height, weight and
growth charts for growth charts for blood pressure are
children 2-20 years, children 2-20 years, recorded as structured data
including BMI including BMI
Record smoking status for Record smoking status for More than 50% of all
patients 13 years old or older patients 13 years old or older unique patients 13 years
old or older seen by the
EP or admitted to the
eligible hospital’s or
CAH’s inpatient or
emergency department
(POS 21 or 23) have
smoking status recorded
CMS-0033-F 223

as structured data

Implement one clinical Implement one clinical decision Implement one clinical
decision support rule relevant support rule related to a high decision support rule
to specialty or high clinical priority hospital condition along
priority along with the ability with the ability to track
to track compliance that rule compliance with that rule
Report ambulatory clinical Report hospital clinical quality For 2011, provide
quality measures to CMS or measures to CMS or the States aggregate numerator,
the States denominator, and
exclusions through
attestation as discussed in
section II(A)(3) of this
final rule
For 2012, electronically
submit the clinical quality
measures as discussed in
section II(A)(3) of this
final rule
Engage patients Provide patients with an Provide patients with an More than 50% of all
and families in electronic copy of their health electronic copy of their health patients of the EP or the
their health care information (including information (including inpatient or emergency
diagnostic test results, diagnostic test results, problem departments of the eligible
problem list, medication lists, list, medication lists, medication hospital or CAH (POS 21
medication allergies), upon allergies, discharge summary, or 23) who request an
request procedures), upon request electronic copy of their
health information are
provided it within 3
business days
Provide patients with an More than 50% of all
electronic copy of their patients who are
discharge instructions at time of discharged from an
discharge, upon request eligible hospital or CAH’s
inpatient department or
emergency department
(POS 21 or 23) and who
request an electronic copy
of their discharge
instructions are provided it
Provide clinical summaries for Clinical summaries
patients for each office visit provided to patients for
more than 50% of all
office visits within 3
business days
CMS-0033-F 224

Improve care Capability to exchange key Capability to exchange key Performed at least one test
coordination clinical information (for clinical information (for of certified EHR
example, problem list, example, discharge summary, technology's capacity to
medication list, medication procedures, problem list, electronically exchange
allergies, diagnostic test medication list, medication key clinical information
results), among providers of allergies, diagnostic test
care and patient authorized results), among providers of
entities electronically care and patient authorized
entities electronically

Ensure adequate Protect electronic health Protect electronic health Conduct or review a
privacy and information created or information created or security risk analysis per
security maintained by the certified maintained by the certified 45 CFR 164.308 (a)(1)
protections for EHR technology through the EHR technology through the and implement security
personal health implementation of appropriate implementation of appropriate updates as necessary and
information technical capabilities technical capabilities correct identified security
deficiencies as part of its
risk management process
MENU SET
Stage 1 Objectives
Health Outcomes
Eligible Professionals Eligible Hospitals and Stage 1 Measures
Policy Priority
CAHs
Improving quality, Implement drug- Implement drug-formulary The EP/eligible hospital/CAH has
safety, efficiency, formulary checks checks enabled this functionality and has
and reducing access to at least one internal or
health disparities external drug formulary for the
entire EHR reporting period
Record advance directives More than 50% of all unique
for patients 65 years old or patients 65 years old or older
older admitted to the eligible hospital’s or
CAH’s inpatient department (POS
21) have an indication of an
advance directive status recorded
Incorporate clinical lab- Incorporate clinical lab-test More than 40% of all clinical lab
test results into certified results into certified EHR tests results ordered by the EP or by
EHR technology as technology as structured an authorized provider of the
structured data data eligible hospital or CAH for
patients admitted to its inpatient or
emergency department (POS 21 or
23) during the EHR reporting
period whose results are either in a
positive/negative or numerical
format are incorporated in certified
EHR technology as structured data
Generate lists of patients Generate lists of patients by Generate at least one report listing
by specific conditions to specific conditions to use patients of the EP, eligible hospital
use for quality for quality improvement, or CAH with a specific condition
improvement, reduction reduction of disparities,
of disparities, research research or outreach
or outreach
CMS-0033-F 225

Send reminders to More than 20% of all unique

patients per patient patients 65 years or older or 5 years
preference for old or younger were sent an
preventive/ follow up appropriate reminder during the
care EHR reporting period

Engage patients Provide patients with More than 10% of all unique
and families in timely electronic access patients seen by the EP are provided
their health care to their health timely (available to the patient
information (including within four business days of being
lab results, problem list, updated in the certified EHR
medication lists, technology) electronic access to
medication allergies) their health information subject to
within four business the EP’s discretion to withhold
days of the information certain information
being available to the
EP
Use certified EHR Use certified EHR
technology to identify technology to identify More than 10% of all unique
patient-specific patient-specific education patients seen by the EP or admitted
education resources and resources and provide those to the eligible hospital’s or CAH’s
provide those resources resources to the patient if inpatient or emergency department
to the patient if appropriate (POS 21 or 23) are provided
appropriate patient-specific education resources
Improve care The EP, eligible hospital The EP, eligible hospital or The EP, eligible hospital or CAH
coordination or CAH who receives a CAH who receives a performs medication reconciliation
patient from another patient from another setting for more than 50% of transitions of
setting of care or of care or provider of care care in which the patient is
provider of care or or believes an encounter is transitioned into the care of the EP
believes an encounter is relevant should perform or admitted to the eligible hospital’s
relevant should perform medication reconciliation or CAH’s inpatient or emergency
medication department (POS 21 or 23)
reconciliation
The EP, eligible hospital The EP, eligible hospital or The EP, eligible hospital or CAH
or CAH who transitions CAH who transitions their who transitions or refers their
their patient to another patient to another setting of patient to another setting of care or
setting of care or care or provider of care or provider of care provides a
provider of care or refers their patient to summary of care record for more
refers their patient to another provider of care than 50% of transitions of care and
another provider of care should provide summary of referrals
should provide summary care record for each
of care record for each transition of care or referral
transition of care or
referral
CMS-0033-F 226

Improve Capability to submit Capability to submit Performed at least one test of

population and electronic data to electronic data to certified EHR technology's capacity
public health2 immunization registries immunization registries or to submit electronic data to
or Immunization Immunization Information immunization registries and follow
Information Systems Systems and actual up submission if the test is
and actual submission in submission in accordance successful (unless none of the
accordance with with applicable law and immunization registries to which
applicable law and practice the EP, eligible hospital or CAH
practice submits such information have the
capacity to receive the information
electronically)
Capability to submit Performed at least one test of
electronic data on certified EHR technology’s
reportable (as required by capacity to provide electronic
state or local law) lab submission of reportable lab results
results to public health to public health agencies and
agencies and actual follow-up submission if the test is
submission in accordance successful (unless none of the
with applicable law and public health agencies to which
practice eligible hospital or CAH submits
such information have the capacity
to receive the information
electronically)
Capability to submit Capability to submit Performed at least one test of
electronic syndromic electronic syndromic certified EHR technology's capacity
surveillance data to surveillance data to public to provide electronic syndromic
public health agencies health agencies and actual surveillance data to public health
and actual submission in submission in accordance agencies and follow-up submission
accordance with with applicable law and if the test is successful (unless none
applicable law and practice of the public health agencies to
practice which an EP, eligible hospital or
CAH submits such information
have the capacity to receive the
information electronically)

Table 3: Stage 1 Meaningful Use Objectives and Associated Measures Sorted by Method of

Measure Calculation

Measures with a Denominator of Unique Patients Regardless of Whether the Patient’s Records Are
Maintained Using Certified EHR Technology
Stage 1 Objectives
Stage 1 Measures
Eligible Professionals Eligible Hospitals and CAHs

2
Unless an EP, eligible hospital or CAH has an exception for all of these objectives and measures they must complete at least
one as part of their demonstration of the menu set in order to be a meaningful EHR user.
CMS-0033-F 227

Maintain an up-to-date problem Maintain an up-to-date problem More than 80% of all unique patients seen
list of current and active list of current and active by the EP or admitted to the eligible
diagnoses diagnoses hospital’s or CAH’s inpatient or
emergency department (POS 21 or 23)
have at least one entry or an indication
that no problems are known for the patient
recorded as structured data
Maintain active medication list Maintain active medication list More than 80% of all unique patients seen
by the EP or admitted to the eligible
hospital’s or CAH’s inpatient or
emergency department (POS 21 or
23)have at least one entry (or an
indication that the patient is not currently
prescribed any medication) recorded as
structured data
Maintain active medication Maintain active medication More than 80% of all unique patients seen
allergy list allergy list by the EP or admitted to the eligible
hospital’s or CAH’s inpatient or
emergency department (POS 21 or 23)
have at least one entry (or an indication
that the patient has no known medication
allergies) recorded as structured data
Record demographics Record demographics More than 50% of all unique patients seen
o Preferred language o Preferred language by the EP or admitted to the eligible
o Gender o Gender hospital’s or CAH’s inpatient or
o Race o Race emergency department (POS 21 or 23)
o Ethnicity o Ethnicity have demographics recorded as structured
o Date of Birth o Date of Birth data
o Date and preliminary cause of
death in the event of
mortality in the eligible
hospital or CAH
Provide patients with timely More than 10% of all unique patients seen
electronic access to their health by the EP are provided timely (available
information (including lab results, to the patient within four business days of
problem list, medication lists, being updated in the certified EHR
medication allergies) within four technology) electronic access to their
business days of the information health information subject to the EP’s
being available to the EP discretion to withhold certain information
Use certified EHR technology to Use certified EHR technology to
identify patient-specific education More than 10% of all unique patients seen
identify patient-specific education
resources and provide those resources and provide those by the EP or admitted to the eligible
resources to the patient if resources to the patient if hospital’s or CAH’s inpatient or
appropriate appropriate emergency department (POS 21 or 23) are
provided patient-specific education
resources
Measures with a Denominator of Based on Counting Actions for Patients whose Records are Maintained
Using Certified EHR Technology
Stage 1 Objectives
Stage 1 Measures
Eligible Professionals Eligible Hospitals and CAHs
CMS-0033-F 228

Use CPOE for medication orders Use CPOE for medication orders More than 30% of unique patients with at
directly entered by any licensed directly entered by any licensed least one medication in their medication
healthcare professional who can healthcare professional who can list seen by the EP or admitted to the
enter orders into the medical enter orders into the medical eligible hospital’s or CAH’s inpatient or
record per state, local and record per state, local and emergency department (POS 21 or 23)
professional guidelines professional guidelines have at least one medication order entered
using CPOE
Generate and transmit More than 40% of all permissible
permissible prescriptions prescriptions written by the EP are
electronically (eRx) transmitted electronically using certified
EHR technology

Record and chart changes in vital Record and chart changes in vital For more than 50% of all unique patients
signs: signs: age 2 and over seen by the EP or admitted
o Height o Height to eligible hospital’s or CAH’s inpatient
o Weight o Weight or emergency department (POS 21 or 23),
o Blood pressure o Blood pressure height, weight and blood pressure are
o Calculate and display o Calculate and display recorded as structured data
BMI BMI
o Plot and display growth o Plot and display growth
charts for children 2-20 charts for children 2-20
years, including BMI years, including BMI
Record smoking status for Record smoking status for More than 50% of all unique patients 13
patients 13 years old or older patients 13 years old or older years old or older seen by the EP or
admitted to the eligible hospital’s or
CAH’s inpatient or emergency department
(POS 21 or 23) have smoking status
recorded as structured data
Record advance directives for More than 50% of all unique patients 65
patients 65 years old or older years old or older admitted to the eligible
hospital have an indication of an advance
directive status recorded
Incorporate clinical lab-test Incorporate clinical lab-test results More than 40% of all clinical lab tests
results into certified EHR into certified EHR technology as results ordered by the EP or by an
technology as structured data structured data authorized provider of the eligible hospital
or CAH for patients admitted to its
inpatient or emergency department (POS
21 or 23) during the EHR reporting period
whose results are either in a
positive/negative or numerical format are
incorporated in certified EHR technology
as structured data
Provide patients with an Provide patients with an More than 50% of all patients of the EP or
electronic copy of their health electronic copy of their health the inpatient or emergency departments of
information (including diagnostic information (including diagnostic the eligible hospital or CAH (POS 21 or
test results, problem list, test results, problem list, 23) who request an electronic copy of
medication lists, medication medication lists, medication their health information are provided it
allergies), upon request allergies, discharge summary, within 3 business days
procedures), upon request
CMS-0033-F 229

Provide patients with an More than 50% of all patients who are
electronic copy of their discharge discharged from an eligible hospital or
instructions at time of discharge, CAH’s inpatient department or emergency
upon request department (POS 21 or 23) and who
request an electronic copy of their
discharge instructions are provided it

Provide clinical summaries for Clinical summaries provided to patients

patients for each office visit for more than 50% of all office visits
within 3 business days

Send reminders to patients per More than 20% of all unique patients 65
patient preference for preventive/ years or older or 5 years old or younger
follow up care were sent an appropriate reminder during
the EHR reporting period

The EP, eligible hospital or CAH The EP, eligible hospital or CAH The EP, eligible hospital or CAH
who receives a patient from who receives a patient from performs medication reconciliation for
another setting of care or provider another setting of care or provider more than 50% of transitions of care in
of care or believes an encounter is of care or believes an encounter is which the patient is transitioned into the
relevant should perform relevant should perform care of the EP or admitted to the eligible
medication reconciliation medication reconciliation hospital’s or CAH’s inpatient or
emergency department (POS 21 or 23)
The EP, eligible hospital or CAH The EP, eligible hospital or CAH The EP, eligible hospital or CAH who
who transitions their patient to who transitions their patient to transitions or refers their patient to another
another setting of care or provider another setting of care or provider setting of care or provider of care provides
of care or refers their patient to of care or refers their patient to a summary of care record for more than
another provider of care should another provider of care should 50% of transitions of care and referrals
provide summary of care record provide summary of care record
for each transition of care or for each transition of care or
referral referral
Measures Requiring Only a Yes/No Attestation
Stage 1 Objectives
Stage 1 Measures
Eligible Professionals Hospitals
Implement drug-drug and drug- Implement drug-drug and drug- The EP/eligible hospital/CAH has enabled
allergy interaction checks allergy interaction checks this functionality for the entire EHR
reporting period
Implement drug-formulary Implement drug-formulary checks The EP/eligible hospital/CAH has enabled
checks this functionality and has access to at least
one internal or external drug formulary for
the entire EHR reporting period
CMS-0033-F 230

Generate lists of patients by Generate lists of patients by Generate at least one report listing patients
specific conditions to use for specific conditions to use for of the EP, eligible hospital or CAH with a
quality improvement, reduction quality improvement, reduction of specific condition
of disparities, research or disparities, research or outreach
outreach
Implement one clinical decision Implement one clinical decision Implement one clinical decision support
support rule relevant to specialty support rule related to a high rule
or high clinical priority along priority hospital condition along
with the ability to track with the ability to track
compliance that rule compliance with that rule

Capability to exchange key Capability to exchange key Performed at least one test of certified
clinical information (for example, clinical information (for example, EHR technology's capacity to
problem list, medication list, discharge summary, procedures, electronically exchange key clinical
medication allergies, diagnostic problem list, medication list, information
test results), among providers of medication allergies, diagnostic
care and patient authorized test results), among providers of
entities electronically care and patient authorized
entities electronically
Capability to submit electronic Capability to submit electronic Performed at least one test of certified
data to immunization registries or data to immunization registries or EHR technology's capacity to submit
Immunization Information Immunization Information electronic data to immunization registries
Systems and actual submission in Systems and actual submission in and follow up submission if the test is
accordance with applicable law accordance with applicable law successful (unless none of the
and practice and practice immunization registries to which the EP,
eligible hospital or CAH submits such
information have the capacity to receive
the information electronically)
Capability to submit electronic Performed at least one test of certified
data on reportable (as required by EHR technology capacity’s to provide
state or local law) lab results to electronic submission of reportable lab
public health agencies and actual results to public health agencies and
submission in accordance with follow-up submission if the test is
applicable law and practice successful (unless none of the public
health agencies to which eligible hospital
or CAH submits such information have
the capacity to receive the information
electronically)
Capability to submit electronic Capability to submit electronic Performed at least one test of certified
syndromic surveillance data to syndromic surveillance data to EHR technology's capacity to provide
public health agencies and actual public health agencies and actual electronic syndromic surveillance data to
submission in accordance with submission in accordance with public health agencies and follow-up
applicable law and practice applicable law and practice submission if the test is successful (unless
none of the public health agencies to
which an EP, eligible hospital or CAH
submits such information have the
capacity to receive the information
electronically)
CMS-0033-F 231

Protect electronic health Protect electronic health Conduct or review a security risk analysis
information created or maintained information created or maintained per 45 CFR 164.308 (a)(1) and implement
by the certified EHR technology by the certified EHR technology security updates as necessary and correct
through the implementation of through the implementation of identified security deficiencies as part of
appropriate technical capabilities appropriate technical capabilities its risk management process

3. Sections 4101(a) and 4102(a)(1) of the HITECH Act: Reporting on Clinical Quality

Measures Using EHRs by EPs, Eligible Hospitals, and CAHs3

a. General

As discussed in the meaningful use background in section II.A.2.a. there are three

elements of meaningful use. In this section, we discuss the third requirement: using certified

EHR technology, the EP, eligible hospital, or CAH submits to the Secretary, in a form and

manner specified by the Secretary, information for the EHR reporting period on clinical quality

measures and other measures specified by the Secretary. The submission of other measures is

discussed in section II.A.2.c of this final rule. The two other elements of meaningful use are

discussed in section II.A.2.d.1 of this final rule.

b. Requirements for the Submission of Clinical Quality Measures by EPs, Eligible Hospitals,

and CAHs

Sections 1848(o)(2)(B)(ii) and 1886(n)(3)(B)(ii) of the Act provide that the Secretary

may not require the electronic reporting of information on clinical quality measures unless the

Secretary has the capacity to accept the information electronically, which may be on a pilot

basis.

In the proposed rule, we stated that we do not anticipate that HHS will complete the

necessary steps for us to have the capacity to electronically accept data on clinical quality

3
For purposes of this final rule, the term “eligible hospital” for the Medicaid EHR incentive program is inclusive of
Critical Access Hospitals (CAHs) as defined in this final rule.
CMS-0033-F 232

measures from EHRs for the 2011 payment year. We believe that it is unlikely that by 2011

there will be adequate testing and demonstration of the ability to receive the required transmitted

information on a widespread basis. The capacity to accept information on clinical quality

measures also would depend upon the Secretary promulgating technical specifications for EHR

vendors with respect to the transmission of information on clinical quality measures sufficiently

in advance of the EHR reporting period for 2011, so that adequate time has been provided either

for such specifications to be certified, or for EHR vendors to code such specifications into

certified systems. Therefore, for 2011, we proposed that Medicare EPs, eligible hospitals, and

CAHs use an attestation methodology to submit summary information to us on clinical quality

measures as a condition of demonstrating meaningful use of certified EHR technology, rather

than electronic submission.

We proposed that from the Medicaid perspective, delaying the onset of clinical quality

measures electronic reporting until 2012 addresses concerns about States having the ready

infrastructure to receive and store clinical quality measures data before then. More importantly,

we recognized that since Medicaid providers are eligible to receive incentive payments for

adopting, implementing, or upgrading certified EHR technology, Medicaid providers may not be

focused on demonstrating meaningful use until 2012 or later.

We stated that we anticipate that for the 2012 payment year we will have completed the

necessary steps to have the capacity to receive electronically information on clinical quality

measures from EHRs, including the promulgation of technical specifications for EHR vendors to

use for obtaining certification of their systems. Therefore, for the Medicare EHR incentive

program beginning in CY 2012 we proposed that an EP using a certified EHR technology or

beginning in FY 2012 an eligible hospital or CAH using a certified EHR technology, as

CMS-0033-F 233

appropriate for clinical quality measures, must submit information on clinical quality measures

electronically, in addition to submitting the other measures described in section II.2.d.2, in order

for the EP, eligible hospital, or CAH to be a meaningful EHR user, regardless of whether CY

2012 is their first or second payment year. However, if the Secretary does not have the capacity

to accept the information on clinical quality measures electronically in 2012, consistent with

sections 1848(o)(2)(B)(ii) and 1886(n)(3)(B)(ii) of the Act, we will continue to rely on an

attestation methodology for reporting of clinical quality measures as a requirement for

demonstrating meaningful use of certified EHR technology for payment year 2012. We stated in

the proposed rule that should we not have the capacity to accept information on clinical quality

measures electronically in 2012, we would inform the public of this fact by publishing a notice in

the Federal Register and providing instructions on how this information should be submitted to

us.

We also are finalizing in this final rule that States must identify for us in their State

Medicaid HIT Plans how they plan to accept data from Medicaid providers who seek to

demonstrate meaningful use by reporting on clinical quality measures, either via attestation or

via electronic reporting, subject to our prior approval. If they initiate their program by accepting

attestations for clinical quality measures, they must also describe how they will inform providers

of their timeframe to accept submission of clinical quality measures electronically. We expect

that States will have the capacity to accept electronic reporting of clinical quality measures by

their second year implementing their Medicaid EHR incentive program.

For purposes of the requirements under sections 1848(o)(2)(A)(iii) and 1886 (n)(3)(iii) of

the Act, we defined “clinical quality measures” to consist of measures of processes, experience,

and/or outcomes of patient care, observations or treatment that relate to one or more quality aims
CMS-0033-F 234

for health care such as effective, safe, efficient, patient-centered, equitable, and timely care. We

noted that certain statutory limitations apply only to the reporting of clinical quality measures,

such as the requirement discussed in the previous paragraph prohibiting the Secretary from

requiring the electronic reporting of information on clinical quality measures unless the Secretary

has the capacity to accept the information electronically, as well as other statutory requirements

for clinical quality measures that are discussed below in section II.A.3.c.1 of this final rule.

These limitations apply solely to the submission of clinical quality measures, and do not apply to

other measures of meaningful EHR use. The clinical quality measures on which EPs, eligible

hospitals, or CAHs will be required to submit information using certified EHR technology, the

statutory requirements and other considerations that were used to select these measures, and the

reporting requirements are described below.

With respect to Medicaid EPs and eligible hospitals, we noted that section 1903(t)(6) of

the Act recognizes that the demonstration of meaningful use may also include the reporting of

clinical quality measures to the States. We proposed that in the interest of simplifying the

program and guarding against duplication of meaningful use criteria, the clinical quality

measures adopted for the Medicare EHR incentive program, would also apply to EPs and eligible

hospitals in the Medicaid EHR incentive program.

Despite the statutory limitation prohibiting the Secretary from requiring the electronic

submission of clinical quality measures in the Medicare EHR incentive program, if HHS does

not have the capacity to accept this information electronically, as previously discussed, the

Secretary has broad discretion to establish requirements for meaningful use of certified EHR

technology and for the demonstration of such use by EPs, eligible hospitals, and CAHs.

Although we proposed to require the electronic submission of information on clinical quality

CMS-0033-F 235

measures in 2012, we stated that we do not desire this to delay the use of certified EHR

technology by EPs, eligible hospitals, and CAHs to measure and improve clinical quality.

Specifically, we stated that using EHR functionalities that support measurement of clinical

quality is critical to a central goal of the HITECH Act, improving health care quality. Measuring

quality is a fundamental aspect of improving such quality, because it allows EPs, eligible

hospitals, and CAHs to receive quantitative information upon which they can then act in order to

improve quality.

Accordingly, although we did not propose under sections 1848(o)(2)(A)(iii) and

1886(n)(3)(A)(iii) of the Act to require that for 2011 EPs, eligible hospitals, and CAHs report

clinical quality measures to us or States electronically, we proposed to require as an additional

condition of demonstrating meaningful use of certified EHR technology under sections

1848(o)(2)(A)(i), 1886(n)(3)(A)(ii), and 1903(t)(6) of the Act that EPs and eligible hospitals use

certified EHR technology to capture the data elements and calculate the results for certain

clinical quality measures. Further, we proposed that EPs, eligible hospitals, and CAHs

demonstrate that they have satisfied this requirement during the EHR reporting period for 2011

through attestation. We also proposed to require that Medicare EPs, eligible hospitals, and

CAHs attest to the accuracy and completeness of the numerators and denominators for each of

the applicable measures. Finally, in accordance with our authority under sections

1848(o)(C)(i)(V) and 1886(n)(3)(C)(i)(V) of the Act, which grants us broad discretion to specify

the means through which EPs, eligible hospitals, and CAHs demonstrate compliance with the

meaningful use criteria, we proposed that EPs, eligible hospitals, and CAHs demonstrate their

use of certified EHR technology to capture the data elements and calculate the results for the

applicable clinical quality measures by reporting the results to us for all applicable patients. For
CMS-0033-F 236

the Medicaid incentive program, we proposed that States may accept provider attestations in the

same manner to demonstrate meaningful use in 2011. However, we indicated that we expect that

most Medicaid providers will qualify for the incentive payment by adopting, implementing, or

upgrading to certified EHR technology, and therefore will not need to attest to meaningful use of

certified EHR technology in 2011, for their first payment year.

We stated that we recognize that considerable work needs to be done by measure owners

and developers with respect to the clinical quality measures that we proposed. This includes

completing electronic specifications for measures, implementing such specifications into EHR

technology to capture and calculate the results, and implementing the systems, themselves. We

also recognized that some measures are further developed than others, as discussed in the

measures section (see 75 FR 1871) of the proposed rule. Nevertheless we stated our belief that

overall there is sufficient time to complete work on measures and measures specifications so as

to allow vendors and EPs, eligible hospitals, and CAHs to implement such systems. We stated

that it was our intention not to finalize those specific measures should the necessary work on

measure specifications not be completed for particular measures according to the timetable we

discuss below. As we discuss below, we finalize in this final rule only those clinical quality

measures for which clearly defined electronic specifications have been finalized by the date of

display of this final rule. Finalized clinical quality measures are listed in Table 6 for EPs and

Table 7 for eligible hospitals and CAHs. We also clarify that while States may not have the

capacity to accept electronic reporting of clinical quality measures in 2011 or their first year

implementing their Medicaid EHR incentive program, we expect that they will have such

capacity by their second implementation year. However, if they do not, as with the Federal

government, the State would continue to rely on an attestation methodology for reporting clinical
CMS-0033-F 237

quality measures as a requirement for demonstrating meaningful use of certified EHR

technology, subject to CMS prior approval via an updated State Medicaid HIT plan.

Comment: A few commenters requested that the definition of “clinical quality measures”

be expanded to include “appropriate clinical prevention.”

Response: We agree that appropriate clinical prevention is a pertinent topic for clinical

quality measures, but we do not believe the definition of clinical quality measures needs to

delineate every aspect of quality care included in the definition.

Comment: Several commenters said it will be difficult to develop the EHR capability to

capture, integrate and train staff regarding measure specifications if the clinical quality measures

are not posted with sufficient time to allow these activities. Other commenters said there is

insufficient time allowed for vendors to retool their products and complete development of the

reports and/or systems. Several commenters indicated that the clinical quality measures have not

been tested, and reliability and validity testing should be performed. Other commenters indicated

that standard, clearly defined electronic specifications do not exist and new specifications should

be pilot tested and published for stakeholder/public comment. A commenter requested that CMS

establish an explicit process for development and testing of evidence based electronically

specified measures (eMeasure), and ensure adequate time for field testing.

Response: In general we agree with the desirability of having electronic specifications

available, pilot tested, and published for stakeholder viewing sufficiently in advance so as to

allow adequate time for modifications if necessary and vendors to incorporate them into certified

EHR technology, and for EPs, eligible hospitals, and CAHs to integrate the measures into their

operations and train staff on the measures. In this case, however, there is a process for

certification of certified EHR technology which includes testing of the capability of the certified
CMS-0033-F 238

EHR. The final rule issued by ONC (found elsewhere in this issue of the Federal Register)

provides that certified EHR technology must have the ability to calculate clinical quality

measures as specified by us. We interpret this requirement to mean that certified EHR

technology must have the capability to calculate those clinical quality measures selected in this

final rule based on the specifications we select and post on the CMS website. In order to provide

sufficient time for vendors to retool their products and complete development of the necessary

reports and/or systems for calculation of the results for the required clinical quality measures,

and for certifying bodies to test and certify that EHR technologies adequately do so, we are

adopting only those electronic specifications that are posted on the CMS website as of the date of

display of this final rule. We believe testing that is part of the process for certification of EHR

technology will substitute for testing that might otherwise occur. Additionally, some of the

selected measures have undergone various amounts of testing already. For example, the

Emergency Department Throughput, Stroke and Venous Thromboembolism (VTE) measures

mentioned by the commenter were tested during the January 2010 Connectathon and

demonstrated at the Health Information and Management Systems Society (HIMSS) 2010

Interoperability Showcase which demonstrated the use of the measures by participating vendors.

However, we expect the EHR certification process to carry out the necessary testing to assure

that applicable certified EHR technology can calculate sufficient number of EP, eligible hospital

and CAH clinical quality measures required to qualify for the meaningful use incentive program.

In order to permit greater participation by EHR vendors, including specialty EHRs, the

certification program (see ONC final rule found elsewhere in this issue of the Federal Register)

will permit EHRs to be certified if they are able to calculate at a minimum three clinical quality

measures in addition to the six core and alternative core measures. In addition, the fact that EPs,
CMS-0033-F 239

eligible hospitals, and CAHs can adopt an EHR reporting period toward the end of FY/CY 2011,

we believe, will provide additional time for providers to implement and train staff on the

measures we adopt in this final rule.

c. Statutory Requirements and Other Considerations for the Selection of Clinical Quality

Measures for Electronic Submission by EPs, Eligible Hospitals, and CAHs

(1) Statutory Requirements for the Selection of Clinical Quality Measures for Electronic

Submission by EPs, Eligible Hospitals, and CAHs

Sections 1848(o)(2)(B)(i)(II) and 1886(n)(3)(B)(i) of the Act require that prior to any

clinical quality measure being selected, the Secretary will publish in the Federal Register such

measure and provide for a period of public comment on such measure. The proposed clinical

quality measures for EPs, eligible hospitals, and CAHs for 2011 and 2012 payment were listed in

Tables 3 through 21 of the proposed rule (see 75 FR 1874 through 1900).

In the proposed rule, we noted that for purposes of selecting clinical quality measures on

which EPs will be required to submit information using certified EHR technology, section

1848(o)(2)(B)(i)(I) of the Act, as added by section 4101 of the HITECH Act, states that the

Secretary shall provide preference to clinical quality measures that have been endorsed by the

entity with a contract with the Secretary under section 1890(a) of the Act, as added by section

183 of the Medicare Improvement for Patients and Providers Act (MIPPA) of 2008. For

submission of clinical quality measures by eligible hospitals and CAHs, section

1886(n)(3)(B)(i)(I) of the Act, as added by section 4102(a) of the HITECH Act, requires the

Secretary to provide preference to those clinical quality measures that have been endorsed by the

entity with a contract with the Secretary under section 1890(a) of the Act, as added by section

183 of the MIPPA, or clinical quality measures that have been selected for the purpose of
CMS-0033-F 240

applying section 1886(b)(3)(B)(viii) of the Act (that is, measures that have been selected for the

Reporting Hospital Quality Data for Annual Payment Update (RHQDAPU) program).

On January 14, 2009, the U.S. Department of Health and Human Services awarded the

contract required under section 1890(a) of the Act to the National Quality Forum (NQF).

Therefore, we explained in the proposed rule that when selecting the clinical quality measures

EPs must report in order to demonstrate meaningful use of certified EHR technology in

accordance with section 1848(o)(2)(B)(i)(I) of the Act, we will give preference to the clinical

quality measures endorsed by the NQF, including NQF endorsed measures that have previously

been selected for the Physician Quality Reporting Initiative (PQRI) program. Similarly, we

stated that when selecting the clinical quality measures eligible hospitals and CAHs must report

in order to demonstrate meaningful use of certified EHR technology in accordance with section

1886(n)(3)(B)(i)(I) of the Act, we will give preference to the clinical quality measures selected

from those endorsed by the NQF or that have previously been selected for the RHQDAPU

program. In some instances we proposed measures for EPs, eligible hospitals, and CAHs that are

not currently NQF endorsed in an effort to include a broader set of clinical quality measures. In

the proposed rule, we noted that the HITECH Act does not require the use of NQF endorsed

measures, nor limit the measures to those included in PQRI or RHQDAPU. We stated that if we,

professional societies, or other stakeholders identify clinical quality measures which may be

appropriate for the EHR incentive programs, we will consider those measures even if they are

not endorsed by the NQF or have not been selected for the PQRI or RHQDAPU programs,

subject to the requirement to publish in the Federal Register such measure(s) for a period of

public comment.
CMS-0033-F 241

We proposed certain clinical quality measures for EPs, eligible hospitals, and CAHs, and

listed these measures in Tables 3 through 21 of the proposed rule (see 75 FR 1874-1900) for use

in the 2011 and 2012 payment years. We stated that no changes (that is, additions of clinical

quality measures) would be made after publication of the final rule, except through further

rulemaking. However, we stated that we may make administrative and/or technical

modifications or refinements, such as revisions to the clinical quality measures titles and code

additions, corrections, or revisions to the detailed specifications for the 2011 and 2012 payment

year measures. We stated that the 2011 specifications for user submission of clinical quality

measures would be available on our website when they are sufficiently developed or finalized.

Specifications for the EHR incentive programs must be obtained only from the specifications

documents for the EHR incentive program clinical quality measures.

Comment: Numerous comments were received regarding the criteria for selection of

clinical quality measures. Some commenters noted the importance of scientific and medical

evidence supporting the measure, as well as concerns regarding how the clinical quality

measures are maintained. Many other commenters indicated that all clinical quality measures

should be evidence-based and up-to-date with current medical standards. Several commenters

communicated support for using NQF; Hospital Quality Alliance (HQA); Ambulatory care

Quality Alliance (AQA); and the American Medical Association-Physician Consortium for

Performance Improvement (AMA-PCPI) clinical quality measures. Another commenter

suggested that measures that have a related U.S. Preventative Services Task Force (USPSTF)

recommendation should follow the USPSTF guidelines and the regulations should allow for

clinical quality measures to be updated as the evidence base changes. Another commenter

indicated CMS should ensure that all clinical quality measures are endorsed through a
CMS-0033-F 242

stakeholder consensus process. Commenters also questioned why some clinical quality measures

in the proposed rule do not have identifiers for example, NQF number and another commenter

indicated some of the clinical quality measures titles were different in the clinical quality

measure tables. Some commenters also stated that clinical quality measures should be phased in,

implementing the clinical quality measures by clinically related sets, and that all CMS proposed

clinical quality measures should be NQF endorsed.

Some commenters suggested that CMS should consult with other quality measure

stakeholders, such as, NQF, the Hospital Quality Alliance (HQA), and the National Committee

for Quality Assurance (NCQA), The Joint Commission (TJC), and Regional Health

Improvement Collaboratives to verify the validity, reliability, and appropriateness of proposed

clinical measures. In addition when developing, validating and recommending clinical quality

measures for the pediatric population, a commenter suggested CMS include consultation with the

Child Healthcare Corporation of America (CHCA) or the National Association of Children’s

Hospitals (NACHRI).

Response: The HITECH Act requires that we give preference to clinical quality

measures that are NQF endorsed. NQF is the only organization that we are aware of which is

in compliance with the requirements of National Technology Transfer and Advancement Act

(NTTAA), to endorse quality measures through voluntary consensus standards. However, the

HITECH Act does not require the exclusive use of NQF endorsed measures, nor limit the

measures to those produced by any particular developer or adopted or supported by any

particular organization, such as those suggested by the commenters. We gave preference to

NQF endorsed clinical quality measures in this final rule. However, we do not adopt a policy

that would restrict the Secretary’s discretion of beyond what is required by the statute.
CMS-0033-F 243

Measures listed in the proposed rule that did not have an NQF identifying number were not

NQF endorsed.

With respect to specific organizations, we have received broad input regarding clinical

quality measures including from many organizations mentioned by commenters and have

considered their comments in determining which clinical quality measures to finalize in this

final rule. We also note that, for NQF endorsed measures, the NQF provides a venue for public

and member input as a part of the endorsement process. With respect to commenters urging

consideration of whether the scientific and medical evidence support the measure, whether the

clinical quality measures are evidence-based and consistent with current medical standards, and

how the clinical quality measures are maintained, we note that these factors are part of the NQF

process, as well as standard measure development processes. We are committed to working

with national, State and local associations to identify or develop additional electronically

specified clinical quality measures, particularly for pediatric populations, for later stages of

meaningful use.

In selecting clinical quality measures for the Medicare EHR incentive program, the

Secretary is required to provide for notice in the Federal Register with public comment. This

provides broad public input which we fully consider. However, as we stated in the proposed

rule, we are finalizing the policy that technical specifications for clinical quality measures are

developed and finalized through the sub-regulatory process. Further, this requirement does not

pertain to the Medicaid EHR incentive program. We expect to develop a process in the future to

solicit public input on Medicaid-specific clinical quality measures for future stages of

meaningful use, if needed. However, because there are no such Medicaid-specific measures in
CMS-0033-F 244

this final rule, and all measures apply uniformly across both the Medicare and Medicaid EHR

incentive program, we have not developed such a process in this final rule.

After consideration of the public comments received, the HITECH Act requires that we

give preference to clinical quality measures that are NQF endorsed. However, it does not require

the exclusive use of NQF endorsed measures, nor limit the measures to those produced by any

particular developer nor be adopted by any particular organization. In this case, all clinical

quality measures we are finalizing are NQF endorsed and have current electronic specifications

as of the date of display of this final rule. Effective with the publication of this final rule, these

specifications are final for clinical quality measure reporting under the HITECH Act beginning

with 2011 and 2012. The detailed electronic specifications of the clinical quality measures for

EPs, eligible hospitals, and CAHs are displayed on the CMS website at

http://www.cms.gov/QualityMeasures/03_ElectronicSpecifications.asp#TopOfPage.

Sections 1848(o)(2)(B)(iii) and 1886(n)(3)(B)(iii) of the Act requires that in selecting

clinical quality measures, the Secretary shall seek to avoid redundant or duplicative reporting

otherwise required, including reporting under section 1848(k)(2)(C) of the Act (the PQRI

program) and eligible reporting under section 1886(b)(3)(B)(viii) of the Act (RHQDAPU

program). For EPs, when the proposed rule was issued there was no statutory authority to

provide PQRI incentive payments for services furnished for 2011 or subsequent years. Since

then, the PQRI incentive payment for 2011 has been authorized. We acknowledge there is

overlap within the clinical quality measure reporting for EPs in the EHR incentive program with

the PQRI incentive program. However, the reporting periods in these two incentive programs

are different. Currently, the PQRI has a six and a twelve month reporting period. The reporting

period for the HITECH EHR incentive program for the first payment year is 90 days, which does
CMS-0033-F 245

not meet the PQRI reporting requirement of six or twelve month reporting period, as currently

provided. However, in the second payment year of the HITECH EHR incentive program the

reporting period is one year, and the PQRI reporting period, would be synchronous. The

requirement for qualification for PQRI is subject to a separate regulation. Although there may be

additional issues beyond the reporting periods, we anticipate efforts to avoid redundant and

duplicative reporting in PQRI of the same clinical quality measures as required in the EHR

incentive program. We envision a single reporting infrastructure for electronic submission in the

future, and will strive to align the EHR incentive program and PQRI as we develop the reporting

framework for clinical quality measures to avoid redundant or duplicative reporting. Further, we

also note that the Affordable Care Act (Pub. L. 111-148) requires that the Secretary develop a

plan to integrate the EHR incentive program and PQRI by January 1, 2012. In doing so we

expect to further address the issue of redundant and duplicative reporting. For eligible hospitals

and CAHs, for the EHR incentive program, we are finalizing one set of 15 clinical quality

measures for both Medicare and Medicaid. For Stage 1 (for clinical quality measures Stage 1 is

2011 and beginning in 2012), none of the finalized 15 clinical quality measures for eligible

hospitals and CAHs are currently included in the RHQDAPU program, and therefore there is no

issue of redundant and duplicative reporting based upon the HITECH Act. Nevertheless, clinical

quality measures in the EHR incentive program for eligible hospitals and CAHs were

electronically specified for use in the RHQDAPU program with the anticipation to place these

measures in RHQDAPU once we have completed and implemented the mechanism to accept

quality measures through electronic submission. For the future, we do not anticipate having one

set of clinical quality measures for the EHR incentive program and another set for RHQDAPU.

Rather, we anticipate a single set of hospital clinical quality measures, most of which we
CMS-0033-F 246

anticipate can be electronically specified. We note some of the RHQDAPU quality measures,

for example HCAHPS experience of care measures, do not lend themselves to EHR reporting.

Similarly, certain outcome quality measures, such as the current RQHDAPU readmission

measures, are based on claims rather than clinical data. In the future, we anticipate hospitals that

report RHQDAPU measures electronically would receive incentives from both the RHQDAPU

and EHR incentive program, in addition to properly reporting any required quality measures that

are not able to be derived from EHRs; this is however subject to future rulemaking. Further, in

the future, for hospitals that do not report electronically we anticipate that they may only qualify

for an incentive through the RHQDAPU program, and not through the EHR incentive program.

Again this is subject to future rulemaking. We envision a single reporting infrastructure for

electronic submission in the future, and will strive to align the hospital quality initiative

programs to seek to avoid redundant and duplicative reporting of quality measures for eligible

hospitals and CAHs.

Comment: Many commenters also suggested aligning clinical quality measure reporting

across federal agencies (for example, HRSA, CMS) as well as across programs, (for example,

PQRI, CHIP, Medicare and Medicaid) to avoid duplicative and redundant quality performance

reporting. Additionally, several commenters suggested that similar clinical quality measures

and/or quality data efforts included in the proposed rule are included in other clinical quality

recognition programs and EPs who successfully report in these programs via a certified EHR

should be deemed to have successfully reported in the EHR incentive program. Other

commenters suggested using the PQRI reporting process to satisfy the meaningful use

requirement under the EHR incentive program for EPs. Another commenter indicated that

clinical quality measures employed by this program and others will be valuable if EPs using
CMS-0033-F 247

EHRs have an in-depth understanding of how to leverage the technology and the data they

produce to improve care. A number of commenters requested that only clinical quality measures

chosen for use in the RHQDAPU program should be considered for implementation in the EHR

incentive program for eligible hospitals and CAHs that qualify for both incentives. Additionally,

the commenters stated they would like the process for avoiding duplicative reporting clearly

defined.

Response: The HITECH Act requires that the Secretary seek to avoid redundant and

duplicative reporting, with specific reference to PQRI for EPs and RHQDAPU for eligible

hospitals and CAHs. We have sought to avoid duplicative and redundant reporting in the

implementation of the HITECH Act as discussed elsewhere in our responses to comments in this

final rule. We will seek to align quality initiative programs in future rulemaking.

(2) Other Considerations for the Selection of Clinical Quality Measures for Electronic

Submission by EPs, Eligible Hospitals, and CAHs

In addition to the requirements under sections 1848(o)(2)(B)(i)(I) and 1886(n)(3)(B)(i)(I)

of the Act and the other statutory requirements described above, we also proposed applying the

following considerations to the selection of the clinical quality measures for electronic

submission under the Medicare and Medicaid EHR incentive programs:

• Clinical quality measures that are included in, facilitate alignment with, or allow

determination of satisfactory reporting in other Medicare (for example, PQRI or the RHQDAPU

program), Medicaid, and Children's Health Insurance Program (CHIP) program priorities.

• Clinical quality measures that are widely applicable to EPs and eligible hospitals based

on the services provided for the population of patients seen.

CMS-0033-F 248

• Clinical quality measures that promote CMS and HHS policy priorities related to

improved quality and efficiency of care for the Medicare and Medicaid populations that would

allow us to track improvement in care over time. These current and long term priority topics

include: prevention; management of chronic conditions; high cost and high volume conditions;

elimination of health disparities; healthcare-associated infections and other conditions; improved

care coordination; improved efficiency; improved patient and family experience of care;

improved end-of-life/palliative care; effective management of acute and chronic episodes of

care; reduced unwarranted geographic variation in quality and efficiency; and adoption and use

of interoperable HIT.

• Clinical quality measures that address or relate to known gaps in the quality of care and

measures that through the PQRI program, performed at low or highly variable rates.

• Clinical quality measures that have been recommended for inclusion in the EHR

incentive by the HIT Policy Committee.

We noted in the proposed rule that the Children's Health Insurance Program

Reauthorization Act (CHIPRA) of 2009 (Pub. L. 111-3) Title IV, section 401 requires the

Secretary to publish a core set of clinical quality measures for the pediatric population. We

stated that, to the extent possible, we would align the clinical quality measures selected under the

EHR incentive program with the measures selected under the CHIPRA core measure set.

Included in the proposed clinical quality measures were nine clinical quality measures pertaining

to pediatric providers. Four of these nine measures were on the list of CHIPRA initial core

measures that were recommended to the Secretary by the Subcommittee to AHRQ's National

Advisory Committee (SNAC). In our proposed rule, we noted that not all CHIPRA initial

measures recommended to the Secretary were applicable to EHR technology or to the EHR
CMS-0033-F 249

incentive payment program. For example, some of the measures are population-based, survey-

derived, or not yet NQF endorsed. We stated that new or additional measures for the next

iteration of the CHIPRA core set would have EHR extractability as a priority.

Since the publication of the proposed rule, the CHIPRA core measure set has been

published in a final rule (see 74 FR 68846 through 68849). In this EHR incentive program final

rule, there are four clinical quality measures that are also in the published CHIPRA initial core

measure set. These clinical quality measures are shown below in Table 4:

Table 4: Clinical Quality Measures in the EHR Incentive Program Final Rule that are also
in the CHIPRA Initial Core Measure Set

Measure Number Clinical Quality Measure Title

NQF 0024 Weight Assessment Counseling for Children and Adolescents
NQF 0033 Chlamydia Screening for Women
NQF 0038 Childhood Immunization Status
NQF 0002 Appropriate Testing for Children with Pharyngitis
PQRI 66

Due to the concurrent CHIPRA and ARRA HIT implementation activities, we believe

there is an exciting opportunity to align the two programs and strive to create efficiencies for

States and pediatric providers, where applicable. Similarly, the adult quality measures

requirements enacted in the ACA will provide another opportunity for CMS to align its quality

measures programs for consistency and to maximize use of electronic reporting. As these

programs move forward, we will continue to prioritize consistency in clinical quality measure

selection for providers when possible.

We solicited comments on the inclusion or exclusion of any clinical quality measure or

measures proposed for the 2011 and 2012 payment years, and to our approach in selecting

clinical quality measures.

CMS-0033-F 250

We stated in the proposed rule that we do not intend to use notice and comment

rulemaking as a means to update or modify clinical quality measure specifications. A clinical

quality measure that has completed the consensus process through NQF has a designated party

(usually, the measure developer/owner) who has accepted responsibility for maintenance of the

clinical quality measure. In general, it is the role of the clinical quality measure owner,

developer, or maintainer/steward to make basic changes to a clinical quality measure in terms of

the numerator, denominator, and exclusions. We proposed that the clinical quality measures

selected for the 2011 and 2012 payment year be supplemented by our technical specifications for

EHR submission. We proposed to post the complete clinical quality measures specifications

including technical specifications to our website and solicited comments on our approach.

We received various comments as to our proposed considerations for selection of clinical

quality measures for submission by EPs, eligible hospitals, and CAHs.

Comment: One commenter said that there needs to be longer than nine months for the

look back for capturing clinical quality measures data. Several commenters indicated that

baseline measurements that have used the clinical quality measure in the past have not been

performed. Commenters also recommended the linkage of clinical decision support to clinical

quality measures to strengthen quality improvement efforts. A commenter supported our

inclusion of measures that address both quality and resource use efficiency. Another commenter

indicated support for the clinical quality measures as represented in the proposed rule.

Response: The look back for capturing clinical quality measures is the period of time for

which data would be considered as applying to the measure calculation. The look back period

for a clinical quality measure and the method of documentation of prior information is defined

by the clinical quality measure specification. The clinical quality measures require reporting and
CMS-0033-F 251

not achievement on particular performance thresholds. We agree with the commenters regarding

the benefits of linking clinical decision support tools to the clinical quality measures, and

anticipate that as EHR technology evolves, many of the clinical quality measures will be

supported by clinical decision support tools. We also agree with the benefits of efficiency

measures and we expect that in future program years the scope and variety of measures that

address these factors will expand.

Comment: Commenters requested a definition for “Eligible Provider and Non-

Qualifying Eligible Provider” with respect to the provider’s ability to meet meaningful use if

there are no appropriate clinical quality measures to report, the application of financial penalties

beginning in 2015, and the handling of exclusions. Another commenter stressed the need for

detailed information regarding what is included and excluded in the numerator and denominator

for each measure so as to ensure that certified EHR technology’s programmed analytics capture

all patients who meet the relevant criteria and to ensure that clinical quality measures are

properly evaluated. Others indicated that reporting measures electronically will reduce

administrative reporting costs. Other commenters supported the ability to report “N/A” for

clinical quality measures where an insufficient denominator exists. Other commenters urged that

CMS not include any clinical quality measures in Stage 1 of Meaningful Use because they

believe Stage 1 should focus on the initial implementation of certified EHR systems and its use

for patient care, and that EPs must gain experience with their certified EHR technology before

attesting to the accuracy and completeness of numerators, denominators and quality calculations

generated from these systems.

Response: While some commenters recommended we not include any clinical quality

measures in Stage 1 (2011 and beginning in 2012), as previously described for Stage 1 EPs are
CMS-0033-F 252

required to attest to the clinical quality measures calculated results (numerator, denominator, and

exclusions) as automatically calculated by the certified EHR technology. Given that the

statutory requirement for clinical quality measures is an element of meaningful use, we believe

that providing this information on clinical quality measures is appropriate for Stage 1 (2011 and

beginning in 2012). We would expect that the patient for whom a clinical quality measure does

not apply will not be included in the denominator of the clinical quality measure. If not

appropriate for a particular EP we would expect that either patients would not appear in the

denominator of the measure (a zero value) or an exclusion would apply. Therefore reporting

“N/A” is not necessary. Exclusion parameters–-that is, information on what is included and

excluded in the numerator and denominator for a clinical quality measure–are included in the

measure specifications. We agree that reporting measures electronically will reduce

administrative reporting costs, however as discussed in this final rule we will not require

electronic submission of clinical quality measures until 2012. Also discussed earlier in this final

rule, we believe collecting clinical quality measure data is an important part of meaningful use.

Comment: A commenter indicated that CMS should take ownership of each of the EP

clinical quality measures so that CMS can then adjudicate issues related to the clinical quality

measures, instead of referring the EP to the measure owner. One commenter believes that EPs

and their specialty societies should be the only owners of EP clinical quality measures.

Response: We are the owner/developer for certain clinical quality measures. More

commonly, we use the clinical quality measures developed and owned by others, who are then

responsible for the clinical quality measure specifications as endorsed by NQF. Numerous

measures have been developed over the years by various organizations and CMS, and therefore

we do not believe that specialty societies should be the only owners of EP clinical quality
CMS-0033-F 253

measures. The HITECH Act does not suggest or require that we should be the sole

owner/developer of clinical quality measures.

Comment: A commenter questioned whether clinical quality measures would be updated

during the bi-annual review process and how much lead time will be given.

Response: The measures for Stage1 (2011 and beginning in 2012) of meaningful use are

finalized in this final rule and will not change during that stage. Additionally, the electronic

specifications, as posted on the CMS website at the time of publication of this final rule, are

final. We intend to expand the clinical quality measures again for Stage 2 of meaningful use,

which we anticipate will first be effective for the 2013 payment year. As required by the

HITECH Act for the Medicare EHR incentive program, prior to selecting any new clinical

quality measure(s) for Stage 2 of meaningful use, we will publish notice of the proposed

measure(s) and request and consider public comments on the proposed measures. We note that

the Medicaid EHR incentive program does not have the same statutory requirement. If future

stages of meaningful use include clinical quality measures specific for Medicaid providers, we

will consider a process to receive public input on such measures.

Comment: One commenter suggested that only measures chosen for use in the pay-for-

reporting program should be considered for implementation in the EHR incentive program.

Response: We selected clinical quality measures that are broadly applicable for the 2011

and 2012 EHR incentive program. Many clinical quality measures used in other Medicare

pay-for-reporting programs are not applicable to all Medicaid eligible providers, such as

pediatricians, certified nurse-midwives, and children’s hospitals.

Comment: Commenters suggested alignment between measures with vocabulary

standards, in order to promote interoperability of clinical data. Stage 1 allows alternative

CMS-0033-F 254

vocabularies for problems, drugs, and procedures; and measures should only be included if

alternative specifications using all Stage 1 vocabularies are provided. Commenters

recommended incorporating HL7, LOINC, SNOMED, ICD-9, and ICD-10 for data exchange.

Response: Standards for certified EHRs, including vocabulary standards, are included in

ONC’s final rule (found elsewhere in this issue of the Federal Register).

Comment: Commenter recommended that in the beginning stages of implementation of

the EHR incentive programs, CMS should base its reporting initiatives on existing industry

models to prevent delays, consumer mistrust, and potential legal issues.

Response: We have conducted extensive reviews of industry standards, employed the

comments of industry experts and solicited public comments on all proposed processes.

Comment: Many commenters are concerned that there will not be adequate time to

communicate and implement the electronic specification for 2011 clinical quality measure

requirements. Additionally, one commenter expressed concern that the additional clinical

quality measures required for 2011 reporting will not be posted by CMS in time for careful

review and assessment, since currently there are only 15 measures electronically specified and

posted. Commenters requested clinical quality measures to be posted with implementation

guides for each quality reporting metric to ensure successful reporting.

Response: We have limited the requirements for clinical quality measure reporting for

eligible hospitals and CAHs to the 15 measures that were electronically specified and posted at

the time of publishing the proposed rule. All measures specifications for clinical quality

measures selected are final effective upon publication of the EHR incentive program final rule.

d. Clinical Quality Measures for EPs

For the 2011 and 2012 EHR reporting periods, based upon the considerations for
CMS-0033-F 255

selecting clinical quality measures discussed above, we proposed certain clinical quality

measures that were identified in the proposed rule (see 75 FR 1874-1889) for EPs. Tables 4

though 19 of the proposed rule divided the clinical quality measures identified in Table 3 into

core measures and specialty group measures (see 75 FR 1890 through 1895). The concept of

core measures and specialty group measures is discussed below.

We also stated that some measures were in a higher state of readiness than others, and

requested comment on each measure’s state of readiness for use in the EHR incentive programs.

For those measures where electronic specifications did not, at the time of the proposed rule,

exist, we solicited comment on how quickly electronic specifications could be developed, and

the period of time required from final posting of the electronic specifications for final measures

to ensure the effective implementation of the measures. We stated our intention to publish

electronic specifications for the proposed clinical quality measures on the CMS website as soon

as they become available from the measure developer(s). Electronic specifications may be

developed concurrently with the development of measures themselves and potentially with the

NQF endorsement processes. We stated that all of the proposed clinical quality measures

included in Table 3 (see 75 FR 1874-1889) meet one or more of the criteria for the selection of

clinical quality measures, discussed in the proposed rule. A large portion of these measures had

been through notice and comment rulemaking for PQRI, and nearly all PQRI clinical quality

measures are NQF endorsed. Additionally, they have broad applicability to the range of

Medicare designated specialties, and the services provided by EPs who render services to

Medicare and Medicaid beneficiaries and many others. Further, nine of the proposed 90 clinical

quality measures listed in Table 3 (see 75 FR 1874-1889) (PQRI numbers 1, 2, 3, 5, 7, 110, 111,

112, and 113) had preliminary specifications for electronic submission that had already been
CMS-0033-F 256

developed for the purpose of testing the submission of clinical quality data extracted from an

EHR for the PQRI program. The link to the preliminary electronic specifications for nine PQRI

clinical quality measures was provided: http://www.cms.hhs.gov/pqri.

We stated that in terms of CMS and HHS healthcare quality priorities, clinical quality

PQRI measures numbered 1, 2, 3, 5, and 7 address high priority chronic conditions, namely

diabetes, coronary artery disease, and heart disease. Clinical quality PQRI measures numbered

110, 111, 112, 113, 114, 115, and 128 support prevention which is a high CMS and HHS

priority. The PQRI clinical quality measure specifications for claims-based or registry-based

submission of these clinical quality measures for the most current PQRI program year can be

found on the PQRI section of the CMS website at

http://www.cms.hhs.gov/PQRI/15_MeasuresCodes.asp#TopOfPage. A description of the

clinical quality measure, including the clinical quality measure's numerator and denominator, can

be found in the PQRI clinical quality measure specifications.

We pointed out that the PQRI clinical quality measures that were proposed largely align

with the recommendations of the HIT Standards Committee. However, in addition to proposed

clinical quality measures that are currently included in PQRI, we also proposed certain other

clinical quality measures that we stated are of high importance to the overall population. Those

clinical quality measures are Ischemic Vascular Disease (IVD): Use of Aspirin or another

Antithrombotic; IVD: Complete Lipid Profile; IVD: Low Density Lipoprotein (LDL-C) Control,

and Blood Pressure Management. Finally, we proposed an array of other measures which

address important aspects of clinical quality.

We stated our belief that the proposed clinical quality measures were broad enough to

allow for reporting for EPs and addressed high priority conditions. We recognized the
CMS-0033-F 257

importance of integrating the measures into certified EHR technologies for calculation of

measures results, and that not all measures would be feasible for 2011 and 2012. We invited

comment on the advisability of including the measures for payment years 2011 and 2012.

Although we recognized that there are many other important clinical quality measures of health

care provided by EPs, we anticipated expanding the set of clinical quality measures in future

years and listed a number of clinical quality measures for future consideration in section II.A.3.g

of the proposed rule preamble, on which we also invited comment.

Comment: Many of the proposed clinical quality measures received favorable comments

and support for inclusion in the final clinical quality measure set. A few examples of measures

that were supported for inclusion were measures related to prevention and screening, and

diabetes. It was stated by a commenter that the proposed rule includes some similar clinical

quality measures. For example, the commenter indicated NQF 0059 and NQF 0575 both deal

with hemoglobin A1c control. Others commented that some measures should be eliminated and

not utilized in the final set of clinical quality measures for EPs. For example, a few commented

that the following two measures should be eliminated, NQF 0052 and NQF 0513 were intended

to be implemented at the administrator site level using outpatient hospital claims and not at the

individual practitioner level. A number of commenters stated that the specifications for certain

clinical quality measures, for example, NQF 0022, NQF 0031, NQF 0032, NQF 0033, NQF

0034, and NQF 0061 were not consistent with current clinical practice guidelines. Another

commenter requested clarification for the specifications for NQF 0013 because blood pressures

are not routinely monitored for 2 month old patients. Many commenters provided suggestions

for other clinical quality measures not included in the proposed rule
CMS-0033-F 258

Response: We appreciate all of the suggestions from the commenters. We are unable to

add any clinical quality measures that were not identified in the proposed rule due to language in

sections 1848(o)(2)(B)(i)(II) and 1886(n)(3)(B)(i) of the Act requiring a period of public

comment for any finalized measures. This requirement does not pertain to the Medicaid EHR

incentive program, we expect to develop a process in the future to solicit public input on

Medicaid-specific clinical quality measures for future stages of meaningful use, if needed.

However, we will consider those additional clinical quality measures recommended by

commenters for future inclusion in the clinical quality measure sets.

In regard to suggested changes/revisions and/or elimination of the proposed clinical

quality measures, we considered these suggestions when finalizing clinical quality measures in

this final rule. In regard to this, we considered these suggestions when evaluating the clinical

quality measures for selection in this final rule. Of the clinical quality measures in the proposed

rule that we are not finalizing, we removed the measures that do not have electronic

specifications by the date of display of this final rule. Additionally, some of the proposed

clinical quality measures were recommended for deletion or modification, and therefore were

recommended to not be used in the final rule; this is delineated in other comments and responses

in this final rule. Further, we are only finalizing clinical quality measures that are electronically

specified the date of display of the final rule. The electronic specifications included in the final

set of clinical quality measures for EPs are posted to the CMS website at:

http://www.cms.gov/QualityMeasures/03_ElectronicSpecifications.asp#TopOfPage.

Comment: Numerous commenters were concerned about the burden (economic and

other) of reporting on the large number of clinical quality measures and the overall quality

reporting burden this will add to EPs. Some commenters stated that the use of numerators and
CMS-0033-F 259

denominators for some measures will require manual calculation on the part of the EPs since

there are no automated reports that can capture all of the information that must be tabulated. One

commenter stated that there are insufficient resources to calculate the denominators of the

required measures. Other commenters suggested using the PQRI requirements of reporting only

three measures, and others suggested reporting on significantly smaller number of measures.

Response: In response to the many comments received regarding the undue burden

associated with reporting on a large number of clinical quality measures, or measures that

involve a manual process, we have finalized only those clinical quality measures that can be

automatically calculated by a certified EHR technology. We further limited the measures to

those for which electronic specifications are currently available, which we posted as final by the

date of display of this final rule. This limitation significantly reduces the number of measures

EPs are required to report in 2011 and 2012, thus reducing the EPs’ reporting burden as well as

addressing commenters’ concerns about readiness. Although for 2011, Medicare EPs, eligible

hospitals, and CAHs will still need to manually report (attest) to the results automatically

calculated by their certified EHR technology, we believe that with the reduction in the number of

measures that the burden is reasonable. Additionally, this provides for the reporting of clinical

quality measures beyond simply the core clinical quality measures that EPs identify as suitable to

report.

Table 5, below, shows the proposed clinical quality measures for submission by Medicare

and Medicaid EPs for the 2011 and 2012 payment year as stated in the proposed rule (see 75 FR

1874-1889) for EPs, but that are not being finalized. Table 5 conveys the NQF measure number

and PQRI implementation number (that is, the number used in the PQRI program to identify the

measure as implemented in PQRI (for the 2010 PQRI measures list see
CMS-0033-F 260

https://www.cms.gov/PQRI/Downloads/2010_PQRI_MeasuresList_111309.pdf)), clinical

quality measure title and description, and clinical quality measure steward and contact

information. The measures listed below in Table 5 do not have electronic specifications finished

before the date of display of this final rule, thus we have eliminated these measures for this final

rule and will consider the addition of these measures in future rulemaking. Also several

measures listed below were only concepts at the time of publication of the proposed rule (that is,

Hysterectomy rates, Appropriate antibiotic use for ear infections, Statin after Myocardial

Infarction, 30 day Readmission Rate, 30 Readmission Rate following deliveries, and Use of CT

Scans). These concept measures were not developed or electronically specified clinical quality

measures, nor NQF endorsed; and there was not adequate time to consider these concepts for

development for this final rule. Therefore, the concepts listed below will be considered in future

rulemaking. Lastly, NQF 0026 has since been retired since publication of the proposed rule.
CMS-0033-F 261

TABLE 5: Proposed Clinical Quality Measures for Submission by Medicare or Medicaid EPs for
the 2011 and 2012 Payment Year; Included in the Proposed Rule (see 75 FR 1874 through 1889)
and Not in the Final Rule

NQF Measure
Number & PQRI Clinical Quality Measure
Implementation Steward & Contact
Number Clinical Quality Measure Title & Description Information
NQF 0246 Title: Stroke and Stroke Rehabilitation: AMA-PCPI/NCQA
Computed Tomography (CT) or Magnetic Contact Information:
PQRI 10 Resonance Imaging (MRI) Reports [email protected]
Description: Percentage of final reports for CT or www.ncqa.org
MRI studies of the brain performed within 24
hours of arrival to the hospital for patients aged 18
years and older with either a diagnosis of ischemic
stroke or transient ischemic attack (TIA) or
intracranial hemorrhage or at least one documented
symptom consistent with ischemic stroke or TIA or
intracranial hemorrhage that includes
documentation of the presence or absence or each
of the following: hemorrhage and mass lesion and
acute infarction.
NQF 0270 Title: Perioperative Care: Timing of Antibiotic AMA-PCPI/NCQA
Prophylaxis – Ordering Physician Contact Information:
PQRI 20 Description: Percentage of surgical patients aged [email protected]
18 years and older undergoing procedures with the www.ncqa.org
indications for prophylactic parenteral antibiotics,
who have an order for prophylactic antibiotic to be
given within one hour (if fluoroquinolone or
vancomycin, two hours), prior to the surgical
incision (or start of procedure when no incision is
required)
NQF 0268 Title: Perioperative Care: Selection of AMA-PCPI/NCQA
Prophylactic Antibiotic – First OR Second Contact Information:
PQRI 21 Generation Cephalosporin [email protected]
Description: Percentage of surgical patients aged www.ncqa.org
18 years and older undergoing procedures with the
indications for a first OR second generation
cephalosporin prophylactic antibiotic, who had an
order for cefazolin OR cefuroxime for
antimicrobial prophylaxis
NQF 0271 Title: Perioperative Care: Discontinuation of AMA-PCPI/NCQA
Prophylactic Antibiotics (Non-Cardiac Procedures) Contact Information:
PQRI 22 Description: Percentage of non-cardiac surgical [email protected]
patients aged 18 years and older undergoing www.ncqa.org
procedures with the indications for prophylactic
antibiotics AND who received a prophylactic
antibiotic, who have an order for discontinuation
of prophylactic antibiotics within 24 hours of
surgical end time
CMS-0033-F 262

NQF Measure
Number & PQRI Clinical Quality Measure
Implementation Steward & Contact
Number Clinical Quality Measure Title & Description Information
NQF 0239 Title: Perioperative Care: Venous AMA-PCPI/NCQA
Thromboembolism (VTE) Prophylaxis (When Contact Information:
PQRI 23 Indicated in ALL Patients) [email protected]
Description:Percentage of patients aged 18 years www.ncqa.org
and older undergoing procedures for which VTE
prophylaxis is indicated in all patients, who had an
order for Low Molecular Weight Heparin
(LMWH), Low-Dose Unfractionated Heparin
(LDUH), adjusted-dose warfarin, fondaparinux or
mechanical prophylaxis to be given within 24
hours prior to incision time or within 24 hours after
surgery end time
NQF 0241 Title: Stroke and Stroke Rehabilitation: AMA-PCPI/NCQA
Anticoagulant Therapy Prescribed for Atrial Contact Information:
PQRI 33 Fibrillation at Discharge [email protected]
Description: Percentage of patients aged 18 years www.ncqa.org
and older with a diagnosis of ischemic stroke or
transient ischemic attack (TIA) with documented
permanent, persistent, or paroxysmal atrial
fibrillation who were prescribed an anticoagulant
at discharge
NQF 0102 Title: Chronic Obstructive Pulmonary Disease AMA-PCPI
(COPD): Bronchodilator Therapy Contact Information:
PQRI 52 Description: Percentage of patients aged 18 years [email protected]
and older with a diagnosis of COPD and who have
an FEV1/FVC less than 70% and have symptoms
who were prescribed an inhaled bronchodilator
NQF 0069 Title: Treatment for Children with Upper NCQA
Respiratory Infection (URI): Avoidance of Contact Information:
PQRI 65 Inappropriate Use www.ncqa.org
Description: Percentage of children aged 3
months through 18 years with a diagnosis of URI
who were not prescribed or dispensed an antibiotic
prescription on or within 3 days of the initial date
of service
NQF 0323 Title: End Stage Renal Disease (ESRD): Plan of AMA-PCPI
Care for Inadequate Hemodialysis in ESRD Contact Information:
PQRI 81 Patients [email protected]
Description: Percentage of calendar months
during the 12-month reporting period in which
patients aged 18 years and older with a diagnosis
of ESRD receiving hemodialysis have a Kt/V ≥ 1.2
OR patients who have a Kt/V < 1.2 with a
documented plan of care for inadequate
hemodialysis
CMS-0033-F 263

NQF Measure
Number & PQRI Clinical Quality Measure
Implementation Steward & Contact
Number Clinical Quality Measure Title & Description Information
NQF 0321 Title: End Stage Renal Disease (ESRD): Plan of AMA-PCPI
Care for Inadequate Peritoneal Dialysis Contact Information:
PQRI 82 Description: Percentage of patients aged 18 years [email protected]
and older with a diagnosis of ESRD receiving
peritoneal dialysis who have a Kt/V ≥ 1.7 OR
patients who have a Kt/V < 1.7 with a documented
plan of care for inadequate peritoneal dialysis at
least three times (every 4 months) during the 12-
month reporting period
NQF 0397 Title: Hepatitis C: Antiviral Treatment Prescribed AMA-PCPI
Description: Percentage of patients aged 18 years Contact Information:
PQRI 86 and older with a diagnosis of chronic hepatitis C [email protected]
who were prescribed peginterferon and ribavirin
therapy within the 12-month reporting period
NQF 0401 Title: Hepatitis C: Counseling Regarding Risk of AMA-PCPI
Alcohol Consumption Contact Information:
PQRI 89 Description: Percentage of patients aged 18 years [email protected]
and older with a diagnosis of hepatitis C who were
counseled about the risks of alcohol use at least
once within the 12-month reporting period
NQF 0103 Title: Major Depressive Disorder (MDD): AMA-PCPI
Diagnostic Evaluation Contact Information:
PQRI 106 Description: Percentage of patients aged 18 years [email protected]
and older with a new diagnosis or recurrent
episode of MDD who met the DSM-IV criteria
during the visit in which the new diagnosis or
recurrent episode was identified during the
measurement period
NQF 0104 Title: Major Depressive Disorder (MDD): Suicide AMA-PCPI
Risk Assessment Contact Information:
PQRI 107 Description: Percentage of patients aged 18 years [email protected]
and older with a new diagnosis or recurrent
episode of MDD who had a suicide risk
assessment completed at each visit during the
measurement period
NQF 0066 Title: Coronary Artery Disease (CAD): AMA-PCPI
Angiotensin-Converting Enzyme (ACE) Inhibitor Contact Information:
PQRI 118 or Angiotensin Receptor Blocker (ARB) Therapy [email protected]
for Patients with CAD and Diabetes and/or Left
Ventricular Systolic Dysfunction (LVSD)
Description: Percentage of patients aged 18
years and older with a diagnosis of CAD who also
have diabetes mellitus and/or LVSD (LVEF <
40%) who were prescribed ACE inhibitor or ARB
therapy
CMS-0033-F 264

NQF Measure
Number & PQRI Clinical Quality Measure
Implementation Steward & Contact
Number Clinical Quality Measure Title & Description Information
PQRI 121 Title: Chronic Kidney Disease (CKD): AMA-PCPI
Laboratory Testing (Calcium, Phosphorus, Intact Contact Information:
Ambulatory Quality Parathyroid Hormone (iPTH) and Lipid Profile) [email protected]
Alliance (AQA) Description: Percentage of patients aged 18 years
adopted and older with a diagnosis of advanced CKD
(stage 4 or 5, not receiving Renal Replacement
Therapy [RRT]), who had the following laboratory
testing ordered within 12 months: serum levels of
calcium, phosphorus and intact PTH, and lipid
profile
PQRI 122 Title: Chronic Kidney Disease (CKD): Blood AMA-PCPI
Pressure Management Contact Information:
AQA adopted Description: Percentage of patient visits for [email protected]
patients aged 18 years and older with a diagnosis
of advanced CKD (stage 4 or 5, not receiving
Renal Replacement Therapy [RRT]), with a blood
pressure < 130/80 mmHg OR blood pressure ≥
130/80 mmHg with a documented plan of care
PQRI 123 Title: Chronic Kidney Disease (CKD): Plan of AMA-PCPI
Care – Elevated Hemoglobin for Patients Contact Information:
AQA adopted Receiving Erythropoiesis-Stimulating Agents [email protected]
(ESA)
Description: Percentage of calendar months
during the 12-month reporting period in which
patients aged 18 years and older with a diagnosis
of advanced CKD (stage 4 or 5, not receiving
Renal Replacement Therapy [RRT]), receiving
ESA therapy, have a hemoglobin < 13 g/dL OR
patients whose hemoglobin is ≥ 13 g/dL and have a
documented plan of care
NQF 0416 Title: Diabetes Mellitus: Diabetic Foot and Ankle American Podiatric
Care, Ulcer Prevention – Evaluation of Footwear Medical Association
PQRI 127 Description: Percentage of patients aged 18 years (APMA)
and older with a diagnosis of diabetes mellitus who Contact Information:
were evaluated for proper footwear and sizing http://www.apma.org/
NQF 0510 Title: Radiology: Exposure Time Reported for AMA-PCPI/NCQA
Procedures Using Fluoroscopy Contact Information:
PQRI 145 Description: Percentage of final reports for [email protected]
procedures using fluoroscopy that include www.ncqa.org
documentation of radiation exposure or exposure
time
NQF 0508 Title: Radiology: Inappropriate Use of "Probably AMA-PCPI/NCQA
Benign" Assessment Category in Mammography Contact Information:
PQRI 146 Screening [email protected]
Description: Percentage of final reports for www.ncqa.org
screening mammograms that are classified as
"probably benign"
CMS-0033-F 265

NQF Measure
Number & PQRI Clinical Quality Measure
Implementation Steward & Contact
Number Clinical Quality Measure Title & Description Information
NQF 0511 Title: Nuclear Medicine: Correlation with Existing AMA-PCPI
Imaging Studies for All Patients Undergoing Bone Contact Information:
PQRI 147 Scintigraphy [email protected]
Description: Percentage of final reports for all
patients, regardless of age, undergoing bone
scintigraphy that include physician documentation
of correlation with existing relevant imaging
studies (for example,, x-ray, MRI, CT, etc.) that
were performed
PQRI 153 Title: Chronic Kidney Disease (CKD): Referral AMA-PCPI
for Arteriovenous (AV) Fistula Contact Information:
AQA adopted Description: Percentage of patients aged 18 years [email protected]
and older with the diagnosis of advanced CKD
(stage 4 or 5, not receiving Renal Replacement
Therapy [RRT]), who were referred for AV fistula
at least once during the 12-month reporting period
NQF 0399 Title: Hepatitis C: Hepatitis A Vaccination in AMA-PCPI
Patients with HCV Contact Information:
PQRI 183 Description: Percentage of patients aged 18 years [email protected]
and older with a diagnosis of hepatitis C who
received at least one injection of hepatitis A
vaccine, or who have documented immunity to
hepatitis A
NQF 0400 Title: Hepatitis C: Hepatitis B Vaccination in AMA-PCPI
Patients with HCV Contact Information:
PQRI 184 Description: Percentage of patients aged 18 years [email protected]
and older with a diagnosis of hepatitis C who
received at least one injection of hepatitis B
vaccine, or who have documented immunity to
hepatitis B
PQRI 185 Title: Endoscopy & Polyp Surveillance: AMA-PCPI/NCQA
Colonoscopy Interval for Patients with a History of Contact Information:
AQA adopted Adenomatous Polyps – Avoidance of Inappropriate [email protected]
Use www.ncqa.org
Description: Percentage of patients aged 18 years
and older receiving a surveillance colonoscopy and
a history of colonic polyp(s) in a previous
colonoscopy, who had a follow-up interval of 3 or
more years since their last colonoscopy
documented in the colonoscopy report
NQF 0507 Title: Stenosis Measurement in Carotid Imaging AMA-PCPI/NCQA
Reports Contact Information:
PQRI 195 Description: Percentage of final reports for [email protected]
carotid imaging studies (neck MR angiography www.ncqa.org
[MRA], neck CT angiography [CTA], neck duplex
ultrasound, carotid angiogram) performed for
patients aged 18 years and older with the diagnosis
of ischemic stroke or transient ischemic attack
(TIA) that include direct or indirect reference to
measurements of distal internal carotid diameter as
the denominator for stenosis measurement
CMS-0033-F 266

NQF Measure
Number & PQRI Clinical Quality Measure
Implementation Steward & Contact
Number Clinical Quality Measure Title & Description Information
NQF 0022 Title: Drugs to be avoided in the elderly: a. NCQA
Patients who receive at least one drug to be Contact Information:
avoided, b. Patients who receive at least two www.ncqa.org
different drugs to be avoided.
Description: Percentage of patients ages 65 years
and older who received at least one drug to be
avoided in the elderly in the measurement year.
Percentage of patients 65 years of age and older
who received at least two different drugs to be
avoided in the elderly in the measurement year.
NQF 0026 Title: Measure pair - a. Tobacco use prevention for Institute for Clinical
infants, children and adolescents, b. Tobacco use Systems Improvement
cessation for infants, children and adolescents (ICSI)
Description: Percentage of patients' charts Contact Information:
showing either that there is no tobacco http://www.icsi.org/
use/exposure or (if a user) that the current use was
documented at the most recent clinic visit.
Percentage of patients with documented tobacco
use or exposure at the latest visit who also have
documentation that their cessation interest was
assessed or that they received advice to quit.
NQF 0060 Title: Hemoglobin A1c test for pediatric patients NCQA
Description: Percentage of pediatric patients with Contact Information:
diabetes with a HBA1c test in a 12-month www.ncqa.org
measurement period.
NQF 0106 Title: Diagnosis of attention deficit hyperactivity ICSI
disorder (ADHD) in primary care for school age Contact Information:
children and adolescents http://www.icsi.org/
Description: Percentage of patients newly
diagnosed with attention deficit hyperactivity
disorder (ADHD) whose medical record contains
documentation of Diagnostic and Statistical
Manual of Mental Disorders, Fourth Edition
(DSM-IV) or Diagnostic and Statistical Manual for
Primary Care (DSM-PC) criteria being addressed.
NQF 0107 Title: Management of attention deficit ICSI
hyperactivity disorder (ADHD) in primary care for Contact Information:
school age children and adolescents http://www.icsi.org/
Description: Percentage of patients diagnosed
with attention deficit hyperactivity disorder
(ADHD) and on first-line medication whose
medical record contains documentation of a
follow-up visit twice a year.
CMS-0033-F 267

NQF Measure
Number & PQRI Clinical Quality Measure
Implementation Steward & Contact
Number Clinical Quality Measure Title & Description Information
NQF 0108 Title: ADHD: Follow-Up Care for Children NCQA
Prescribed Attention-Deficit/Hyperactivity Contact Information:
Disorder (ADHD) Medication. www.ncqa.org

Description: a. Initiation Phase: Percentage of

children 6 – 12 years of age as of the Index
Prescription Episode Start Date with an
ambulatory prescription dispensed for and ADHD
medication and who had one follow-up visit with a
practitioner with prescribing authority during the
30-Day Initiation

Phase b. Continuation and Maintenance (C&M)

Phase: Percentage of children 6 – 12 years of age
as of the Index Prescription Episode Start Date
with an ambulatory prescription dispensed for
ADHD medication who remained on the
medication for at least 210 days and who in
addition to the visit in the Initiation Phase had at
least two additional follow-up visits with a
practitioner within 270 days (9 months) after the
Initiation Phase ends.
NQF 0110 Title: Bipolar Disorder and Major Depression: Center for Quality
Appraisal for alcohol or chemical substance use Assessment and
Description: Percentage of patients with Improvement in Mental
depression or bipolar disorder with evidence of an Health
initial assessment that includes an appraisal for Contact Information:
alcohol or chemical substance use http://www.cqaimh.org/
NQF 0299 Title: Surgical Site Infection Rate Centers for Disease Control
Description: Percentage of surgical site infections and Prevention (CDC)
occurring within thirty days after the operative Contact Information:
procedure if no implant is left in place or with one http://www.cdc.gov/
year if an implant is in place in patients who had
an NHSN operative procedure performed during a
specified time period and the infection appears to
be related to the operative procedure.
NQF 0471 Title: Cesarean Rate for low-risk first birth women California Maternal
(aka NTSV CS rate) Quality Care Collaborative
Description: Percentage of low-risk first birth (CMQCC)
women (aka NTSV CS rate: nulliparous, term, Contact Information:
singleton, vertex) with a Cesarean rate that has the http://cmqcc.org/
most variation among practicioners, hospitals,
regions and states. Unlike other cesarean measures,
it focuses attention on the proportion of cesarean
births that is affected by elective medical practices
such as induction and early labor admission.
Furthermore, the success (or lack thereof) of
management of the first labor directly impacts the
remainder of the woman's reproductive life
(especially given the current high rate of repeat
cesarean births).
CMS-0033-F 268

NQF Measure
Number & PQRI Clinical Quality Measure
Implementation Steward & Contact
Number Clinical Quality Measure Title & Description Information
NQF 0513 Title: Use of Contrast: Thorax CT CMS
Description: Thorax CT – Use of combined Contact Information:
studies (with and without contrast) http://www.cms.hhs.gov/
NQF 0519 Title: Diabetic Foot Care and Patient Education CMS
Implemented Contact Information:
Description: Percent of diabetic patients for http://www.cms.hhs.gov/
whom physician-ordered monitoring for the
presence of skin lesions on the lower extremities
and patient education on proper foot care were
implemented during their episode of care
Not applicable Title: Hysterectomy rates
Description:
Not applicable Title: Appropriate antibiotic use for ear infections
Description:
Not applicable Title: Statin after Myocardial Infarction
Description:
Not Applicable Title: 30 day Readmission Rate
Description:
Not Applicable Title: 30 Readmission Rate following deliveries
Description:
Not applicable Title: Use of CT scans
Description: Number of repeat CT scans within 60
days

Comment: Some commenters requested that CMS implement feedback reports early in

the process that document whether EPs are successfully participating in the PQRI Program, the

EHR incentive program, and the e-prescribing program, and that the report communicate

whether the information received by CMS for these programs was successfully submitted and

received.

Response: As the PQRI and e-prescribing programs are beyond the scope of this rule, we

do not address suggestions that we implement feedback reports related to these programs. The

criteria to qualify for the EHR incentive payments are based on results automatically calculated

by EPs’ certified EHR technology, as attested by the EPs. As such, we believe that the EP will

be able to determine whether they have reported the required clinical quality measures to CMS

or the State, rendering it unnecessary that CMS or the State provide the EP with a feedback
CMS-0033-F 269

report. We expect the system through which EPs, must submit information would indicate

successful receipt beginning the first year of Stage 1.

Comment: A commenter indicated that the clinical quality measure that addresses

tobacco use and the measure that addresses smoking status apply to different age groups, and

stated that they should be consistent. A number of commenters recommended removing

smoking status as an objective from meaningful use section of this final rule, and only including

it in the clinical quality measures in order to avoid confusion.

Response: We are in agreement that the meaningful use objective and the clinical quality

measure address the same topic of smoking. The clinical quality measure requires measurement

of a clinical action performed by the EP to address the negative consequences of smoking,

whereas the meaningful use objective seeks to make sure smokers are identified. Additionally,

the age for recording smoking status for meaningful use is 13 years and older, and the population

addressed by the clinical quality measure is 18 years and older, thus they are different with

respect to intent of the objective/measure and the age population. For the clinical quality

measure, we are keeping the age range at 18 years and older because the measure is currently

NQF endorsed with these specifications. We will consider merging these in the future to

reconcile the age range.

Comment: Some commenters stated that reporting of ambulatory quality measures

should remain voluntary for EPs, based on the view that many process measures do not correlate

with outcomes and are not evidence based. A process measure focuses on a process which leads

to a certain outcome, meaning that a scientific basis exists for believing that the process, when

executed well, will increase the probability of achieving a desired outcome. A commenter stated

that EPs serving needy patients, minorities, and populations with lower socioeconomic levels
CMS-0033-F 270

will experience lower performance on many clinical quality measures, and therefore will be

deterred from participating in the EHR incentive program.

Response: The EHR incentive program is voluntary. Similar to other Medicare quality

measure reporting programs, EPs are not required to satisfy minimum clinical quality

performance levels in order to qualify for the EHR payment incentive, but rather merely report

on their ambulatory quality measure results. Thus, as currently structured, we do not believe the

requirement that EPs report clinical quality measures would deter EPs who serve minority

patients or patients of lower socioeconomic status or otherwise disadvantaged from participating

in the program.

After consideration of the public comments received, we are finalizing the basic

requirement that EPs submit results for clinical quality measures. This requirement applies to

both the 2011 and 2012 reporting periods (and will potentially continue to apply, until CMS

issues a subsequent final rule that supplants this final rule). We are limiting the clinical quality

measures to those for which electronic specifications are available (posted by CMS on the

website at the time of display of this final rule.) These measures are listed in Table 6 of this final

rule for EPs. They constitute the clinical quality measures “specified by CMS” for the purposes

of the ONC final rule (found elsewhere in this issue of the Federal Register) and are the

measures that certified EHRs are required to be able to calculate. Of these, nine EP measures

have preliminary electronic specifications for which we provided links for in the proposed rule.

The remaining 35 clinical quality measures for EPs were electronically specified more recently

and posted on the CMS website by the date of display of this final rule. We are finalizing only

those measures for which there are available electronic specifications as of the date of display of

this final rule. Although we are not finalizing all of 90 proposed clinical quality measures that
CMS-0033-F 271

were proposed for EPs in Table 3 (see 75 FR 1874-1889) of the proposed rule, because of lack of

electronic specifications, our intent is to include all of them in our proposed Stage 2

requirements, or to propose alternative measures following a transparent process that includes

appropriate consultation with stakeholders and other interested parties. In addition, we plan to

add new measures to fill gaps where measures were not previously proposed, such as in behavior

and mental health (e.g. depression and alcoholism). Certified EHR technology must be able to

calculate each measure numerators, denominators and exclusions for each of the clinical quality

measures finalized for the EHR incentive program. Table 6 conveys the applicable NQF

measure number and PQRI implementation number (that is, the number used in the PQRI

program to identify the measure as implemented in PQRI (for the 2010 PQRI measures list see

https://www.cms.gov/PQRI/Downloads/2010_PQRI_MeasuresList_111309.pdf)), title,

description, the owner/steward, and a link to existing electronic specifications. The NQF number

is an identifying number that is associated with the NQF endorsed measure number. All of the

clinical quality measures in Table 6 are NQF endorsed and have broad applicability to the range

of Medicare designated specialties, and the services provided by EPs who render services to

Medicare and Medicaid beneficiaries and many others. In terms of CMS and HHS healthcare

quality priorities, clinical quality PQRI measures numbered 1, 2, 3, 5, and 7 address high priority

chronic conditions, namely diabetes, coronary artery disease, and heart disease. Clinical quality

PQRI measures numbered 66, 110, 111, 112, 113, 114, 115, and 128 support screening and

prevention all of which is a high CMS and HHS priority.

 CMS-0033-F 272

TABLE 6: Clinical Quality Measures for Submission by Medicare or Medicaid EPs for the 2011 and 2012 Payment Year4

NQF Measure Core Clinical Quality

Number & Measure
PQRI Clinical Quality Measure Electronic Measure
Implementation Steward & Contact Specifications
Number Clinical Quality Measure Title & Description Information Information
NQF 0059 Title: Diabetes: Hemoglobin A1c Poor Control National Committee for
Description: Percentage of patients 18 - 75 years of age Quality Assurance (NCQA)
PQRI 1 with diabetes (type 1 or type 2) who had hemoglobin A1c Contact Information: http://www.cms.gov/Quali
> 9.0%. www.ncqa.org tyMeasures/03_Electronic
Specifications.asp#TopOf
Page
NQF 0064 Title: Diabetes: Low Density Lipoprotein (LDL) NCQA
Management and Control Contact Information:
PQRI 2 Description: Percentage of patients 18-75 years of age www.ncqa.org http://www.cms.gov/Quali
with diabetes (type 1 or type 2) who had LDL-C < 100 tyMeasures/03_Electronic
mg/dL). Specifications.asp#TopOf
Page
NQF 0061 Title: Diabetes: Blood Pressure Management NCQA
Description: Percentage of patients 18 - 75 years of age Contact Information:
PQRI 3 with diabetes (type 1 or type 2) who had blood pressure www.ncqa.org http://www.cms.gov/Quali
<140/90 mmHg. tyMeasures/03_Electronic
Specifications.asp#TopOf
Page
NQF 0081 Title: Heart Failure (HF): Angiotensin-Converting American Medical
Enzyme (ACE) Inhibitor or Angiotensin Receptor Association-sponsored
PQRI 5 Blocker (ARB) Therapy for Left Ventricular Systolic Physician Consortium for
Dysfunction (LVSD) Performance Improvement
Description: Percentage of patients aged 18 years and (AMA-PCPI) http://www.cms.gov/Quali
older with a diagnosis of heart failure and LVSD (LVEF Contact Information: tyMeasures/03_Electronic
< 40%) who were prescribed ACE inhibitor or ARB [email protected] Specifications.asp#TopOf
therapy. Page

4 *∗
In the event that new clinical quality measures are not adopted by 2013, the clinical quality measures in this Table would continue to apply.
 CMS-0033-F 273

NQF Measure Core Clinical Quality

Number & Measure
PQRI Clinical Quality Measure Electronic Measure
Implementation Steward & Contact Specifications
Number Clinical Quality Measure Title & Description Information Information
NQF 0070 Title: Coronary Artery Disease (CAD): Beta-Blocker AMA-PCPI
Therapy for CAD Patients with Prior Myocardial Contact Information:
PQRI 7 Infarction (MI) [email protected] http://www.cms.gov/Quali
Description: Percentage of patients aged 18 years and tyMeasures/03_Electronic
older with a diagnosis of CAD and prior MI who were Specifications.asp#TopOf
prescribed beta-blocker therapy. Page
NQF 0041 Title: Preventive Care and Screening: Influenza AMA-PCPI
Immunization for Patients ≥ 50 Years Old Contact Information: Alternate Core
PQRI 110 Description: Percentage of patients aged 50 years and [email protected] http://www.cms.gov/Quali
older who received an influenza immunization during the tyMeasures/03_Electronic
flu season (September through February). Specifications.asp#TopOf
Page
NQF 0043 Title: Pneumonia Vaccination Status for Older Adults NCQA
Description: Percentage of patients 65 years of age and Contact Information:
PQRI 111 older who have ever received a pneumococcal vaccine. www.ncqa.org http://www.cms.gov/Quali
tyMeasures/03_Electronic
Specifications.asp#TopOf
Page
NQF 0031 Title: Breast Cancer Screening NCQA
Description: Percentage of women 40-69 years of age Contact Information:
PQRI 112 who had a mammogram to screen for breast cancer. www.ncqa.org http://www.cms.gov/Quali
tyMeasures/03_Electronic
Specifications.asp#TopOf
Page
NQF 0034 Title: Colorectal Cancer Screening NCQA
Description: Percentage of adults 50-75 years of age Contact Information:
PQRI 113 who had appropriate screening for colorectal cancer. www.ncqa.org http://www.cms.gov/Quali
tyMeasures/03_Electronic
Specifications.asp#TopOf
Page
 CMS-0033-F 274

NQF Measure Core Clinical Quality

Number & Measure
PQRI Clinical Quality Measure Electronic Measure
Implementation Steward & Contact Specifications
Number Clinical Quality Measure Title & Description Information Information
NQF 0067 Title: Coronary Artery Disease (CAD): Oral Antiplatelet AMA-PCPI
Therapy Prescribed for Patients with CAD Contact Information: http://www.cms.gov/Quali
PQRI 6 Description: Percentage of patients aged 18 years and [email protected] tyMeasures/03_Electronic
older with a diagnosis of CAD who were prescribed oral Specifications.asp#TopOf
antiplatelet therapy. Page

NQF 0083 Title: Heart Failure (HF): Beta-Blocker Therapy for Left AMA-PCPI
Ventricular Systolic Dysfunction (LVSD) Contact Information:
PQRI 8 Description: Percentage of patients aged 18 years and [email protected] http://www.cms.gov/Quali
older with a diagnosis of heart failure who also have tyMeasures/03_Electronic
LVSD (LVEF < 40%) and who were prescribed beta- Specifications.asp#TopOf
blocker therapy. Page
NQF 0105 Title: Anti-depressant medication management: (a) NCQA http://www.cms.gov/Quali
Effective Acute Phase Treatment,(b)Effective Contact Information: tyMeasures/03_Electronic
PQRI 9 Continuation Phase Treatment www.ncqa.org Specifications.asp#TopOf
Description: The percentage of patients 18 years of age Page
and older who were diagnosed with a new episode of
major depression, treated with antidepressant medication,
and who remained on an antidepressant medication
treatment.
NQF 0086 Title: Primary Open Angle Glaucoma (POAG): Optic AMA-PCPI
Nerve Evaluation Contact Information:
PQRI 12 Description: Percentage of patients aged 18 years and [email protected]
older with a diagnosis of POAG who have been seen for http://www.cms.gov/Quali
at least two office visits who have an optic nerve head tyMeasures/03_Electronic
evaluation during one or more office visits within 12 Specifications.asp#TopOf
months. Page
 CMS-0033-F 275

NQF Measure Core Clinical Quality

Number & Measure
PQRI Clinical Quality Measure Electronic Measure
Implementation Steward & Contact Specifications
Number Clinical Quality Measure Title & Description Information Information
NQF 0088 Title: Diabetic Retinopathy: Documentation of Presence AMA-PCPI
or Absence of Macular Edema and Level of Severity of Contact Information:
PQRI 18 Retinopathy [email protected]
Description: Percentage of patients aged 18 years and
older with a diagnosis of diabetic retinopathy who had a
dilated macular or fundus exam performed which http://www.cms.gov/Quali
included documentation of the level of severity of tyMeasures/03_Electronic
retinopathy and the presence or absence of macular Specifications.asp#TopOf
edema during one or more office visits within 12 months. Page
NQF 0089 Title: Diabetic Retinopathy: Communication with the AMA-PCPI
Physician Managing Ongoing Diabetes Care Contact Information:
PQRI 19 Description: Percentage of patients aged 18 years and [email protected]
older with a diagnosis of diabetic retinopathy who had a
dilated macular or fundus exam performed with
documented communication to the physician who http://www.cms.gov/Quali
manages the ongoing care of the patient with diabetes tyMeasures/03_Electronic
mellitus regarding the findings of the macular or fundus Specifications.asp#TopOf
exam at least once within 12 months. Page
NQF 0047 Title: Asthma Pharmacologic Therapy AMA-PCPI
Description: Percentage of patients aged 5 through 40 Contact Information:
PQRI 53 years with a diagnosis of mild, moderate, or severe [email protected] http://www.cms.gov/Quali
persistent asthma who were prescribed either the tyMeasures/03_Electronic
preferred long-term control medication (inhaled Specifications.asp#TopOf
corticosteroid) or an acceptable alternative treatment. Page
NQF 0001 Title: Asthma Assessment AMA-PCPI
Description: Percentage of patients aged 5 through 40 Contact Information:
PQRI 64 years with a diagnosis of asthma and who have been seen [email protected] http://www.cms.gov/Quali
for at least 2 office visits, who were evaluated during at tyMeasures/03_Electronic
least one office visit within 12 months for the frequency Specifications.asp#TopOf
(numeric) of daytime and nocturnal asthma symptoms. Page
 CMS-0033-F 276

NQF Measure Core Clinical Quality

Number & Measure
PQRI Clinical Quality Measure Electronic Measure
Implementation Steward & Contact Specifications
Number Clinical Quality Measure Title & Description Information Information
NQF 0002 Title: Appropriate Testing for Children with Pharyngitis NCQA
Description: Percentage of children 2-18 years of age Contact Information:
PQRI 66 who were diagnosed with pharyngitis, dispensed an www.ncqa.org http://www.cms.gov/Quali
antibiotic and received a group A streptococcus (strep) tyMeasures/03_Electronic
test for the episode. Specifications.asp#TopOf
Page
NQF 0387 Title: Oncology Breast Cancer: Hormonal Therapy for AMA-PCPI
Stage IC-IIIC Estrogen Receptor/Progesterone Receptor Contact Information:
PQRI 71 (ER/PR) Positive Breast Cancer [email protected]
Description: Percentage of female patients aged 18
years and older with Stage IC through IIIC, ER or PR http://www.cms.gov/Quali
positive breast cancer who were prescribed tamoxifen or tyMeasures/03_Electronic
aromatase inhibitor (AI) during the 12-month reporting Specifications.asp#TopOf
period. Page
NQF 0385 Title: Oncology Colon Cancer: Chemotherapy for Stage AMA-PCPI
III Colon Cancer Patients Contact Information:
PQRI 72 Description: Percentage of patients aged 18 years and [email protected]
older with Stage IIIA through IIIC colon cancer who are http://www.cms.gov/Quali
referred for adjuvant chemotherapy, prescribed adjuvant tyMeasures/03_Electronic
chemotherapy, or have previously received adjuvant Specifications.asp#TopOf
chemotherapy within the 12-month reporting period. Page
NQF 0389 Title: Prostate Cancer: Avoidance of Overuse of Bone AMA-PCPI
Scan for Staging Low Risk Prostate Cancer Patients Contact Information:
PQRI 102 Description: Percentage of patients, regardless of age, [email protected]
with a diagnosis of prostate cancer at low risk of
recurrence receiving interstitial prostate brachytherapy,
OR external beam radiotherapy to the prostate, OR http://www.cms.gov/Quali
radical prostatectomy, OR cryotherapy who did not have tyMeasures/03_Electronic
a bone scan performed at any time since diagnosis of Specifications.asp#TopOf
prostate cancer. Page
 CMS-0033-F 277

NQF Measure Core Clinical Quality

Number & Measure
PQRI Clinical Quality Measure Electronic Measure
Implementation Steward & Contact Specifications
Number Clinical Quality Measure Title & Description Information Information
NQF 0027 Title: Smoking and Tobacco Use Cessation, Medical NCQA
assistance: a. Advising Smokers and Tobacco Users to Contact Information:
PQRI 115 Quit, b. Discussing Smoking and Tobacco Use Cessation www.ncqa.org
Medications, c. Discussing Smoking and Tobacco Use
Cessation Strategies
Description: Percentage of patients 18 years of age and
older who were current smokers or tobacco users, who
were seen by a practitioner during the measurement year
and who received advice to quit smoking or tobacco use http://www.cms.gov/Quali
or whose practitioner recommended or discussed tyMeasures/03_Electronic
smoking or tobacco use cessation medications, methods Specifications.asp#TopOf
or strategies. Page
NQF 0055 Title: Diabetes: Eye Exam AMA-PCPI
Description: Percentage of patients 18 -75 years of age Contact Information:
PQRI 117 with diabetes (type 1 or type 2) who had a retinal or [email protected] http://www.cms.gov/Quali
dilated eye exam or a negative retinal exam (no evidence tyMeasures/03_Electronic
of retinopathy) by an eye care professional. Specifications.asp#TopOf
Page
NQF 0062 Title: Diabetes: Urine Screening NCQA
Description: Percentage of patients 18 - 75 years of age Contact Information:
PQRI 119 with diabetes (type 1 or type 2) who had a nephropathy www.ncqa.org http://www.cms.gov/Quali
screening test or evidence of nephropathy. tyMeasures/03_Electronic
Specifications.asp#TopOf
Page
NQF 0421 Title: Adult Weight Screening and Follow-Up CMS/Quality Insights of
Description: Percentage of patients aged 18 years and Pennsylvania (QIP)
PQRI 128 older with a calculated BMI in the past six months or Contact Information: Core
during the current visit documented in the medical record www.usqualitymeasures.o http://www.cms.gov/Quali
AND if the most recent BMI is outside parameters, a rg tyMeasures/03_Electronic
follow-up plan is documented. Specifications.asp#TopOf
Page
 CMS-0033-F 278

NQF Measure Core Clinical Quality

Number & Measure
PQRI Clinical Quality Measure Electronic Measure
Implementation Steward & Contact Specifications
Number Clinical Quality Measure Title & Description Information Information
NQF 0056 Title: Diabetes: Foot Exam NCQA
Description: The percentage of patients aged 18 - 75 Contact Information: http://www.cms.gov/Quali
PQRI 163 years with diabetes (type 1 or type 2) who had a foot www.ncqa.org tyMeasures/03_Electronic
exam (visual inspection, sensory exam with Specifications.asp#TopOf
monofilament, or pulse exam). Page
NQF 0074 Title: Coronary Artery Disease (CAD): Drug Therapy AMA-PCPI
for Lowering LDL-Cholesterol Contact Information:
PQRI 197 Description: Percentage of patients aged 18 years and [email protected] http://www.cms.gov/Quali
older with a diagnosis of CAD who were prescribed a tyMeasures/03_Electronic
lipid-lowering therapy (based on current ACC/AHA Specifications.asp#TopOf
guidelines). Page
NQF 0084 Title: Heart Failure (HF): Warfarin Therapy Patients AMA-PCPI
with Atrial Fibrillation Contact Information:
PQRI 200 Description: Percentage of all patients aged 18 years [email protected] http://www.cms.gov/Quali
and older with a diagnosis of heart failure and tyMeasures/03_Electronic
paroxysmal or chronic atrial fibrillation who were Specifications.asp#TopOf
prescribed warfarin therapy. Page
NQF 0073 Title: Ischemic Vascular Disease (IVD): Blood Pressure NCQA
Management Contact Information:
PQRI 201 Description: Percentage of patients 18 years of age and www.ncqa.org
older who were discharged alive for acute myocardial
infarction (AMI), coronary artery bypass graft (CABG)
or percutaneous transluminal coronary angioplasty
(PTCA) from January 1- November 1 of the year prior to
the measurement year, or who had a diagnosis of
ischemic vascular disease (IVD) during the measurement http://www.cms.gov/Quali
year and the year prior to the measurement year and tyMeasures/03_Electronic
whose recent blood pressure is in control (<140/90 Specifications.asp#TopOf
mmHg). Page
 CMS-0033-F 279

NQF Measure Core Clinical Quality

Number & Measure
PQRI Clinical Quality Measure Electronic Measure
Implementation Steward & Contact Specifications
Number Clinical Quality Measure Title & Description Information Information
NQF 0068 Title: Ischemic Vascular Disease (IVD): Use of Aspirin NCQA
or Another Antithrombotic Contact Information:
PQRI 204 Description: Percentage of patients 18 years of age and www.ncqa.org
older who were discharged alive for acute myocardial
infarction (AMI), coronary artery bypass graft (CABG)
or percutaneous transluminal coronary angioplasty
(PTCA) from January 1-November 1 of the year prior to
the measurement year, or who had a diagnosis of
ischemic vascular disease (IVD) during the measurement http://www.cms.gov/Quali
year and the year prior to the measurement year and who tyMeasures/03_Electronic
had documentation of use of aspirin or another Specifications.asp#TopOf
antithrombotic during the measurement year. Page
NQF 0004 Title: Initiation and Engagement of Alcohol and Other NCQA
Drug Dependence Treatment: (a) Initiation, (b) Contact Information:
Engagement www.ncqa.org
Description: The percentage of adolescent and adult
patients with a new episode of alcohol and other drug
(AOD) dependence who initiate treatment through an
inpatient AOD admission, outpatient visit, intensive
outpatient encounter or partial hospitalization within 14 http://www.cms.gov/Quali
days of the diagnosis and who initiated treatment and tyMeasures/03_Electronic
who had two or more additional services with an AOD Specifications.asp#TopOf
diagnosis within 30 days of the initiation visit. Page
NQF 0012 Title: Prenatal Care: Screening for Human AMA-PCPI
Immunodeficiency Virus (HIV) Contact Information:
Description: Percentage of patients, regardless of age, [email protected] http://www.cms.gov/Quali
who gave birth during a 12-month period who were tyMeasures/03_Electronic
screened for HIV infection during the first or second Specifications.asp#TopOf
prenatal care visit. Page
NQF 0013 Title: Hypertension: Blood Pressure Measurement AMA-PCPI
Description: Percentage of patient visits for patients Contact Information: http://www.cms.gov/Quali
aged 18 years and older with a diagnosis of hypertension [email protected] tyMeasures/03_Electronic Core
who have been seen for at least 2 office visits, with blood Specifications.asp#TopOf
pressure (BP) recorded. Page
 CMS-0033-F 280

NQF Measure Core Clinical Quality

Number & Measure
PQRI Clinical Quality Measure Electronic Measure
Implementation Steward & Contact Specifications
Number Clinical Quality Measure Title & Description Information Information
NQF 0014 Title: Prenatal Care: Anti-D Immune Globulin AMA-PCPI
Description: Percentage of D (Rh) negative, Contact Information: http://www.cms.gov/Quali
unsensitized patients, regardless of age, who gave birth [email protected] tyMeasures/03_Electronic
during a 12-month period who received anti-D immune Specifications.asp#TopOf
globulin at 26-30 weeks gestation. Page
NQF 0018 Title: Controlling High Blood Pressure NCQA http://www.cms.gov/Quali
Description: The percentage of patients 18-85 years of Contact Information: tyMeasures/03_Electronic
age who had a diagnosis of hypertension and whose BP www.ncqa.org Specifications.asp#TopOf
was adequately controlled during the measurement year Page
NQF 0024 Title: Weight Assessment and Counseling for Children NCQA
and Adolescents Contact Information:
Description: Percentage of patients 2 -17 years of age www.ncqa.org Alternate Core
who had an outpatient visit with a Primary Care
Physician (PCP) or OB/GYN and who had evidence of http://www.cms.gov/Quali
BMI percentile documentation, counseling for nutrition tyMeasures/03_Electronic
and counseling for physical activity during the Specifications.asp#TopOf
measurement year. Page
NQF 0028 Title: Preventive Care and Screening Measure Pair: a. AMA-PCPI
Tobacco Use Assessment, b. Tobacco Cessation Contact Information:
Intervention [email protected] Core
Description: Percentage of patients aged 18 years and
older who have been seen for at least 2 office visits who
were queried about tobacco use one or more times within
24 months b. Percentage of patients aged 18 years and http://www.cms.gov/Quali
older identified as tobacco users within the past 24 tyMeasures/03_Electronic
months and have been seen for at least 2 office visits, Specifications.asp#TopOf
who received cessation intervention. Page
NQF 0032 Title: Cervical Cancer Screening NCQA http://www.cms.gov/Quali
Description: Percentage of women 21-64 years of age, Contact Information: tyMeasures/03_Electronic
who received one or more Pap tests to screen for cervical www.ncqa.org Specifications.asp#TopOf
cancer Page
 CMS-0033-F 281

NQF Measure Core Clinical Quality

Number & Measure
PQRI Clinical Quality Measure Electronic Measure
Implementation Steward & Contact Specifications
Number Clinical Quality Measure Title & Description Information Information
NQF 0033 Title: Chlamydia Screening for Women NCQA
Description: Percentage of women 15- 24 years of age Contact Information: http://www.cms.gov/Quali
who were identified as sexually active and who had at www.ncqa.org tyMeasures/03_Electronic
least one test for chlamydia during the measurement Specifications.asp#TopOf
year. Page
NQF 0036 Title: Use of Appropriate Medications for Asthma NCQA
Description: Percentage of patients 5 - 50 years of age Contact Information:
who were identified as having persistent asthma and were www.ncqa.org http://www.cms.gov/Quali
appropriately prescribed medication during the tyMeasures/03_Electronic
measurement year. Report three age stratifications (5-11 Specifications.asp#TopOf
years, 12-50 years, and total). Page
NQF 0038 Title: Childhood Immunization Status NCQA
Description: Percentage of children 2 years of age who Contact Information:
had four diphtheria, tetanus and acellular pertussis www.ncqa.org Alternate Core
(DTaP); three polio(IPV), one measles, ,mumps and
rubella (MMR); two H influenza type B (HiB); three
hepatitis B (Hep B); one chicken pox (VZV); four
pneumococcal conjugate (PCV); two hepatitis A (Hep
A); two or three rotavirus (RV); and two influenza (flu) http://www.cms.gov/Quali
vaccines by their second birthday. The measure tyMeasures/03_Electronic
calculates a rate for each vaccine and nine separate Specifications.asp#TopOf
combination rates. Page
NQF 0052 Title: Low Back Pain: Use of Imaging Studies NCQA
Description: Percentage of patients with a primary Contact Information: http://www.cms.gov/Quali
diagnosis of low back pain who did not have an imaging www.ncqa.org tyMeasures/03_Electronic
study (plain x-ray, MRI, CT scan) within 28 days of Specifications.asp#TopOf
diagnosis. Page
 CMS-0033-F 282

NQF Measure Core Clinical Quality

Number & Measure
PQRI Clinical Quality Measure Electronic Measure
Implementation Steward & Contact Specifications
Number Clinical Quality Measure Title & Description Information Information
NQF 0075 Title: Ischemic Vascular Disease (IVD): Complete NCQA
Lipid Panel and LDL Control Contact Information:
Description: Percentage of patients 18 years of age and www.ncqa.org
older who were discharged alive for acute myocardial
infarction (AMI), coronary artery bypass graft (CABG)
or percutaneous transluminal angioplasty (PTCA) from
January 1-November1 of the year prior to the
measurement year, or who had a diagnosis of ischemic
vascular disease (IVD) during the measurement year and http://www.cms.gov/Quali
the year prior to the measurement year and who had a tyMeasures/03_Electronic
complete lipid profile performed during the measurement Specifications.asp#TopOf
year and whose LDL-C<100 mg/dL. Page
NQF 0575 Title: Diabetes: Hemoglobin A1c Control (<8.0%) NCQA http://www.cms.gov/Quali
Description: The percentage of patients 18-75 years of Contact Information: tyMeasures/03_Electronic
age with diabetes (type 1 or type 2) who had hemoglobin www.ncqa.org Specifications.asp#TopOf
A1c <8.0%. Page
CMS-0033-F 283

e. Clinical Quality Measures Reporting Criteria for EPs

For the 2011 and 2012 EHR reporting periods, to satisfy the requirements for reporting

on clinical quality measures for Medicare under section 1848(o)(2)(A)(i) and (iii) of the Act and

for Medicaid under section 1903(t)(6)(C) of the Act, we proposed to require that each EP submit

information on two measure groups: a core measures group (Table 4 of the proposed rule see

75 FR 1890), and the subset of clinical measures most appropriate given the EP’s specialty

(Tables 5 through 19 specialty group measures see 75 FR 1891 through 1895). For the core

measure group, we stated our belief that the clinical quality measures were sufficiently general in

application and of such importance to population health; we would require that all EPs treating

Medicare and Medicaid patients in the ambulatory setting report on all of the core measures as

applicable for their patients.

We proposed that with the inclusion of measures applicable to targeting children and

adolescents and the wide applicability of the measures like Blood Pressure Management, we

believed the proposed core set of clinical quality measures and specialty measures was broad

enough to enable reporting by all EPs. However, we encouraged commenters to identify the EPs

in question and propose specific remedies if the public believed that other EPs would not have

sufficient patients in the denominator of these core measures.

Comment: Several commenters requested clarification about the core measures group.

Many comments were received regarding the inclusion of a core measure set for EPs. Some

commenters favored the inclusion of one or more core measures (for example, preventive

care) and others indicated core measures were essential for improving the quality of care.

Conversely, numerous commenters suggested eliminating the core measure set for EPs. The

primary reason offered by commenters for excluding core measures was that these clinical
CMS-0033-F 284

quality measures were outside their scope of practice and/or not relevant to their specific patient

population. A commenter requested that the core set of clinical quality measures be better

defined and/or increased for each reporting period. Many commenters indicated the clinical

quality measures included in the core measure set are not appropriate to all EPs and specialists

(for example, EPs that do not have direct physical access to the patients such as teleradioloists,

EPs that do not routinely report blood pressure in patients with diagnosed hypertension, such as

dermatologists) and they would not be able to report on these clinical quality measures. Many

commenters supported reporting exclusions. A commenter recommended the use of PQRI

128/NQF 0421 Preventive Care and Screening: BMI Screening and Follow-up as a core clinical

quality measure. Other commenters indicated these clinical quality measures were important for

improving care and the core measure set should be expanded.

Response: After considering the comments, we agree there may be circumstances such

that the core clinical quality measures are not applicable for specific patient populations and/or a

specific EP’s scope of practice. In such circumstances we anticipate that the patients will not

appear in the denominator at all or will be excluded. We have defined the core measure set for

EPs in Table 7 of this final rule, and these core measures will be required for Stage 1. We

expanded the core measures set to include three alternate measures, as well as added PQRI

128/NQF0421 as a required core measure, based on commenters feedback. Although we require

all EPs to report the core measures, there is no requirement that the EP have any particular

number of patients in the denominator, which could be zero as calculated by the EHR. Therefore

we have changed the reporting criteria to require EPs to report on all three core measures (as

shown in Table 7, below), and three additional clinical quality measures selected from Table 6

(other than the core or alternate core measures listed in Table 6). The clinical quality measures
CMS-0033-F 285

included in this final rule reflect a subset of measures that were included in the proposed rule

(see 75 FR 1874 through 1889). The clinical quality measures included in Table 6 of this final

rule were selected from the Tables included in the proposed rule, based on having

electronic specifications fully developed by the date of display of this final rule.

Comment: Many commenters indicated that NQF 0022 Drugs to be avoided in the

elderly is an inappropriate clinical quality measure and should be removed. The rationale given

for removal is that the numerator (at least one prescription for any drug to be avoided in the

elderly in the measurement year or at least two different drugs to be avoided in the elderly in the

measurement year) tends to be very small. Others considered polypharmacy a more significant

problem in the elderly than avoidance of specific drugs. A number of commenters indicated this

clinical quality measure should include a list of the drugs to be avoided.

Response: We agree with the concerns expressed by the commenters and have removed

the measure NQF 0022. Additionally, electronic specifications are not available for this measure

by the date of display of this final rule making this measure impractical to use for Stage 1. We

will consider this measure in future rulemaking.

After consideration of the public comments received, we are finalizing the requirement

that all EPs must submit calculated results for three core measures using the certified EHR

technology. However, we are finalizing only two of the clinical quality measure that were

proposed as “core measures” in the proposed rule. The other core measures presented in Table 6

of this final rule were selected because they have broad applicability, support prevention, were

recommended by commenters, and have electronic specifications by the date of display of this

final rule. Insofar as a measure does not apply to patients treated by the EP, this will be reflected

in the calculation of the clinical quality measure either by the patient not being included in the
CMS-0033-F 286

denominator for the measure or the patient being excluded. Therefore, it is not necessary for

CMS to delineate for a particular specialty which measures may or not apply. We note that to

qualify as a meaningful EHR user, EPs need only report the required clinical quality measures;

they need not satisfy a minimum value for any of the numerator, denominator, or exclusions

fields for clinical quality measures. The value for any or all of those fields, as reported to CMS

or the States, may be zero if these are the results as displayed by the certified EHR technology.

Thus, the clinical quality measure requirement for 2011 and beginning in 2012 is a reporting

requirement and not a requirement to meet any particular performance standard for the clinical

quality measure, or to in all cases have patients that fall within the denominator of the measure.

The three core measures that EPs will be required to report are: [NQF 0013:

Hypertension: Blood Pressure Management; NQF 0028: Preventative Care and Screening

Measure Pair: a. Tobacco Use Assessment b. Tobacco Cessation Intervention; and

NQF0421/PQRI 128: Adult Weight Screening and Follow-up]. Insofar as the denominator for

one or more of the core measures is zero, EPs will be required to report results for up to three

alternate core measures [NQF 0041/PQRI 110: Preventative Care and Screening: Influenza

Immunization for Patients ≥50 Years Old; NQF 0024: Weight Assessment and Counseling for

Children and Adolescents; and NQF 0038: Childhood Immunization Status]. We believe this

final set of core clinical quality measures provides EPs a greater opportunity for successful

reporting. The EP will not be excluded from reporting any core or alternate clinical quality

measure because the measure does not apply to the EPs scope of practice or patient population.

The expectation is that the EHR will automatically report on each core clinical quality measure,

and when one or more of the core measures has a denominator of zero then the alternate core

measure(s) will be reported. If all six of the clinical quality measures in Table 7 have zeros for
 CMS-0033-F 287

the denominators (this would imply that the EPs patient population is not addressed by these

measures), then the EP is still required to report on three additional clinical measures of their

choosing from Table 6 in this final rule. In regard to the three additional clinical quality

measures, if the EP reports zero values, then for the remaining clinical quality measures in Table

6 (other than the core and alternate core measures) the EP will have to attest that all of the other

clinical quality measures calculated by the certified EHR technology have a value of zero in the

denominator, if the EP is to be exempt from reporting any of the additional clinical quality

measures (other than the core and alternate core measures) in Table 6. Thus, EPs are not

penalized in the Stage 1 reporting years as long as they have adopted a certified EHR and that

EHR calculates and the EP submits the required information on the required clinical quality

measures, and other meaningful use requirements as defined in this final rule in section

II.A.2.d.1 of this final rule.

Table 7, below, shows the core measure groups for all EPs for Medicare and Medicaid to

report.

TABLE 7: Measure Group: Core for All EPs, Medicare and Medicaid

NQF Measure Number

& PQRI
Implementation
Number Clinical Quality Measure Title
NQF 0013 Title: Hypertension: Blood Pressure Measurement
NQF 0028 Title: Preventive Care and Screening Measure Pair: a. Tobacco Use Assessment
b. Tobacco Cessation Intervention
NQF 0421 Title: Adult Weight Screening and Follow-up
PQRI 128

Alternate Core Measures

NQF 0024 Title: Weight Assessment and Counseling for Children and Adolescents
NQF 0041 Title: Preventive Care and Screening: Influenza Immunization for Patients ≥ 50
PQRI 110 Years Old
 CMS-0033-F 288

NQF Measure Number

& PQRI
Implementation
Number Clinical Quality Measure Title
NQF 0038 Title: Childhood Immunization Status

We proposed that EPs were to submit calculated results on at least one of the sets listed in

Tables 5 and 19 as specialty groups (see 75 FR 1891-1895). The specialty groups were

Cardiology, Pulmonary Diseases, Endocrinology, Oncology, Proceduralist/Surgery, Primary

Care Physicians, Pediatrics, Obstetrics and Gynecology, Neurology, Psychiatry, Ophthalmology,

Podiatry, Radiology, Gastroenterology, and Nephrology.

We recognized that clinical quality measures as specified by measures developers and as

endorsed by the NQF were not specific to particular specialties. Rather, the denominator of

clinical quality measures and the applicability of a measure is determined by the patient

population to whom the measure applies and the services rendered by the particular EP.

Nevertheless, we grouped the proposed measures according to the types of patients

commonly treated and services rendered by EPs of various specialties. We did this for purposes

similar to measures groups used in PQRI which, however, are based on clinical conditions, rather

than specialty types. We proposed that the general purpose of each specialty measures grouping

was to have standardized sets of measures, all of which must be reported by the EP for the self-

selected specialty measures groups in order to meet the reporting requirements. We expected to

narrow down each set to a required subset of three-five measures based on the availability of

electronic measure specifications and comments received.

We also proposed to require for 2011 and 2012 that EPs would select a specialty

measures group, on which to report on all applicable cases for each of the measures in the
CMS-0033-F 289

specialty group. We also proposed that the same specialty measures group selected for the first

payment year would be required for reporting for the second payment year. We invited comment

on whether there were EPs who believed no specialty group would apply to them. In accordance

with public comments, we noted that we would specify in the final rule which EP specialties

would be exempt from selecting and reporting on a specialty measures group. As stated, we

proposed, EPs that are so-designated would be required to attest, to CMS or the States, to the

inapplicability of any of the specialty groups and would not be required to report information on

clinical quality measures from a specialty group for 2011 or 2012, though the EP would still be

required to report information on all of the clinical quality measures listed in the proposed core

measure set (see 75 FR 1890).

Comment: Several commenters asked if certain specialties, such as chiropractors,

audiologists, allergist and immunology, otolaryngologists, etc., could be exempt from having to

report all specific clinical quality specialty measures. Many of these EPs indicated the clinical

quality measures included in Table 3 were not relevant to their specific practice and/or patient

population. Other commenters requested that specialty groups be created for specialties not

included in the proposed rule measure groups, (for example, chiropractors, dentists,

dermatologists, infectious disease, pediatric oncology, neurosurgery, interventional radiology,

plastic & reconstructive surgery, physical therapists, occupational therapists, eye care specialists,

family planning, genetics, ear/nose/throat, and nutritionists providers, etc.). Other commenters

indicated that specialty clinical quality measures were specific to a subset of patients, but were

not broadly applicable to their specialty for treating other conditions within their specialty area.

Other commenters asked that CMS reconsider allowing EPs to attest only and be exempt from

reporting if no applicable clinical quality measures specialty group exists for them. Another
CMS-0033-F 290

commenter indicated support of specific measure sets for different clinical specialties. Many

commenters supported the elimination of specialty groups altogether as a mandatory set and

instead supported the reporting of a fixed number of relevant clinically quality measures

regardless of the specialty group. A commenter asked for a definition of “specialist” which is

not included in the proposed rule. Several commenters expressed concern about the large

number of clinical quality measures in certain measure groups versus other measure groups (for

example, the primary care, pediatric and ob/gyn measure groups) as well as the applicability of

clinical quality measures assigned to primary care EPs when they do not manage conditions that

are typically referred to a specialist for example, ischemic vascular disease. A commenter

requested clarification and suggestions on how to select a clinical quality measure group.

Several commenters wanted clarification on the proposed EP Specialty Measures Tables (see

75 FR 1874), and whether the EPs are accountable for only the clinical quality measures for their

specialty. One comment indicated agreement with CMS regarding requiring EPs to report on the

same specialty measure groups for 2011 and 2012 and another commenter indicated that CMS

should not delay reporting of clinical quality measures as early adopters of EHRs will be ready to

report. A few commenters suggested adding NQF 0033 Chlamydia screening in women to all

other appropriate specialty clinical quality measure groups. A commenter indicated that PQRI

#112, 113, and NQF 0032 should be removed from the oncology clinical quality specialty

measure group as oncologists do not perform routine cancer screenings.

Response: We are appreciative of the detail provided by commenters to the potential

inapplicability of the proposed specialty measures groups to various practitioner types or to the

inapplicability of certain measures within groups to the specialties designated. Our primary

purpose, similar to the core measures, was to encourage a certain consistency in reporting of
CMS-0033-F 291

clinical quality measures by EPs. However, after consideration of the comments we do not

believe that the proposed specialty measures groups are sufficient to have a robust set of

specialty measures groups. Further, given the lack of electronic specifications or final

development of many of these measures, requiring specialty measures groups becomes even

more impractical. We expect that electronic specifications will be developed for measures which

would allow for a broadly applicable set of specialty measures groups in the future.

After consideration of the public comments received, we removed the requirement for

EPs to report on specialty measures groups as proposed. We intend to reintroduce the proposed

rule’s specialty group reporting requirement in Stage 2 with at least as many clinical quality

measures by specialty as we proposed for Stage 1 in the proposed rule. We expect to use a

transparent process for clinical quality measure development that includes appropriate

consultation with specialty groups and other interested parties, and we expect that electronic

specifications will be developed for all of the measures that we originally proposed for Stage 1 or

alternative related measures, which would allow for a broadly applicable set of specialty

measures groups and promote consistency in reporting of clinical quality measures by EPs.

Also, in consideration of public comments received, we are finalizing the requirement (in

addition to the core measure requirement) that EPs must report on three measures to be selected

by the EP from the set of 38 measures as shown in Table 6, above. As stated previously, in

regard to the three additional clinical quality measures, if the EP reports zero values, then for the

remaining clinical quality measures in Table 6 (other than the core and alternate core measures)

the EP will have to attest that all of the other clinical quality measures calculated by the certified

EHR technology have a value of zero in the denominator. In sum, EPs must report on six total

measures, three core measures (substituting alternate core measures where necessary) and three
CMS-0033-F 292

additional measures (other than the core and alternate core measures) selected from Table 6.

We also proposed that although we do not require clinical quality measure reporting

electronically until 2012, we would require clinical quality reporting through attestation in the

2011 payment year. We solicited comment on whether it may be more appropriate to defer some

or all clinical quality reporting until the 2012 payment year. If reporting on some but not all

measures in 2011 was feasible, we solicited comment on which key measures should be chosen

for 2011 and which should be deferred until 2012 and why. We discuss comments received

regarding the reporting method for clinical quality measures in section II.A.3.h. of this final rule.

f. Clinical Quality Measures for Electronic Submission by Eligible Hospitals and CAHs

Our proposed rule would have required eligible hospitals and CAHs to report summary

data to CMS on the set of clinical quality measures identified in Table 20 and 21 of the proposed

rule (see 75 FR 1896-1899), with eligible hospitals attesting to the measures in 2011 and

electronically submitting these measures to CMS using certified EHR technology beginning in

2012. For hospitals eligible for only the Medicaid EHR incentive program, we proposed that

reporting would be to the States. In the proposed rule, for eligible hospitals under both

programs, we proposed that they would have to also report on the clinical quality measures

identified in Table 21 of the proposed rule to meet the requirements for the reporting of clinical

quality measures for the Medicaid program incentive (see 75 FR 1896 through 1900). Tables 20

and 21 of the proposed rule (see 75 FR 1896 through 1900) conveyed the clinical quality

measure's title, number, owner/developer and contact information, and a link to existing

electronic specifications where applicable.

We included in the proposed hospital measures set several clinical quality measures

which have undergone development of electronic specifications. These clinical quality measures
CMS-0033-F 293

have been developed for future RHQDAPU consideration. The electronic specifications were

developed through an interagency agreement between CMS and ONC to develop interoperable

standards for EHR electronic submission of the Emergency Department Throughput, Stroke, and

Venous Thromboembolism clinical quality measures on Table 20 of the proposed rule (see

75 FR 1896 through 1899). We also proposed to test the submission of these clinical quality

measures in Medicare (see 75 FR 43893). The specifications for the RHQDAPU clinical quality

measures for eligible hospitals and CAHs that are being used for testing EHR-based submission

of these clinical quality measures can be found at

http://www.hitsp.org/ConstructSet_Details.aspx?&PrefixAlpha=5&PrefixNumeric=906 (A

description of the clinical quality measure, including the clinical quality measure's numerator and

denominator, can be found here as well.) Other measures we proposed derived from the

RHQDAPU program or were measures we considered important for measuring or preventing

adverse outcomes. In addition to risk standardized readmission clinical quality measures, we

proposed that non-risk-adjusted readmission rates also be reported. For the proposed rule, we

also considered HIT Standards Committee recommendations, including the Committee’s

recommendation to include a measure on Atrial Fibrillation Receiving Anticoagulation Therapy

which was included on Table 20 of the proposed rule Our proposed rule noted that we did not

propose one measure recommended by the HIT Standards Committee: surgery patients who

received Venous Thromboembolism prophylaxis within 24 hours period to surgery to 24 hours

after surgery end time. We noted that the measure is a current clinical quality measure collected

in the RHQDAPU program through chart abstraction for all applicable patients (SCIP-VTE-2),

and that the VTE-2 clinical quality measure in Table 20 of the proposed rule (see 75 FR 1896

through 1899) was a parallel clinical quality measure to SCIP-VTE-2. SCIP-VTE-2 includes
CMS-0033-F 294

surgical and non-surgical patients, and can be more easily implemented for the EHR incentive

program because electronic specifications had been completed. We added SCIP-VTE-2 for

future consideration.

Comment: Many commenters recommended reducing the number of eligible hospital

clinical quality measures and indicated that such a large number of measures would pose a

significant financial and administrative burden on hospitals. Commenters suggested a variety of

solutions which include: eliminating duplication between clinical quality measures and

meaningful use objectives and associated measures, reducing the number of clinical quality

measures for reporting and allowing organizations to select a limited number of clinical quality

measures on which they would like to report.

We received comments supporting many of the measures in the proposed rule including

Venous Thromboembolism, Emergency Department, Stroke, RHQDAPU, and measures that are

evidence-based that could improve the quality of care. Others recommended additional clinical

quality measures, changes to the specifications for clinical quality measures or the elimination of

certain clinical quality measures such as risk adjusted re-admission measures or measures not

applicable to CAHs. Many commenters supported the process through which the electronic

specifications were developed for the Emergency Department Throughput, Stroke and Venous

Thromboembolism measures while also pointing out the length of time necessary to adequately

develop electronic specifications and test the clinical quality measures. Many commented that

the remaining measures had not been electronically specified or had otherwise not completed

development and would not be ready in time for the 2011-2012 implementation. Others stated

their concerns about duplicate reporting systems and the belief that the HITECH Act reporting

requirements should be based on the RHQDAPU program, similar to the conceptual framework
CMS-0033-F 295

of hospitals value-based purchasing plan. Others pointed to measures that are already currently

reported in RHQDAPU and the statutory provision that clinical quality measure reporting

required for the HITECH Act should seek to avoid duplicative and redundant reporting of

measures reported under RHQDAPU.

Response: We are appreciative of the comments supporting many of the clinical quality

measure sets and the process utilized for electronically specifying the Emergency Department

Throughput, Stroke, and Venous Thromboembolism sets. As we have discussed for the EP

measures, we agree that we should limit the required clinical quality measures to those measures

for where there are electronic specifications as of the date of display of this final rule. This will

allow EHR vendors sufficient time to ensure that certified EHR technology will be able to

electronically calculate the measures. Therefore, we are not finalizing those clinical quality

measures that either have not been fully developed, are currently only specified for claims based

calculation, or for which there are not fully developed electronic specifications as of the date of

display of this final rule. Accordingly, we are only finalizing the 15 measures listed in Table 10

of this final rule. We note that none of these measures are duplicate measures which are

currently required for reporting in the RHQDAPU program. We therefore do not need to address

the issue of duplicate or redundant reporting. We will consider adding, changing, developing,

and eliminating duplicative clinical quality measures and meaningful use objectives/associated

measures in future rulemaking.

Table 8, shows the proposed clinical quality measures for submission by Medicare and

Medicaid Eligible Hospitals for the 2011 and 2012 payment year as stated in the proposed rule

(see 75 FR 1896-1899) for EPs, but that are not being finalized. Table 9, shows the proposed

alternative Medicaid clinical quality measures for Medicaid eligible hospitals in the proposed
CMS-0033-F 296

rule (see 75 FR 1899-1900). Tables 8 and 9 convey the NQF measure number, clinical quality

measure title and description, and clinical quality measure steward and contact information. The

measures listed below in Tables 8 and 9 do not have electronic specifications finished before the

date of display of this final rule, thus we have eliminated these measures for this final rule and

will consider the addition of these measures in future rulemaking. Also several measures listed

below were only concepts at the time of publication of the proposed rule (that is, Hospital

Specific 30 day Rate following AMI admission, Hospital Specific 30 day Rate following Heart

Failure admission, Hospital Specific 30 day Rate following Pneumonia admission, and

All-Cause Readmission Index). These concept measures were not developed or electronically

specified clinical quality measures, nor NQF endorsed; and there was not adequate time to

consider these concepts for development for this final rule. Therefore, the concepts listed below

will be considered in future rulemaking.

TABLE 8: Proposed Clinical Quality Measures for Submission by Medicare or Medicaid

Eligible Hospitals for the 2011 and 2012 Payment Year; Included in the Proposed Rule (see
75 FR 1896 through 1899) and Not in the Final Rule

Measure
Number
Identifier Measure Title, Description & Measure Developer
Emergency Title: Emergency Department Throughput – discharged patients
Department Median Time from ED Arrival to ED Departure for Discharged ED
(ED)-3 Patients
Description: Median Time from ED arrival to time of departure from the
NQF 0496 ED for patients discharged from the ED
Measure Developer: CMS/OFMQ
RHQDAPU Title: Primary PCI Received Within 90 Minutes of Hospital Arrival
AMI-8a Description: Acute myocardial infarction (AMI) patients with ST-
segment elevation or LBBB on the ECG closest to arrival time receiving
NQF 0163 primary PCI during the hospital stay with a time from hospital arrival to
PCI of 90 minutes or less
Measure Developer: CMS/OFMQ
CMS-0033-F 297

Measure
Number
Identifier Measure Title, Description & Measure Developer
RHQDAPU Title: Blood Cultures Performed in the Emergency Department Prior to
PN-3b Initial Antibiotic Received in Hospital
Description: Pneumonia patients whose initial emergency room blood
NQF 0148 culture specimen was collected prior to first hospital dose of antibiotics.
This measure focuses on the treatment provided to Emergency
Department patients prior to admission orders.
Measure Developer: CMS/OFMQ
RHQDAPU Title: Aspirin Prescribed at Discharge
AMI-2 Description: Acute myocardial infarction (AMI) patients who are
prescribed aspirin at hospital discharge
NQF 0142 Measure Developer: CMS/OFMQ
RHQDAPU Title: Angiotensin Converting Enzyme Inhibitor(ACEI) or Angiotensin
AMI-3 Receptor Blocker (ARB) for Left Ventricular Systolic
Dysfunction (LVSD)
NQF 0137 Description: Acute myocardial infarction (AMI) patients with left
ventricular systolic dysfunction (LVSD) who are prescribed an ACEI or
ARB at hospital discharge. For purposes of this measure, LVSD is defined
as chart documentation of a left ventricular ejection fraction (LVEF) less
than 40% or a narrative description of left ventricular systolic (LVS)
function consistent with moderate or severe systolic dysfunction.
Measure Developer: CMS/OFMQ
RHQDAPU Title: Beta-Blocker Prescribed at Discharge
AMI-5 Description: Acute myocardial infarction (AMI) patients who are
prescribed a betablocker at hospital discharge
NQF 0160 Measure Developer: CMS/OFMQ
RHQDAPU Title &Description: Hospital Specific 30 day Risk-Standardized
AMI-READ Readmission Rate following AMI admission

NQF 0505 Measure Developer: CMS

Not Title: Hospital Specific 30 day Rate following AMI admission
applicable
RHQDAPU Title &Description: Hospital Specific 30 day Risk-Standardized
HF-READ Readmission Rate following Heart Failure admission

NQF 0330 Measure Developer: CMS/OFMQ

Not Title: Hospital Specific 30 day Rate following Heart Failure admission
applicable
RHQDAPU Title &Description: Hospital Specific 30 day Risk-Standardized
PNE-READ Readmission Rate following Pneumonia admission
Measure Developer: CMS
NQF 0506
Not Title: Hospital Specific 30 day Rate following Pneumonia admission
applicable
CMS-0033-F 298

Measure
Number
Identifier Measure Title, Description & Measure Developer
NQF 0528 Title: Infection SCIP Inf-2 Prophylactic antibiotics consistent with
current recommendations
Description: Surgical patients who received prophylactic antibiotics
consistent with current guidelines (specific to each type of surgical
procedure).
Measure Developer : CMS/OFMQ
NQF 0302 Title: Ventilator Bundle
Description: Percentage of intensive care unit patients on mechanical
ventilation at time of survey for whom all four elements of the ventilator
bundle are documented and in place. The ventilator bundle elements are:
•Head of bed (HOB) elevation 30 degrees or greater (unless medically
contraindicated); noted on 2 different shifts within a 24 hour period •Daily
"sedation interruption" and daily assessment of readiness to extubate;
process includes interrupting sedation until patient follow commands and
patient is assessed for discontinuation of mechanical ventilation;
Parameters of discontinuation include: resolution of reason for intubation;
inspired oxygen content roughly 40%; assessment of patients ability to
defend airway after extubation due to heavy sedation; minute ventilation
less than equal to 15 liters/minute; and respiratory rate/tidal volume less
than or equal to 105/min/L(RR/TV< 105)•SUD (peptic ulcer disease)
prophylaxis•DVT (deep venous thrombosis) prophylaxis
Measure Developer: IHI
NQF 0298 Title: Central Line Bundle Compliance
Description: Percentage of intensive care patients with central lines for
whom all elements of the central line bundle are documented and in place.
The central line bundle elements include:•Hand hygiene , •Maximal
barrier precautions upon insertion •Chlorhexidine skin antisepsis •Optimal
catheter site selection, with subclavian vein as the preferred site for non-
tunneled catheters in patients 18 years and older •Daily review of line
necessity with prompt removal of unnecessary lines
Measure Developer: IHI
NQF 0140 Title: Ventilator-associated pneumonia for ICU and high-risk nursery
(HRN) patients
Description: Percentage of ICU and HRN patients who over a certain
amount of days have ventilator-associated pneumonia
Measure Developer: CDC
NQF 0138 Title: Urinary catheter-associated urinary tract infection for intensive care
unit (ICU) patients
Description: Percentage of intensive care unit patients with urinary
catheter-associated urinary tract infections
Measure Developer: CDC
CMS-0033-F 299

Measure
Number
Identifier Measure Title, Description & Measure Developer
NQF 0139 Title: Central line catheter-associated blood stream infection rate for ICU
and high-risk nursery (HRN) patients
Description: Percentage of ICU and high-risk nursery patients, who over
a certain amount of days acquired a central line catheter-associated blood
stream infections over a specified amount of line-days
Measure Developer: CDC
NQF 0329 Title: All-Cause Readmission Index (risk adjusted)
Description: Overall inpatient 30-day hospital readmission rate.
Measure Developer: United Health Group
Not Title: All-Cause Readmission Index
applicable Description: Overall inpatient 30-day hospital readmission rate.

TABLE 9: Proposed Alternative Medicaid Clinical Quality Measures for Medicaid

Eligible Hospitals; Included in the Proposed Rule (see 75 FR 1899-1900) and Not in the
Final Rule

NQF
Measure
Number Measure Title, Description & Measure Developer
0341 Title: PICU Pain Assessment on Admission
Description: Percentage of PICU patients receiving:
a. Pain assessment on admission
b. Periodic pain assessment.
Measure Developer: Vermont Oxford Network
0348 Title: Iotrogenic pneumothorax in non-neonates (pediatric up to 17 years of
age)
Description: Percent of medical and surgical discharges, age under 18 years,
with ICD-9-CM-CM code of iatrogenic pneumothorax in any secondary
diagnosis field.
Measure Developer: AHRQ
0362 Title: Foreign body left after procedure, age under 18 years
Description: Discharges with foreign body accidentally left in during
procedure per 1,000 discharges
Measure Developer: AHRQ
0151 Title: Pneumonia Care PNE-5c Antibiotic
Description: Percentage of pneumonia patients 18 years of age and older who
receive their first dose of antibiotics within 6 hours after arrival at the hospital
Measure Developer: CMS/OFMQ
0147 Title: Pneumonia Care PN-6 Antibiotic selection
Description: Percentage of pneumonia patients 18 years of age or older selected
for initial receipts of antibiotics for community-acquired pneumonia (CAP).
Measure Developer: CMS/OFMQ
CMS-0033-F 300

NQF
Measure
Number Measure Title, Description & Measure Developer
0356 Title: Pneumonia Care PN-3a Blood culture
Description: Percent of pneumonia patients, age 18 years or older, transferred
or admitted to the ICU within 24 hours of hospital arrival who had blood
cultures performed within 24 hours prior to or 24 hours after arrival at the
hospital.
Measure Developer: CMS/OFMQ
0527 Title: Infection SCIP Inf-1 Prophylactic antibiotic received within 1 hour prior
to surgical incision
Description: Surgical patients with prophylactic antibiotics initiated within one
hour prior to surgical incision. Patients who received vancomycin or a
fluoroquinolone for prophylactic antibiotics should have the antibiotics initiated
within two hours prior to surgical incision. Due to the longer infusion time
required for vancomycin or a fluoroquinolone, it is acceptable to start these
antibiotics within two hours prior to incision time.
Measure Developer: CMS/OFMQ
0529 Title: Infection SCIP Inf-3 Prophylactic antibiotics discontinued within 24
hours after surgery end time
Description: Surgical patients whose prophylactic antibiotics were discontinued
within 24 hours after Anesthesia End Time.
Measure Developer: CMS/OFMQ

Comment: Commenters stated that current health information technology is not capable

of electronically collecting or reporting on clinical quality measures. Commenters also stated we

should not require reporting on clinical quality measures that cannot easily be derived from

EHRs. Other commenters believed the timeline was unreasonable to obtain the functionality

required in the EHR system to report on these clinical quality measures and were concerned that

there were no vocabulary standards.

Response: We agree with the comment that eligible hospitals should only be required to

submit information that can be automatically obtained from certified EHR technology. As we

discussed elsewhere, ONC’s final rule (found elsewhere in this issue of the Federal Register)

requires that certified EHR technology must be able to calculate clinical quality measures
CMS-0033-F 301

specified by us in this final rule. Standards for certified EHRs, including vocabulary standards,

are included in ONC’s final rule (found elsewhere in this issue of the Federal Register).

Comment: Commenters recommended that CMS conduct a pilot test of the NQF

endorsed HITSP electronic specifications of measures in the proposed rule for Stage 1 prior to

their adoption. Commenters requested CMS publish results of the pilot and use this information

to inform the setting of Stage 2 and 3 objectives and clinical quality measures. Commenters also

requested allowing adequate time for implementation after the pilot test before such measures are

considered for certification, and 24 months before requiring them for meaningful use. One

commenter stated that the Emergency Department Throughput, Stroke, and Venous

Thromboembolism have not yet been thoroughly tested for automated reporting and data element

capture. Additional commenters recommended that the measures selected for the eligible

hospitals incentive program should be comprehensively standardized and tested in the field to

ensure that they are thoroughly specified, clinically valid when the data are collected through the

eligible hospitals system, feasible to collect, and are regularly updated and maintained with a

well established process.

Response: We agree with the commenters that it is important to allow adequate time for

pilot testing and implementation before clinical quality measures should be considered for

certification, as well as requiring these measures for meaningful use. Emergency Department 1,

Emergency Department 2, and Stroke 3, clinical quality measures for eligible hospitals and

CAHs that are included in this final rule, were tested during the January 2010 Connectathon and

demonstrated at the HIMSS 2010 Interoperability Showcase. Additionally, as part of the process

of certification of EHR technology it is expected that certifying bodies will test the ability of

EHR technology to calculate the clinical quality measures finalized in this final rule.
CMS-0033-F 302

After consideration of the public comments received, eligible hospitals and CAHs will be

required to report on each of the 15 clinical quality measures, as shown in Table 10. Requiring

eligible hospitals and CAHs to report on each of the 15 clinical quality measures in the EHR

incentive program is consistent with the RHQDAPU program, which requires reporting on all

applicable quality measures. Eligible hospitals and CAHs will report numerators, denominators,

and exclusions, even if one or more values as displayed by their certified EHR is zero. We note

that to qualify as a meaningful EHR user, eligible hospitals and CAHs need only report the

required clinical quality measures; they need not satisfy a minimum value for any of the

numerator, denominator, or exclusions fields for clinical quality measures. The value for any or

all of those fields, as reported to CMS or the States, may be zero if these are the results as

displayed by the certified EHR technology. Thus, the clinical quality measure requirement for

2011 and beginning with 2012 is a reporting requirement and not a requirement to meet any

particular performance standard for the clinical quality measure, or to in all cases have patients

that fall within the denominator of the measure. Further, the criteria to qualify for the EHR

incentive payments are based on results automatically calculated by eligible hospitals or CAHs

certified EHR technology, as attested by the eligible hospital or CAH. As such, we believe that

the eligible hospitals or CAHs will be able to determine whether they have reported the required

clinical quality measures to CMS or the State, rendering it unnecessary that CMS or the State

provide the eligible hospital or CAH with a feedback report, which provides information to

eligible hospitals and CAHs as to whether they have reported their required clinical quality

measures. We expect successful receipt of Medicare eligible hospitals and CAHs’ information,

beginning the first year of Stage 1.

We are finalizing Table 10, which conveys the clinical quality measure's title, number,
 CMS-0033-F 303

owner/steward and contact information, and a link to existing electronic specifications.

TABLE 10: Clinical Quality Measures for Submission by Eligible Hospitals and CAHs for
Payment Year 2011-20125

Electronic Measure
Measure Number Specifications
Identifier Measure Title, Description & Measure Steward Information
Emergency Title: Emergency Department Throughput – admitted http://www.cms.gov/Q
Department (ED)-1 patients Median time from ED arrival to ED departure for ualityMeasures/03_El
admitted patients ectronicSpecifications.
NQF 0495 Description: Median time from emergency department asp#TopOfPage
arrival to time of departure from the emergency room for
patients admitted to the facility from the emergency
department
Measure Developer: CMS/Oklahoma Foundation for
Medical Quality (OFMQ)
ED-2 Title: Emergency Department Throughput – admitted http://www.cms.gov/Q
patients ualityMeasures/03_El
NQF 0497 Admission decision time to ED departure time for admitted ectronicSpecifications.
patients asp#TopOfPage
Description: Median time from admit decision time to time
of departure from the emergency department of emergency
department patients admitted to inpatient status
Measure Developer: CMS/OFMQ
Stroke-2 Title: Ischemic stroke – Discharge on anti-thrombotics http://www.cms.gov/Q
Description: Ischemic stroke patients prescribed antithromboticualityMeasures/03_El
NQF 0435 therapy at hospital discharge ectronicSpecifications.
Measure Developer: The Joint Commission asp#TopOfPage
Stroke-3 Title: Ischemic stroke – Anticoagulation for A-fib/flutter http://www.cms.gov/Q
Description: Ischemic stroke patients with atrial ualityMeasures/03_El
NQF 0436 fibrillation/flutter who are prescribed anticoagulation therapy ectronicSpecifications.
at hospital discharge. asp#TopOfPage
Measure Developer: The Joint Commission
Stroke-4 Title: Ischemic stroke – Thrombolytic therapy for patients http://www.cms.gov/Q
arriving within 2 hours of symptom onset ualityMeasures/03_El
NQF 0437 Description: Acute ischemic stroke patients who arrive at ectronicSpecifications.
this hospital within 2 hours of time last known well and for asp#TopOfPage
whom IV t-PA was initiated at this hospital within 3 hours of
time last known well.
Measure Developer: The Joint Commission

5*
In the event that new clinical quality measures are not adopted by 2013, the clinical quality measures in this Table
would continue to apply.
 CMS-0033-F 304

Electronic Measure
Measure Number Specifications
Identifier Measure Title, Description & Measure Steward Information
Stroke-5 Title: Ischemic or hemorrhagic stroke – Antithrombotic http://www.cms.gov/Q
therapy by day 2 ualityMeasures/03_El
NQF 0438 Description: Ischemic stroke patients administered ectronicSpecifications.
antithrombotic therapy by the end of hospital day 2. asp#TopOfPage
Measure Developer: The Joint Commission
Stroke-6 Title: Ischemic stroke – Discharge on statins http://www.cms.gov/Q
Description: Ischemic stroke patients with LDL ≥ 100 ualityMeasures/03_El
NQF 0439 mg/dL, or LDL not measured, or, who were on a lipid- ectronicSpecifications.
lowering medication prior to hospital arrival are prescribed asp#TopOfPage
statin medication at hospital discharge.
Measure Developer: The Joint Commission
Stroke-8 Title: Ischemic or hemorrhagic stroke – Stroke education http://www.cms.gov/Q
Description: Ischemic or hemorrhagic stroke patients or ualityMeasures/03_El
NQF 0440 their caregivers who were given educational materials during ectronicSpecifications.
the hospital stay addressing all of the following: activation of asp#TopOfPage
emergency medical system, need for follow-up after
discharge, medications prescribed at discharge, risk factors
for stroke, and warning signs and symptoms of stroke.
Measure Developer: The Joint Commission
Stroke-10 Title: Ischemic or hemorrhagic stroke – Rehabilitation http://www.cms.gov/Q
assessment ualityMeasures/03_El
NQF 0441 Description: Ischemic or hemorrhagic stroke patients who ectronicSpecifications.
were assessed for rehabilitation services. asp#TopOfPage
Measure Developer: The Joint Commission
Venous Title: VTE prophylaxis within 24 hours of arrival http://www.cms.gov/Q
Thromboembolism Description: This measure assesses the number of patients ualityMeasures/03_El
(VTE)-1 who received VTE prophylaxis or have documentation why ectronicSpecifications.
no VTE prophylaxis was given the day of or the day after asp#TopOfPage
NQF 0371 hospital admission or surgery end date for surgeries that start
the day of or the day after hospital admission.
Measure Developer: The Joint Commission
VTE-2 Title: Intensive Care Unit VTE prophylaxis http://www.cms.gov/Q
Description: This measure assesses the number of patients ualityMeasures/03_El
NQF 0372 who received VTE prophylaxis or have documentation why ectronicSpecifications.
no VTE prophylaxis was given the day of or the day after the asp#TopOfPage
initial admission (or transfer) to the Intensive Care Unit
(ICU) or surgery end date for surgeries that start the day of or
the day after ICU admission (or transfer).
Measure Developer: The Joint Commission
 CMS-0033-F 305

Electronic Measure
Measure Number Specifications
Identifier Measure Title, Description & Measure Steward Information
VTE-3 Title: Anticoagulation overlap therapy http://www.cms.gov/Q
Description: This measure assesses the number of patients ualityMeasures/03_El
NQF 0373 diagnosed with confirmed VTE who received an overlap of ectronicSpecifications.
parenteral (intravenous [IV] or subcutaneous [subcu]) asp#TopOfPage
anticoagulation and warfarin therapy. For patients who
received less than five days of overlap therapy, they must be
discharged on both medications. Overlap therapy must be
administered for at least five days with an international
normalized ratio (INR) ≥ 2 prior to discontinuation of the
parenteral anticoagulation therapy or the patient must be
discharged on both medications.
Measure Developer: The Joint Commission
VTE-4 Title: Platelet monitoring on unfractionated heparin http://www.cms.gov/Q
Description: This measure assesses the number of patients ualityMeasures/03_El
NQF 0374 diagnosed with confirmed VTE who received intravenous ectronicSpecifications.
(IV) UFH therapy dosages AND had their platelet counts asp#TopOfPage
monitored using defined parameters such as a nomogram or
protocol.
Measure Developer: The Joint Commission
VTE-5 Title: VTE discharge instructions http://www.cms.gov/Q
Description: This measure assesses the number of patients ualityMeasures/03_El
NQF 0375 diagnosed with confirmed VTE that are discharged to home, ectronicSpecifications.
to home with home health, home hospice or asp#TopOfPage
discharged/transferred to court/law enforcement on warfarin
with written discharge instructions that address all four
criteria: compliance issues, dietary advice, follow-up
monitoring, and information about the potential for adverse
drug reactions/interactions.
Measure Developer: The Joint Commission
VTE-6 Title: Incidence of potentially preventable VTE http://www.cms.gov/Q
Description: This measure assesses the number of patients ualityMeasures/03_El
NQF 0376 diagnosed with confirmed VTE during hospitalization (not ectronicSpecifications.
present on arrival) who did not receive VTE prophylaxis asp#TopOfPage
between hospital admission and the day before the VTE
diagnostic testing order date.
Measure Developer: The Joint Commission

We proposed that to satisfy the requirements of reporting on clinical quality measures

under sections 1886(n)(3)(A)(iii) and 1903(t)(6)(C) of the Act for the 2011 - 2012 payment year,

we would require eligible hospitals and CAHs to report on all EHR incentive clinical quality
CMS-0033-F 306

measures for which they have applicable cases, without regard to payer. We proposed that

Medicare eligible hospitals and CAHs, who are also participating in the Medicaid EHR incentive

program, will also be required to report on all Medicaid clinical quality measures for which the

eligible hospital has applicable cases. We also proposed that to demonstrate an eligible hospital

or CAH is a meaningful EHR user, the eligible hospital or CAH would be required to

electronically submit information on each clinical quality measures for each patient to whom the

clinical quality measure applies, regardless of payer, discharged from the hospital during the

EHR reporting period and for whom the clinical quality measure is applicable. Although as

proposed, we did not require clinical quality reporting electronically until 2012, we would begin

clinical quality reporting though attestation in the 2011 payment year. We solicited comment on

whether it may be more appropriate to defer some or all clinical quality reporting until the 2012

payment year. If reporting on some but not all measures in 2011 was feasible, we solicited

comment on which key measures should be chosen for 2011 and which should be deferred until

2012 and why.

Comment: We received numerous comments strongly opposed to requiring the reporting

of clinical quality measures by eligible hospitals prior to 2013, although some comments favored

the reporting in 2011 and 2012. Comments in favor pointed to the importance of quality

measurement to achieving improvement in healthcare quality. Those opposed to the reporting of

clinical quality measures in 2011 and 2012 cited concerns as to the readiness of EHR technology

for automated calculation and reporting of clinical quality measures as well as financial and

administrative burden. Many commenters stated that measures should be fully automated and

tested prior to implementation, and recommended the process for Emergency Department

Throughput, Stroke, and Venous Thromboembolism measures where CMS developed the
CMS-0033-F 307

specifications and has in place a plan to test the submission of such measures for RHQDAPU.

Commenters stated their expectation that the testing process would reveal important insights as

to potential challenges of electronic submission. Numerous commenters opposed measures

already in RHQDAPU and not able to be calculated by the EHR technology. Many commenters

stated that electronic data submission should be developed through the RHQDAPU program

rather than have a separate quality measure reporting program, such as the EHR incentive

program. Further, commenters stated that RHQDAPU should provide the foundation for

migration to electronic reporting. Numerous commenters were opposed to having a temporary

data collection and reporting process through attestation that would need to be updated or

replaced once CMS has the appropriate infrastructure in place. Many commenters stated that

requiring hospitals to report summary data through attestation, without the ability for CMS to

receive the summary data electronically, creates a dual reporting burden for measures currently

in RHQDAPU. Many commenters stated concerns as to the timing of the certification process

for EHRs since having a certified EHR is an essential element for quality incentives. Numerous

commenters pointed out that only 15 of the proposed measures have electronic specifications

currently available.

Response: We are sensitive to and appreciate the many comments urging us not to require

the submission of clinical quality measures, through attestation or electronic submission, prior to

2013, based on lack of readiness of many of the proposed measures, fully automating and testing

prior to implementation, burden, and the potential duplication of quality measures reporting

requirements under the RHQDAPU and the EHR incentive payment programs. Having carefully

considered these comments, we have sought to address them while still retaining the important

goal of beginning the process of using the capacity of EHRs to promote improved quality of care
CMS-0033-F 308

in hospitals by providing calculated results of clinical quality measures. In terms of readiness,

we are limiting the clinical quality measures to those measures having existing electronic

specifications as of the date of display of this final rule. Additionally, as recommended by

commenters, we will only require hospitals to submit that information that can be automatically

calculated by their certified EHR technology. Thus we will require no separate data collection

by the hospital, but require submission solely of that information that can be generated

automatically by the certified EHR technology; that is, we only adopt those clinical quality

measures where the certified EHR technology can calculate the results. Further, we are not

adopting any measures which are already being collected and submitted in the RHQDAPU

program. Therefore, we are imposing no duplicate reporting requirement on hospitals who

participate in RHQDAPU. Through future rulemaking we will seek to align the EHR incentive

program with RHQDAPU.

Comment: Some commenters stated that CMS contradicts itself, where the proposed rule

states that Medicare eligible hospitals who are also participating in Medicaid EHR incentive

program will need to report on all of the Medicaid clinical quality measures and where it says

that Table 21 is an alternative set of clinical quality measures if the hospital does not have any

patients in the denominators of the measures in Table 20. Many commenters requested

clarification of the Medicare and Medicaid reporting.

Response: We agree that the description of the eligible hospital and CAH reporting

requirements was unclear. To clarify, our proposal was that if a hospital could submit

information on clinical quality measures sufficient to meet the requirements for Medicare that

would also be sufficient for Medicaid. However, hospitals for which the Medicare measures did

not reflect their patient populations could satisfy the Medicaid requirements by reporting the
CMS-0033-F 309

alternate Medicaid clinical quality measures. Reporting the alternate Medicaid measures would

only qualify for the Medicaid program and would not qualify eligible hospitals as to the

Medicare incentive program. In this final rule, this clarification is moot, however, because we

removed the alternate Medicaid list of clinical quality measures listed in Table 21 (see

75 FR 1896 through 1900) of the proposed rule for eligible hospitals. This was based on the lack

of electronic specifications for these measures available at the time of display of this final rule.

Hospitals that report information on all 15 of the clinical quality measures, as applicable to their

patient population, will qualify for both the Medicare and the Medicaid submission requirements

for clinical quality measures. We recognize that many of the measures in the Medicare list

would likely not apply to certain hospitals, such as children’s hospitals. However, an eligible

hospital would meet the clinical quality measure requirement by reporting values for the 15

clinical quality measures, including, values of zero for the denominator, if accurate. Some value

is required for each of the 15 clinical quality measures for eligible hospitals and CAHs.

Therefore, for example, a children’s hospital would enter zero for the denominator for any of the

15 measures for which they do not have any patients as described in the measure.

After consideration of public comments received, we are finalizing 15 clinical quality

measures that eligible hospitals and CAHs will be required to report for Stage 1 (2011 and

beginning 2012), as applicable to their patient population. Those 15 clinical quality measures for

eligible hospitals and CAHs can be found in Table 10 of this final rule.

g. Potential Measures for EPs, Eligible Hospitals, and CAHs in Stage 2 and Subsequent Years

We stated our expectation that the number of clinical quality measures for which EPs,

eligible hospitals, and CAHs would be able to electronically submit information would rapidly

expand in 2013 and beyond.

CMS-0033-F 310

We plan to consider measures from the 2010 PQRI program. These clinical quality

measures can be found at

http://www.cms.hhs.gov/PQRI/05_StatuteRegulationsProgramInstructions.asp

For future considerations of clinical quality measures for Stage 2 of meaningful use and beyond

for eligible hospitals and CAHs, we also plan to consider other clinical quality measures from the

RHQDAPU program which are identified in the FY 2010 IPPS final rule (75 FR 43868-43882).

We invited comments on inclusion of clinical quality measures for the 2013 and beyond for the

HITECH Act Medicare and Medicaid incentive program. We note that as with the other

meaningful use objectives and measures, in the event that we have not promulgated clinical

quality measures for the 2013 payment year, the measures for Stage 1 (beginning in 2011) would

continue in effect.

For the Stage 2 of meaningful use, we indicated in the proposed rule that we are

considering expanding the Medicaid EHR incentive program’s clinical quality measure set for

EPs and eligible hospitals to include clinical quality measures that address the following clinical

areas, to address quality of care for additional patient populations, and facilitate alignment with

Medicaid and CHIP programs:

• Additional pediatrics measures (such as completed growth charts, electronic

prescriptions with weight-based dosing support and documentation of newborn screening).

• Long-term care measures.

• Additional obstetrics measures.

• Dental care/oral health measures.

• Additional behavioral/mental health and substance abuse measures.

CMS-0033-F 311

The above list does not constitute a comprehensive list of all clinical quality measures that may

be considered. We stated that specific measures for Stage 2 of meaningful use and beyond may

be addressed by CMS in future notice and comment rulemaking. To assist us in identifying

potential clinical quality measures for future consideration for Stage 2 of meaningful use and

beyond, we solicited comments on the potential topics and/or clinical quality measures listed

above as well as suggestions for additional clinical quality measure topics and/or specific clinical

quality measures.

The following is a summary of comments received regarding the request for public

comment on potential measures for EPs, eligible hospitals, and CAHs for Stage 2 of meaningful

use and subsequent stages, and our responses.

Comment: A commenter suggested using newly adopted NQF Level 3 measures that

incorporate common electronic administrative and clinical data that represent a better measure of

the patient’s condition. A commenter suggested adding long term care and post acute care

measures in the next stage of meaningful use. A few commenters suggested future clinical

quality measures be coordinated with Healthy People 2020. Another comment regarding

measures included a request for medication measures that evaluate provider intervention. Other

commenters indicated CMS should provide a more structured process for the adoption of clinical

quality measures such that specialty EPs would have greater input into and ownership of the

process. A commenter requested consideration that future clinical quality measures address both

quality and resource use efficiency (for example potentially preventable Emergency Department

visits and hospitalizations and inappropriate use of imaging MRI for acute low back pain). A

commenter requested future clinical quality measures for the following areas: reduce hospital

readmissions and to improve medication management, specifically safe and efficient

CMS-0033-F 312

management of heart disease, diabetes, asthma, mental health conditions and hospital

procedures. A commenter requested clinical quality measures that will aid in increasing

improved patient safety and reduce disparities. A commenter also recommended developing

new clinical quality outcomes measures to address overuse and efficiency, care coordination, and

patient safety. Some commenters requested the inclusion of HIV testing and reporting for

preventive service quality measures. Some commenters stated that this would help to facilitate

continued efforts to promote and implement the 2006 CDC Revised Recommendation on HIV

testing, especially to non-HIV medical specialties. Some commenters recommended measure

development in the areas of community mental health, home health, renal dialysis centers, long

term care, post acute care, and nursing homes. A commenter recommended including 3 month

treatment of pulmonary emboli (NQF 0593) and deep vein thrombosis (NQF 0434) for the next

stage of meaningful use and beyond. A commenter requested including health disparity data in

all clinical quality measure analyses. Some commenters also recommended future clinical

quality measure development in the following areas: diabetes, heart disease, asthma, disease

screening, chronic disease management, patient safety, nursing sensitive measures, atrial

fibrillation, and ethnic disparities. Commenters requested expanding pediatric measures to

provide expanded focus on childhood diseases that require hospitalization such as asthma,

developmental issues and weight-based medication dosage safety issues. Additional commenters

requested measures for blood test for lead levels for children up to 1 year of age and between 1

and 2 years of age, co-morbid conditions and dental utilization. A commenter recommended that

only one EP should be accountable for the quality intervention and clinical quality measure such

as NQF 0323 Title: End Stage Renal Disease (ESRD): Plan of Care for Inadequate

Hemodialysis in ESRD Patient. The commenter indicated that this type of measure could
CMS-0033-F 313

involve more than one provider, for example, nephrologist and a dialysis facility. Because

provider clinical practices may vary, practice variations may independently influence patient

outcomes. Some commenters suggested future development of measures foster greater use of the

clinical information available in EHRs to improve clinical processes and evaluate patient

outcomes and suggested use of outcomes measures instead of process measures. Furthermore,

commenters support the inclusion of outcomes measures rather than process measures and

composite versus individual measures. Several commenters indicated support for the preventive

care measures included in the proposed rule and suggested expanding the set of preventive care

measures to include HIV and STD screening and eye care specialty measures. A commenter

requested CMS provide information about their strategic plan for future Medicare clinical quality

measurement selection, how they will improve care delivery, proposed stages of reporting, goals

and metrics.

Response: We are appreciative of the many suggestions and acknowledge the breadth of

interest in certified EHR technology being the vehicle for clinical quality measures reporting.

We expect to consider these suggestions for future measure selection in the Medicare and

Medicaid EHR incentive payment programs.

Comment: We received various comments pertaining to future clinical quality measures

applicable principally to the Medicaid population. One commenter urged CMS to include

clinical quality measures specific to newborn screening in Stage 1 of meaningful use for

pediatric providers.

Response: We agree that newborn screening, both as a clinical quality measure, and from

a data standards perspective, is a prime candidate for inclusion in the Stage 2 definition of

meaningful use. We affirm our proposed statement about our commitment to work with the
CMS-0033-F 314

measure development community to fill noted gaps. We are appreciative of the many

suggestions. We expect to consider these suggestions for immunizations, prenatal screening,

infectious disease, etc. in measure selection in future rulemaking.

Comment: A commenter indicated CMS should make explicit the health goals and

targets for the HITECH Act investments that are already implied by the proposed clinical

measures. Making them explicit allows CMS to set national targets.

Response: In general, the goal with respect to clinical quality measures is to improve

healthcare quality as measured by the clinical quality measures. We believe that specific

quantitative targets are impractical at this stage given lack of established base level notes and no

prior clinical quality measure reporting via certified EHR technology.

Comment: Several commenters asked how CMS plans to develop further measure

specifications for clinical quality measures. Another commenter asked for an electronic source

for ICD-9 and CPT codes defining the specific conditions or diagnoses or treatments in order to

maintain an up-to-date capability.

Response: For many clinical quality measures, clearly defined electronic specifications

are not yet available. In general, CMS relies on the measures’ stewards to both develop

measures and to provide the specifications. Nevertheless, we recognize that many existing

measures, some of which are owned and maintained by us or its contractors, do not currently

have electronic specifications. We are aware of work currently taking place to fill this gap. We

expect to actively work in a collaborative way with measures developers and stewards to help

assure the development of electronic specifications for clinical quality measures, but we also

expect to engage a contractor to perform work developing electronic specifications which may or

may not involve measure developers and stewards. As for CPT codes, these are copyrighted by
CMS-0033-F 315

and are available from the American Medical Association. The National Center for Health

Statistics (NCHS) and CMS are the U.S. governmental agencies responsible for overseeing all

changes and modifications to the ICD-9 codes.

Comment: Some commenters suggested specific new clinical quality measures which are

listed below in Table 11. Several commenters suggested new or revised clinical quality

measures or the use of existing measures from other programs.

Table 11: EP Proposed New Clinical Quality Measures

Clinical Quality Measure Title and/or

Measure Number Description
PQRI 27 Diabetes Mellitus: Diabetic foot and ankle care,
ulcer prevention evaluation of footwear;
preventive care and screening
PQRI 30 Timely administration of prophylactic parenteral
antibiotics
PQRI 76 Prevention of catheter related bloodstream
infections CBSI
PQRI 124 HIT: Adoption/use of medical records
PQRI 126 Diabetes Mellitus: Diabetic foot and ankle care,
peripheral neuropathy neurological evaluation
PQRI 128 BMI Screening and follow-up
PQRI 130 Documentation and Verification of Current
Medications in the Medical Record
PQRI 131 Pain Assessment Prior to Initiation of Patient
Treatment
PQRI 148 Back Pain: Initial Visit
PQRI 149 Back Pain: Physical Exam
PQRI 150 Back Pain: Advice for Normal Activities
PQRI 151 Back Pain: Advice Against Bed Rest
PQRI 154 Falls: Plan of care
PQRI 155 Falls: Risk Assessment
PQRI 159 HIV/AIDS: CD4 + Cell Count or CD4 +
Percentage
PQRI 160 HIV/AIDS: Pneumocystis jirovecii Pneumonia
Prophylaxis
PQRI 161 HIV/AIDS: Adolescent and Adult Patients with
HIV/AUDS who are Prescribed Potent
Antiretroviral Therapy
PQRI 162 HIV/AIDS: HIV RNA Control After 6 Months of
Potent Antiretroviral Therapy
CMS-0033-F 316

Clinical Quality Measure Title and/or

Measure Number Description
PQRI 193 Perioperative temperature management
PQRI 205 HIV/AIDS: STDs, Chlamydia and Gonorrhea
Screenings
PQRI 206 HIV/AIDS: Screening for High Risk Sexual
Behaviors
PQRI 207 HIV/AIDS: Screening for Injection Drug Use
PQRI 208 HIV/AIDS: STDs Syphilis Screening
NQF 0021 Therapeutic Monitoring: Annual monitoring for
patients on persistent medications
NQF 0039 Flu Shots for Adults Ages 50-64
NQF 0058 Inappropriate antibiotic treatment for adults with
acute bronchitis
NQF 0071 Acute Myocardial Infarction: Persistence of Beta-
Blocker Treatment After a Heart Attack
NQF 0082 Heart Failure: Patient Education
NQF 0111 Bipolar Disorder: Appraisal for risk of suicide
NQF 0116 CABG: Anti-Platelet Medication at Discharge
NQF 0117 CABG: Beta Blockage at Discharge
NQF 0118 CABG: Anti-Lipid Treatment at Discharge
NQF 0278 Low Birth Weight
NQF 0477 Rate of Very Low Birth Weight Deliveries
NQF 0309 LBP: Appropriate Use of Epidural Steroid
Injections
NQF 0602 Migraine: Adults with frequent use of acute
medications that also received prophylactic
medications
NQF 0613 MI: Use of beta blocker therapy
NQF 0632 Primary prevention of cardiovascular events in
diabetics (older than 40 yrs): Use of Aspirin or
Antiplatelet Therapy
NQF EC-20-08 Warfarin – INR Monitoring
NQF EC-203-08 Hyperlipidemia (Primary Prevention) – Lifestyle
changes and/or lipid lowering therapy
NQF EC-227-08 High Risk for Pneumococcal Disease –
Pneumococcal vaccination.
NQF EC-231-08 Diabetes with LDL greater than 100 – Use of
lipid lowering agent
NQF EC-232-08 Diabetes with Hypertension or Proteinuria – Use
of an ACE Inhibitor or ARB.
NQF EC-238-08 Non-diabetic Nephropathy
NQF EC-252-08 Chronic Kidney Disease with LDL greater than
130
CMS-0033-F 317

Clinical Quality Measure Title and/or

Measure Number Description
NQF EC-256-08 Male Smokers or Family History of AAA
Screening for AAA
NQF EC-262-08 Diabetes and elevated HbA1c – Use of diabetes
medications
NQF EC-272-08 Secondary Prevention of Cardiovascular Events –
Use of Aspirin or anti-platelet therapy
NQF EC-274-08 Primary prevention of cardiovascular events in
diabetics older than 40 yrs – Use of aspirin or anti
platelet therapy
NQF EC-281-08 Osteopenia and Chronic Steroid Use – Treatment
to prevent Osteoporosis
NQF EC-285-08 Chronic Liver Disease – Hepatitis A vaccination
NQF EC-288-08 Atherosclerotic Disease and LDL greater than
100-use of a Lipid Lowering Agent
N/A Family Planning - Percent of sexually active
clients at risk for unintended pregnancy –
screened at least once annually for use of
contraceptive method at last intercourse.
N/A Percent of patients for which EP retrieves and acts
on prescription refill data obtained through the e-
Rx system
N/A Percent of patients for which a generic drug has
been prescribed
N/A Provider follow-up on growth chart information
where clinically indicated
N/A Inappropriate Use of Antibiotics in Bronchitis
N/A Chronic Disease Self Management Goal: Percent
of Asthmatics, Diabetics, Diagnosed
Hypertension, or Other CVD-Related Illness with
a Self-Management Goal/Readiness Plan ( 4
possible measures)
N/A Good glycemic control: A1C < 7
N/A Elective Preterm Induction Rate
N/A Diabetes Mellitus A1C Frequency: Percent of
patients with Diabetes Mellitus with two A1C
measures in most recent 12 month period
N/A Pediatric Type I Diabetes Mellitus Diabetic
Retinopathy
NA Performing a complete lipid panel to assess CVD
risk
N/A Adolescent Preventive Care
N/A Child Preventive Care
CMS-0033-F 318

Clinical Quality Measure Title and/or

Measure Number Description
N/A Preventive Screening Lipid Disorders: Percent of
male patients over age 35 who have been
screened for lipid disorders, percent of females
over age 45 screened if they have risk factors for
CAD
N/A Preventive Care & Screening: Screening for
Diabetes

N/A Cervical Cancer Prevention: Percent of female

patients age 9-26 yrs who received three doses of
HPV vaccine
N/A Asthma Action Plan: Percent of asthma patients
with a documented asthma action plan that has
been developed or updated within the past 6
months.
N/A Asthma Assessment of Percent of asthma patients
who have a documented level of control at last
asthma visit
N/A Asthma Assessment/Spirometry -Percent of
asthma patients ages 5 and older who received
spirometry in the past 12 months.
N/A Asthma Assessment of Severity: Percent of
Patients who have a Documented Level of
Asthma Severity for the Last Asthma Visit

Response: Many of the proposed clinical quality measures are in the existing PQRI

program or are NQF endorsed. Others are not. We are appreciative of these many specific

suggestions and will retain the comments for future consideration. Prior to including measures

in the Medicare EHR incentive payment program, as required by the HITECH Act, we will

publish the measures in the Federal Register and provide an opportunity for public comment.

We will examine all options for soliciting public comment on future Medicaid-specific clinical

quality measures, as the Federal Register notice requirement does not apply to the Medicaid

EHR incentive program.

Comment: Some commenters suggested the following new topics for clinical quality
CMS-0033-F 319

measure development for our program:

Table 12: EP Proposed New Topics

Measure Number Proposed Clinical Quality Measure Topics

N/A Measures dealing with overuse e.g, antibiotics and epidural
injections and unwarranted procedures-spine surgery, PTCA,
hysterectomy, CT, polypharmacy
N/A History regarding new or changing moles
N/A Counseling on monthly skin self exam
N/A Melanoma patients entered into recall system
N/A Newborn Screening
N/A Preventing Eye Disease
N/A Epilepsy
N/A Health Disparities
N/A Long Term Care
N/A Mental Health
N/A Substance Abuse
N/A School Health Services for Children
N/A Newborn Hearing and Bloodspot Screening
N/A Children at Risk for Developmental Disabilities
N/A Children with Chronic Disabling Conditions
N/A Child Health-Related Quality of Life
N/A Child Specific Health Outcomes
N/A Lead Poisoning Screening for Children
N/A Hepatitis A (childhood immunization)
N/A Hepatitis B and hepatitis immune globulin (for newborns of
mothers with chronic hepatitis)
N/A Functional Status
N/A Use of epidural injections
N/A Healthy Weight/Reduction in Obesity
N/A Population-level lipid test results
N/A Population-level Blood pressure results
N/A Population-level Aspirin therapy
N/A Pharmacologic Prescription for Tobacco Cessation
N/A Alcohol/Drug Misuse
Family History for Chronic Diseases
CMS-0033-F 320

Measure Number Proposed Clinical Quality Measure Topics

N/A Sexually activity status (13+) to trigger screening for STDs
N/A Screening pregnant women for STDs
N/A Screening for infectious disease risk factors
N/A Vaccine Reminders
N/A STD HIV Screening
N/A Central Line Placement-Related Pneumothorax for Pediatric
Population
N/A Acute Otitis Externa-Topical Therapy, Pain assessment, and
systemic antimicrobial therapy
N/A Otitis media with effusion (OME)- diagnostic evaluation of
tympanic membrane mobility
N/A NQF Care Coordination Measures
N/A Additional new pediatric measures
N/A Radiation dose
N/A Dental measures/Oral Health
N/A HRSA Clinical Measures for Health Center Grantee
Performance Reviews
N/A Patient centered quality measures

N/A Outcomes Measures

N/A Outpatient Measure core set (NQA/AQA/HQA)
N/A Nutrition-related measures
N/A Efficiency Measures
N/A Patient Engagement Measures
N/A Decision Support Measures
N/A New Radiation Oncology measures
N/A Tobacco Use Assessment
N/A Tobacco Use Treatment
N/A Tobacco Use Treatment at Discharge
N/A Tobacco Use Follow-up
N/A Preventive Screening: Tobacco Use
N/A Preventive Screening: Falls in Older Adults
N/A Preventive Counseling: Breastfeeding
N/A Preventive Counseling: Use of Folic Acid
N/A HRSA/BPHC Measures
75, 610, 120, 355, 560, CDS alert responses
79,
684, 132, 566, 356
N/A Population health measures
N/A Identifying patients with paroxysmal atrial fibrillation
N/A Group practice measures
N/A Genetic Measures
N/A Ear, nose, throat measures
N/A Home health
CMS-0033-F 321

Measure Number Proposed Clinical Quality Measure Topics

N/A ESRD Center measures
N/A Adherence related measures by therapeutic class
N/A Medication dosing for certain disease states such as diabetes
N/A Suboptimal treatment regimens for chronic disease such as
diabetes and asthma
N/A Absence of control therapy in persistent asthma patients
N/A HEDIS high risk medication use in the elderly measures
N/A TB Screening
N/A Patient self report satisfaction
N/A Prescribing and monitoring of psychotropic medications for
children and adolescents with psychiatric illness
N/A Measure for treatment of ADD and other mood disorders
N/A Measure immunizations for adolescents including TDaP,
HPV, and meningococcal.
N/A Hepatitis B/immune globulin to newborns to mothers who
have chronic hepatitis B infection as recommended by CDC
N/A Underutilization of medication measures
N/A Improve active engagement of patients in their care
N/A Improved care coordination and reduce gaps in care

Response: We appreciate the suggested measure topics submitted by commenters for

potential new clinical quality measures. Any future clinical quality measures developed will be

in consideration of the clinical practices particular to EPs and eligible hospitals. We have

captured these recommendations and will have them available for consideration in future years.

h. Reporting Method for Clinical Quality Measures for 2011 and Beginning with the 2012

Payment Year

(1) Reporting Method for 2011 Payment Year

As we previously discussed, we proposed to use attestation as a means for EPs, eligible

hospitals and CAHs, for purposes of the Medicare incentive program, to demonstrate the

meaningful use requirement for the calculation and submission of clinical quality measure results

to CMS.
CMS-0033-F 322

Specifically, for 2011, we proposed to require that Medicare EPs and hospitals attest to

the use of certified EHR technology to capture the data elements and calculate the results for the

applicable clinical quality measures. State Medicaid HIT Plans submitted to CMS will address

how States will verify use of certified EHR technology to capture and calculate clinical quality

measures by Medicaid EPs and eligible hospitals.

Further, we proposed to require that Medicare EPs, eligible hospitals, and CAHs attest to

the accuracy and completeness of the numerators, denominators, and exclusions submitted for

each of the applicable measures, and report the results to CMS for all applicable patients. We

expect that States will follow a similar strategy as Medicare for the Medicaid EHR incentive

program.

We proposed that attestation will utilize the same system for other attestation for

meaningful use objectives, and proposed we would require for Medicare EPs that they attest to

the following:

• The information submitted with respect to clinical quality measures was generated as

output of an identified certified EHR technology.

• The information submitted is accurate to the best of the knowledge and belief of the

EP.

• The information submitted includes information on all patients to whom the clinical

quality measure applies.

• The NPI and TIN of the EP submitting the information, and the specialty group of

clinical quality measures that are being submitted.

• For an EP who is exempt from reporting each of the core measures, an attestation that

one or more of the core measures do not apply to the scope of practice of the EP.
CMS-0033-F 323

• For an EP who is exempt from reporting on a specialty group, an attestation that none

of the specialty groups applies to the scope of practice of the EP.

• For an EP who does report on a specialty group, but is exempt from reporting on each

of the clinical quality measures in the group, an attestation that the clinical quality measures not

reported do not apply to any patients treated by the EP.

• The numerators, denominators, and exclusions for each clinical quality measure result

reported, providing separate information for each clinical quality measure including the

numerators, denominators, and exclusions for all patients irrespective of third party payer or lack

thereof; for Medicare FFS patients; for Medicare Advantage patients; and for Medicaid patients.

• The beginning and end dates for which the numerators, denominators, and exclusions

apply.

Again, State Medicaid Agencies will determine the required elements for provider attestations

for clinical quality measure reporting, subject to CMS prior approval via the State Medicaid HIT

Plan.

For eligible hospitals, we proposed to require that they attest to the following:

• The information submitted with respect to clinical quality measures was generated as

output from an identified certified EHR technology.

• The information submitted to the knowledge and belief of the official submitting on

behalf of the eligible hospital.

• The information submitted includes information on all patients to whom the measure

applies.

• The identifying information for the eligible hospital.

CMS-0033-F 324

• For eligible hospitals that do not report one or more measures an attestation that the

clinical quality measures not reported do not apply to any patients treated by the eligible hospital

during the reporting period.

• The numerators, denominators, and exclusions for each clinical quality measure result

reported, providing separate information for each clinical quality measure including the

numerators, denominators, and exclusions for all patients irrespective of third party payer or lack

thereof; for Medicare FFS patients; for Medicare Advantage patients; and for Medicaid patients.

• The beginning and end dates for which the numerators, denominators, and exclusions

apply.

The following is a summary of comments received regarding the proposed reporting

method for clinical quality measures for the 2011 payment year, and our responses.

Comment: The majority of commenters were against requiring attestation for 2011,

rather than suggesting modification of the specific attestation requirements. Others commented

that reporting should not be delayed to realize quality improvements and better health outcomes

for patients as soon as possible. Many commenters suggested deferral of clinical quality

measures submission until CMS can electronically accept data. Commenters indicated that this is

consistent with allowing delayed reporting by Medicaid providers until 2012 or beyond. A

number of commenters suggested that attestation should be confined to attesting that the EP’s

had reviewed or selected relevant clinical quality measures.

Response: While we received many comments to delay attestation past 2011, we are

finalizing our proposed requirement for EPs and eligible hospitals to attest to the numerators,

denominators, and exclusions in their first payment year for the required clinical quality

measures as described in section II.A.3.d through f of this final rule. Medicaid providers do not
CMS-0033-F 325

have “delayed reporting of clinical quality measures.” The statute and this final rule allow

Medicaid providers the option of receiving the EHR Incentive Payment for having adopted,

implemented or upgraded to certified EHR technology, in lieu of meeting the meaningful use bar

in their first participation year. We expect that most Medicaid providers would choose to adopt,

implement or upgrade to certified EHR technology, rather than demonstrating they are

meaningful EHR users in their first participation year.

Comment: Some commenters also suggested EPs should only have to attest that the EP

is entering the required data elements for clinical quality measure reporting where those fields

exist in the certified EHR technology and provide feedback to the vendor where structured data

fields are not available. Other commenters indicated the burden of adding numerous new data

elements is high and labor intensive.

Response: We considered the suggestion of only requiring attestation of documentation

of clinical encounters. While we agree that this could be considered “information on clinical

quality measures,” however, we do not believe that such information is needed when including

the submission of information on clinical quality measures, which is a required element of

meaningful use. We also believe that submission of such information would be of limited value.

We believe that by limiting the clinical quality measure submission requirement to those results

calculated by certified EHR technology, we have limited the potential burden.

After consideration of the public comments received, we are requiring EPs, eligible

hospitals, and CAHs to attest to the numerator, denominator, and exclusions for the payment

year 2011 at §495.8. We are finalizing the following requirements for EPs in this final rule for

reporting clinical quality measures:

CMS-0033-F 326

• The information submitted with respect to clinical quality measures was generated as

output of an identified certified electronic health record.

• The information submitted is accurate to the best of the knowledge and belief of the

EP.

• The information submitted includes information on all patients to whom the clinical

quality measure applies for all patients included in the certified EHR technology.

• The NPI and TIN of the EP submitting the information at §495.10.

• The numerators, denominators, and exclusions for each clinical quality measure result

reported, providing separate information for each clinical quality measure including the

numerators, denominators, and exclusions for all applicable patients contained in the certified

EHR technology irrespective of third party payer or lack thereof.

• The beginning and end dates for which the numerators, denominators, and exclusions

apply (the Medicare EHR reporting period in payment year 1 is 90 days as stated at §495.4, and

for payment year 2 is the beginning and end date of the reporting period as stated at §495.4. For

Medicaid providers, as there is no EHR reporting period for adopting, implementing or

upgrading for their first payment year, it is in their second payment year/first year of

demonstrating meaningful use that they have a 90-day EHR reporting period. Therefore, it is

their 2nd year of demonstrating meaningful use that has a 12 months EHR reporting period.

For eligible hospitals and CAHs, we are finalizing the following requirements in this final rule:

• The information submitted with respect to clinical quality measures was generated as

output from an identified certified EHR technology.

• The information submitted is accurate to the best of the knowledge and belief of the

official submitting on behalf of the eligible hospital or CAHs.

CMS-0033-F 327

• The information submitted includes information on all patients to whom the measure

applies for all patients included in the certified EHR technology.

• The identifying information for the eligible hospital and CAH at §495.10.

• The numerators, denominators, and exclusions for each clinical quality measure result

reported, providing separate information for each clinical quality measure including the

numerators, denominators, and exclusions for all applicable patients contained in the certified

EHR technology irrespective of third party payer or lack thereof.

• The beginning and end dates for which the numerators, denominators, and exclusions

apply (the Medicare EHR reporting period in payment year 1 is 90 days as stated at §495.4, and

for payment year 2 is the beginning and end date of the reporting period as stated at §495.4. For

Medicaid providers, as there is no EHR reporting period for adopting, implementing or

upgrading for their first payment year, it is in their second payment year/first year of

demonstrating meaningful use that they have a 90-day EHR reporting period. Therefore, it is

their 2nd year of demonstrating meaningful use that has a 12 month EHR reporting period.

States must implement the same meaningful use requirements, including clinical quality

measures, with the exceptions described in section II.A. of this final rule. Therefore, Medicaid

EPs and eligible hospitals must submit the same required information described above for

clinical quality measures. States will propose in their State Medicaid HIT Plans how they will

accept provider attestations in the first year they implement their Medicaid EHR incentive

program, and how they will accept electronic reporting of clinical quality measures from

providers’ certified EHR technology in their second and subsequent implementation years.

(2) Reporting Method Beginning In 2012

CMS-0033-F 328

In our proposed rule, we proposed that for the 2012 payment year, the reporting method

for clinical quality measures would be the electronic submission to CMS of summary

information, (that is, information that is not personally identifiable) on the clinical quality

measures selected by the Secretary using certified EHR technology. For Medicaid, we proposed

that EPs and hospitals eligible only for the Medicaid EHR incentive program must report their

clinical quality measures data to States. We proposed that States would propose to CMS how

they plan to accept and validate Medicaid providers' clinical quality measures data in their State

Medicaid HIT Plans, subject to CMS review and approval.

As we did for payment year 2011, for 2012, we also proposed reporting on all cases to

which a clinical quality measures applies in order to accurately assess the quality of care

rendered by the particular EP, eligible hospital, or CAH generally. Otherwise it would only be

possible to evaluate the care being rendered for a portion of patients and lessen the ability to

improve quality generally. We solicited comments on the impact of requiring the submission of

clinical quality measures data on all patients, not just Medicare and Medicaid beneficiaries.

The following is a summary of comments received regarding the proposed reporting

method beginning in 2012 in regard to the collection of aggregate level data on all patients.

Comment: Several commenters noted that it appears that EPs are supposed to submit

clinical quality measures electronically to the States in 2012. The commenters noted that several

States have aging Medicaid Management Information Systems that may not be capable of

accepting this data/information. The commenters requested clarification about whether CMS

expects the States to utilize and report this data immediately.

Response: To clarify, States may propose to CMS in their State Medicaid HIT Plans (See

Section 495.332) the means by which they want to receive providers’ clinical quality measures,
CMS-0033-F 329

starting with States’ second implementation year of their Medicaid EHR incentive program.

States are not obliged to receive this data using their MMIS but can consider other options such

as but not limited to: an external data warehouse, registries or health information exchanges that

include data repositories.

Comment: A commenter asked that we state the authority which provides us the ability

to require EPs and hospitals to report on non-Medicare and Medicaid patients.

Response: Sections 1848(o)(A)(2)(iii) and 1886(n)(3)(A)(iii) of the Act broadly state

that as a condition of demonstrating meaningful use of certified EHR technology, an EP, CAH or

eligible hospital must “submit information” for the EHR reporting period on the clinical quality

or other measures selected by the Secretary “in a form and manner specified by the Secretary.”

Likewise, section 1903(t)(6) of the Act states that demonstrating meaningful use may include

clinical quality reporting to the States, and may be based upon the methodologies that are used in

sections 1848(o) and 1886(n). This language does not limit us to collecting only that information

pertaining to Medicare and Medicaid beneficiaries. Therefore, we believe that we have the

authority to collect summarized clinical quality measures selected by the Secretary, with respect

to all patients to whom the clinical quality measure applies, treated by the EP, eligible hospital,

or CAH. We believe that the quality of care of our EP, eligible hospitals, and CAHs, as well as

the ability to demonstrate the meaningful use of certified EHR technology, is best reflected by

the care rendered to all patients, not just Medicare or Medicaid beneficiaries.

Comment: Some commenters recommended patient level data for clinical quality

measure reporting while others supported CMS’ requirement to submit summary level data for

EPs and hospitals. There were several commenters that indicated support for reporting clinical

quality measure data on all patients rather than just on Medicare and Medicaid patients. Another
CMS-0033-F 330

commenter stated that CMS should not require hospitals to submit patient level data and that the

data should be at the aggregated level for all payment years. Another commenter stated that it is

well proven in other disciplines that aggregated clinical data on quality measures can drive

improvements in outcomes. Another commenter recommended patient level data that would be

useful to State health programs and link information to managed care organizations.

Response: We agree with the commenters that stated that reporting clinical quality

measure data for all patients provides a more comprehensive measure of quality. We

acknowledge that there are potential advantages to patient level data in measuring quality such as

those stated by the commenter. However, for Stage 1 we have elected to require aggregate level

data since the EHR standards as adopted by ONC’s final rule (found elsewhere in this issue of

the Federal Register) do not provide standards for the submission of patient level data.

Comment: The commenter requested that CMS should have a process in place to support

end-users with on-going help desk support.

Response: We agree with the suggestion for the implementation of a help desk to

respond to questions related to the various CMS related questions after implementation of the

proposed rule. Information about how we will provide assistance to providers will occur outside

this final rule.

Comment: A few commenters asked for clarification regarding the Stage 1 audit process

to ensure accuracy for the reporting of clinical quality measures (for example, numerator,

denominator, and exception data).

Response: EPs, eligible hospitals, and CAHs are required for 2011 to attest to results as

automatically calculated by certified EHR technology. Beginning with 2012, such information

will be submitted electronically with respect to these requirements; we expect our audit strategy
CMS-0033-F 331

would be based on verifying that the results submitted accord with how they were calculated by

the certified EHR technology.

Comment: We received comments requesting that CMS require that eligible providers

report their clinical quality measures data to not only States and CMS, but also to Regional

Health Improvement Collaboratives, where such programs exist. The commenters believed that

this represents an alternative means for data submission rather than attestation and would allow

States and CMS to test this alternative in 2011 or 2012. A commenter requested that CMS

interpret the statutory requirement (Sections 1848(o)(2)(B)(iii) and 1886(n)(3)(B)(iii)) to avoid

redundant or duplicative reporting of quality measures to include not just other CMS reporting

efforts but also to avoid duplicative and redundant reporting with State and/or regional quality

measurement and reporting efforts. They therefore requested that for Medicaid, CMS require

EPs and hospitals report their clinical quality measures to not only States/CMS but also to

Regional Health Improvement Collaboratives, where such programs exist.

Response: Clinical quality measures need to be reported to CMS for the Medicare

program. For 2011, we intend to provide a web based tool for attestation. Beginning with 2012

for Medicare, we will provide one or more alternative options for electronic submission which

may include intermediaries. For Medicaid, information will go to the States as directed by the

States. We believe it would go well beyond the purview of this provision to require additional

reporting other than to CMS or the States. To clarify the issue raised by the commenter, sections

1848(o)(2)(B)(iii) and 1886(n)(3)(B)(iii) are tied to the Secretary and Federally-required quality

measures reporting programs. However, CMS agrees that State and regional redundancies could

be very problematic. We therefore clarify our proposed policy. States must include in their State

Medicaid HIT Plans an environmental scan of existing HIT and quality measure reporting
CMS-0033-F 332

activities related to Medicaid. We expect States to include details in their SMHP about how

these other on-going efforts can be leveraged and supported under HITECH; and how HITECH

will not result in duplicative and/or burdensome reporting requirements on the same providers or

organizations.

In the proposed rule, we proposed that Medicare EPs, eligible hospitals, and CAHs would

be required to report the required clinical quality measures information electronically using

certified EHR technology via one of three methods. The primary method we proposed would

require the EP, eligible hospital, or CAH to log into a CMS-designated portal. Once the EP,

eligible hospital, or CAH has logged into the portal, they would be required to submit, through

an upload process, data payload based on specified structures, such as Clinical Data Architecture

(CDA), and accompanying templates produced as output from their certified EHR technology.

As an alternative to this data submission method, we proposed to permit Medicare EPs,

eligible hospitals, and CAHs to submit the required clinical quality measures data using certified

EHR technology through Health Information Exchange (HIE)/Health Information Organization

(HIO). This alternative data submission method would be dependent on the Secretary's ability to

collect data through a HIE/HIO network and would require the EP, eligible hospital, or CAH

who chooses to submit data via an HIE/HIO network to be a participating member of the

HIE/HIO network. Medicare EPs, eligible hospitals, and CAHs would be required to submit

their data payload based on specified structures or profiles, such as Clinical Data Architecture

(CDA), and accompanying templates. The EPs, eligible hospitals, or CAHs data payload would

be an output from their respective certified EHR technologies, in the form and manner specified

from their HIE/HIO adopted architecture into the CMS HIE/HIO adopted architecture.
CMS-0033-F 333

As another potential alternative, we proposed to accept submission through registries

dependent upon the development of the necessary capacity and infrastructure to do so using

certified EHRs.

We stated in the proposed rule that we intended to post the technical requirements for

portal submission and the alternative HIE/HIO submission, the HIE/HIO participating member

definition, and other specifications for submission on our web site for Medicare EPs on or before

July 1, 2011 and for Medicare eligible hospitals and CAHs on or before April 1, 2011 for EHR

adoption and incorporation and to accommodate EHR vendors.

The following is a summary of comments received regarding the proposed reporting

method for clinical quality measures beginning with the 2012 payment year, and our responses.

Comment: A commenter recommended that CMS test a range of reporting options for

clinical quality measures to establish uniform and reliable rates of data transmission. Several

commenters supported the three data submission methodologies listed in the proposed rule to

allow flexibility in the quality reporting mechanisms. Many commenters requested reporting via

registries.

Response: We agree with the desirability of considering the three transmission

methodologies listed in the proposed rule. The submission through a portal is the only

mechanism that is feasible and practical for 2012 electronic clinical quality measure submission.

We plan to test HIE/HIO and registry submission for future possible implementation through

HITECH.

Comment: A commenter requested clarification as to when CMS would no longer accept

data for 2012 for Medicare EPs.

Response: The specific technical mechanism for attestation and electronic submission
CMS-0033-F 334

will be posted on the CMS website, and through various educational products in development.

We anticipate that the last date for attestation or electronic submission will be two-three months

after the close of the applicable EHR reporting period for EPs, eligible hospitals, and CAHs

respectively.

Comment: Several commenters requested that CMS continue programs that incentivize

advanced patient care for providers who are not eligible for the EHR incentive program and/or

who do not become meaningful users of certified EHR technology.

Response: CMS clarifies, based upon the comments, that our efforts to avoid duplicative

quality reporting requirements do not necessarily mean the discontinuation of other quality

reporting programs. CMS and State Medicaid agencies support several quality reporting

programs that are legislatively mandated or approach quality measurement in ways that are not

exclusively tied to HIT, or that, are voluntary and/or address emerging or developing quality

measure focus areas. We are committed to determining where the EHR incentive program’s

quality measure reporting can support other quality objectives, where it cannot and how to best

align our overall quality measurement efforts across programs.

Comment: Many commenters requested deferring quality measure reporting until 2012

and/or 2013, at which time all measures will be electronically specified and tested. Commenters

believed that this was especially important for new clinical quality measures such as Emergency

Department Throughput and Stroke, and recommended gradually phasing in or gradually

increasing the number of reportable measures and measure sets over time to allow for sufficient

testing and harmonization between programs. Some commenters suggested that for Stage 1,

eligible hospitals should be required to report only on the 15 measures that have been

electronically specified and those that are appropriate for that organization. One commenter
CMS-0033-F 335

requested clinical quality measure reporting should be optional. Also, commenters requested for

2011 and 2012 that hospitals continue to report clinical quality measures through the current pay-

for-reporting (RHQDAPU and HOP QDRP) programs or on clinical quality measures that

coincide with HEDIS reporting measures including HOS and CAHPS, using the existing

approaches, while quality measurement specialists and vendors create valid, reliable, and field-

tested e-measures for deployment in the eligible hospitals for 2013. Finally, commenters stated

that the proposed timeline may negatively impact credibility of data produced and have

potentially negative impact on patient safety.

Response: With respect to comments received regarding the timeline for implementation

of the EHR incentive program, we are only finalizing clinical quality measures that are

electronically specified by the date of display of this final rule. For eligible hospitals and CAHs,

we are finalizing 15 clinical quality measures as listed in Table 10 of this final rule that will be

required to report for 2011 and 2012, as applicable to their patient population. Although we

understand the suggestion that reporting through RHQDAPU should suffice for the HITECH

Act, the difficulty is that HITECH specifically requires that EPs, eligible hospitals, and CAHs

use “certified EHR technology” in connection with the submission of clinical quality measures.

Thus the HITECH Act introduces a requirement that at least some clinical quality measures be

submitted in connection with the use of certified EHR technology, whereas RHQDAPU has no

such requirement. We have limited the measures to those that have been electronically specified

and that are able to be automatically calculated by the certified EHR technology. These results

will be reported by EPs, eligible hospitals, and CAHs. We will seek to align the EHR incentive

program and quality reporting programs in future rulemaking.

CMS-0033-F 336

Comment: A number of commenters urged CMS not to require submission of clinical

quality measures data beyond what a certified EHR can produce. Specifically, commenters stated

that no clinical quality measures required for submission in Stage 1 should require a manual

chart review. Some commenters also requested allowing submission of clinical quality measures

through other EHRs that are not certified.

Response: We have adopted the suggested approach for 2011 and 2012 that limits the

required information on clinical quality measures results to that which can be automatically

calculated by the certified EHR technology. As to non-certified EHR technology, the HITECH

Act incentive program specifically requires the meaningful use of certified EHR technology.

Comment: Several commenters stated that currently the data required to be used in the

calculation of clinical quality measures are obtained from EHR discrete fields, free text and

paper records. Commenters recommended a uniform reporting structure. Commenters

questioned if they would be submitting raw data, numerators and denominators only, if there will

be an intermediary file that will allow manual edits to the file prior to submission, and if not will

validity be based entirely on discrete electronic data. Commenters asked if sampling will be

permitted or if hospitals will be required to report on entire populations. Commenters supported

the value of reporting clinical quality measures for all patients, not just Medicare and Medicaid

patients, in order to see the whole picture of the patient population which will enhance quality

improvement.

Response: As discussed elsewhere, the submission requirement is limited to calculated

results of clinical quality measures from certified EHR technology, as specified in this final rule,

and as is consistent with the ONC final rule (see 75 FR 2014) which requires certified EHR

technology to be able to calculate clinical quality measures as specified by CMS.

CMS-0033-F 337

Comment: Several commenters suggested the clinical quality measures requiring

medication administration data be delayed for reporting because they require advanced features

of EHR systems with implementation of the features, in particular Electronic Medication

Administration Record (eMAR).

Response: The Department has adopted certification criteria for EHR Modules and

Complete EHRs, as identified in the Health Information Technology: Initial Set of Standards,

Implementation Specifications, and Certification Criteria for Electronic Health Record

Technology; Interim Final Rule (75 FR 2014). It has also proposed temporary and permanent

certification programs for testing and certifying health information technology in a

March 10, 2010 proposed rule (75 FR 11328). The certification of EHRs will assure

functionality of the information system to obtain clinical quality data from the EHR.

After consideration of the public comments received, starting in payment year 2012, in

addition to meeting requirements for measures on meaningful EHR use and other requirements,

Medicare EPs, eligible hospitals, and CAHs will be required to electronically submit clinical

quality measures results (numerators, denominators, exclusions) as calculated by certified EHR

technology at §495.8. Medicaid EPs will be required to do so in the State’s second

implementation year for their Medicaid EHR incentive program. The clinical quality measures

will be for all patients, regardless of payer, and will be for the period of the EHR reporting

period. Medicare EPs, eligible hospitals, and CAHs will be required to report the required

clinical quality measures information electronically using certified EHR technology via one of

three methods. The primary method will require the EP, eligible hospital, or CAH to log into a

CMS-designated portal. Once the EP, eligible hospital, or CAH has logged into the portal, they

will be required to submit, through an upload process, data payload based on specified structures,
CMS-0033-F 338

such as Clinical Data Architecture (CDA), and accompanying templates produced as output from

their certified EHR technology.

As an alternative to this data submission method, contingent on feasibility, we will permit

Medicare EPs, eligible hospitals, and CAHs to submit the required clinical quality measures data

using certified EHR technology through a Health Information Exchange (HIE)/Health

Information Organization (HIO). This alternative data submission method will be dependent on

the Secretary's ability to collect data through a HIE/HIO network and would require the EP,

eligible hospital, or CAH who chooses to submit data via an HIE/HIO network to be a

participating member of the HIE/HIO network. Medicare EPs, eligible hospitals, and CAHs

would be required to submit their data payload based on specified structures or profiles. The

EPs, eligible hospitals, or CAHs data payload should be an output from their respective certified

EHR technologies, in the form and manner specified from their HIE/HIO adopted architecture

into the CMS HIE/HIO adopted architecture.

As another alternative, we will also accept submission through registries dependent upon

the development of the necessary capacity and infrastructure to do so using certified EHRs.

Finally, qualifying Medicare Advantage organizations for their eligible Medicare Advantage

EPs, as well as, Medicare Advantage-affiliated eligible hospitals and CAHs will continue to

submit HEDIS, HOS and CAHPS data instead of the clinical quality measures results under this

final rule in section II.C.6.

We will post the technical requirements for portal submission and the alternative

HIE/HIO submission, the HIE/HIO participating member definition, and other specifications for

submission on our website for Medicare EPs on or before July 1, 2011 and for Medicare eligible
CMS-0033-F 339

hospitals and CAHs on or before April 1, 2011 for EHR adoption and to accommodate EHR

vendors.

State Medicaid Agencies must follow the same requirements for meaningful use,

including clinical quality measures, for example, across all payers and for the entire EHR

reporting period for EPs and eligible hospitals. We expect that States will be able to accept the

electronic reporting of clinical quality measures by their second year of implementing the EHR

incentive program. States will include in their State Medicaid HIT Plan a description of how

Medicaid providers will be able to electronically report clinical quality measures, subject to CMS

prior approval.

i. Alternative Reporting Methods for Clinical Quality Measures

We proposed several alternative reporting methods to create a dataset of provider-

submitted summary data. One such alternative we proposed is the development of a distributed

network of EHRs where health information is retained locally in individual EP, eligible hospital,

and CAH EHRs and only summary reports are submitted to CMS. Another alternative we

proposed is the creation of databases of patient-level EHR data stored at the state or regional

level.

The following is a summary of comments received regarding the proposed alternative

reporting methods for clinical quality measures and our responses.

Comment: A commenter recommends aggregate reporting necessary for clinical quality

measures to be able to be completed in secondary systems such as data warehouses.

Response: For Medicare, we require that the data source be from certified EHR

technology. EPs, eligible hospitals and CAHs may use intermediaries (data warehouses) to

submit the EHR-generated clinical quality measure if available, assuming all requirements are
CMS-0033-F 340

met. States may seek CMS prior approval via their State Medicaid HIT Plans for how they

expect Medicaid providers to report the required meaningful use data, including clinical quality

measures. For example, States may propose that the data, while it originates in the providers’

certified EHR technology, may be reported using a health information exchange organization or

registry as an intermediary.

Comment: A few commenters communicated that the calculation and submission of

quality measures may depend on the use of health information technology systems beyond those

used by the EP such as data warehouses or registries that have to manipulate the data received.

They indicated the final rule should not exclude the use of additional non-certified EHR

technology to assist EPs in satisfying the quality reporting requirements provided the EP uses

certified EHR technology to capture the data and to calculate the results.

Response: Certified EHR technology will be required to calculate the clinical quality

measure results for the CMS specified measures we finalize in this final rule and transmit under

the PQRI Registry XML specification, as provided in the ONC final rule (found elsewhere in this

issue of the Federal Register).

Comment: Several commenters recommended inclusion of QRDA with PQRI XML for

reporting, thus allowing vendors the ability to bypass PQRI XML if they plan to ultimately

implement QRDA. There is also concern that switching to QRDA from XML will require

duplicative investments. They recommended attestation for 2011 and 2012 as well as allowing

use of QRDA in 2012.

Response: Electronic specifications will need to utilize standards that the certified EHR

can support. ONC’s final rule (found elsewhere in this issue of the Federal Register) limits this

to PQRI Registry XML specifications. There is no current requirement that a certified EHR be
CMS-0033-F 341

able to produce QRDA.

j. Reporting Period for Reporting of Clinical Quality Measures

Sections 1848(o)(A)(2)(iii) and 1886(n)(3)(A)(iii) of the Act state that to demonstrate

meaningful use of certified EHR technology for an EHR reporting period, an EP, eligible

hospital, and CAH must submit information “for such period” on the clinical quality measures

and other measures selected by the Secretary. Therefore we proposed that the reporting period

for the clinical quality measures selected by the Secretary be the EHR reporting period.

Another alternative we proposed was a fixed reporting period of four quarterly reporting

periods, or two six -month reporting periods. In terms of practice and precedent for other

Medicare clinical quality measure reporting programs, all of these programs submit data to us at

specific reporting intervals.

The following is a summary of comments received regarding the proposed EHR reporting

period for EPs, eligible hospitals, and CAHs.

Comment: Some commenters asked for clarification on whether the EP must

continuously report during the “entire payment year” or whether the reporting period for clinical

quality measures covers 12 month period. Other commenters questioned the timing of the

requirements associated with the measures—whether the specifications for Stage 1 payment year

1 apply to EPs regardless of when the EPs become first eligible or whether the clinical quality

measure specifications follow the calendar year.

Response: The EP only needs to report clinical quality measures once a year, as

described at §495.4. For Medicare EPs, eligible hospitals and CAHs, the EHR reporting period

is 90 days for their first payment year. For Medicaid eligible providers, their first payment year

in which they demonstrate meaningful use (which may be their second payment year, if they
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adopted, implemented or upgraded in their first payment year) also has a 90-day EHR reporting

period. For Medicare EPs, eligible hospitals and CAHs, in their second payment year, the

reporting period is 12 months. For Medicaid EPs and eligible hospitals, in their second payment

year of demonstrating meaningful use, they also have a 12-month EHR reporting period. Related

to the timing of the requirements, the final clinical quality measure specifications for 2011 and

2012 will be posted at the time of display of this final rule.

Comment: Some commenters requested clarification of the process for reporting in the

entire payment year. A commenter requested clarification regarding whether the EP must

continuously report during the entire payment year or whether the reporting period for clinical

quality measures covers an entire 12 month period. Some commenters pointed out that reporting

capability may not be available every day of the year due to information system availability.

Response: Technical requirements for electronic reporting will be posted on the CMS

website prior to the reporting period. The reporting period refers to parameters of the data

captured in the EHR or the services documented in the EHR, not the time when the submission

of information regarding clinical quality measures is made. States will dictate for Medicaid EPs

and eligible hospitals the timing of submission of their clinical quality measures data via

electronic reporting. Submission could be as infrequent as once a year after the close of the

reporting period. The reporting period beyond 2011 and 2012 for clinical quality measures will

be determined in future rulemaking.

4. Demonstration of Meaningful Use

Section 1848(o)(3)(C) of the Act, as added by section 4101(a) of the HITECH Act,

requires that as a condition of eligibility for the incentive payment, an EP must demonstrate

meaningful use of certified EHR technology (other than the reporting on clinical quality and
CMS-0033-F 343

other measures) as discussed in section II.A.3 of this final rule in the manner specified by the

Secretary, which may include the following: an attestation, the submission of claims with

appropriate coding, a survey response, reporting of clinical quality or other measures, or other

means. Similarly, section 1886(n)(3)(c) of the Act, as added by section 4102(a) of the HITECH

Act, requires that hospitals seeking the incentive payment demonstrate meaningful use of

certified EHR technology in the manner specified by the Secretary. Section 1903(t)(6)(C)(i)(II)

of the Act, as added by section 4201(a)(2) under the HITECH Act, states that a Medicaid EP or

eligible hospital must demonstrate meaningful use through a “means that is approved by the

State and acceptable to the Secretary.” In addition, pursuant to section 1903(t)(9) of the Act, a

State must demonstrate to the satisfaction of the Secretary that the State is conducting adequate

oversight, including the routine tracking of meaningful use attestations and reporting

mechanisms.

a. Common Methods of Demonstration in Medicare and Medicaid

As proposed, in the final rule, we are adopting a common method for demonstrating

meaningful use in both the Medicare and Medicaid EHR incentive programs, for the same

reasons we have a uniform definition of meaningful use. The demonstration methods we adopt

for Medicare would automatically be available to the States for use in their Medicaid programs.

The Medicare methods are segmented into two parts, as discussed in section II.4.b of this final

rule. States seeking to modify or propose alternative demonstration methods must submit the

proposed methods for prior CMS approval. This process is discussed more fully in section

II.D.7.b.2.c. of this final rule.

b. Methods for Demonstration of the Stage 1 Criteria of Meaningful Use

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Our final regulations, at §495.8, will require that for CY 2011, EPs demonstrate that they

satisfy each of the fifteen objectives and their associated measures of the core set listed at

§495.6(d) and five of the objectives and their associated measures from the menu set listed at

§495.6(e) unless excluded as described in §495.6(a)(2). (An exclusion will reduce the number of

objectives/measures the EP must satisfy by the number that is equal to the EP’s exclusions. For

example, an EP that can exclude two menu objectives/measures is required to satisfy only three

of the objectives and associated measures from the menu set. Similarly, an exclusion will reduce

the number of core objectives/measures that apply). We permit only those exclusions that are

specifically indicated in the description of each objective and its associated measure (§495.6(d)

for the core set and §495.6(e) for the menu set). If an exclusion exists and the EP meets the

criteria for it, the EP would report to CMS or the States that fact rather than demonstrating that

they satisfy the objective and associated measure. At §495.8, we will require that for FY 2011,

eligible hospitals and CAHs demonstrate that they satisfy each of the fourteen objectives and

their associated measures of the core set listed at §495.6(f) and five of objectives and their

associated measures from the menu set listed at §495.6(g) unless excluded as described in

§495.6(b)(2). As with EPs, all exclusions are specifically indicated, in the description of the

objective and associated measures (§495.6(f) for the core set and §495.6(g) for the menu set) and

an exclusion will reduce the number of objectives and associated measures an eligible hospital or

CAH must satisfy (see above example for EPs). If an exclusion exists and the hospital meets the

criteria for it, the eligible hospital or CAH would report to CMS or the States that fact rather than

demonstrating that they satisfy the objective and associated measure. Finally, as specified in

495.316(d), for those participating in the Medicaid EHR incentive program, the State may alter

the requirements for demonstrating that an EP or eligible hospital is a meaningful user, with
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regard to four specific objectives and measures. For these objectives and measures, the State

may also choose to make a menu-set objective a core objective. Such State additions could

increase the core or menu set objectives and measures that must be satisfied.

For payment years beginning in CY 2012 and subsequent years, our final regulations, at

§495.8, will require that for Stage 1 of meaningful use, EPs demonstrate that they satisfy each of

the 15 objectives and their associated measures of the core set listed at §495.6(d), except

§495.6(d)(4) “Report ambulatory quality measures to CMS or, in the case of Medicaid EPs, the

states” and 5 of the objectives and their associated measures from the menu set listed at

§495.6(e) unless excluded as described in §495.6(a)(2). The form and mechanism for excluding

an objective and its associated measure is the same for CY2012 and subsequent years as it is for

CY2011. The ability for States to add certain requirements is the same for CY 2012 and

subsequent years as it is for CY 2011. The EP must demonstrate that they satisfy the objective

“Submitting quality measure to CMS or the States” through electronic reporting of clinical

quality measures to CMS or the States, as specified in section II.A.3 of this final rule. For

payment years beginning in FY2012 and subsequent years, our final regulations, at §495.8, will

require that eligible hospitals and CAHs demonstrate that they satisfy each of the fourteen

objectives and their associated measures of the core set listed at §495.6(f), except §495.6(f)(3)

“Report hospital quality measures to CMS or, in the case of Medicaid EPs, the states” and five of

the objectives and associated measures from the menu set listed at §495.6(g) unless excluded as

described in §495.6(b)(2). The form and mechanism for excluded an objective and its associated

measure is the same for FY2012 and subsequent years as it is for FY2011. The ability for States

to add certain requirements also is the same for FY 2012 and subsequent years as it is for FY

2011. The eligible hospital or CAH must demonstrate that they satisfy the objective “Submitting
CMS-0033-F 346

quality measure to CMS or the States” through electronic reporting of clinical quality measures

to CMS or the States, as specified in section II.A.3 of this final rule.

Except for the clinical quality measures (for which we require electronic reporting in CY

or FY 2012 and subsequent years as discussed above), satisfaction of meaningful use objectives

and associated measures may be demonstrated through attestation. Specifically, we will require

that EPs, eligible hospitals and CAHs attest through a secure mechanism, such as through claims

based reporting or an online portal. For the Medicare FFS and MA EHR incentive programs,

CMS will issue additional guidance on this mechanism. For the Medicaid EHR incentive

program, the States will include additional information in the State Medicaid HIT plans they

submit to CMS to implement the program. We will require that an EP, eligible hospital or CAH

would, through a one-time attestation following the completion of the EHR reporting period for a

given payment year, identify the certified EHR technology they are utilizing and the results of

their performance on all the measures associated with the reported objectives of meaningful use.

We would require attestation through a secure mechanism because we do not believe that HIT

will advance enough from its current state to allow for more automated and/or documented

options of demonstrating meaningful use. As HIT matures we expect to base demonstration

more on automated reporting by certified EHR technologies, such as the direct electronic

reporting of measures both clinical and non clinical and documented participation in HIE. The

first example is to the move from attestation for clinical quality measures to direct reporting in

2012 and subsequent years for EPs, eligible hospitals and CAHs. As HIT advances we expect to

move more of the objectives away from being demonstrated through attestation. However, given

the current state of HIT, we believe that imposing such demonstration requirements for 2011

would pose significant barriers to participation in the EHR incentive programs.

CMS-0033-F 347

We believe that the means by which EPs, eligible hospitals and CAHs demonstrate

meaningful use should work for all provider types. We also believe that uniform means of

demonstration for EPs, eligible hospitals and CAHs are preferred and that a greater burden

should not be placed on one or the other. In addition, we do not believe that demonstration of

meaningful use could require use of certified EHR technology beyond the capabilities certified

according to the ONC FR.

In addition to requiring electronic reporting of clinical quality measures beginning in

2012 in Medicare and Medicaid, we also leave open the possibility for CMS and/or the States to

test options to utilize existing and emerging HIT products and infrastructure capabilities to

satisfy other objectives of the meaningful use definition. The optional testing could involve the

use of registries or the direct electronic reporting of some measures associated with the

objectives of the meaningful use definition. We do not require any EP, eligible hospital or CAH

to participate in this testing in either 2011 or 2012 in order to receive an incentive payment. The

state of electronic exchange varies widely across the country and is dependent on numerous

Federal, State, local, non-profit and for-profit initiatives. Given this high state of flux, CMS

and/or the States would have to issue considerable updated guidance to EPs, eligible hospitals

and CAHs who wish to join in our efforts to explore the electronic exchange of information.

Any testing should be based on the principle of electronic exchange of information from certified

EHR technology either directly to the States or through an intermediary. For purposes of the

programs in this final rule it would be counterproductive for an intermediary to collect

information through paper abstraction.

We will issue further instructions on the specifics for submitting attestation through

established outreach venues.

CMS-0033-F 348

Comment: Several commenters submitted comments regarding the methods of

demonstration for clinical quality measures.

Response: We summarize and respond to those comments in section II.A.3 of this final

rule.

Comment: A few commenters submitted comments regarding section 1848(o)(2)(A) of

the Act, which provides discretion to the Secretary to provide for the use of alternative means for

meeting the requirements of meaningful use in the case of an eligible professional furnishing

covered professional services in a group practice. Some of these commenters suggested that

CMS provide such an alternative means in the final rule, while other suggested we consider

doing so in future rulemaking.

Response: We did not propose any alternative means in the proposed rule. Given the per

EP basis for most of the objectives and their associated measures, we did not believe group

reporting would provide an accurate reflection of meaningful use. In addition, as the incentives

payments are calculated on a per EP basis it is unclear to us how variance of meaningful use

among EPs within the group should be treated. We believe the possible reduction in burden of

attesting once per group versus once per EP is outweighed by the less accurate reporting,

increased possibility of duplicate payments and decreased transparency. We note that many of

the measures rely on data which could easily be stored at a group level such as a patient’s

demographics or medication lists and any EP with access to that information about a patient in

their certified EHR technology and who sees that same patient in the EHR reporting period

would receive credit for that patient in their numerator and denominator. Other aspects such as

the enabling of drug-drug, drug-allergy checks, using CPOE and eRx could vary widely from EP

to EP within the same group. We would also be concerned with EPs in multi-specialty group
CMS-0033-F 349

practices some of whom might be eligible for an exclusion, while others would not be. As

requested by commenters we will continue to review this option in future rulemaking, but for this

final rule we do not include the option to demonstrate meaningful use at a group level.

While we did not make changes to the demonstration of meaningful use requirements

based on the comments above, we did make modifications to other aspects of the Stage 1

definition of meaningful use that required the descriptions of how many and which objectives

and their associated measure EPs, eligible hospitals and CAHs to be altered accordingly. These

changes are to the first paragraph of this section (II.4.b).

5. Data Collection for Online Posting, Program Coordination, and Accurate Payments

As described below, the HITECH Act requires the Secretary to post online the names of

Medicare EPs and eligible hospitals and CAHs who are meaningful EHR users for the relevant

payment year. Section 1903(t)(2) of the Act also requires us to ensure that EPs do not receive an

EHR incentive payment under both Medicare and Medicaid. To fulfill these mandates, we must

collect several data elements from EPs and eligible hospitals. Beyond these two direct HITECH

Act requirements, CMS and the States also require certain data in order to accurately calculate

and distribute the incentive payments.

a. Online Posting

In the proposed rule, we said that section 1848(o)(3)(D) of the Act requires the Secretary

to list in an easily understandable format the names, business addresses, and business phone .

numbers of the Medicare EPs and, as determined appropriate by the Secretary, of group practices

receiving incentive payments for being meaningful EHR users under the Medicare FFS program

on our internet web site. We will not post information on group practices because we will not

base incentive payments at the group practice level. Section 1886(n)(4)(B) of the Act, as added
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by section 4102(c) of the HITECH Act, requires the Secretary to list in an easily understandable

format the names and other relevant data, as she determines appropriate, of eligible hospitals and

CAHs who are meaningful EHR users under the Medicare FFS program, on our internet web

site. Eligible hospitals and CAHs will have the opportunity to review the list before the list is

publicly posted. Sections 1853(m)(5) and 1853(l)(7) of the Act, as added by sections 4101(c)

and 4102(c) of the HITECH Act, require the Secretary to post the same information for EPs and

eligible hospitals in the MA program as would be required if they were in the Medicare FFS

program. Additionally, the Secretary must post the names of the qualifying MA organizations

receiving the incentive payment or payments. We would collect the information necessary to

post the name, business address and business phone numbers of all EPs, eligible hospitals and

CAHs participating in the Medicare FFS and MA EHR incentive programs, and to post this

information on our web site. The HITECH Act did not require Medicaid EPs and eligible

hospitals to be identified online so we will not do so.

We did not receive any comments and we are finalizing these provisions as proposed.

b. Program Election Between Medicare FFS/MA and Medicaid for EPs

In the proposed rule, we said section 1903(t)(2) of the Act prohibits an EP from receiving

incentive payments under the Medicaid program unless the EP has waived any rights to incentive

payments under the Medicare FFS or MA programs. Furthermore, section 1903(t)(7) of the Act

requires the Secretary to assure no duplication of funding with respect to the Medicaid program,

and the physician and MA incentive payments under sections 1848(o) and 1853(l) of the Act

This waiver and non-duplication requirement applies only to EPs meeting both the Medicare

FFS/MA and Medicaid EHR incentive programs eligibility criteria, and does not apply to

hospitals (which, if eligible, could receive incentive payments from both Medicare and Medicaid
CMS-0033-F 351

simultaneously). Section 495.10 allows an EP meeting the eligibility criteria for both the

Medicare FFS/MA and Medicaid programs to participate in either program. We would also

allow an EP to change his or her election once during the life of the EHR incentive programs

after making the initial election, for payment years 2014 and before. We believe this one-time

election rule allows an EP whose patient volume no longer makes him or her eligible for the

Medicaid program to nevertheless continue to receive incentive payments that would encourage

the meaningful use of certified EHR technology. For example, an EP who moves to a different

practice or geographically relocates practices may reduce his or her Medicaid patient volume,

and therefore become ineligible for the Medicaid incentive payments. Allowing this EP to

continue to receive incentive payments under Medicare (if eligible) continues the availability to

the EP of the incentive for meaningfully using EHR technology, and would allow EPs a certain

amount of flexibility in their operations. While allowing this flexibility creates administrative

complexity, we believe a significant number of EPs could have their participation in the EHR

incentive programs endangered due to changing circumstances unrelated to the EHR incentive

programs.

In the proposed rule, we proposed at 495.10(e)(5), that an EP switching program is

“placed in the payment year the EP would have been in, had the EP not switched programs.” For

example, if an EP decides to switch after receiving his or her Medicare FFS incentive payment

for their second payment year, then the EP would be in its third payment year for purposes of the

Medicaid incentive payments. For the final rule, we are clarifying that the EP is “placed in the

payment year the EP would have been in had the EP begun in and remained in the program to

which he or she has switched.” We have modified 495.10(e)(5) accordingly.

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We believe this clarification is necessary in order to address comments we received on

non-consecutive payments. As outlined in II.A.1.c and d of this final rule, the definition of first,

second, third, fourth, fifth, and sixth payment year differs across the Medicare and Medicaid

programs. Section 1848(o)(1)(E)(ii) of the Act requires that the second Medicare payment year

be successive to the first payment year and immediately follow it. Similarly, the third payment

year must immediately follow the second, and so on. Thus, as explained in II.A.1.c., “if a

Medicare EP receives an incentive in CY2011, but does not successfully demonstrate meaningful

use or otherwise fails to qualify for the incentive in CY2012, CY2012 still counts as one of the

EP's five payment years and they would only be able to receive an incentive under the Medicare

EHR incentive program for three more years.” The same rule, however, does not apply to the

Medicaid EHR incentive program. For that program, EP payments may generally be non-

consecutive. If an EP does not receive an incentive payment for a given CY or FY then that year

would not constitute a payment year. For example, if a Medicaid EP receives incentives in

CY2011 and CY2012, but fails to qualify for an incentive in CY 2013, they would still be

potentially eligible to receive incentives for an additional four payment years.

The rules on consecutive payment, discussed above, govern how an EP should be treated

after switching from the Medicaid to the Medicare EHR incentive program, or vice versa. As

stated above, we believe that an EP that switches from the Medicaid to the Medicare program

should be treated in the same manner as if such EP had started in the Medicare program.

Payment years that are skipped in the Medicaid EHR incentive program thus become payment

years that count against the EP’s five years of payment in Medicare. For example, an EP that

receives nonconsecutive payment under Medicaid for CYs 2011 and 2013 (but skips CY 2012),

and then switches to the Medicare program in CY 2014, is in the fourth payment year in 2014,
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and is limited to that payment year’s limit on incentive payments. Such an EP may receive only

one more year of incentive payments under the Medicare EHR incentive program. We believe

this rule is equitable, given that, had the EP started in the Medicare program, the EP would not

have been able to benefit from non-consecutive payments available under the Medicaid EHR

incentive program. We see no reason why EPs that switch from the Medicaid to the Medicare

program should be treated differently from those who initially began in the Medicare program,

and believe that any other rule might encourage gaming on the part of eligible professionals.

By the same token, an EP that switches from the Medicare to the Medicaid EHR

incentive program will not be penalized for non-consecutive payment years accrued while in the

Medicare program. For example, an EP that receives nonconsecutive payment under Medicare

for CYs 2011 and 2013 (but skips CY 2012), and then switches to the Medicaid program in CY

2014, is in the third year of payment in 2014, and is potentially eligible to receive three

additional years of payment under Medicaid (after 2014), for a total of six years of payment.

Similar to our rationale described in the paragraph above, we do not believe an EP that switches

to the Medicaid program should be treated differently from the EP that initially begins in the

Medicaid program, as once the EP switches to the Medicaid program, there is no statutory

requirement that the payment year ordering be consecutive.

We believe it is self-evident that an EP switching to a new program is subject to the

requirements of such new program. Thus, for example, an EP switching from Medicaid to

Medicare might be subject to a higher stage of meaningful use upon moving to the Medicare

program. The EP also would be subject to fewer years of payment and to the requirement that no

incentive payments may be made after 2016.

CMS-0033-F 354

Finally, even after lining up the payment years, it is possible for an EP to exceed the

payment cap under Medicaid by switching programs at the right time. We do not believe that the

Congress intended for the payment caps to be exceeded under any circumstance, and therefore

proposed that no EP should receive more than the maximum incentive available to them under

Medicaid, which is the higher of the two caps. The last year incentive payment would be

reduced if awarding the EP the full amount would exceed the overall maximum available under

Medicaid. This is possible if an EP receives their first two payment years from Medicare and

then the last four from Medicaid, as the cap would be exceeded by $250. If the EP receives the

HPSA bonus available under the Medicare FFS EHR incentive program, this amount could be as

much as $4,450. An EP who switches from Medicaid to Medicare could potentially exceed the

Medicare threshold in a number of circumstances; however, since they will not be allowed to

exceed the Medicaid threshold under any circumstance, we would pay the incentive for which

they are eligible for a given payment year in whichever program they are in for that payment

year until they exceed the Medicaid threshold. No incentive payments will be made to any EP

that would allow the EP to exceed the Medicaid threshold. We anticipate that this would result

in a prorated final year incentive payment. Finally, we proposed that the last year for making an

incentive payment program switch would be CY 2014. In making this proposal, we considered

that it is both the last year an EP can enroll in the Medicare EHR incentive program, and also the

last year before the payment adjustments under Medicare can begin.

Comment: We received comments requesting clarification on when an EP could make

their one switch.

Response: As described in our example, the EP could make their one switch anytime

after the receipt of an incentive payment under either the Medicare or Medicaid program. Since
CMS-0033-F 355

this policy would also apply to other program changes (for example, changing from one State to

another, or updating registration data elements), we want to clarify when program registration

changes can take place. An EP, eligible hospital or CAH sets into motion receipt of the incentive

payment when they attempt to demonstrate meaningful use or demonstrate to the State efforts to

adopt, implement, or upgrade to certified EHR technology. Therefore, prior to their first

successful attempt to demonstrate meaningful use or demonstrate to the State efforts to adopt,

implement, or upgrade to certified EHR technology, the EP could change their registration in

either the Medicare or Medicaid EHR incentive program as many times as they wish.

Furthermore, EPs and hospitals selecting the Medicaid incentive program may also switch freely

prior to payment as described here. However, there may only be one payment from one State in

any one payment year.

After consideration of the public comment received, we are modifying the provision at

§495.10(e)(2) to “(2) After receiving at least one EHR incentive payment, may switch between

the two EHR incentive programs only one time , and only for a payment year before 2015”. This

modification better reflects our clarification in response to the comment received on the ability to

switch between programs. For the final rule, we have made a few other technical changes to

§495.10, in addition to the changes made to §495.10(e)(2) and (e)(5).

c. Data to be Collected

In addition to information regarding the demonstration of meaningful use, in §495.10 of

this final rule we would collect the following administrative data for the Medicare and Medicaid

EHR incentive programs to fulfill our requirements of online posting, avoidance of duplication

of incentive payments, and to ensure accurate and timely incentive payments:

● Name, NPI, business address, and business phone of each EP or eligible hospital.
CMS-0033-F 356

● Taxpayer Identification Number (TIN) to which the EP or eligible hospital wants the

incentive payment made. For Medicaid EPs this must be consistent with assignment rules at

§495.10.

● For EPs, whether they elect to participate in the Medicare EHR incentive programs or

the Medicaid EHR incentive program.

● For eligible hospitals and CAHs, their CCN.

To coordinate with the States to avoid duplication of payments, we would make available

to the States through a single National Level Repository (NLR) the following additional data:

● Whether an EP or eligible hospital is a meaningful EHR user, and

● The remittance date and amount of any incentive payments made to an EP or eligible

hospital.

● Other information as specified by CMS.

CMS, our contractors, and the States will have access to these data elements through the

NLR maintained by CMS. The States will have to provide information to us on whether EPs or

eligible hospitals are eligible for the Medicaid incentive program, whether EPs or eligible

hospitals participating in the Medicaid program are meaningful EHR users, and when any

Medicaid incentive payments are made and the amount of the payment. We will put in place

processes for an EP or eligible hospital to change their information, including the one-time

switch in EHR incentive program election by EPs.

Comment: We received comments that some EPs do not use TINs, but rather the EPs

social security number (SSN).

Response: In these cases the EP would submit a TIN, which is their SSN. An

incorporated EP would have a TIN for the corporation that would be an EIN. The EP’s own TIN
CMS-0033-F 357

remains his/her SSN.

Comment: Some commenters requested clarification on whether the business address is

the physical location or the mailing address.

Response: We believe that the HITECH Act required reporting of this information to

assist the public in identifying meaningful EHR users. We believe the practice location address

serves this purpose better than the mailing address. However we will allow EPs to enter

alternate address for posting purposes but will not allow that address to be a post office box.

Comment: Commenters suggested that States would be allowed to determine the

requirements associated with Medicaid provider TIN assignments.

Response: We discuss the requirements associated with TIN assignment in 495.10(f) and

in the requirements associated with SMHPs in this preamble at section 495.332 SMHPs. States

are responsible for making sure the providers are providing an acceptable TIN, consistent with

the regulations at 495.10(f), which states that providers may only assign to certain TINs.

We clarified 495.10(f), to reflect this and other changes.

Comment: CMS received numerous comments about the schedule for and State’s role in

the national single repository where CMS will collect data elements on all registrants.

Response: The technological requirements and systems interfaces are outside this

regulation and we look forward to providing additional guidance.

Comment: Some commenters recommended a shorter record retention period that the ten

years proposed. Commenters recommended periods ranging from three to eight years. The

reasons given for a shorter time period were the cost of record retention, no perceived need for a

retention period longer than the incentive period, rapid changes in EHR technology and

consistency with other unspecified retention requirements.

CMS-0033-F 358

Response: After reviewing the comments, we agree with commenters that ten years in

longer than necessary to ensure the integrity of the program. In considering a shorter retention

period, we believe that there may be cause to look over the entire incentive period. As a

Medicaid EP would be eligible for incentives over a six year period if they successfully receive

an incentive each year and that is the longest such period available to any participant in the

Medicare and Medicaid EHR incentive programs, we adopt a new retention period of six years

for this final rule.

Comment: We received a comment suggesting that Medicare adopt an appeals process

similar to the one proposed for Medicaid.

Response: We expect to address Medicare appeals in future guidance.

6. Hospital-based Eligible Professionals

Section 1848(o)(1)(C)(i) of the Act, as added by section 4101(a) of the HITECH Act,

states that hospital-based EPs are not eligible for the Medicare incentive payments. Similarly,

the majority of hospital-based EPs will not be eligible for Medicaid incentive payments under

1903(t)(2)(A) of the Act (the only exception to this rule is for those practicing predominantly in

an FQHC or RHC). Sections 4101(a) and 4201(a) of the HITECH Act originally defined the

term “hospital-based eligible professional” to mean an EP, such as a pathologist,

anesthesiologist, or emergency physician, who furnishes substantially all of his or her Medicare-

covered professional services during the relevant EHR reporting period in a hospital setting

(whether inpatient or outpatient) through the use of the facilities and equipment of the hospital,

including the hospital's qualified EHRs. Following publication of our proposed rule, Congress

modified the definition of hospital-based EPs. More specifically, on April 15, 2010, President

Obama signed into law the Continuing Extension Act of 2010 (Pub.L. 111-157) which, in
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Section 5, made the following changes to the Social Security Act as it applies to both the

Medicare and Medicare EHR incentives for EPs:

(1) Medicare- Section 1848(o)(1)(C)(ii) of the Social Security Act (42 U.S.C.

1395w-4(o)(1)(C)(ii)) is amended by striking `setting (whether inpatient or outpatient)' and

inserting `inpatient or emergency room setting'.

(2) Medicaid- Section 1903(t)(3)(D) of the Social Security Act (42 U.S.C.

1396b(t)(3)(D)) is amended by striking `setting (whether inpatient or outpatient)' and inserting

`inpatient or emergency room setting'.

These amendments were effective as if included in the enactment of the HITECH Act.

The above sections indicate that the determination of whether an EP is a hospital-based

EP shall be made on the basis of the site of service, as defined by the Secretary, and without

regard to any employment or billing arrangement between the EP and any other provider. For

example, the hospital-based determination for an EP would not be affected by whether the EP is

an employee of the hospital, under a contractual relationship with the hospital, or with respect to

whether he or she has made a reassignment to the hospital for Part B billing purposes.

In addition, as discussed below, section 1848(a)(7)(D) of the Act, as added by section

4101(b) of the HITECH Act, exempts hospital-based EPs from the downward payment

adjustment applied under section 1848(a)(7)(A)(i) of the Act to covered professional services

provided during a payment year by EPs who are not meaningful EHR users for the relevant

payment year beginning in 2015.

Based on section 4101(a) of the HITECH Act (and prior to the amendments in the

Continuing Extension Act of 2010), we proposed that an EP would be a hospital based EP and

therefore ineligible to receive a Medicare or Medicaid EHR incentive payment if more than 90
CMS-0033-F 360

percent of their services are provided in the following place of service (POS) codes for HIPAA

standard transactions: 21—Inpatient Hospital, 22 – Outpatient Hospital, 23 – Emergency Room.

In addition, because of concerns that some primary care EPs who provide services to

Medicare and Medicaid beneficiaries would be ineligible for the incentive payments under this

proposed definition, in the proposed rule, we asked for comments on whether we should use

another method for defining hospital-based EPs. We estimated that under this proposal, 12–13

percent of family practitioners under Medicare would be considered hospital-based. We did not

have corresponding data for Medicaid EPs.

Comment: Many congressional representatives, hospital associations, individual

providers and other commenters indicated that they believed that the proposal would

inappropriately exclude from receiving EHR incentive payments EPs practicing in ambulatory

settings such as those that practice in hospital provider-based departments (referred to by most

commenters as “outpatient centers and clinics”). They indicated these centers and clinics

provide services similar to services furnished by EPs in private offices. Many suggested that this

definition may inhibit hospital investments in their outpatient primary care sites. Commenters

believe the absence of any EP incentive payment in these settings may discourage hospitals from

adopting EHR in ambulatory settings, particularly if doing so requires the purchase of an

ambulatory-based EHR system (or an ambulatory component to be added to the hospital’s EHR

system.) This is because the hospital's total incentive payment is based on total inpatient

services. A hospital with a large outpatient department will not receive a higher incentive

payment as a result of their outpatient services. These commenters indicated that ambulatory

care EHRs are very different from inpatient EHRs because of the inherent differences between

the types of care provided in each setting. Commenters differed somewhat to the extent that they
CMS-0033-F 361

provided specific alternatives. Some commenters went so far as to suggest that all EPs should be

eligible to receive EHR incentive payments, regardless of where they practice.

Response: The changes to the hospital-based definition that are included in the

Continuing Extension Act of 2010 (Pub. L. 111-157) discussed above address commenters

concerns about ambulatory settings. These changes have been incorporated into the final rule.

An EP will be a hospital based EP and therefore ineligible to receive a Medicare (or Medicaid)

EHR incentive payment if more than 90 percent of their Medicare (or Medicaid) services are

provided in the following two place of service (POS) codes for HIPAA standard transactions:

21—Inpatient Hospital, 23 – Emergency Room.

Comment: Some commenters argued that the proposed rule failed to make a critical

distinction between hospital-based EPs who primarily use an EHR paid for and maintained by

the hospital and those that did not. Some commenters suggested that an EP should be eligible for

an EHR incentive payment if he or she had contributed 15 percent or more toward the cost of

acquiring or maintaining the certified EHR. Some commenters requested that CMS change the

definition of a hospital-based EP to read: “An EP who furnishes 90 percent or more of his or her

covered professional services in the CY preceding the payment year in a hospital setting and

primarily through the use of the qualified electronic health records of the hospital.” The

commenters believed that Congress’s intent was to exclude only those EPs using qualified EHRs

of the hospital, and that their approach would allow separate EHR incentive payments for EPs

who have developed cutting-edge, patient centered EHR modules, thereby allowing for a clinical

specificity not currently available in more generalized, hospital-wide EHR systems.

Commenters stated that these EHR technologies are currently used in hospital settings and

interoperate with hospital systems, but are paid for and primarily maintained by physician groups
CMS-0033-F 362

who see patients in hospital settings. The commenters indicate that these physician groups

continue to invest in their EHRs through improvements, ongoing maintenance, and support staff

employed to ensure optimal use of such technology. The commenters indicated that many early

health IT champions, including hospital-based anesthesiologists, radiologists, pathologists,

hospitalists, emergency medicine physicians, and neonatal physicians would be negatively

affected by the proposal. These comments would apply to EP services provided in all hospital

settings, including inpatient, outpatient, and emergency rooms.

Response: The statute, as now amended, indicates that hospital-based EPs are those who

furnish substantially all their services in an inpatient or emergency room setting, such as a

pathologist, anesthesiologist, or emergency physician, and who do so using the facility and

equipment, including qualified electronic health care records, of the hospital. While commenters

focused on the statutory language: “…including qualified electronic health care records of the

hospital”, they did not address the broader meaning of the section which also includes the

requirement that hospital-based EPs are those who furnish services “using the facility and

equipment”, including qualified electronic health care records of the hospital. We believe both

phrases together are intended to provide an explanation of why hospital-based EPs are to be

excluded from receiving EHR incentive payments (that is, that they would typically use the

facilities and equipment, including the EHR, of the hospital and that therefore it would represent

double payment if both hospitals and hospital-based EPs were to be paid incentives). We do not

believe that the intent of this language was to require CMS to evaluate each EP as to whether

they are using the EHR of the hospital. Further, the commenters did not address the significance

of the next sentence of the statute, which clearly indicates that: “The determination of whether an

eligible professional is a hospital-based eligible professional shall be made on the basis of the
CMS-0033-F 363

site of service…”. Since Congress directed that site of service must be the determinant of

whether an EP is hospital-based, we could not use individualized determinations of whether an

EP is using the EHR of the hospital to deliver his or her services. Also, the subsequent

legislation in the Continuing Extension Act of 2010 is consistent with the interpretation that the

determination of whether an EP is hospital-based is based on the place where the EP furnishes

services, as that subsequent legislation further limited hospital-based to those EPs providing

substantially all services in the emergency room or inpatient hospital settings. Furthermore, our

final policy is that eligible hospitals must demonstrate meaningful use based upon all applicable

cases in the inpatient (21) and emergency department (23) site of service codes. Therefore, there

would be duplication in measuring meaningful use for the purposes of making EHR incentive

payments in the scenario proposed by these commenters.

The HITECH Act does not define the term ‘hospital” for purposes of establishing a

definition of hospital-based EPs for Medicare and Medicaid. However, section 1861(e) of the

Act defines the term a “'hospital” to mean an institution that “is primarily engaged in providing,

by or under the supervision of physicians, to inpatients (A) diagnostic services and therapeutic

services for medical diagnosis, treatment, and care of injured, disabled, or sick persons, or (B)

rehabilitation services for the rehabilitation of injured, disabled, or sick persons.” Therefore,

clearly EPs that practice primarily in inpatient hospital settings, as referenced in section 1861(e)

of the Act, would be considered hospital-based EPs.

We will consider the use of place of service (POS) codes on physician claims to

determine whether an EP furnishes substantially all of their professional services in a hospital

setting and is, therefore, hospital-based. This code set is required for use in the implementation

guide adopted as the national standard for electronic transmission of professional health care
CMS-0033-F 364

claims under the provisions of the Health Insurance Portability and Accountability Act of 1996

(HIPAA). HIPAA directed the Secretary of HHS to adopt national standards for electronic

transactions. These standard transactions require all health plans and providers to use standard

code sets to populate data elements in each transaction. The Transaction and Code Set Rule (65

FR 50312) adopted the ASC X12N-837 Health Care Claim: Professional, volumes 1 and 2,

version 4010, as the standard for electronic submission of professional claims. This standard

names the POS code set currently maintained by CMS as the code set to be used for describing

sites of service in such claims and is available at

http://www4.cms.gov/PlaceofServiceCodes/Downloads/posdatabase110509.pdf

From this code set, we would consider the use of the following POS codes to determine

whether an EP is a hospital-based eligible professional for Medicare:

• 21—Inpatient Hospital – is a facility, other than psychiatric, which primarily provides

diagnostic, therapeutic (both surgical and nonsurgical), and rehabilitation services by, or under,

the supervision of physicians, to patients admitted for a variety of medical conditions.

• 23 – Emergency Room, Hospital – is a portion of a hospital where emergency

diagnosis and treatment of illness or injury is provided

Comment: Most commenters were supportive of the proposal to define “substantially

all” of his or her covered professional services in a hospital setting as EPs who furnish at least 90

percent of his/her services in a hospital setting. However, some commenters expressed concerns

that this threshold will be too high starting in 2015 when the time comes to determine which EPs

should be subject to penalties for failure to become meaningful users of certified EHR

technology. A few commenters misunderstood the proposal and requested that a hospital-based
CMS-0033-F 365

EP be defined as one who provides at least 90 percent of his or her services, defined as

encounters and not as charges.

Response: The statutory definition of hospital-based EP provides that to be considered a

hospital-based EP, the EP must provide “substantially all” of his or her covered professional

services in a hospital setting. Therefore, we must identify the minimum percentage of an EP's

covered professional services that must be provided in a hospital setting in order for the EP to be

considered as providing “substantially all” of his or her covered professional services in a

hospital setting. Consistent with the statute, we proposed to make this determination on the basis

of services performed by each EP, not the charges for each EP. We are finalizing the proposed

definition of “substantially all” as furnishing at least 90 percent of services in a hospital setting.

We believe a 90 percent threshold certainly would qualify as “substantial.”

Comment: Representatives of surgeons asked that CMS make an accommodation to the

hospital-based definition to account for services paid under a global fee.

Response: The determination of whether or not an EP is hospital-based is determined

individually for each EP. A global fee is a single payment for a bundle of services, some of

which could be performed in a hospital such as major surgery or hospital visits, whereas some

could be performed in an office such as follow-up visits, CMS does not have data, for the place

of service for services performed by individual EPs when the services are paid as part of a global

fee. We considered possibilities for using national level estimates for individual services

typically performed under global fees as proxies for services provided by individual EPs.

However, this would add significant additional operational complexity to the determination of

hospital-based status and we have not pursued this approach.

Comment: Some commenters requested that CMS establish a process by which EPs
CMS-0033-F 366

could know in advance of a payment year whether CMS considered them as being hospital-based

and therefore ineligible for an incentive payment.

Response: To the extent practical, we intend on establishing a process whereby the EP

would know his/her hospital-based status during the registration period. We plan to provide

information to EPs regarding their hospital-based status as early as possible (that is, no later than

early in each payment year). As indicated in the proposed rule, we will make a determination for

Medicare incentive payment purposes, as to whether or not an EP is hospital-based by annually

analyzing an EP's claims history from the prior year. In the proposed rule we indicated that we

would use claims data from the prior calendar year to make hospital-based determinations for

EPs. However, in order to provide information regarding the hospital-based status of each EP at

the beginning of each payment year, we will need to use claims data from an earlier period.

Therefore, we will use claims data from the prior fiscal year (October through September).

Under this approach, the hospital-based status of each EP would be reassessed each year, using

claims data from the fiscal year preceding the payment year. The hospital-based status will be

available for viewing beginning in January of each payment year. For Medicaid purposes, State

Medicaid agencies will make the determination about whether or not an EP is hospital-based by

analyzing an EP's Medicaid claims data, or in the case of EPs who deliver care via Medicaid

managed care programs, by analyzing either encounter data or other equivalent data sources, at

the State's option. For purposes of making this determination, States would be permitted to use

data either from the prior fiscal or calendar year.

After consideration of the public comments received, we are revising the definition of

hospital based EPs in this final rule. An EP will be defined as being hospital-based and therefore

ineligible to receive an EHR incentive payment under either Medicare or Medicaid, regardless of
CMS-0033-F 367

the type of service provided, if more than 90 percent of their services are identified as being

provided in places of service classified under two place of service codes 21 (Inpatient Hospital)

or 23 Emergency Room, Hospital. We plan to reassess the hospital-based status of each EP for

Medicare purposes each year, using claims data from the fiscal year immediately preceding the

payment year. Based on preliminary claims data from the first 9 months of 2009, CMS currently

estimates that, under this final definition of hospital-based EPs, about 14 percent of Medicare

EPs (physicians) would be considered hospital-based and thus not eligible to receive any

incentive payments. We do not have any data on Medicaid practitioners.

7. Interaction with Other Programs

In the proposed rule, we described how the HITECH Act addresses interactions between

the Medicare EHR incentive program and the E-prescribing Incentive Program authorized by

MIPPA. Under section 1848(m)(2)(D) of the Act, as added by section 4101(f)(2)(B) of the

HITECH Act, if a Medicare FFS or MA EP receives an incentive payment from the Medicare

EHR incentive program, the EP (or group practice) is not eligible to also receive the incentive

payment under the E-prescribing Incentive Program created by MIPPA. Given the payment

timelines in this final rule for the Medicare EHR incentive program and the existing payment

timeline for the E-prescribing Incentive Program, we will know whether an EP received a

Medicare EHR incentive payment before the e-prescribing Incentive Program payment is

calculated. Thus we will exclude those EPs (or group practices) who accept a Medicare EHR

incentive payment for a given year from being eligible for the e-prescribing Incentive Program

payment for that same year. EPs receiving a Medicaid EHR incentive payment would remain

eligible for the Medicare MIPAA E-Prescribing Incentive Program payment.

CMS-0033-F 368

As the HITECH Act does not specify any other restrictions on participation in other

programs and participation in the Medicare and Medicaid EHR incentive programs, we do not

propose any other restrictions. There may be opportunities to avoid duplication of reporting

requirements among our various programs. In section II.A.3. of this final rule, we discuss how

we will avoid duplication of reporting requirements for clinical quality measures.

Comment: Some commenters requested more information on efforts to avoid duplication

of requirements and highly encouraged CMS to do everything it could in this regard.

Response: We address comments on the avoidance of duplication of requirements in

several other areas of this rule where more specifics can be provided.

Comment: Commenters generally supported our proposal to only apply the limitation of

participation in multiple programs to the limitation outlined in the HITECH Act.

Response: We continue to believe that providers should be able to participate in every

program for which they are statutorily eligible and therefore are maintaining our proposal to only

limit Medicare EPs from receiving either the Medicare EHR incentive payment or the Medicare

E-Prescribing incentive payment.

B. Medicare Fee-for Service Incentives

1. Incentive Payments for Eligible Professionals (EP)

Section 1848(o)(1)(A) of the Act, as amended by section 4101(a) of the HITECH Act,

provides for incentive payments to EPs who are meaningful users of certified EHR technology

during the relevant EHR reporting periods. Section 1848(o)(1)(A)(i) of the Act provides that

EPs who are meaningful EHR users during the relevant EHR reporting period are entitled to an

incentive payment amount, subject to an annual limit, equal to 75 percent of the Secretary's

estimate of the Medicare allowed charges for covered professional services furnished by the EP
CMS-0033-F 369

during the relevant payment year. Under section 1848(o)(1)(B)(ii)(VI) of the Act, an EP is

entitled to an incentive payment for up to 5 years. In addition, in accordance with section

1848(o)(1)(A)(ii) of the Act, there shall be no incentive payments made with respect to a year

after 2016. The incentive payments would be disbursed from the Federal Supplementary

Medical Insurance Trust Fund, as provided for under section 1848(o)(1)(A)(i) of the Act. As

noted in section II.A. of this final rule, EPs who qualify for both the Medicare and Medicaid

incentive payments must elect to receive payments from one program or the other.

a. Definitions

In accordance with section 1848(o)(5)(C) of the Act, we will add a definition of the term

"eligible professional" in our regulations at §495.100 to mean a physician as defined under

section 1861(r) of the Act. Section 1861(r) of the Act defines the term "physician" to mean the

following five types of professionals, each of which must be legally authorized to practice their

profession under state law: a doctor of medicine or osteopathy, a doctor of dental surgery or

dental medicine, a doctor of podiatric medicine, a doctor of optometry, or a chiropractor. As

discussed in section II.B.1.a of this final rule, in accordance with section 1848(o)(1)(C) of the

Act, hospital-based EPs are not eligible for an incentive payment.

Section 1848(o)(5)(A) of the Act defines covered professional services as having the

same meaning as in section 1848(k)(3) of the Act, that is, services furnished by an eligible

professional for which payment is made under, or is based on, the Medicare physician fee

schedule.

In accordance with section 1848(a)(1) of the Act, the Medicare allowed charge for

covered professional services is the lesser of the actual charge or the Medicare physician fee

schedule amount established in section 1848 the Act. As specified under section
CMS-0033-F 370

1848(o)(1)(A)(i) of the Act, the Secretary's estimate of allowed charges is based on claims

submitted to Medicare no later than 2 months following the end of the relevant payment year.

We proposed to codify these specifications and definitions in our regulations at 495.102.

Comment: The commenters who expressed concerns about the EP definition under the

Medicare program had one overall theme. It is that the definition is too narrow and that it should

be more inclusive of other health professionals in order to serve the goals of the HITECH Act.

The commenters stated that they believe that the intent of the electronic health records (EHR)

legislation is to encompass a wide range of health professionals to incorporate efficient and

effective EHR technology. Specifically, these commenters stated that the Medicare EP

definition should be expanded to include nonphysician practitioners and health professionals

such as physician assistants (PAs), nurse practitioners (NPs), clinical nurse specialists (CNSs),

certified nurse- midwives (CNMs), clinical psychologists (CPs), clinical social workers (CSWs),

certified registered nurse anesthetists (CRNAs), registered nurses (RNs), occupational therapists

(OTs), and credentialed pedorthists who make shoes for diabetic patients. Additionally, we

received a comment that the Medicare EP definition should recognize health professionals who

provide health support services as members of an interdisciplinary health care team such as a

team consisting of diabetes nurse educators, NPs, pharmacists, PAs, dieticians, and case

managers.

Representatives of rural health clinics (RHCs), Federally qualified health centers

(FQHCs), ambulatory surgical centers (ASCs), outpatient clinics and dialysis facilities

commented that their providers should also be included under the Medicare EP definition to

qualify for Medicare incentive payments. These providers believe that they are a key set of

contributors that will implement and meaningfully utilize electronic health care record program
CMS-0033-F 371

modules that directly benefit their patient populations. Alternatively, one of these commenters

recommended that provider eligibility should be determined by type of service provided rather

than by location of service and should include non-physician clinicians and providers.

The sub-theme of the comments that we received on the Medicare EP definition is that the

definition of an "eligible provider" that qualifies for EHR incentive payments should be a

common definition for the Medicare and Medicaid programs. The commenters believe that a

uniform definition of an EP would be more administratively efficacious for the Medicare and

Medicaid programs considering that EPs are permitted to switch participation between the

Medicare and Medicaid incentive programs one-time after the initial payment year.

An organization representing pathologists expressed concern that the Medicare EP

definition, as currently drafted would subject certain pathologists to payment incentive penalties

for not being meaningful EHR users if the pathologists performed less than 90 percent of their

professional services in any inpatient or outpatient setting in the prior year. All EPs have to

report on all Core Measures and a subset of clinical measures that pathologists could not meet in

their day-to-day practice given the nature of pathology’s scope of practice. Accordingly, this

organization recommended that CMS ensure that pathologists who are currently defined as

Medicare EPs be considered as "non-qualifying" EPs, that are exempt from future meaningful

user penalties.

Response: While we appreciate the comments that we received on the Medicare EP

definition, we are unable to expand or alter this statutory definition or consolidate it with the

Medicaid program EP definition as suggested by the commenters. Under the EHR incentive

payment program, the law provided a separate Medicare EP definition rather than giving the

Secretary authority or discretion to determine who is a Medicare EP or, who is an EP for both the
CMS-0033-F 372

Medicare and Medicaid programs.

Comment: A commenter requested clarification of the method used for determining

Medicare incentives for EPs practicing in a rural health clinic.

Response: The amount of the EHR incentive payment is based on the estimated allowed

charges for all covered professional services furnished by an EP during the payment year, subject

to the maximum payment amount for the payment year for the EP. For EPs that practice in an

RHC, EHR incentive payments are based on the amount of covered professional services that are

not part of the RHC package of services and are billed by the EP through the physician fee

schedule.

Comment: A commenter suggested that the definition of allowable charges be amended

to include the RHC schedule of services, or allow providers who use UB92 and HCFA 1500

forms to be eligible for the EHR incentive payment.

Response: The allowed charge is the amount that Medicare determines to be reasonable

payment for a provider or service under Part B, including coinsurance and deductibles. RHC

services furnished by an EP are not considered covered professional services for purposes of the

Medicare EHR because they are not billed or paid under the physician fee schedule.

After consideration of the public comments received on the term, "eligible professional"

for the Medicare program, we are adopting the Medicare EP definition in our regulations at

§495.100 that state that a Medicare EP is a physician as defined under §1861(r) of the Social

Security Act. That is, a Medicare EP is a doctor of medicine or osteopathy, a doctor of dental

surgery or dental medicine, a doctor of podiatric medicine, a doctor of optometry, or a

chiropractor and a doctor who is legally authorized to practice their profession under State law.
CMS-0033-F 373

b. Incentive Payment Limits

Section 1848(o)(1)(B)(i) of the Act sets forth the annual limits on the EHR-related

incentive payments to EPs. Specifically, section 1848(o)(1)(B) of the Act provides that the

incentive payment for an EP for a given payment year shall not exceed the following amounts:

• For the EP's first payment year, for such professional, $15,000 (or, $18,000 if the EP's

first payment year is 2011 or 2012).

• For the EP's second payment year, $12,000.

• For the EP's third payment year, $8,000.

• For the EP's fourth payment year, $4,000.

• For the EP's fifth payment year, $2,000.

• For any succeeding year, $0.

Under section 1848(o)(1)(B)(iv) of the Act, for EPs who predominantly furnish services in a

geographic HPSA (as designated by the Secretary under section 332(a)(1)(A) of the Public

Health Service (PHS) Act), the incentive payment limitation amounts for each payment year are

increased by 10 percent. Section 1848(o)(1)(B)(iii) of the Act also provides for a phased

reduction in payment limits for EPs who first demonstrate meaningful use of certified EHR

technology after 2013. Specifically, if the EP's first payment year is after 2013, then the annual

limit on the incentive payment equals the annual limit applicable to an EP whose first payment

year is 2013. Accordingly, if the EP's first payment year is 2014, the EP's maximum incentive

payment will be $12,000 in 2014, $8,000 in 2015, and $4,000 in 2016. Section 1848(o)(1)(B)(v)

of the Act provides that if the EP's first payment year is after 2014, then the applicable incentive

payment limit for such year and any subsequent year shall be $0. In other words, an EP who
CMS-0033-F 374

does not qualify to receive an EHR-related incentive payment prior to 2015 will not receive any

of these incentive payments.

Comment: One commenter believes that the methodology for determining the incentive

payments under the incentive program does not offer each EP an equal incentive, despite being

held to the same standards of adoption and implementation.

Response: We are uncertain why the commenter believes that the methodology for

determining the incentive payments under the incentive program does not offer each EP an equal

incentive to adopt EHR technology. However, the payment methodology in the statute for EPs

(as well as the methodologies for hospitals and CAHs) is quite prescriptive, and offers no

discretion for us to adopt revisions designed to enhance incentives for adoption. For EPs, the

HITECH Act defines the incentive payment amount as, "an amount equal to 75 percent of the

Secretary’s estimate…of the allowed charges under this part of all such covered professional

services furnished by the eligible professional during such year."

c. Increase in Incentive Payment for EPs who Predominantly Furnish Services in a Geographic

Health Professional Shortage Area (HPSA)

Section 1848(o)(1)(B)(iv) of the Act provides that the amount of the annual incentive

payment limit for each payment year be increased by 10 percent for EPs who predominantly

furnish services in an area that is designated by the Secretary (under section 332(a)(1)(A) of the

PHS Act) as a geographic health professional shortage area (HPSA). This section of the PHS

Act refers to geographic HPSAs, which are areas that have been designated by the Secretary as

having a shortage of health professionals, based on the population-to-provider ratio and other

factors. HPSAs are located in every State, and in both rural and urban areas.
CMS-0033-F 375

Geographic HPSAs are defined in 42 CFR Part 5 and include primary medical care,

dental, and mental health HPSAs. In accordance with the statute, we will increase the limits per

payment year by 10 percent for EHR-related incentive payments to EPs who predominantly

furnish covered professional services in a geographic primary medical care, dental, or mental

health HPSA.

We proposed that for an EP to be considered as "predominantly" furnishing covered

professional services in a geographic HPSA, more than 50 percent of the EP's covered

professional services must be furnished in a geographic HPSA. We stated that using "more than

50 percent" as the criterion to define "predominantly" is consistent with how the term is defined

in general parlance as well as how the definition is used for purposes of other aspects of the

Medicare program. Our data indicates that most physicians furnishing services in a HPSA

furnish 100 percent of their covered services in a HPSA, and only very few furnish services in

both HPSA and non-HPSA areas.

To determine whether an EP has furnished more than 50 percent of his/her covered

professional services in a geographic HPSA, we proposed to utilize frequency of services

provided over a 1-year period from January 1 to December 31, rather than basing it on the

percentage of allowed charges. We proposed to make the incentive payment to the EP based on

an EP's estimated allowed charges for the relevant payment year.

We proposed that once we compile a full year of data, we would determine eligibility for

the EHR HPSA payment limit increase for the payment year based on whether the EP provided

more than 50 percent of his/her services in a geographic HPSA during the payment year. The

determination would be made based on claims submitted not later than 2 months after the end of

the year. If we determine that the EP provided more than 50 percent of his/her services in a
CMS-0033-F 376

geographic HPSA and is therefore eligible for the EHR HPSA payment limit increase, we would

then make an additional lump sum payment to reflect that increased limit amount based on the

estimated allowable charges for that EP for the prior year. The additional amount would be paid

no later than 120 days after the end of the prior year for which the EP was eligible for the 10

percent EHR HPSA payment limit increase.

Most physicians furnishing services in a HPSA furnish 100 percent of their covered

services in a HPSA. Section 1848(o)(1)(B)(iv) of the Act also authorizes us to apply the

provisions of sections 1833(m) and (u) of the Act in implementing this 10 percent EHR HPSA

payment limit increase, as the Secretary determines appropriate. Section 1833(m) of the Act

establishes the HPSA bonus program, which provides a 10 percent bonus to physicians who

furnish Medicare covered professional services in a geographic HPSA.

Section 1833(m)(1) of the Act provides that physicians who furnish covered professional

services in a year in an area that is designated as a geographic HPSA prior to the beginning of

the year are eligible to receive the HPSA bonus for services furnished during the current year.

We have interpreted this to mean that bonus payments should continue throughout the current

year, even if the area loses its designation as a geographic HPSA during the current year.

Physicians furnishing Medicare-covered professional services in an area that is not designated as

a geographic HPSA by December 31 of the prior year are not eligible to receive the HPSA bonus

for the current year, even if the area is subsequently designated as a geographic HPSA during the

current year. We will apply these same rules for the 10 percent EHR HPSA payment limit

increase provided under section 1848(o)(1)(B)(iv) of the Act.

Section 1833(m)(2) of the Act also provides that geographic HPSAs that consist of an

entire county be identified and the bonus paid automatically. We publish a list annually of the
CMS-0033-F 377

zip codes that are in these areas on our website at

http://www.cms.hhs.gov/HPSAPSAPhysicianBonuses/01_Overview.asp#TopOfPage.

Physicians furnishing Medicare-covered professional services in a zip code that is on this list

automatically receive the HPSA bonus payment. Physicians furnishing Medicare covered

professional services in a zip code that is not on this list but that was designated as a geographic

HPSA as of December 31 of the prior year must use a modifier when submitting a Medicare

claim in order to receive the HPSA bonus.

Comment: We received a comment stating that many EPs who work in a HPSA do so

only on a part- time basis and that most would not qualify for the 10 percent increase in the

payment limit based on the proposed threshold of furnishing more than 50 percent of his/her

covered professional services in a geographic HPSA. The commenter suggested that an EP

should be able to qualify for the ten percent increase in the payment limit if at least 25 percent of

his/her covered services during an EHR reporting period are furnished in a HPSA.

Response: The statute states that the annual payment limit be increased by ten percent

for EPs who predominantly furnish services in a geographic HPSA. We continue to believe that

"more than fifty percent" correctly reflects the meaning of the word "predominantly" as used in

this statute. As noted above, our data also indicate that most physicians furnish all of their

services either in a HPSA or outside of a HPSA, and only very few furnish services in both

HPSA and non-HPSA areas.

Comment: Several commenters requested that Federally Qualified Health Centers

(FQHCs) be eligible to receive the ten percent increase in the payment limit for EPs who

predominantly furnish services in a HPSA since the FQHC is a legal entity that bills Medicare

and receives payment for services provided by physicians.

CMS-0033-F 378

Response: The 10 percent increase in the payment limit applies to EPs who

predominantly furnish services in a geographic HPSA. FQHCs and RHCs are not eligible for the

ten percent increase in the payment limit because they do not meet the definition of EP as

specified in section 1848(o)(5)(C) of the Act. Please see others sections of the regulation that

discuss the criteria to be considered an EP. Additionally, we wish to restate that FQHCs are not

entitled to any Medicare or Medicaid incentive payments under this program.

Comment: A commenter suggested that "predominantly" be defined as the location

where the EP provides the most services, so that an EP who sees patients in more than two

locations could receive the increase in the payment limit if he/she provided more care in the

HPSA location than any other location. The commenter also suggested that if this is too difficult

to administer, we should accept an attestation from the EP.

Response: We are aware that many physicians, especially in rural areas, furnish services

in more than one location, and appreciate the commenter’s interest in making the HPSA payment

limit increase available to these EPs. If we were to accept this recommendation, then an EP who

worked in three locations at forty percent, thirty percent, and thirty percent time respectively,

would be eligible for the HPSA payment limit increase if the first location was in a geographic

HPSA. If the EP worked in four locations at thirty percent, twenty-five percent, twenty five

percent, and twenty percent time respectively, he/she would be eligible for the HPSA payment

limit increase if the first location was in a geographic HPSA. We considered this suggestion and

concluded that lowering the threshold for services furnished in a HPSA would be inconsistent

with the intent of the HPSA payment limit increase, which is to provide an incentive to promote

the use of EHR by EPs who practice predominantly in HPSAs. Also, if an EP who worked in

more than two locations and furnished services in a HPSA only thirty or forty percent of his/her
CMS-0033-F 379

time was eligible for the HPSA payment limit increase, this would be unfair to an EP who

worked in two locations and spent forty-five percent of his/her time in a HPSA and fifty-five

percent time in a non-HPSA, because this EP would not be eligible for the HPSA payment limit

increase even though he/she spent more total time in a HPSA.

Comment: A commenter stated that the proposed HPSA payment limit increase was

being applied inconsistently because an EP would still get the payment limit increase if the

designation was removed mid-year, and would not get the payment limit increase if the

designation was added mid-year.

Response: Section 1848(o)(1)(B)(iv) of the Act authorizes us to apply the provisions of

the HPSA bonus program to the implementation of the EHR HPSA payment limit increase. The

HPSA bonus is paid to physicians who furnish Medicare-covered professional services in an area

that is designated as a geographic HPSA as of December 31 of the prior year. They are

authorized to receive the HPSA bonus throughout the current year, even if the area loses its

designation as a geographic HPSA during the current year. Physicians furnishing Medicare-

covered professional services in an area that is not designated as a geographic HPSA as of

December 31 of the prior year are not eligible to receive the HPSA bonus for the current year,

even if the area is subsequently designated as a geographic HPSA during the current year. We

proposed to use the same methodology for the HPSA EHR program, and believe that this is

consistent with the statute.

After consideration of the public comments received, we are finalizing these provisions

as proposed.
CMS-0033-F 380

d. Form and Timing of Payment

Section 1848(o)(1)(D)(i) of the Act, as amended by section 4101(a) of the HITECH Act,

provides that the incentive payments may be disbursed as a single consolidated payment or in

periodic installments as the Secretary may specify. We proposed to make a single, consolidated,

annual incentive payment to EPs. Payments would be made on a rolling basis, as soon as we

ascertained that an EP had demonstrated meaningful use for the applicable reporting period (that

is, 90 days for the first year or a calendar year for subsequent years), and reached the threshold

for maximum payment.

Section 1848(o)(1)(A) of the Act provides that "with respect to covered professional

services provided by an eligible professional," the incentive payment "shall be paid to the

eligible professional (or to an employer or facility in the cases described in clause (A) of section

1842(b)(6))." Section 1842(b)(6)(A) of the Act allows for reassignment to an employer or entity

with which the physician has a valid contractual arrangement allowing the entity to bill for the

physician's services. Therefore, we proposed that EPs would be allowed to reassign their

incentive payment to their employer or an entity which they have a valid employment agreement

or contract providing for such reassignment, consistent with all rules governing reassignments.

We proposed to preclude an EP from reassigning the incentive payment to more than one

employer or entity. To implement this requirement, we proposed to use the EP's Medicare

enrollment information to determine whether an EP belongs to more than one practice (that is,

whether the EP's National Provider Identifier (NPI) is associated with more than one practice).

In cases where the EP was associated with more than one practice, we proposed that EPs would

select one tax identification number to receive any applicable EHR incentive payment.

As mentioned above, we proposed that payments would be made on a rolling basis, as

CMS-0033-F 381

soon as we ascertain that an EP has demonstrated meaningful use for the applicable reporting

period (that is, 90 days for the first year or a calendar year for subsequent years), and reached the

threshold for maximum payment. We proposed to add a new part 495.10 (e) and (f) to permit

reassignment of the incentive payment with certain limitations. The following is a summary of

the comments we received and our responses.

Comment: Several commenters, including one representing Rural Health Clinics,

requested clarification of the statement in the proposed rule (75 FR 1910) that an eligible

professional (EP) is allowed to reassign his/her EHR incentive payment to an employer or other

entity to which the EP has reassigned his/her payments for Medicare covered services. The

commenters believe that the HITECH Act requires in such cases that any Medicare EHR

incentive for which the EP qualifies must be paid to such employer or other entity. The

commenters reference the phrases from the HITECH Act, "shall be paid" to an eligible

professional (or to an employer or facility in cases described in the reassignment provisions of

the Social Security Act). In addition, the commenters referenced the phrase regarding the

transfer of an EP’s Medicaid EHR incentive which states that "such incentives are paid directly

to such provider (or to an employer or facility to which such provider has assigned payments)".

The commenters interpret these phrases to mean that an EP’s EHR incentive payments (both

Medicare and Medicaid) must be paid to an employer or other entity to which the EP has

reassigned payments for his/her services.

Response: We do not agree with the commenters’ conclusions regarding to whom the

payments must be made. As we stated in the proposed rule, Section 1842(b)(6) of the Act

allows, but does not require reassignment to an employer or entity with which the physician has

a valid contractual arrangement allowing the employer or entity to bill for the physician’s
CMS-0033-F 382

services. The HITECH Act provisions cited by the commenter similarly do not require that the

EHR incentive payment be made pursuant to a reassignment, but provide that the payment may

be made directly to the EP or to the employer or other entity. A physician reassigns payment

based on the scope of his or her employment or contractual arrangement. Based upon our

interpretation of the applicable provisions, we are finalizing our proposal at §495.10(f) to permit

EPs to reassign their incentive payments to their employer or to an entity with which they have a

contractual arrangement, consistent with all rules governing reassignments including part 424,

subpart F.

We are taking this opportunity to remind the public that if the EP wishes to reassign his

or her incentive payment to the employer or entity with which the EP has a contractual

arrangement, the parties should review their existing contract(s) to determine whether the

contract(s) currently provides for reassignment of the incentive payment or if the contract(s)

needs to be revised. Reassignment of the incentive payment must be consistent with applicable

Medicare laws, rules, and regulations, including, without limitation, those related to fraud, waste,

and abuse. For Medicaid, a discussion of reassignment of the incentive payment is found in

section II.D.3.e of this final rule "Entities Promoting the Adoption of Certified EHR

technology."

Comment: Several commenters stated that the rationale and objectives of the HITECH

Act provisions regarding transfer of the EP’s EHR incentives are merely to align EHR incentives

and EHR costs. Therefore, they believe that the HITECH Act provisions support their view that

Congressional intent was to prevent windfall EHR incentives to EPs who incur no EHR-related

costs. The commenters also asserted that CMS’s failure to address this issue will require entities

that employ or contract with EPs to enter into negotiations and a separate agreement transferring
CMS-0033-F 383

the EP’s EHR incentive payments to the employer or other entity.

Response: We do not agree with the commenters’ statement that the Congress intended

to prevent windfall EHR incentives to EPs who incur no EHR-related costs. Title IV, Division B

of the HITECH Act establishes incentive payments under the Medicare and Medicaid programs

for certain professionals and hospitals that meaningfully use certified EHR technology. The

provisions are not focused solely upon the costs associated with the EHR technology. Rather, as

we stated in the proposed rule (75 FR 1849), it focuses upon the adoption, implementation,

upgrade, or meaningful use of the technology.

However, we do agree that some entities may have to review and/or negotiate current

contractual arrangements to address the transfer of the incentive payments. The first payment

year for the incentive payment is CY 2011, which we believe should afford parties sufficient

time to reach a new agreement. For Medicaid, a discussion of reassignment of the incentive

payment is found in section II.D.3.e of this final rule "Entities Promoting the Adoption of

Certified EHR technology."

Comment: Several commenters supported our proposal that if an EP has reassigned his

or her payments for services to more than one employer or entity, that only one of those

employers or entities should receive the EP’s EHR incentive payments for a particular EHR

Reporting Period (75 FR 1910). The commenters do not believe that EPs should decide which

employer or entity should receive his or her EHR incentive payment. Rather, the commenters

stated that such payments should automatically be paid to the employer or entity that has

received for the reporting period the largest percentage of the EP’s Medicare or Medicaid

payments for services.

Response: We are not persuaded to adopt the commenters' suggestion. We believe that
CMS-0033-F 384

the suggestion by the commenters would create administrative complexities for both CMS and

EPs with little benefit. Many of these obstacles would be similar to those described in the

proposed rule when discussing the possibility of making proportional EHR incentive payments

(75 FR 1911). Therefore, we are finalizing our proposal to revise §495.10(e) to preclude an EP

from reassigning the incentive payment to more than one employer or entity. In cases where the

EP is associated with more than one practice, EPs must select one TIN to receive any applicable

EHR incentive payment.

Comment: The commenters also state that if an EP has incurred out-of-pocket costs in

connection with an EHR provided by an employer or other entity to which the EP has reassigned

payments for his or her services, the EP should be permitted to keep an amount of his or her

EHR incentives equal to the amount of such costs incurred.

Response: The statute does not address this issue. It simply provides that the incentive

payments are to be made directly to the EP or to an employer or other entity to which the EP has

reassigned the incentive payment. Reassignment of the incentive payment must be consistent

with applicable Medicare laws, rules, and regulations, including, without limitation, those related

to fraud, waste, and abuse. We believe that any cost-sharing or subsequent distribution of the

incentive payment, such as in the manner described by the commenter, should be resolved

between the parties.

Comment: Several commenters urged CMS to clarify that any reassignment of the EP’s

EHR incentive payment should not constitute a financial arrangement within the meaning of the

physician self-referral law, or remuneration within the meaning of the federal anti-kickback

statute.

Response: The physician self-referral law prohibits a physician from making a referral
CMS-0033-F 385

for designated health services to an entity with which the physician or a member of the

physician’s immediate family has a financial relationship, unless an exception applies. For

purposes of the physician self-referral law, a financial arrangement includes ownership or

investment interests and compensation arrangements. The statute defines a "compensation

arrangement" to mean any arrangement involving remuneration, direct or indirect, overt or

covert, in cash or in kind. A reassignment of an EP’s EHR payment would constitute

remuneration, and we note that reassignment generally occurs in the context of an existing

compensation arrangement (for example, employment). There are many potentially applicable

exceptions for compensation arrangements that involve a physician’s reassignment of Medicare

payments.

Similarly, with respect to the anti-kickback statute, absent compliance with a safe harbor,

a determination of whether a reassignment constitutes prohibited remuneration would be made

on a case-by-case basis and we therefore decline to issue any statement regarding the application

of the anti-kickback statute to a reassignment. For additional information regarding the

anti-kickback statute, please refer to the OIG’s website at http://oig.hhs.gov.

Comment: One commenter representing American Indian and Alaska Native health

providers urged CMS to require that the HITECH/EHR Meaningful Use provider incentive

payments be reassigned to the Tribal outpatient clinics, because the Tribal clinics developed the

infrastructure not the EPs themselves, and purchased electronic medical record systems to

complement the current Registration Patient Management Systems (RPMS) of the Indian Health

Service. In addition, the commenter noted that many tribal outpatient clinics have employment

contracts with their EPs. Thus, the commenters urged CMS to require that incentive EHR

payments should be included in employment contracts to help protect the EP as employee and
CMS-0033-F 386

the Tribe as the employer.

Response: As stated above, section 1848(o)(1)(A) of the Act provides that the EP’s

incentive payment shall be paid to the eligible professional (or to an employer or other entity

with which the physician has a valid contractual arrangement allowing the employer or other

entity to bill for the physician's services). We recognize that some tribes purchased EHR

systems based upon criteria established by the Indian Health Service. However, after careful

consideration, we believe that the same standards concerning the incentive payments should

apply. The EP and the Tribal outpatient clinic should jointly resolve whether the EP's EHR

incentive payment will be reassigned to the Tribal outpatient clinic or made directly to the EP.

Similarly, any decision by the Tribal outpatient clinic concerning whether to include language in

its employment contract (or in the alternative, whether any pre-existing contract already requires

reassignment of the payment), is a matter of contract interpretation that should be resolved by the

parties themselves. This discussion is also addressed in the Medicaid section of this rule at

II.D.4.a.3.

Comment: One commenter expressed concern about the potential tax consequences

associated with an EP’s reassignment of the EHR incentive payment by an independent

contractor to a larger organization. The commenter recommended that a 1099 independent

contractor should consult with his/her tax advisor before agreeing to reassign incentive payments

and to ensure that the election to reassign is made before payment is sent from CMS or the State

Medicaid Agency.

Response: The commenter's recommendation falls outside the scope of our authority.

This is a matter for the 1099 independent contractor EP to consider.

Comment: Many national and state medical associations expressed concern regarding the
CMS-0033-F 387

proposed requirement that the EP must identify a Tax Identification Number (TIN) to which the

EP’s incentive payment should be made. They assert that this will not work for physicians who

do not have a TIN, and are enrolled in Medicare or Medicaid through their Social Security

Number (SSN). Therefore, the commenters recommend that CMS accept the SSN in lieu of the

TIN, so that all eligible physicians are able to participate in the Medicare and Medicaid EHR

incentive programs.

Response: We recognize that many physicians are enrolled in Medicare or Medicaid

through their Social Security Number (SSN). Therefore, we are revising our proposal at §495.10

that an EP must submit, in a manner specified by CMS, the Taxpayer Identification Number

(TIN) to which the EP’s incentive payment should be made. In finalized §495.10(c), we provide

that the TIN may be the EP's Social Security Number (SSN) to which the EP’s incentive

payment should be made. We note that if the physician is part of a group with more than one

owner or organization that is incorporated, they would have a TIN for the corporation that is not

the EP’s SSN.

Comment: Some commenters recommended that the employer or entity to which an EP

reassigns payment for covered services, should be deemed authorized to provide, on the EP’s

behalf, any documentation necessary for the EP to qualify for EHR incentive payments.

Response: We believe that this should be resolved by the parties themselves. There is

nothing in the statute that requires an EP’s employer or other entity to which an EP reassigns

payment to provide any necessary documentation for an EP to qualify for EHR incentive

payments. Rather, the finalized regulatory provision at §495.8 provides that an EP must

demonstrate that he or she satisfies each of the applicable objectives and associated measures

under §495.6. If the parties wish to have the necessary documentation furnished by the employer
CMS-0033-F 388

or entity, they should resolve this pursuant to an employment or contractual agreement.

We are finalizing our proposal because we believe that making a single, consolidated payment

would be the least administratively burdensome for both CMS and EPs. In addition, we believe

a single, consolidated payment would reduce the possibility of fraud and duplicate payments.

Several of these issues related to reassignment of payment are also addressed in the Medicaid

section. See II.D.3.e.

e. Payment Adjustment Effective in CY 2015 and Subsequent Years for EPs who are not

Meaningful Users of Certified EHR Technology

Section 1848(a)(7) of the Act, as amended by section 4101(b) of the HITECH Act,

provides for payment adjustments effective for CY 2015 and subsequent years for EPs who are

not meaningful EHR users during the relevant EHR reporting period for the year. In general,

beginning in 2015, if an EP is not a meaningful EHR user for any EHR reporting period for the

year, then the Medicare physician fee schedule amount for covered professional services

furnished by the EP during the year (including the fee schedule amount for purposes of

determining a payment based on the fee schedule amount) is adjusted to equal the "applicable

percent" of the fee schedule amount (defined below) that would otherwise apply. The HITECH

Act includes a significant hardship exception, discussed below, which, if applicable, could

exempt certain EPs from this payment adjustment. The payment adjustments do not apply to

hospital-based EPs.

The term "applicable percent" means: "(I) for 2015, 99 percent (or, in the case of an EP

who was subject to the application of the payment adjustment if the EP is not a successful

electronic prescriber under section 1848(a)(5) for 2014, 98 percent); (II) for 2016, 98 percent;

and (III) for 2017 and each subsequent year, 97 percent."

CMS-0033-F 389

In addition, section 1848(a)(7)(iii) of the Act provides that if for 2018 and subsequent

years the Secretary finds that the proportion of EPs who are meaningful EHR users is less than

75 percent, the applicable percent shall be decreased by 1 percentage point from the applicable

percent in the preceding year, but in no case shall the applicable percent be less than 95 percent.

Significant Hardship Exception—section 1848(a)(7)(B) of the Act provides that the Secretary

may, on a case-by-case basis, exempt an EP who is not a meaningful EHR user for the year from

the application of the payment adjustment if the Secretary determines that compliance with the

requirements for being a meaningful EHR user would result in a significant hardship, such as in

the case of an EP who practices in a rural area without sufficient Internet access. The exemption

is subject to annual renewal, but in no case may an EP be granted a hardship exemption for more

than 5 years.

Comment: Some commenters believed that when an EP’s performance leads to a negative

financial impact under Medicare payment policy, it would be unfair and overly punitive for them

to face a separate and potentially more significant financial impact – whether through a denial of

funding and/or ARRA’s penalties. Further, some commenters indicated that they interpreted

these requirements to mean that Medicaid participants would or would not experience

fee-schedule adjustments if they are not meaningful users by the end of 2014.

Response: We will reduce payments as specified under the statute. Under sections

4101(b) and (c) of the HITECH Act, we are required to pay EPs less than 100 percent of the fee

schedule and to make downward adjustments to MA-affiliated EPs for their professional services

if they are not meaningful users of certified EHR beginning in CY 2015. Under sections

4102(a), (a)(2), and (c) of the HITECH Act, we are authorized to pay eligible hospitals a reduced

annual payment update, provide downward payment adjustment to CAHs for cost reporting
CMS-0033-F 390

periods, and provide downward payment adjustment to MA-affiliated hospitals respectively, if

they are not meaningful users of certified EHR technology beginning in FY 2015. The Medicare

fee schedule adjustments will impact any EP or subsection(d) hospital that is not a meaningful

user by the end of 2014. The adjustments are not authorized under Medicaid, but the adjustments

will still apply to Medicaid EPs who are also Medicare EPs and also to Medicaid acute care

hospitals that are also subsection(d) hospitals.

We are finalizing these provisions as proposed.

2. Incentive Payments for Hospitals

a. Definition of Eligible Hospital for Medicare

Section 1886(n) of the Act, as amended by section 4102(a)(1) of the HITECH Act,

provides for incentive payments, beginning in FY 2011 (that is, October 1, 2010 through

September 30, 2011) for eligible hospitals that are meaningful users of certified EHR technology

during the EHR reporting period for the payment year. In the proposed rule, we proposed a new

§495.104 to implement this provision. As we noted in the proposed rule, section 1886(n)(6)(B)

of the Act defines "eligible hospitals" for purposes of the incentive payments provision, as

"subsection (d) hospitals," referring to the definition of that term in section 1886(d)(1)(B) of the

Act. Section 1886(d)(1)(B) of the Act generally defines a "subsection (d) hospital" as a "hospital

located in one of the fifty States or the District of Columbia." The term therefore does not

include hospitals located in the territories or hospitals located in Puerto Rico. Section

1886(d)(9)(A) of the Act separately defines a "subsection (d) Puerto Rico hospital" as a hospital

that is located in Puerto Rico and that "would be a subsection (d) hospital if it were located in

one of the 50 states." Therefore, because section 4102(a)(1) of the HITECH Act does not refer

to "subsection (d) Puerto Rico hospitals," we proposed that incentive payments for meaningful
CMS-0033-F 391

users of certified EHR technology would not available under this provision to hospitals located

in Puerto Rico. The provision does apply to inpatient, acute care hospitals located in the State of

Maryland. These hospitals are not currently paid under the IPPS in accordance with a special

waiver provided by section 1814(b)(3) of the Act. Despite this waiver, the Maryland hospitals

continue to meet the definition of a "subsection (d) hospital" because they are hospitals located in

the 50 states. Therefore we proposed that incentive payments for meaningful users of certified

EHR technology would be available under this provision to acute care hospitals located in the

State of Maryland. The statutory definition of a subsection (d) hospital also does not apply to

hospitals and hospital units excluded from the IPPS under section 1886(d)(1)(B) of the Act, such

as psychiatric, rehabilitation, long term care, children's, and cancer hospitals. We also proposed

that, for purposes of this provision, we would provide incentive payments to hospitals as they are

distinguished by provider number in hospital cost reports. We proposed that incentive payments

for eligible hospitals would be calculated based on the provider number used for cost reporting

purposes, which is the CMS Certification Number (CCN) of the main provider (also referred to

as OSCAR number). Payments to eligible hospitals are made to each provider of record. The

criteria for being a meaningful EHR user, and the manner for demonstrating meaningful use, are

discussed in section B.2. of this final rule.

Comment: We received numerous comments on our proposal to identify all individual

hospitals eligible for incentive payments based on the provider number used for cost reporting

purposes (the CCN of the main provider). These commenters, including national and regional

hospital associations, hospital systems, and hospitals with multiple campuses, objected to the

proposed policy on various grounds. Many of these commenters pointed out that there is no

standard policy that defines the specific types of facilities to which a single CCN applies. As a
CMS-0033-F 392

result, a single CCN could encompass multiple hospitals within a hospital system in some cases,

while in other cases multiple hospitals within a system could have separate CCNs. These

commenters therefore maintained that our proposed policy would unjustifiably lead to disparate

treatment of hospital systems based solely on whether the system had one or more provider

numbers. Commenters also maintained that, because the Medicare and Medicaid payment

incentives are calculated using a per-hospital base amount, plus a capped per-discharge amount

per hospital, identifying individual hospitals solely by CCN would result in distributing

payments in a manner that does not foster widespread EHR adoption and use. The for this

argument regarding limited EHR adoption and use is that multi-campus systems with a single

CCN would receive only one base payment, and would be more likely to reach the discharge cap.

Some commenters also argued that linking incentive payments only to a single CCN would not

accurately reflect the pattern of costs required for deploying EHR systems across all sites in a

hospital system. For example, even hospital sites that are part of the same system often require

significant variations in their EHR systems, accommodating local policies and processes, as well

as different legacy systems, physician preferences, clinical protocols, and other variables. Some

commenters cited as a precedent our policy with regard to hospitals with one CCN, but multiple

sites spanning more than one wage index region. CMS has instructed such hospitals to report

wage data for each site separately on the cost report, and pays for discharges under the wage

index that applies where the service is provided, that is , under a different wage index for each

site.

These commenters recommended various approaches to recognizing and verifying the

status of separate hospitals under one CCN number. Many of them recommended that we adopt

a "multi-pronged approach that allows a "hospital" to be defined in ways that acknowledge the
CMS-0033-F 393

varied organizational structures of multi-hospital systems, including by a distinct CCN, a distinct

emergency department, or a distinct hospital license." Commenters recommended that we

indentify and verify the distinct hospitals within hospital systems either by revising the cost

report or by developing an attestation process similar to the process employed under §413.65 of

the regulations to verify provider-based status. Commenters also recommended that we either

collect the data necessary for determining payment amounts (for example, discharge counts)

directly from each hospital within a system with a single provider number, or develop a method

of allocating discharges, bed days, and other relevant data among the hospital campuses

represented in a hospital cost report under a single CCN.

Finally, a number of the commenters advocating a different approach contended that our

proposed policy ran counter to the intent of the EHR incentive provision, which is to promote

broader adoption of EHR systems. These commenters argued in various ways that recognizing

each campus of a multi-campus hospital for separate payment was most consistent with the

statute because it would provide a greater overall level of funding for EHR efforts, especially to

hospital systems that have elected to enroll multiple campuses under a single Medicare provider

agreement, and thus support diffusion of EHR systems more broadly. One of these commenters

did, however, acknowledge that "in most circumstances the term 'subsection(d) hospital' under

the Medicare Program includes all of a hospital system's inpatient facilities that operate under a

single provider number," before going on to argue that CMS has both the authority and the

obligation under the HITECH Act to diffuse EHR incentive payment more broadly by treating

each facility under a hospital system as a separate hospital, regardless of whether any of the

facilities share a single provider number.

Response: We appreciate the commenters’ concerns, but we continue to believe that our
CMS-0033-F 394

proposal represents the best policy approach in determining what constitutes an "eligible

hospital." In the absence of clear direction from the statute to the contrary, we believe that the

most appropriate policy is to interpret the terms in subsection (d) “acute care hospital" and

"children’s hospital" in the light of existing Medicare and Medicaid program policies and

precedents. It is quite true, as a number of the commenters noted, that hospital systems have

considerable latitude (although not unlimited) in choosing whether to obtain one CCN for all

their facilities, or to obtain separate CCNs for some or all of their facilities. However, once a

hospital has sought and obtained a single CCN for two or more facilities, that hospital has chosen

to represent itself to CMS as a single hospital, including for purposes of payment, cost reporting,

and satisfying the conditions of participation. Such systems submit unified cost reports

integrating data (including charges, discharges, bed days, and other relevant data) from every

facility under the single CCN. For purposes of DSH and IME payments under the IPPS, both

eligibility for payment and the applicable payment amounts are determined on the basis of this

integrated data. Most significantly, the Medicare conditions of participation require that a

system with a single CCN establish and maintain a single governing structure, medical staff,

nursing staff, and record services. Section 482.2 states that a "hospital must have an organized

medical staff that operates under by-laws approved by the governing body." Section 482.21(e)

states that the governing body must ensure, among other matters, that "the hospital-wide quality

assessment and performance improvement efforts address priorities for improved quality of

care." In addition, §482.24 states that the hospital must have "a medical record service that has

administrative for medical records.". For these reasons, we believe that recognition of the

decision made by each hospital or hospital to represent and organize itself as a single entity

under one CCN, or as two or more distinct entities under separate CCNs is a strength, rather than
CMS-0033-F 395

a weakness, of our proposed policy. Each institution that has exercised available latitude to

obtain one CCN for all their facilities not only represents itself as a single hospital, but also

agrees to conduct itself in significant ways as a single hospital.

We also do not agree with those commenters who argue that our policy of applying

different wage indexes to the campuses comprising a hospital system operating under a single

CCN warrants our treating each campus as a separate eligible hospital for purposes of the EHR

incentive payment program. Our policy for these few cases when a multi-campus hospital spans

two or more wage index areas does not amount to recognizing that each campus is a separate

hospital for payment purposes, but rather to accounting for the fact that, in these few cases, one

hospital is located in two wage index areas. In these cases, it is appropriate to pay, and to

account for wages, on the basis of where each discharge occurs rather than on the basis of where,

for example, the main campus of a hospital may be located.

With regard to the disparate treatment argument advanced by a number of commenters,

we acknowledge that, under our proposed policy, a single hospital system with two campuses

will receive (all other things being equal) lower incentive payments than the combined incentive

payments of two-single-campus hospitals with the same number of discharges. However, an

equivalent disparate treatment situation would arise under the policy advocated by these

commenters. Under the policy of recognizing each campus of a multi-campus system as a

separate hospital, a single-campus hospital would received lower incentive payments than a

multi-campus hospital with the same number of discharges, despite the fact that both hospitals

have a single CCN and are recognized for administrative and financial purposes, and for

purposes of the conditions of participation, as a single hospital.

Example: Hospital A is a multicampus hospital with 30,000 discharges and a Medicare

CMS-0033-F 396

share of 50 percent. Hospital A’s discharges are evenly split between its two campuses.

Hospital B is a single campus hospital with 30,000 discharges and a Medicare share of 50

percent. During the first year of the transition, each campus of Hospital A would receive a

separate incentive payment determined on the following manner:

($2,000,000 base amount + [(15,000 – 1,149) x $200] discharge-related amount) x .5 Medicare

share x 1.0 transition factor = ($2,000,000 + $2,770,200) x .5 x 1.0 = $2,385,100

Hospital A’s total payment would therefore be $4,770,200. In contrast, Hospital B would

receive a single payment determined in the following manner:

($2,000,000 base amount + [(23,000 – 1,149) x $200] discharge-related amount) x .5 Medicare

share x 1.0 transition factor = ($2,000,000 + $4,370,200) x .5 x 1.0 = $3,185,100.

Hospital B would thus receive a payment that is $1,585,100 smaller than Hospital A’s total

payment for the same number of discharges.

The change in policy recommended by these commenters will therefore replace one

equity issue with another. We see no reason to privilege one of these arguments over the other,

and therefore we believe that the decision on a final policy ought to turn on the other

considerations that we discuss.

Finally, we cannot agree with the commenters that determining the appropriate policy on

this question should turn on which alternative produces the greatest overall level of spending on

EHR systems. Many decisions could result in lower potential payments to some or all potential

meaningful users of EHR payments. Congress deliberately chose to limit incentive payments

based on the statutory formula (using the current statutory and regulatory definition of

"subsection (d) hospital"), and further limited the amount of incentive payments available to

large hospitals by not increasing incentive payments above 23,000 discharges.

CMS-0033-F 397

After consideration of the public comments received, we are finalizing our policy as

proposed. For purposes of this provision, we will provide incentive payments to hospitals as

they are distinguished by provider number in hospital cost reports. Incentive payments for

eligible hospitals will be calculated based on the provider number used for cost reporting

purposes, which is the CMS Certification Number (CCN) of the main provider (also referred to

as OSCAR number). Payments to eligible hospitals will be made to each provider of record.

b. Incentive Payment Calculation for Eligible Hospitals: Initial Amount

Section 1886(n)(2) of the Act, as amended by 4102(a) of the HITECH Act, describes the

methodology for determining the incentive payment amount for eligible hospitals that are

meaningful users of certified EHR technology during the EHR reporting period for a payment

year. In general, that section requires the incentive payment for each payment year to be

calculated as the product of: (1) an initial amount; (2) the Medicare share; and (3) a transition

factor applicable to that payment year.

As amended by section 4201(a) of the HITECH Act, section 1886(n)(2)(A)(i) of the Act

defines the initial amount as the sum of a "base amount," as defined in section 1886(n)(2)(B) of

the Act, and a "discharge related amount," as defined in section 1886(n)(2)(C) of the Act. The

base amount is $2,000,000, as defined in section 1886(n)(2)(B) of the Act. The term "discharge

related amount" is defined in section 1886(n)(2)(C) of the Act as "the sum of the amount,

estimated based upon total discharges for the eligible hospital (regardless of any source of

payment) for the period, for each discharge up to the 23,000th discharge as follows:

(i) for the first through the 1,149th discharge, $0.

(ii) for the 1,150th through the 23,000th discharge, $200.
(iii) for any discharge greater than the 23,000th, $0.
CMS-0033-F 398

In addition to the base amount, the discharge related amount provides an additional $200

for each hospital discharge during a payment year, beginning with a hospital's 1,150th discharge

of the payment year, and ending with a hospital's 23,000th discharge of the payment year. No

additional payment is made for discharges prior to the 1,150th discharge, or for those discharges

subsequent to the 23,000th discharge. We proposed to implement the "initial amount’ within the

formula as that term is defined in the statute.

Comment: Several commenters requested that we identify the sources of the discharge

data we plan to employ for purposes of determining the discharge related amount. These

commenters also requested confirmation of their understanding that no type of discharge,

regardless of source of payment, would be excluded from the discharge count for this purpose.

Commenters specifically cited nursery discharges and discharges from non-PPS areas of a

hospital as examples of discharges that should not be excluded under the statutory language,

which they believe requires the inclusion of all patient discharges regardless of type of patient

within the inpatient areas of the hospital.

Response: We cannot agree with the commenters that the statutory language includes all

patient discharges within the inpatient areas of the hospital. Rather, the statutory language

clearly restricts the discharges to be counted for purposes of determining the discharge-related

amount to discharges from the acute care portion of the hospital. As we discussed in the

proposed rule, the term "discharge related amount" is defined in section 1886(n)(2)(C) of the Act

as "the sum of the amount, estimated based upon total discharges for the eligible hospital

(regardless of any source of payment) for the period, for each discharge up to the 23,000th

discharge as follows:

(i) for the first through the 1,149th discharge, $0.

(ii) for the 1,150th through the 23,000th discharge, $200.
CMS-0033-F 399

(iii) for any discharge greater than the 23,000th, $0."

The phrase "total discharges for the eligible hospital (regardless of any source of

payment)" limits the count of discharges to the acute care inpatient discharges. This is because

of the reference to "eligible hospital." "Eligible hospital" is defined in section 1886(n)(6)(B) of

the Act for purposes of the incentive payments provision, as "a subsection (d) hospital,"

referring in turn to the definition of that term in section 1886(d)(1)(B) of the Act. Section

1886(d)(1)(B) of the Act generally defines a "subsection (d) hospital" as a "hospital located in

one of the fifty States or the District of Columbia," excluding hospitals that are not paid under

the IPPS in accordance with section 1886(d)(1)(B) of the Act, such as psychiatric, rehabilitation,

long term care, children's, and cancer hospitals. However, 1886(d)(1)(B) also specifies that the

"term ‘subsection (d) hospital… does not include a psychiatric or rehabilitation unit of the

hospital which is a distinct part of the hospital (as defined by the Secretary)." Therefore, the

term "eligible hospital" for purposes of the incentive payments provision does not extend to the

excluded units of the hospital. The term does, of course, include the inpatient portion of the

hospital that receives payment for Medicare purposes under the inpatient PPS. The phrase

"regardless of any source of payment," however, indicates that the count of "total discharges" for

this purpose should include not only patients for whom Medicare is the source of payment, but

also patients for whom payment is received from Medicaid or any other source of payment.

Accordingly, in the revised cost report form that is currently pending and which will be finalized

in time for the 2011 payment year, CMS Form 2552-10, Hospital and Hospital Health Care

Complex Cost Report, we have included a cell for entry of "Total hospital discharges as defined

in section 4102 of AARA," in the new Worksheet E-1, Part II, "Calculation of Reimbursement

for Settlement for HIT." This new cell is derived from "line 14, from "Worksheet S-3, Part I
CMS-0033-F 400

column 15." In turn, this cell from Worksheet S-3, Part I, column 15 incorporate all discharges

from the inpatient, acute care portion of the hospital, regardless of payment source. In this final

rule, we have also revised the definition of "eligible hospital" in §495.100 of the regulations, as

well as the specification of "initial amount" in §495.104(c)(3) of the regulations, in order to

clarify this point.

Section 1886(n)(2)(C) of the Act, as amended by section 4102(a) of the HITECH Act,

specifies that a "12-month period selected by the Secretary" may be employed for purposes of

determining the discharge related amount. While the statute specifies that the payment year is

determined based on a Federal fiscal year (FY), section 1886(n)(2)(C) of the Act provides the

Secretary with authority to determine the discharge related amount on the basis of discharge data

from a relevant hospital cost reporting period, for use in determining the incentive payment

during a FY. FYs begin on October 1 of each calendar year, and end on September 30 of the

subsequent calendar year. Hospital cost reporting periods can begin with any month of a

calendar year, and end on the last day of the 12th subsequent month. We proposed, for purposes

of administrative simplicity and timeliness, for each eligible hospital during each incentive

payment year, to use data on the hospital discharges from the hospital fiscal year that ends during

the FY that is prior to the FY that serves as the payment year as the basis for making preliminary

incentive payments. Similarly, we proposed that final payments would be determined at the time

of settling the cost report for the hospital fiscal year that ends during the payment year, and

settled on the basis of the hospital discharge data from that cost reporting period.

Example of proposal: FY 2011 begins on October 1, 2010 and ends on

September 30, 2011. For an eligible hospital with a cost reporting period running from

July 1, 2009 through June 30, 2010, we would employ the relevant data from the hospital's cost
CMS-0033-F 401

reporting period ending June 30, 2010 in order to determine the incentive payment for the

hospital during FY 2011. This timeline would allow us to have the relevant data available for

determining payments in a timely manner for the first and subsequent payment years. This

timeline would also render it unnecessary to develop a cumbersome process to extract and

employ discharge data across more than one hospital cost reporting period in order to determine

the discharge related amount for a FY-based payment period. However, final payments would

be based on hospital discharge data from the cost report ending June 30, 2011, and determined at

the time of settlement for that cost reporting period.

Commenters raised several issues with regard to our proposals regarding the timing of the

cost reports to be used for purposes of determining preliminary and final incentive payments.

Each of these issues embraces the use of several data elements, including discharge counts, bed

days, and other factors employed in the payment calculations. For purposes of simplicity, we

will address these issues in general terms in this section. As we will note at several junctures

below, this discussions of these issues, however, are applicable to the cost report data for other

elements of the computation.

Comment: Several commenters called our attention to timing issues with regard to the

cost reporting periods that we proposed to use for purposes of determining preliminary and final

incentive payments. These commenters noted that, if we finalize our proposal to use data from

the hospital fiscal year that ends during the FY prior to the FY that serves as the payment year as

the basis for making preliminary incentive payments, hospitals with cost reporting periods on the

October-to-September cycle would face a delay of two months or longer after potentially

qualifying as a meaningful user before receiving a preliminary incentive payment. Specifically,

for hospitals on this cycle, the cost report that would be used for determining interim payments
CMS-0033-F 402

for the first payment year (the October 1, 2009 through September 30, 2010 cost report) would

not be due until February 28, 2011, two months after the hospital may have been able to qualify

as a meaningful user (January 1, 2011). For hospitals on the September-to-August cycle, the

delay could be one month. The commenters pointed out that over one-fifth of subsection(d)

hospitals have cost reporting periods beginning on September 1 or October 1. The commenters

therefore recommended that we employ discharge and other data from a hospital’s most recently

filed cost report as the basis for determining the hospital's preliminary incentive payment once

the hospital has qualified as a meaningful user.

Response: We agree with these commenters, and in this final rule we are therefore

adopting the policy that we employ discharge and other data from a hospital’s most recently filed

12-month (see discussion below) cost report as the basis for determining the hospital's

preliminary incentive payment once the hospital has qualified as a meaningful user. However,

the precise timing of payments, especially during the first payment year, may be affected by

other factors such as the timeline for implementing the requisite systems to calculate and

disburse the payments. We are adopting the policy recommended by the commenters in order to

avoid any unnecessary delays in making interim payments due merely to the timing of cost

reporting periods.

Example: FY 2011 begins on October 1, 2010 and ends on September 30, 2011. For an

eligible hospital with a cost reporting period on the October-to-September cycle, we would

employ the relevant data from the hospital's most recently submitted cost reporting period in

order to determine the incentive payment for the hospital during FY 2011. If the hospital

qualifies for incentive payments on January 1, 2011, this would probably be the cost report for

the period running from October 1, 2008 through September 30, 2009. However, we would also
CMS-0033-F 403

employ the October 1, 2009 through September 30, 2010 cost report, if that cost report is

submitted before the point when preliminary incentive payments can be calculated.

Comment: A number of commenters also raised concerns about our proposal to

determine final incentive payments at the time of settling the cost report for the hospital fiscal

year that ends during the payment year, and to be settled on the basis of the hospital discharge

and other data from that cost reporting period. These commenters pointed out that that the

pending CMS Form 2552-10, will not be effective in time for all hospitals and CAHs to

complete the new S-10 worksheet, Hospital Uncompensated Care and Indigent Care Data,

reporting charity care for their cost reporting period ending during the payment year. The

effective date of the new cost report will be for cost reporting periods beginning on or after

May 1, 2010 (as opposed to February 1, 2010 date anticipated in the proposed rule). For

purposes of our proposal for determining final incentive payments, including the Medicare

share/charity calculation, the first cost reporting period for which the new cost report will be

available is the period running from May 1, 2010 through April 30, 2011. This means that, for

cost reporting periods ending in FY 2011 before April 30, hospitals will not be able to complete

the new S-10 worksheet to report charity care charges. Therefore, these commenters

recommended that we revise our proposed policy, so that final incentive payments will be

determined at the time of settlement for the cost reporting period beginning in the payment year.

In this way all hospitals, regardless of their cost reporting cycle, will have adequate time to

submit the revised cost reports in time for determining final incentive payments.

Response: We agree with these commenters, and in this final rule we are therefore

adopting the policy that we determine final incentive payments at the time of settling the

12-month (see discussion below) cost report for the hospital fiscal year that begins after the
CMS-0033-F 404

beginning of the payment year, and to be settled on the basis of the hospital discharge and other

data from that cost reporting period.

Example: FY 2011 begins on October 1, 2010 and ends on September 30, 2011. For an

eligible hospital with a cost reporting period running from July 1 through June 30, we would

employ the relevant data from the hospital's cost reporting period ending June 30, 2009 in order

to determine the preliminary incentive payment for the hospital during FY 2011 (or June 30,

2010, if that cost report was filed prior to the calculation). However, final payments would be

based on hospital discharge data from the cost report beginning on July 1, 2011 and ending

June 30, 2012, and determined at the time of settlement for that cost reporting period.

Comment: Several commenters requested that we explain how the occurrence of non-

standard cost reporting periods will be taken into account in determining the appropriate cost

reporting periods to employ for determining preliminary and final EHR incentive payments.

Non-standard cost reporting periods run for periods shorter than the standard 12-month cost

reporting periods (for example, 3 months, 6 months), and are typically employed to

accommodate the circumstances of hospitals in several distinct situations, such as newly

constructed hospitals, changes of ownership, and reorganization of a single multicampus hospital

into multiple separate providers. In these cases, one non-standard cost reporting period may be

employed before the hospital resumes (or begins) cost reporting on a 12-month cycle. One

commenter recommended that we account for these situations by adopting three changes to our

proposed regulations:

• For purposes of determining preliminary incentive payments, employ the most recently

submitted 12-month cost reporting period that ends in the year prior to the payment year, in order

to account for those situations in which the most recent cost reporting period ending prior to the
CMS-0033-F 405

payment year is a non-standard period.

• For purposes of determining final incentive payments, employ the first 12-month cost

reporting period that begins after the start of the payment year, in order to account for those

situations in which the cost reporting period ending during the payment year is a non-standard

period.

• Provide that a hospital may address the CMS regional office responsible for its

payment area for determination of the appropriate cost reporting period to employ for calculating

preliminary or final incentive payment in cases that are not anticipated by the rules adopted in

the final regulation.

Response: We acknowledge that we failed to address the circumstances of non-standard

cost reporting periods in the proposed rule, and we agree with the commenters that it is only

appropriate to do so. Non-standard cost reporting periods are not likely to be truly representative

of a hospital’s experience, even if methods were to be adopted for extrapolating data over a

normal 12-month cost reporting period. This is because these periods are often quite short (for

example, 3 months), which makes it questionable to extrapolate the data over a full cost

reporting period. In addition, these abbreviated periods often capture the experience of a hospital

during a period of transition (for example, change of ownership), which often renders the data

highly unrepresentative. We also agree with the logic of the policy revisions proposed by the

commenter cited above, subject only to the necessity of adapting the recommendations slightly to

the revisions, as discussed above, we are also adopting to our proposals for identifying the cost

reporting periods to be employed in determining preliminary and final EHR incentive payments.

After consideration of the public comments we receive with regard to the use of cost

reporting periods for preliminary and final incentive payment determinations, we are adopting
CMS-0033-F 406

the following policies in this final rule:

• For purposes of determining preliminary incentive payments, we will employ

discharge and other relevant data from a hospital’s most recently submitted 12-month cost report

once the hospital has qualified as a meaningful user.

• For purposes of determining final incentive payments, we will employ the first

12-month cost reporting period that begins after the start of the payment year, in order to settle

payments on the basis of the hospital discharge and other data from that cost reporting period.

In this final rule, we are revising section 495.104(c)(2) of the regulations accordingly. We are

not adopting the recommendation to allow the CMS regional offices to make a determination

about the appropriate cost reporting period in situations not anticipated by these rules because we

believe that these two rules cover all possible situations. For example, even in complicated cases

involving non-standard cost reporting periods, the cost reporting period for a hospital adjusts to a

standard 12-month cycle within a brief period.

c. Incentive Payment Calculation for Eligible Hospitals: Medicare Share

As previously discussed, the initial amount must be multiplied by the eligible hospital's

Medicare share and an applicable transition factor to determine the incentive payment to an

eligible hospital for a payment year. As added by section 4102(a) of the HITECH Act, section

1886(n)(2)(D) of the Act defines the Medicare share for purposes of calculating incentive

payments as a fraction based on estimated Medicare FFS and managed care inpatient bed days,

divided by estimated total inpatient bed-days, modified by charges for charity care. This section

specifies that the Medicare share fraction is determined for the incentive payment year "for an

eligible hospital for a period selected by the Secretary." As in the case of the discharge data

discussed above, this clause provides the Secretary with authority to determine the eligible
CMS-0033-F 407

hospital’s Medicare share fraction on the basis of data from a relevant hospital cost reporting

period, for use in determining the incentive payment during a FY. For purposes of

administrative simplicity and timeliness equivalent to those discussed above with regard to

discharge data, we proposed, for each eligible hospital during each payment year, to employ data

on the hospital's Medicare fee-for-service and managed care inpatient bed days, total inpatient

bed-days, and charges for charity care from the hospital FY that ends during the FY prior to the

FY that serves as the payment year as the basis for preliminary payment. We also proposed that

final payment would be made on the basis of the data from the hospital fiscal year that ends

during the FY that serves as the payment year at the time of the settlement of the cost report for

the latter period.

As a result of the changes we are making to these proposed policies in response to the

comments discussed in the previous section, in this final rule we are adopting the following

policies for employing data on the eligible hospital's Medicare fee-for-service and managed care

inpatient bed days, total inpatient bed-days, and charges for charity care from the hospital in

making preliminary and final EHR incentive payment determinations:

• For purposes of determining preliminary incentive payments, we will employ data on

the hospital's Medicare fee-for-service and managed care inpatient bed days, total inpatient

bed-days, and charges for charity care from a hospital’s most recently submitted 12-month cost

report once the hospital has qualified as a meaningful user.

• For purposes of determining final incentive payments, we will employ the first

12-month cost reporting period that begins after the start of the payment year, in order to settle

payments on basis of the hospital's Medicare fee-for-service and managed care inpatient bed

days, total inpatient bed-days, and charges for charity care data from that cost reporting period.
CMS-0033-F 408

Section 1886(n)(2)(D) of the Act, as amended by section 4102 of the HITECH Act,

defines the numerator and denominator of the Medicare share fraction for an eligible hospital in

terms of estimated Medicare FFS and managed care inpatient bed-days, estimated total inpatient

bed-days, and charges for charity care. Specifically, section 1886(n)(2)(D)(i) of the Act defines

the numerator of the Medicare share fraction as the sum of--

• The estimated number of inpatient-bed-days (as established by the Secretary) which

are attributable to individuals with respect to whom payment may be made under part A; and

• The estimated number of inpatient-bed-days (as so established) that are attributable to

individuals who are enrolled with a MA organization under Part C.

We proposed to determine the numbers of Medicare Part A and Part C inpatient-bed-days

using the same data sources and methods for counting those days that we employ in determining

Medicare's share for purposes of making payments for direct graduate medical education costs,

as provided under section 1886(h) of the Act and §413.75 of our regulations. Specifically, we

proposed to derive "the estimated number of inpatient-bed-days… attributable to individuals

with respect to whom payment may be made under part A" from lines 1, 6 through 9, 10, and 14

in column 4 on Worksheet S-3, Part I of CMS Form 2552-96, Hospital and Hospital Health Care

Complex Cost Report. We stated that the data entered on these lines in the cost report include all

patient days attributable to Medicare inpatients, excluding those in units not paid under the IPPS

and excluding nursery days.

Comment: A number of commenters pointed out an apparent contradiction between the

cost report sources from which we proposed to derive the "the estimated number of

inpatient-bed-days… attributable to individuals with respect to whom payment may be made

under part A" (lines 1, 6 through 9, 10, and 14 in column 4 on Worksheet S-3, Part I of CMS
CMS-0033-F 409

Form 2552-96,), and our statement that "the data entered on these lines in the cost report include

all patient days attributable to Medicare inpatients, excluding those in units not paid under the

IPPS and excluding nursery days." These commenters supported our proposal to employ the

data from those lines of the cost report, on the grounds that these cost report lines "adequately

capture the necessary data. However, as the commenters pointed out, the data on the identified

lines do include patient days in units not paid under the inpatient PPS. These commenters also

contended that the relevant statutory language ("inpatient-bed-days… attributable to individuals

with respect to whom payment may be made under part A"; emphasis supplied) would seem to

include patient days in units not paid under the inpatient PPS.

Response: We agree with the commenters that our citation of the specific cost report

sources from which we proposed to derive the "the estimated number of inpatient-bed-days…

attributable to individuals with respect to whom payment may be made under part A" was not

consistent with our statement the data entered on these lines in the cost report include "all patient

days attributable to Medicare inpatients, excluding those in units not paid under the IPPS and

excluding nursery days." In this case, our error was in the specific cost report lines that we cited,

rather than in our statement that the relevant statutory language ("inpatient-bed-days…

attributable to individuals with respect to whom payment may be made under part A") includes

"all patient days attributable to Medicare inpatients, excluding those in units not paid under the

IPPS and excluding nursery days." As in the case which we discussed above with regard to

counting "total discharges," the relevant statutory language directs that the numerator and

denominator of the Medicare share fraction incorporate inpatient bed-day counts for the eligible

hospital, and, as discussed in our section on total discharges, "eligible hospital" is defined with

reference to section 1886(d)(1)(B) of the Act, which specifically excludes from the definition
CMS-0033-F 410

psychiatric or rehabilitation units that are a distinct part of the hospital. Specifically, the

"Medicare share" is to be "specified… for an eligible hospital." The numerator of the Medicare

share fraction is further defined as "the sum (…with respect to the eligible hospital) of--

"(I) the estimated number of inpatient-bed-days (as established by the Secretary) which

are attributable to individuals with respect to whom payment may be made under part A; and

"(II) the estimated number of inpatient-bed-days (as so established) which are attributable

to individuals who are enrolled with a Medicare Advantage organization under part C."

Finally, the denominator of the Medicare share fraction includes "the estimated total

number of inpatient-bed-days with respect to the eligible hospital." Therefore, the

inpatient-bed-day counts included in the Medicare share fraction for purposes of the incentive

payments provision do not extend to inpatient-bed-days in excluded units of the hospital, but

only to inpatient-bed-days in the acute care portion of the hospital that receives Medicare

payment under the inpatient PPS. In this final rule, we are revising section 495.104(c)(4) of the

regulations in order to clarify this point.

Since the publication of the proposed rule, we have adopted various changes to the

Medicare cost report, including changes designed to accommodate the appropriate computation

and final settlement of EHR incentive payments for qualifying hospitals. These changes are

included in the pending cost report form, CMS Form 2552-10. In this revised form, the relevant

Medicare inpatient days are entered in line 2 of the new Worksheet E-1, Part II, "Calculation of

Reimbursement for Settlement for HIT." This new line is defined as the sum of lines 1 and 8

through 12, from Worksheet S-3, Part I, column 6 of CMS Form 2552-10. These lines include

all patient days attributable to Medicare inpatients, excluding those in units not paid under the

IPPS, and excluding nursery days.

CMS-0033-F 411

Comment: Several commenters also contended that our proposed exclusion of nursery

days from the determination of "inpatient-bed-days… attributable to individuals with respect to

whom payment may be made under part A" is inappropriate. These commenters maintained that

the statutory language is broad enough to include all inpatient days associated with Medicare

eligible individuals without restriction based on the type of Part A patient.

Response: In excluding nursery days from the count of Medicare inpatient bed days, we

are following the precedent of not counting such days for purposes of the direct medical

education, indirect medical education, and disproportionate share adjustments under the

Medicare IPPS. As in the case of the term "subsection (d)" hospital, we believe that, in the

absence of clear direction from the statute to the contrary, the most appropriate policy is to

interpret terms such as "inpatient bed-days" in the light of existing Medicare program policies

and precedents. Under our policies for the direct medical education, indirect medical education

and disproportionate share adjustments, a bed must be permanently maintained for lodging

inpatients in order to be included in available inpatient bed and inpatient bed day counts. We

exclude the days provided to newborns (except for those in intensive care units of the hospital)

because healthy new born infants are not provided with an acute level of hospital care. (This is

not the case with newborns assigned to intensive care units, who are included in the counts for

those units.) For these reasons, nursery days are explicitly excluded from;

• The counts of Medicare inpatient hospital days and total inpatient hospital days for

purposes of direct graduate medical education payments under section 413.75(b) of the

regulations, where the definition of Medicare patient load reads: "inpatient days in any distinct

part of the hospital are included and nursery days are excluded."
CMS-0033-F 412

• The counts of bed days for purposes of the Medicare indirect graduate medical education

adjustment under section 412.105(b): the "count of available bed days excludes bed days

associated with… (5) Beds or bassinets in the healthy newborn nursery…."

• The count of beds for purposes of the Medicare DSH adjustment under section

412.106(a)(i) of the regulations: "The number of beds in a hospital is determined in accordance

with §412.105(b)."

We note that, in addition to excluding nursery days from the numerator of the Medicare

share fraction, these days are excluded for the same reasons from the count of total inpatient bed

days in the denominator of the Medicare share fraction. We therefore do not believe that

excluding these days would result in disadvantage to hospitals in determining their Medicare

share fractions for purposes of calculating EHR incentive payments. (See our discussion of the

cost report data employed to determine total inpatient bed days in the denominator of the

Medicare share fraction, below.)

Comment: Other commenters maintained that swing bed days should also be included in

the determination of "inpatient bed-days… attributable to individuals with respect to whom

payment may be made under part A."

Response: Once again, as in the case of the term "subsection(d)" hospital, we believe

that, in the absence of clear direction from the statute to the contrary, the most appropriate policy

is to interpret terms such as "inpatient bed-days" in the light of existing Medicare program

policies and precedents. We are therefore also following the precedent of Medicare payment

adjustments in excluding certain swing bed days from the count of Medicare inpatient days. As

in these cases, swing bed days are excluded when the swing bed is used to furnish SNF care,

because only the days used for inpatient hospital care will be included in the count of "inpatient
CMS-0033-F 413

bed-days… attributable to individuals with respect to whom payment may be made under part

A." Otherwise, we would be including non-inpatient bed-days in the count.

Comment: One commenter objected that, for purposes of the Medicare inpatient day

count in the Medicare share, we appeared to be proposing to use only paid Medicare days. This

commenter argued that all eligible Medicare days should be counted in order to reflect a

hospital’s true Medicare utilization. The commenter also maintained that the statute’s reference

to days "attributable to individuals with respect to whom payment may be made under part A"

requires inclusion of all days when a beneficiary was eligible for Medicare, on the grounds that

this language "does not require actual payment by Medicare." The commenter further noted that

the other factor in the numerator of the Medicare share fraction requires inclusion of all patient

days associated with individuals enrolled in a Part C Medicare Advantage plan, and maintained

that there "would be no rational basis for Congress to include all enrolled Part C days, quite

clearly regardless of whether they are paid, but to limit part A days to those paid by Medicare.’

Response: We assume that, by the term "unpaid" Medicare days, the commenter is

referring to days provided to Medicare entitled beneficiaries for which the services are

non-covered, such as the cases in which a beneficiary has exhausted coverage of inpatient

hospital services, or in which the services are not covered under a national or local coverage

determination. We do not agree with the commenter that these days ought to be included in the

count of "inpatient-bed-days… attributable to individuals with respect to whom payment may be

made under part A." Indeed, we believe that the best reading of this statutory language suggests

the opposite of what the commenter maintains: in cases of non-covered days, payment may not

be made under Part A, and therefore these days should not be included in a count of days

"attributable to individuals with respect to whom payment may be made under part A." We
CMS-0033-F 414

agree with the commenter that the language for the other factor in the numerator of the Medicare

share fraction ("inpatient-bed-days attributable… to individuals who are enrolled with a MA

organization under Part C") is more inclusive. However, we must assume that the difference in

the statutory language is meaningful. Therefore, we are finalizing our proposal not to include

days provided to Medicare entitled beneficiaries for which the services are non-covered in the

count of Medicare inpatient days. It is important to note that we do include such "non-paid" days

for purposes of other Medicare payment provisions, where it is appropriate to do so under the

governing statutory provisions. For example, for purposes of the Medicare DSH adjustment the

relevant statutory language requires inclusion of days associated with individuals who are

"entitled" to benefits under Medicare Part A, rather than days for which "payment may be made

under part A."

After consideration of these comments, we are finalizing our proposals with regard to the

data to be used to determine the "inpatient bed-days… attributable to individuals with respect to

whom payment may be made under part A" in the numerator of the Medicare share fraction.

Accordingly, we will derive this information from Worksheet E-1, Part II, line 2 of the pending

Medicare cost report, Form CMS-2552-10, which is defined as the sum of lines 1 and 8 through

12 in column 6, Worksheet S-3, Part I of the pending cost report. As we have just discussed, we

are revising the cost report data sources from which we are deriving this information in order to

be consistent with the statutory requirement. We are also revising §495.104(c)(4)(ii)(A)(2) of

the regulations to clarify this point.

Comment: One commenter inquired about the status of inpatient-bed-days attributable to

individuals enrolled in the 1876 Medicare cost plan operating under "billing option 2," under

which the section 1876 cost contractor pays hospitals for Part A benefits, and then claims
CMS-0033-F 415

reimbursement from CMS. The cost-contractor pays Part A benefits for its 36,000 enrolled

Medicare beneficiaries to contracted hospitals in one State. The commenter maintained that a

reasonable interpretation of the statutory language suggests that the inpatient bed days for these

beneficiaries should be counted in the numerator of the Medicare share fraction. The commenter

requested clarification concerning the inclusion of these days in the data sources we proposed to

employ, or the development of an appropriate remedy in order ensure that they are counted.

Another commenter noted that Worksheet S-3, Part I, column 4, line 2 in of the Medicare cost

report, CMS 2552-96, has historically been completed primarily by teaching hospitals, based on

patient days reported on Provider Statistical and Reimbursement (PS&R) Report Type 118. The

commenter further stated that there have been many situations in which non-teaching hospitals

reporting days on this cost report line have the days removed by the Medicare fiscal intermediary

or Medicare administrative contractor (MAC), as PS&R Report Type 118 contains no patient day

data for non-teaching hospitals. The commenter recommended that we clarify our plans with

regard to PS&R Report Type 118 and allow the form to populate with accurate data for all

hospitals submitting no-pay bills for Medicare beneficiaries who are enrolled in Medicare

Advantage (MA) plans and who receive Medicare-covered hospital services. The commenter

further noted that, at this time, CAHs and IPPS hospitals that do not receive the DSH adjustment

are not required to submit no-pay bills for Medicare Advantage patients.

Response: We agree with the commenters that all these days should be counted in the

numerator of the Medicare share fraction. With respect to MA plan enrollees, these patients are

already included in the "estimated number of inpatient-bed-days attributable… to individuals

who are enrolled with a MA organization under Part C." In order for the data on the inpatient

days attributable to individuals enrolled in MA plans to be included on the Medicare cost report,
CMS-0033-F 416

the hospital must submit a "no-pay" bill to the Medicare contractor. We have issued instructions

clarifying that hospitals must submit no-pay bills for inpatient days attributable to individuals

enrolled in MA plans. Specifically, CR 5647, dated July 20, 2007, required all hospitals paid

under the inpatient prospective payment system (IPPS), inpatient rehabilitation facility

prospective payment system (IRF PPS), and long term care hospital prospective payment system

(LTCH PPS) to submit informational only Medicare Advantage claims. Furthermore, CR 6821,

dated May 5, 2010, provided that applicable IPPS, IRF PPS and LTC hospitals will be given one

final opportunity to comply with the requirement to submit FY 2007 informational only claims.

In addition, these hospitals are required to attest in writing to their Medicare contractor that they

have either submitted all of their Medicare Advantage claims for FY 2007 or that they have no

Medicare Advantage claims for that fiscal year. After consideration of the comments, we are

finalizing our proposals for determining the "inpatient bed-days …attributable to individuals

with respect to whom payment may be made under part A" and the "estimated number of

inpatient-bed-days attributable… to individuals who are enrolled with a MA organization under

Part C." However, we are modifying the language of §495.104(c)(4)(ii)(A)(1) regarding the

counting of inpatient days bed-days attributable to individuals with respect to whom payment

may be under part A to clarify that this count includes days attributable to enrollees under section

1876 cost contracts where payments for Part A benefits are made by the section 1876 contractor.

We intend to derive this information from Worksheet E-1, Part II, line 3 of the pending Medicare

cost report, Form CMS-2552-10, which is derived from line 2 in column 6, Worksheet S-3, Part I

of the pending cost report. This data source on the revised Medicare cost report is the equivalent

of the source we cited in the proposed rule.

CMS-0033-F 417

Section 1886(n)(2)(D)(ii) of the Act defines the denominator of the Medicare share

fraction as the product of--

• The estimated total number of inpatient-bed-days with respect to the eligible hospital

during such period; and

• The estimated total amount of the eligible hospital's charges during such period, not

including any charges that are attributable to charity care (as such term is used for purposes of

hospital cost reporting under Title XVIII), divided by the estimated total amount of the hospital’s

charges during such period.

As in the case of Medicare Part A and Part C inpatient-bed days, for purposes of

determining total inpatient-bed days in the denominator of the Medicare share fraction, we

proposed to use the same data sources, and the same methods, that we employ in determining

Medicare's share for purposes of making payments for direct graduate medical education costs.

Specifically, we proposed to derive the relevant data from lines 1, 6 through 9, 10, and 14 in

column 6 on Worksheet S-3, Part I of the Medicare cost report. We noted that the data entered

on these lines in the cost report include all patient days attributable to inpatients, excluding those

in units not paid under the IPPS.

Comment: Several commenters noted, regarding our proposal concerning Medicare

inpatient days in the denominator of the Medicare share fraction, an apparent contradiction

between the cost report sources from which we proposed to derive "estimated total number of

inpatient-bed-days with respect to the eligible hospital during such period"" (lines 1, 6 through 9,

10, and 14 in column 6 on Worksheet S-3, Part I), and our statement that "the data entered on

these lines in the cost report include all patient days attributable to inpatients, excluding those in

units not paid under the IPPS ." These commenters supported our proposal to employ the data
CMS-0033-F 418

from those lines of the cost report, on the grounds that these cost report lines adequately capture

the necessary data. However, as the commenters pointed out, the data on the identified lines do

include patient days in units not paid under the inpatient PPS. And these commenters contended

that the relevant statutory language ("the estimated total number of inpatient-bed-days with

respect to the eligible hospital during such period") would seem to include patient days in units

excluded from the inpatient PPS.

Response: As in the case of the equivalent issue with regard to Medicare inpatient bed

days, we agree with the commenters that our citation of the specific cost report sources from

which we proposed to derive the "the estimated total number of inpatient-bed-days with respect

to the eligible hospital during such period" was not consistent with our statement that the data

entered on these lines in the cost "include all patient days attributable to inpatients, excluding

those in units not paid under the IPPS." And as in the case of Medicare inpatient-bed-days, our

error was in the specific cost report lines that we cited, rather than in our statement that the

relevant statutory language ("the estimated total number of inpatient-bed-days with respect to the

eligible hospital") includes "all patient days attributable to inpatients, excluding those in units not

paid under the IPPS.", As we have discussed in connection with counting discharges and

Medicare inpatient-bed-days, the relevant statutory language directs that the denominator of the

Medicare share fraction incorporate inpatient bed-day counts for the eligible hospital. Therefore,

the inpatient-bed-day counts included in the Medicare share fraction for purposes of the

incentive payments provision do not extend to inpatient-bed-days in excluded units of the

hospital, but only to inpatient-bed-days in the acute care portion of the hospital that receives

payment for Medicare purposes under the inpatient PPS.

CMS-0033-F 419

We are finalizing our proposal for determining the count of total inpatient-bed days in the

denominator of the Medicare share fraction as including all patient days attributable to inpatients,

excluding those in units not paid under the IPPS. Accordingly, we will derive this information

from Worksheet E-1, Part II, line 4 of the pending Medicare cost report, Form CMS-2552--10,

which is defined as the sum of lines 1and 8 through 12, in column 8, Worksheet S-3, Part I of the

pending cost report. As we have just discussed, we are revising the cost report data sources from

which we are deriving this information in order to be consistent with the statutory requirement.

In this final rule, we are also revising §495.104(c)(4)(ii)(B)(1) to clarify this point.

As we noted above, the denominator of the Medicare share fraction also includes the

"estimated total amount of the eligible hospital's charges during such period, not including any

charges that are attributable to charity care (as such term is used for purposes of hospital cost

reporting under Title XVIII), divided by the estimated total amount of the hospital’s charges

during such period." We discuss the data sources and methods for calculating the charges and

charity care portions of this formula in the next section.

d. Incentive Payment Calculation for Eligible Hospitals: Charity Care and Charges

In determining the denominator of the Medicare share fraction, we also must determine

any charges that are attributable to charity care furnished by an eligible hospital or CAH. The

exclusion of charges attributable to charity care has the effect of decreasing the denominator of

the Medicare share fraction as the proportion of charity care (charity care charge ratio) provided

by a hospital increases. This is because the ratio of estimated total hospital charges, not

including charges attributable to charity care, to estimated total hospital charges during a period

decreases, relatively speaking, as a hospital provides a greater proportion of charity care. The

effect of a greater charity care factor on the denominator of the Medicare share fraction is
CMS-0033-F 420

therefore to decrease the denominator (as the total number of inpatient-bed days is multiplied by

a relatively lower charity care charge ratio), as a hospital provides a greater proportion of charity

care. A smaller denominator increases the Medicare share factor, providing for higher incentive

payments, to a hospital that provides a greater proportion of charity care. Conversely, as a

hospital provides a lower proportion of charity care, the ratio of estimated total hospital charges,

not including charges attributable to charity care, to estimated total hospital charges during a

period increases.

For the purposes of this final rule, we define charity care as part of uncompensated and

indigent care described for Medicare cost reporting purposes in the Medicare cost report

instructions at section 4012 of the Provider Reimbursement Manual (PRM), Part 2; Worksheet

S-10; Hospital Uncompensated and Indigent Care Data. Subsection (d) hospitals and CAHs are

required to complete the Worksheet S-10.

As part of the Form CMS-2552-10 described above, the revised Worksheet S-10

instructions define uncompensated care as follows: ". . . charity care and bad debt which

includes non-Medicare bad debt and non-reimbursable Medicare bad debt. Uncompensated care

does not include courtesy allowances or discounts given to patients." These instructions further

define charity care to include health services for which a hospital demonstrates that the patient is

unable to pay. Charity care results from a hospital's policy to provide all or a portion of services

free of charge to patients who meet certain financial criteria. For Medicare purposes, charity

care is not reimbursable, and unpaid amounts associated with charity care are not considered as

an allowable Medicare bad debt. Therefore, we proposed to use the charity care charges that are

reported on line 19 of the revised Worksheet S-10 in the computation of the Medicare share of

the incentive payments. Line number 19 of the revised Worksheet S-10, as proposed, has
CMS-0033-F 421

changed to line number 20 based on the pending OMB approved final Form CMS-2552-10.

Only the line number has changed as the instructions are the same for line 19 as proposed and for

line 20 in the pending final OMB approved Worksheet S-10. Thus, the charity care charges used

to calculate the final Medicare share is reported on line 20 of the pending final OMB approved

Worksheet S-10.

Under section 1886(n)(2)(D) of the Act, if the Secretary determines that data are not

available on charity care necessary to calculate the portion of the formula specified in clause

(ii)(II) of section 1886(n)(2)(D) of the Act, the Secretary shall use data on uncompensated care

and may adjust such data so as to be an appropriate proxy for charity care including a downward

adjustment to eliminate bad debt data from uncompensated care data. In the absence of the data

necessary for the Secretary to compute the amount described in clause (ii)(II) of section

1886(n)(2)(D) of the Act, the amount under such clause shall be deemed to be 1.

We believe that the charity care charges reported on line 20 of the pending final OMB

approved Worksheet S-10 represent the most accurate measure of charity care charges as part of

the hospital's overall reporting of uncompensated and indigent care for Medicare purposes.

Therefore, since eligible hospitals and CAHs are required to complete the Worksheet S-10, if a

hospital has not properly reported any charity care charges on line20, we may question the

accuracy of the charges used for computing the final Medicare share of the incentive payments.

With appropriate resources, we believe the charity care data can be obtained by the MAC. This

data would be used to determine if the hospital's charity care criteria are appropriate, if a hospital

should have reported charity care charges, and if the reported charges are proper. If we

determine, as based on the determination of the MAC, that the hospital did not properly report

charity care charges on line 20 of the pending final OMB approved Worksheet S-10, then we
CMS-0033-F 422

proposed to deem the portion of the denominator described in section 1886(n)(2)(D)(ii)(II) of

the Act to be 1.

In the proposed rule, we specifically solicited public comments on the charity care

financial criteria established by each hospital and reviewed by the MACs, the collection of

charity care data on the Worksheet S-10, and whether proxies for charity care may be developed

with other data available to us.

Comment: Some commenters requested that CMS clarify the definition of charity care.

One commenter believed the CMS incorrectly indicated that Medicare does not reimburse for

charity care. The commenter believed this statement is inconsistent with section 312 of the

Provider reimbursement Manual (PRM).

Response: Section 1886(n)(2)(D)(ii)(II) of the Act defines charity care charges to

compute the Medicare share as such term is used for purposes of hospital cost reporting under

Medicare. Thus, we are adopting our proposed definition of charity care as part of

uncompensated and indigent care described for Medicare cost reporting purposes in the Medicare

cost report instructions as described above.

In addition, we believe that our statement is correct in that Medicare does not pay for

charity care in accordance with the regulations and manual instructions. Specifically, section

413.89(b)(1) of the Medicare regulations defines bad debts as amounts considered to be

uncollectible from accounts and notes receivable that were created or acquired in providing

services. "Accounts receivable" and "notes receivable" are designations for claims arising from

the furnishing of services, and are collectible in money in the relatively near future. Section

413.89(b)(2) of the Medicare regulations defines charity allowances as reductions in charges

made by the provider of services because of the indigence or medical indigence of the patient.
CMS-0033-F 423

Cost of free care (uncompensated services) furnished under a Hill-Burton obligation are

considered as charity allowances. Furthermore, section 413.89(g) states that charity allowances

have no relationship to beneficiaries of the Medicare program and are not allowable costs. These

charity allowances include the costs of uncompensated services furnished under a Hill-Burton

obligation.

Also, section 312 of the PRM states that, for Medicare bad debt purposes, a non-

Medicaid beneficiary may be considered indigent or medically indigent and that once indigence

is determined and the provider concludes that no improvements in the beneficiary’s financial

condition exist, the debt may be deemed uncollectible without applying the collection

requirements of section 310 of the PRM. We believe that the instructions at section 312 of the

PRM specify bad debt amounts that may be allowable under section 413.89 of the regulations

and, thus, these instructions are not related to charity care amounts that are not allowable for

Medicare.

After consideration of the public comments received, we are finalizing the definition of

charity care these provisions as proposed.

Comment: We received some comments asking if CMS will adopt standards to

determine if a hospital’s charity care policy is sufficient to qualify for the inclusion of charges in

the formula for EHR and whether that same policy would suffice to meet the criteria to

determine the eligibility for Medicare bad debt.

Response: Currently for bad debt purposes, section 312 of the PRM requires the provider

to perform asset/income tests of patient resources for non-Medicaid beneficiaries. These tests

will be used to determine if the beneficiary meets the provider’s indigent policy to qualify an

unpaid deductible and/or coinsurance amount as a Medicare bad debt. The provider is
CMS-0033-F 424

responsible for developing its indigent policy. Currently, the Medicare contractor will determine

if the indigent policies are appropriate for determining allowable Medicare bad debt under

section 312 of the PRM and §413.89 of the regulations. We believe that the Medicare contractor

will continue to determine if the provider's indigent policy for bad debt purposes is appropriate

and can determine if the same policy would be sufficient to use for charity care purposes.

Comment: We received many comments on the use of charity care charge data from line

19 of the revised worksheet S-10, as proposed. Commenters urge CMS to calculate charity care

costs by starting with the amount of charges a hospital has written off. Commenters noted that

this modification would help streamline and unify charity care reporting across the Federal

government (based on the way Internal Revenue Service (IRS)) requires charity care to be

reported) ensure consistency of reporting, and avoid significantly increasing hospitals’

administrative burden.

Response: As described above, we use charity care charges from line 20 of the pending

final OMB approved worksheet S-10 that captures "total initial payment obligations of the

patients who are given full or partial discounts, based on the hospital’s charity care criteria

(measured a full charge), for care delivered during the cost reporting period for the entire

facility." Similar comments received on our proposed rule were also received on the Agency

Information Collection Activities: Proposed Collection: Comment Request published in the

July 2, 2009 Federal Register (74 FR 31738).CMS issued a revised package, Agency

Information Collection Activities: Submission for OMB Review: Comment Request, in the

April 30, 2010 Federal Register (75 FR 22810). The comment period for the submission for

OMB review ended June 1, 2010. OMB will review the comments received and issue an

approved Form CMS 2552 10. The OMB approved Form CMS-2552-10 will be effective for
CMS-0033-F 425

cost reporting periods beginning on or after May 1, 2010.

Comment: Some commenters noted that the Hospital Uncompensated Care and Indigent

Care Worksheet S-10 that CMS proposed to revise in the July 2, 2009 Federal Register

(74FR 31738) would not be timely (based on the anticipated effective date for cost reporting

periods beginning on or after February 1, 2010 as stated in the proposed rule), and therefore,

hospitals with cost reporting periods beginning on November 1, 2009, December 1, 2009 or

January 1, 2010 would not have the opportunity to report charity care data for the first year of

the incentive payment. Commenters further highlighted their concern for available data

necessary to be included in interim payments and for final payments for periods that end

December 31, 2010. Commenters urged CMS to develop an interim mechanism for hospitals

to report the necessary information so that no hospital receives a charity care adjustment of "1"

merely because of its cost reporting cycle. Some commenters suggested that CMS use other

charity care data. Some commenters suggested that CMS use the current version of the Medicare

cost report, Form CMS-2552-96, to determine interim incentive payments.

Response: To calculate the Medicare share, which includes the charges for charity care,

we proposed in the proposed rule to employ data from the hospitals fiscal year that ends during

the FY prior to the FY that serves as the payment year as the basis for preliminary payment. We

further stated that final payment would be made on the basis of the data from the hospital fiscal

year that ends during the FY that serves as the payment year. After consideration of the public

comments received, we are revising the provision that for purposes of determining preliminary

incentive payments, we will employ data on the hospital’s/CAH's Medicare fee-for-service and

managed care inpatient bed days, total inpatient bed-days, and charges for charity care from a

hospital’s/CAH’s most recently submitted 12-month cost report once the hospital has qualified as
CMS-0033-F 426

a meaningful user. For purposes of determining final incentive payments, we will employ the

first 12-month cost reporting period that begins after the start of the payment year, in order to

settle payments on the basis of the hospital’s/CAH's Medicare fee-for-service and managed care

inpatient bed days, total inpatient bed-days, and charges for charity care data from that cost

reporting period.

In addition, as described in the proposed rule, hospitals have been required to fill out the

worksheet S-10 of the Form CMS 2552-96 since the BBRA of 1999 was enacted. We recognize

that the charity care data from the 2552-96 worksheet S-10 may have some limitations because,

in some cases, providers failed to complete the worksheet either partially or in its entirety.

Furthermore, in the past CMS did not review the worksheet S-10 because the data had no

Medicare payment implications. Thus, in the absence of availability of charity care data from

the OMB approved Form CMS 2552-10, a hospital for the purposes of calculating the charity

care charges in the interim may use the information from the 2552-96 worksheet S-10; line 22

until the revised worksheet is available. We believe that the Medicare contractor can make a

determination if the charity care charges from the 2552-96 are appropriate, and if so, use such

charges in determining the preliminary incentive payment amount for hospitals, as described

above. Since CAHs were not required to fill out the 2552-96 worksheet S-10, charity care

charges may not be available to determine preliminary incentive payments until the revised

worksheet is available. However, using data from the first 12-month cost reporting period that

begins after the start of the payment year, as described above, hospitals and CAHs will calculate

the final incentive payment amount with data from the pending Form CMS-2552-10 Medicare

cost report that is effective for cost reporting periods beginning on or after May 1,2010.
CMS-0033-F 427

Comment: Several commenters pointed out that we had failed to identify the source of

the data for "estimated total amount of the eligible hospital's charges" in the proposed rule.

Some of these commenters recommended that we employ Worksheet C, Column 8, line 103 for

this purpose.

Response: We did neglect to identify the source of the data for "estimated total amount

of the eligible hospital's charges" in the proposed rule. In the final rule, we are providing that,

for this purpose, we will employ the data from Worksheet E-1, Part II, line 5 of the revised

Medicare cost report, Form CMS-2552-10, which in turn derives this information from line 200

in column 8, Worksheet C, Part I of the pending cost report. We note that line 200 in column 8,

Worksheet C, Part I of the revised cost report is the equivalent of 101, Column 8, Worksheet C

of the current cost report. We are employing the equivalent of line 101, rather than the

equivalent of line 103, as recommended by the commenters, because line 101 (current line 200)

includes the charges for observation, and accordingly reflects the "total amount of the eligible

hospital's charges" more truly than line 103, which excludes those charges.

e. Incentive Payment Calculation for Eligible Hospitals: Transition Factor

As we have previously discussed, the initial amount must be multiplied not only by the

Medicare share fraction, but also by an applicable transition factor in order to determine the

incentive payment to an eligible hospital for an incentive payment year. Section 1886(n)(2)(E)(i)

of the Act designates that the applicable transition factor equals one (1) for the first payment

year, three-fourths for the second payment year, one-half for the third payment year, one-fourth

for the fourth payment year, and zero thereafter. However, section 1886(n)(2)(E)(ii) of the Act

provides that if "the first payment year for an eligible hospital is after 2013, then the transition

factor specified in this subparagraph for a payment year for such hospital is the same as the
CMS-0033-F 428

amount specified in clause (i) for such payment year for an eligible hospital for which the first

payment year is 2013." Accordingly, if a hospital's first payment year is FY 2014, then the

applicable transition factor equals three-fourths (¾) for the first payment year (FY 2014), one-

half (½) for the second payment year (FY 2015), one-fourth (¼) for the third payment year (FY

2015), and zero thereafter. If a hospital's first payment year is FY 2015, then the applicable

transition factor equals (½) for the first payment year (FY 2015), (¼) for the second payment

year (FY 2016), and zero thereafter. As discussed in more detail below, under section

1886(n)(2)(E)(ii) of the Act, the transition factor for a hospital for which the first payment year is

after 2015 equals zero for all years. In other words, 2015 is the last year for which eligible

hospitals may begin participation in the Medicare EHR Incentive Program.

Figure 1--Incentive Payment Calculation for Subsection D Hospitals

Incentive Amount = [Initial Amount] x [Medicare Share] x [Transition Factor]

Initial Amount = $2,000,000 + [$200 per discharge for the 1,150th – 23,000th discharge]

Medicare Share = Medicare/(Total*Charity Care) = [M/(T*C)]

M = [# of Inpatient Bed Days for Part A Beneficiaries] + [# of Inpatient Bed Days for
MA Beneficiaries]
T = [# of Total Inpatient Bed Days]
C = [Total Charges – Charges for Charity Care*]/[Total Charges]
*If data on charity care is not available, then the Secretary would use data on uncompensated
care as a proxy. If the proxy data is not also available, then "C" would be equal to 1.

Table13: Transition Factor

Consecutive Payment Year Transition Factor

1 1
2 ¾
3 ½
4 ¼
CMS-0033-F 429

f. Duration and Timing of Incentive Payments

Section 1886(n)(2)(E)(i) of the Act establishes that an eligible hospital that is a

meaningful user of certified EHR technology could receive up to 4 years of financial incentive

payments. The transition factor phases down the incentive payments over the 4-year period.

Therefore, an eligible hospital that is a meaningful user of certified EHR technology during the

relevant EHR reporting period, in payment year FY 2011, could receive incentive payments

beginning with FY 2011 (transition factor equals 1), and for FY 2012 (transition factor

equals ¾ ), 2013 (transition factor equals ½ ), and 2014 (transition factor equals ¼ ) if they

continue to be a meaningful user of certified EHR technology during the relevant EHR reporting

periods.

Section 1886(n)(2)(E)(ii) of the Act establishes the range of time during which a hospital

may begin to receive incentive payments, and the applicable transition periods for hospitals that

are permitted to begin receiving incentive payments after FY 2011. Specifically, that section

provides that if the "first payment year for an eligible hospital is after 2015, the transition factor .

. . for such hospital and for such year and subsequent year shall be 0." This clause in effect

provides that no incentive payments will be available to a hospital that would begin to receive

such payments after FY 2015. In other words, FY 2015 is the last FY in which a hospital can

begin to receive incentive payments. Taken together, sections 1886(n)(2)(G)(i) and

1886(n)(2)(E)(ii) of the Act allow hospitals to begin receiving incentive payments during FYs

2011 through 2015. Section 1886(n)(2)(E)(ii) of the Act also establishes the transition periods

and factors that will be in effect for hospitals that begin to receive transition payments during FY

2014 and 2015. As discussed previously, that section states that if "the first payment year for an

eligible hospital is after 2013, then the transition factor specified in this subparagraph for a
CMS-0033-F 430

payment year for such hospital is the same as the amount specified in clause (i) for such payment

year for an eligible hospital for which the first payment year is 2013." Section 1886(n)(2)(E)(ii)

of the Act also establishes the transition periods that will be in effect for hospitals that begin to

receive transition payments during FYs 2014 through 2015. That section states that if "the first

payment year for an eligible hospital is after 2013, then the transition factor specified in this

subparagraph for a payment year for such hospital is the same as the amount specified in clause

(i) for such payment year for an eligible hospital for which the first payment year is 2013." By

implication, this clause establishes that, for hospitals that begin to receive incentive payments in

FYs 2012 and 2013, the transition periods are equivalent to those for hospitals that begin to

receive such payments in FY 2011. An eligible hospital that is a meaningful user of certified

EHR technology could receive incentive payments beginning with FY 2012 (transition factor

equals 1), and for FY 2013 (transition factor equals ¾ ), FY 2014 (transition factor equals ½ ),

and FY 2015 (transition factor equals ¼ ). Similarly, an eligible hospital that is a meaningful

EHR user could receive incentive payments beginning with FY 2013 (transition factor equals 1),

and for FYs 2014 (transition factor equals ¾), 2015 (transition factor equals ½), and 2016

(transition factor equals ¼).

However, this section also specifically provides that the transition factor is modified for

those eligible hospitals that first become meaningful users of certified EHR technology

beginning in 2014 or 2015. Such hospitals would receive payments as if they became

meaningful EHR users beginning in 2013. In other words, if a hospital were to begin to

demonstrate meaningful use of EHR certified technology in 2014, the transition factor used for

that year (2014) would be ¾ instead of 1, ½ for the second year (2015), ¼ for the third year

(2016), and zero thereafter. Similarly, if a hospital were to begin meaningful use of certified
CMS-0033-F 431

EHR technology in 2015, the transition factor used for that year would be ½ instead of 1, ¼ for

the second year (2016), and zero thereafter.

Table 25 shows the possible years an eligible hospital could receive an incentive payment

and the transition factor applicable to each year.

TABLE 14: Transition Factor for Medicare FFS Eligible Hospitals

Fiscal Year Fiscal Year that Eligible Hospital First Receives the
Incentive Payment
2011 2012 2013 2014 2015
2011 1.00 ------ ------ ------ ------
2012 0.75 1.00 ------ ------ ------
2013 0.50 0.75 1.00 ------ ------
2014 0.25 0.50 0.75 0.75 ------
2015 ------ 0.25 0.50 0.50 0.50
2016 ------ ------ 0.25 0.25 0.25

Comment: Several commenters pointed out an apparent inconsistency in the regulation

text that we proposed to implement the transition period and applicable transition factors for

EHR incentive payments. Specifically, the commenters noted that proposed section

495.104(b)(5) states that hospitals "whose first payment year is FY 2015 may receive such

payments for FY 2015 through 2017"(emphasis supplied), while proposed section 495.104(c)(5)

states that the transition factors for hospitals "whose first payment year is FY 2015" are:

(A) ½ for FY 2015; and

(B) ¼ for FY 2016. (Emphasis supplied.)

Response: These commenters are correct. Our proposed section 495.104(b)(5) contained

a typographical error. In order to be consistent with the clear requirements of the statute, section

495.104(b)(5) should have stated that hospitals "whose first payment year is FY 2015 may

receive such payments for FY 2015 through 2016." In this final rule, we are revising section

495.104(b)(5) of the final regulations accordingly.

CMS-0033-F 432

g. Incentive Payment Adjustment Effective in FY 2015 and Subsequent Years for Eligible

Hospitals who are not Meaningful EHR Users

In addition to providing for incentive payments for meaningful use of EHRs during a

transition period, section 1886(b)(3)(B) of the Act, as amended by section 4102(b)(1) of the

HITECH Act, provides for an adjustment to the market basket update to the IPPS payment rate

for those eligible hospitals that are not meaningful EHR users for the EHR reporting period for a

payment year, beginning in FY 2015 . Specifically, section 1886(b)(3)(B) of the Act provides

that, "for FY 2015 and each subsequent FY," an eligible hospital that is not "a meaningful EHR

user… for an EHR reporting period" will receive a reduced update to the IPPS standardized

amount. This reduction will apply to "three-quarters of the percentage increase otherwise

applicable." For FY 2015 and each subsequent FY, the reduction to three-quarters of the

applicable update for an eligible hospital that is not a meaningful EHR user will be "33 1/3

percent for FY 2015, 66 2/3 percent for FY 2016, and 100 percent for FY 2017 and each

subsequent FY." In other words, the Secretary is required to subject eligible hospitals who are

not meaningful users to ¼, ½, and ¾ reductions of their market basket updates in FY 2015, FY

2016, and FY 2017 and subsequent years respectively. Section 4102(b)(1)(B) of the HITECH

Act also provides that such "reduction shall apply only with respect to the FY involved and the

Secretary shall not take into account such reduction in computing the applicable percentage

increase … for a subsequent FY." This provision establishes a continuing incentive for hospitals

to become meaningful EHR users, because a hospital that does become a meaningful EHR user

in any year after the effective date of the update reduction will receive the same, fully updated

standardized amount for that year, and subsequent years, as those hospitals that were already

meaningful EHR users at the time when the update reduction went into effect (although hospitals
CMS-0033-F 433

would remain subject to a separate reduction for failure to report quality data under RHQDAPU).

In order to conform with this new update reduction, section 4102(b)(1)(A) of the HITECH Act

revises section 1886(b)(3)(B)(viii)(1) of the Act to provide that, beginning with FY 2015, the

reduction to the IPPS applicable percentage increase for failure to submit data on quality

measures to the Secretary shall be one-quarter of the applicable market basket update. In this

way, even the combined reductions for EHR use and quality data reporting will not produce an

update of less than zero for a hospital in a given FY as long as the hospital market basket

remains a positive number.

In the proposed rule, we noted that specific proposals to implement these payment

adjustments for subsection (d) hospitals that are not meaningful EHR users were not being made

at that time, but would be subject to future rule-making prior to the 2015 implementation date.

We invited comments on these payment adjustments, and stated any comments received would

be considered in developing future proposals to implement these provisions.

We received a few comments on this provision.

3. Incentive Payments for Critical Access Hospitals (CAHs)

Section 1814(l)(3)(A) of the Act, as amended by section 4102(a)(2) of the HITECH Act,

also provides for incentive payments for CAHs that are meaningful users of certified EHR

technology during an EHR reporting period for a cost reporting period beginning during a

payment year after FY 2010 but before FY 2016. The criteria for being a meaningful EHR user,

and the manner for demonstrating meaningful use, are discussed in section II.A.2. of this final

rule.
CMS-0033-F 434

a. Definition of CAHs for Medicare

Section 1861(mm)(1) of the Act defines a CAH as a facility that has been certified as a

critical access hospital under section 1820(c). CAHs are reimbursed for services furnished to

Medicare beneficiaries under section 1814(l) of the Act for inpatient services and section

1834(g) of the Act for outpatient services. Incentive payments for CAHs under section

1814(l)(3)(A) of the Act will be calculated based on the provider number used for cost reporting

purposes, which is the CCN of the main provider. The process for making incentive payments to

CAHs is discussed in section II.B.4.c. of this final rule.

Comment: We received many comments on the use of the CCN to identify CAHs. Most

comments were similar to those received on the use of the CCN for determining incentive

payments to eligible hospitals.

Response: We responded to the comments for eligible hospitals elsewhere in this final

rule. Our responses to comments received on using the CCN to identify CAHs are the same as

the responses for eligible hospital.

After consideration of the public comments received, we are finalizing our policy as

proposed. For purposes of this provision, we will provide incentive payments to qualifying

CAHs as they are distinguished by the provider number in the CAH’s cost reports. Incentive

payments for qualifying CAHs will be calculated based on the provider number used for cost

reporting purposes, which is the CCN of the main provider (also referred to as OSCAR number).

Payments to qualifying CAHs will be made to each provider of record.

b. Current Medicare Payment of Reasonable Cost for CAHs

For Medicare purposes, CAHs are paid for most inpatient and outpatient services to

Medicare beneficiaries on the basis of reasonable cost under section 1814(l) and section 1834(g)
CMS-0033-F 435

of the Act, respectively. Thus, CAHs are not subject to the IPPS and Hospital Outpatient

Prospective Payment System (OPPS).

Section 1861(v)(1)(A) of the Act is the statutory basis for reasonable cost reimbursement

in Medicare. Under the reasonable cost reimbursement methodology, payments to providers are

based on the reasonable cost of furnishing Medicare-covered services to beneficiaries.

Reasonable cost includes all necessary and proper costs in furnishing the services, subject to the

principles of reasonable cost reimbursement relating to certain specific items of revenue and

cost. Reasonable cost takes into account both direct and indirect costs of providers of services,

including normal standby costs. The objective of the reasonable cost methodology is to ensure

that the costs for individuals covered by the program are not borne by others not so covered, and

the costs for individuals not so covered are not borne by the program. The reasonable costs of

services and the items to be included are determined in accordance with the regulations at 42

CFR part 413, manual guidance, and other CMS instructions.

Currently, under section 1814(l)(1) of the Act and §413.70(a) of the regulations, effective

for cost reporting periods beginning on or after January 1, 2004, payment for inpatient services

of a CAH, other than services of a distinct part unit of a CAH, is 101 percent of the reasonable

costs of the CAH in providing CAH services to its inpatients, as determined in accordance with

section 1861(v)(1)(A) of the Act and with the applicable principles of cost reimbursement in

Parts 413 and 415 of the regulations. However, payment for inpatient CAH services is not

subject to the reasonable cost principles of the lesser of cost or charges, the reasonable

compensation equivalent limits for physician services to providers, the ceilings on hospital

operating costs, or the payment window provisions for preadmission services, specified in
CMS-0033-F 436

§412.2(c)(5) and §413.40(c)(2). Section 1834(g) of the Act and §413.70(b) of the regulations

describe the payment methodology for outpatient services furnished by a CAH.

Currently, reasonable cost reimbursement for CAHs includes payment for depreciation of

depreciable assets used in providing covered services to beneficiaries, as described under Part

413 subpart G of our regulations and §104 of the Medicare Provider Reimbursement Manual

(PRM). In general, the depreciation expense of an asset, representing a portion of the

depreciable asset's costs which is allocable to a period of operation, is determined by distributing

the acquisition costs of the depreciable asset, less any salvage costs, over the estimated useful

life of the asset.

c. Changes made by the HITECH Act

Sections 4102(a)(2) and 4102(b)(2) of the HITECH Act amended section 1814(l) of the

Act, which governs payment for inpatient CAH services. The HITECH Act did not amend

section 1834(g) of the Act, which governs payment for outpatient CAH services.

Sections 4102(a)(2) and 4102(b)(2) of the HITECH Act amended section 1814(l) of the

Act by adding new paragraphs (3), (4), and (5) as follows:

Section 1814(l)(3)(A) of the Act provides the following:

The following rules shall apply in determining payment and

reasonable costs . . . for a critical access hospital that would be a
meaningful EHR user (as would be determined under paragraph
(3) of section 1886(n)) for an EHR reporting period for a cost
reporting period beginning during a payment year if such critical
access hospital was treated as an eligible hospital under such
section:
(i) The Secretary shall compute reasonable costs by
expensing such costs in a single payment year and not depreciating
these costs over a period of years (and shall include as costs with
respect to cost reporting periods beginning during a payment year
costs from previous cost reporting periods to the extent they have
not been fully depreciated as of the period involved).
CMS-0033-F 437

(ii) There shall be substituted for the Medicare share that

would otherwise be applied [to CAHs under section 1814(l)(1),] a
percent (not to exceed 100 percent) equal to the sum of—
(I) the Medicare share (as would be specified under
paragraph (2)(D) of section 1886(n)) for such critical access
hospital if such critical access hospital was treated as an eligible
hospital under such section; and
(II) 20 percentage points.

Section 1814(l)(3)(B) of the Act provides that the incentive payment for CAHs

will be paid “through a prompt interim payment (subject to reconciliation) after

submission and review of such information (as specified by the Secretary) necessary to

make such payment.” The provision also states that “[i]n no case may payment under

this paragraph be made with respect to a cost reporting period beginning during a

payment year after 2015 and in no case may a critical access hospital receive payment

under this paragraph with respect to more than 4 consecutive payment years.”

Section 1814(l)(3)(C) of the Act provides that the reasonable costs for which a CAH may

receive an incentive payment are costs for the purchase of certified EHR technology to which

purchase depreciation (excluding interest) would otherwise apply under section 1814(l)(1) of the

Act.

Section 1814(l)(4)(A) of the Act provides for an adjustment, subject to the hardship

exemption in section 1814(l)(4)(C) of the Act, to a CAH's reimbursement at 101 percent of its

reasonable costs if the CAH has not met the meaningful EHR user definition for an EHR

reporting period that begins in FY 2015 or a subsequent fiscal year. Section 1814(l)(4)(B) of the

Act specifies that if a CAH is not a meaningful EHR user during the cost reporting period

beginning in FY 2015, its reimbursement will be reduced from 101 percent of its reasonable

costs to 100.66 percent. For FY 2016, the percentage of reimbursement for a CAH that is not a

meaningful EHR user is reduced to 100.33 percent of its reasonable costs. For FY 2017 and
CMS-0033-F 438

each subsequent FY, the percentage of reimbursement is reduced to 100 percent of reasonable

costs. Section 1814(l)(4)(C) of the Act states that, as provided for eligible subsection (d)

hospitals, the Secretary may, on a case-by-case basis, exempt a CAH from this adjustment if the

Secretary determines, subject to annual renewal, that requiring the CAH to be a meaningful EHR

user during a cost reporting period beginning in FY 2015 or a subsequent fiscal year would result

in a significant hardship, such as in the case of a CAH in a rural area without sufficient Internet

access. However, in no case may a CAH be granted an exemption under this provision for more

than 5 years.

Section 1814(l)(5) provides that there shall be no administrative or judicial review under

sections 1869 or 1878 of the Act, or otherwise, of: (1) the methodology and standards for

determining the amount of payment under section 1814(l)(3) of the Act and payment adjustments

under section 1814(l)(4) of the Act; (2) the methodology and standards for determining a CAH to

be a meaningful EHR user; (3) the methodology and standards for determining if the hardship

exemption applies to a CAH; (4) the specification of EHR reporting periods; and (5) the

identification of reasonable costs used to compute CAH incentive payments.

d. Incentive Payment Calculation for CAHs

Consistent with section 1814(l)(3)(A) of the Act, we proposed to amend §413.70(a) to

add a new paragraph (5) to provide for an incentive payment to a qualifying CAH for the

reasonable costs incurred for the purchase of certified EHR technology in a cost reporting period

beginning during a payment year after FY 2010 but before FY 2016. We proposed to include a

cross-reference to §495.106 which defines the terms associated with the CAH incentive payment,

including the definition of a “qualifying CAH” that is eligible to receive the CAH incentive

payment, and the methodology for determining the amount of that incentive payment. In
CMS-0033-F 439

addition, we proposed to amend §413.70(a) to add a new paragraph (6) to provide for the

adjustment of a CAH's reasonable costs of providing inpatient services starting in FY 2015 if the

CAH is not a qualifying CAH.

In computing the CAH incentive payment and applying the adjustments to a CAH's

payment if the CAH is not a qualifying CAH, we proposed to apply the definitions of certified

EHR technology, EHR reporting period, meaningful EHR user and qualified EHR in §495.4 that

are discussed elsewhere in this final rule.

In §495.106(a), we proposed to define a qualifying CAH as a CAH that would meet the

meaningful EHR user definition for eligible hospitals in §495.4, which is discussed in section II

A.1. of this final rule if it were an eligible hospital. Also in §495.106(a), for the purposes of

computing the CAH incentive payment, we proposed that the reasonable costs for the purchase

of certified EHR technology mean the reasonable acquisition costs, excluding any depreciation

and interest expenses associated with the acquisition, incurred for the purchase of depreciable

assets as described at part 413 subpart G, such as computers and associated hardware and

software, necessary to administer certified EHR technology as defined in §495.4 of this final

rule. We also proposed to define payment year for CAHs to mean a fiscal year beginning after

FY 2010 but before FY 2016.

Under proposed §495.106(b), we specified that a qualifying CAH must receive an

incentive payment for its reasonable costs incurred for the purchase of certified EHR technology.

The CAH incentive payment will be for a cost reporting period that begins during a payment

year after FY 2010 but before FY 2016.

Consistent with section 1814(l)(3)(A) of the Act, we proposed under §495.106(c) that the

payment methodology for computing the incentive payment for a qualifying CAH for a cost
CMS-0033-F 440

reporting period during a payment year would be equal to the product of-- (1) the reasonable

costs incurred for the purchase of certified EHR technology in that cost reporting period and any

similarly incurred costs from previous cost reporting periods to the extent they have not been

fully depreciated as of the cost reporting period involved and (2) the CAH's Medicare share

which equals the Medicare share as computed for eligible hospitals including the adjustment for

charity care (described in sections II.A.2.b. and A.3. of this final rule) plus 20 percentage points.

However, in no case will the resulting Medicare share for a CAH exceed 100 percent. This

payment methodology will be used in place of payment at 101 percent of reasonable costs

typically applied under section 1814(l)(1) of the Act and §413.70(a)(1) of the regulations.

For example, a CAH first requests an incentive payment for its cost reporting period

beginning on January 1, 2012 which is in FY 2012. The CAH incurred reasonable costs of

$500,000 for the purchase of certified EHR technology in its previous cost reporting period

beginning on January 1, 2011. This CAH is a meaningful user of certified EHR technology

during the relevant EHR reporting period and thus qualifies for an incentive payment for

FY 2012. (For illustrative purposes this example assumes no salvage value of the assets

acquired.) The CAH depreciated $100,000 of the costs of these items in the cost reporting period

beginning on January 1, 2011. As a result, the amount used to compute the incentive payment

will be the remaining $400,000 of undepreciated costs. The CAH's Medicare share is 90 percent

(its Medicare share of 70 percent using the methodology described in section II.A.2.b. of this

final rule plus 20 percentage points). Therefore, the CAH's incentive payment for FY 2012 is

$360,000 ($400,000 times 90 percent). This CAH's first payment year is FY 2012, and it can

receive incentive payments through 4 consecutive payment years which, in this example, would

be FYs 2012 through 2015.

CMS-0033-F 441

If, in the above example, the CAH also incurred reasonable costs of $300,000 for the

purchase of certified EHR technology in its cost reporting period beginning in FY 2012 that will

not be depreciated, then the incentive payment for FY 2012 is $630,000 ($700,000 ($400,000 in

FY 2011 plus $300,000 in FY 2012) times 90 percent).

(The preceding examples are offered for illustrative purposes only and are not intended to

encompass all possible computations of the CAH incentive payment.)

Under proposed §495.106(d)(1), the amount of the incentive payment made to a

qualifying CAH under this section represents the expensing and payment of the reasonable costs

of certified EHR technology computed as described above in a single payment year and, as

specified in §413.70(a)(5), such payment is made in lieu of any payment that would have been

made under §413.70(a)(1) for the reasonable costs of the purchase of certified EHR technology

including depreciation and interest expenses associated with the acquisition. The Medicare

contractor will review the CAH's current year and each subsequent year's cost report to ensure

that the assets associated with the acquisition of certified EHR technology are expensed in a

single period and that depreciation and interest expenses associated with the acquisition are not

allowed.

Under proposed §495.106(d)(2), the amount of the incentive payment made to a

qualifying CAH under this section would be paid through a prompt interim payment for the

applicable payment year after -- (1) the CAH submits the necessary documentation, as specified

by CMS or its Medicare contractor, to support the computation of the incentive payment amount;

and (2) CMS or its Medicare contractor reviews such documentation and determines the interim

amount of the incentive payment.

CMS-0033-F 442

Under proposed §495.106(d)(3), the interim incentive payment would be subject to a

reconciliation process as specified by CMS and the final incentive payment as determined by

CMS or its Medicare contractor would be considered payment in full for the reasonable costs

incurred for the purchase of certified EHR technology in a payment year.

Under §495.106(d)(4), we proposed that an incentive payment may be made with respect

to a cost reporting period beginning during a payment year beginning with FY 2011 (October 1,

2010 through September 30, 2011) through FY 2015 (October 1, 2014 through

September 30, 2015), but in no case may a CAH receive an incentive payment with respect to

more than four consecutive payment years. Therefore, a CAH, that is a meaningful EHR user,

may begin receiving an incentive payment for its cost reporting period beginning in FY 2011 for

the incurred reasonable costs for the purchase of certified EHR technology during that cost

reporting period and in previous cost reporting periods to the extent that the item or items have

not been fully depreciated. These incentive payments will continue for no more than 4

consecutive payment years and will not be made for a cost reporting period beginning during a

payment year after 2015. As discussed above and in section II.B.4. of this final rule, the CAH

must submit supporting documentation for its incurred costs of purchasing certified EHR

technology to its Medicare contractor (Fiscal Intermediary (FI)/MAC).

CAHs cannot receive an incentive payment for a cost reporting period that begins in a

payment year after FY 2015. If the first payment year for a CAH is FY 2013 then the fourth

consecutive payment year would be 2016. However, the CAH cannot be paid an incentive

payment for FYs 2016 and beyond. For FY 2016 and beyond, payment to CAHs for the

purchase of additional EHR technology will be made under §413.70(a)(1) in accordance with the
CMS-0033-F 443

reasonable cost principles, as described above, which would include the depreciation and interest

cost associated with such purchase.

Comment: We received many comments requesting CMS to provide a list of those

depreciable items that would be used to determine the CAH incentive payment under this

provision. The commenters were concerned that certain expenses, such as staff training,

associated with an EHR system may not be included in the CAH’s incentive payment. We also

received comments requesting a further explanation of what documentation will be required to

support the reasonable costs incurred by the CAH.

Response: Section 1814(l)(3)(C) of the Act, as amended by the HITECH Act, provides

that the costs for which a CAH may receive an incentive payment are reasonable costs for the

purchase of certified EHR technology to which purchase depreciation (excluding interest)

would otherwise apply under section 1814(l)(1) of the Act. Furthermore, section 1814(l)(3)(A)

of the Act, as amended by the HITECH Act, mandates that the Secretary shall compute

reasonable costs for the purchase of certified EHR technology by expensing such costs in a

single payment year and not depreciating these costs over a period of years (and shall include

as costs with respect to cost reporting periods beginning during a payment year costs from

previous cost reporting periods to the extent they have not been fully depreciated as of the

period involved). As described in the proposed rule, for the purposes of computing the CAH

incentive payment, we proposed that the reasonable costs for the purchase of certified EHR

technology mean the reasonable acquisition costs, excluding any depreciation and interest

expenses associated with the acquisition, incurred for the purchase of depreciable assets as

described at part 413 subpart G, such as computers and associated hardware and software,

necessary to administer certified EHR technology as defined in §495.4 of this final rule.
CMS-0033-F 444

CAHs will incur both depreciable and non-depreciable reasonable costs in a payment

year that are associated with implementing and maintaining certified EHR technology.

According to the statute, only the reasonable costs for the purchase of certified EHR

technology to which purchase depreciation (excluding interest) would otherwise apply are to

be included in the CAH incentive payment. Thus, CAHs will not have to depreciate these

reasonable costs over the useful life of the EHR asset purchased as such costs will be expensed

in a single payment year. Any non-depreciable reasonable costs incurred in that same single

payment year that are associated with an EHR system may be paid for under the current

Medicare reasonable cost payment system at 101 percent.

Currently, the CAH’s Medicare contractor determines if an item purchased is a

depreciable asset under Medicare principles or other accounting standards. The Medicare

contractor also determines the CAH’s reasonable cost for acquiring depreciable assets. For the

purposes of computing the CAH incentive payment, we are not changing the Medicare

contractor’s current responsibilities described above. We, therefore, suggest that CAHs

communicate with their Medicare contractors to determine the necessary documentation to

support their reasonable costs incurred for the purchase of certified EHR technology and to

determine if the items that they purchase are depreciable assets under Medicare principles or

other accounting standards.

Comment: We received some comments requesting clarification of how the incentive

payments will be computed if an eligible CAH converts to or from an eligible “subsection d”

hospital.

Response: If during a payment year an eligible CAH is converted to or from a

“subsection d” hospital, the CAH may receive an incentive payment as long as it incurred the
CMS-0033-F 445

reasonable costs of purchasing certified EHR technology in a payment year (or in a previous cost

reporting period) when it was a CAH and as long as the affected providers meet the meaningful

use criteria described elsewhere in this final rule. When a conversion takes place, the affected

CAH and “subsection d” hospital are each required to file a Medicare cost report under section

413.24 of the regulations. For instance, if in month 6 of a cost reporting period that begins

January 1, 2011 and ends December 31, 2011, a “subsection d” hospital converts to a CAH, the

“subsection d” hospital will file a terminating 6 month cost report (January 1, 2011 to June 30,

2011). If the CAH retains the same year end of December 31, 2011, the CAH will file a 6 month

cost report from July 1, 2011 to December 31, 2011. In this instance, the CAH’s 6 month cost

report would be used to determine if it incurred reasonable costs for the purchase of certified

EHR technology that may qualify for a CAH incentive payment during that period. The

“subsection d” hospital’s 6 month terminating cost report would be used to determine the

possible amount of any incentive payment for that eligible hospital.

After consideration of the public comments received, with the exception of a few minor,

technical and conforming changes, we are finalizing the applicable provisions as proposed.

Comment: We received many comments regarding the use of data from the revised

Medicare cost report (Form CMS-2552-10) described in the proposed rule to compute the

Medicare share portion of the CAH incentive payment. Commenters were also concerned that

certain cost report data may not be available at the time of computing a CAH’s incentive

payment.

Response: As discussed elsewhere in this final rule, we are addressing concerns with

data from the revised cost report in a final collection that is currently in the Paperwork Reduction

Act clearance process. In addition, we address the timing issues with the revised cost report data
CMS-0033-F 446

elsewhere in this final rule.

e. Reduction of Reasonable Cost Payment in FY 2015 and Subsequent Years for CAHs that are

not Meaningful EHR Users

Section 4102(b)(2) of the HITECH Act amends section 1814(l) to include an adjustment

to a CAH's reimbursement at 101 percent of its reasonable costs if the CAH has not met the

meaningful EHR user definition for an EHR reporting period that begins in FY 2015, FY 2016,

FY 2017, and each subsequent FY thereafter. Consistent with this provision, we proposed that

under §495.106(e) and §413.70(a)(6), if a CAH has not demonstrated meaningful use of certified

EHR technology for FY 2015, its reimbursement would be reduced from 101 percent of its

reasonable costs to 100.66 percent. For FY 2016, its reimbursement would be reduced to

100.33 percent of its reasonable costs. For FY 2017 and each subsequent FY, its reimbursement

would be reduced to 100 percent of reasonable costs.

However, as provided for eligible hospitals, a CAH may, on a case-by-case basis, be

exempted from this adjustment if CMS or its Medicare contractor determines, on an annual basis,

that requiring the CAH to be a meaningful EHR user would result in a significant hardship, such

as in the case of a CAH in a rural area without sufficient Internet access. However, in no case

may a CAH be granted an exemption under this provision for more than 5 years.

Comment: We received some comments requesting further clarification of how CMS

will be determining whether a significant hardship exists to warrant an exemption.

Response: We received a few comments on this provision which is not effective until

FY 2015. We will take these comments into account when we develop proposals for

implementing this provision at a later date.

CMS-0033-F 447

After consideration of the public comments received, we are finalizing sections

495.106(e) as proposed. We have renumbered proposed section 413.70(a)(6)(iv) as 413.70(a)(7),

but are otherwise finalizing section 413.70(a)(6) as proposed.

Section 1814(l)(5) of the Act exempts the determinations made under paragraphs (l)(3)

and (l)(4) from administrative and judicial review. Accordingly, under §413.70(a)(6)(iv) and

§495.106(f), we proposed that there shall be no administrative or judicial review under sections

1869 or 1878 of the Act, or otherwise, of the following:

• The methodology and standards for determining the amount of payment under section

1814(l)(3) of the Act and payment adjustments under section 1814(l)(4) of the Act for CAHs,

including selection of periods under section 1886(n)(2) of the Act for determining, and making

estimates or using proxies of, inpatient-bed-days, hospital charges, charity charges, and the

Medicare share under subparagraph (D) of section 1886(n)(2) of the Act;

• The methodology and standards for determining a CAH to be a meaningful EHR user

under section 1886(n)(3) of the Act as would apply if the CAH was treated as an eligible hospital

under section 1886(n) of the Act;

• The methodology and standards for determining if the hardship exemption under

section 1814(l)(4)(C) of the Act applies to a CAH;

• The specification of EHR reporting periods under section 1886(n)(6)(B) of the Act as

applied under section 1814(l)(3) and (4) of the Act for CAHs; and

• The identification of reasonable costs used to compute the CAH incentive payment

under section 1814(l)(3)(C) of the Act.

Comment: We received some comments requesting clarification of whether CAHs will

be able to appeal their incentive payment amounts.

CMS-0033-F 448

Response: We believe that the limitation of administrative and judicial review does not

apply to the amount of the CAH incentive payment. The CAH may appeal the statistical and

financial amounts from the Medicare cost report used to determine the CAH incentive payment.

The CAH would utilize the current provider appeal process pursuant to section 1878 of the Act.

Accordingly, after consideration of the public comments received, we are finalizing

§495.106(f) as proposed. We have renumbered proposed §413.70(a)(6)(iv) as §413.70(a)(7), but

are otherwise finalizing the provision as proposed.

4. Process for Making Incentive Payments Under the Medicare FFS Program

As previously discussed in section II.B.1. and 2. of this final rule and sections 1848(o)(1)

and 1886(n)(1) of the Act, the statute provides for incentive payments to eligible professionals,

eligible hospitals, and CAHS who are meaningful users of certified EHR technology as early as

FY 2011 for qualifying eligible hospitals and CAHs and CY 2011 for qualifying EPs. The

statute does not specify the process for making these payments to qualifying EPs and qualifying

eligible hospitals and CAHs participating in the FFS Medicare incentive payment program, but

instead leaves the payment process to the Secretary's discretion.

We proposed that FIs, carriers, and MACs, as appropriate, would be responsible for

determining the incentive payment amounts for qualifying EPs and qualifying eligible hospitals

and CAHs in accordance with the methodology set forth in section II.B.1.b. and B.2.b. of this

final rule based on the previously discussed meaningful use criteria, disbursing the incentive

payments to qualifying EPs and qualifying eligible hospitals and CAHs, and resolving any

reconciliation issues.

a. Incentive Payments to EPs

CMS-0033-F 449

We proposed that the carriers/MACs calculate incentive payment amounts for qualifying

EPs, where incentive payments would be disbursed on a rolling basis, as soon as they ascertained

that an EP demonstrated meaningful use for the applicable reporting period (that is, 90 days for

the first year or a calendar year for subsequent years), and reached the threshold for maximum

payment. In accordance with section 1848(l)(3)(B) of the Act, we proposed that if a qualifying

EP is not eligible for the maximum incentive payment amount for the payment year and if the

qualifying EP was also a qualifying MA EP, the qualifying MA organization with which the EP

is affiliated would receive the incentive payment for the EP through the MA EHR incentive

program. If the qualifying EP either does not also qualify as a MA EP or he or she qualifies as a

MA EP but is not eligible for the maximum incentive payment for the payment year, we

proposed that the carriers/MAC would calculate the amount of the qualifying EP's incentive

payment and disburse the incentive payment to the qualifying EP in the year following the

payment year. The proposed rule also outlined that incentive payments would not be issued to

qualifying EPs if an incentive payment was already made under the Medicaid program for the

relevant payment year, and as required by section 1848(m)(2) of the Act as amended by section

4101(f) of the HITECH Act, qualifying EPs who received incentive payments from the Medicare

EHR incentive payment program would not be eligible to receive an e-prescribing incentive

payment. Additionally, we proposed that the incentive payments would be tracked at the

qualifying EP's TIN level, and disbursed to the TIN that the qualifying EP indicated during the

registration process; qualifying EPs who do not have individual TINs (that is, a qualifying EP

who works solely in a group practice) would be paid at the group practice level's TIN. We

proposed that qualifying EPs select one TIN for disbursement of their Medicare EHR incentive

payment. Of course, after the payment is disbursed to their designated TIN, qualifying EPs may
CMS-0033-F 450

decide to allocate their incentive payment among the multiple practices in which they furnish

covered professional services subject to applicable laws, regulations and rules, including, without

limitation, those related to fraud, waste, and abuse.

To be clear, we note that financial relationships, including those arising from the

reallocation/reassignment of incentive payments, between physicians and their employers/other

entities may implicate certain fraud, waste, and abuse laws, regulations, and rules. Therefore, we

proposed to include specific safeguards to limit the risk that the allocation/reassignment of

incentive payments could raise under those and other applicable laws, regulations and rules.

Section II.B.1.d. above finalizes our proposal at §495.10(f) to permit EPs to reassign their

incentive payments to their employer or to an entity with which they have a contractual

arrangement, consistent with all rules governing reassignments including part 424, subpart F.

Comment: Several commenters expressed concern that the proposed rule contained

limited information on how the incentive program for Medicare EPs will be operationalized.

They requested additional information on the expected timeframe and process for payments.

Response: The HITECH Act requires that EHR incentive program payments be

separately tracked and monitored because these funds cannot be commingled with other

Medicare funds. Therefore, to facilitate funds control, payments will be made through a single

payment contractor rather than through the carriers/MACs as was originally proposed.

Additionally, the Integrated Data Repository (IDR), rather than the carriers/MACs will be

accumulating the allowed charges for each qualified EP’s NPI. Payments would be made on a

rolling basis, as soon as we ascertain that an EP has successfully demonstrated meaningful use

for the applicable reporting period (that is, 90 days for the first year or a calendar year for

subsequent years) and the EP’s allowed charges has reached the threshold that qualifies an EP
CMS-0033-F 451

for maximum incentive payment, for the relevant payment year. Once this determination has

been made, the National Level Repository (NLR) will calculate the EP’s incentive payment. The

payment will then be made by the single payment contractor. We anticipate that it will take

anywhere from 15 to 46 days from the time an EP successfully attests to being a meaningful user

to the time an incentive payment is made, and that for FY 2011, incentive payments will be made

to EPs who successfully demonstrate that they were meaningful EHR users for the EHR

reporting period (that is, 90 days) as early as May 2011. As proposed, we will pay a qualifying

EP a single consolidated incentive payment for a payment year, rather than make periodic

installment payments. In order to accommodate different attestation dates throughout the first

year for EPs, our payment cycle is on a monthly basis as previously described; however,

qualifying EPs will receive one single payment per year. In other words, CMS will issue

payments as soon as possible after a qualifying EP attested to meaningfully using a certified

EHR system, hence the monthly payment cycle; however, an EP will only receive one incentive

payment for each year he/she qualifies. For qualifying EPs whose allowed charges for the

payment year do not reach the maximum thresholds, the single payment contractor will disburse

an incentive payment in the following year.

Comment: One commenter recommended CMS make semi-annual incentive payments

for the second and subsequent payment years to ensure physician practices have cash flow to

deploy certified EHR systems and train employees how to use the systems.

Response: When the EHR reporting period is a full year, no EPs will have successfully

demonstrated that they are meaningful users at the mid-year mark. Therefore, as previously

described, qualifying Medicare EPs will receive a single payment per year, issued on a monthly

payment cycle. We intend to finalize this provision as proposed; there will be a single successful
CMS-0033-F 452

attestation per year and a single payment following the attestation for qualifying EPs.

Comment: One commenter questioned whether the scopes of work for the

MACs/Medicare Carriers would be revised to reflect the additional work that this program will

entail.

Response: As previously discussed in the first comment and response, the IDR, rather

than the MACs/Medicare Carriers, will accumulate the EPs allowed charges. The MAC/Carrier

work related the Medicare EHR incentive program will be within their current scope of work and

will be handled through the normal change request process.

Comment: One commenter believes an EP’s program selection (Medicare or Medicaid),

is tied to the TIN where the EP assigns incentive payments. The commenter recommended CMS

permit additional changes in program selection if EPs change their TIN. The commenter

believes allowing only one program change in the life of the program is too restricting given that

patient mix might change due to a practice being purchased by another TIN or an EP becoming a

part-time employee of another TIN.

Response: Section II.A.5.b. of this final rule outlines our policy decision around

changing program selections.

After consideration of the public comments received, we are finalizing our policy as proposed.

For purposes of this provision, payments will be made through a single payment contractor with

the IDR accumulating the allowed charges for each qualified EP’s NPI. Payments will be made

on a rolling basis, as soon as we ascertain that an EP has successfully demonstrated meaningful

use for the applicable reporting period (that is, 90 days for the first year or a calendar year for

subsequent years), and reached the threshold for maximum payment then the NLR will calculate
CMS-0033-F 453

the incentive payment. We estimate it will take anywhere from 15 to 46 days from the time an

EP successfully attests to being a meaningful user to the time an incentive payment is made.

b. Incentive Payments to Eligible Hospitals

We proposed that the FIs/MACs would calculate incentive payments for qualifying

eligible hospitals, and would disburse such payments on an interim basis once the hospital has

demonstrated it is a meaningful EHR user for the EHR reporting period for the payment year.

As discussed above in section B.2.b. of the final rule, the formula for calculating a qualifying

eligible hospital's incentive payment requires the following data: (1) an initial amount; (2) the

Medicare share; and (3) a transition factor applicable to that payment year. We proposed that

FIs/MACs would use the prior-year cost report, Provider Statistical and Reimbursement (PS&R)

System data, and other estimates to calculate the interim incentive payment. As discussed in

section II.B.2.c. of this final rule, beginning in 2010, cost reports will capture charity care data

which will be used in calculating the Medicare share of the payment. We proposed that the

MACs/FIs calculate a qualifying hospital's final incentive payment using data from the cost

report for the hospital's fiscal year that ends during the FY prior to the FY that serves as the

payment year. We also proposed that the FIs/MACs calculate the final incentive payment using

actual cost report data report for the hospital's fiscal year that ends during the FY prior to the

fiscal year that serves as the payment year, and would reconcile the incentive payment as

necessary at settlement of the cost report. Additionally, incentive payments for qualifying

eligible hospitals would be calculated based on the provider number used for cost reporting

purposes, which is the CCN of the main provider. Therefore, incentive payments for qualifying

hospitals would be disbursed to the CCN rather than the TIN.

Comment: Several commenters expressed concern that the proposed rule contained
CMS-0033-F 454

limited information on how the incentive program for hospitals will be operationalized. They

requested additional information on the expected timeframe and process for payments as wells as

requesting clarification that the incentive payments would be distributed as a "lump sum

payment". One commenter requested CMS disburse one lump sum payment at the start of each

eligible year for those hospitals that meet all of the meaningful use requirements.

Response: Hospital EHR incentive payments will be calculated by the FIs/MACs;

however, to facilitate funds control, payments will be made through a single payment contractor.

We will direct the payment contractor to issue to qualifying hospitals, that is those hospitals who

successfully demonstrate that they are meaningful EHR users, a single initial payment for the

year. We anticipate that payments will be made to qualifying Medicare hospitals beginning in

May 2011. No payment will be made prior to an eligible Medicare hospital successfully

demonstrating that it was a meaningful EHR user during the EHR period for the relevant

payment year. For purposes of determining interim incentive payments, we will employ data on

the hospital's Medicare fee-for-service and managed care inpatient bed days, total inpatient bed-

days, and charges for charity care from a hospital’s most recently submitted 12-month cost report

once the hospital has qualified as a meaningful user. For purposes of determining final incentive

payments, we will employ the first 12-month cost reporting period that begins after the start of

the payment year, in order to settle payments on the basis of the hospital's Medicare

fee-for-service and managed care inpatient bed days, total inpatient bed-days, and charges for

charity care data from that cost reporting period.

Comment: One commenter requested that CMS allow hospitals to make an interim

attestation 90 days after the start of the second and subsequent payment years. They suggested

the interim attestation would note that they are in compliance with the meaningful use rules and
CMS-0033-F 455

intend to remain in compliance. They requested that CMS instruct the contractor to issue interim

EHR payments after receipt of such attestation. The commenter believes this would cut down on

the time frame of 21 months between their first and second hospital interim payments.

Response: The reporting period requirements for a hospital’s second and subsequent

years are 365 days. Due to the year-long reporting period, we do not believe we can allow for an

interim attestation that the provider is a meaningful EHR user. Under our definitions at §495.4, a

provider is not a meaningful EHR user unless it has "for an EHR reporting period for a payment

year," demonstrated meaningful use "in accordance with §495.8 by meeting the applicable

objectives and associated measures under §495.6." Thus, we could not determine that the

provider is a meaningful user at an interim point in time, and there would be no basis for

providing the interim payment.

Comment: One commenter expressed confusion over the term "demonstration period"

and questioned if a hospital had to complete the full demonstration period before payments

would be made.

Response: We assume the commenter means EHR "reporting period" when using the

phrase, "demonstration period." A hospital must demonstrate that it met the requirements for

meaningful use for the full EHR reporting period for the relevant payment year before we will

direct the payment contractor to issue an incentive payment to the hospital for the payment year.

A hospital therefore must complete the full EHR reporting period before demonstrating that it

was a meaningful EHR user and before any payments would be made.

Comment: Several commenters recommended that CMS’ payment process for eligible

hospitals be consistent with its payment process for EPs, and that hospital’s initial incentive

payment thus be distributed no later than two months after the hospital successfully demonstrates
CMS-0033-F 456

meaningful use. The same commenters requested CMS specify that the final incentive payment

be issued no later than two months after the hospital submits its cost report from the FY that ends

during the payment year.

Response: We anticipate that for FY 2011, interim incentive payments will be made to

eligible hospitals that successfully demonstrate that they were meaningful EHR users for the

EHR reporting period for FY 2011 (that is , 90 days) as early as May 2011. The exact timing of

when a qualifying eligible hospital receives its interim incentive payment will depend on when

the hospital successfully demonstrates that it was a meaningful EHR user; the sooner a hospital

successfully demonstrate that is was a meaningful EHR user during the EHR reporting period for

the payment year, the sooner it will receive its interim incentive payment. For a Medicare

hospital’s second and subsequent participation years, after a hospital successfully demonstrates

that it was a meaningful EHR user during the EHR reporting period (that is, the federal fiscal

year) for the payment year, the hospital will receive the interim incentive payment in the

following year; the initial incentive payments will be made on a monthly payment cycle

beginning shortly after the hospital is determined to be a meaningful user. To the commenters’

point of requesting that we be consistent with the approach to paying EPs, there seems to be

confusion around what was proposed as to the timing and distribution of the EP’s incentive

payment. The proposal for the EP’s incentive payment was that EP’s accumulated allowed

charges would be based on claims submitted not later than two months after the end of the

payment year. The incentive payment for a qualifying EP’s second and subsequent payment

years was always to be disbursed in the year following the payment year. We did not propose

paying an EP within two months of being deemed a meaningful user.

Comment: Several commenters questioned how CMS would treat a hospital that
CMS-0033-F 457

qualified for an incentive payment one year, but did not qualify the next or subsequent years;

what is the impact on the stream of incentive payments to the hospital?

Response: An eligible hospital’s first payment year is the first year they successfully

demonstrate that they were a meaningful EHR user for the EHR reporting period for the payment

year. Section 1886(n)(2)(G) of the Act defines the second through fifth payment years for a

hospital as each successive year immediately following the first payment year for such hospital.

An eligible hospital's second payment year, then, is the year following its first payment year,

regardless of whether the eligible hospital qualifies for an incentive payment in the year

following its first payment year. Similarly, an eligible hospital's third, fourth, and fifth payment

year are the third, fourth, and fifth years, respectively, following the hospital's first payment year,

even if the hospital does not receive an incentive payment for one or more of those years.

Comment: Several commenters requested that CMS clarify that EHR incentive payments

for which a hospital qualifies or receives under the EHR incentive program (whether directly or

pursuant to an assignment, reassignment or other transfer) shall not affect or be taken into

account in the calculation or other payments made to the eligible hospital under Medicare,

Medicaid, or any other state or federal healthcare program, such as disproportionate share

payments, graduate medical education and indirect medical education payments, and payments

for un-compensated care payments.

Response: EHR incentive payments will have no bearing on the hospital’s Medicare

disproportionate share, indirect medical education or direct graduate medical education

payments. This discussion is also addressed in the Medicaid section at II.D.4.b.

After consideration of the public comments received, we are finalizing our policy as

proposed. For purposes of this provision, Hospital incentive payments will be calculated by the
CMS-0033-F 458

FIs/MACs; however, to facilitate funds control, payments will be made through a single payment

contractor. We will direct the payment contractor to issue to qualifying hospitals a single initial

payment per year, and expect initial payment may begin as early as May 2011, for those who

demonstrate they are meaningful EHR users at the earliest date possible. We estimate it will take

anywhere from 15 to 46 days from the time a hospital successfully attests to being a meaningful

user to the time an incentive payment is made.

c. Incentive Payments to CAHs

In the proposed rule, CMS proposed that because CAHs are paid on a cost reimbursement

basis once a CAH incurs actual EHR costs, it could submit supporting documentation to the

FI/MAC for review. The FIs/MACs would determine an incentive payment amount, as

discussed in section II.A.3 of the proposed rule by substituting for the Medicare share amount

that would otherwise be applied under the formula used for computing payments for eligible

hospitals, a percent (not to exceed 100 percent) equal to the sum of-- (1) the Medicare share for

such CAH, and (2) 20 percentage points.

As discussed in the proposed rule, the FIs/MACs would reconcile the cost report and

ensure the EHR expenses are adjusted on the cost report to avoid duplicate payments. Incentive

payments for qualifying CAHs would be calculated based on the provider number used for cost

reporting purposes, which is the CCN number of the main provider. Therefore, incentive

payments for qualifying CAHs would be based on the CCN rather than the TIN.

Comment: Several commenters expressed concern that the proposed rule contained

limited information on how the incentive program would be operationalized for CAHs. They

requested additional information on the expected timeframe and process for payments to CAHs.

Response: To facilitate funds control, payments will be made through a single payment
CMS-0033-F 459

contractor. In order to receive a HITECH incentive payment, a CAH will have to attest that it is

a meaningful user, and submit documentation to its FI/MAC to support the costs incurred for its

HIT system. Once the FI/MAC reviews the documentation and the allowable amount is

determined, we will direct the payment contractor to release to the CAH a single incentive

payment in the next HITECH payment cycle. Payment cycles will begin in May 2011.

Comment: Several commenters requested more information on the timing of the

distribution of payments to CAHs once the necessary documentation has been submitted and that

recommended CMS be consistent with its proposal on incentive payments for EPs and specify

that the CAH’s initial incentive payment will be distributed no later than two months after it

submits the necessary documentation. The same commenters requested that CMS specify that

the final incentive payment be issued no later than two months after the CAH submits its cost

report.

Response: CAHs will receive a single initial incentive payment per year with the initial

payments beginning in May 2011. Once the FIs/MACs review the documentation and the

allowable amount is determined, we will direct the payment contractor to release a single

incentive payment in the next incentive payment cycle to qualifying CAHs. We anticipate the

initial payments will generally be made within two months of the determination of the allowable

amount. The final payment will be calculated on the cost report, and the process to settle the cost

report will not be modified for these incentive payments. It will continue to follow the normal

final settlement process. For the CAHs’ second and subsequent participation years, CAHs will

also receive a single initial incentive payment per year and a final incentive payment as

described above. With respect to the commenters’ request that we be consistent with the

proposed approach to paying EPs, there seems to be confusion around what was proposed as to
CMS-0033-F 460

the timing and distribution of incentive payments to EPs. The proposal for EP incentive

payments was that an EP’s accumulated allowed charges would be based on claims submitted

not later than two months after the end of the payment year. The incentive payment for a

qualifying EP’s second and subsequent payment years was always to be disbursed in the year

following the payment year. We did not propose to make incentive payments to an EP within

two months of the EP being deemed a meaningful user.

Comment: Several commenters questioned what is considered "necessary

documentation" for CAHs to submit in order to receive Medicare CAH incentive payments. The

same commenters requested CMS propose and obtain comments on "necessary documentation"

and finalize a rule before FY 2011.

Response: The documentation submitted should include information reflecting what was

purchased, and support the costs incurred. Such documentation may include invoices, receipts,

or other comparable materials.

Comment: One commenter recommended CMS (not the MACs/FIs) should make all

determinations regarding CAHs.

Response: The documentation review process for Medicare CAH incentive payments is

similar to processes currently performed by FIs/MACs. Also, the data needed to calculate the

Medicare Share is on the cost reports, which are submitted to the FIs/MACs. Accordingly, we

believe it would be most appropriate for the payment determinations be made by the FIs/MACs,

and not by CMS.

After consideration of the public comments received, we are finalizing our policy as

proposed. For purposes of this provision, CAH payments will be calculated by the FIs/MACs;

however, as discussed above, to facilitate funds control, payments will be made through a single
CMS-0033-F 461

payment contractor. Once the FIs/MACs review the documentation and the allowable amount is

determined, we will direct the payment contractor to release to the CAH a single incentive

payment in the next HITECH payment cycle. Payment cycles will begin in May 2011.

d. Payment Accounting under Medicare

We will conduct selected compliance reviews of EPs, eligible hospitals, and qualified

CAHs who register for the incentive programs and of recipients of incentive payments for the

meaningful use of certified EHR technology. The reviews will validate provider eligibility

through their meaningful use attestations including verification of meaningful use and would also

review components of the payment formulas.

We will identify and recoup overpayments made under the incentive payment programs

that result from incorrect or fraudulent attestations, quality measures, cost data, patient data, or

any other submission required to establish eligibility or to qualify for a payment. The

overpayment will be recouped by CMS or its agents from the EP, eligible hospital, MA

organization, CAH, other entities to whom the right to payment has been assigned/reassigned, or,

in the case of Medicaid, from the State Medicaid agencies. Medicare FFS EPs and eligible

hospitals will need to maintain evidence of qualification to receive incentive payments for

10 years after the date they register for the incentive program.

5. Preclusion of Administrative and Judicial Review

We did not discuss preclusion of administrative and judicial review in our proposed rule.

We are now including a discussion, in order to make the public aware of the preclusion. Also,

the sections of this final rule discussing payments to Medicare Advantage (MA) organizations

and CAHs both include a description of the preclusion, as well as accompanying regulation text.

Therefore, while we believe statutory provisions on preclusion of review are self-implementing,

CMS-0033-F 462

below, we include a discussion of the preclusion of review that applies to EPs and eligible

hospitals. We have also added regulation text to maintain consistency with the CAH and MA

organization provisions.

For EPs, section 1848(o)(3)(C) of the Act prohibits administrative or judicial review

under section 1869, section 1878, or otherwise, of all of the following:

• The methodology and standards for determining EP incentive payment amounts.

• The methodology and standards for determining the payment adjustments that apply to

EPs beginning with 2015.

• The methodology and standards for determining whether an EP is a meaningful EHR

user, including: (1) the selection of clinical quality measures; and (2) the means of demonstrating

meaningful EHR use.

• The methodology and standards for determining the hardship exception to the payment

adjustments.

• The methodology and standards for determining whether an EP is hospital-based.

• The specification of the EHR reporting period, as well as whether payment will be

made only once, in a single consolidated payment, or in periodic installments.

For eligible hospitals, section 1886(n)(4)(A) of the Act similarly prohibits administrative

or judicial review under section 1869, section 1878, or otherwise, of the following:

• The methodology and standards for determining the incentive payment amounts made

to eligible hospitals, including: (1) the estimates or proxies for determining discharges, inpatient-

bed-days, hospital charges, charity charges, and Medicare share; and (2) the period used to

determine such estimate or proxy.

• The methodology and standards for determining the payment adjustments that apply to
CMS-0033-F 463

eligible hospitals beginning with FY 2015.

• The methodology and standards for determining whether an eligible hospital is a

meaningful EHR user, including: (1) the selection of clinical quality measures; and (2) the means

of demonstrating meaningful EHR use.

• The methodology and standards for determining the hardship exception to the payment

adjustments.

• The specification of the EHR reporting period, as well as whether payment will be

made only once, in a single consolidated payment, or in periodic installments.

We note that the above listing may summarize or abbreviate portions of the statute. For precise

language on the preclusion of judicial review, readers should always refer to the statute.

C. Medicare Advantage (MA) Organization Incentive Payments

1. Definitions

a. Qualifying MA Organization

Section 1853(l)(1) of the Act, as added by section 4101(c) of the HITECH Act, provides

for incentive payments to qualifying MA organizations for certain of their affiliated EPs who are

meaningful users of certified EHR technology during the relevant EHR reporting period for a

payment year. Section 1853(l)(5) of the Act defines the term “qualifying MA organization” as

an MA organization that is organized as a health maintenance organization (HMO) as defined in

section 2791(b)(3) of the PHS Act. Section 2791(b)(3) of the PHS Act in turn defines a health

maintenance organization as a federally qualified HMO, an organization recognized as an HMO

under State law, or a similar organization regulated for solvency under State law in the same

manner and to the same extent as an HMO. Since there are few federally qualified HMOs, we

expect MA organizations to primarily qualify for incentive payments as State-licensed HMOs, or

CMS-0033-F 464

as organizations regulated for solvency under State law in the same manner and to the same

extent as HMOs.

In §495.200 we proposed to define “qualifying MA organization.” Specifically, in

§495.202(a)(2), we proposed to deem MA organizations offering MA HMO plans that are not

federally-qualified HMOs to meet the definition of HMO in section 2791(b)(3) of the PHS Act,

as HMOs recognized under State law, or as entities subject to State solvency rules in the same

manner as HMOs. We believe this is reasonable because under the MA application process,

State regulators are required to certify that MA organizations operating in their State are

authorized to offer the type of MA plan they proposed to offer, and meet solvency standards that

are adequate for these purposes. For each MA organization offering MA HMO plans, the State

has thus recognized that the organization is able to assume risk as an HMO. Therefore, we have

determined that absent evidence to the contrary, an MA organization offering HMO plans is

recognized by the State as a health maintenance organization, or that it is subject to State

solvency standards in the same manner and to the same extent as an HMO and therefore provides

sufficient assurance that the section 2791(b)(3) of the PHS Act definition is met.

In §495.202(a)(3), for MA organizations that offer other coordinated care MA plans

(Preferred Provider Organization (PPO) plans, Provider Sponsored Organization (PSO) plans,

and Regional Preferred Provider Organization (RPPO) plans) and for other MA organizations

offering other MA plan types (private fee-for-service (PFFS) plans, Medical Savings Account

(MSA) plans), we proposed that the sponsoring MA organization would be required to attest that

the MA organization is recognized under State law as an HMO, or that it is a similar organization

regulated under State law for solvency in the same manner and to the same extent as an HMO
CMS-0033-F 465

before we would make a determination that the MA organization is a qualifying MA

organization for purposes of incentive payments.

Although we did not receive any comments on these provisions and are finalizing them as

proposed, there is one exception. In order to bring 422.202(a) into conformance with the change

we are making to 422.202(b)(1), we are changing the date by which MAOs are required to

identify themselves to us from the bidding deadline in June 2010 (for plan year 2011) to the

bidding deadline in June 2011 (for plan year 2012).

b. Qualifying MA Eligible Professional (EP)

A qualifying MA organization may receive an incentive payment only for those EPs

described under section 1853(l)(2) of the Act, as added by section 4101(c) of the HITECH Act.

Section 1853(l)(2) of the Act provides that MA EPs must be “eligible professionals” as defined

under section 1848(o) of the Act as added by section 4101(a) of the HITECH Act, and must

either--

• Be employed by the qualifying MA organization; or

• Be employed by, or be a partner of, an entity that through contract with the qualifying

MA organization furnishes at least 80 percent of the entity's Medicare patient care services to

enrollees of the qualifying MA organization.

Further, the EP must furnish at least 80 percent of his or her professional services covered under

Title XVIII (Medicare) to enrollees of the qualifying MA organization and must furnish, on

average, at least 20 hours per week of patient care services.

As discussed in section II.A.1. of this final rule, an EP is defined as a physician (under

section 1861(r) of the Act).

CMS-0033-F 466

We said we interpreted “employed by” to mean that the EP is considered an employee of

a qualifying MA organization or qualifying entity under the usual common law rules applicable

in determining the employer-employee relationship under section 3121(d)(2) of the Internal

Revenue Code of 1986.

We said we interpreted “to be a partner of” to mean that the qualifying MA EP has an

ownership stake in the entity. Under this interpretation, a professional that contracts with an

entity, but who has no ownership stake in the entity, would not be considered a qualifying MA

EP.

We said we interpreted “furnishing at least 80 percent” of the entity's “patient care

services” to enrollees of the organization to mean at least 80 percent of the qualifying entity’s

total Medicare revenue in a year (that is, total revenue from Medicare FFS as well as from all

MA organizations) must be from a single qualifying MA organization.

We proposed to interpret the requirement that a qualifying MA EP furnish at least 80

percent of their professional services covered under Title XVIII to enrollees of the organization

to mean that at least 80 percent of the professional's total Medicare revenue in a year (that is,

total revenue from Medicare FFS as well as from all MA organizations) must be from a single

qualifying MA organization. We said we believed that in establishing the rule that qualifying

MA EPs need to furnish at least 80 percent of their Title XVIII covered services “to enrollees of

the organization,” the statute limits payment related to any specific qualifying MA EP to a single

qualifying MA organization. Thus, if a qualifying MA EP provided an average of 20 hours per

week of patient care services to two distinct qualifying MA organizations, we said we would pay

the qualifying MA organization for the MA EP only if such a qualifying EP provided at least 80
CMS-0033-F 467

percent of his or her professional services covered under Title XVIII to enrollees of that

organization.

For purposes of determining whether a qualifying MA EP furnishes, on average, at least

20 hours per week of patient care services, we interpreted the requirement to include both

Medicare and non-Medicare patient care services. Moreover, we proposed that the relevant time

period for determining whether an MA EP furnishes at least 20 hours per week of patient care

services should be the EHR reporting period. (We discuss the definition of EHR reporting

period in section II.A. 1. e. of this final rule.) Therefore, we said that over the EHR reporting

period, the qualifying MA EP must provide on average 20 hours per week of patient care

services. Finally, we interpreted “patient care services” to mean services that would be

considered “covered professional services” under sections 1848(o)(5)(A) and (k)(3) of the Act.

That is, health care services for which payment would be made under, or for which payment

would be based on, the fee schedule established under Medicare Part B if they were furnished by

an eligible professional to a Medicare beneficiary.

We considered various methods of determining when at least 20 hour per week, on

average, of patient care services would be considered to be provided by MA EPs. We considered

methods such as defining a dollar or service threshold, or the number of hours of direct patient

care services actually provided. After due consideration we proposed to require qualifying MA

organizations to attest to the fact that MA EPs for whom they are requesting EHR incentive

payments have provided, on average, 20 hours of patient care services during the EHR reporting

period.

Comment: A few commenters referenced the Report to Congress required by section

4101(d) of the HITECH Act. The commenters suggested ways in which we could combine
CMS-0033-F 468

original FFS Medicare claims-payment data and MA services provided by EPs in order to arrive

at a single, combined EHR payment. One commenter asked whether payments to a provider

from a Medicare Advantage plan can contribute to the volume of Allowed Charges for the

purpose of calculating maximum Meaningful Use rewards, saying that he believed that they

should. Another commenter said that a substantial percentage of senior citizens receive their

care from EPs providing services by way of Medicare Advantage plans. The commenter

continued that current proposed rules provide incentive payment only to EPs in whose practices

80 percent or more of total services are to Medicare Advantage patients. The commenter

concluded that this would exclude many EPs treating our most vulnerable citizens from the

opportunity to meaningfully adopt EHRs in their practices and that the 80 percent [MA] practice

requirement should be eliminated. Other commenters argued that the regulation was unclear

regarding an exclusion of covered professional services of an EP not employed by an MAO

when determining their participation or level of payment because those services are provided to

MA beneficiaries. The commenter believed that the Secretary should provide a mechanism,

whereby EPs can supplement their record to the appropriate carrier/MAC with their MA charges.

Response: We do not have statutory authority to combine payments across the FFS and

MA EHR incentive payment programs. The statutory provision at section 1853(l)(3)(B) of the

Act, as added by section 4101 of the HITECH, entitled “Avoiding Duplication of Payments,”

specifically prohibits us from making payments to EPs for both FFS and MA services.

Additionally, had Congress wanted CMS to combine FFS and MA charges it could have

included a provision similar to the provision in section 1886(n)(2)(D)(i) of the Act, as added by

section 4102(a) of the HITECH Act, where FFS and MA inpatient-bed-days are added together

to derive the numerator of the Medicare share fraction. We do not have the authority to
CMS-0033-F 469

eliminate the requirement that an EP provide 80 percent of Medicare services to enrollees of an

MA organization, as that requirement is set forth in section 1853(l)(2)(A)(i)(II) of the Act, as

added by the HITECH Act, which is clear in requiring that an MA EP provide “80 percent of ...

professional services ... covered under this title to enrollees of the [MA] organization.”

Comment: One commenter recommended that CMS retain its proposal regarding how

the 80 percent and the 20 hours per week criteria will be met by MA EPs. Another commenter

said that many EPs in Puerto Rico would not qualify for incentives under this test. The

commenter said that the single MA organization requirement of 80 percent revenue and 20 hours

per week for MA EPs would not be met due to the competition and market changes from year to

year. The commenter suggested eliminating the single MA organization requirement. Instead,

the commenter said we should change the standards to consider all enrollees of all MA

organizations to which an EP furnishes services. The commenter continued by saying that if the

requirements are not modified to accept multiple MA organizations, the commenter anticipated

several unintended consequences in the Puerto Rico market. First, the commenter said, it would

be impossible for providers to meet the single MA organization requirement of 80 percent

revenue and 20 hours per week, and therefore, the standard would create disinterest in adopting

EHRs in their practice. Second, the commenter said, the single MA organization requirement

standard would stymie competition. An unanticipated consequence of the requirement would be

providers dropping out of MA plans to consolidate revenue in order to meet the standard from a

single MA organization. Third, the commenter concluded, patients would have fewer options to

select among MA plans, and to a lesser degree, MA enrollees might be forced to discontinue care

with long time MA providers in light of the providers’ determination to consolidate revenue

under a single MA organization.

CMS-0033-F 470

Response: As noted above, the 80 percent of Medicare revenue standard is set forth in

the statute, and may not be changed by regulation. The 20 hour per week rule is also statutory

and based on section 1853(l)(2)(B) of the Act, as added by the HITECH Act. We note, however,

that it is not the case that all 20 hours of patient care services per week be provided by an EP to

MA enrollees of a single MA organization. Rather, the 20 hours of patient care services to

enrollees of a single MA organization can include both Medicare and non-Medicare services and

patients.

Comment: One commenter asked CMS to continue to work with Congress to develop an

equitable mechanism by which to provide incentives to physicians that provide health care

services through participation with more than one MAO.

Response: As previously mentioned in the preamble to this final rule, the statute clearly

limits payment related to any specific MA EP to a single qualifying MA organization. Potential

changes in the statute are outside the scope of this rulemaking.

After consideration of the public comments received, we are implementing the foregoing

provisions as proposed.

As discussed in section II.B. of this final rule relating to Medicare FFS EPs, a qualifying

MA EP is also defined as a physician under section 1861(r) of the Act. Section 1853(l)(1) of the

Act, as added by section 4101(c) of the HITECH Act, provides that the provisions of sections

1848(o) and 1848(a)(7) of the Act, as amended and added by sections 4101(a) and (b) of the

HITECH Act, respectively, which establish the incentive payments for EPs under Medicare FFS,

apply to a qualifying MA organization's qualifying MA EPs “in a similar manner” as they apply

to EPs under Medicare FFS. As discussed above in section II.A.6. of this final rule, section

1848(o)(1)(C)(i) of the Act, as added by section 4101(a) of the HITECH Act, states that hospital-
CMS-0033-F 471

based EPs are not eligible for incentive payments. Therefore, we proposed that, similar to the

Medicare FFS incentive program, MA incentive payments would also not be available for

hospital-based EPs. We note that the hospital where a hospital-based EP provides his or her

Medicare covered services would be potentially entitled to an incentive payment either through

the Medicare FFS incentive program, or through the MA-affiliated hospital EHR incentive

program. Therefore, we proposed that for such a hospital-based MA EP, a qualifying MA

organization would be no more entitled to an MA EP incentive payment under the MA EHR

incentive program than a similarly situated EP would be entitled to an incentive payment under

the Medicare FFS EHR incentive program.

Comment: We received one comment related to hospital-based MA EPs, and specifically

to our proposal in the proposed rule that “similar to the Medicare FFS incentive program, MA

incentive payments would also not be available for hospital-based EPs.” The commenter noted,

however, that unlike the proposed regulatory definition of “Qualifying Eligible Professional

(EP)” under the Medicare FFS incentive program, the proposed regulatory definition of

“Qualifying MA EP” under the MA EHR incentive program did not expressly exclude hospital-

based EPs. The commenter went on to say that if hospital-based MA EPs are excluded from the

MA EHR incentive program (for example, because they provide 90% or more of their covered

services in the CY preceding the payment year in an outpatient hospital setting), unless there is

an exception for MA EPs who are hospital-based in qualifying MA-Affiliated Eligible Hospitals

that would not qualify for an incentive payment under the MA Affiliated hospital EHR incentive

program payment criteria, Qualifying MA Organizations with MA EPs who are hospital-based in

such qualifying MA-Affiliated Hospitals would not qualify for an incentive, with regard to those

MA EPs, under any HITECH Act Medicare incentive program. The commenter concluded that
CMS-0033-F 472

this outcome would not be consistent with the objective of the HITECH Act to promote

widespread adoption of HIT through the payment of monetary incentives for meaningful use of

EHRs. The commenter recommended that if hospital-based MA EPs are excluded from the MA

EHR incentive program, then we should include an exception for MA EPs who are hospital-

based in Qualifying MA-Affiliated Eligible Hospitals that would not qualify for an incentive

payment (or would only qualify for a very minimal incentive payment) under the MA-Affiliated

hospital EHR incentive program payment criteria.

Response: We thank the commenter for pointing out our oversight in not including the

hospital-based physician exclusion in the proposed regulation text related to the MA EP EHR

incentive program. We will include in regulation text the fact that an MA EP is not a “hospital-

based EP,” as that term is defined in §495.4 of this final rule. As to a possible exception for

hospital-based EPs who are practicing in MA-affiliated hospitals that do not qualify for incentive

payments (or that qualify for very minimal incentive payments), we cannot provide such an

exception. MA-affiliated eligible hospitals will receive EHR incentive payments based on the

same statutory formula used to make EHR incentive payments to other “subsection (d)” hospitals

– see section II.C.3. of this final rule, below. There is no statutory authority nor is there a valid

reason to treat MA EPs, in this respect, any differently that other EPs that are hospital-based.

After consideration of the public comment received, we are modifying the regulation text

related to the definition of MA EP by the additional of an item 5) to the definition of “Qualifying

MA EP” at §495.200 to add a specific hospital-based MA EP exclusion.

As discussed in the proposed rule, an MA EP must either be employed by the qualifying

MA organization, or be employed by, or be a partner of, an entity that through contract with the

qualifying MA organization furnishes at least 80 percent of the entity's Medicare patient care
CMS-0033-F 473

services to enrollees of the qualifying MA organization. With respect to the later criteria, we did

not propose to define the term “entity,” but instead recognized that there exist a range of entities

with which MA organizations contract for patient care services, including physician groups,

Independent Practice Associations (IPAs), Exclusive Provider Organizations (EPOs), Physician

Hospital Organizations (PHOs), and Preferred Provider Organizations (PPOs).

Moreover, we recognized that an EP may contract with more than one such entity, and

that these entities often contract with a number of MA organizations and other health care

insurers. An EP also may directly contract with more than one MA organization. In general, we

said, it is only when an EP is employed by a single qualifying MA organization, or is employed

by or in partnership with an entity that contracts with a single qualifying MA organization, that

an EP can satisfy the criteria to be an MA EP.

We said that the qualifying MA organization must attest to the fact that each MA EP is a

meaningful user of certified EHR technology in accordance with §495.4. If all of these

conditions are met, such an individual is identified as an MA EP. We proposed to define the

term “MA eligible professional (EP)” at §495.200 as an EP who satisfies all of these conditions.

Finally, we discussed section 4101(d) of the HITECH Act which directed the Secretary to

study and report on “nearly exclusive” physicians that primarily treat MA enrollees and that

would not otherwise qualify for incentive payments under current law. We explained that this

rule does not address such individuals, as it is limited to codifying in regulation existing statutory

language as discussed herein.

We did not receive any comments on these provisions and are finalizing them as proposed.

c. Qualifying MA-Affiliated Eligible Hospital

We proposed to define “qualifying MA-affiliated eligible hospital” in §495.200. A

CMS-0033-F 474

qualifying MA organization may receive an incentive payment only for a qualifying

MA-affiliated eligible hospital described under section 1853(m)(2) of the Act, as added by

section 4102(c) of the HITECH Act, that is a meaningful user of certified EHR technology as

defined in §495.4 . Section 1853(m)(2) of the Act provides that such MA-affiliated eligible

hospitals are “eligible hospitals” as defined under section 1886(n)(6) of the Act and must be

under common corporate governance with a qualifying MA organization that serves individuals

enrolled under MA plans offered by such organization where more than two-thirds of the

Medicare hospitals discharges (or bed-days) are Medicare individuals enrolled under MA plans

offered by such organization. As discussed in section II.A.1. of this final rule, section 1886(n)(6)

of the Act defines an “eligible hospital” as a subsection (d) hospital (as defined under section

1886(d)(1)(B) of the Act). In §495.200, we also proposed to define “under common corporate

governance”, as a qualifying MA organization and a qualifying MA-affiliated eligible hospital

that have a common parent corporation, where one is a subsidiary of the other, or where the

organization and the hospital have a common board of directors.

Section 1853(m)(3)(B)(i) of the Act, as added by section 4101(c) of the HITECH Act,

provides that if for a payment year at least one-third (33 percent) of a MA eligible hospital's

discharges (or bed-days) of Medicare patients are covered under Part A (rather than under Part

C), the hospital may only receive an incentive payment under section 1886(n) of the Act – the

Medicare FFS incentive program.

In §495.200 we proposed to define “inpatient-bed-days” in the same manner as that term

is defined for purposes of implementing section 4201(a) of the HITECH Act in the preamble of

this final rule. The term will be used in the same way in computing incentive payments due
CMS-0033-F 475

qualifying MA organizations under the qualifying MA-affiliated eligible hospital incentive

payment program.

We note that, as discussed in section II.B.2.b. of this final rule, under section

1886(n)(2)(D)(i)(II) of the Act, the portion of the Medicare FFS hospital incentive payment

comprising the discharge related amount, or Medicare share, is based in part on the estimated

number of inpatient-bed-days attributable to individuals enrolled in MA plans under Part C. This

means that hospitals that treat individuals enrolled in MA plans will receive a Medicare FFS

hospital incentive payment partially based on the number of MA-enrollee bed-days. To the

extent a hospital does not meet the 33 percent threshold requiring payment through the FFS

Medicare EHR hospital incentive program, incentive payments can be made to a qualifying MA

organization under common corporate governance to the extent other requirements of the MA

EHR hospital incentive program are met. (See section II.C.3 of this final rule for the

computation of incentive payments to qualifying MA organizations.)

Therefore, we proposed to make EHR incentive payments to qualifying MA-affiliated

eligible hospitals under the FFS EHR incentive program. Finally, we said that to the extent such

data necessary to estimate the inpatient-bed-days-related incentive payment amount are not

already available to us through the normal submission of hospital cost reports; we proposed to

require that qualifying MA organizations seeking reimbursement for qualifying MA-affiliated

eligible hospitals submit similar data.

We did not receive any comments on these provisions and are finalizing them as

proposed.
CMS-0033-F 476

2. Identification of Qualifying MA Organizations, MA EPs, and MA-Affiliated Eligible

Hospitals

In §495.202 we proposed to require an MA organization that intended to ask for

reimbursement under the MA EHR incentive payment program to so indicate as part of

submissions of their initial bid under section 1854(a)(1)(A) of the Act, and to attest, in some

cases, that they meet the requirements of a qualifying MA organization. For MA organizations

offering an MA HMO plan type, we proposed to deem such organizations to meet the definition

of HMO in 42 U.S.C. 300-gg(b)(3), (that is, section 2791(b)(3) of the PHS Act). As noted

previously, for MA organizations offering plan types other than HMOs, we proposed to require

an attestation by the organization that the MA organization is recognized under State law as an

HMO, or that it is a similar organization regulated under State law for solvency in the same

manner and to the same extent as an HMO before we would make a determination that the MA

organization is a qualifying MA organization for purposes of incentive payments. We proposed

to require this beginning with bids due in June 2010 (for plan year 2011) for MA organizations

seeking reimbursement for MA EPs and MA-affiliated eligible hospitals.

We also proposed requiring qualifying MA organizations, as part of their initial bids

starting with plan year 2011, to make a preliminary identification of potentially qualifying MA

EPs and potentially qualifying MA-affiliated eligible hospitals for which the organizations would

seek EHR incentive payments.

In developing the preliminary and final lists of potentially qualifying MA EPs, qualifying

MA organizations, we said that qualifying MA organizations must exclude hospital-based MA

EPs. We proposed that qualifying MA organizations identify hospital-based MA EPs using the
CMS-0033-F 477

same criteria outlined in section II.A.6 of this final rule for identifying hospital-based EPs in the

Medicare FFS EHR incentive program.

Along with both the preliminary and final lists of potentially qualifying MA EPs and

MA-affiliated hospitals, we said that qualifying MA organizations would be required to submit

an attestation that these professionals and hospitals meet the criteria to be considered eligible.

For example, for hospitals, the qualifying MA organization would need to attest that they are

under common corporate governance with the qualifying MA organization and for EPs, the

qualifying MA organization would need to attest that the list does not include any hospital-based

EPs.

We proposed requiring qualifying MA organizations to provide final identification of

potentially qualifying MA EPs by the end of the MA EP payment year (December 31), and final

identification of potentially qualifying MA-affiliated eligible hospitals by the end of the

MA-affiliated hospital payment year (the FFY ending on September 30), for which MA EHR

incentive payments were sought. We also proposed requiring qualifying MA organizations to

report the name, practice address, and other identifying information, like NPI, for all physicians

that meet the requirements of a qualifying MA EP for which the qualifying MA organization

would be requesting payment under the MA EHR incentive payment program.

We said that once a qualifying MA organization identifies potential EPs, we are required

to ensure that such EPs did not receive the maximum EHR incentive payment for the relevant

payment year under the Medicare FFS program under section 1848(o)(1)(A) of the Act, as added

by section 4101(a) of the HITECH Act, before releasing an incentive payment to a qualifying

MA organization related to such EP. (See section 1853(l)(3)(B)(i) of the Act, as added by

section 4101(c) of the HITECH Act). Therefore, in order to allow us time to determine whether
CMS-0033-F 478

an MA EP received the maximum EHR incentive payment under the Medicare FFS program, we

proposed not to make incentive payments to qualifying MA organizations for the MA EPs for a

payment year until after the final computation of EP incentive payments for that year under the

Medicare FFS program. Additionally, we proposed to require qualifying MA organization to

ensure that all MA EPs are enumerated through the NPI system, in order to detect and prevent

duplicate payment for EPs under both the FFS and MA EHR incentive payment programs.

Comment: Two commenters contended that requiring MA organizations to provide even

a preliminary list of MA EPs by June 2010 (for payment year 2011) would be unrealistic and

burdensome, especially when publication of a Final Rule seems unlikely before May 2010 at the

earliest. For 2011, any preliminary list will be inaccurate, despite good faith efforts and

reasonable due diligence. Moreover, CMS has not stated any justifiable purpose for requiring

such a preliminary list.

Response: We agree with the commenters that it would be unnecessarily burdensome

and unrealistic to require MA organizations to provide preliminary lists as early as June of 2010

of potential MA EPs for incentive payment year 2011. We will change the timing of this

requirement in §495.202(b)(1) to say that as part of initial bids for plan year 2012 MA

organizations will be required to submit preliminary lists in June of 2011 (when bids are due for

2012) of potential MA EPs for incentive payment year 2011. Thus, we will delay the

requirement for a full year. The purpose of such preliminary lists is to identify potential MA EPs

that have, for instance, registered as FFS Medicare or Medicaid EPs on the National Level

Repository. The intent of getting these lists before payment is due, or before a final

determination of eligibility can be made, is to help qualifying MA organizations know of any

potential conflicts in time to “cure” them before final payment determinations are made.
CMS-0033-F 479

Comment: One commenter objected to CMS’s proposal that MA organizations be

required to submit final lists of MA EPs and MA hospitals by the last day of the payment year,

including the attestations of meaningful use and accurate payment calculation. The commenter

argued that this timing would not allow sufficient time to ensure that data are complete and

accurate, especially considering that MA organizations bear the additional burden of having to

develop and support internal administrative systems to determine eligibility and to calculate

payment (we will calculate FFS EP payments based on claims submitted). The commenter

recommended that we extend the deadlines to produce both preliminary and final lists of MA

EPs and hospitals. The commenter suggested that MA organizations be given until 90 to 120

days after the close of the payment year to identify and list eligible EPs and hospitals (for

example, after 31 December 2011 for plan year 2011).

Response: We agree with the commenter that additional time should be permitted and we

are therefore adding a due date in §495.202(b)(3) for final identification of potentially qualifying

MA EPs and MA-affiliated eligible hospitals of 60 days after the close of the payment year. We

believe 60 days is reasonable, since it is the same as the time in which FFS EPs have to submit

claims for consideration under the Medicare FFS EHR incentive payment program.

After consideration of the public comments received, we are modifying the regulation

text related to the timing of both preliminary and final identification of MA EPs and MA-

affiliated eligible hospitals. Preliminary identification of MA EPs and MA-affiliated hospitals

for payment year 2011 will need to occur by the bidding deadline in June 2011, and final

identification will need to occur within 60 days of the close of the payment year. Accordingly,

we are respectively modifying the regulation text at §495.202(b)(1) and §495.202(b)(3). We are

also modifying the regulation text at §495.204(b)(2) to be consistent with the change to
CMS-0033-F 480

§495.202(b)(3), since final identification in §495.202(b)(3) should occur at the same time as final

revenue reporting under §495.204(b)(2), so calculations of payments due under the MA EP

incentive payment program can be finalized. We are also modifying the regulation text at

§495.210(b) and (c) to be consistent with the changes to §495.204(b)(2) and §495.202(b)(3),

since the deadline for attestations of meaningful use should be consistent with deadlines for

revenue reporting for MA EPs, and final identification of MA EPs and MA-affiliated hospitals.

Finally, as noted (above) in our discussion of the definition of qualifying MA organization, we

are modifying the date in §495.202(a)(1) by which MAOs are required to identify themselves to

us from the bidding deadline in June 2010 (for plan year 2011) to the bidding deadline in June

2011 (for plan year 2012).

We also proposed to require all qualifying MA organizations to self-report and identify

themselves, regardless of whether they have qualifying MA EPs or MA-affiliated eligible

hospitals for whom or which the organization plans to claim incentive payments at the time the

initial bid is due (the first Monday of June, see section 1854(a)(1)(A) of the Act) beginning in

2014 for bids related to plan year 2015. We proposed to require this reporting by all qualifying

MA organizations in years beginning with 2014 in anticipation of the statutory requirement in

sections 1853(l)(4) and 1853(m)(4) of the Act, to negatively adjust our capitation payments to

qualifying MA organizations for MA EPs and MA-affiliated eligible hospitals that are not

meaningful users of certified EHR technology for years beginning with 2015.

We did not receive any comments on these provisions and are finalizing them as

proposed.
CMS-0033-F 481

3. Computation of Incentives to Qualifying MA Organizations for MA EPs and Hospitals

In §495.204, we proposed a methodology under which payments to qualifying MA

organizations for qualifying MA EPs will be computed. Section 1853(l)(3)(A) of the Act

provides that in applying section 1848(o), instead of the additional payment amount specified

under section 1848(o)(1)(A) of the Act, the Secretary may substitute an amount determined by

the Secretary, to the extent feasible and practical, to be similar to the estimated amount in the

aggregate that would be payable under, or would be based on, the Medicare physician fee

schedule under Part B instead of Part C. Section II.B.1. of this final rule discusses these

provisions.

Section 1853(m)(3)(A) of the Act provides that, in providing an incentive payment to

qualifying MA organizations for MA-affiliated hospitals, we substitute for the amount specified

under section 1886(n)(2) of the Act – the incentive payment amount under Medicare FFS for

qualifying eligible hospitals – an amount determined by the Secretary to be similar to the

estimated amount in the aggregate that would be payable if payment for services furnished by

such hospitals was payable under Part A instead of Part C. (For more detailed information see

section II.B.2. of this final rule.)

Sections 1848(o)(1)(D)(i) and 1886(n)(2)(F) of the Act permit us to make incentive

payments for a year in installments, although we proposed to make a single lump sum payment

with respect to MA EPs. With respect to MA EP incentive payments, we said we read the term

“aggregate” to mean the aggregate installment payments made by us under the FFS EHR

incentive program to a qualifying EP over the course of the relevant payment year.

The duplicate payment provisions in section 1853(l)(3)(B)(i)(II) of the Act direct us to

make payment for EPs “only under” the MA EHR incentive program “and not under” the
CMS-0033-F 482

Medicare FFS EHR incentive program to the extent any EP earned “less than [the] maximum

incentive payment for the same period” under the Medicare FFS EHR incentive program. We

noted in the proposed rule that section 1853(l)(1) of the Act provides that section 1848(o) of the

Act applies in a “similar,” but not the same, manner to qualifying MA organizations as it applies

to EPs under Part B. The Medicare FFS incentive payment program under section 1848(o) does

not include payment for professional services provided to MA enrollees, but rather only for

services paid under Part B. In a similar manner we proposed to limit payment to an MA

organization to only payment for their EPs' services to MA enrollees of plans offered by the MA

organization. We said we did not believe it would be appropriate to provide an incentive

payment to an MA organization for services provided to individuals covered under Part B.

Therefore, we proposed, that in calculating qualifying MA EP incentive payments, we would

only consider covered professional services provided to enrollees of MA plans offered by

qualifying MA organizations and would not include in the calculation any services reimbursed

by Medicare FFS.

Comment: Many commenters asked if MA plan beneficiaries and services would be

counted in the calculation of FFS EHR incentives and, if so, if it would require separate

submissions to each MA plan in the local market.

Response: As we explained in the preamble of the proposed rule, we cannot make MA

EP incentive payments for Part B services covered and paid for on a fee-for-service basis under

the original Medicare program. We also cannot make MA EP incentive payments to entities

other than qualifying MAOs. In short, the Medicare Advantage services provided by EPs that

are not qualifying MA EPs – defined in statute and in this rule at §495.200 – are not

reimbursable under the EHR incentive payment program.

CMS-0033-F 483

Comment: Two commenters contended that the proposed Medicare Advantage incentive

computation was inconsistent. They said that sections II.C.3. through 5. of this final rule discuss

compensation, but the preamble says that the Secretary may substitute a different amount. This

discrepancy should be clarified.

Response: We disagree. The statute says that we can substitute an amount “that is

similar to the estimated amount that would be payable or based on the fee schedule.” It does not

say that we can substitute a different amount.

After consideration of the public comments received, we are implementing these

provisions as proposed.

We also said that under the Medicare FFS EHR incentive program, an EP's incentive

payment could not exceed the annual limits specified under section 1848(o)(1)(B)(i) of the Act.

We proposed that similar payment limits apply to qualifying MA organizations for their

qualifying MA EPs. Specifically, section 1848(o)(1)(B) of the Act provides that the incentive

payment for an EP for a given year shall not exceed the following amounts:

• For the EP's first payment year, $15,000 (or, if the first payment year is 2011 or 2012,

$18,000).

• For the EP's second payment year, $12,000.

• For the EP's third payment year, $8,000.

• For the EP's fourth payment year, $4,000.

• For the EP's fifth payment year, $2,000.

• For any succeeding year, $0.

Note that, similar to the Medicare FFS EHR incentive program, there will be no incentive

payments made with respect to a year after 2016. We proposed similar restrictions related to
CMS-0033-F 484

qualifying MA organizations. So, the maximum cumulative incentive payment over 5 years to a

qualifying MA organization for each of its qualifying MA EPs that meaningfully use certified

EHRs beginning on or before 2012 would be $44,000 per qualifying MA EP. For qualifying MA

organizations first reporting the meaningful use of certified EHRs by qualifying MA EPs after

2014, there is no incentive payment amount available. Subject to an exception discussed below,

for MA organizations first reporting the meaningful use of certified EHRs by qualifying MA EPs

in 2013 or 2014, the maximum potential incentive payment per qualifying EP is, respectively,

$39,000 over 4 years, and $24,000 over 3 years.

We did not receive any comments on these provisions and are finalizing them as

proposed.

We proposed to make MA EP incentive payments to qualifying MA organizations on the

same payment cycle for all employed/partnering qualifying EPs of the organization. In other

words, all MA EPs of a specific qualifying MA organization will be in the same payment year

with respect to the amount of the incentive payment per qualifying EP that we will make. So, for

instance, if a qualifying MA organization is in its second payment year in 2013 and it hires a new

EP for which the qualifying MA organization had not previously received an EHR incentive

payment, we will nevertheless make a second year incentive payment (up to $12,000 in 2013)

with respect to such an MA EP – assuming all other conditions are met. Thus, the limits on MA

EP incentive payments discussed above are applied to the qualifying MA organization's entire

MA EP population in any specific payment year relative to that MA organization, regardless of

the length of employment/partnership of/between that specific MA EP and that specific

qualifying MA organization.
CMS-0033-F 485

Under section 1848(o)(1)(B)(iv) of the Act, the annual incentive payment limit for EPs

who predominantly furnish Part B services in a geographic health professional shortage area

(HPSA) is increased by 10 percent. While we do not anticipate that MA EPs would generally

practice in a HPSA area, to the extent that an MA EP practices in an area where he or she would

be entitled to the 10 percent increase, that amount would apply to MA EPs as well.

We did not receive any comments on these provisions and are finalizing them as

proposed.

We explored various ways of computing the EP-level incentive payments due qualifying

MA organizations whose qualifying MA EPs meaningfully use certified EHR technology. One

option that we considered was using MA plan bidding and payment data to estimate average

annual MA revenue for qualifying MA EPs with respect to a qualifying MA organization.

However, we did not pursue this option because the approach results in an average revenue

amount across all potentially qualifying MA EPs with respect to a qualifying MA organization

and, therefore, would include revenue amounts that exceed the annual per-professional ceiling on

incentive payments under FFS for all EPs. We said we believed such a result is contrary to the

legal requirement that qualifying MA organizations are to receive incentive payments only for

qualifying MA EPs that actually provide at least 20 hours per week of patient care services.

Under this method there would be also be no way to know if the EP provided 80 percent of

his/her professional Medicare services to enrollees of the organization.

We also considered a reporting system for which qualifying MA organizations would be

required to report eligible-professional-specific information along with MA patient encounters

for nonhospital-based office visits. Specifically, we examined requiring qualifying MA

CMS-0033-F 486

organizations reporting qualifying MA EP encounters with MA plan enrollees based on the five

levels of office visit codes recognized by Medicare FFS.

We said we believed that such a process would be administratively burdensome and

difficult to operationalize. Therefore, we proposed an alternative approach, but sought input

from interested parties as to which of the approaches, or perhaps others, would best address the

statutory requirement to compensate qualifying MA organizations for qualifying MA EPs the

amount that would be payable if payment for services furnished by such professionals were made

under Part B instead of Part C.

Therefore, in §495.204(b)(1) through (3) we proposed an approach in which the revenue

received by the qualifying MA EP for services provided to enrollees of the qualifying MA

organization would serve as a proxy for the amount that would have been paid if the services

were payable under Part B. Under our proposed approach, the qualifying MA organization

would report to us the aggregate annual amount of revenue received by each qualifying MA EP

for MA plan enrollees of the MA organization. We said we would calculate the incentive

payment amount due the qualifying MA organization for each qualifying MA EP as an amount

equal to 75 percent of the reported annual MA revenue of the qualifying MA EP, up to the

maximum amounts specified under section 1848(o)(1)(B) of the Act.

For qualifying MA EPs who were compensated on a salaried basis, we proposed in

§495.204(b)(4) requiring the qualifying MA organization to develop a methodology for

estimating the portion of the qualifying MA EP's salary attributable to providing services that

would otherwise be covered as professional services under Part B of Medicare to MA plan

enrollees of the MA organization. The methodology, which would require review and approval

by us, could be based on the relative share of patient care hours spent with MA enrollees of the
CMS-0033-F 487

organization or another reasonable method. So, for instance, if a qualifying MA EP spends 30

percent of his or her time providing covered Part B physician office services to MA plan

enrollees, then the qualifying MA organization would report 30 percent of the qualifying MA

EP's salary as annual revenue, which would be used to compute the amount of the MA incentive

payment due to the qualifying MA organization for the qualifying MA EP. Thus, if the

qualifying MA EP had a base salary of $150,000, 30 percent would be $45,000 – which is well

over the threshold of $24,000 needed by the MA organization to qualify for a maximum

incentive payment of up to $18,000 (70 percent of $24,000) for such a qualifying MA EP in any

year. We also proposed to require that salaries be prorated to ensure that the amount reported

reflects the salary paid for the applicable year, where necessary.

We also said that salaried physicians' compensation typically does not include an

allowance for administrative practice costs. Given that Part B allowed amounts do include

practice expense costs, we proposed allowing qualifying MA organizations to identify, where

appropriate, an additional amount related to overhead that would be added to the qualifying MA

EP's estimated Part B compensation. To the extent Medicare FFS compensation to physicians

includes an amount for office space rental, office staffing, and equipment, we believe that

qualifying MA organizations should also be permitted to include an amount for overhead related

to such costs not directly experienced by salaried qualifying MA EPs. In §495.204(b)(4)(ii), we

proposed requiring qualifying MA organizations to develop a methodology for estimating the

additional amount related to overhead attributable to providing services that would otherwise be

covered under Part B of Medicare. We said the methodology would require review and approval

by us.
CMS-0033-F 488

For qualifying MA EPs who are not salaried, (that is, who are paid on a capitated or

fee-for-service basis), we proposed in §495.204(b)(5) to require qualifying MA organizations to

obtain attestations from such EPs and to submit to us information from the attestations as to the

amount of compensation received by the EPs for MA plan enrollees of the MA organization.

We are proposing such attestations because many EPs are not paid directly by MA organizations,

but rather by intermediary contracting entities, such as physician groups, and as a result the

qualifying MA organization may not otherwise know how much compensation is received by

each qualifying MA EP. In reporting compensation, we are proposing that the EPs include only

those amounts for professional services that would otherwise be payable under Part B and for

which payment would be made under, or would be based on, the Medicare physician fee

schedule.

Comment: One commenter recommended that final CMS regulations retain the exact

requirements outlined in §§495.204(b)(4) and (5). Two commenters said that CMS should allow

flexibility in methods MA organizations propose for computing incentive payments so long as

the organization’s approach is reasonable, straightforward, and fairly equates to the Medicare

fee-for-service approach without imposing undue burdens on MA organization systems or

compromising EP privacy. The proposed rule describes how incentive payment amounts will be

calculated for eligible hospitals and EPs. The proposed rule presents options for a MA payment

methodology, but expressly solicits comments from MA organizations about how such a

methodology could be designed to fairly approximate the FFS payment calculation. The

commenters included recommendations about how MA organizations could be reimbursed and

what methodology would be a reasonable proxy for the Part B-based payment applied to FFS

physicians, based on the amount of individual physician care provided to MA members. The
CMS-0033-F 489

commenters said that MA EPs who are employed by their organizations are independent

physician group practices that contract exclusively with their organizations to meet the health

needs of their members, including MA enrollees. Their organizations do not pay the salaries of

MA EPs who provide patient care services to their members and patients. They said that CMS

has proposed that the organization that directly pays the EP salaries would perform a calculation

and attest to the MA organization about the amount of payment. They said that while this would

mitigate some of the confidentiality concerns related to sharing salary information with the

health plans, salary information would still be potentially exposed to CMS. They said that

another disadvantage of using actual salary as a basis for calculating the incentive payment is

that this approach potentially introduces unacceptable variability into the estimation of proxy

amounts for Medicare services. For example, two MA EPs, whose salaries vary significantly but

provide the same Medicare services in a reporting period, would have different proxy amounts.

Further, they said, if such EPs were billing under Part B, the amount of Medicare services each

billed would be the same, regardless of whether their incomes were the same. These

commenters went on to propose an alternative method of computing a proxy Part B amount.

They said that as a first step, the MA organization would calculate the percentage of clinic time

each physician spends caring for MA members. This MA Practice percentage could be derived

by either: 1) capturing the total scheduled appointment time for MA members for each MA EP

and dividing that amount by the total scheduled time for that MA EP (for all appointments); or 2)

capturing the number of MA member visits/procedures for each MA EP and dividing that

amount by the total number of visits/procedures for that MA EP (for all members). The

organization would then calculate the average practice cost by specialty for all specialties

identified in the annual American Medical Group Association’s (“AMGA”) salary survey. The
CMS-0033-F 490

commenters explained that AMGA survey provides the median compensation per physician in

most specialties as well as the non-compensation related clinic costs per physician (staffing,

supplies, overhead, etc.) in most specialties. Adding specialty specific compensation data (for

groups > 100 physicians) to the combined average non-compensation related clinic costs for that

specialty (for all sized groups) would provide a surrogate amount for each specialty’s total

operating costs. This would produce the Average Operating Costs by Specialty. Multiplying

each MA EP’s MA Practice percentage and the Average Operating Costs by Specialty for that

MA EP’s practice specialty would produce a surrogate Medicare Part B amount. For each MA

EP, the MA organization would be paid an incentive equal to 75 percent of the surrogate

Medicare billing amount for that physician, such incentive not to exceed the maximum incentive

for each payment year of the program (for example, $18,000 if the first year of participation is

2011).

Response: While we appreciate the thought and effort that went into this proposed

alternative method of calculating MA EP incentive payments, we are reluctant to adopt it for the

simple reason that where salaries, practice costs, or actual MA EP compensation can be known,

we believe it is a better read of statutory requirements to work from that actual compensation and

cost data than it would be to allow estimation of both. In many respects the proposed alternative

method is similar to the method discussed and disposed of in the proposed rule related to

estimating physician compensation based on MA bidding and payment data. Although the

commenters’ alternative version factors in actual practice time, we believe using AMGA salary

survey data would be inferior to using actual physician compensation practice cost information.

To the extent actual salary information is unknown or unavailable to the MA organization, we

believe it could be provided to us in a manner that would protect the privacy of individual MA
CMS-0033-F 491

EPs and physician groups. Furthermore, the proposal also estimates “non-compensation related

clinic costs” based on AMGA data, which is, again, inappropriate, when actual overhead costs

might be quite different in a specific MA organization. However, based on the commenters

concerns regarding provider privacy and the need to develop a consistent and verifiable method

of computing the amount payable to qualifying MA organizations for MA EPs we are modifying

the regulation text at §495.204(b)(5) to say that qualifying MA organizations “may” obtain

attestations from qualifying MA EPs and “may” submit such information to us – rather than

“must.” And, we add a new subparagraph (6) that allows the physician group or other payer to

provide EP reimbursement information directly to us. We also provide assurances that we will

use the EP reimbursement data for no other purpose than to compute the MA EP incentive

payment due the qualifying MA organization.

Comment: One commenter said that in the proposed rule the methodology for estimating

the portion of the qualifying MA EP’s salary attributable to providing services that would

otherwise be covered as professional services under Part B of Medicare to MA plan enrollees of

the MA organization would require review and approval by CMS; and that such methodology

“could be based on the relative share of patient care hours spent with MA enrollees of the

organization or another reasonable method.” However, the commenter opined, the proposed rule

offers no details about how the review and approval process would be conducted, including dates

and timelines for the process. Thus, the commenter recommended that CMS permit flexibility in

allowing MA organizations to develop methodologies that will be reasonable in light of

organization structure and systems, it is important to provide some guidance about how CMS

will review and approve such proposals. CMS should permit, the commenter said, any

reasonable payment methodology method that is fair, relatively easy to administer, subject to
CMS-0033-F 492

audit and that provides a reliable approximation of Medicare Part B billing. In addition, the

commenter concluded, CMS should provide a simple process for submission and approval of

MA payment methodologies.

Response: In the proposed rule at §495.204(b)(4) we offered flexibility related to the

“methodology for estimating the portion of each qualifying MA EP’s salary attributable to

providing services that would otherwise be covered as professional services under Part B,” said

that the methodology had to be “approved by CMS,” and that the amount could include an

“additional amount related to overhead.” Based on this comment we are adding a new clause

(iii) that says that such methodological proposals must be submitted to CMS by June of the

payment year, must be auditable by an independent third-party, and that CMS will review and

approve or disapprove such proposals in a timely manner.

Comment: One commenter wanted to know what percentage of the incentive payments

will go to eligible professionals under Medicare Advantage.

Response: No known percentage of incentive payment will go to eligible professionals

under Medicare Advantage, since MA EP payments are made solely to qualifying MA

organizations.

In the proposed rule we said that in applying the instruction in section 1853(m)(3)(A) of

the Act to substitute for the amount specified under section 1886(n)(2) of the Act an amount

similar to the estimated amount in the aggregate that would be payable if payment for the

hospitals' services were made under Part A instead of Part C, we read the term “aggregate” to

mean the aggregate installment payments made by us if EHR incentive payments were made

under Part A instead of Part C.

CMS-0033-F 493

Incentive payments to eligible hospitals under the Medicare FFS EHR incentive program

are comprised of three components: (1) an initial amount composed of a base incentive payment

of $2,000,000 and a second incentive payment amount of $200 per discharge for discharges

1,150 – 23,000 during a 12- month period selected by the Secretary; (2) the Medicare share; and

(3) a transition factor. As discussed in the preamble related to §495.104(c), for purposes of

calculating incentive payments to eligible hospitals under the Medicare FFS EHR incentive

program, we are proposing that the 12-month period be based on the FFY. For the purpose of

calculating incentive payments for qualifying MA-affiliated eligible hospitals, we similarly are

proposing that the 12-month period be based on the FFY.

Section II.B. of this final rule discusses our methodology for calculating the incentive

payment for qualifying eligible hospitals under the Medicare FFS EHR program. As set forth in

§495.204(c)(2), we proposed to use the FFS EHR hospital incentive program for purposes of

calculating and making the incentive payment for qualifying MA-affiliated hospitals. To the

extent data are not available to reimburse MA-affiliated hospitals through the FFS hospital

incentive program, we proposed to require submission of such data to us and adopt the same

definition of “inpatient-bed-days” and other terms under the Medicare FFS EHR hospital

incentive program specified in §495.104 of this final rule. In such a case we proposed in

§495.204(c)(1) to make payment for such MA-affiliated eligible hospitals to the qualifying MA

organization.

The formula for calculating the hospital incentive payment under the Medicare FFS

hospital incentive program is an initial amount of the sum of the base amount of $2,000,000 per

hospital plus an additional $200 per discharge for discharges 1,150 through 23,000 for that

hospital in that payment year. This initial amount is then multiplied by a transition factor and
CMS-0033-F 494

then again by the Medicare share. These last two numbers are fractions and will tend to reduce

the initial amount computed in the first step.

Similar to the Medicare FFS EHR hospital incentive program, we proposed to use

inpatient-bed-day data, discharges, and other components of the FFS calculation for each

qualifying MA-affiliated eligible hospital from the hospital-specific fiscal year that ends during

the FFY prior to the FFY that serves as the payment year. To the extent such data are not

already available to us through the normal submission of hospital cost reporting data; we

proposed requiring qualifying MA organizations seeking reimbursement for their qualifying

MA-affiliated eligible hospitals to submit similar data.

We said we can only pay for qualifying MA-affiliated eligible hospitals under common

corporate governance based on inpatient-bed-days computed on a fiscal year basis where less

than one third of the inpatient-bed-days of Medicare patients are covered under Medicare FFS -

Part A. However, it does not appear that reimbursement only under the MA EHR incentive

program is required for qualifying MA-affiliated eligible hospitals that are under common

corporate governance. Rather, section 1853(m)(3)(B), of the Act only prohibits payment under

the MA EHR incentive program when Medicare hospital inpatient-bed-days covered under Part

A exceed 33 percent of all Medicare inpatient-bed-days. Although eligibility under the MA

EHR hospital incentive program is not available to qualifying MA organizations for any specific

hospital when FFS inpatient-bed-days exceed 33 percent of the Medicare total, a qualifying MA

organization could be reimbursed through the Medicare FFS EHR hospital incentive payment

program for qualifying hospitals under common corporate governance even for hospitals with

very low ratios of FFS to MA inpatient-bed days.

CMS-0033-F 495

Given that the hospital incentive payment methodology and payment amount will be

identical under the Medicare FFS EHR incentive program and the MA EHR incentive program,

and given that there is no statutory prohibition on reimbursing a qualifying MA-affiliated eligible

hospital through the Medicare FFS EHR incentive program, for purposes of administrative

efficiency, and pursuant to our authority under section 1857(e) of the Act to add new

“appropriate” contract terms (incorporated for Part D by section 1860D-12(b)(3)(D) of the Act),

we proposed requiring that qualifying MA organizations receive incentive payments for

qualifying MA-affiliated eligible hospitals through their affiliated hospitals under the Medicare

FFS EHR incentive program if they are eligible for such payments, rather than through the MA

EHR incentive program. We believe this is the most efficient way in which to administer the

MA EHR hospital incentive program in light of the expected low volume of MA-affiliated

eligible hospitals (approximately 50 hospitals), and in light of preliminary data which indicates

that MA-affiliated eligible hospitals already submit Medicare cost reporting data to us from

which we can compute hospital incentive payments due. To the extent sufficient data do not

exist to make such payments under the Medicare FFS EHR incentive program, qualifying MA

organizations will be required to submit additional data to us.

We did not receive any comments on these provisions and are finalizing them as

proposed.

To the extent payments are made to qualifying MA organizations for qualifying MA EPs

or qualifying MA-affiliated eligible hospitals, we proposed to conduct selected compliance

reviews to ensure that EPs and eligible hospitals for which such organizations received incentive

payments were actually meaningful users of certified EHR technology, in accordance with our

existing authority in section 1857(d) of the Act and 42 CFR 422.504 of the regulations related to
CMS-0033-F 496

protections against fraud. The reviews would include validation of meaningful user attestations,

the status of the organization as a qualifying MA organization, and verification of both

meaningful use and data used to calculate incentive payments. We proposed requiring MA

organizations to maintain evidence of compliance with all aspects of the MA EHR incentive

payment program for 10 years after the date payment is made with respect to a given payment

year. Payments that result from incorrect or fraudulent attestations, cost data, or any other

submission required to establish eligibility or to qualify for a payment, will be recouped by CMS

from the MA organization.

We did not receive any comments on these provisions and are finalizing them as

proposed.

Finally, as we indicated above in section II.C.2. of this final rule, we are modifying the

regulation text at §495.204(b)(2) to be consistent with the change to §495.202(b)(3), since final

identification in §495.202(b)(3) should occur at the same time as final revenue reporting under

§495.204(b)(2), in order to ensure that calculations of payments due under the MA EP incentive

payment program can be finalized.

4. Timeframe for Payment

For payments to qualifying MA EPs, in §495.206 we proposed the timeframe for

payment to be after the Medicare FFS program computes incentive payments due under the

Medicare FFS EHR incentive program – so the first possible incentive payments would be made

sometime in early 2012. We proposed that payments for qualifying MA-affiliated eligible

hospitals under common corporate governance occur in the same manner and in the same time

frame as payments made under the Medicare FFS EHR incentive program to “subsection (d)”

hospitals as discussed in section II.B.2.d. of this final rule.

CMS-0033-F 497

We proposed to define “payment year” with respect to qualifying MA EPs in §495.200.

Section 1853(l)(3)(C) of the Act directs us to establish the same first payment year for all EPs

with respect to any specific qualifying MA organization. Consistent with the statute, we

proposed to pay a qualifying MA organization on the same schedule for all of its qualifying MA

EPs. In other words, the first year during which the qualifying MA organization receives an

incentive payment for its qualifying EPs will be considered the first payment year for all of its

qualifying EPs. Accordingly, for purposes of determining the applicable incentive payment

limits, the second, third, fourth, and fifth years during which the qualifying MA organization

receives an incentive payment for its qualifying EPs will be considered the second, third, fourth,

and fifth payments years for each of its qualifying EPs, regardless of whether the MA

organization claimed an incentive payment for a particular EP for a prior payment year. Such a

consistent payment cycle relative to qualifying MA organizations and qualifying MA EPs

obviates the need to track payment years and payment adjustment years based on prior payments

or adjustments with respect to any individual qualifying MA EP. Rather, for purposes of

payment years and payment adjustment years, any EP employed by or partnering with any

specific MA organization will be on the same cycle with respect to that organization.

We said that similar to the Medicare FFS EHR incentive program, payment to qualifying

MA organizations for qualifying MA EPs and payment for qualifying MA-affiliated eligible

hospitals is available only for a finite number of years. As previously discussed in the section on

the calculation of MA incentive payments, above, a qualifying MA organization can receive an

incentive payment of up to $18,000 for each of its qualifying MA EPs for its first payment year

if its first payment year is 2011 or 2012, or up to $15,000, if its first payment year is 2013, or up
CMS-0033-F 498

to $12,000, if its first payment year is 2014. Note that, similar to the Medicare FFS EHR

incentive program, there would be no incentive payments made with respect to a year after 2016.

We proposed to define “payment year” with respect to qualifying MA-affiliated eligible

hospitals in §495.200. For incentive payments for qualifying MA-affiliated eligible hospitals,

the first year for which an MA organization may claim payment is FY 2011. Similar to the

Medicare FFS EHR hospital incentive program, we proposed to use the hospital inpatient

bed-days data from the hospital FY that ends during the FFY prior to the FY that serves as the

payment year. For qualifying MA-affiliated eligible hospitals, we proposed to compute hospital

EHR incentive payments due in the same manner as they are being computed in the Medicare

FFS hospital incentive payment program. For qualifying MA-affiliated eligible hospitals for

which the first payment year is 2011 through 2013, up to 3 additional years of incentive

payments are available. For qualifying MA-affiliated eligible hospitals for which the first

payment year is after 2015, no EHR payment incentive can be made for that year or any

subsequent year. Finally, for qualifying MA-affiliated eligible hospitals for which the first

payment year is 2014 or 2015, only 2 (or 1) additional year(s) of hospital incentive payments

will be available.

Unlike the fixed schedule for application of limitation on incentive payments for MA EPs

discussed previously in this section of the final rule in which all employed/partnering MA EPs

will be paid on the same schedule (first payment year, second payment year, etc.) with respect to

any specific qualifying MA organization, we proposed to make payments to MA organizations

for MA-affiliated eligible hospitals on a hospital specific basis. In other words, if a qualifying

MA organization has some MA-affiliated eligible hospitals with a first payment year of FY
CMS-0033-F 499

2011, it may have other MA-affiliated eligible hospitals with a first payment year of FYs 2012

through 2015.

Comment: Two commenters said that payments to MA organizations will be delayed

every year by an unspecified amount of time. The commenters said that it was understood that

CMS is charged by statute to avoid making duplicate payments, however MA organizations

should be paid without unspecified delay. A suggested alternative by the commenters was to

permit MA organizations to attest that their MA EPs will not seek any payment under the

Medicare FFS Incentive Program. Alternatively, the commenters suggested, CMS could use an

installment payment system (permitted under statute as stated) for MA organizations. The

commenters said that this would permit partial payment until the resolution of the duplicate

payment issue and would avoid long delays in paying MA incentives.

Response: We do not agree that MA organization EHR incentive payments are subject to

“unspecified delay.” Rather, since MA organizations will be paid for MA EPs only if such EPs

were not paid the maximum incentive payment under the FFS EHR incentive payment program,

and since final claims data will not be available until two months after the close of the payment

year – see §495.102(a)(2) – CMS will not be able to compute MA EP payments until the FFS

EHR incentive payment program has completed its calculations. This will occur in the early

spring of the year after the close of a payment year. Moreover, MA-affiliated eligible hospitals

will receive EHR incentive payments on the same schedule as other “subpart (d)” hospitals.

Finally, note that MA EPs are free to leave qualifying MA organizations at any time, and since

EPs are also free to register for eligibility under FFS Medicare or Medicaid EHR incentive

payments, an attestation by a qualifying MA organization would have little merit. For these
CMS-0033-F 500

reasons we cannot accept the suggestion that qualifying MA organizations receive interim or

partial mid-year payments for MA EPs.

After consideration of the public comment received, we are implementing these

provisions as proposed.

5. Avoiding Duplicate Payment

We proposed duplicate payment avoidance provisions in §495.208. Section

1853(l)(3)(B) of the Act, as added by the HITECH Act, is entitled “Avoiding Duplication of

Payments.” Subclause (I) of clause (i) of this paragraph of the Act states that to the extent an

MA EP is entitled to the maximum incentive payment under section 1848(o)(1)(A) of the Act,

the Medicare FFS EHR incentive payment program, such incentive payment will only be made

under the Medicare FFS EHR incentive program. Therefore, before payments can be made to

qualifying MA organizations for MA EPs, we must first determine if a maximum incentive

payment under the Medicare FFS program has been previously earned by potential MA EPs.

Under the Medicare FFS incentive payment program, incentive payment calculations will not be

completed for the first payment year, 2011, until the early part of 2012. Therefore, we said we

would not be able to make payments to qualifying MA organizations for MA EPs until claims

submissions counted for Medicare FFS incentive payments for CY 2011 have been closed, and

payment calculations for participating EP under the Medicare FFS EHR incentive program have

been completed. This will occur in the early part of CY 2012. In the MA EHR incentive

payment program we proposed to follow the FFS EHR incentive payment program schedule –

first computing Medicare FFS incentive payments for EPs and then computing and paying MA

EP incentive payments, where appropriate – in all subsequent payment years.

CMS-0033-F 501

We went on to explain that subclause (II) of section 1853(l)(3)(B)(i) of the Act further

states that to the extent an MA EP is entitled to less than the maximum incentive payment under

the Medicare FFS EHR incentive program, that payment is to be made solely under the MA

provision. In other words, we will need to withhold Medicare FFS incentive payments from EPs

of less than the maximum to the extent such professionals are also identified as MA EPs under

section 1853(l)(2) of the Act. Again, we would need to await the computation of payments due

EPs under the Medicare FFS EHR incentive program before we can determine whether the EP is

entitled to less than the maximum payment amount under the Medicare FFS EHR program, in

which case any incentive payment for the EP will only be made to the qualifying MA

organization under the MA EHR program, and not to the EP under the Medicare FFS EHR

program.

We also said that section 1853(m)(3)(B) of the Act states that incentive payments for

qualifying MA-affiliated eligible hospitals are to be made under either the Medicare FFS hospital

incentive payment program, or under the MA hospital incentive payment program. If more than

33 percent of discharges or bed-days of all Medicare patients for a year are covered under Part A,

then payment for that year is to only be made under section 1886(n) of the Act – the Medicare

FFS EHR incentive program - and no payment is to be made under the MA hospital incentive

payment program. Otherwise, to the extent less than 33 percent of bed days of all Medicare

patients for an incentive payment year are covered under Part A, then payment for that incentive

payment year may be made under the MA EHR incentive payment program.

Unlike the process we proposed to follow related to qualifying EPs (where we will wait

for the Medicare FFS incentive payment program to compute eligible physician incentive

payments due under that program before determining the amount due under the MA EHR
CMS-0033-F 502

incentive program), we would not need to rely on Medicare FFS EHR incentive payment

program calculations before determining eligibility for MA-affiliated hospital incentive

payments. We said we would reimburse all hospitals, including MA-affiliated eligible hospitals,

under the Medicare FFS hospital incentive program. We believe that by doing so, we will

prevent duplicate payments being made for the same hospitals by Medicare FFS and the MA

incentive payment programs. To the extent that qualifying MA organizations are to receive

incentive payments through the MA program rather than through their hospitals under the

Medicare FFS EHR incentive program due to a lack of sufficient data to make payments under

the FFS program, we would identify and reimburse only appropriate qualifying MA

organizations for qualifying MA-affiliated eligible hospitals. Such reimbursement will be in a

manner similar to the manner in which the Medicare FFS EHR incentive program will reimburse

eligible hospitals due an incentive payment under the Medicare FFS EHR incentive program.

Finally, we said that in order to avoid duplicate payments and in accordance with section

1853(m)(3)(B)(ii)(II) of the Act, we will not make MA EHR hospital incentive payments to

qualifying MA organizations for MA-affiliated eligible hospitals other than through the

Medicare FFS EHR hospital incentive payment program without first ensuring that no such

payments under the Medicare FFS EHR hospital incentive payments were made.

We did not receive any comments on these provisions and are finalizing them as

proposed.

6. Meaningful User Attestation

We proposed meaningful user attestation requirements in §495.210. For each MA EP

and MA-affiliated hospital for which a qualified MA organization seeks an incentive payment,

the organization must attest, in a form and manner specified by us, that its MA EPs and
CMS-0033-F 503

MA-affiliated eligible hospitals are meaningful EHR users, as required by sections 1853(l)(6)

and 1853(m)(1) of the Act. We further proposed to adopt the definitions of meaningful user

under the Medicare FFS program related to EPs and eligible hospitals in §495.4. We are

requiring qualifying MA organizations to attest each payment year whether each of its MA EPs

and MA-affiliated eligible hospitals for which it is seeking an incentive payment was a

meaningful EHR user for the EHR reporting period for a payment year. A qualifying MA

organization must make this attestation for each payment year for which it is seeking an

incentive payment for MA EPs and MA-affiliated eligible hospitals. We believe attestations

should occur toward the end of a year with respect to that year, since qualifying MA

organizations will need to attest to, based on our proposed rule, meaningful use for the

appropriate duration and during the appropriate period related to MA EPs and MA-affiliated

eligible hospitals before claiming incentive payments for them.

In the proposed rule we said that unlike the Medicare FFS EHR incentive program, where

we will require the reporting of clinical quality measures – see §495.8 – we will not require

qualifying MA organizations to submit clinical quality measures per section 1848(o)(2)(B) of the

Act, with respect to EPs, and section 1886(n)(3)(B) of the Act, with respect to eligible hospitals.

Consistent with sections 1848(o)(2)(B)(iii) and 1886(n)(3)(B)(iii) of the Act, we note that

qualifying MA organizations sponsoring coordinated care MA plans are already required to

submit Healthcare Effectiveness Data and Information Set (HEDIS), Health Outcomes Survey

(HOS), and Consumer Assessment of Healthcare Providers and Systems (CAHPS) measures per

§422.152 and §422.516. Coordinated care MA plans include HMO, PPO and RPPO (Regional

PPO) plans. Beginning with CY 2010, PFFS and MSA plans will also be required to begin

collecting and submitting administrative HEDIS measures.

CMS-0033-F 504

We believe that all qualifying MA organizations will be organizations offering MA

coordinated care plans, and therefore; those MA organizations from which we routinely receive

complete HEDIS dataset reporting. Pursuant to sections 1848(o)(2)(B)(iii) and

1886(n)(3)(B)(iii) of the Act, for clinical quality measures which overlap between the existing

MA quality reporting program and under the EHR incentive program, we proposed to allow

qualifying MA organizations to continue reporting under the existing MA quality reporting

program. For those HITECH clinical quality measures that do not overlap and that are

appropriate for the MA program, we are considering requiring that qualifying MA organizations

that receive an incentive payment report those measures to CMS. This would ensure that clinical

quality measure reporting under HITECH is consistent between the FFS program and MA. An

alternative approach would be to require that qualifying MA organizations that receive an

incentive payment report all of the HITECH clinical quality measures under section II.A.2 of this

final rule that are appropriate for the MA program directly to CMS, while also reporting those

HEDIS, HOS, and CAHPS measures under the existing MA quality program. This may result in

duplicative reporting under the HITECH program and current MA quality reporting, but may

provide us with more direct access to quality data under the HITECH program. We invite public

comment on these approaches, including alternative methods to consistently treat MA-affiliated

providers and FFS providers under the HITECH Medicare incentive program.

Comment: The meaningful use criteria make reference to checking eligibility

electronically and submitting claims electronically for 80 percent of patients seen. This would

not be possible for us because, for most of our visits, there is no insurance company with which

to check, and there is no eligibility to submit claims to. We are a capitated system and for most

of the patient visits, the concept of checking eligibility and submitting claims in not relevant.
CMS-0033-F 505

Response: This comment points out the difficulty in adopting FFS Medicare meaningful

use measures for qualifying MA organizations, MA-affiliated hospitals and MA EPs. For

purposes of determining meaningful use in a Medicare Advantage environment, we agree that

submitting claims electronically is not a useful standard in a capitated environment where

virtually all patients are members of the same insurance plan.

Comment: One commenter said that given the sensitivity of the data, and the

RHQDAPU program specifications, the commenter believes CMS should never request that

hospitals submit patient-level data to CMS, but that the data submitted should always be at the

aggregated, summary level. The commenter encouraged us to state specifically that this is its

intention in FY 2012 and all future years of EHR incentive program reporting. Some other

commenters said that their health care delivery systems were based on an integrated care delivery

model, where coordination of care is supported through program-wide EHR implementation that

enables a patient’s medical record to be shared among the members of the patient’s care team.

The commenters said they believed patient-centric electronic medical record models that

integrate clinical information across providers align with goals of ONC’s Strategic Plan and

reform efforts that seek to enable more patient-centric integration of care. The commenters said

that during any given reporting period under the EHR incentive payment program, patients may

receive health care services from various providers (for example, the primary care physician, one

or more specialists, nurse practitioners, etc.). The commenters said they had adopted program-

wide policies and procedures for using their EHR system to promote coordinated delivery of

care. Thus, the commenters said they intended to use their EHR system to support the

functionality and care delivery criteria of meaningful use for all providers across their

organizations. Within their organizations, they said, a single provider is never solely responsible
CMS-0033-F 506

for all the information in a given patient’s electronic medical record. In fact, they said, many

providers may access the patient’s electronic record to view or add information, order tests or

medications, review results, etc. They said the shared record makes it extremely difficult to

reliably track all the meaningful use criteria to each EP in their organizations without adding

additional administrative functionality to their systems that would do nothing to improve patient

care. It would be inappropriate and not the intent of the EHR incentive payment program, they

said they believed, to add unnecessary redundancy in care delivery (that is, providers re-entering

correct demographic information to get “credit” for that measure). They said they intended to

participate in the EHR incentive payment program under provisions for Medicare Advantage

organizations. They went on to say that since the proposed rule states, “the qualifying MA

organization must attest to the fact that each MA EP is a meaningful user of certified EHR

technology….,” they believed such attestation can be based on measuring criteria at a MA

organizational level. While they acknowledged that meeting basic eligibility criteria is

appropriate on an individual provider level (that is, the MA EP must meet the same definition for

EP under FFS, satisfy minimum hours per week delivering patient care services, not be hospital-

based, etc.), they said they should be able to meet meaningful use criteria as a MA organization

on behalf of all of their individual EPs, so long as they are able to demonstrate that their EHR

system itself meets the criteria and its use is pervasive and consistent throughout their healthcare

delivery sites. They recommended that where a patient’s electronic medical record is shared

among a team of providers within a MA organization, the meaningful use criteria be measured

on an organizational versus an individual provider level. As an alternative they proposed that for

any provider who treats a given patient, if the criterion is met in that patient’s electronic record,

all EPs who are members of the patient’s care delivery team would receive “credit” for meeting
CMS-0033-F 507

that measure.

Response: We agree with the commenters in large part. We believe that continued

reporting by qualifying MA organizations under the HEDIS program is the most appropriate way

to protect personally identifiable patient information. We also believe that in integrated care

delivery systems, it does not make sense to require specific individuals to enter specific data in

order to obtain meaningful user status – especially in a Medicare Advantage environment where

we will require only continued HEDIS reporting as a demonstration of meaningful use. Finally,

we believe that reporting of clinical quality measures at the MA organization level is the most

effective and appropriate means of attaining the ultimate goal of EHR adoption – improved

patient outcomes and reduced healthcare costs.

Comment: Some commenters said that the proposed rule states that, “unlike the

Medicare FFS EHR Incentive Program, where we will require the reporting of clinical quality

measures…we will not require qualifying MA organizations to submit clinical quality

measures…with respect to EPs…and with respect to eligible hospitals….[W]e note that

qualifying MA organizations sponsoring coordinated care plans are already required to submit

Healthcare Effectiveness Data and Information Set (“HEDIS”), Health Outcomes Survey

(“HOS”), and Consumer Assessment of Healthcare Providers and Systems (“CAHPS”)

measures.” The proposed rule suggests allowing MA organizations to continue reporting these

measures, but also considers requiring that MA organizations report those HITECH clinical

quality measures that do not overlap with these currently reported measures “and are appropriate

for the MA program.” We believe this current reporting is both appropriate and sufficient to

measure the clinical quality of MA programs and should be deemed to satisfy the clinical quality

reporting requirements under the EHR incentive payment program. HEDIS, HOS and CAHPS
CMS-0033-F 508

reporting are well-established and subject to audit. The measures are specifically chosen to

capture quality within MA organizations, in particular to measure the clinical quality of the team

approach we use to deliver care. While we support consistency across the EHR incentive

payment program, we are concerned that requiring MA organizations to create new mechanisms

for this additional reporting would be unduly burdensome, especially if these additional

measures would have to be reported at the individual provider or patient level. Another

commenter said that their considerable experience with developing responses for new measures

demonstrated how resource and labor intensive clinical quality measurement can be. For

example, the commenter continued, during a recent effort to automate ten TJC (The Joint

Commission) measures, we identified 87 data elements, only 37 of which are captured as discrete

data. Of the remaining 50 measures, some are captured using discrete data in different places in

the EHR, and some are captured using free text (for example, clinical trials and other irregular

exclusion criteria) and will require the creation of new documentation tools. We estimate it will

take one to two years of work for these ten measures to be fully automated, despite our relatively

sophisticated use of data warehousing tools and our high level of automation in the data

management process. The burden is especially heavy when measurement elements are ill-

defined. Under meaningful use clinical quality reporting, over 120 measures have been

proposed. Of these, 94 would be measures not currently calculated or reported on a routine

basis. We anticipate a considerable increase in workload to create and maintain these measures.

Adding new and duplicate – possibly less reliable – measures and reporting systems will be

costly, time-consuming and may not have an incrementally significant impact on improving

patient care. While we are not opposed to new metrics (those without similar known

specifications), such measures should be field tested prior to becoming requirements; in

CMS-0033-F 509

particular, subject to rigorous testing of the electronic specifications. Such measures should also

be supported by robust clinical evidence to show they will impact clinical outcomes. MA

organizations should be deemed to have satisfied all clinical quality reporting required in the

EHR incentive payment program by meeting their current reporting requirements. If additional

measures are required, we recommend staged adoption, beginning with those measures that MA

organizations already report or can report in the near future. We recommend eliminating

measures that have little or no evidence to link them to improved outcomes. Overall, we

strongly recommend that CMS significantly reduce the overall number of clinical quality

measures that would be required for meaningful use.

Response: We agree with the commenters and believe that HEDIS, HOS and CAHPS are

the appropriate means of reporting measures for both MA EPs and MA-affiliated hospitals.

Where appropriate we will consider adding elements to these already existing quality reporting

programs. We will consider adding HEDIS elements over time, as experience and clinical data

warrant.

Comment: One commenter said one of the five priorities specified by CMS is to improve

care coordination. However, the siloed nature of the incentive payments, lack of a robust set of

care coordination measures, and the narrow definition of eligible professionals do not fully

support this priority. The commenter also said that the current structure of the proposed

incentive program, as required by statute, maintains the current siloed structure of Medicare and

Medicaid payments. The selected functionality and quality measures in large part do the same.

However, this siloed structure does not support or encourage integrated coordinated care across

providers and settings. As greater attention is paid to improving care coordination and the

quality of care through integrated care models (for example, accountable care organizations,
CMS-0033-F 510

patient-centered medical homes), greater attention should be given to selecting measures that

focus on patient-centered episodes of care. Furthermore, consideration should be given to

refining the incentive payment structure to foster integration and accountability among and

across providers and settings.

Response: We believe that HEDIS reporting and other existing quality reporting

programs (that is, HOS and CAHPS) go a long way toward assuring that coordination and

integration of care will continue to occur in the Medicare Advantage environment. One of the

purposes of EHR adoption is to facilitate the coordination of care in health care environments

where care coordination is not currently perceived to occur. We are asking providers to pick a

program through which they are most likely to be eligible for EHR incentive payments. For MA

organizations that treat Medicare, Medicaid and dually-eligible patients, EHR incentive

payments will be made only under one program (Medicare or Medicaid) with respect to any

specific EP. However care coordination should occur regardless of health insurance or EHR

incentive payer. After consideration of the public comments received we are not changing our

proposed policy to allow qualifying MA organizations to establish meaningful use through

attestation and to demonstrate meaningful use through continued HEDIS reporting.

Finally, we proposed requiring qualifying MA organizations to submit attestations to us

related to meaningful use by MA-affiliated hospitals within 30 days of the close of the FFY –

which is the payment year for MA-affiliated hospitals – by October 30. We also proposed

requiring qualifying MA organization to submit attestations to us related to meaningful use by

MA EPs within 30 days of the close of the MA EP payment year – which is a CY – by

January 30. In this final rule we are modifying the regulation text at §495.210(b) and (c) to be

consistent with the changes to §495.204(b)(2) and §495.202(b)(3), since the deadline for
CMS-0033-F 511

attestations of meaningful use should be consistent with deadlines for revenue reporting for MA

EPs, and final identification of MA EPs and MA-affiliated hospitals. We are extending the

timeframe for reporting meaningful use to 60 days after the close of the payment year.

7. Posting Information on the CMS Website

In the proposed rule we said that sections 1853(l)(7) and 1853(m)(5) of the Act require us

to post information on an Internet website related to the receipt of incentive payments under the

MA EHR incentive program. We said posted information would include the names, business

addresses, and business phone numbers of each qualifying MA organization receiving an

incentive payment under this section for qualifying MA EPs and hospitals. A list of the names of

each qualifying MA EP and qualifying MA-affiliated eligible hospital for which an incentive

payment has been made would also be posted. Since this requirement is applicable to other

Medicare EPs and eligible hospitals, we have included this requirement in §495.108.

We did not receive any comments on these provisions and are finalizing them as

proposed.

8. Limitation on Review

In the proposed rule we said that section 1853(l)(8) of the Act states that there shall be no

administrative or judicial review under section 1869 of the Act, section 1878 of the Act, or

otherwise of the methodology and standards for determining payment amounts and payment

adjustments under the MA EHR EP incentive program. We said this includes provisions related

to duplication of payment avoidance and rules developed related to the fixed schedule for

application of limitation on incentive payments for all qualifying MA EPs related to a specific

qualifying MA organization. This also includes the methodology and standards developed for

determining qualifying MA EPs and the methodology and standards for determining a
CMS-0033-F 512

meaningful EHR user, including the means of demonstrating meaningful use and the selection of

measures. We proposed to codify these requirements in §495.212(b).

Section 1853(m)(6) of the Act, as added by the HITECH Act, states that there shall be no

administrative or judicial review under section 1869, section 1878, or otherwise of the

methodology and standards for determining payment amounts and payment adjustments under

the MA EHR hospital incentive program. This includes provisions related to duplication of

payment. This also includes the methodology and standards developed for determining

qualifying MA hospitals and the methodology and standards for determining a meaningful EHR

user, including the means of demonstrating meaningful use and the selection of measures. We

proposed to codify these requirements in §495.212(c).

We did not receive any comments on these provisions and are finalizing them as

proposed.

9. Conforming Changes

In the proposed rule we said that sections 4101(e) and 4201(d)(2) and (3) of the HITECH

Act provide conforming amendments to Part C of the Social Security Act. Therefore, we

proposed the following conforming changes to the regulations text:

• Revising §422.304 by adding a new paragraph (f) to account for the amendment to

section 1853(a)(1)(A) of the Act referencing the additional EHR incentive payments that may be

made to qualifying MA organizations in the section of the statute that provides for monthly

capitation payments to MA organizations. (This addition would also act as a cross-reference to

MA EHR incentive payment rules in subpart C of part 495 of this chapter.)

• Revising §422.306(b)(2) by adding a new paragraph (iv) to address the amendments to

section 1853(c)(1)(D)(i) of the Act which exclude the EHR incentive payments made to EPs and
CMS-0033-F 513

hospitals under the Medicare FFS program from the computation of FFS costs in a year for the

purpose of computing MA monthly capitation amounts.

• Revising §422.308 by adding a new paragraph (a)(1) to address the amendments to

section 1853(c)(1)(D)(1) and (c)(6)(A) of the Act regarding the exclusion of FFS Medicare EHR

incentive payments and adjustments from the calculation of the national per capita growth

percentage.

• Revising §422.322 by adding a new paragraph (a)(3) to account for the amendments to

section 1853(c)(6)(A) and (f) of the Act specifying that the source of EHR incentive payments to

qualifying MA organizations are from the Federal Hospital Insurance Trust Fund or the

Supplementary Medical Insurance Trust Fund.

• Revising §422.322(b) by adding a reference to §495.204 to address the amendment to

section 1851(i)(1) of the Act that indicates that EHR incentive payments are instead of incentive

payments that would otherwise be payable under original Medicare.

We did not receive any comments on these provisions and are finalizing them as

proposed.

10. Payment Adjustment and Future Rulemaking

In the proposed rule we said that in future rulemaking we will develop standards related

to payment adjustments to qualifying MA organizations related to MA EPs and MA-affiliated

eligible hospitals that are not meaningful users of certified EHR technology. We solicited

comment on how we can most effectively and efficiently apply payment adjustments to

qualifying MA organizations whose MA eligible EPs and hospitals have not successfully

meaningfully used certified EHR technology.

CMS-0033-F 514

The statutory requirement related to imposition of payment adjustments with respect to

MA EPs is set forth in section 1853(l) of the Act. Specifically, section 1853(l)(4) of the Act

requires that instead of applying the payment adjustment in section 1848(a)(7) of the Act, we

apply the payment adjustment to the Medicare physician expenditure proportion. This is our

estimate of the proportion of the expenditures under Parts A and B paid to the qualifying MA

organization in the form of capitation payments under section 1853 of the Act that are not

attributable to the EHR incentive payment program, that are attributable to expenditures for

physician services. In the case of a qualifying MA organization that attests that not all MA EPs

of the organization are meaningful EHR users with respect to years beginning with 2015, we are

directed to apply the payment adjustment on the proportion of the capitation payment with

respect to all such EPs of the organization that are not meaningful users for such year. The

adjustment amount is 1 percent for 2015, 2 percent in 2016, and 3 percent in 2017 and

subsequent years.

Comment: Two commenters said that the EHR Incentive Program (the Medicare

component) is limited to providers who bill for Part B covered services under traditional FFS

Medicare or for MA organizations that provide equivalent services to MA beneficiaries. In

addition to incentive payments, the program will impose penalties on providers who do not adopt

technology and meet criteria for meaningful use of electronic health records; those penalties will

be in the form of percentage reductions in Medicare reimbursements, beginning in 2016.

Medicare section 1876 (of the Act) cost contract programs by statute are not eligible for the EHR

Incentive Program. The proposed rule does not expressly state whether physicians paid under a

cost plan will be required to meet meaningful use criteria to avoid the payment adjustments that

will take effect after 2015. CMS should clearly state that those providers who are not eligible to
CMS-0033-F 515

participate in the EHR Incentive Program will not be subject to reductions in payment for not

achieving meaningful use, for instance any providers reimbursed under Medicare cost contract

arrangements.

Response: While it is true that current statute applies payment adjustments beginning in

2015 only to FFS and MA providers, it is also true that cost plan providers might provide either

FFS or MA services to which adjustments would apply. So, while it is true that cost plan

payments are unaffected, a blanket statement that cost plan providers are unaffected is not

possible.

The statutory requirement related to imposition of payment adjustments with respect to

MA-affiliated eligible hospitals is provided in section 1853(m) of the Act. Specifically, section

1853(m)(4) of the Act requires us to apply the adjustment to the hospital expenditure proportion,

which is our estimate of the proportion of the expenditures under Parts A and B paid to the

qualifying MA organization in the form of capitation payments under section 1853 of the Act

that are not attributable to the EHR incentive payment program, that are attributable to

expenditures for inpatient hospital services. In the case of a qualifying MA organization that

attests that not all MA-affiliated eligible hospitals of the organization are meaningful EHR users

with respect to years beginning with 2015, we are directed to apply the payment adjustment on

the proportion of all such MA-affiliated eligible hospitals of the organization that are not

meaningful users for such year. The adjustment amount is of three-fourths of the market basket

increase related to a hospital by a 33 1/3 percent reduction in 2015, by a 66 2/3 percent reduction

in 2016, and by a 100 percent reduction in 2017 and all subsequent years. Effectively, the

reduction is of all but 25 percent of the market basket increase for a specific hospital in years

after 2016.
CMS-0033-F 516

We received no additional comments.

D. Medicaid Incentives

1. Overview of Health Information Technology in Medicaid

Under the HITECH Act, State Medicaid programs, at their option, may receive Federal

financial participation (FFP) for expenditures for incentive payments to certain Medicaid

providers to adopt, implement, upgrade, and meaningfully use certified EHR technology.

Additionally, FFP is available to States for reasonable administrative expenses related to

administration of those incentive payments as long as the State meets certain conditions. Section

1903(a)(3)(F)(i) of the Act, as amended by section 4201 of the HITECH Act, establishes 100

percent FFP to States for providing incentive payments to eligible Medicaid providers (described

in section 1903(t)(2) of the Act) to adopt, implement, upgrade, and meaningfully use certified

EHR technology. The incentive payments are not direct reimbursement for the purchase and

acquisition of such technology, but rather are intended to serve as incentives for EPs and eligible

hospitals to adopt and meaningfully use certified EHR technology.

Section 1903(a)(3)(F)(ii) of the Act, as amended by section 4201 of the HITECH Act,

also establishes 90 percent FFP to States for administrative expenses related to carrying out the

substantive requirements associated with the incentive payments.

Finally, as required by section 1903(t)(10) of the Act, CMS will be reporting to Congress

on the status, progress, and oversight of the overall EHR incentive program. These reports will

discuss steps taken to avoid duplicate Medicare and Medicaid incentive payments to EPs, the

extent to which Medicaid EPs and hospitals have adopted certified EHR technology as a result of

the incentive payments, and any improvements in health outcomes, clinical quality, or efficiency

resulting from the adoption of such technology.

CMS-0033-F 517

Comment: A commenter requested additional discussion in the final rule of the many

challenges that exist to adopting electronic health record technology experienced by the

Medicaid Transformation Grantees.

Response: The primary challenges faced by the Medicaid Transformation Grantees

involved assisting providers to adopt the EHRs and to successfully integrate utilization of the

EHRs into their practice workflow. Workflow redesign is unique to each practice based upon

practice size, clinical specialty area, practice operation (for example, medical home teams or

specialty care) and the providers' hardware and software. In addition, Grantees reported that

providers value the EHRs only in so far as the patient data in the EHR is timely and complete.

Therefore lagging data feeds or gaps in data from certain sources, such as labs or Part D claims

for dual eligibles, were observed to discourage providers from investing their time and effort into

learning how to use the EHRs. Many Grantees noted that early negative experiences with

workflow or with timely and accurate access to relevant data discouraged providers from using

the system. They reported needing to dedicate significant time and resources to provider

outreach, technical assistance and training. Some Grantees focused on identifying or developing

the right EHR product only to conclude afterwards that their focus needed to be equally, if not

more, on supporting their providers’ use of the EHR, including fostering health information

exchange through interface development. In summary, the Medicaid Transformation Grantees

affirmed that the barriers faced by Medicaid providers to EHR adoption and use were not unique

to Medicaid. There were several challenges to HIT/EHR implementation that were specific to

Medicaid programs that may be useful for States in light of HITECH. These include, integration

of HIT into the State Medicaid Management Information System (MMIS); churning of Medicaid

patients on/off Medicaid eligibility; issues of consent with patients with diminished capacity,
CMS-0033-F 518

children and their parents and caregivers, and foster children/wards of the State; costs associated

with transaction fees for pharmacy hubs on a statewide scale; and how to calculate return on

investment and quality outcomes as a result of HIT programs that are running concurrent with

other quality initiatives with the same goals, such as the medical home model, disease

management/care coordination and provider pay-for-performance.

While this information is valuable in terms of understanding and addressing the

challenges to EHR adoption, we continue to believe that the benefits of meaningful use of EHRs

far outweigh the implementation challenges.

2. General Medicaid Provisions

In §495.320 and §495.322 we provide the general rule that States, at their option, may

receive: (1) 90 percent FFP for State expenditures related to the administration of an EHR

incentive program for certain Medicaid providers that are adopting, implementing, or upgrading

and meaningfully using certified EHR technology; and (2) 100 percent FFP for State

expenditures for those incentive payments.

We did not receive any comments and we are finalizing these provisions as proposed.

3. Identification of Qualifying Medicaid EPs and Eligible Hospitals

a. Overview

As specified in section 1903(t)(2) of the Act, only certain Medicaid providers will be

eligible for incentive payments. This section discusses some of these eligibility requirements,

including requirements relating to patient volume, whether a provider is hospital-based, and

whether an EP is practicing predominantly in a federally-qualified health center (FQHC) or a

rural health clinic (RHC). Regulations relating to these requirements may be found at §495.304

through §495.306.
CMS-0033-F 519

b. Program Participation

As specified under section 1903(t)(2)(A) of the Act, Medicaid participating providers

who wish to receive a Medicaid incentive payment must meet the definition of a “Medicaid EP.”

This definition (1903(t)(3)(B) of the Act) lists five types of Medicaid professionals: physicians,

dentists, certified nurse-midwives, nurse practitioners, and physician assistants practicing in an

FQHC or RHC that is so led by a physician assistant.

Additionally, to qualify for incentives, most Medicaid EPs cannot be “hospital-based.”

We will use the same definition of “hospital-based” as used in the Medicare EHR incentive

program, as sections 1848(o)(1)(C) and 1903(t)(3)(D) of the Act use almost identical definitions

of the term. We refer readers to section II.A. for a definition of “hospital-based,” and for a

thorough discussion of our methodology.

The only exception to this rule is that Medicaid EPs practicing predominantly in an

FQHC or RHC are not subject to the hospital-based exclusion.

Medicaid EPs must also meet the other criteria for Medicaid incentive payment

eligibility, such as the patient volume thresholds or practicing predominantly in an FQHC or

RHC, as described in this subpart. Since the statute at 1903(t)(2)(A)(iii) of the Act does not

define “practices predominantly,” we specify that an EP practices predominantly at an FQHC or

an RHC when the clinical location for over 50 percent of his or her total patient encounters over

a period of 6 months occurs at an FQHC or RHC.

Acute care and children's hospitals are listed in section 1903(t)(2) of the Act as the only

two types of institutional providers potentially eligible for Medicaid incentive payments. These

terms are specific to the Medicaid EHR incentive program and are not currently defined in the

Medicaid regulations. Consequently, we define these terms in §495.302.

CMS-0033-F 520

As specified under section 1903(t)(2)(B) of the Act, to qualify for incentive payments

acute care hospitals also must meet patient volume threshold requirements, as specified in

§495.306. Children's hospitals do not have patient volume requirements for Medicaid incentive

program participation.

Comment: Commenters expressed confusion about the restrictions on physician

assistants' (PAs) participation. Numerous commenters suggested that PAs should be eligible

without conditions, particularly the condition that they are practicing in an FQHC or RHC that is

"so led by a physician assistant" and/or CMS should exercise flexibility in defining "so led," in

order to capture the highest number of PAs. We received specific comments on how to define

"so led" to provide the greatest flexibility to PAs. Suggestions included allowing clinics under a

larger FQHC to be led by a PA, but not necessarily the entire FQHC. Also, commenters asked

that we consider "led" to mean the dominant clinical provider, which is the case for PAs in many

RHCs.

Response: As stated in the statute at 1903(t)(3)(B)(v), regarding the program eligibility

for PAs, PAs are eligible when they are a "physician assistant insofar as the assistant is

practicing in a rural health clinic that is led by a physician assistant or is practicing in a Federally

qualified health center that is so led." These conditions on PAs' eligibility apply whether the PA

is qualifying because they meet Medicaid patient volume requirements or if they are qualifying

because they practice predominantly in an FQHC or RHC. Since this language requiring that a

PA must be leading the FQHC or RHC is derived from statute, we have no flexibility to change

or remove it.

However, we agree that we have the authority to interpret what it means for a PA to lead

an FQHC or RHC, and we believe a PA would be leading an FQHC or RHC under any of the
CMS-0033-F 521

following circumstances:

1) When a PA is the primary provider in a clinic (for example, when there is a part-time

physician and full-time PA, we would consider the PA as the primary provider);

2) When a PA is a clinical or medical director at a clinical site of practice; or

3) When a PA is an owner of an RHC.

We agree that FQHCs and RHCs that have PAs in these leadership roles can be

considered "PA-led." Furthermore, since RHCs can be practitioner owned (FQHCs cannot), we

will allow ownership to be considered "PA-led."

With the exception of this clarification of PA-led, we are adopting this language as

proposed. We have not changed our regulatory language, as we consider this clarification to be

an interpretation of our regulations as to what it means to be a PA to be leading an FQHC or

RHC.

Comment: We received questions about eligibility related to FQHC look-alikes, tribal

clinics, and other similar facilities.

Response: As previously mentioned, in accordance with section 1903(t)(2)(B), the only

two facilities eligible for incentives are acute care and children's hospitals. However, EPs at

facilities such as FQHCs, RHCs, and tribal clinics may be eligible for participation when they

practice predominantly at an FQHC or RHC or meet the other patient volume requirements. The

statute defines FQHCs at 1905(l)(2)(B) and defines RHCs at 1905(l)(1) by essentially

incorporating the definition in 1861(aa).

Comment: Numerous commenters opposed the proposed definition for "hospital-based."

Response: This is a consideration for Medicare and Medicaid and is addressed in II.A.

After consideration of the public comments received, we are making changes under II.A.
CMS-0033-F 522

(1) Acute Care Hospitals

For purposes of Medicaid incentive payments, we proposed to define an “acute care

hospital” as a health care facility where the average length of patient stay is 25 days or fewer and

with a CCN that has the last four digits in the series 0001 through 0879 (that is, short-term

general hospitals and the 11 cancer hospitals in the United States).

We excluded from this proposed definition a category of long-term care hospitals, which

are defined for Medicare purposes in regulations at §412.23(e). Specifically §412.23(e)(2)(i)

states that the hospital must have an average Medicare inpatient length of stay of greater than 25

days (which includes all covered and non-covered days of stay of Medicare patients).

Comment: We received numerous comments recommending that CAHs be included in

the definition of acute care hospitals for purposes of the Medicaid EHR incentive payment

program. Commenters pointed out that the CAHs would qualify on all criteria except for the

requirement to have a CCN in the range 0001-0879. CAHs have CCNs in the range 1300-1399.

Moreover, many commenters pointed out that, because of their rural location and distance from

other hospitals to which they frequently transfer patients, the CAHs would benefit from having

electronic records that could be shared with the subsequent provider of care to the patient.

Commenters also asked what reimbursement methodology CMS would use if it decided to

include CAHs in the Medicaid incentive payment program.

Response: We agree with the commenters that CAHs conform to our definitional criteria

for acute care hospital except for the CCN range. Moreover, we recognize the positive impact on

quality that may ensue from the CAH's being able to electronically communicate with the

hospitals to which it transfers patients. Therefore, in the final rule, we are amending the

definition of acute care hospital for purposes of the Medicaid EHR incentive payment program
CMS-0033-F 523

as "those hospitals with an average patient length of stay of 25 days or fewer, and with a CCN

that falls in the range 0001-0879 or 1300-1399." This definition will now encompass general

short-term hospitals, cancer hospitals, and critical access hospitals that meet the Medicaid patient

volume criteria. Since we are including CAHs under the category of "acute care hospital," we

are not developing a separate Medicaid incentive payment calculation for CAHs. States will pay

the incentive payment to qualifying CAHs using the acute care methodology described at section

495.310(g). In summary, CAHs will be eligible for the Medicaid hospital incentive insofar as

they meet the requirements under an acute care hospital described here. While the statute issued

specific calculation requirements for CAHs under Medicare, there is no special Medicaid

calculation. Like other acute care hospitals, some CAHs may be eligible for Medicare and

Medicaid incentives.

We will reflect this definitional change in the final regulation at section 495.302.

Comment: Further guidance was requested on the determination of average length of

stay. Commenters questioned whether the average length of stay should be calculated relative to

the fiscal year prior to the payment year or relative to the calendar year prior to the payment

year. Commenters also questioned whether outliers in terms of extremely long length of stay

could be left out of the calculation, and if so, could CMS provide detail on this and any similar

exclusions; for example, other exclusions with respect to observation stays.

Response: After consideration of these comments, we believe the best policy is to allow

the States to decide whether they will use a fiscal year or calendar year for calculating length of

stay, as the State will be in the best position to determine what documentation exists in order to

support any length of stay calculation. With respect to outliers, we point readers to the State

Operations Manual, page 303, Revision 57, dated January 29, 2010 and we note that these
CMS-0033-F 524

long (and short) stay outliers are included in average length of stay calculations for other

purposes, such as reporting statistics to States, Medicare, and other payers. We do not find a

basis for excluding outliers from the average length of stay for purposes of the incentive

payment. In fact, since acute care hospitals have CCNs in either the 0001-0879 or the 1300-1399

range, and length of stay is one of the definitional criteria for CCNs in these ranges, all of the

acute care hospitals are very likely to meet length of stay criteria. Observation stays are

considered to be outpatient services and, therefore, cannot be included in average length of stay

calculations. This is consistent with the treatment of observation days under Medicare.

In summary we are making no revisions to the regulation as a result of this comment.

(2) Children's Hospitals

For purposes of the Medicaid EHR incentive program, in the proposed rule, we proposed

one definition to include only separately certified children's hospitals, with CCNs in the 3300-

3399 series in the definition of eligible “children's hospital.” By defining “children's hospital” in

this way, we: (1) prevented general acute care hospitals, which could not themselves qualify

for the incentive because they did not meet the 10 percent Medicaid patient volume, from using

the fact that they have a pediatric wing as justification for requesting a Medicaid incentive

payment; (2) excluded many of the facilities that are perceived by the public as children's

hospitals, but do not meet the Medicare standards as either freestanding or

hospital-within-hospital children's hospitals; and (3) excluded some pediatric specialty hospitals

which have CCNs as psychiatric or rehabilitation hospitals.

An alternative definition of a “children's hospital” was also proposed to include those

hospitals with Medicare provider numbers in the following series:

• 0001 through 0879--Short-term (General and Specialty) Hospitals.

CMS-0033-F 525

• 3025 through 3099-- Rehabilitation Hospitals (Excluded from Prospective Payment

Systems).

• 3300 through 3399-- Children's Hospitals (Excluded from Prospective Payment

Systems).

• 4000 through 4499-- Psychiatric Hospitals (Excluded from Prospective Payment

Systems).

This definition, for the purposes of the Medicaid HIT incentive payments, applied only to

those freestanding hospitals within the above mentioned series that exclusively furnish services

to individuals under age 21.

This broader definition still: (1) prevented acute care hospitals that cannot independently

qualify for the incentive because they do not meet the 10 percent Medicaid patient volume from

using the fact that they have a pediatric wing as justification for requesting an HIT incentive

payment; (2) allowed for participation in the incentive program by the greatest number of

children's hospitals, including rehabilitative and psychiatric specialty hospitals; and (3) aligned

with Federal efforts aimed at improving healthcare quality for all children, including those with

physical and mental diseases/disabilities.

Comment: CMS received several comments on this issue. Specifically, the commenters

stated that the proposed rule limited the definition of children's hospitals to those that provide

care to individuals under the age of 21; the commenters stated that children's hospitals actually

may provide care to older individuals who have conditions such as congenital cardiac problems,

sickle cell disease and cystic fibrosis.

Response: We agree with the commenters that children's hospitals do on occasion treat

patients who are over the age of 21, especially if the patient is on a continued course of treatment
CMS-0033-F 526

for a condition that began in childhood, such as those conditions mentioned. Accordingly, in the

proposed rule published on January 13, 2010 at section 495.302, we defined a children's hospital

for purposes of the HIT incentive payment program as a hospital that is separately certified as a

children's hospital, with a CCN in the 3300-3399 series and predominantly treats individuals

under the age of 21. We used the term "predominantly" to recognize that not all patients of the

children's hospital are in fact under age 21.

This definition addresses the commenters' concerns and we are not revising it in the final

rule. The commenter’s may have been responding to the alternate definition in which we

requested comments. While that alternate definition mentioned specialty hospitals that

exclusively treat individuals under the age of 21, we are not adopting that definition in this final

rule, as noted in the response to the comment below.

Comment: CMS also received a few comments that supported our proposed definition of

children's hospital as those that are separately certified and predominantly treating individuals

under 21 years of age. The commenters urged us to adopt this definition rather than the alternate

definition discussed in the proposed rule and on which we requested comments.

Response: We agree with the commenters and are adopting the definition that we

originally proposed at section 495.302. See the response to the comment below.

Comment: CMS received one comment that recommended use of the alternative

definition as providing more opportunity for hospital participation.

Response: We considered the merits of both definitions and we have decided to maintain

the definition originally proposed in section 495.302 as representing the clearest definition of a

children's hospital. As previously stated, we only intend to include children's hospitals with

CCNs within a specific range; this will not include pediatric wings of larger hospitals.
CMS-0033-F 527

In summary, after considering the comments, we are adopting the definition of children's

hospital as originally proposed.

c. Medicaid Professionals Program Eligibility

For Medicaid EPs, the general rule (subject to the two exceptions listed below) is that the

EP must have at least 30 percent patient volume attributable to those who are receiving

Medicaid. Section 1903(t)(2)(A)(i) of the Act provides authority to the Secretary to establish the

methodology by which such patient volume will be estimated; our proposed methodologies

which follow, are based on this discretion. To establish such patient volume, we proposed that

the EP have a minimum of 30 percent of all patient encounters attributable to Medicaid over any

continuous, representative 90-day period within the most recent calendar year prior to reporting.

There are two statutory exceptions to the general 30 percent rule discussed previously. The first

exception is that a pediatrician may have at least 20 percent patient volume attributable to those

who are receiving medical assistance under the Medicaid program, as estimated in accordance

with a methodology established by the Secretary (section 1903(t)(2)(A)(ii) of the Act). Again,

the method we proposed to use was that the pediatrician have a minimum 20 percent of all

patient encounters attributable to Medicaid over any continuous, representative 90-day period

within the most recent calendar year prior to reporting.

The second exception is that Medicaid EPs practicing predominantly in an FQHC or

RHC must have a minimum of 30 percent patient volume attributable to “needy individuals.”

Again, the method we would use is that 30 percent of all patient encounters be attributable to

needy individuals over any continuous 90-day period within the most recent calendar year prior

to reporting.
CMS-0033-F 528

Section 1903(t)(3)(F) of the Act defines needy individuals as individuals meeting any of

the following three criteria: (1) they are receiving medical assistance from Medicaid or the

Children's Health Insurance Program (CHIP); (2) they are furnished uncompensated care by the

provider; or (3) they are furnished services at either no cost or reduced cost based on a sliding

scale determined by the individual's ability to pay.

Comment: Many commenters requested that CMS consider groups outside of the statute

eligible for incentive payments. These facilities and practitioners included: community mental

health centers and other behavioral health providers (including psychiatric clinics); nursing

homes, nursing facilities, and skilled nursing facilities; long-term care providers (community and

institutional), including home health care providers; pharmacists and pharmacies; social workers;

blood centers; provider based departments; professional societies; Medicaid-participating health

plans; speech-language pathologists and audiologists; FQHCs, RHCs, tribal providers, and other

community clinics; health aides; and podiatrists. The commenters included numerous

testimonials, research, and statements to note that these providers are critical partners in

improving the quality and coordination of care for the Medicaid population. Some of the

commenters acknowledged that this is a statutory issue but assert that exclusion of such

providers impacts Medicaid’s ability to improve the quality and efficiency of care. Furthermore,

some of these commenters based several additional comments upon presumed eligibility. For

example, some commenters said that social workers could not afford EHRs and should not be

required to participate.

Another group of comments came from health care professionals that sought eligibility

for incentives by virtue of early adoption of EHRs but who do not participate in either Medicaid

or Medicare. They suggested a third incentive option available for providers that either do not
CMS-0033-F 529

participate with Medicaid/Medicare or would not reach the threshold of patient visits to receive

Medicaid incentive payments.

Response: We note that the commenters are correct to recognize that this is a statutory

issue. The definition of a “Medicaid EP," at 1903(t)(3)(B) of the Act, lists five types of

professionals that are eligible for Medicaid incentive payments: physicians, dentists, certified

nurse-midwives, nurse practitioners, and physician assistants practicing in an FQHC that is led

by a physician assistant or RHC that is so led. Additionally, the statute at 1903(t)(2)(B)

designates acute care hospitals and children's hospitals as the only two types of facilities eligible

for the Medicaid incentives. These providers must also meet all other program requirements,

including Medicaid patient volume thresholds.

Since the commenters recommend including providers that are not among those explicitly

mentioned in the statute, these providers cannot be eligible for the incentive payments.

Additionally, professionals who do not participate in either Medicaid or Medicare are

also not eligible for incentives due to the statutory requirements associated with each program.

Specifically, the Medicaid incentives program requires providers to meet Medicaid patient

volume thresholds or practice predominantly in an FQHC or RHC, where they must serve needy

individuals (as defined at section 495.10). Additionally, the hospital calculations for Medicare

and Medicaid are based, in part, on Medicare or Medicaid inpatient bed-days. For Medicare

EPs, the incentive is based on the associated Medicare claims. Hence, these professionals cannot

meet the statutory requirements for eligibility.

After consideration of these comments, we are maintaining the list of providers eligible

for the Medicaid incentive payment program as originally proposed and as identified by statute.

It is worth noting that while the facilities recommended for inclusion by the commenters
CMS-0033-F 530

will not be considered eligible to participate in these incentives, some of the EPs at these

facilities may be eligible. One example is that a psychiatrist (physician) or NP is likely to treat

individuals at a behavioral health facility. Per our rules at section 495.10, the EP must identify a

TIN to which the incentive payment should be made. We believe that, in accordance with

1903(t)(6)(A) of the Act, an EP could reassign payment to a TIN associated with his or her

employer or the facility in which she or he works. This facility could be one of those

recommended for inclusion by the commenters. Any reassignment of payment must be

voluntary and we believe the decision as to whether an EP does reassign incentive payments to a

specific TIN is an issue which EPs and these other parties should resolve. Any reassignment of

payment must be consistent with applicable laws, rules, and regulations, including, without

limitation, those related to fraud, waste and abuse

We have provided clarifying language at section 495.10(f) to further clarify the

reassignment of incentive payments by EPs to specific TINs.

d. Calculating Patient Volume Requirements

As required by section 1903(t)(2) of the Act and discussed in the previous section, all EPs

and the vast majority of hospitals will need to meet certain patient volume thresholds in order to

be eligible for incentive payments. (The only exception to this rule is for children's hospitals,

which have no patient volume threshold requirement).

In addition, where patient volume is a criterion, most providers will be evaluated

according to their “Medicaid” patient volume, while some professionals (those practicing

predominantly in an FQHC or RHC) will be evaluated according to their “needy individual”

patient volume.
CMS-0033-F 531

We define “patient volume” in §495.302 to be a minimum participation threshold for

each individual Medicaid provider (with the exception of children's hospitals). In the proposed

rule, we proposed methodologies for estimating the patient volume thresholds and listed them by

entity type.

Further, we proposed that States could submit alternative approaches to the established

timeframe for estimating patient volume, through their State Medicaid HIT Plans (SMHP) and

we would make a determination of whether it was an acceptable alternative.

In determining the “needy individual” patient volume threshold that applies to EPs

practicing predominantly in FQHCs or RHCs, section 1902(t)(2) of the Act authorizes the

Secretary to require the downward adjustment to the uncompensated care figure to eliminate bad

debt data. We interpret bad debt to be consistent with the Medicare definition, as specified at

§413.89(b)(1). In order to remain as consistent as possible between the Medicare and Medicaid

EHR incentive programs, States will be required to downward adjust the uncompensated care

figure. Under Medicare, bad debts are amounts considered to be uncollectible from accounts and

notes receivable that were created or acquired in providing services. “Accounts receivable” and

“notes receivable” are designations for claims arising from the furnishing of services, and are

collectible in money in the relatively near future. Providers should be required to use cost

reports (for FQHCs and clinics this would be the Medicare 222-92 cost report, or the most recent

version of the 222), or other auditable records to identify bad debts. All information under

attestation is subject to audit. Our proposed regulations on calculating the needy individual

patient volume can be found at §495.302 and §495.306.

Further, in establishing the Medicaid patient volume thresholds for EPs and acute care

hospitals, section 1902(t)(2) of the Act requires that individuals enrolled in a Medicaid managed
CMS-0033-F 532

care plan be included. We interpret this to mean that individuals enrolled in MCOs, prepaid

inpatient health plans (PIHPs), or prepaid ambulatory health plans (PAHPs), under 42 CFR Part

438 be included in the calculation. Therefore, in determining patient volume, providers and

States should be aware that individuals enrolled in such plans will be included in the patient

volume calculation. Acute care hospitals have to meet the 10 percent Medicaid volume

threshold.

Comment: Commenters recommended that CMS provide flexibility in the specific

volume thresholds required for program participation (for example, 30 percent for most EPs, 20

percent for pediatricians) and apply a lower percentage or a minimum number of encounters.

Some commenters referenced research stating that practices with a 30 percent patient volume

may not be financially viable.

Response: The patient volume thresholds of 30 percent and 20 percent are required by

statute and cannot be changed in the rulemaking process.

After consideration of the public comments received, we are not making any changes to

these statutory requirements.

Comment: Commenters suggested that CMS define "encounter" and take a menu

approach to patient volume to allow States several options, based on their data sources. Some

commenters provided specific suggestions for patient volume "menu" items. Some commenters

further noted that there were inconsistencies in how we applied "encounter" data. Finally, one

commenter noted that we should consider how "encounter" data is applied to EPs that bill

services through another provider (for example, PAs that bill through MDs). Other commenters

asked for a clarification of how "encounters" would apply to the dually-eligible

Medicare/Medicaid beneficiaries. Additionally, several commenters provided specific

CMS-0033-F 533

suggestions for alternative methods making an approximate determination of providers' patient

volume by [not using patient volume] and extending the look-back period to two years.

Response: We agree with the approach of offering at least some options to States

regarding patient volume. This approach allows States to audit their programs using the data

sources available to them, while also including the largest number of providers that may treat

Medicaid patients. We believe our new approach will correct the inconsistencies in how we

applied "encounter." Furthermore, our new definition of encounter will capture the dually-

eligible beneficiaries, as well as individuals who are in a Title XIX-funded 1115 demonstration

project. Specifically, the statute at 1903(t)(2) states that Medicaid patient volume will be

"attributable to individuals who are receiving medical assistance under [Title XIX]," and also

states that the patient volume calculation for those practicing predominantly in an FQHC or RHC

will be "attributable to needy individuals.” Needy individual is defined at 1903(t)(3)(F) as “an

individual – (i) who is receiving assistance under Title XIX; (ii) who is receiving assistance

under Title XXI; (iii) who is furnished uncompensated care by the provider; or (iv) for whom

charges are reduced by the provider on a sliding scale basis based on the individual's ability to

pay." We believe our final rule definition of "encounter" captures care to all of these individuals.

Additionally, consistent with the statute, we expect providers and States to make

estimation in accordance with the methodologies we established here. This estimation would

need to be made with reasonable effort, using verifiable data sources by the provider and the

State.

Finally, we do not agree with any of the suggestions from commenters that involve using

a benchmark number of Medicaid patients or other suggestions that involve a deviation from the

statutory language. The statute is clear that Medicaid patient volume must be considered and
CMS-0033-F 534

explicitly specified percentages of caseload mix compositions attributable to either Medicaid

and/or “needy” individuals that must be achieved for participation in the incentive program. We

also do not agree with allowing the provider to consider a period longer than a year prior to

registering because that is not a current, accurate portrayal of the provider's participation in

Medicaid.

After consideration of the public comments received, we are revising the patient volume

approach to the following two options. The State may choose one of the two options listed below

(or both options), or a State-proposed alternative, if approved by CMS. The State's strategy must

be submitted for review and approval through the SMHP, in accordance with all requirements at

section 495.332.

A Medicaid provider may demonstrate patient volume by:

1) Having patient encounters within the 90-day period by using the same methodology

we proposed in the proposed rule.

This first option preserves the methodology we proposed in the proposed rule, however

we clarify "encounter" below. For the Medicaid patient volume, the methodology for estimating

patient volume would require calculation of a threshold (represented below) using as the

numerator the individual hospital's or EP's total number of Medicaid patient encounters in any

representative continuous 90-day period in the preceding calendar year and the denominator is

all patient encounters for the same individual professional or hospital over the same 90-day

period. We are not prescribing standards for what is a “representative” period, but we intend to

apply a plain meaning test. In other words, if a reasonable person would not consider the

selected period to be representative (for example, because the selected period included a short-

term temporary Medicaid outreach program), then it would not support a threshold calculation.
CMS-0033-F 535

[Total (Medicaid) patient encounters in any representative continuous 90-day period in the

preceding calendar year/Total patient encounters in that same 90-day period] * 100

For the needy individual patient volume, the methodology for estimating patient volume

would require the same calculation, but with the numerator equal to the EP's total number of

needy individual patient encounters in any representative 90-day period in the preceding calendar

year.

[Total (Needy Individual) patient encounters in any representative continuous 90-day period in

the preceding calendar year/Total patient encounters in that same 90-day period] * 100

Table 15, below, demonstrates the above-referenced patient volume thresholds. (This

same Table appeared in the proposed rule, with a few minor clarifications included in this

Table).

TABLE 15: Qualifying Patient Volume Threshold for Medicaid EHR Incentive Program

Entity Minimum 90-day Medicaid

Patient Volume Threshold
Physicians 30%
Pediatricians 20% Or the Medicaid EP
Dentists 30% practices predominantly
Certified nurse midwives 30% in an FQHC or RHC -
Physician Assistants when 30% 30% “needy individual”
practicing at an FQHC/RHC patient volume threshold
led by a physician assistant
Nurse Practitioner 30%
Acute care hospital 10% N/A
Children's hospital N/A N/A

(2) Having a Medicaid enrollee on the panel assigned to the EP (for example, managed

care or medical homes) within that representative 90-day period.

With more than 70 percent of Medicaid and CHIP enrollees receiving care in a managed

care delivery system, and additional enrollees in medical homes, we determined that it was
CMS-0033-F 536

necessary to look for flexibility in how we applied these requirements. Under this option, we

wanted to capture the EP's panel assignments, as well as any additional unduplicated Medicaid

encounters. In other words, we do not intend for the EP to count an assigned patient who was

also an encounter more than once.

The methodology for estimating the Medicaid patient volume threshold (represented

above) would use as the numerator the individual hospital's or EP's total number of Medicaid

patients assigned through a Medicaid managed care panel, medical or health home program

panel, or similar provider structure with capitation and/or case assignment, plus all other

Medicaid encounters for that EP. The assignment must be current within the 90-day period and

we will consider as a proxy for this an encounter with any patient on the panel within the

previous calendar year prior to the representative 90-day period when the patient was on the

panel. Note that, as stated above, while the EP may add in encounters with other, non-panel

Medicaid patients to the numerator, these encounters must be patients who are not assigned to a

panel and would be encounters that occurred during the representative 90-day period. The

denominator is all patients assigned to the EP or hospital for the same 90-day period, also with

whom the provider had at least one encounter in the prior calendar year as a proxy, as well as any

other unduplicated Medicaid encounters during the representative 90-day period.

{[Total (Medicaid) patients assigned to the provider in any representative continuous 90-day

period in the preceding calendar year, with at least one encounter taking place during the

calendar year preceding the start of the 90-day period] + [Unduplicated (Medicaid) encounters in

the same 90-day period]/[Total patients assigned to the provider in that same 90-day period, with

at least one encounter taking place during the calendar year preceding the start of the 90-day

period] + [All unduplicated encounters in that same 90-day period]} * 100

CMS-0033-F 537

For the needy individual patient volume for EPs enrolled in managed care and medical

homes, the threshold (represented below) would be calculated in the same manner, but with the

numerator equal to the EP's total number of needy individuals assigned to the patient panel in

any representative 90-day period in the preceding calendar year with at least one encounter

within that year.

{[Total (Needy Individual) patients assigned to the provider in any representative

continuous 90-day period in the preceding calendar year, with at least one encounter taking

place during the year preceding the 90-day period] + [Unduplicated (Needy Individual)

encounters in the same 90-day period]/[Total patients assigned to the provider in that same 90-

day period, with at least one encounter taking place during the year preceding the 90-day period]

+ [All unduplicated encounters in that same 90-day period]} * 100

Table 15 demonstrates the above-referenced patient volume thresholds per provider type.

In order to resolve any inconsistencies with the definitions of "encounter," for

purposes of EP patient volume, we have allowed the following to be considered Medicaid

encounters:

1) Services rendered on any one day to an individual where Medicaid or a Medicaid

demonstration project under section 1115 of the Act paid for part or all of the service; or

2) Services rendered on any one day to an individual for where Medicaid or a Medicaid

demonstration project under section 1115 of the Act paid all or part of their premiums, co-

payments, and/or cost-sharing.

For purposes of calculating hospital patient volume, we have allowed the following to be

considered Medicaid encounters:

CMS-0033-F 538

(1) Services rendered to an individual per inpatient discharges where Medicaid or a

Medicaid demonstration project under section 1115 paid for part or all of the service;

(2) Services rendered to an individual per inpatient discharge where Medicaid or a

Medicaid demonstration project under section 1115 of the Act paid all or part of their premiums,

co-payments, and/or cost-sharing;

(3) Services rendered to an individual in an emergency department on any one day where

Medicaid or a Medicaid demonstration project under section 1115 of the Act either paid for part

or all of the service; or

(4) Services rendered to an individual in an emergency department on any one day where

Medicaid or a Medicaid demonstration project under section 1115 of the Act paid all or part of

their premiums, co-payments, and/or cost-sharing.

We wanted to adequately reflect what an encounter looked like for a hospital and apply

these concepts consistently across the numerous areas of this final rule. We used inpatient

discharges and emergency department services for the hospitals because this is consistent with

how we will make hospital-based determinations for EPs and how we collect meaningful use

information for hospitals. We decided that services rendered on one day would be an encounter.

An emergency department must be part of the hospital under the qualifying CCN.

For purposes of calculating needy individuals patient volume, we have allowed the

following to be considered needy patient encounters:

(1) Services rendered on any one day to an individual where Medicaid or CHIP or a

Medicaid or CHIP demonstration project under section 1115 of the Act paid for part or all of the

service;
CMS-0033-F 539

(2) Services rendered on any one day to an individual where Medicaid or CHIP or a

Medicaid or CHIP demonstration project under section 1115 of the Act paid all or part of their

premiums, co-payments, and/or cost-sharing; or

(3) Services rendered to an individual on any one day on a sliding scale or that were

uncompensated.

We understand that multiple providers may submit an encounter for the same individual.

For example, it may be common for a PA or NP to provide care to a patient, then a physician to

also see that patient. It is acceptable in circumstances like this to include the same encounter for

multiple providers when it is within the scope of practice.

We considered whether Medicaid providers or States should pick from the two options

provided above. Since States are responsible for auditing the program and must have reliable

sources of data, we agree with commenters that it must be States that make a determination as to

whether either option will be permitted (or both).

In the proposed rule, we also proposed that if States had an alternative approach for the

timeframe in accounting for the methodology, they would be allowed to submit it in the SMHP

for review and approval. For the final rule, we are modifying this option. As stakeholders'

understanding of the program matures and new technologies become available, there may be new

solutions that we did not consider here, but would be a better option for one or several States. To

that end, in this final rule we are providing flexibility to consider States' alternative

methodologies for measuring not just the timeframe that is used in establishing patient volume,

but all of the elements included in the patient volume calculation (except the thresholds

established by statute). Therefore, we have revised our final regulations to allow States to offer

alternatives regarding the methodology used to establish patient volume, and for the Secretary to
CMS-0033-F 540

adopt these options, so that they may be used by other States as well. An alternative would need

a verifiable data source. A State also would need to provide us with an analysis to demonstrate

that the methodology being proposed by the State did not result, in the aggregate, in fewer

providers becoming eligible than under the two options presented in this final rule. Finally, if a

State is reviewed and approved for an alternative methodology, we will post this alternative

methodology on the CMS internet website, and allow other States to adopt the methodology as

well, thereby ensuring that the alternative is a methodology that is "established by the Secretary."

While we believe that States will not submit alternative methodologies until after the first year of

the program, allowing for such alternatives will permit the patient volume calculation to evolve

along with State and provider experience of the program.

We believe that these solutions will help address issues for providers practicing across

State lines, who may have their Medicaid patient volume derived from more than one State. We

encourage States to build partnerships, particularly through data sharing agreements. Medicaid

providers must still annually re-attest to meeting the patient volume thresholds.

After consideration of the comments, we are revising §495.302, §495.306, and §495.332

regarding patient volume, patient encounters and the associated revisions to the SMHP

requirements.

Comment: Commenters asked CMS to include all individuals receiving services through

section 1115 demonstrations as eligible encounters.

Response: Although the commenter did not elaborate, we believe the commenter is

referring to section 1115 demonstrations under the authority of section 1115(a)(2) of the Act.

Our final regulations allow two alternate methods for States to estimate Medicaid patient

volume. Under both methods, however, the State must review whether a Medicaid "patient
CMS-0033-F 541

encounter" occurred. Our regulations, at 495.306(e) state that a Medicaid encounter will exist

where Medicaid (or a Medicaid demonstration project approved under section 1115) paid for part

or all of the service; or where Medicaid (or a Medicaid demonstration project approved under

section 1115) paid all or part of the individual's premiums, co-payments and/or cost-sharing.

Because our methodology is based upon Medicaid payment for an encounter, and because we

believe it will be difficult or impossible for EPs and eligible hospitals to distinguish between

payment that is due to patients receiving medical assistance under Title XIX and payment that is

due to expansion populations (who are not receiving Title XIX medical assistance), we will

allow providers to include in the patient volume calculation individuals who are part of

expansion populations under section 1115(a)(2) of the Act. The statute confers broad authority

on the Secretary to establish the methodology that is used to estimate the patient volume

percentage. Thus, although individuals in section 1115(a)(2) demonstrations are not receiving

Title XIX medical assistance, we use our broad authority to allow a methodology that considers

these individuals in the estimate that is used. (Limited to Medicaid patient volume

determinations, the same reasoning would not apply to CHIP demonstrations or to State-only

programs, because no Title XIX funding is received for these projects. However, in calculating

Needy Individual patient volume, it is permissible to consider Medicaid or CHIP demonstration

projects approved under section 1115).). Our above discussion noting what will be considered a

patient encounter includes encounters which were paid for with Title XIX funds under a section

1115 Medicaid demonstration.

Comment: Several commenters asked that CMS allow CHIP patients to be considered in

the Medicaid patient volume requirements, particularly for pediatricians.

CMS-0033-F 542

Response: The requirement that the methodology for estimating Medicaid patient

volume is based on Medicaid and not CHIP is related to the statutory language at section

1903(t)(2)(A)(i)-(ii)). Such language requires that the Secretary establish a methodology that

can be used to estimate “Medicaid” patient volume for those individuals receiving medical

assistance under Title XIX. However, the statute at 1903(t)(2)(A)(iii) allows for an EP practicing

predominantly in an FQHC or RHC to consider CHIP patients under the needy individual patient

volume requirements.

After consideration of these public comments, we are making no further revisions to this

section of the rule.

Comment: Many commenters urged CMS to allow practice- or clinic-level patient

volume data to apply to practitioners as a proxy to establish patient volume. This would apply for

both Medicaid and needy individual patient volume calculations. The commenters stated that

many clinics and group practices do not necessarily track the pay or data per EP and it would be

very disruptive to their current practice to begin collecting data like this.

Response: We agree with commenters and acknowledge that it is not our intent to disrupt

the practice with new additional burdens, but rather to leverage efficiencies. We will allow

clinics and group practices to use the practice or clinic Medicaid patient volume (or needy

individual patient volume, insofar as it applies) and apply it to all EPs in their practice under

three conditions: 1) The clinic or group practice's patient volume is appropriate as a patient

volume methodology calculation for the EP (for example, if an EP only sees Medicare,

commercial, or self-pay patients, this is not an appropriate calculation); 2) there is an auditable

data source to support the clinic's patient volume determination; and 3) so long as the practice

and EPs decide to use one methodology in each year (in other words, clinics could not have some
CMS-0033-F 543

of the EPs using their individual patient volume for patients seen at the clinic, while others use

the clinic-level data). The clinic or practice must use the entire practice's patient volume and not

limit it in any way. EPs may attest to patient volume under the individual calculation or the

group/clinic proxy in any participation year. Furthermore, if the EP works in both the clinic and

outside the clinic (or with and outside a group practice), then the clinic/practice level

determination includes only those encounters associated with the clinic/practice.

We have revised our regulations to make clear that when patient volume is calculated on

a group-practice/clinic level, the above rules will apply.

Comment: Similar to the last comment, we received comments requesting clarification

on how the patient volume requirements will apply in States with seamless eligibility

determinations and payments for their program. For example, some States have streamlined

their programs so that the potential beneficiary is applying for any public health care program for

which they might be eligible (for example, Medicaid, CHIP, State-only) in one application.

Often these States have one enrollment card as well. In other words, it is likely that both the

beneficiary and the health care provider might have no indication as to whether the beneficiary is

receiving assistance under Title XIX, Title XXI, or State-only funds. This becomes a problem

when attempting to determine if the provider meets the patient volume requirements.

Response: If there is a combined program like the one in the example, this does not mean

that all the encounters are being paid for with Title XIX funds (or the individual’s premium or

cost-sharing is funded through Title XIX), which is how we explained we would determine

Medicaid patient encounters. We do not believe it would be reasonable to allow an encounter

that is paid for with Title XXI or State-only funds to be considered a “Medicaid encounter.”

Thus, States with combined programs (for example, Medicaid/CHIP expansion programs), may
CMS-0033-F 544

indeed have difficulty determining who is eligible for participation in this incentive program.

Considering these States have made enormous strides to reduce the confusion and burden

associated with eligibility and payment for these programs, and also to reduce the stigma

sometimes associated with Medicaid, we want to support the work they have done.

After consideration of the public comments received, we believe that the best course of

action is to work with these States on a case-by-case basis through providing guidance as they

develop the SMHP. We believe that each State will have different data and information

available to them. The States should make sure that the health IT coordinators are working

closely with the Medicaid (and CHIP, as it pertains to this program) policy staff on all aspects of

the program. The goal will be to find a solution that leverages the State's existing and/or future

data sources, as well as looking for flexible alternatives, while still honoring Congress' intent for

the patient volume requirements, as established in the statute.

Comment: Some commenters pointed out that not all Medicaid providers use an EHR or

submit electronic claims, making it tedious to capture a numerator and denominator for patient

volume until the providers have adopted an EHR. Additionally, some commenters expressed

concern about how providers would determine the denominator for patient volume and how

States would audit the resulting percentage.

Response: While the commenters may be correct about the assertion that not all

providers use an EHR or submit electronic claims, we do not believe it will prevent EPs and

eligible hospitals from participating. These providers are businesses and there is an expectation

that they are tracking their receivables from all entities (including Medicaid) associated with

specific patients. In other words, we do not see a connection between electronic claims and

current EHR use and calculation of the patient volume. Furthermore, when EHRs are used with
CMS-0033-F 545

practice management systems, we believe that in most cases, this data should be derived from the

electronic systems.

When States consider their audit strategies, they should leverage existing data sources to

the extent possible, but also consider future data sources. Part of the Medicaid Information

Technology Architecture (MITA) principles associated with the SMHP development includes

consideration of the "as is" world, as well as the "to be" world. While States may not have the

systems in place today for a complete picture, we expect a longer-term strategy leveraging better

data systems.

After consideration of the public comments received, we are not making any change on

the basis of this comment. We provided additional flexibility in the patient volume

requirements, which may help providers more easily calculate their patient volume and provide

for flexibility when States begin to audit providers.

Comment: Commenters requested clarification on how to determine eligibility for the

five types of Medicaid EPs. Commenters also noted that there was a potential difference

between Medicare and Medicaid for the definition of "physician." Finally, other commenters

were confused if, as a specialty practitioner, they qualified as one of the EP types.

Response: We agree with the commenters that there is a distinction between the

Medicare and Medicaid definitions of physician. The Medicare statute at section 1848(o)(5)(C)

defines an eligible professional as including all the professionals listed in section 1861(r) of the

Act (which, generally stated, includes podiatrists, chiropractors and optometrists), the Medicaid

statute does not incorporate all of 1861(r). Rather, the Medicaid statute defines what are

physician services for purposes of qualifying as medical assistance under section 1905(a)(5)(A)

of the Act, and states that physician services constitutes services furnished by a physician as
CMS-0033-F 546

defined in section 1861(r)(1) (which includes only doctors of medicine or osteopathy legally

authorized to practice medicine and surgery by their State). In addition, section 1905(e) permits

States the option to consider optometrist services as physician services. In this case, the State

plan must specifically provide that the term “physicians’ services” includes services of the type

which an optometrist is legally authorized to perform.

Thus, in keeping with the statute, a physician would be limited to doctors of medicine or

osteopathy legally authorized to practice in their State, and, in cases where States have

specifically adopted the option of 1905(e) in their State plans, optometrists.

In addition, States would need to refer to their own scope of practice rules to determine

whether an individual qualifies as providing dental, nurse practitioner, physician assistant, or

certified nurse midwife services. Also, States and EPs would need to refer to CMS regulations.

These regulations, at 42 CFR 440.60 require that practitioners be licensed and that they are

within the scope of practice defined under State law (see also 1905(a)(6)). 42 CFR 440.100(b),

defines a dentist as an individual licensed to practice dentistry or dental surgery in his or her

State. 42 CFR 440.165 defines a nurse midwife as a registered professional nurse who meets the

following requirements: (1) is currently licensed to practice in the State as a registered

professional nurse; (2) is legally authorized under State law or regulations to practice as a nurse-

midwife, (3) has completed a program of study and clinical experience for nurse-midwives as

specified in the State, unless the State does not specify such a program. (4) In the case where the

State has not specified a particular program of study and clinical experience, the regulation

provides alternative means for demonstrating this training. See also section 1905(a)(17),

defining certified nurse midwife with reference to section 1861(g). 42 CFR 440.166 contains a

definition of what qualifies as nurse practitioner services and requires a nurse practitioner to be a
CMS-0033-F 547

registered professional nurse who meets the State’s advanced educational and clinical practice

requirements, if any, beyond the 2 to 4 years of basic nursing education required of all registered

nurse. States will have a Medicaid State Plan (and often State regulations) that designates how

each provider is eligible to participate in the Medicaid program by practice type. All of these

practitioners must meet all other eligibility requirements (including Medicaid patient volume) in

order to participate.

Regarding the confusion by some specialty providers (for example, advanced practice

nurses, pediatricians, physician sub-specialties, etc.), so long as an EP qualifies as a practitioner

within the State's scope of practice rules for each of the five EP types, they are eligible for this

program. In other words, since pediatricians are physicians, they must meet the physician scope

of practice rules and then they may be eligible for an incentive when they meet all other

requirements. Advanced practice nurses who meet their State’s criteria for qualifying as a nurse

practitioner would qualify as nurse practitioners. We believe most States would recognize APNs

as NPs within their scope of practice rules. Eligible provider types must be specified in a State’s

SMHP.

After consideration of the public comments received, we are revising the definition of

these EPs under section 495.304 to clarify additional scope of practice requirements.

Comment: Commenters requested clarification on how full- or part-time status impacts

an EP's eligibility for incentives.

Response: Full or part-time status does not affect patient volume calculations or whether

an EP’s practice is predominantly in an FQHC or RHC. There is no mention of requisite number

of hours in the statute or this final rule as a pre-condition for eligibility.

After consideration of the public comments received, we are not making any revisions to
CMS-0033-F 548

this section of the final rule.

e. Entities Promoting the Adoption of Certified EHR Technology

We define “promoting the adoption of certified EHR technology” in §495.302. Under

section 1903(t)(6)(A)(i), incentive payments must generally be made directly to the EP. Section

1903(t)(6)(A)(ii) of the Act provides an exception to permit payment of incentive payments to

“entities promoting the adoption of certified EHR technology,” as designated by the State, if

participation in the payment arrangement is voluntary for the EP involved. Additionally, the

entity must not retain more than 5 percent of the payment for costs unrelated to certified EHR

technology (and support services including maintenance and training) that is for, or is necessary

for, the operation of the technology. While the Act authorizes States to designate these entities,

the Secretary nevertheless retains authority to define what it means to be “promoting the

adoption of certified EHR technology,” as specified in section 1903(t)(6)(A)(ii) of the Act.

Section 1102 of the Act authorizes the Secretary to “make and publish such rules and

regulations, not inconsistent with this Act, as may be necessary to the efficient administration of

the functions with which he or she is charged under this Act.” Since one of our functions is to

approve Title XIX plans under sections 1902(b) and 1116 of the Act, and States would need to

submit plans as to how they would spend section 4201 of the HITECH Act funds, we have the

authority to determine whether a State's plan for allowing EPs to assign their Medicaid incentive

payments to these entities is in compliance with our interpretation of the Act.

We define “promoting” certified EHR adoption to mean the enabling and oversight of the

business, operational and legal issues involved in the adoption and implementation of EHR

and/or exchange and use of electronic health information between participating providers, in a

secure manner, including maintaining the physical and organizational relationship integral to the
CMS-0033-F 549

adoption of certified EHR technology by EPs. Under 1903(t)(6)(A)(ii) of the Act and as

proposed in §495.332, States must establish verification procedures that enable Medicaid EPs to

voluntarily assign payments to entities promoting EHR technology. States must guarantee that

the assignment is voluntary and that the entity does not retain more than 5 percent of those

assigned Medicaid incentive payments for costs unrelated to certified EHR technology. We

proposed requiring States to publish and make available to all Medicaid EPs the procedures they

developed for assigning incentive payments to the third party entities before payments can be

assigned. Such publication must also include information about the State's verification

mechanism. The State's method must assure compliance with the requirement that no more than

5 percent of the Medicaid EP's annual incentive payment is retained by the entity for costs not

related to certified EHR technology.

Although section 1903(t)(6)(A)(ii) of the Act allows assignment of payment to entities

promoting the adoption of EHR technology, we wish to clarify that such assignment would not

remove the responsibility of the Medicaid EP to individually demonstrate meaningful use of the

EHR technology (as discussed in greater detail below). Therefore, entities promoting the

adoption would not receive the assigned payments unless the Medicaid EP meets all eligibility

criteria. Our definition for promoting the adoption of certified EHR technology is in §495.302.

Comment: A commenter recommended that CMS require that entities designated by

States that promote the adoption of EHR technology must use qualified EHR technology and be

able to capture, query and/or exchange data from beyond a practice or closed system in order to

foster interoperability, and to promote competition among EHR vendors with vendor-neutral and

provider-neutral solutions. The commenter recommended that entities that promote the adoption
CMS-0033-F 550

of certified EHR technology be certified to an electronic hub that permits the exchange of

electronic structured data on a provider-neutral basis.

Commenters also requested that the Regional Extension Centers funded by ONC be

permissible as entities designated by the State to be eligible to receive EPs assigned incentive

payments.

Response: States will have the discretion to identify entities that promote the adoption of

certified EHR technology in accordance with our definition in regulation. We do not agree that

the definition of “promotion of the adoption of EHR technology” requires the designated entity

itself to utilize certified EHR technology. A variety of entities might offer services that meet the

language included in this final rule defining promoting EHR adoption. We wish to point out that

there is also a discussion of reassignment of payments in Section II.B.1.d. of this rule.

After consideration of the comments, we are adopting the language as written with the

additional clarification that we encourage States to consider how they will verify on an on-going

basis that the entities that they designate are in fact promoting EHR adoption, per the

requirements. Their responsibility to audit this element might be a factor in identifying which

entities they wish to designate, in terms of tangible EHR promotion activities.

We agree that our definition of “promoting EHR adoption” does not preclude the ONC-

funded Regional Extension Centers from being designated by States for this role.

4. Computation of Amount Payable to Qualifying Medicaid EPs and Eligible Hospitals

The statute, at sections 1903(t)(1), (t)(4), and (t)(5) of the Act, creates different payment

formulas for Medicaid EPs versus hospitals. The payment methodology for Medicaid hospitals

shares many aspects of the methodology used for Medicare hospitals.

a. Payment Methodology for EPs

CMS-0033-F 551

(1) General Overview

Pursuant to section 1903(t)(1)(A) of the Act, payment for EPs equals 85 percent of “net

average allowable costs.” While the Secretary is directed to determine “average allowable costs”

based upon studies of the average costs of both purchasing and using EHR technology, the net

average allowable costs that set payment are capped by statute. As discussed in more detail

further on, generally stated, these caps equal $25,000 in the first year, and $10,000 for each of

5 subsequent years (there is an exception for pediatricians with under 30 percent Medicaid

patient volume, whose caps are two-thirds of these amounts). Thus, the maximum incentive

payment an EP could receive from Medicaid equals 85 percent of $75,000, or $63,750, over a

period of 6 years. EPs must begin receiving incentive payments no later than CY 2016.

(2) Average Allowable Costs

Section 1903(t)(4)(C) of the Act gives the Secretary the authority to determine average

allowable costs. Specifically, the Secretary is directed to study the average costs associated with

the purchase, initial implementation, and upgrade of certified EHR technology, including support

services, and integral related training. The Secretary also is directed to study the average costs of

operating, maintaining, and using certified EHR technology. The statute permits the Secretary to

use studies submitted by the States.

We conducted a literature review of recent studies on EHR technology to determine the

average allowable cost of implementing and using such technology. We reviewed the results

from four recent, comprehensive studies.

In conducting a review of the data, we determined that the studies demonstrate a cross-

sectional view of small and large practices and community health centers. There was adequate

data to support a depiction of costs across multiple provider types.

CMS-0033-F 552

To summarize, we determined that the average costs of EHRs vary greatly because of the

size and type of provider practices, the differences in available features of systems, and the

additional costs associated with licensing, support, training, and maintenance. However, based

on the information reviewed, we determined that the average costs for initial EHR systems

currently can range from $25,000 to $54,000 in the implementation year, per professional. Since

the average costs of EHR technology in the first year can be as much as $54,000 and no less than

$25,000, and since we believe the costs of such technology will be increasing, we set the average

allowable cost at $54,000. We established this average allowable cost at the high end of the

range since the data we reviewed is based on certification criteria that may not be appropriate

moving forward. Specifically, since the ONC is establishing new certification criteria for EHR

technology, we believe the average cost of certified EHR technology incorporating the new

criteria will be higher than the current costs of EHR technology. It is our assumption that

making improvements to incorporate the new certification standards into current EHR

technology will be costly. Thus, we believe that establishing the average allowable cost at

$54,000 is reasonable.

Additionally, our analysis determined that the range for subsequent incentive payment

year costs for most providers will fall into a large range, based on a number of factors. On one

end of the range, costs related to maintenance could be as low as $3,000 to $9,000 per provider,

where other studies state that maintenance will be as high as $18,000 to $20,610 per provider.

Given the requirements in the ONC interim final rule for the adoption of an initial set of

standards, implementation specifications, and certification criteria for EHRs and the health

measures data discussed in this final rule that CMS and the States will need to collect from
CMS-0033-F 553

professionals, we believe that the costs for maintaining certified EHR technology will also be on

the higher end of the range at $20,610.

(3) Net Average Allowable Costs.

As originally required by section 1903(t)(3)(E) of the Act, in order to determine “net”

average allowable costs, average allowable costs for each provider must be adjusted in order to

subtract any payment that is made to Medicaid EPs and is directly attributable to payment for

certified EHR technology or support services of such technology. The only exception to this

requirement is that payments from State or local governments do not reduce the average

allowable costs. The resulting figure is the “net” average allowable cost, that is, average

allowable cost minus payments from other sources (other than State or local governments). The

statute indicates that EPs may receive 85 percent of a maximum net average allowable cost in the

first year of $25,000 and a maximum net average allowable cost of $10,000 in subsequent years.

This would mean that, as required by the statute, the net average allowable costs are capped at

these amounts.

Since we set the average allowable cost at $54,000 in the first year, EPs could receive as

much as $29,000 in funding from sources (other than from State or local governments) as

contributions to the certified EHR technology and the incentive payment would still be based on

85 percent of the maximum net average allowable cost of $25,000 (or $21,250). This is

appropriate since $54,000 (the average allowable cost) minus $29,000 (contributing sources of

funding from other than State or local governments) equals $25,000. Since $25,000 is equal to

the level of the maximum net average allowable cost or capped amount discussed above,
CMS-0033-F 554

providers could receive 85 percent of $25,000 or $21,250 in year one as a Medicaid incentive

payment.

The same logic would hold true for subsequent years. Specifically, if in the following

years an eligible professional received as much as $10,610 in contributing funds from sources

other than State or local governments, the maximum incentive payment of $8,500 would be

unaffected in such subsequent years. This result is due to the fact that the average allowable

costs of $20,610 for maintaining EHR technology minus the $10,610 received would still equal

$10,000, the maximum net average allowable costs permitted under the statute.

In reviewing whether a reduction in the net average allowable cost was warranted based

on other contributions to EHR technology, we considered the situation of EPs who may have

been provided with the actual certified EHR technology, as well as training, support services,

and other services that would promote the implementation and meaningful use of such

technology. In some cases, we do not believe the contribution would reduce average allowable

costs at all. For example, if an FQHC or RHC has provided technology to its staff EPs to use,

we do not believe that such technology provision would be considered a “payment” from another

source that would reduce average allowable costs. Moreover, we believe the situations in which

an EP has been provided with the actual technology, support service, or training from another

source are extremely limited in light of the statutory prohibitions on “kickbacks” at Section

1128B(b) of the Act.

Comment: Several commenters are concerned that States are required to develop a

method to determine the payment amount for each provider. Commenters believed that incentive

payments should be based on the maximum amount and that individual calculations are

cumbersome and a difficult process for both States and eligible professionals.
CMS-0033-F 555

Response: We would like to clarify the requirements in the statute and the process by

which incentive payments will be established. Specifically, the Secretary is directed to study the

average costs associated with the purchase, initial implementation, and upgrade of certified EHR

technology, including support services, and integral related training. The Secretary is also

directed to study the average costs of operating, maintaining, and using certified EHR

technology. The statute permits the Secretary to use studies submitted by the States. CMS

conducted a literature review of recent studies on EHR technology to determine the average

allowable cost of implementing and using such technology. CMS reviewed the results from four

recent, comprehensive studies and determined that these costs are $54,000 per professional. We

recognize that this cost is variable and since the ONC is establishing certification criteria for

EHR technology, we believe this cost is reasonable since we expect that current EHR technology

will need to be upgraded in order to meet the new certification criteria.

Next, in accordance with the statute, in order to determine the net average allowable costs

for each provider, average allowable costs for each provider must be adjusted in order to subtract

any payment that is made to Medicaid eligible professionals and is directly attributable to

payment for certified EHR technology or support services of such technology. The only

exception to this requirement, as discussed above, is that payments from State, or local

governments do not reduce the average allowable costs. The resulting figure is the net average

allowable costs. The statute further indicates that Medicaid eligible professionals can receive up

to 85 percent of a maximum of the net average allowable cost. In year one the maximum net

average allowable cost is $25,000 and in subsequent years is $10,000. Additionally, the statute

indicates that Medicaid eligible professionals are responsible for the remaining 15 percent of the

net average allowable cost (1903(t)(6)(B)). We believe the commenters are concerned with the
CMS-0033-F 556

85 percent of net average allowable cost maximum incentive payment amount and the

responsibility of the Medicaid professional for the remaining 15 percent of the net average

allowable cost.

Since the statute is clear that to get to the net average allowable cost, payments made to

the EP that are directly attributable to the payment for certified EHR technology or support

services for such technology for each provider have to be subtracted from the average allowable

cost, this must be an individual provider calculation. We do not believe we have discretion to

change this netting process directed by the Congress. We have provided an example calculation

so that in using the average allowable cost established by the Secretary of $54,000 professionals

could receive as much as $29,000 in payments from outside sources and still receive 85 percent

of the maximum capped net average allowable cost of $25,000. We have also required that

States must have a process in place and a methodology for verifying that payment incentives are

not paid at amounts higher than 85 percent of the net average allowable cost and a process in

place and a methodology for verifying that professionals pay 15 percent of the net average

allowable cost of the certified EHR technology.

States may wish to establish a process whereby individuals attest to having completed

their forms correctly and risk the circumstance of audit in the event the State has reason to

believe individuals did not complete the forms appropriately. States could develop a process for

providers to attest to having received no other sources of funding from other than State and local

governments as payment that is directly attributable to the cost of the technology. States could

select a random sample of providers to audit after the incentive payment has been paid.

Additionally, States could determine that certain types of providers should be selected for a more

extensive review since it may be true that this particular provider group was most likely to have
CMS-0033-F 557

received payment for certified EHR technology from sources other than State, or local

governments. This process could eliminate some of the burden.

Comment: Commenters also asked that we provide some examples of the costs that must

be subtracted to get to the net average allowable cost and therefore the incentive payment

amount. Commenters do not want to be penalized because they did not have a fair chance at

understanding the rule before participating in the program. Commenters further argued that

reducing incentive payments due to other non-State/local resources could immobilize innovation

and temper research activities.

Response: When States begin to think through the payments that are not considered

acceptable and that must be subtracted from the average allowable cost to get to the net average

allowable costs and consequently, the incentive payment, we believe that States should consider

the situation in which professionals may have been provided with the certified EHR technology

through, for example, an employer/employee relationship. We do not believe in this case that

there could be any payments directly attributable to the professional for the certified EHR

technology; therefore, there are no payments that must be subtracted. This situation would apply

in the case of clinics like FQHCs/RHCs or IHS facilities. Additionally, States should consider

that any in-kind contributions such as EHR technology or free software provided by vendors are

not cash payments and therefore are also not costs that must be subtracted. Further, in the case

of grants like the HRSA Capital Improvement Program grants that are used to finance many

projects within an organization; for example, research projects, infrastructure, construction or

repair and renovation of health centers, health care services, etc., we do not believe these grants

are directly attributable as payments for the certified technology but rather are payments for

several projects of the organization. Again, we do not believe that these costs are directly
CMS-0033-F 558

attributable to payment costs for the certified technology and therefore must be subtracted.

These are just some examples but the clarifying point is that any costs that are subtracted from

the average allowable cost to get to the net average allowable cost have to be cash payment that

is “directly attributable to the professional for the certified EHR technology.” Aside from

specific costs related to computer hardware, software, staff training, and/or upgrades of the

technology, we believe there are limited situations that exist in which cash payment has been

made that is directly attributable to the professional solely for the purpose of certified EHR

technology.

In any case, we are requiring that States submit to CMS for review and approval a

description of their process and methodology for verifying payment incentives in State Medicaid

HIT plans. CMS has the flexibility to approve State Medicaid HIT plans that require provider

attestation initially with subsequent auditing of either a random sample, or a sample of payment

incentive recipients most likely to have received funding from other sources.

We also would like to provide clarifying information concerning the responsibility of the

professional for 15 percent of the net average allowable cost. Section 1903(t)(6)(B) of the Act

dictates that EPs are responsible for payment of the remaining 15 percent of the net average

allowable cost and States are responsible for ensuring that the Secretary pays no more than

85 percent of the net average allowable cost as incentive payments. In ensuring EPs’

responsibility for the remaining 15 percent, we believe States may consider funding that the EP

receives from other sources as essentially meeting the EPs responsibility. For example, as stated

earlier, States should consider the previous examples of employer/employee relationship, certain

grants, and in-kind contributions. Specifically, if a professional is an employee at an

FQHC/RHC or IHS facility, since the employer has provided the technology to the employee it is
CMS-0033-F 559

assumed that the employer has contributed the 15 percent to the net average allowable cost on

behalf of the employee. Additionally, in the case of in-kind contributions, the professional’s 15

percent responsibility to the net average allowable cost is of no consequence since the entity has

assumed that responsibility for the professional. It should be noted that in the case of a vendor

supplying the 15 percent on behalf of the EP because the technology, training, support services,

etc. was either in-kind contributions or free, conflict of interest safeguards apply and the parties

should be mindful of the requirement to comply with applicable fraud, waste, and abuse laws,

rules, and regulations.

In those cases in which the professional himself must satisfy the responsibility for the 15

percent net average allowable costs, we believe in determining the calculation, States should

consider costs related to the providers’ efforts to address workflow redesign and training to

facilitate meaningful use of EHRs as contributing to the providers’ 15 percent share.

Considering the costs of training, preparing for, and installing or upgrading EHR

technology, we believe the vast majority of EPs will spend, or receive funding from other

sources in the amount of 15 percent of the maximum net average allowable cost (or $3,750 in the

first year and $1,500 in subsequent years). We also believe that for providers’ first payment for

having adopted, implemented or upgraded certified EHR technology, States should take into

consideration providers’ verifiable contributions up through the date of attestation. For example,

if a provider adopted EHR technology for $100 in January 2010 and then paid for the upgrade to

the newly certified version for an additional $100 in December of 2010, the sum of both

investments; that is, $200, should be applicable to their 15 percent of the net average allowable

cost.

In summary, in response to these comments, we are clarifying in the final rule that State
CMS-0033-F 560

Medicaid HIT plans must explain the process and methodology States will put in place to ensure

that Medicaid eligible professionals comply with this responsibility (see section 495.332).

Additionally, we have clarified the rules at section 495.310 that providers are responsible for 15

percent of the net average allowable costs of the certified EHR technology.

The following chart is useful in depicting the effect of this calculation.

Payments: NAAC calculation

Average allowable costs (AAC) minus payments
from other sources:
– State and local sources not considered
= Net average allowable costs (NAAC)
$54,000 AAC Other sources?
Count only cash
Max allowed from other payment to EP
$29,000 sources directly attributable
to only the EHR
Maximum incentive technology . Don’t
$25,000 (example only) and also the count: in kind,
maximum NAAC employer provided,
grant to entity, etc.
$21,250 Reduced to 85%= actual
incentive payment 15%?
Remaining 15% Count all: in kind,
$3,750 responsibility of EP employer provided,
grant to entity, etc.
1

Comment: Several commenters have raised questions about the cost of the certified EHR

technology for hospitals. Specifically, commenters believed that $54,000 is identified as the

initial costs for providers with 20 percent per year thereafter for ongoing costs; and $5 million

for initial costs for hospitals with 20 percent per year thereafter for ongoing costs. The

commenters believed that the $54,000 assumption for providers may be accurate; however, the

$5 million assumption for hospitals could be off by a factor of 4 or 5. Other commenters

believed that even the $54,000 assumption seriously underestimates the total cost of ownership

for EHR systems and their ongoing expenses and argued that this assumption does not account
CMS-0033-F 561

for the training and labor costs associated with implementation of an EHR system, nor does it

account for the lost revenues resulting from the decreases in productivity during the initial

implementation phase. One commenter questioned whether the $54,000 average allowable cost

for certified EHR technology takes into account leasing of an ASP (applicable service provider

web based) model as an allowable cost.

Response: As explained above, we conducted a literature review of recent studies on

EHR technology and determined that these costs are $54,000 per professional. We are not

establishing an average allowable cost for hospitals. The reference to the costs of EHRs for

hospitals was only to make the point that the costs of EHRs vary greatly because of the size and

type of provider practices, differences in available features of systems, and the additional costs

associated with licensing, support, training and maintenance. Additionally, there is no reason to

establish the average allowable costs of EHR technology for hospitals since the hospital

incentive payments are based on a formula that is defined in the statute and that does not rely on

the average allowable cost. In terms of the $54,000 average allowable cost figure, we indicated

that we believe this is a reasonable figure but recognize that there are many variables to

determining the average allowable cost of certified EHR technology because of practice size, the

differences in available features of systems, and the additional costs associated with licensing,

support, training and maintenance. The $54,000 average allowable cost figure does take into

account web based models since the Secretary is tasked to study the average costs associated

with the purchase, initial implementation, and upgrade of certified EHR technology, including

support services, and integral related training.

We are making no additional revisions to this section of the final rule as a result of this

comment.
CMS-0033-F 562

Comment: One commenter requested that CMS make clear that any funding an FQHC

receives because the Medicaid eligible professional voluntarily chooses to reassign his/her

incentive payment or any funds the center may have received through HRSA Capital

Improvement Funds cannot be the basis for a State reducing its per visit payment to FQHCs

required under Section 1902(bb).

Response: We agree with the commenter with respect to the incentive payments

authorized under section 1903(t); however, we are not addressing the HRSA Capital

Improvement funds, as this funding is outside the scope of this rulemaking. Since FQHCs are

not eligible providers, incentive payments will not be made to FQHCs. It is true, however, that

an eligible professional could choose to reassign his/her incentive payment to the FQHC. Any

reassignment of payments must be consistent with applicable laws, rules, and regulations,

including, without limitation, those related to fraud, waste, and abuse. Incentive payments are

payments designed to promote the adoption and meaningful use of certified EHR technology and

are not payments for medical assistance provided in the FQHC. We do not have the authority

under this program to provide that these funds be the basis for the State to reduce its per visit

payment to the FQHC.

After consideration of this comment, we are making no further additions to this section of

the final rule.

(4) Payments for Medicaid Eligible Professionals

One important difference we proposed between the payments to Medicaid EPs and

hospitals is that States would disburse the payments to EPs in alignment with the calendar year,

whereas hospitals will receive payments in alignment with the fiscal year, as described in section

II.D.4.b. of this final rule. There are two primary reasons for this. The first is to align Medicaid
CMS-0033-F 563

incentive payment disbursements with that of the Medicare program, in order to support

consistency between the two programs, as well as among the States. We will undertake national

outreach activities to encourage provider EHR adoption and to align the annual payment periods.

As previously discussed in this final rule, based on the 85 percent threshold applied to the

net average allowable costs, we proposed that most Medicaid EPs may receive up to a maximum

incentive payment of $21,250 in the first payment year.

In subsequent years of payment, Medicaid EPs' incentive payments will be limited to 85

percent of the $10,000 cap on net average allowable cost, or up to a maximum of $8,500

annually for most Medicaid EPs.

Since pediatricians are qualified to participate in the Medicaid EHR incentive program as

physicians, and therefore classified as Medicaid EPs, they may qualify to receive the full

incentive (that is, the 85 percent threshold applied to the net average allowable cost) if the

pediatrician is not hospital-based and can demonstrate that they meet the minimum 30 percent

Medicaid patient volume requirements discussed in this subpart.

Pediatricians who are not hospital-based, and have a minimum of 20 percent of their

patient encounters paid by Medicaid are also encouraged to participate in the Medicaid EHR

incentive program. The maximum payment amount for these pediatricians, who meet the

20 percent Medicaid patient volume, but fall short of the 30 percent patient volume, is reduced to

two-thirds of the net average allowable cost, subject to the 85 percent threshold. The reduction

accounts for the reduced patient volume, but the intent is to offer an incentive to attract

pediatricians to participate. This means pediatricians with a minimum 20 percent patient volume

may qualify for up to a maximum of $14,167 in the first incentive payment year and to up a
CMS-0033-F 564

maximum of $5,667 in the 5 subsequent incentive payment years, or no more than $42,500 over

the maximum 6 year period.

Table 16 demonstrates the various maximum incentive payment amounts for Medicaid

professionals.

TABLE 16: Maximum Incentive Payment Amount for Medicaid Professionals

85 percent Maximum
Allowed for Cumulative
Cap on Net Average Allowable Costs, Eligible Incentive over 6-year
per the HITECH Act Professionals Period
$25,000 in Year 1 for most professionals $21,250
$10,000 in Years 2-6 for most professionals $8,500 $63,750
$16,667 in Year 1 for pediatricians with a
minimum 20 percent patient volume, but less than
30 percent patient volume, Medicaid patients $14,167
$6,667 in Years 2-6 for pediatricians with a
minimum 20 percent patient volume, but less than
30 percent patient volume, Medicaid patients $5,667 $42,500

All State Medicaid EHR incentive program calculations, payments, and limits under this

section are subject to our review.

Comment: Commenters suggested that CMS apply the health professional shortage area

(HPSA) bonus offered under Medicare to Medicaid providers.

Response: There is no statutory authority for HPSA bonuses in the Medicaid incentive

program. However, it is worth noting that in comparing the maximum participation period for

EPs in Medicare and Medicaid, EPs can earn higher total incentive payments under Medicaid,

even when compared to the Medicare payments with the HPSA bonus.

We are not making any changes to this rule as a result of this comment.

Comment: Commenters requested clarification on how the Medicare payment

adjustments apply to Medicaid providers. Commenters suggested that if these apply to Medicaid
CMS-0033-F 565

providers, it could be a reason not to participate. One commenter asked about a provider who

began in the Medicare incentive program and then switched to Medicaid, but then stopped

meaningfully using the certified EHR.

Response: The Medicaid program does not have the payment adjustments that apply,

beginning in 2015, in the Medicare program. However, all Medicare providers will have a

payment reduction in 2015 if they are not demonstrating meaningful use, regardless of whether

they participate in the Medicare or Medicaid EHR incentive program. Whether an EP, hospital

or CAH is a meaningful user of certified EHR technology will continue to be determined on a

year-by-year basis. A provider who stops meaningfully using certified EHR cannot receive an

incentive payment. This is discussed in greater detail in II.A.

We are not making any changes to this rule as a result of this comment.

(5) Basis for Medicaid EHR Incentive Program First Payment Year and Subsequent Payment

Years

(i) Medicaid EP Who Begins Adopting, Implementing or Upgrading Certified EHR Technology

in the First Year

A Medicaid EP who begins by adopting, implementing, or upgrading certified EHR

technology in the first year will be eligible for the incentive payments not in excess of the

maximum amount. Under section 1903(t)(4) of the Act he or she is eligible to receive up to the

maximum first year Medicaid incentive payments discussed in the previous sections, plus

additional incentive payments for up to 5 years for demonstrating meaningful use of certified

EHR technology. In other words, these providers may participate in the Medicaid EHR incentive

program for up to 6 years.

CMS-0033-F 566

Table 17 demonstrates the payment scenarios available to a Medicaid EP who begins in

their first year by adopting, implementing, or upgrading certified EHR technology, and receives

all six years of payments consecutively. As can be seen from the table, the EP can begin

receiving payments as late as 2016, and still receive up to the maximum payments under the

program.

TABLE 17: Payment Scenarios For Medicaid EPs Who Begin Adoption in the First Year

Medicaid EPs who begin adoption in

Calendar Year 2011 2012 2013 2014 2015 2016
2011 $21,250 ------------- ------------- ------------- ------------- -------------
2012 $8,500 $21,250 ------------- ------------- ------------- -------------
2013 $8,500 $8,500 $21,250 ------------- ------------- -------------
2014 $8,500 $8,500 $8,500 $21,250 ------------- -------------
2015 $8,500 $8,500 $8,500 $8,500 $21,250 -------------
2016 $8,500 $8,500 $8,500 $8,500 $8,500 $21,250
2017 ------------- $8,500 $8,500 $8,500 $8,500 $8,500
2018 ------------- ------------- $8,500 $8,500 $8,500 $8,500
2019 ------------- ------------- ------------- $8,500 $8,500 $8,500
2020 ------------- ------------- ------------- ------------- $8,500 $8,500
2021 ------------- ------------- ------------- ------------- ------------- $8,500
TOTAL $63,750 $63,750 $63,750 $63,750 $63,750 $63,750

(ii) Medicaid EP who has Already Adopted, Implemented or Upgraded Certified EHR

Technology and Meaningfully Uses EHR Technology

For a Medicaid EP who has already adopted, implemented, or upgraded certified EHR

technology and can meaningfully use this technology in the first incentive payment year, we

proposed that the Medicaid EP be permitted to receive the same maximum payments, for the

same period of time, as the Medicaid EP who merely adopted, implemented or upgraded certified

EHR technology in the first year. Section 1903(t)(6)(C)(ii) of the Act states that for a Medicaid

EP or hospital who has completed “adopting, implementing, or upgrading” certified EHR

technology “prior to the first year of payment. . . clause (i)(I) shall not apply and clause (i)(II)
CMS-0033-F 567

[discussing the demonstration of meaningful use] shall apply to each year of payment to the

Medicaid provider under this subsection, including the first year of payment.” We believe this

provision supports an interpretation that a Medicaid EP who has already adopted certified EHR

technology, would still receive a “first year” of payment under section 1903(t)(4) of the Act, and

like all other first years of payment, this payment could not exceed $21,250. Then, under section

1903(t)(4)(A)(ii) and (iii) of the Act, such Medicaid EPs could receive an additional 5 years of

payment for subsequent years of payment, with payments not exceeding $8,500 in each of these

5 subsequent years. This approach allows early adopters of certified EHR to begin meaningfully

using technology, without being at a competitive disadvantage, and without losing incentive

payments for the previous costs associated with adopting, implementing, or upgrading certified

EHR technology.

Thus, the maximum incentive payments for Medicaid EPs demonstrating that they are

meaningful users in the first payment year, would be identical to the maximum payments

available to those demonstrating adoption, implementation, or upgrading certified EHR

technology in the first year, as depicted in Table 18.

TABLE 18: Maximum Incentive Payments for Medicaid EPs Who Are Meaningful Users
in the First Payment Year

Medicaid EPs who begin meaningful use of certified EHR technology in--
Calendar Year 2011 2012 2013 2014 2015 2016
2011 $21,250 ------------- ------------- ------------- ------------- -------------
2012 $8,500 $21,250 ------------- ------------- ------------- -------------
2013 $8,500 $8,500 $21,250 ------------- ------------- -------------
2014 $8,500 $8,500 $8,500 $21,250 ------------- -------------
2015 $8,500 $8,500 $8,500 $8,500 $21,250 -------------
2016 $8,500 $8,500 $8,500 $8,500 $8,500 $21,250
2017 ------------- $8,500 $8,500 $8,500 $8,500 $8,500
2018 ------------- ------------- $8,500 $8,500 $8,500 $8,500
2019 ------------- ------------- ------------- $8,500 $8,500 $8,500
2020 ------------- ------------- ------------- ------------- $8,500 $8,500
CMS-0033-F 568

Medicaid EPs who begin meaningful use of certified EHR technology in--
Calendar Year 2011 2012 2013 2014 2015 2016
2021 ------------- ------------- ------------- ------------- -------------- $8,500
TOTAL $63,750 $63,750 $63,750 $63,750 $63,750 $63,750

We also requested comment on an alternative approach that would limit the incentive

payment for Medicaid EPs who have already adopted, implemented, or upgraded certified EHR

technology to 5 years of payment, at a maximum payment of $8,500 per year. We refer readers

to our proposed rule (75 FR 1937) for a discussion of this approach.

Medicaid EPs are not required to participate on a consecutive annual basis, however, the

last year an EP may begin receiving payments is 2016, and the last year the EP can receive

payments is 2021. See our discussion on consecutive versus non-consecutive payments in

section II.A. of this final rule. We wish to point out to readers that this is one area where the

Medicare and Medicaid incentive payment programs differ. That is, Medicare EPs do not have

the same flexibility afforded to Medicaid EPs, who are permitted to participate in a non-

consecutive annual basis, or to skip years, in other words, without the omitted years necessarily

reducing the total number of years for which they may receive payment. The tables in this

section demonstrate how a Medicaid EP would maximize the aggregate incentive under different

scenarios, considering that a Medicaid EP may initiate participation in 2011 through 2016.

Additionally, these tables do not include the alternative Medicaid maximum incentive payment

for pediatricians discussed in the previous section, which is two-thirds of the total amount listed

in Tables 27 through 30. Finally, these tables do not represent EPs whose incentive payments

may be reduced because net average allowable costs may actually be lower than $25,000 in the

first year, or $10,000 in subsequent years, due to payments from other, non-State/local sources.
CMS-0033-F 569

Comment: Some commenters rejected the alternative scenario (including 5 years of

payment instead of 6), as it would effectively result in a penalty for early adopters, and reward

those who delayed adoption.

Response: We agree that early adopters should not be penalized. Further, we agree that

Medicaid EPs that have adopted EHR technology before the first year should have an

opportunity for the same maximum incentive payments as EPs that are meaningful users in the

first year. Accordingly, the alternative scenario we presented in Table 30 of the proposed rule

will not be used for incentive payments.

As we are adopting our proposed policy as final, we are not making any changes to the

regulations as a result of this comment.

b. Payment Methodology for Eligible Hospitals

Statutory parameters placed on Medicaid incentive payments to hospitals are largely

based on the methodology applied to Medicare incentive payments. The specifications described

in this section are limits to which States must adhere when developing aggregate EHR hospital

incentive amounts for Medicaid-eligible hospitals. States will calculate hospitals' aggregate

EHR hospital incentive amounts on the FFY to align with hospitals participating in the Medicare

EHR incentive program.

States may pay children's hospitals and acute care hospitals up to 100 percent of an

aggregate EHR hospital incentive amount provided over a minimum of a 3-year period and a

maximum of a 6-year period. Section 1905(t)(5)(D) requires that no payments can be made to

hospitals after 2016 unless the provider have been paid a payment in the previous year; thus,

while Medicaid EPs are afforded flexibility to receive six years of payments on a non-

consecutive, annual basis, hospitals receiving a Medicaid incentive payment must receive
CMS-0033-F 570

payments on a consecutive, annual basis after the year 2016. Prior to 2016, Medicaid incentive

payments to hospitals can be made on a non-consecutive, annual basis. The maximum incentive

amounts for these providers are statutorily defined by a formula at section 1903(t)(5)(B) of the

Act. The statute requires that Medicaid refer, with some adjustments, to the calculation for the

Medicare hospital incentive payment described at sections 1886(n)(2)(A), 1886(n)(2)(C), and

1886(n)(2)(D) of the Act, to determine the aggregate EHR amount allowable for individual

hospitals. The aggregate EHR hospital incentive amount is calculated using an overall EHR

amount multiplied by the Medicaid share.

States are responsible for using auditable data sources to calculate Medicaid aggregate

EHR hospital incentive amounts, as well as determining Medicaid incentive payments to those

providers. Auditable data sources include--

• Providers' Medicare cost reports;

• State-specific Medicaid cost reports;

• Payment and utilization information from the State's MMIS (or other automated claims

processing systems or information retrieval systems); and

• Hospital financial statements and hospital accounting records.

All State Medicaid EHR incentive program calculations, payments, and limits under this

section are subject to our review.

For purposes of the Medicaid EHR hospital incentive program, the overall EHR amount

is equal to the sum over 4 years of (I)(a) the base amount (defined by statute as $2,000,000); plus

(b) the discharge related amount defined as $200 for the 1,150th through the 23,000th discharge

for the first year (for subsequent years, States must assume discharges increase by the provider's

average annual rate of growth for the most recent 3 years for which data are available per year):
CMS-0033-F 571

multiplied by (II) the transition factor for each year equals 1 in year 1, ¾ in year 2, ½ in year 3,

and ¼ in year 4.

The statute specifies that the payment year is determined based on a Federal fiscal year.

Section 1886(n)(2)(C) of the Act provides the Secretary with authority to determine the

discharge related amount on the basis of discharge data from a relevant hospital cost reporting

period, for use in determining the incentive payment during a Federal fiscal year. Federal fiscal

years begin on October 1 of each calendar year, and end on September 30 of the subsequent

calendar year. Hospital cost reporting periods can begin with any month of a calendar year, and

end on the last day of the 12th subsequent month in the next calendar year. For purposes of

administrative simplicity and timeliness, we require that States use data on the hospital

discharges from the hospital fiscal year that ends during the Federal fiscal year prior to the fiscal

year that serves as the first payment year.

The discharge-related amount is $200 per discharge for discharges 1,150 through 23,000.

To determine the discharge-related amount for the 3 subsequent years that are included in

determining the overall EHR amount, States should assume discharges for an individual hospital

have increased by the average annual growth rate for an individual hospital over the most recent

3 years of available data from an auditable data source. Note that if a hospital's average annual

rate of growth is negative over the 3 year period, it should be applied as such.

The overall hospital EHR amount requires that a transition factor be applied to each year.

This transition factor equals 1 for year 1, ¾ for year 2, ½ for year 3, and ¼ for year 4, as

provided for in sections 1886(n)(2)(A) and 1886(n)(2)(E) of the Act, and as incorporated

through section 1902(t)(5)(B) of the Act. We note that although, for purposes of the Medicare

incentives, section 1886(n)(2)(E)(ii) of the Act requires a transition factor of 0, if the first
CMS-0033-F 572

payment year is after 2013, we do not believe this rule would apply in the context of the

Medicaid incentive payments. Nothing in section 1903(t) of the Act specifically cross references

this 0 transition factor, and, notably, section 1903(t) of the Act allows Medicaid incentive

payments to begin as late as 2016.

The “Medicaid Share,” against which the overall EHR amount is multiplied, is essentially

the percentage of a hospital's inpatient, non-charity care days that are attributable to Medicaid

inpatients. More specifically, the Medicaid share is a fraction expressed as--

• Estimated Medicaid inpatient-bed-days plus estimated Medicaid managed care

inpatient-bed-days;

Divided by;

• Estimated total inpatient-bed days multiplied by ((estimated total charges minus

charity care charges) divided by estimated total charges).

As indicated in the above formula, the Medicaid share includes both Medicaid inpatient-

bed-days and Medicaid managed care inpatient-bed-days. This is in keeping with section

1903(t)(5)(C) of the Act, which provides that in computing inpatient-bed-days, the Secretary

shall take into account inpatient-bed-days that are paid for individuals enrolled in a Medicaid

managed care plan under sections 1903(m) or 1932 of the Act. We interpreted these managed

care individuals to be individuals enrolled in an managed care organization (MCO), prepaid

inpatient health plan (PIHP), or prepaid ambulatory health plan (PAHP) under 42 CFR part 438.

Some Medicaid managed care entities (that is, MCOs, PIHPs, and PAHPs with risk

contracts) provide substitute services (or, “in-lieu-of services”) in more cost effective or efficient

settings than the State plan services in the managed care contract. For example, in a hospital

inpatient setting, these services could be in a different unit, such as a sub-acute wing or skilled
CMS-0033-F 573

nursing wing, so long as States and contracting entities are in compliance with the actuarial

soundness rules in §438.6(c), provision of substitute services is allowed. Although we

understand that these substitute service days may be used to achieve efficiency and cost

effectiveness, we do not believe such substitute service days should count as

“inpatient-bed-days” in the hospital EHR incentive payment calculation. The statute requires us

to calculate the Medicaid share “in the same manner” as the Medicare share under section

1886(n)(2)(D) of the Act and such substitute service days would not be considered “in the same

manner.” Thus, we proposed that for purposes of the Medicaid formula, we would count only

those days that would count as inpatient-bed-days for Medicare purposes under section

1886(n)(2)(D) of the Act.

In addition, because the formula for calculating the Medicaid share requires a

determination of charity care charges, States should use the revised Medicare 2552-10,

Worksheet S-10 or another auditable data source to determine the charity care portion of the

formula. In the absence of sufficient charity care data to complete the calculation, section

1886(n)(2)(D) of the Act, requires the use of uncompensated care data to derive an appropriate

estimate of charity care, including a downward adjustment for bad debts. We interpreted bad

debt to be consistent with the Medicare definition of bad debt as promulgated at §413.89(b)(1).

Finally, per section 1886(n)(2)(D) of the Act, to the extent there is simply not sufficient

data that would allow the State to estimate the inpatient bed-days attributable to Medicaid

managed care patients, the statute directs that such figure is deemed to equal 0. Likewise, if

there is simply not sufficient data for the State to estimate the percentage of inpatient bed days

that are not charity care (that is, [estimated total charges - charity care charges]/ estimated total

charges), the statute directs that such figure is deemed to equal 1.

CMS-0033-F 574

Unlike Medicaid EPs, who must waive rights to duplicative Medicare incentive

payments, hospitals may receive incentive payments from both Medicare and Medicaid,

contingent on successful demonstration of meaningful use and other requirements under both

programs.

The last year that a hospital may begin receiving Medicaid incentive payments is

FY 2016. States must make payments over a minimum of 3 years and a maximum of 6 years.

Additionally, in any given payment year, no annual Medicaid incentive payment to a hospital

may exceed 50 percent of the hospital's aggregate incentive payment. Likewise, over a 2-year

period, no Medicaid payment to a hospital may exceed 90 percent of the aggregate incentive.

Table 19 demonstrates several scenarios for Medicaid hospitals. However, there are

other scenarios not included here. For example, this table assumes that a hospital would

participate on a consecutive annual basis until the incentive is exhausted. The purpose of

Table 19 is to illustrate the general timeline for Medicaid hospital incentives.

CMS-0033-F 575

TABLE 19: Hospital Incentives

States will monitor compliance of hospitals coming onto the program with different
requirements depending on the year. Incentive determination will also be based on Y1
versus subsequent years. This chart is an example, noting that hospitals may collect the
incentive over 3-6 years.
CY Demonstration of Compliance
2011 Y1 Y1 participants must demonstrate that they engaged in efforts
to adopt, implement, or upgrade to certified EHR technology.
←←Becomes more difficult to establish meaningful use.

However, if users already adopted, they may proceed to Y2

requirements in Y1.
2012 Y2 Y1 Y1, same as above. Y2 must become a meaningful
EHR user. We expect to issue definition of
meaningful use on a biannual basis beginning in
2011.
2013 Y3 Y2 Y1 Y1, same as above. Y2-3 will be the same.
2014 Y4 Y3 Y2 Y1 Y1, same as above. Y2-4, same as
above.
2015 Y5 Y4 Y3 Y2 Y1 Y1, same as above. Y2-5,
same as above.
2016 Y6 Y5 Y4 Y3 Y2 Y1 Y1, same as above.
2017 Y6 Y5 Y4 Y3 Y2 Y2-6, same as
2018 Y6 Y5 Y4 Y3 above.
2019 Y6 Y5 Y4
2020 Y6 Y5
2021 Y6

Comment: Many commenters recommended that CMS instruct States to provide

hospitals the maximum incentive payments possible in their first two payment years.

Commenters provided many examples of how CMS should instruct States to make payments.

For instance, commenters suggested that CMS require States to pay 50 percent of hospitals'

aggregate incentive payment in the first year and another 40 percent in the second year - as a

limited source of capital for adoption, implementation, and upgrades. Many commenters stated

that it is critical that EHR incentive payments be made in a timely manner and not delayed or

affected by State budgetary problems or changes.

Response: After consideration of the public comments received, we are finalizing these
CMS-0033-F 576

provisions as originally proposed, with one clarification to ensure the statutory requirement that

eligible hospitals, after 2016, may not receive an incentive payment, unless a payment was

received in the prior year. The statute is imposing maximums on what the State is authorized to

pay eligible hospitals. At section 1903(t)(5)(A) the statute requires that a State can make no

more than 50 percent of the hospital's aggregate incentive payment in any one year. Likewise,

over a 2-year period, the State cannot pay more than 90 percent of the aggregate incentive.

Finally, under 1903(t)(5)(D) no more than six years of payment may be made, and payment may

not be paid for any year beginning after 2016, unless the hospital was provided an incentive

payment for the preceding year. However, these are limits on State payments, not required

minimums. We believe that States should work with their provider communities to determine

the best timeframes for implementing their EHR programs and making payments to providers.

Comment: Some commenters indicated that incentive payments should not be included

in any calculation of total Medicaid payments for the purpose of determining Medicaid

shortfalls, disproportionate share payments, upper payment limits, or any general Medicaid

program service.

Response: According to the statute, Medicaid HIT incentive payments are made to

encourage the adoption and use of certified EHR technology defined by the statute, as well as

support services including maintenance and training that is for, or is necessary for the adoption

and operation of, such technology. Payments to providers under this rule are not being made for

the provision of services or the cost of the provision of services to Medicaid beneficiaries or the

uninsured. Therefore, we are clarifying that EHR incentive payments made to providers in

accordance with the statute and final regulation are not subject to the same limits as payments for

items and services provided to Medicaid beneficiaries and the uninsured including Medicaid
CMS-0033-F 577

upper payment limits and disproportionate share hospital limits. This comment is also addressed

in the Medicare section at II.B.4.b.

Comment: One commenter noted a technical error in the proposed rule at 495.310 (g) (2)

Medicaid Share. The commenter questioned whether (2)(iii) meant to qualify (2)(ii) or (2)(i),

noting that the latter would result in dual eligibles being removed from Medicaid days (the

numerator) and would not conform to the Act which would require that they be removed from

the denominator.

Response: We agree that the regulation includes a technical error, and we read the statute

as requiring that dually eligible individuals be excluded from the denominator. Section

1903(t)(5)(C) states that the Medicaid share should be calculated using a numerator that does not

include individuals “described in section 1886(n)(2)(D)(i).” Individuals described in that section

are individuals for whom payment may be made under Medicare Part A as well as individuals

enrolled with a Medicare Advantage Organization under Part C. Thus, dually eligible

individuals are excluded from the numerator in determining the Medicaid share.

We are therefore revising section 495.310(g)(2)(iii) to ensure that it refers to clause (i),

rather than clause (ii), of §495.310(g)(2).

Comment: One commenter highlighted a technical error in the proposed rule at

§495.310(g)(1)(i)(B) when he requested clarification for that section which reads: "The

discharge related amount for a 12-month period selected by the State but with the Federal fiscal

year before the hospital's fiscal year that serves as the payment year." He interpreted the

language to mean that if the payment year begins in 2011, the Federal fiscal year would be 2010;

and the discharge related amount would be for 2009.

CMS-0033-F 578

Response: Section 495.310(g)(1)(i)(B) is improperly worded in the proposed rule and

should read, "The discharge related amount for a 12-month period selected by the State, but

ending in the Federal fiscal year before the hospital's fiscal year that serves as the first payment

year." For example: FY 2011 begins on October 1, 2010 and ends on September 30, 2011. For

an eligible hospital with a cost reporting period running from July 1, 2010 through June 30,

2011, the State would employ the relevant data from the hospital's cost reporting period ending

June 30, 2010 in order to determine the EHR incentive payment amount for the hospital.

We are revising this language in the final rule at section 495.310(g)(1)(i)(B) to be clear.

Comment: Some commenters indicated that CMS should specify an alternative source of

charity care data that States may use so that Medicare and Medicaid incentive payments can be

determined appropriately. Others commented that while CMS has proposed the Medicare cost

report, Medicaid cost report data, MMIS data, hospital financial statements, and accounting

records to determine Medicaid EHR incentives, there is no absence of State-level usable data to

implement this definition.

Response: We agree that there are a number of data sources available at the State and

hospital levels that would allow States to accurately capture charity care data for the purposes of

calculating hospital EHR amounts. However, we have no vehicle for identifying which of these

tools exist in individual States or across the country. Medicare cost reports, Medicaid cost report

data, MMIS data, hospital financial statements, and accounting records are all items that we feel

confident are accessible to all States and providers. Additionally, we believe that States and their

provider communities are better versed at determining the tools that will be most beneficial for

their individual programs. As such, we included the standard items listed as auditable data
CMS-0033-F 579

sources, but did not prohibit the use of other appropriate auditable data sources. States must

describe their auditable data sources in their SMHP and submit to CMS for review and approval.

After consideration of this comment, we are making no further additions to this section of

the final rule.

Comment: One commenter asked whether the criteria for determining Medicaid eligible

days and Medicaid managed care days in the Medicaid share portion of the hospital incentive

payment calculation is the same criteria for determining Medicare DSH payments.

Response: The criteria for determining Medicaid eligible days and Medicaid managed

care days for Medicare DSH and Medicaid managed care days for EHR incentive payments are

not the same. Medicare DSH includes unpaid days, while the EHR incentive payment

calculation requires the inclusion of only paid inpatient-bed days.

After consideration of this comment, we are making no further additions to this section of

the final rule.

Comment: One commenter asked for clarification of the term "estimated" Medicaid

inpatient bed days.

Response: We are unclear about the commenter’s question. Specifically, the statute

permits the use of "estimated" days in the Medicaid share portion of the EHR hospital incentive

payment calculation. Therefore, we refer the reader to the hospital calculation at section

1903(t)(5) and section 495.310 of this rule.

After consideration of this comment, we are making no further additions to this section of

the final rule.

Comment: One commenter requested that for purposes of accurately calculating and

auditing the Medicaid Share, CMS should eliminate data provisions at 2080.18 of the State
CMS-0033-F 580

Medicaid Manual.

Response: We disagree. The provisions at 2080.18 of the State Medicaid Manual do not

adversely impact the calculation or auditing of the Medicaid Share.

We have not made any changes to the regulation related to this comment.

Comment: On commenter requested that we include as an auditable data sources, data

acquired through authorized trading partners, such as clearing houses, eligibility systems

maintained by CMS, state Medicaid programs, and/or their agents.

Response: We agree that there are a number of data sources available that would allow

States to accurately data for the purposes of calculating the Medicaid Share. However, we have

no vehicle for identifying which of these tools exist in individual States or across the country.

Medicare cost reports, Medicaid cost report data, MMIS data, hospital financial statements, and

accounting records are all items that we feel confident are accessible to all States and providers.

Additionally, we believe that States and their provider communities are better versed at

determining the tools that will be most beneficial for their individual programs. As such, we

included the standard items listed as auditable data sources, but did not prohibit the use of other

appropriate auditable data sources.

After consideration of this comment, we are making no further additions to this section of

the final rule.

Comment: One commenter asked whether the Medicaid payment is based on an

annually-calculated Medicaid Share, or is the Medicaid Share established in the base year only

and to be applied to the duration of payments.

Response: For purposes of calculating the Medicaid hospital incentive, the Medicaid

Share is established in the base year.

CMS-0033-F 581

After consideration of this comment, we are making no further additions to this section of

the final rule.

c. Alternative and Optional Early State Implementation to Make Incentive Payments for

Adopting, Implementing, or Upgrading Certified EHR Technology

Unlike Medicare, Medicaid has no statutory implementation date for making EHR

incentive payments. In our proposed rule we discussed the fact that some States might be

prepared to implement their programs and make EHR incentive payments to Medicaid providers

in 2010 for adopting, implementing, or upgrading certified EHR technology. We proposed to

allow States to initiate implementation of these payments to Medicaid EPs and hospitals after the

effective date of the final rule if they could successfully demonstrate to CMS that they are ready

to make timely and accurate payments through the SMHP. States would include an additional

attestation for providers assuring that they are not accepting payment in any other State.

We also proposed that to be approved for early implementation, a State would be

required to have an electronic system for provider registration capable of collecting the relevant

information (this information is identified in section II.A.5.c of this final rule, where we describe

the data collection requirements).

Participating States would be responsible for transmitting the required data to CMS so

that CMS could ensure that no duplicate payments were made to providers. We proposed to use

the single provider election repository described in section II.A.5.c. of this final rule to assure no

duplicative payments were made between States.

We did not propose that States would be able to make early payments to meaningful

users. Rather, our proposal was intended to offer Medicaid providers an early opportunity for

capital so that they would be more likely to have the certified EHR technology required to
CMS-0033-F 582

demonstrate meaningful use in successive periods. We stated that since hospitals may qualify

under both programs, we hoped that they would use the early capital to qualify as meaningful

users under the Medicare program in the first year.

Comment: We received comments suggesting that our proposal on early State

implementation creates unreasonable pressure on States, particularly given the status and

timeline of the ONC rule on certification criteria.

Response: We agree with commenters. We proposed this option in order for States with

very mature programs to proceed with early incentive payments for adoption, implementation,

and upgrading certified EHR technology. However, in considering the complexity associated

with States establishing an electronic registration system (which would only be temporary), as

well as the fact that very few providers (if any) will have certified EHR technology early enough

for this option, we believe that this may not be an efficient, cost-effective option for many States.

Consequently, as a result of these comments, we are removing this option. States will not

be permitted to make payments until January 2011. Additionally, we wish to reiterate that States

must have a SMHP approved by CMS before making any payments to EPs and eligible hospitals.

d. Process for Making and Receiving Medicaid Incentive Payments

The process for making payments involves coordination between Medicare and State

Medicaid agencies to avoid duplication of payments, prevent fraud and abuse, and create

program efficiencies to encourage adoption. While we have responsibility regarding payments

to Medicare EPs and eligible hospitals, State Medicaid agencies (or their contractors) are fully

responsible for administering and disbursing the incentive payments to Medicaid eligible

providers.
CMS-0033-F 583

We proposed to require that EPs make a selection between receiving incentive payments

through either the Medicare or Medicaid EHR incentive programs. Medicaid EPs who practice

in multiple States would be required to choose only one State from which to receive Medicaid

incentive payments in each payment year. (We note that readers should also refer to section

section II.A of this final rule for additional information regarding the EHR reporting period and

the single provider election repository).

As we noted in the proposed rule, the statute anticipates coordination between the

Medicare and Medicaid EHR incentive programs to ensure no duplicate payments are made to

EPs (see 1903(t) and 1848(o)(1)(D)(iii). Additionally, section 1848(o)(1)(B) of the Act requires

that Medicare incentive payments for eligible professionals begin no earlier than 2011. While

the Medicaid provisions have no statutory start date, before States may begin implementing the

Medicaid EHR incentives, CMS, and ONC need to provide further direction to States in the form

of rulemaking and other policy guidance. To that end, Medicaid will not begin to provide 100

percent FFP for incentive payments any earlier than January 1, 2011. This also gives CMS,

ONC, and States an opportunity to coordinate between Medicare and Medicaid, which will

simplify administrative complexity in the EHR incentive program and facilitate provider

adoption.

Under this final rule Medicaid EPs, as discussed in section II.D.5 and II.A.5.c, will enroll

in the program through the single provider election repository. Once an EP selects the Medicaid

EHR incentive program, States must have a system for reporting and tracking necessary

information to qualify an EP for an incentive payment. In addition, as detailed in §495.316

States are required to submit to CMS data on the number, type and practice location(s) of

providers who qualified for an incentive payment on the basis of having adopted, implemented,
CMS-0033-F 584

or upgraded certified EHR technology or who qualified for an incentive payment on the basis of

having meaningfully used such technology as well as aggregate de-identified data on meaningful

use. States' systems and processes must receive prior approval, concurrent with the requirements

described in section II.D.8 of this final rule for review and approval of the SMHP.

The specific timeframes for EPs and eligible hospitals to report and submit the required

information in order to demonstrate they have adopted, implemented, or upgraded certified EHR

technology, as well as meaningful use of such EHR technology are discussed in section II.A.1.e.

of this final rule. As discussed in that section, for the first payment year based on meaningful

use, the reporting period for eligible hospitals and EPs will be a continuous 90-day period that

both starts and ends within the payment year. As long as the period spans the 90-day continuous

period and ends within the payment year (fiscal year for hospitals, calendar year for EPs), the

reporting period can begin at any time during such payment year. States also are expected to

process payments on a rolling basis. We will issue further guidance regarding the timing

expectations needed for State systems to coordinate with CMS and make timely payments

Comment: Several commenters were concerned that Medicaid EPs and eligible hospitals

that qualify for incentive payments in their first year by adopting, implementing or upgrading

certified EHR technology are not afforded the same flexibility as Medicare EPs and eligible

hospitals in their second payment year. The commenters wrote that they would be required to

demonstrate meaningful use for the full year, rather than 90 days in their second payment year,

(even though it will be their first year demonstrating meaningful use). The commenters

recommended that Medicaid EPs and eligible hospitals be subject to a 90-day reporting period in

their second payment year when it is the first year they are demonstrating meaningful use.

Response: We agree with the commenters and as discussed in section II.A., we clarify
CMS-0033-F 585

that there is no EHR reporting period for adopting, implementing, or upgrading certified EHR

technology for Medicaid provider’s first payment year. In order to offer parity with Medicare

providers who must achieve meaningful use in the first year over a 90-day period and over 12

months in subsequent years, the same policy will apply to Medicaid providers. In other words,

Medicaid providers in their second participation year (or in their first payment year if they are

qualifying based on meaningful use) shall demonstrate meaningful use over a 90-day reporting

period and over 12-months for their third and subsequent years.

e. Avoiding Duplicate Payment

In our proposed rule, we discussed the statutory requirement at section 1903(t)(7) of the

Act that the Medicare and Medicaid programs coordinate payments to avoid duplication, and that

CMS and the States coordinate payments through a data matching process, utilizing NPIs to the

extent practicable. We also discussed section 1903(t)(2) of the Act, which states that Medicaid

EPs must waive rights to Medicare incentive payments under sections 1848(o) and 1853(l) of the

Act; hospitals, however, may qualify for incentives under both programs. We also proposed

requirements under the review and approval of SMHPs in part 495 subpart D for States to verify

that providers meet these requirements.

In section II.A of this final rule, we discuss the final requirements we are adopting in

order to avoid duplicate payments in the Medicare and Medicaid incentive programs. We also

respond to comments in that section (see section II.A.5.c. of this final rule). As discussed in that

section of the final rule, to ensure against duplicate incentive payments, we believe three

conditions are required: (1) knowing which EHR incentive program a provider has selected, (2)

uniquely identifying each provider participating in each incentive program; and (3) ensuring that
CMS-0033-F 586

each State has access to the information on which EPs or hospitals intend to receive incentive

payments from another State, or from the Medicare program.

To achieve all three of these conditions, we will collect this data in a single provider

election repository. Next, in administering each State Medicaid EHR incentive program, States

will cross-check for potential duplicative payments through the data available to them through

the single provider election repository, which is based on the NPIs. We believe that this

coordinates with our requirements that a State must have an approved SMHP that will include a

mechanism for cross-checking this information prior to payment.

f. Flexibility for EPs to Alternate Between Medicare and Medicaid EHR Incentive Programs

One Time

We refer readers to section II.A.5.b of this final rule, which discusses rules that would

allow Medicare and Medicaid EPs to make one EHR incentive program election change prior to

the 2015 payment year, and not to permit any switching after the 2014 payment year. Under

such a proposal, even if an EP initially received incentive payments under the Medicare program,

such an EP could still switch to the Medicaid program one time prior to 2015 (assuming the

professional meets all eligibility criteria for the Medicaid incentives program). Similarly, an EP

who initially selected the Medicaid EHR incentive program could switch to the Medicare

program one time prior to 2015. (In other words, the last payment year an EP could switch

would be the 2014 payment year.)

Comments received on these policies are addressed in section II.A.5.b. of this final rule.

g. One State Selection

In the proposed rule, we proposed that EPs and hospitals with multi-State Medicaid

practice locations annually pick only one State from which to receive incentive payments. In
CMS-0033-F 587

other words, a provider would not be able to receive incentive payments from more than one

State in the same year. Medicaid EPs and hospitals could annually change the State they select

when they re-attest to program requirements.

We considered the possible impact of this proposed approach with respect to patient

volume calculations on Medicaid EPs and hospitals in border State areas, stating that because the

Medicaid incentive payment for EPs will remain the same – regardless of whether they receive

payment from one State or from multiple States – we did not think the administrative complexity

associated with dividing and administering payments between or among more than one State

could be justified. We recommended, however, that States consider border State providers when

developing their policies on patient volume and the attestation methodology. We afforded

additional flexibility in the patient volume at proposed §495.306 to account for unique

circumstances and data collection.

Comment: Providers inquired whether it is permissible for an EP who practices in more

than one State to aggregate patient encounters in order to achieve the 30 percent Medicaid

patient volume criteria.

Response: First, it is not clear that aggregating patient volume across States will be an

issue once EPs actually begin tallying up patient volume. Patient volume is calculated as a

percentage, and not an absolute number. Thus, it does not appear that, but for aggregating

patient volume across multiple States, an EP would not be able to qualify for incentive payments

in any State. For example, if an EP has 10 percent patient volume in one State (10 of 100

encounters are Medicaid) and 20 percent patient volume in a second State (20 of 100 encounters

are Medicaid), this does not add up to 30 percent patient volume (but, rather, results in a 15

percent patient volume as a result of dividing 30 by 200). To restate, we do not believe that an
CMS-0033-F 588

EP will need to sum patient encounters across multiple States in order to reach the 30 percent

patient volume – as in order to reach this patient volume threshold, the EP would likely meet the

30 percent in at least one State. Indeed, it appears that the only benefit of aggregating patient

volume across States would be to permit an EP who has more than a 30 percent patient volume

in one State to receive incentive payments from another State in which s/he does not meet the 30

percent threshold.

Nevertheless, we recommend that States consider the circumstances of border State

providers when developing their policies and attestation methodologies. To afford States

maximum flexibility to develop such policies, we will not be prescriptive about whether a State

may allow a Medicaid EP to aggregate his/her patients across practice sites, if the State has a

way to verify the patient volume attestation when necessary. States will propose their policies

and attestation methodologies to CMS for approval in their State Medicaid HIT plans.

We are making no additional revisions to this section of the rule as a result of this

comment.

5. Single Provider Election Repository and State Data Collection

We refer readers to section II.A.5.c of this final rule for a discussion of the single

provider election repository and the comments received on this policy. As discussed in that

section, the repository will collect a minimum amount of information on all EPs and hospitals to

prevent duplicative payments and coordinate technical assistance.

6. Collection of Information Related to the Eligible Professional's National Provider Identifier

and the Tax Identification Number

In our proposed rule, we proposed that EPs in multiple group practices or multiple types

of practice locations would be required to select one TIN for Medicaid EHR payment
CMS-0033-F 589

disbursement. In other words, such EPs would not be permitted to require a State to divide

payments among different practices or practice locations based upon group TINs. We explained

that requiring EPs to use only one TIN would reduce administrative complexity, as it would

ensure that States are not put in the position of dividing payments in any way an EP requests

(such as by patient encounters or amount contributed to EHR technology). We also stated that

requiring reimbursement to be made to one TIN would reduce opportunities for fraud or abuse,

as States would be able to cross-check EP and TIN combinations more easily to verify EP

attestations.

We also stated that although the State would not divide payments among the various

TINs of an individual EP, Medicaid EPs could, themselves, decide to divide payment. These

EPs could independently distribute funds among their respective group practices or practice

locations after the initial disbursement from the State to their designated TIN.

Comment: We received comments suggesting that EPs should be allowed to proportion

their payments and give multiple TINs.

Response: For these reasons advanced in the proposed rule, we believe that permitting

an EP to divide the incentive payment among multiple TINs would introduce an unnecessary

level of administrative complexity into this temporary program. It also could increase the

opportunities for fraud and abuse as it would be more administratively cumbersome for States to

track multiple payments (to ensure correct payments) and to track and verify multiple eligibility-

related EP attestations. Once a payment is disbursed from the State, nothing precludes the EP

from further disbursing the incentive payment, subject to the applicable fraud, waste, and abuse

laws, regulations, and rules.

CMS-0033-F 590

After consideration of the public comments received, we are finalizing these provisions

as proposed.

7. Activities Required to Receive Incentive Payments

a. General Overview

As we discussed in our proposed rule, to qualify to receive a first year Medicaid incentive

payment, section 1903(t)(6)(C)(i) of the Act indicates that EPs and eligible hospitals must

demonstrate that they are “engaged in efforts to adopt, implement, or upgrade certified EHR

technology.” For providers who meet this standard in their first year of participation in the

Medicaid incentive program, in subsequent years of participation, they must then demonstrate

“meaningful use of certified EHR technology through a means that is approved by the State and

acceptable to the Secretary,” and that may be based upon the methods employed under the

Medicare incentive payments to physicians and hospitals, per sections 1848(o) or 1886(n) of the

Act.

b. Definitions Related to Certified EHR Technology and Adopting, Implementing or Upgrading

Such Technology

(1) Certified EHR Technology

As noted previously, in order to receive a Medicaid incentive payment the EHR

technology must be “certified.” Section 1903(t)(3) of the Act defines “certified EHR

technology” as “a qualified electronic health record (as defined in section 3000(13) of the Public

Health Service Act) that is certified pursuant to section 3001(c)(5) of such Act as meeting

standards adopted under section 3004 of such Act that are applicable to the type of record

involved (as determined by the Secretary), such as an ambulatory electronic health record for

office-based physicians or an inpatient hospital electronic health record for hospitals).” In

CMS-0033-F 591

section II.A of this final rule, for both Medicare and Medicaid, we discussed incorporating

ONC's definition of certified EHR technology.

(2) Adopting, Implementing or Upgrading

Unlike the Medicare incentive programs, the Medicaid program allows eligible providers

to receive an incentive payment even before they have begun to meaningfully use certified EHR

technology. These providers may receive a first year of payment if they are engaged in efforts to

“adopt, implement, or upgrade” certified EHR technology. In proposed §495.302, we define

adopting, implementing or upgrading certified EHR technology as the process by which

providers have installed and commenced utilization of certified EHR technology capable of

meeting meaningful use requirements; or expanded the available functionality and commenced

utilization of certified EHR technology capable of meeting meaningful use requirements at the

practice site, including staffing, maintenance, and training.

For the purposes of demonstrating that providers adopted, implemented, or upgraded

certified EHR technology, we proposed that Medicaid EPs and hospitals would have to attest to

having adopted, (that is, acquired and installed) or commenced utilization of (that is,

implemented) certified EHR technology; or expanded (that is, upgraded) the available

functionality of certified EHR technology and commenced utilization at their practice site. We

proposed that States would be responsible for ensuring that processes are in place to verify that

providers have actually adopted, implemented or upgraded certified EHR technology, patient

volume, as well as other requirements in this section, including verifying that attestations are

consistent with methodologies to combat fraud and abuse (see proposed §495.366 through 370,

Financial Oversight, Program Integrity, and Provider Appeals). We proposed that the State's

SMHP would detail these processes.

CMS-0033-F 592

The CMS Medicaid Transformation Grants demonstrated the many challenges that exist

to adopting EHR technology. EHR system availability is not the same as EHR system

utilization. It is for that reason that we proposed to include staff training and efforts to redesign

provider workflow under the definition of implementing certified EHR technology. We

explained that success is not simply defined by the acquisition and installation of new or

upgraded certified EHR technology, but more importantly by providers demonstrating progress

towards the integration of EHRs into their routine health care practices to improve patient safety,

care, and outcomes.

In establishing criteria for the “adoption” portion of the “adopt, implement, or upgrade”

requirement, we proposed that there be evidence that a provider demonstrated actual installation

prior to the incentive, rather than “efforts” to install. We stated that this evidence would serve to

differentiate between activities that may not result in installation (for example, researching EHRs

or interviewing EHR vendors) and actual purchase/acquisition or installation. As Medicaid

incentive payments are intended to stimulate meaningful use of EHR technology, we stated our

belief that the payments need to result in tangible adoption, implementation, or upgrading of

certified EHR technology. We stated that States would be responsible for verifying this evidence

of EHR adoption.

In establishing criteria for the “implementation” portion of “adopt, implement or

upgrade” requirement, we proposed that “implementation” mean that the provider has installed

certified EHR technology and has started using the certified EHR technology in his or her

clinical practice. Implementation activities would include staff training in the certified EHR

technology, the data entry of their patients' demographic and administrative data into the EHR,
CMS-0033-F 593

or establishing data exchange agreements and relationships between the provider's certified EHR

technology and other providers, such as laboratories, pharmacies, or HIEs.

In establishing the criteria for the “upgrade” portion of “adopt, implement or upgrade”

requirement, we proposed “upgrade” to mean the expansion of the functionality of the certified

EHR technology, such as the addition of clinical decision support, e-prescribing functionality,

CPOE or other enhancements that facilitate the meaningful use of certified EHR technology. We

proposed that States describe in their SMHPs the process that would be in place for ensuring that

providers have actually adopted, upgraded or implemented certified EHR technology. We

encourage States to consider the submission of a vendor contract from providers to ensure the

existence of EHR technology.

Comment: Several commenters recommended that CMS clarify if “upgrade” does or

does not apply to an already certified EHR. They recommended that CMS confirm that an

upgrade is intended to enable a provider to expand existing functionality of an EHR so that it

meets the new certification criteria.

Response: To clarify this question, an example of upgrading that would qualify for the

EHR incentive payment would be upgrading from an existing EHR to a newer version that is

certified per the EHR certification criteria promulgated by ONC related to meaningful use.

Upgrading may also mean expanding the functionality of an EHR in order to render it certifiable

per the ONC EHR certification criteria.

We are making no additional revisions to this section of the final rule as a result of this

comment.

Comment: Commenters wrote that given that adopt/implement/upgrade (AIU) involves

significant practice workflow redesign and that the States’ overarching goal is to increase the
CMS-0033-F 594

level of provider participation, the commenters recommended that CMS require only AIU for

participation Year 1 and Year 2. They further recommended that CMS allow AIU compliance to

be further defined as the provider developing, submitting, and following a customized plan for

the necessary workflow changes with timelines (whose development can be assisted by the

Regional Extension Centers); the provider would have to meet their timelines for each year in

Stage 1 to qualify for the incentive payment; and the AIU plan timelines would have to be

structured so submission of HIT and clinical quality measures would begin in Stage 2.

Response: The statute at section 1903(t)(6)(C) permits Medicaid providers to receive the

EHR incentives for adopting, implementing or upgrading to certified EHR technology in their

first participation year. A provider's first participation year may be any year between 2011

through 2016. In their State Medicaid HIT Plans, States will propose to CMS how they will audit

and oversee Medicaid providers’ adoption, implementation or upgrading to certified EHR

technology. States should propose further details to CMS about how they will verify that

providers have met this requirement.

After consideration of the comments received, we do not believe that just the

development and submission of an implementation plan for EHR adoption is a significant

enough commitment to warrant the AIU incentive payment. There is nothing binding, nor is

there any financial contribution towards such a plan.

We are making no additional revisions to this section of the final rule as a result of this

comment.

Comment: Many commenters suggested that they believe the goal of this incentive is to

help defray some of the costs of adopting, implementing, and upgrading to certified EHR

technology. As such, the commenters believe “proof” of AIU should not require completion of
CMS-0033-F 595

AIU but demonstrated commitment to AIU. For example, a proof of purchase, a schedule for

training and implementation, and periodic reporting from practices on progress on the schedule

could suffice. The commenters requested that States have flexibility to define what is sufficient

to trigger payment.

Response: States should provide details to CMS on how they will audit and oversee

Medicaid providers’ adoption, implementation or upgrading to certified EHR technology in their

SMHP. States' SMHP should include further details about how they will verify that providers

have met this requirement. However, while States may propose how they will determine what

AIU activities are sufficient for the EHR incentive payment; CMS must approve their proposals

via the SMHP. The definitions included in this final regulation by CMS for adopt, implement or

upgrade do imply completion of at least one of the three tasks. A proof of purchase or signed

contract would likely be an acceptable indicator of EHR adoption per the States. Implementation

is on-going, therefore working actively with Regional Health IT Extension Centers on

implementation, completion of specific benchmarks or other activities towards implementation

would be acceptable.

We are making no additional revisions to this section of the final rule as a result of this

comment.

Comment: A commenter recommended that State Medicaid agencies provide eligible

hospitals with the maximum incentive payments for their first two payment years as a limited

source of capital for AIU.

Response: The Medicaid hospital calculation was part of the HITECH statute and not

defined by CMS. Eligible Medicaid hospitals can receive their first year’s payment for AIU and

not meaningful use, but must meet the meaningful use requirement in their second and
CMS-0033-F 596

subsequent participation years.

We are making no additional revisions to this section of the final rule as a result of this

comment.

Comment: A commenter recommended that a Medicaid provider be permitted to qualify

for their first year Medicaid EHR incentive even if they have not actually installed certified EHR

technology but have spent or are committed to spend an amount equal to at least the lesser of

$50,000 or 5 percent of the Medicaid EHR incentive amount.

Response: In consideration of the comments, we are clarifying that the final definition of

adopt, implement or upgrade is inclusive of providers’ acquisition, such as a purchase, of a

certified EHR. Providers will be responsible for providing documentation which substantiates

AIU as required by the State Medicaid Agency.

We are revising the definition of adopt, implement, and upgrade as a result of this

comments, see section 495.302.

c. Other General Terminology

In our proposed rule, we proposed definitions for “EHR reporting period” and “payment

period,” stating that these definitions relate to the requirements for Medicaid EPs participating in

the Medicaid EHR incentive program. As discussed previously, the reporting period is

significant for EPs and eligible hospitals because it will define the period during which the

provider must demonstrate meaningful use of certified EHR technology. The reporting period

also is significant for States, because States will refer to such reporting periods in assuring us

that providers are eligible to participate in the Medicaid EHR incentive program. (Requirements

relating to the components that must be included in the SMHP were specified in proposed

§495.332). In the proposed rule, we specified that States would need to refer to the providers'
CMS-0033-F 597

reports of the activities that establish their efforts to adopt, implement, or upgrade certified EHR

technology. Similarly, once meaningful use of EHR technology is required, States would need

to refer to providers’ reports on meaningful use, including reporting of clinical quality measures

(see section II.A. of this final rule for requirements for clinical quality measures), in accordance

with the appropriate EHR reporting period. States could not appropriately make incentive

payments in the absence of such reporting.

We proposed that States would be required to validate to us that the Medicaid EPs and

hospitals meet all of the eligibility criteria to qualify for Medicaid incentive payments, including

the applicable patient volume thresholds, hospital-based requirements, and all other

requirements. States would develop their own administration, payment and audit processes, and

as described in §495.332, we would require that States include in their SMHPs how they would

obtain Medicaid EPs' and hospitals' attestations of eligibility to qualify for the Medicaid

incentive payments. We proposed that permissible means for ensuring patient volume and all of

the requirements described in this section would include survey, attestation, or the creation of

special codes on claims, subject to our prior approval.

Section 1903(t)(6)(C)(ii) of the Act also indicates that in the case of an early adopter,

that is, a Medicaid EP or eligible hospital that has already adopted certified EHR technology,

such provider would receive payment in the first year and all subsequent years of the incentive

program by demonstrating meaningful use.

In our proposed rule, we discussed our expectation that the bar for demonstrating

meaningful use of certified EHR technology will rise in years to come. In this final rule,

meaningful use and its evolving criteria are discussed in section II.A. In order to receive

Medicaid incentive payments, providers will be required to demonstrate (and States will be
CMS-0033-F 598

required to track and validate) meaningful use, as described in section II.A.2. of this final rule.

In section II.D.8 of this final rule, we also discuss our policies regarding States’ ability to require

additional objectives in the demonstration of “meaningful use,” or otherwise add to the Federal

definition of meaningful use. We also discuss the requirement that States receive prior approval

of any such additions.

As we discussed in the proposed rule, we believe that States should carefully consider

how to build upon their existing EHR activities and infrastructure without deterring eligible

Medicaid providers from participating by compelling them to use a particular system. We

encourage States that were awarded Federal HIT/EHR grants, such as the Medicaid

Transformation Grants, to the extent practicable, to connect the tools and infrastructure

developed under their Federal grant funds with providers' efforts to adopt, implement, and

upgrade certified EHR technology and to become meaningful users of certified EHR

technology. We will be evaluating States' HIT Planning Advanced Planning Documents

(PAPDs) and SMHPs with this objective in mind, as described section II.D.8 of this final rule.

As we discussed in the proposed rule, States’ system requirements for monitoring

meaningful use must include the capacity to determine the appropriate stage of meaningful use

and the appropriate incentive payment amount, depending upon the providers’ payment year. In

other words, regardless of the calendar year, a provider's first year as a participant in the

Medicaid EHR incentive program is when that provider must demonstrate either adoption,

implementation, upgrading or meaningful use of certified EHR technology. States' systems must

be able to track a provider’s year of entry into the Medicaid EHR incentive program to determine

the correct eligibility criteria and generate the appropriate Medicaid incentive payments.
CMS-0033-F 599

Once States are giving providers the Medicaid EHR incentive payments for being

meaningful users of EHRs, and in 2012 begin receiving clinical quality measures data from those

providers, we proposed that States would be required to share any such reported data with CMS

in an aggregated, de-identified manner, on an annual basis. The timetable and format for sharing

the clinical quality measurement data would be provided to States in future policy guidance

issued by CMS. States' failure to submit these required reports to us could result in discontinued

funding or disallowances. See the discussion below regarding the SMHP and the State reporting

requirements. We would use the States' reports, including data on meaningful use and clinical

quality measures, in order for the Secretary to fulfill her responsibilities to Congress under

section 1903(t)(10) of the Act. This provision requires that the Secretary report to Congress on

the improvement of health outcomes, clinical quality, or efficiency as a result of implementing

this program. For hospitals eligible for both the Medicare and Medicaid EHR incentive

programs, we proposed that we would use the meaningful use measures hospitals report to us to

make quality data on Medicaid eligible hospitals available to States.

Comment: Commenters requested clarification on the reporting period for adopting,

implementing ,and upgrading, and whether this period is similar to the 90-day period for

demonstrating meaningful use in the first year.

Response: As discussed earlier, we are clarifying that there is a no reporting period for

AIU for the providers’ first participation year. However, there is a 90-day reporting period for

the first participation year in which Medicaid providers qualify by demonstrating meaningful

use. The rationale is that we understand that not all AIU activities require 90 days, such as EHR

acquisition. States will determine how they plan to implement this requirement.

As a result of this comment and a similar comment above, we are revising section 495.4
CMS-0033-F 600

to indicate that there is no EHR reporting period for adopting, implementing, or upgrading in

Medicaid providers’ first participation year, if they qualify based on AIU, and there is a 90-day

reporting period for both the first year that a Medicaid provider demonstrates MU (regardless of

whether they demonstrated AIU in their first participation year or are qualifying based on MU in

their first participation year).

Comment: Several commenters requested that CMS clarify the process that will assure

Medicaid access to Medicare meaningful use data, at a minimum for (1) hospitals who receive

both Medicaid and Medicare payments and (2) eligible providers that may switch once between

the Medicaid and Medicare incentive programs. Commenters requested that CMS provide States

with Medicare quality reporting/data in a timely fashion (for example, within 30 days of receipt

of such information). Alternatively, commenters suggested that the providers could be required

to report separately to both Medicare and Medicaid.

Response: We are finalizing our policy as proposed. We believe that it would represent

an undue burden on hospitals eligible for both EHR incentive payments to report their data to

both CMS and the States. We will issue further guidance about how States will be able to access

the meaningful use data submitted to CMS by hospitals eligible for both Medicare and Medicaid

EHR incentive payments in order for the State to meet its audit and oversight requirements. It is

not clear to CMS why a State would require access from CMS to an eligible professional's

meaningful use data if they were a Medicare EHR Incentive Program participant in the prior

year. States can only base a Medicaid provider's EHR incentive payment, as it pertains to

meaningful use, on the current participation year's EHR reporting period.

We are making no additional revisions to our regulations as a result of this comment.

CMS-0033-F 601

Other than the changes explained above, we are finalizing the remainder of our proposed

policies as they were proposed.

d. Quality Measures

We refer readers to section II.A.3 of this final rule for a discussion of the clinical quality

measure reporting required for demonstrating meaningful use of certified EHR technology. As

discussed previously, we intend to update our definition of meaningful use biennially, and we

expect that our updated, Stage 2 definition would include additional Medicaid clinical quality

measures to be reported from EHRs. We intend to work with the quality measurement

community to develop these Stage 2 quality measures (see section II.B.1.d. of this final rule).

Comment: Several commenters believe that the current clinical measures do not reflect

key clinical services and issues for the Medicaid population, including behavioral health, dental,

long-term care, and care coordination (particularly across physical and behavioral health care).

The commenters recommend that CMS work with the Medicaid Medical Directors and

ONC and consider the development and inclusion of clinical and non-clinical quality measures

that are more representative of the Medicaid population. Alternatively they wrote that CMS and

ONC should have a “placeholder” to accommodate data and interoperability for these measures.

Commenters wrote that the areas with gaps are behavioral health, dental care, long-term care,

special needs populations and care coordination, particularly across physical and behavioral

health. The commenters recommended that new clinical quality measures be added as

“placeholders” for care provided by non-eligible, but critical Medicaid providers, such as

Community Mental Health Centers, Home Health, and Renal Dialysis Centers.

Many commenters noted that with regard to pediatric clinical quality measures, they

recommend that first-year measures focus on immunizations, diabetes, asthma, autism, and lead
CMS-0033-F 602

screening. They also recommend measures to introduce in 2012 and beyond to include smoking,

obesity, disease- or condition-specific measures, and measures aimed at reducing disparities.

They further recommended measures to introduce in 2013 and beyond include the development

of clinical quality measures on psychology, child abuse, developmental delays, and efficiency

measures.

Response: We agree that these measures (listed directly above) have clinical relevance

for providers. However we are aligning with the Medicare Stage 1 meaningful use provisions

regarding publication and opportunity for public comment on quality measures before they are

finalized. We are not including additional meaningful use objectives and measures that were not

discussed in the proposed rule.

Comment: Several commenters believed that the quality measures proposed in the

interim rule do not match the quality measures that HRSA currently requires FQHCs to report.

The commenters would like to work with CMS and HRSA to move forward and harmonize the

quality measures by 2013 but requested that until quality measures are harmonized across the

federal government system, FQHCs and the EPs who qualify and assign their Medicaid incentive

payments to the FQHC should be allowed to report on the current HRSA measures.

Response: Meaningful use applies to each individual EP. Therefore the HRSA quality

measures, which are facility-based, not necessarily NQF-endorsed, or reportable from EHRs are

not an acceptable alternative for EPs who practice at an FQHC. Furthermore, as explained in

section II.A. of this final rule, we are not including in the final rule quality measures that were

not included in the proposed rule. To ensure uniformity across both programs, we have adopted

this same policy for Medicaid. We believe it is important to offer Medicaid providers and

stakeholders the same opportunity for public comment on quality measures.

CMS-0033-F 603

We agree with the goal of harmonizing quality measure reporting across Federal

programs and will engage with stakeholders and experts to address this priority as part of the

development of the Stage 2 definition of meaningful use.

We are finalizing these provisions as proposed and we will continue to work to identify,

and develop electronic specifications for additional clinical quality measures that address current

gaps, such as long-term care, behavioral health, pediatrics and oral health for Stage 2 of

meaningful use. In particular, we recognize the lack of endorsed oral health clinical quality

measures, with identified and tested electronic specifications. This poses a challenge for

dentists, who are eligible professionals for the Medicaid EHR incentives, to demonstrate

meaningful use, other than with the general, profession-neutral measures.

While an eligible professional can report "zero" for the denominator of any measure for

which s/he does not have any relevant patients, we will work to include in Stage 2 of meaningful

use, clinical quality measures that would provide useful data to CMS and States on oral health

care as reported by EHRs.

In addition, in order to minimize provider burden, and to maximize measure reporting

efforts and resources, we seek to align the quality measures for the Stage 2 definition of

meaningful use with other quality measures development and reporting related to health care

reform and other CMS quality measures programs, as appropriate and feasible. Stage 1 of

meaningful use is limited to objectives and measures that are already in existence, not those still

under development. Measures will be included that have operational relevance to the care

provided to Medicaid and CHIP beneficiaries by eligible professionals and hospitals defined in

the HITECH Act.

CMS-0033-F 604

8. Overview of Conditions for States to Receive Federal Financial Participation (FFP) for

Incentive Payments and Implementation Funding

Section 1903(a)(3)(F) of the Act provides that States are eligible for 100 percent FFP for

direct payment expenditures to certain Medicaid EPs and eligible hospitals to encourage the

adoption and use of certified EHR technology. States are also eligible for 90 percent FFP for

reasonable administrative expenses, contingent on State compliance with the following

requirements: (1) using the funds to administer Medicaid incentive payments for certified EHR

technology, including tracking of meaningful use by Medicaid EPs and eligible hospitals; (2)

conducting oversight of the Medicaid EHR incentive program, including routine tracking of

meaningful use attestations and reporting mechanisms; and (3) pursuing initiatives to encourage

the adoption of certified EHR technology for the promotion of health care quality and the

exchange of health care information. (See 1903(t)(9) of the Act.)

This section of the final rule discusses the requirements for States to request FFP from

CMS for the Medicaid EHR incentive program. Additionally, this section is closely connected to

the requirements outlined in Financial Oversight, Program Integrity and Providers Appeals for

purposes of oversight and accountability.

In proposed §495.302, we defined terms used in the Medicaid subpart of the regulations

governing State requests for FFP. Although some of these terms have been defined in other

portions of our regulations, for ease of reference, and in order to define the terms in this specific

context, we proposed to separately include definitions in part 495.

We proposed to include in our regulations the requirements that in order to qualify to

receive FFP for administering the incentive program, States must develop a SMHP, an HIT

Planning APD (PAPD), and an HIT Implementation APD (IAPD). These documents lay out the
CMS-0033-F 605

process used by States to implement and oversee the EHR incentive program, and will help

States to construct an HIT roadmap to develop the systems necessary to support eligible

providers in their adoption and meaningful use of certified EHR technology. The development

of a SMHP (see also §495.332) provides States with the opportunity to analyze and plan for how

EHR technology, over time, can be used to enhance quality and health care outcomes, while

reducing overall health care costs. The uses of EHR technology can be integrated with existing

State resources to achieve these goals.

We provided guidance in a State Medicaid Director's (SMD) letter on September 1, 2009,

on this process and the State efforts necessary to receive the 90 percent FFP for planning-related

expenditures. As stated in that letter, and as further required through this rulemaking, our review

process ensures that States are complying with requirements of the HITECH Act, and that they

demonstrate to the “satisfaction of the Secretary” that they are using the funds in the manner

anticipated by the law. For example, because of our oversight responsibilities, simply proposing

activities would not ensure the 90 percent FFP. As explained in the letter, and as further

reflected in this rulemaking, we must review and prior approve all elements of the State's SMHP,

and APD documents, and work with States to determine the appropriate level and type of FFP.

States are required to submit these advance planning documents in order for us to

approve receipt of the 90 percent Federal match. Specifically, prior approval is required for the

HIT PAPD (see also §495.336). The deliverable resulting from the HIT PAPD is the SMHP.

The SMHP must be reviewed and approved before it is included in an IAPD (see also

§495.338). The IAPD also must be prior approved. Until approval is granted States cannot draw

down funds.
CMS-0033-F 606

For purposes of the Medicaid EHR incentive program, we believe there are two high-

level phases in the process of planning and implementing the incentive program, as well as the

promoting the adoption of EHR. Phase I includes initial planning, including an assessment of

the State EHR environmental landscape, and development of the SMHP. As explained in our

September 1, 2009 letter, the vehicle for informing us of Phase I activities is the HIT PAPD, and

indeed, over 40 States have already submitted their PAPDs and have received funding to begin

Phase I activities. Phase II then involves further development and full implementation of the

SMHP. Consequently, the HIT IAPD is the vehicle for reporting of Phase II activities. As

discussed in the SMD letter, and as further reflected in this final rule, States need to receive prior

approval of their planning documents. In fact, we have already worked closely with the majority

of States in developing their HIT PAPDs, prior to them initiating their EHR planning activities,

and we expect this close coordination to continue between the States and CMS.

Also, as proposed, in this final rule we will require States to obtain prior written approval

of funding, planning documents, proposed budgets, project schedules, and certain

implementation activities that a State may wish to pursue in support of the Medicaid EHR

incentive program to encourage the adoption and use of certified EHR technology in line with

the 90 percent FFP available to States. To minimize the burden on States, we designed the prior

approval conditions, and the prior approval process, to mirror what is presently used in support

of acquiring automated data processing equipment and services in conjunction with development

and operation of State MMIS (the State's automated mechanized claims processing and

information retrieval system approved by CMS).

As proposed, this final rule (at 495.348) will require State Medicaid programs to comply

with current procurement standards. Specifically, at 495.348 we have included language that
CMS-0033-F 607

accords with the procurement requirements in 45 CFR 95 Subpart F and incorporates many of

the procurement standards previously contained in 42 CFR Part 74. Inclusion of these

procurement requirements maintains the long-standing procurement standards and policies for

State information technology contracts. Under these standards the State must ensure that when

procuring HIT equipment and/or services, there is maximum practical open and free

competition, and that any procured materials or services are obtained in a cost-effective manner.

The regulations also make clear that the State, as the grantee, is responsible for meeting its

contractual responsibilities under any of its procurements, and will not have recourse to the

Federal government to settle or satisfy its contractual and administrative issues. Further, States

must have written standards of conduct regarding the performance of its employees that are

engaged in the award and administration of the HIT equipment/services contracts (including

conflict of interest rules contained in 495.348(c)). States must have written procurement

procedures that accord with 495.348(e) and a system for administering contracts in accordance

with 495.348(f). Procurement contracts must meet the additional requirements contained in

495.348(g) as well as describe the conditions under which the contract may be terminated for

default or because of circumstances beyond the control of the contractor (see 495.348(h)).

Procurement contracts must include provisions allowing State and Federal access to the

materials and staff of the contractor, in accordance with 495.348(i).

As was proposed, our final regulations at 495.346 also will require the State agency to

allow the Department access to all records and systems operated by the State in support of the

program. Final regulations at 495.352 impose reporting requirements on States to submit to the

Department, on a quarterly basis, a progress report documenting specific implementation and

oversight activities performed during the quarter. Regulations at 495.354 through 495.360
CMS-0033-F 608

contain rules for charging equipment, non-discrimination requirements, requirements for cost

allocation plans, and requirements for ownership rights in software. Our rules would require

termination of FFP in the case of States failing to provide access to information relating to any

of the requirements we have included in this subpart. We believe the procurement and other

rules discussed above are authorized under section 1902(a)(4) of the Act, as well as under

section 1903(t)(9) of the Act requiring a State to conduct adequate oversight of its program, and

use its funds to administer the incentive payments. In addition, any reporting and other

requirements will assist us in submitting the reports that are required under section 1903(t)(10)

of the Act, which requires us to monitor and report on the progress of implementation of the

EHR provisions.

As proposed, State Medicaid agencies will be required to attest, as required by section

1903(t)(6)(A)(i) of the Act, that States make Medicaid incentive payments to a Medicaid EP or

eligible hospital directly (or to an employer or facility to which such Medicaid EP or eligible

hospital has assigned their Medicaid incentive payments) without any deduction or rebate. States

must also attest that payments to an entity promoting the adoption of certified EHR technology,

as designated by the State, will only be made if participation in such a payment arrangement is

voluntary for the Medicaid EP involved, and if such entity does not retain more than 5 percent of

such assigned Medicaid incentive payments for costs not related to such technology. (See

495.332 of our final rules). States are required to attest that the entire incentive payment has

been forwarded to the eligible Medicaid provider, and that no Medicaid eligible professional or

hospital is required to return any portion of the incentive payment to the State Medicaid agency.

States must establish a process to ensure that any existing fiscal relationships with eligible

professionals or hospitals to disburse the Medicaid incentive payments through Medicaid

CMS-0033-F 609

managed care plans does not result in payments that exceed 105 percent of the capitation rate, in

order to comply with the Medicaid managed care incentive payment rules at §438.6(c)(5)(iii) and

a methodology for verifying such information.

Additionally, we are requiring that termination of funding approved under this proposed

Part 495 subpart D or disallowance of FFP may result if the State fails to meet the requirements

and undertakings of the approved PAPD, SMHP, and IAPD, or fails to provide access to the

required information.

Since section 4201 of the HITECH Act amends section 1903(a)(3) of the Act to provide

for 90 percent FFP for costs associated with certain administrative activities performed by a

State, we have allowed for claiming of such reasonable costs incurred on or after

February 18, 2009, prior to publication of the final rule. Specifically, a State that can show that

initial planning stages of moving the State in the direction of meaningful use of certified EHR

technology through such activities as training efforts, staff support, or contracting with a vendor

may potentially receive retroactive FFP back to the date in which these efforts began, with CMS

approval, but not before February 18, 2009.

Comment: Several commenters expressed concerns about the timing of planning and

implementation and request flexibility in this area. Commenters indicated that there will be a

need for ongoing planning while rules and guidelines are being promulgated. Commenters

indicated that they envision a phased approach to implementation, and request that CMS permit

simultaneous expenditure of both planning and implementation funds.

Response: We proposed specific requirements for States to request FFP from CMS for

the Medicaid EHR incentive program modeled on the process States use to request FFP from

CMS for Medicaid Management Information Systems technology projects. CMS proposed to
CMS-0033-F 610

utilize information and documentation that will result from the process described in this section

to evaluate approaches proposed by States, track and monitor progress of implementation, and

perform the statutory program and financial oversight required for this new program.

In establishing the requirements we believe States will have flexibility to request FFP for

planning and implementation activities to implement the provisions of the EHR incentive

program in a manner that is similar to and consistent with current approaches to receive

enhanced FFP for MMIS systems under the Medicaid program. This will enable States to

modify or adapt as changes occur during the planning and implementation phases envisioned

under this proposed rule. Further, we believe that the information required is consistent with

section 1903(t)(9) of the Act that States must demonstrate to the satisfaction of the Secretary that

the State is conducting adequate oversight.

We agree with the need for flexibility in planning for the Medicaid incentive program,

and the conduct of implementation activities to ensure the program is successful in the long-

term. We have added additional clarifying information in the sections regarding the HIT PAPD,

HIT IAPD, As-needed HIT PAPD update and as-needed HIT IAPD update, Annual HIT IAPD

requirements, and SMHP requirements. These clarifications are consistent with guidance issued

in our State Medicaid Director’s letter on September 1, 2009, which indicated that CMS

anticipates a phased approach to planning and implementation activities.

Finally, for the final rule we are making numerous changes in order to be more specific

and provide additional clarity regarding certain terms and requirements. These revisions are

reflected here; however, regulations text is not updated since the concepts of these terms remain

the same. Clarifications are as follows:

We have further defined the terms “service oriented architecture (SOA)", or "service
CMS-0033-F 611

component based architecture" to indicate that they are a means of organizing and developing

information technology capabilities as collaborating services that interact with each other based

on open standards. We are defining this term in the context of health IT projects authorized

under the Act to ensure that different systems and programming languages provide a basis for

interoperability among and between applications that may reside on different platforms through a

communication protocol to achieve health information exchange required under the Act. CMS

anticipates that States will describe proposed HIT projects in the context of SOA principles, and

intends to evaluate plans for health information exchange, and interoperable health IT based on

these commonly used information technology principles.

We have also further defined the term "State self-assessment (SS-A)," a component of

MITA, as a process that a State will use to review its Medicaid information technology strategic

goals and objectives, measure its current baseline business processes and capabilities against

defined MITA business capabilities, and develop targeted future capabilities to transform the

Medicaid enterprise to be consistent with the MITA principles of interoperability and exchange

of health information. Although we are including a definition of State self assessment in this

final rule, we are deleting the requirement that a State provide the MITA SS-A, as we believe the

as-is assessment supercedes the need for a separate MITA SS-A. . However, we believe it is

important to keep a definition of SS-A, because there is an inter-connection between activities

accomplished under the Medicaid EHR Incentive Program and States’ MMIS enhancements. For

example, data exchanges between various State systems that comprise the Medicaid enterprise of

the State might also support the State’s administration of the EHR Incentive Program

We are further defining MITA, because we expect that States will describe proposed

health IT projects as well as their “as is” landscapes using MITA concepts and principles. We
CMS-0033-F 612

intend to evaluate States’ proposed strategies and plans for development of Medicaid health

information exchange and interoperable health IT using these MITA principles, as applicable.

These strategies and plans must be included in the State Medicaid Health Information

Technology Plan (SMHP), a term discussed below. We have previously published a document

entitled “MITA Framework 2.0” on the CMS web site at

http://www.cms.hhs.gov/MedicaidInfoTechArch. The MITA Framework 2.0 was developed by

CMS in collaboration with State Medicaid agencies and information technology vendors to

facilitate the adoption of information technology principles and practices that will lead to

increased deployment of state-of-the-art technologies and improved management of the

Medicaid program. States presently are utilizing MITA and the SS-A for Medicaid IT projects

approved by CMS, and application of these principles for activities required under this proposed

rule will not add additional burden to State efforts to adopt HIT as envisioned under the Section

1903(a)(3)(F) of the Act.

The MITA principles and tools foster integrated business processes and IT

transformation for all States. It achieves this in part by demonstrating that planned enhancements

to Medicaid systems, including MMIS, support State and Medicaid strategic goals and how intra-

state systems other than the MMIS have been considered in developing the solutions. We

believe that as States and providers implement EHRs, it will be necessary and essential to plan

technology upgrades that will facilitate health information exchange with Medicaid providers

receiving incentive funding.

We are further clarifying that we are defining the Medicaid Management Information

System (MMIS) as it relates to specific requirements for Medicaid claims processing and

information retrieval contained in current regulations at 42 CFR Part 433, Subpart C. We

CMS-0033-F 613

proposed a definition of the term MMIS because it is the common term that CMS, State

Medicaid agencies, and industry use to refer to the Mechanized Claims Processing and

Information Retrieval Systems specified in section 1903(a)(3) of the Social Security Act. MMIS

means the system of software and hardware used to process Medicaid claims from providers of

medical care and services for the medical care and services furnished to recipients under the

medical assistance program and to retrieve and produce service utilization and management

information required by the Medicaid single State agency and Federal Government for program

administration and audit purposes. The objectives of the MMIS include claims processing and

retrieval of utilization and management information necessary for program administration and

audit and must coordinate with other mechanized systems and subsystems that perform other

functions, such as eligibility determination. The MMIS is also compatible with the claims

processing and information retrieval systems used in the administration of the Medicare

program.

We believe that States will utilize their MMIS extensively in administering the provisions of this

proposed rule, including but not limited to payment and tracking of Medicaid incentive

payments, access to data and information necessary to establish the vision for Medicaid health IT

, and achieving interoperability and health information exchange envisioned in the Act.

In the proposed regulation at §495.332 we proposed a definition of the term State

Medicaid Health Information Technology Plan (SMHP) as an integral part of planning and

implementation of the EHR incentive program. The SMHP is a comprehensive document that

describes the State’s current and future health IT activities in support of the Medicaid EHR

incentive program. We further clarify that we require that the SMHP will be developed by the

State Medicaid agency, after consulting with other stakeholders across the State. The SMHP will
CMS-0033-F 614

be reviewed and approved by CMS prior to any activities described in the SMHP being funded

and implemented. We anticipate State agencies will engage a wide range of stakeholders within

and outside of State and Federal government to develop a vision of how the Medicaid EHR

incentive program will operate in concert with the larger health system and statewide efforts.

The SMHP is required to participate in the Medicaid incentive program because we believe that

States must develop a strategic vision and plan that includes clear targets and measurable

outcomes to be consistent with the intent of section 1903(a)(3)(F) of the Act to encourage the

adoption and meaningful use of certified EHR technology.

The SMHP is intended to serve as the vision for developing the desired future state for

the Medicaid IT environment that furthers the goals of health information exchange and

meaningful use envisioned under the Act. The SMHP should be coordinated and integrated with

the Statewide plan for health IT developed under section 3013 of the Public Health Service Act,

which is developed by the designated statewide entity. To ensure that the SMHP is coordinated

and integrated with the Statewide plan, we will develop criteria and processes for the evaluation

of the SMHP consistent with ONC’s review of the Statewide plans. The SMHP must contain: a)

a current health IT landscape assessment; b) a vision of the State’s HIT future landscape, and c)

the specific actions necessary to implement the incentive payments program, including a health

IT roadmap to achieve those actions. This deliverable will be the “plan” to determine how the

incentive payments will be administered; however, it is not the implementation of such plan.

The SMHP must include all of the elements listed in 495.332; however, we realize that States

may not have all of the answers initially. States will not be permitted to make incentive

payments to providers unless they have a comprehensive EHR incentive payment program

established. However, if States are not completely clear, for example, about their “to be” world
CMS-0033-F 615

at the time of the submission of their SMHP, States can present the components that are finalized

and revise the SMHP to further discuss their “to be” world at a later time. Additionally, as stated

previously in this final rule, we have revised the rule to include a requirement that the SMHP

must describe the process in place and the methodology for verifying that eligible professionals

meet their responsibility for 15 percent of the net average allowable cost for certified EHR

technology and that the SMHP include information about how States will validate the patient

volume consistent with the menu of options listed in §495.306.

For this final rule, we are also explaining our understanding that the elements of the

SMHP, as listed in §495.332, may be separated into four categories, as follows:

1) Assessment and Planning. This category of SMHP elements addresses requirements

in the Act relating to increasing the use of health IT, including EHR, ensuring interoperability,

and meaningful use of certified EHRs. As proposed, States will perform comprehensive

assessments of the current health IT landscape environment in the State, including the inventory

of existing health IT in the State, including “as is” and “to be” landscape assessments. Also, as

proposed, States will develop a 5-year strategic plan, and a description of how the State

Medicaid HIT plan will be planned, designed, developed and implemented, including how it will

be implemented, and a description of how intrastate systems, including the MMIS, and other

claims systems, have been considered in developing a health IT solution. The SMHP will

include a description of data-sharing components of proposed health IT solutions, including

security provisions, and description of how the State will support integration of clinical and

administrative data.

2) Ensuring improvements in health outcomes, clinical quality, and efficiency. This

category of SMHP elements will address requirements in the Act relating to improving
CMS-0033-F 616

healthcare quality and lowering costs. As proposed, States will include components that describe

a process for ensuring improvements in health outcomes, clinical quality, or efficiency resulting

from the adoption of certified EHR technology by recipients of Medicaid EHR incentive

payments and a methodology for verifying such information. As proposed, we are requiring a

description of how the State will address, in the long-term, the needs of underserved and

vulnerable populations such as children, individuals with chronic conditions, Title IV-E foster

care children, individuals in long-term care settings and the aged, blind, and disabled. We

proposed that in order to obtain approval for their SMHP and implementation funding, a State

would have to detail how their EHR Incentive Program addressed the concepts of self-direction

including budget development and expenditure tracking for persons with disabilities. After

additional consideration, CMS decided that these concepts are not directly applicable to

electronic health records or meaningful use, per se, and while important, are more associated

with other e-Health tools, such as personal health records. Furthermore, the provider types to

whom this is most directly relevant, such as home, institutional and community-based providers

and facilities, are not eligible for EHR incentives so including planning for this issue was not

perceived as rising to the level of a requirement. It is anticipated that Stage 2 of meaningful use

will include greater levels of patient engagement, including via personal health records.

However, we think it is premature to require that States fully address this issue in their SMHPs

order to initiate their EHR Incentive Programs for Stage 1.

As proposed, we will also require a description of the process in place for ensuring that any

certified EHR technology used as the basis for incentive payments to Medicaid providers is

compatible with State or Federal administrative management systems, including the MMIS, or

other automated claims processing system or information retrieval system, and a methodology
CMS-0033-F 617

for verifying such information.

3) Interoperability and Health Information Exchange. This category of SMHP

elements will address requirements in the Act relating to ensuring interoperability and increasing

health information exchange. We proposed a series of elements that explain how the State will

adopt national data standards for health and data exchange and open standards for technical

solutions as they become available. These elements of the SMHP also are included in our final

rule.

4) Administration and Oversight. This category of SMHP elements address the

requirements in the Act relating to implementation and financial oversight of the program. For

provider eligibility, we proposed that States provide a description of the process they will use for

ensuring that each EP and eligible hospital meets provider enrollment eligibility criteria upon

enrollment and re-enrollment to the Medicaid EHR payment incentive program, and the process

for ensuring patient volume consistent with the criteria in §495.304 and §495.306, and for

ensuring that each Medicaid EP is not hospital-based and that there is a methodology in place

used to verify such information. We are finalizing most of these requirements, as proposed.

However, in response to comments suggesting that CMS define the term "encounter" and take a

menu approach to patient volume to allow States several options, based on their data sources,

CMS has included changes to the SMHP requirements for the patient volume requirement in

§495.302, §495.306, and §495.332. These changes are discussed under the patient volume

section of this final rule. We note that States that wish to offer an alternative for estimating

patient volume would be required to involve key stakeholders in the determination of such

alternative. We also proposed, and are finalizing, specific elements in the SMHP relating to

monitoring and validation of information, including a method of ensuring all information from
CMS-0033-F 618

provider attestations is captured, stored, and verified, and any information added to the CMS

Single Provider Repository is all true and accurate. We also proposed, and are finalizing, that

States include a list of the specific actions planned to implement the EHR incentive program,

including a description and organizational charts for workgroups within State government and

external partners. As proposed, States will need to describe the process they have in place to

ensure that no amounts higher than 100 percent of FFP will be claimed for reimbursement of

expenditures for State payments to Medicaid eligible providers for the certified EHR incentive

payment program, and a methodology for verifying such information is available and the process

to ensure that no amounts higher than 90 percent of FFP will be claimed for CMS-approved

administrative expenses in administering the certified EHR technology incentive payment

program, including a methodology for verifying such information. As proposed, States will need

to include mechanisms for making timely and accurate payments and a requirement that

providers attest that they are not receiving a payment in any other State under the Medicaid EHR

incentive program. This category also includes elements relating to financial management and

auditing necessary to ensure the proper and efficient management and oversight of the program

and FFP.

Finally, we proposed that the States may propose in the SMHP alternatives to

measuring patient volume or achieving meaningful use. The rules for proposing alternatives are

discussed elsewhere in this final rule.

We are further clarifying the definition of Health Information Technology Planning

Advance Planning Document (HIT PAPD) (and any necessary update documents) to mean a

plan of action that requests FFP and approval to initiate and accomplish planning activities

necessary for a State agency to determine the need for and plan the acquisition of HIT equipment
CMS-0033-F 619

and services, and to acquire information necessary to prepare a HIT Implementation Advanced

Planning Document (HIT IAPD), described below, or common procurement instruments, such as

requests for proposals, or requests for qualifications and quotations, necessary to implement the

SMHP. CMS is including a definition of the HIT PAPD so that States may submit proposed

resources and planning activities, which are described in further detail in our State Medicaid

Director’s letter on September 1, 2009, to receive the 90 percent FFP match for initial planning

activities related to the Medicaid EHR incentive payment program. In order to qualify for the 90

percent FFP administrative match, section 1903(t)(9) of the Act requires a State to demonstrate,

to the satisfaction of the Secretary, compliance with three specific criteria:

(A) The State uses the funds for purposes of administering the incentive payments,

including the tracking of meaningful use of certified EHR technology by Medicaid providers;

(B) The State conducts adequate oversight of the incentive program, including routine

tracking of meaningful use attestations and reporting mechanisms; and

(C) The State pursues initiatives to encourage adoption of certified EHR technology to

promote health care quality and the exchange of health care information under Medicaid, subject

to applicable laws and regulations governing such exchange, while ensuring privacy and security

of data provided to its data exchange partners.

We are further clarifying the definition of Health Information Technology

Implementation Advance Planning Document (HIT IAPD) (and any necessary update

documents) to mean a plan of action that requests approval of FFP to acquire necessary resources

to implement and administer the activities and objectives of the State’s proposed SMHP, once

the SMHP is approved by CMS, including the allocation or acquisition of human resources,

services and equipment. To qualify to receive FFP for administering the incentive program,
CMS-0033-F 620

States must develop an HIT PAPD, SMHP, and an HIT IAPD. These documents would lay out

the process States will use to implement and oversee the EHR incentive program, and would help

States to construct and maintain an health IT roadmap to develop the systems necessary to

support providers in their adoption and meaningful use of certified EHR technology.

With respect to FFP under the Medicaid incentive program, we are clarifying that the

incentive payments to providers are matched at 100 percent FFP as described above, and

therefore there is no non-Federal share for these payments. However, there is a non-Federal

share necessary for the administration of the payment incentives. That is, CMS is reimbursing

States at 90 percent FFP for reasonable expenses related to the administration of the payment

incentives. States must fund the 10 percent non-Federal share of Medicaid health information

technology (health IT) administrative payments consistent with existing rules and regulations

regarding funding of the non-Federal share. We review non-Federal share funding sources to

ensure compliance with existing statute and regulations. Consistent with current practice, we

will review non-Federal share funding sources on an individual basis using information provided

by the State and gathered by CMS staff. Existing rules permit States to provide the non-Federal

share of administrative claims through various sources, including appropriations,

intergovernmental transfers, certified public expenditures, bona fide donations, and permissible

health care related taxes. CMS’ regional financial management staff will review funding sources

and will review the Medicaid Budget and Expenditure System to ensure that all claims for

reimbursement are appropriate. Additionally, States are required to submit SMHPs outlining

their process for making payments and ensuring that all claims for reimbursement are

appropriate to CMS for review and approval.

At §495.324 we proposed to review and prior approve all elements of the State's APD
CMS-0033-F 621

documents and SMHP described in this rule to ensure that all of the intended objectives of the

program are addressed. We are finalizing this proposal. States are required to submit these APD

documents and the SMHP in order for us to approve FFP. Specifically, prior approval is

required for the HIT PAPD (see also §495.336). The deliverable resulting from the HIT PAPD

is the SMHP. The SMHP will be reviewed and approved before it is included in an HIT

Implementation APD (HIT IAPD) (see also §495.338). The HIT IAPD also must be prior

approved. After a HIT PAPD is approved for planning activities, and these planning activities are

complete, we anticipate that in certain cases, States may decide to submit the SMHP and HIT

IAPD together in one submission for CMS review and approval. In all cases, until approval is

granted, States cannot draw down Federal funds. We envision that the prior approval process

described at §495.324 will permit States to work closely with CMS in developing the HIT

PAPD prior to initiating EHR planning activities and prior to submission of the initial HIT

PAPD.

We are defining “as needed” and “annual” updates to the HIT PAPD and HIT IAPD at

§495.340 and §495.342. In consultation with States and other key stakeholders, CMS has

determined that planning and implementing the Medicaid EHR incentive payment program will

be a complex process that will result in a need for “as needed” and “annual” updates to the

original scope of work. Therefore, we proposed that the APD process would allow States to

update their APD documents when they anticipate changes in the amount of FFP, duration of the

project, or scope of work or activities under the APD. We are finalizing this proposal, as it

allows States flexibility to add additional tasks and milestones as the project evolves, as

determined since the date the APD was initially approved or since the most recently updated and

approved APD.
CMS-0033-F 622

We initially proposed that we envision two phases in the process of planning and

implementing the incentive program, as well as the promotion of adoption and meaningful use of

EHR. We are further clarifying that based on submission of HIT PAPDs in response to guidance

provided in our State Medicaid Director’s letter of September 1, 2009, initial planning timelines

are ranging from 6 months to 18 months to develop the SMHP. CMS envisions that States will

begin to administer the EHR incentive program on January 1, 2011, once the SMHP and IAPD

are approved. As proposed, we will issue additional written guidance, similar to our earlier SMD

letter, concerning timelines for implementation of the EHR incentive program as States develop

the SMHP.

We require the HIT IAPD as the vehicle for informing us of Phase II activities. We

anticipate that States will also have ongoing planning needs as implementation activities, once

approved under the IAPD, are under way. We further envision that the IAPD “annual” or “as

needed” updates may also include requests for approval of FFP for other Phase II that are

necessary to continue planning and development for the ongoing implementation phases of the

program. In section 495.388, we proposed to require that States submit information in the

IAPD regarding an estimate of prospective cost allocation (OMB Circular A-87, Cost Principles

for State, Local, and Indian Tribal Governments) to the various State and Federal funding

sources and the proposed procedures for distributing costs including a detailed payment list file

to include NPI, name, and type of provider for which the State will provide incentive payments.

For the final rule, we are continuing to require the estimate of prospective cost distribution and

the procedures for distributing costs; however, we are eliminating the requirement that States

have to submit NPI, name and provider type as part of the estimates for cost distribution since we

realize that in continuing to require this information States will not be able to submit approvable
CMS-0033-F 623

IAPDs to CMS because States will not have this information at the time of submittal; hence,

States will not be successful in implementing this program.

We wish to further clarify that in proposing termination of funding if the State fails to

meet the requirements and undertakings of the approved HIT PAPD, SMHP, and HIT IAPD, or

fails to provide access to the required information, this requirement is necessary to ensure the

proper and efficient use of FFP and is consistent with present authority under the Act and

existing regulations that are promulgated by CMS, including at 45 CFR Part 95, Subpart F.

Comment: One commenter questioned whether the EHR incentive payments will be

required to be processed through the Medicaid Management Information System (MMIS).

Response: Payments under the Medicaid EHR incentive program are authorized

under Title XIX of the Social Security Act as part of the Medicaid program. We require that

States have an automated claims processing and information and retrieval system, known as

MMIS to manage health care provider payments for health care services, and provide

information for program management, administration, and auditing. As such, we believe that

most States will choose to process, monitor, and report Medicaid incentive payments to eligible

professionals and hospitals participating in the Medicaid EHR incentive program using the

MMIS. States may propose alternative methods to process, monitor, and report Medicaid

incentive payments in their SMHP. Any proposed method to process, monitor, and report

Medicaid incentive payments, including utilization of the State's MMIS, must be approved by

CMS. Through guidance issued in a State Medicaid Directors Letter and via case by case

analysis of APDs, CMS will collaborate with States to approve system development and

enhancement expenditures under the most appropriate funding source, HITECH or MMIS.

Comment: One commenter provided comments on §495.348(d), Procurement

CMS-0033-F 624

standards; Competition, and §495.360(a). The commenter agrees that procurement transactions

are conducted to provide, to the maximum extent practicable, open and free competition and

recommends that procurement transactions require that bidders bid specifically for the EHR

portion of any project (to ensure that the discrete costs are clearly identified), 2) no certified

EHR technology may be excluded from bidding, and 3) all projects must be both EHR-neutral

and provider-neutral. They further comment that CMS could consider having either a cap or

percentage limits on the amount of administrative costs or consulting fees to ensure that the bulk

of the award is used for the hard costs of the project: equipment, connectivity, and training.

Response: The requirement in §495.348(d) is limited to States and other grantees of

Federal funds authorized under Title XIX of the Social Security Act and does not apply to

procurement standards for vendors bidding on EHR technology for eligible providers. However,

CMS will encourage States to include adoption of interoperable solutions that align with the

MITA principles that address IT architectural and platform neutrality.

We are making no additional revisions to this section of the rule as a result of this

comment.

Comment: One commenter recommended that CMS reconsider the general rule set

forth in §495.360 that “the State or local government must include a clause in all procurement

instruments that provides that the State or local government will have all ownership rights in

software or modifications thereof and associated documentation designed, developed or installed

with FFP under this Subpart.” The commenter states that it is typical for the vendor to own the

underlying software, and State or local governments are provided a license to use the software,

and this is contrary to the proposed general rule.

CMS-0033-F 625

Response: We disagree with the recommendation to exclude a clause in all State

procurement instruments that provides that the State or local government will have all ownership

rights in software developed or modified using Federal funding. This is a long-standing

principal for use of FFP associated with the development of information technology solutions

that may be licensed for use by other State or Federal government agencies to benefit the

Medicaid program, at no additional cost for the license. CMS clarifies that costs of the license

agreements for proprietary software may be reimbursable under the provisions of

1903(a)(3)(F)(ii) of the Act that provides for 90 percent FFP for costs associated with certain

administrative activities performed by a State. However, costs associated with developing or

modifying software may not be funded with Federal funds unless the State has ownership rights

to that software. This provision does not apply to eligible providers or hospitals purchasing

software for which Federal funding has been provided by States through the Medicaid EHR

incentive program. Proposed costs may be submitted for review and consideration for approval

by CMS as part of the HIT PAPD and HIT IAPD requirements described in this proposed rule

under §495.336 and §495.338.

We are making no additional revisions to this section of the rule as a result of this

comment.

Comment: One commenter indicated that the process for State Medicaid plans seems

to be lengthy, with no timeframes specified for initial submission from the State to the

Department, nor is there a timeline for the approval process from CMS back to the State. There

is also no timeline for the implementation of the health IT programs after a State receives

approval. The commenter also notes that with the burden for administration on the States, there

may not be adequate time to get all of the activities completed to have infrastructure and
CMS-0033-F 626

processes in place to accept data or attestations from the Eligible Providers and Eligible

Hospitals.

Response: We provided specific guidance on timelines and process prior to the initial

planning period regarding State planning activities and administrative expenses for provider

incentive payments in our State Medicaid Director's letter on September 1, 2009. We also

indicated in our letter that CMS will work with States to determine when each State is ready to

begin making payments. We have provided additional rationale about the process for submitting

documents and required content in the final rule. In the near future, CMS will issue more

guidance on specific implementation activities and timelines, prior to States submission of their

SMHP and IAPD.

We are making no additional revisions to this section of the rule as a result of this

comment.

Comment: One commenter requested that CMS require that States pass through the

matching funds to providers.

Response: The regulation at section 495.366 requires that States have a process in

place to assure that Medicaid EHR incentive payments are made without reduction or rebate,

have been paid directly to an eligible provider or to an employer, a facility, or an eligible third

party entity to which the Medicaid eligible provider has assigned payments. This language is

consistent with the statutory language at 1903(t)(6). We will require that this process be

established in the SMHP.

We are making no additional revisions to this section of the rule as a result of this

comment.

Comment: One commenter requested that CMS clarify that use of certified public
CMS-0033-F 627

expenditures (CPE) or intergovernmental transfers in the context of the Medicaid EHR incentive

payments would be inappropriate, since these payments do not have a non-federal share. If CMS

does permit use of CPEs in the Medicaid EHR incentive program context, CMS must require that

States pass through the matching funds to providers.

Response: We believe the commenter is not clear. As explained above incentive

payments to providers are matched at 100 percent; thus, there is no non-Federal share for these

payments. However, there is a non-Federal share necessary for the administration of the

payment incentives. CMS is reimbursing States at 90 percent for reasonable expenses related to

the administration of the payment incentives and States must fund the 10 percent non-Federal

share of Medicaid health information technology administrative payments consistent with

existing rules and regulations regarding funding of the non-federal share. Please see our above

discussion of this issue for further detail.

We are making no additional revisions to this section of the rule as a result of this

comment.

Comment: One commenter questioned why Medicaid is allowed to determine its own

requirements and the impact this may have on other stakeholders.

Response: We are clarifying that we have provided specific guidance for State

planning activities that must be addressed in order to qualify to receive FFP for administering the

incentive program. We provided guidance in a State Medicaid Director's letter published on

September 1, 2009, on this process. CMS intends to require submission of documentation that

will enable the agency to evaluate whether the activities for which FFP was, or may be approved

for, are being completed according to Federal requirements, including any terms and conditions

of FFP approval. States must develop a HIT PAPD, a SMHP, and a HIT IAPD. These
CMS-0033-F 628

documents would describe the processes and resources States will use to implement and oversee

the EHR incentive program, and would help States to construct an health IT roadmap to develop

the systems necessary to support providers in their adoption and meaningful use of certified EHR

technology. The development of a SMHP (see also §495.332) also provides States with the

opportunity to analyze and plan for how EHR technology, over time, can be used to enhance

quality and health care outcomes and reduce overall health care costs. Our review process

ensures that States are complying with requirements in the Act, and that they demonstrate to the

“satisfaction of the Secretary” that they are using the funds in the manner anticipated by the law.

For example, because CMS is responsible for overseeing States in their administration of the

Medicaid program, as well as ensuring the overall financial integrity of the program, States

cannot simply propose activities in order to secure the 90 percent FFP. We propose to review

and prior approve all elements of the State's SMHP, and APD documents described in this rule to

ensure that all of the intended objectives of the program are addressed. One of the key

components of the SMHP is stakeholder collaboration and coordination to ensure that an

integrated strategy is developed addressing stakeholder needs.

We are making no additional revisions to this section of the rule as a result of this

comment.

Comment: One commenter recommended that all the source materials needed to

create the quality measure registry, is submitted to the MITA Information Architecture Review

Board (IARB) for approval as a MITA standard and all the source materials be added to the

MITA artifact repository. Doing this will prevent duplicative efforts and associated expense

both by CMS and the participating States.

CMS-0033-F 629

Response: We agree with the commenter. We support the concept that States should

apply MITA principles to any IT development work performed for the EHR incentive program,

where applicable. If a State chooses to integrate a clinical data warehouse into its MMIS system,

all recommended steps, and required approvals, for MMIS development, including application of

MITA guidelines, should apply. The goal of MITA is not to focus on creating new standards so

much as utilizing data standards developed by other national organizations, such as those

responsible for implementation of HITECH and also defining information requirements for new

business processes. If a State is going to develop its own clinical data repository to store

Medicaid providers’ submitted clinical quality measures data (one of the MU objectives), then

use of the MITA Governance boards would be a recommended approach. States whose SMHPs

successfully apply MITA to their EHR incentive program systems are encouraged to store

approved artifacts in the Clemson University MITA repository so that other States may benefit:

http://mita.clemson.edu.”

We are making no additional revisions to this section of the rule as a result of this

comment.

Comment: One commenter, as a large pediatric provider with five physicians and four

nurses in a relatively rural area, is concerned that States have not yet sent, or had approved by

CMS, the State's Medicaid requirements.

Response: States are in the process of developing their SMHPs. States could not be

approved to start offering incentives prior to a final rule becoming effective.

We are making no additional revisions to this section of the rule as a result of this

comment.
CMS-0033-F 630

Comment: Some commenters asked for clarification on how managed care entities

would be involved in this program besides potentially being used to disburse incentive payments,

as mentioned in the proposed rule. Examples included things like monitoring providers in the

health plans to ensure compliance. The commenters suggested that any work done by the

managed care entity should be reflected in the capitation rate.

Response: Service agreements between States and their managed care contractors are

not governed by this regulation, but must be in compliance with 42 CFR Part 438. We agree

there are many opportunities to leverage the efficiencies of the managed care entities' activities

and role with the larger goals and State responsibilities for administering the payments. We

suggest that activities like distributing informational materials about the incentive program and

health IT to health plan providers and enrollees would fall under most current contracts and

would be considered part of the cost of doing business, which may be reflected in the

administrative portion of the capitation rate.

If more significant activities are expected, such as monitoring and reporting

information on the providers, health plans may exceed the normal costs of doing business and

what would be adequately reflected in the administrative portion of the capitation rate. An

alternative option would be for the State and managed care organization to have contractual

requirements and deliverables separate from the capitation rate, including the administrative

component. In the latter scenario, it would be acceptable to develop a contract amendment

specifying the terms.

We are making no additional revisions to this section of the rule as a result of this

comment.

Comment: A commenter asked whether or not a State would need to file a State Plan
CMS-0033-F 631

Amendment that incorporates the SMHP into their State Plan, or if the SMHP can stand alone.

The commenter further asked that if the SMHP can stand alone, then would the state need to file

a State Plan Amendment that references the SMHP in their plan.

Response: CMS clarifies that the State does not need to file a State Plan Amendment or

reference the SMHP in their State Plan. As part of the Advance Planning Document process, the

SMHP is a deliverable that is submitted to CMS for review and approval prior to expending

funds for the incentive program implementation activities.

We are making no additional revisions to this section of the rule as a result of this

comment.

9. Financial Oversight, Program Integrity and Provider Appeals

Pursuant to section 1903(t)(9) of the Act, which requires States to conduct adequate

oversight of the incentive program, and in order to ensure that ARRA funds are expended wisely

and in a manner that impedes waste, fraud or abuse of Federal taxpayer money, at §495.366, we

proposed requirements for States' financial oversight and monitoring of expenditures.

Additionally, we proposed at §495.368 to provide State requirements for combating fraud and

abuse.

Specifically, States would be responsible for estimating the expenditures for the Medicaid

EHR incentive program on the State's quarterly budget estimate reports. These reports are used

as the basis for Medicaid quarterly grant awards that would be advanced to the State for the

Medicaid EHR incentive program. The State submits this Form electronically to CMS via the

Medicaid and State CHIP Budget and Expenditure System (MBES/CBES). States must assure

that requests for reimbursement of FFP comply with all sections of this new part and that the

amounts reported on the Form CMS-64 and its attachments represent actual expenditures for
CMS-0033-F 632

which all supporting documentation, in readily reviewable form, has been compiled and which is

available at the time the claim for reimbursement of provider payment incentives and

administration funding is filed.

We would assure that State expenditures claimed for Federal matching under the

Medicaid program are programmatically reasonable, allowable, and allocable in accordance with

existing Federal laws, regulations, and policy guidance. States would be responsible for

establishing policies, computer systems, edits to process Medicaid EHR incentive payments; and

for conducting analyses of providers' patterns of practice (data-mining) and taking other

reasonable steps to ensure that no duplicate or otherwise improper EHR incentive payments have

been made. States will be responsible for ensuring that provider information, including but not

limited to, attestations, survey, and any information added to CMS' single provider election

repository indicates that any falsification of documentation or concealment of material facts may

be prosecuted under Federal and State laws. States would be responsible for recovering and

returning to CMS FFP for any HIT incentive payments that are discovered to be improper. State

Agencies must have information processing systems, which may include an MMIS -- the

automated mechanized claims processing and information retrieval system, to process Medicaid

EHR incentive payments. MMIS systems can also help to manage information for program

administration and audit purposes.

States must assure that any requests for reimbursement of the 90 percent Federal match

for administration of the program are being requested only because the State has used the funds

for purposes related to administering payments to qualified Medicaid providers for certified EHR

technology, including for tracking of meaningful use of such technology, is conducting adequate

oversight of the program including routine tracking of meaningful use attestations and reporting
CMS-0033-F 633

mechanisms; and is pursuing initiatives to encourage the adoption of certified EHR technology

to promote health care quality and the exchange of health care information because of such

technology. Any initiatives for health information exchange must be consistent with Federal

laws and regulations governing the exchange.

We would monitor State Agency compliance through systems performance reviews,

on-site reviews, and audits of the APD process. Additionally, we would monitor provider

demonstration of meaningful use.

As a result of the authority extended to the Secretary under section 1902(a)(4) of the Act

requiring the effective and efficient administration of the State plan, as well as section 1903(t)(9)

of the Act, requiring that a State demonstrate to the satisfaction of the Secretary that it is

conducting adequate oversight of the program, we also are requiring States to establish §495.370,

Provider Appeals. This section specifies that Medicaid providers who believe that they have

been denied an incentive payment or have received an incorrect payment amount under this part

because of incorrect determinations of eligibility, including, but not limited to, measuring patient

volume; demonstrating meaningful use of, or the efforts to adopt, implement, or upgrade to,

certified EHR technology; whether the professional is hospital-based; whether the professional is

practicing predominantly in an FQHC or RHC; whether the hospital qualifies as an acute care or

children's hospital; or whether the provider is already participating in the Medicare incentive

program and therefore ineligible duplicate Medicaid incentive program payments can appeal the

decision using current Federal processes established at § 447.253(e).

Comment: One individual commented on potential fraud and abuse opportunities if

large amounts of medical data can be mined, as a result of electronic health records.

Response: First, it is important to note that as part of demonstrating meaningful use

CMS-0033-F 634

providers will be submitting only aggregated, not individually identifiable data, to States.

Second, we wish to clarify that providers will be required to comply with the Health Insurance

Portability and Accountability Act of 1996 (HIPAA) to the extent that they are covered entities.

States must provide CMS with details about how their implementation of the EHR incentive

program will address Federal and State privacy laws and how all data will be secured in the

SMHP.

Additionally, the act of preventing fraud should be paramount in implementing this

program. In accordance with Section 1903(t)(9) of the Social Security Act, States must

demonstrate to the satisfaction of the Secretary that they are conducting adequate oversight of

this program and that they are complying with Federal requirements to: a) ensure the

qualifications of providers who request Medicaid EHR incentive payments, b) detect improper

payments and c) refer suspected cases of fraud and abuse to the Medicaid fraud control unit. In

conducting required oversight responsibilities, States can receive 90 percent matching funds for

allowable expenditures. States are required to assure CMS through the State’s Medicaid HIT

plan that they have processes in place to prevent against fraud and abuse. CMS will review and

approve each State’s Medicaid HIT plan.

We are making no additional revisions to this section of the rule as a result of this

comment.

Comment: One commenter noted that use of electronic health records may provide

claims adjudication auditors with documentation to verify that items or services provided are

reasonable and necessary, supporting an upfront clean claims process and the opportunity to

conduct pre- and post- pay audits without the need to request documentation in retrospect.

Another commenter wanted an assurance that CMS will perform audits of a random sample of
CMS-0033-F 635

attestation surveys and that any providers that are found to be making false claims would be

penalized and listed in a public report posted on CMS’ website.

Response: We thank the commenter for the comments, but point out that meaningful

use currently would not include using EHRs to provide electronic documentation in support of

claims adjudication. We do, however, want to address the issue of pre- and post-audits. While

one commenter is concerned with the process for adjudicating claims, the other commenter is

concerned that there are other areas of this program that will necessitate pre- and post-pay

audits. For Medicaid, States are required to provide information to CMS in the State Medicaid

HIT plan outlining the processes and methodologies they will use to ensure that payments are

being made to the right person, at the right time, for the right reason. Specifically, in year one in

order to receive an incentive payment, providers will be attesting to, among other things, whether

they are using a certified EHR, demonstrating meaningful use, demonstrating adopting,

implementing or upgrading certified EHR technology, etc. States will be required to "look

behind" provider attestations. We believe that this will require audits both pre- and post-pay.

CMS believes a combination of approaches is in order which should result in accurate payments.

CMS wishes to point out that States must provide assurances to CMS that they are conducting

adequate oversight in order to receive the 90 percent FFP for administration of the incentive

payments. Additionally, it should be noted that this program is consistent with other programs

under Title XIX. States must properly administer the program or risk FFP. All costs claimed

under the program are subject to review or audit. Furthermore, CMS' approval of the State

Medicaid HIT plan does not relieve the State of its responsibility to comply with changes in

federal laws and regulations and to ensure that claims for federal funding are consistent with all

applicable requirements. We should point out that for Medicaid there is no statutory requirement
CMS-0033-F 636

to post individual provider’s name and/or incentive payment program information to the CMS

website.

We are making no additional revisions to this section of the rule as a result of this

comment.

Comment: One commenter is concerned about the circumstances under which

Medicaid is required to recoup incentive payments from providers. Specifically, the commenter

requests clarification on the scenario in which a provider receives a payment for demonstrating

adoption, implementation, or upgrading EHR technology in year one, demonstrating meaningful

use in years two and three, but receives no payment in year four because the provider could not

demonstrate meaningful use. The commenter is concerned that Medicaid will be responsible for

recouping payments made in years one, two, and three.

Response: First, it should be noted that it is possible for a provider to be able to

demonstrate meaningful use in one year, but not others. Thus, the failure of the provider to

demonstrate meaningful use in year four would not necessarily mean that the provider failed to

demonstrate meaningful use in prior years, although it could possibly alert the State to more

closely review a specific provider’s prior year attestations or demonstrations of meaningful use.

For hospitals demonstrating meaningful use in both the Medicare and Medicaid incentive

payment programs, CMS will issue further guidance about how States will be able to access the

meaningful use data submitted to CMS in order for the State to meet its audit and oversight

requirements. States will be required to outline in the SMHP the process for "looking behind"

provider attestations and the demonstration of meaningful use including any record retention

requirements.

In accordance with section 1903(t)(9) of the Social Security Act and §495.332(c) and
CMS-0033-F 637

(e) of the regulations as well as §495.368, States are required to include in their State’s Medicaid

HIT plan processes for detecting improper payments and for combating fraud and abuse. This

would mean that States will be responsible for conducting audits of providers and ensuring that

any requests for reimbursement for FFP meet all requirements of this subpart. When States

conduct audits and determine that improper payments have been made, States are responsible for

recovering and returning to CMS FFP for any incentive payments that are discovered to be

improper.

We are making no additional revisions to this section of the rule as a result of this

comment.

Comment: Another commenter is concerned with a similar issue. That is, the

commenter requested that CMS identify and develop “safe harbor” processes and methods for

administering the incentive program that would assure States that if these processes/methods are

used, States would not be at risk if the processes/methods are less successful than anticipated.

An example would include a process for auditing the adoption, implementation, and upgrading

process. If an audit approach was agreed to but ended up being less than effective when applied,

the State should not be responsible for re-auditing providers for previous years, nor would it be

denied participation in the incentive program and lose the FFP. Another commenter is similarly

concerned that this is a new program and they requested that CMS explicitly recognize the

States’ ability to revise and redirect the program without penalty from CMS.

Response: Our focus is on ensuring that EHR incentive payments are made to the

eligible provider, and are for the correct amount in the appropriate payment year (or payment

cycle). CMS will ensure that State expenditures claimed for Federal matching under the

Medicaid program are programmatically reasonable, allowable, and allocable in accordance with
CMS-0033-F 638

existing Federal laws, regulations, and policy guidance.

States can receive FFP if they are conducting adequate oversight and States must

provide their plans for financial oversight and the processes and methodologies they will use to

verify provider information to CMS for review and approval as part of its State’s Medicaid HIT

plan. We believe States may want to consider multiple ways in which to audit their providers;

for example, to ensure that a provider is not excluded from the program, the State should review

on a prepay basis the Office of the Inspector General’s List of Excluded Individuals and Entities

to determine if providers are excluded. Additionally, States may wish to consider attestation in

year one for demonstrating adopting, implementing, or upgrading or meaningfully using certified

EHR technology. States will have to “look behind” these attestations and we assume this will be

done on a post-pay basis. One size does not fit all and we believe several audit options should be

used by States to ensure “adequate oversight.” However, if it is determined that the State’s audit

methodologies are proving to be less than effective we will require that the State update its State

Medicaid HIT plan and present more effective audit strategies that will work to accomplish

conducting adequate oversight of the program. States must ensure due diligence in conducting

adequate oversight and all requirements of this subpart must be met or FFP could be at risk.

We are making no additional revisions to this section of the rule as a result of this

comment.

Comment: One commenter requested information regarding the appeals process.

Response: For Medicaid, CMS has specified the appeals process for a Medicaid

provider receiving electronic health record incentive payments in §495.370. Specifically, the

State must have a process in place consistent with the requirements established at §447.253(e) to

allow for providers to appeal incentive payments, incentive payment amounts, provider
CMS-0033-F 639

eligibility determinations, and the demonstration of adopting, implementing or upgrading and

meaningful use of certified EHR technology. CMS is requiring that the State Medicaid HIT plan

describe the process in place for provider appeals. We believe the States, not the Federal

government, are in the best position to determine the administrative process that would best meet

their needs and we believe States are in a position to design an effective appeal procedure; thus,

we are providing for a great deal of State flexibility. Within the parameters of the regulation,

States are free to establish reasonable criteria for appeals, to limit the issues on appeal that may

be appropriate, or to adopt other procedures to prevent frivolous appeals. However, State appeal

processes should be consistent with the requirement in 447.253(e) for prompt administrative

review. (States define what would constitute a prompt review, and we have not specified a time

period for conducting or concluding a provider appeal.) This requirement is in keeping with

providing States flexibility while retaining for providers an opportunity to avail themselves of an

exception process when they believe an exception is warranted. Additionally, §447.253(e)

provides that the Medicaid agency must allow providers an opportunity to submit additional

evidence. Our regulations at §495.370 also require that the appeals processes established by the

States comply with the State’s own administrative procedure laws and that the State provide any

additional appeal rights that would otherwise be available under the procedures established by

the State.

We are making no additional revisions to this section of the rule as a result of this

comment.

III. Information Collection Requirements

Under the Paperwork Reduction Act of 1995, CMS is required to provide 60-day notice

in the Federal Register and solicit public comment before a collection of information
CMS-0033-F 640

requirement is submitted to the Office of Management and Budget (OMB) for review and

approval. In order to fairly evaluate whether an information collection should be approved by

OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that CMS solicit

comment on the following issues:

● The need for the information collection and its usefulness in carrying out the proper

functions of our agency.

● The accuracy of our estimate of the information collection burden.

● The quality, utility, and clarity of the information to be collected.

● Recommendations to minimize the information collection burden on the affected

public, including automated collection techniques.

The following is a discussion of the requirements we believe are subject to PRA and

collection of information requirements as a result of this final rule. This analysis finalizes our

projections which were proposed in the January 13, 2010 Federal Register (75 FR 1844 through

2011). The projected numbers of EPs and eligible hospitals, MA organizations, MA EPs and

MA-affiliated hospitals are based on the numbers used in the impact analysis assumptions as

well as in Table 32 in section IV of this final rule.

A. ICRs Regarding Demonstration of Meaningful Use Criteria (§495.8)

Section 495.8(a)(1) of the proposed rule contained requirements for EPs, in CY 2011, to

attest, through a secure mechanism, to meeting meaningful use criteria. As described in the

proposed rule (75 FR 1949), we divided meaningful use objectives/measures into Sets A and B.

We estimated that the total burden for an EP to attest to §495.8(a)(1) (i) and (ii) for Set A

meaningful use objectives/measures and ambulatory quality measures would be one hour. For

all 442,600 non-hospital-based Medicare and Medicaid EPs (323,500 Medicare EPs, 80,900 dual
CMS-0033-F 641

Medicare/Medicaid EPs, and 38,200 Medicaid-eligible-only EPs), the burden therefore equaled

442,600 hours. We estimated that the associated cost burden was $79.33 for an EP to attest to

§495.8(a)(1) (i) and (ii) for Set A meaningful use objectives/measures and ambulatory quality

measures, and the total associated annual cost burden for all EPs to attest was $35,111,458. We

invited comments on the estimated percentages and the numbers of (registered) EPs that will

attest to the above including Set A meaningful use objectives/measures in CY 2011, but did not

receive any on this issue.

In the proposed rule, we also estimated that it would take 8 hours for an EP to attest to

meeting the Set B meaningful use objectives/measures. We estimated that the total annual

burden for all 442,600 non-hospital-based EPs to attest to Set B meaningful use objectives and

measures was 3,540,800 hours. We estimated the associated cost burden for an EP to attest was

$634.64 and the total cost burden for all non-hospital-based EPs to attest was $280,891,664. We

solicited comments on the estimated percentages and the numbers of (registered) EPs that will

attest to Set B objectives and measures in CY 2011, but did not receive any on this issue.

Although, as we proposed, we continue to have an attestation requirement in §495.8

(a)(1), we are revising the burden estimates for two reasons. First, as described elsewhere in this

final rule, the definition of hospital-based EP has changed, resulting in about 73,000 outpatient

hospital EPs becoming potentially eligible to participate in the EHR incentive program.

Therefore, we are increasing the number of EPs in our burden estimates. We estimate that in

CY 2011, there will be 521,600 non-hospital-based Medicare and Medicaid EPs (382,000

Medicare EPs, 95,500 dual Medicare/Medicaid EPs, and 44,100 Medicaid-eligible-only EPs)

participating in the EHR incentive program. Second, in response to public comments, we have
CMS-0033-F 642

made significant changes in §495.6 meaningful use objectives and measures for EPs, eligible

hospitals and CAHs, which has changed the burden estimates.

In section II.A.2.d. of this final rule, Stage 1 Criteria for Meaningful Use in this final rule,

we have re-categorized meaningful use objectives/measures as core criteria and menu criteria.

Unless an exception applies, §495.6 (a) requires that an EP must meet all 15 Stage 1 meaningful

use core criteria under §495.6(d) and 5 out of 10 meaningful use menu criteria under §495.6(e).

The burden associated with the requirements in §495.8 and §495.6 is the time and effort required

to attest to the required elements.

To comply with §495.8 (a)(1), we estimate that it would take an EP 8 hours 52 minutes to

prepare and attest that during the EHR reporting period, the EP used certified technology, specify

the technology, and satisfied all 15 mandatory Stage 1 meaningful use core criteria. We estimate

that it would take an EP an additional 0.5 hours to select and attest to the clinical quality

measures, in the format and manner specified by CMS. We estimate the total burden associated

with this requirement for an EP is 9 hours 22 minute (8 hours 52 minutes + 0.5 hours) and the

total burden for all the EPs to attest to these requirements is 4,855,827 hours (521,600 EPs x

9 hours 22 minutes). We estimate the associated cost burden for an EP to attest to these

requirements is $743.08 (9 hours 22 minutes x $79.33 (mean hourly rate for physicians based on

the May 2008 Bureau of Labor Statistics)), and the total cost burden for all EPs to attest to these

requirements is $387,592,672(4,855,827hours x $79.33).

We recognize that some Stage 1 meaningful use menu set measures are easier to

accomplish than others. We cannot predict which of the measures in the menu set an EP will

select. Therefore, our burden estimates are based on two scenarios to illustrate how different

scenarios would impact the burden incurred. Our “least burdensome” or “low” scenario of
CMS-0033-F 643

meaningful use demonstration assumes that an EP defers the five most burdensome

objectives/measures while our “most burdensome” or “high” scenario of meaningful use

demonstration assumes that an EP defers the five least burdensome meaningful use menu set

measures. We recognize that in reality, nothing is absolute, and we have no basis for estimating

the “all low” or “all high” scenario and have therefore created estimates for both. To

compensate for the uncertainties of selection of meaningful use criteria by an EP, we use the

averages of the “high” and “low” scenario estimates in Table 33. Section 495.6 (a) requires that

an EP must meet five out of 10 Stage 1 meaningful use menu set measures (unless exceptions

apply). The burden involved is the time and effort to select and attest to the meaningful use

menu set measures. In the “low” scenario, we estimate that an EP may defer the five most

burdensome meaningful use measures. We estimate it will take an EP 42 minutes to comply

with the remaining five Stage 1 meaningful use menu set measures. We estimate the total

burden for all 521,600 EPs to comply with the meaningful use menu set criteria is 365,120 hours

(521,600 EPs x 42 minutes). In the high scenario, we estimate that an EP may defer the five

least burdensome meaningful use criteria. We estimate that it will take an EP 2 hours 40 minutes

to comply with the remaining five Stage 1 meaning use menu measures. We estimate that the

total burden for all 521,600 EPs to comply with the meaningful use menu set criteria is

1,390,586 hours (521,600 EPs x 2 hours 40 minutes). Based on the two scenarios, the average

burden for an EP to comply with meaningful use menu set criteria is 1 hour 41 minutes ((42

minutes + 2 hours 40 minutes)/2). Based on the two scenarios, the average burden for all EPs to

comply with meaningful use menu set criteria is 877,853 hours ((365,120 hours +

1,390,586 hours)/2) We estimate the cost burden for an EP to comply with the “low” scenario

Stage 1 meaningful use menu criteria is $55.53 (42 minutes x $79.33 (mean hourly rate for
CMS-0033-F 644

physicians based on the May 2008 Bureau of Labor Statistics)), and the total cost burden for all

521,600 EPs to comply is $28,964,970 (521,600 EPs x $55.53). We estimate that the cost

burden for an EP to comply with the “high” scenario Stage 1 meaningful use menu criteria is

$211.49 (2 hours 40 minutes x $79.33), and the total cost burden for all EPs is $110,315.156

(521,600 EPs x $211.49). The average cost burden estimate for an EP to comply with the

meaningful use menu set criteria is $133.51 (($55.53 + $211.49)/2). The average cost burden

estimate for all 521,600 EPs to comply with meaningful use menu set criteria is

$69,640,063(($28,964,970 + $110,315.156)/2).

In the proposed rule, we expected that there would be steady growth in the number of

participating EPs. We estimated that in 2012, there would be 447,400 non-hospital-based

Medicare, and Medicaid EPs (326,900 Medicare EPs, 81,700 dual Medicare/Medicaid EPs and

38,800 Medicaid-eligible-only EPs) qualified to receive EHR incentive payment. We estimated

that the burden for meeting §495.8(a)(2), which required attestation for most meaningful use

measures, and electronic reporting of clinical quality measures in CY 2012, would be 0.5 hours

for an EP to attest to the Set A objectives and measures and 8 hours to gather information and

attest to the Meaningful Use Set B objectives/measures. For burden estimate purposes, we

estimated that all 447,400 non-hospital-based Medicare, and Medicaid EPs might attest. We

estimated that the total annual attestation burden for all EPs was 223,700 hours for the Set A

objectives/measures and 3,579,200 hours for Set B objectives/measures. We estimated that the

associated cost burden was $39.67 for the Set A meaningful use objectives/measures and

$634.64 for the Set B meaningful use objectives/measures. The total cost burden for all EPs was

$17,746,121 for Set A and $283,937,936 for Set B. We invited comments on the

estimated percentages and the numbers of registered EPs that would attest to EHR technology
CMS-0033-F 645

used and Meaningful Use Set A and Set B objectives/measures in CY 2012, but we did not

receive any comments on this issue.

We expect steady growth in EPs in CY 2012. In the final rule, based on legislation

altering the definition of “hospital-based,” we are increasing our estimates of participating EPs,

and estimate that in CY 2012, there will be about 527,254 non-hospital-based Medicare and

Medicaid EPs (385,954 Medicare EPs, 96,500 dual Medicare/Medicaid EPs and 44,800

Medicaid-eligible-only EPs) who are qualified to receive EHR incentive payments. The Stage 1

meaningful use criteria (core and menu sets) are the same for CY 2011 and CY 2012. We

estimate that it would take 8 hours 52 minutes for an EP to attest that during the EHR reporting

period, the EP used certified technology, specify the technology, and satisfied all 15 mandatory

Stage 1 meaningful use core criteria. We estimate the total burden associated with this

requirement for all EPs is -4,675,161 hours (527,254 EPs x 8 hours 52 minutes). The associated

cost burden for an EP to comply with this requirement is $703.42 (8 hours 52 minute x $79.33)

and the associated cost burden for all EPs is $370,880.589 (44,675,161 hours x $79.33 (mean

hourly rate of physicians based on the May 2008 Bureau of Labor Statistics)).

The Stage 1 meaningful use objectives and measures are the same for CY 2011 and

CY 2012. Therefore, in CY 2012, the burden associated with attesting to Stage 1 meaningful use

core and menu criteria for an EP is the same as CY 2011. Again, we cannot predict which of the

measures in the menu set will be selected by an EP. Therefore, as explained above, we use a

“low” and “high” scenario to estimate burden. For the “low” scenario, we estimate it will take

an EP 42 minutes to attest to five Stage 1 meaningful use menu-set measures. The total burden

for all 527,254 EPs, therefore, would be estimated at 369,078 hours (527,254 EPs x 42 minutes).

Under the “high” scenario, we estimate it will take 2 hours 40 minutes for an EP to attest to five
CMS-0033-F 646

Stage 1 meaningful use menu-set criteria. The total burden for all 527,254 EPs, therefore, is

estimated to be 1,405,659 hours (527,254 EPs x 2 hours 40 minutes). Based on the two

scenarios, the average burden hours for an EP to attest to meaningful use menu set measures is

1 hour 41 minutes ((42 minutes + 2 hours 40 minutes)/2), and the total average burden for all

EPs is 887,369 hours ((369,078 hours + 1,405,659 hours)/2). Under the “low scenario,” we

estimate that the cost burden for an EP is $55.53 (42 minutes x $79.33 (mean hourly rate for

physicians based on the May 2008 Bureau of Labor Statistics)), and the total cost burden for all

527,254 EPs to comply with is $29, 278,942 (527,254 EPs x $55.53). For the “high scenario,”

we estimate that the cost burden is $211.49 (2 hours 40 minutes x $79.33), and the total cost

burden for all EPs is $111,510,942 (527,254 EPs x $211.49). The average cost burden is $

133.51 (($55.53 + $211.49)/2). The average cost burden for all 527,254 EPs is $70,394,942

(($29,278,942 + 111,510,942)/2).

Section 495.8(a)(2)(iii) requires that for CY 2012, EPs must report electronically to

CMS, or, in the case of Medicaid EPs, the States, clinical quality information in the form and

manner specified by CMS. We have limited the required measures only to those that can be

automatically calculated by a certified EHR, and to those for which we have electronic

specifications currently available and we are able to post as final by the date of display of this

final rule. The burden associated with this requirement is the time and efforts to report the

required clinical quality measures. We estimate the burden for an EP to comply with this

requirement is 0.5 hours and the total burden for all EPs to comply with this requirement is

263,627 hours (527,254 EPs x 0.5 hours). We believed that an EP may assign a medical

secretary to submit the specific clinical quality measures to CMS or the States. We estimate the

cost burden for an EP to comply with this requirement is $7.40 (0.5 hours x $14.81 (mean hourly
CMS-0033-F 647

rate of medical secretaries based on the May 2008 Bureau of Labor Statistics)) and the cost

burden for all EPs to comply with this requirement is $3,904,316 (263,627 hours x $14.81).

To estimate capital costs for EPs, we assume a certified EHR system will cost roughly

$54,000. If 521,600 EPs adopt these EHRs, total capital costs prior to incentives would be

roughly $23.9 billion. We also estimate that in 2011, $0.2 billion of Medicare incentive

payments and $0.2 billion of Medicaid incentive payments would be provided to EPs under a

low scenario, and $0.6 billion Medicare incentive payments and $0.9 billion of Medicaid

incentive payments would be provided to EPs under a high scenario to help offset those costs.

Therefore, we estimate that total net capital costs for EPs in 2011 would be $23.5 billion

($23.9 billion - $0.2 billion - $0.2 billion) under a low scenario and $22.4 billion ($23.9 billion -

$0.6 billion - $0.9 billion). These capital costs would decrease over the course of the EHR

incentive programs as additional incentives are provided. Therefore, in 2012, the total net capital

costs for EPs would be $22.1 billion ($23.5 billion - $1.0 billion of Medicare incentives - $0.4

billion of Medicaid incentives) under the low scenario and 419.0 billion ($22.4 billion - $2.3

billion - $1.1 billion) under the high scenario.

As with EPs, for eligible hospitals and CAHs, we proposed, at section 495.8(b) of the

proposed rule, that hospitals demonstrate they are meaningful EHR users through an attestation

mechanism. As with EPs, we divided meaningful use criteria into Sets A and B. We estimated

that it would take an eligible hospital or CAH 0.5 hours to attest to the requirements in

§495.8(b)(1)(i) and (ii) including the Set A meaningful use objectives/measures, .0.5 hours to

select and attest to the hospital quality measures, and 7 hours to comply with gathering the

information, attesting and reporting Set B objectives/measures. Therefore, the estimated the total

burden for all 5,011 Medicare and Medicaid eligible hospitals and CAHs (3,620 acute care
CMS-0033-F 648

hospitals, 1,302 critical access hospitals, 78 Medicaid children’s hospitals, and 11 Medicaid

cancer hospitals) equaled 5,011 hours. For Set B objectives and measures, we estimated the total

burden at 35,077 hours.

We believed that an eligible hospital or CAH might assign an attorney to attest on their

behalf. We estimated the cost burden for an eligible hospital or CAH to attest to the Set A and

hospital quality requirements was $59.98 and the total estimated annual cost burden for all

eligible hospitals and CAHs to attest was $300,560. For Set B objectives/measures, we

estimated a per-hospital cost burden of $419.86, and a total cost burden of $2,103,918, not

including capital costs. We solicited public comments on the estimated percentages and the

numbers of (registered) eligible hospitals and CAHs that would attest in FY 2011, but we did not

receive any comments on this issue. We also invited comments on the type of personnel or staff

that would mostly likely attest on behalf of eligible hospitals and CAHs, but we did not receive

any comments on this issue.

For the final rule, as proposed, § 495.8 (b) will require demonstration of meaningful use

through an attestation mechanism. However, as with EPs, we have revised the burden estimates

due to the changes in meaningful use objectives and measures, in response to comments. Unless

an exception applies, §495.6 (b) requires that an eligible hospital or CAH must meet all 14 Stage

1 meaningful use core criteria under §495.6 (f) and five out of 10 meaningful use menu criteria

under§495.6(g). The burden associated with the requirements in §495.8 and §495.6 is the time

and effort required to attest to the required elements.

To comply with §495.8(b)(1), we estimate that it would take an eligible hospital or CAH

8 hours 42 minutes to prepare and attest that during the EHR reporting period, the hospital or

CAH used certified technology, specify the technology, and satisfied all 14 mandatory Stage 1
CMS-0033-F 649

meaningful use core criteria. We estimate that it will take an eligible hospital or CAH an extra

0.5 hours to select and attest to the hospital quality measure, in the format and manner specified

by CMS. We estimate the total burden associated with this requirement for an eligible hospital

or CAH is 9 hours 12 minutes ( 8 hours 42 minutes + 0.5 hours) and the total burden all eligible

hospitals and CAHs to attest to these requirements is 46,101 hours (9 hours 12 minutes x 5,011

hospitals). We believe an eligible hospital or CAH may use an attorney to attest on their behalf.

We estimate the associated cost burden for an eligible hospital or CAH to attest to these

requirements is $551.82 (9 hours 12 minutes x $59.98 (mean hourly rate for attorneys based on

the May 2008 Bureau of Labor Statistics)) and the total cost burden for all eligible hospitals and

CAHs to attest to these requirements is $2,765,150 ($551.82 x 5,011 hospitals and CAHs)).

We recognize that some Stage 1 meaningful use menu criteria are easier to accomplish

than others. Therefore, as with the EPs, our burden estimates are based on a “low” and “high”

scenario. Unless an exception applies, §495.6 (b) requires that an eligible hospital or CAH must

meet five out of 10 Stage 1 meaningful use menu criteria. The burden involved is the time and

effort to select and attest to the meaningful use menu-set measures. Under the “low” scenario,

we estimate it will take an eligible hospital or CAH 42 minutes to attest to five Stage 1

meaningful use menu-set measures, resulting in a total burden for all 5,011 eligible hospitals and

CAHs of 3,508 hours (5,011 hospitals x 42 minutes). Under the high scenario, we estimate it

will take an eligible hospital or CAH 3 hours 30 minutes to attest to five Stage 1 meaningful use

menu-set measures, resulting in a total burden for all 5,011 eligible hospitals and CAHs of

17,539 hours (5,011 hospitals x 3 hours 30 minutes). Based on the two scenarios, the average

burden is 2 hours 6 minutes (42 minutes + 3 hours 30 minutes)/2), and the average burden for all

eligible hospitals and CAHs is 10,523 hours (3,508 hours + 17,539 hours)/2).
CMS-0033-F 650

We believe an eligible hospital or CAH may use an attorney to attest on their behalf. For

menu-set meaningful use criteria, low scenario, we estimate the associated cost burden for an

eligible hospital or CAH is $41.99 (42 minutes x $59.98 (mean hourly rate for attorneys based on

the May 2008 Bureau of Labor Statistics)) and the total cost burden for all eligible hospitals and

CAHs is $210,392 ( $41.99 x 5,011 hospitals and CAHs)). For menu-set meaningful use criteria,

high scenario, we estimate the associated cost burden for an eligible hospital or CAH is $209.93

(3 hours 30 minutes x $59.98) and the total cost burden for all eligible hospitals and CAHs is

$1,051,959 ($209.93 x 5,011 hospitals and CAHs)). Based on the two scenarios, the average

cost burden for an eligible hospital or CAH to attest to meaningful use menu set criteria is

$125.96 ($41.99 + $209.93)/2). The average burden for all eligible hospitals and CAHs to attest

to meaningful use menu set criteria is $631,176 (($210,392 + $1,051,959)/2).

As with EPs, our proposed regulations (at §495.8(b)(2)) required that for FY 2012 and

subsequent years, eligible hospitals and CAHs demonstrate meeting most meaningful use criteria

through attestation, and electronically report hospital quality measures. As with EPs, we divided

meaningful use objectives and measures into Sets A and B. For Set A, we estimated that it

would take an eligible hospital or CAH 0.5 hours to attest to the requirements in §495.8(b)(2).

For Set B, we estimated it would take an eligible hospital or CAH 7 hours to gather information

and attest. Assuming that 5,011 hospitals might attest, we estimated that the total annual

attestation burden for all eligible hospitals and CAHs was 2,506 hours (Set A) and 35,077 hours

(Set B). We estimated the total annual cost burden for all eligible hospitals and CAHs to attest

was $150,310 (Set A) and $2,103,918 (Set B). We invited public comments on the

estimated percentages and the numbers of registered EPs that would attest to EHR technology

used in CY 2012, but we did not receive any comments on this issue.
CMS-0033-F 651

In the final rule, we also require that for FY 2012, eligible hospitals and CAHs

demonstrate meeting meaningful use criteria through attestation, except for clinical quality

measures, which must be electronically reported to CMS or the States. We do not expect growth

in the number of eligible hospitals or CAHs. The meaningful use criteria (core and menu sets)

are the same for FY 2011 and FY 2012. To comply with §495.8(b)(1), we estimate that it would

take an eligible hospital or CAH 8 hours 41 minutes to prepare and attest that during the EHR

reporting period, the eligible hospital or CAH used certified technology, specify the technology,

and satisfied all 14 mandatory Stage 1 meaningful use core criteria. We estimate the total

burden associated with this requirement for all eligible hospitals and CAHs to attest to these

requirements is 43,596 hours (8 hours 42 minutes x 5,011 hospitals). We believe an eligible

hospital or CAH may use an attorney to attest on their behalf. We estimate the associated cost

burden for an eligible hospital or CAH to attest to these requirements is $521.83 (8 hours 42

minutes x $59.98 (mean hourly rate for attorneys based on the May 2008 Bureau of Labor

Statistics)) and the total cost burden for all eligible hospitals and CAHs to attest to these

requirements is $2,614,870 ($521.83 x 5,011 hospitals and CAHs).

We recognize that some Stage 1 meaningful use menu criteria are easier to accomplish

than others. We cannot predict which of the measures in the menu criteria will be selected by an

eligible hospital or CAH. Therefore, as with EPs, our burden estimates are based on a “low” and

“high” scenario. Unless an exception applies, §495.6 (b) requires that an eligible hospital or

CAH must meet five out of 10 Stage 1 meaningful use menu criteria. The burden involved is the

time and effort to select and attest to the meaningful use menu criteria. Under the “low”

scenario, we estimate it will take an eligible hospital or CAH 42 minutes to attest to five Stage 1

meaningful use menu-set measures, resulting in a total burden of 3,508 hours (5,011 hospitals x
CMS-0033-F 652

42 minutes). Under the high scenario, we estimate it will take an eligible hospital or CAH

3 hours 30 minutes to attest to five Stage 1 meaningful use menu-set measures, resulting in a

total burden of 17,539 hours (5,011 hospitals x 3 hours 30 minutes). Based on the two scenarios,

the average burden for an eligible hospital or CAH to attest to meaningful use menu Set criteria

is 2 hours 6 minutes (42 minutes + 3 hours 30 minutes)/2), and the average burden hours for all

eligible hospitals and CAHs is 10,523 hours (3,508 hours + 17,539 hours)/2).

We believe an eligible hospital or CAH may use an attorney to attest on their behalf. For

menu-set meaningful use criteria, low scenario, we estimate the associated cost burden for an

eligible hospital or CAH is $41.99 (42 minutes x $59.98) and the total cost burden for all eligible

hospitals and CAHs is $210,392 ($41.99 x 5,011 hospitals and CAHs). For menu-set meaningful

use criteria, high scenario, we estimate the associated cost burden for an eligible hospital or CAH

is $209.93 (3 hours 30 minutes x $59.98) and the total cost burden for all eligible hospitals and

CAHs is $1,051,959 ($209.93 x 5,011 hospitals and CAHs)). Based on the two scenarios, the

average cost burden for an eligible hospital or CAH to attest to meaningful use menu set criteria

is $125.96 (($41.99 + $209.93)/2). The average burden for all eligible hospitals and CAHs to

attest to meaningful use menu set criteria is $631,175 (($210,392 + $1,051,959)/2).

Section 495.8(b)(2)(iii) requires that for FY 2012, eligible hospitals or CAHs must report

electronically to CMS, or, in the case of Medicaid hospitals, the States, clinical quality

information in the format and manner specified by CMS. Given that we limit the required

measures only to those that can be automatically calculated by a certified EHR and to those for

which we have electronic specifications currently available that we are able to post as final by

date of display of this final rule. The burden associated with this requirement is the time and

effort to report the required hospital quality measures. We estimate the burden for an eligible
CMS-0033-F 653

hospital or CAH to comply with this requirement is 0.5 hours and the total burden for all eligible

hospitals or CAHs to comply with this requirement is 2,506 hours (5,011 hospitals and CAHs x

0.5 hours). We believe that an eligible hospital or CAH may assign a medical secretary to

submit the specific hospital clinical quality measures to CMS or the States. We estimated the

cost burden for an eligible hospital or CAH to comply with this requirement is $7.40 (0.5 hours x

$14.81 (mean hourly rate of medical secretary based on may 2008 Bureau of Labor Statistics))

and the cost burden for all eligible hospitals or CAHs to comply with this requirement is $37,107

(2,506 hours x $14.81).

To estimate capital costs for eligible hospitals and CAHs, consistent with the sources

cited in section V.G.4 of this final rule, we assume that achieving meaningful use will require

roughly a $5 million capital investment for the average hospital. If 5,011 hospitals adopt these

EHRs, total capital costs prior to incentives would be roughly $25.1 billion. We also estimate

that in 2011, $0.2 billion of Medicare incentive payments and $0.4 billion of Medicaid incentive

payments would be provided to eligible hospitals and CAHs under the low scenario, and

$0.5 billion of Medicare incentive payments and $0.8 billion of Medicaid incentive payments

would be provided to eligible hospitals and CAHs under the high scenario to help offset those

costs. Therefore, we estimate that total net capital costs for hospitals in 2011 would be

$24.5 billion ($25.1 billion - $0.2 billion - $0.4 billion) under the low scenario and $23.8 billion

($25.1 billion - $0.5 billion – $0.8 billion) under the high scenario. These capital costs would

decrease over the course of the EHR incentive programs as additional incentives are provided.

Therefore, in 2012, the total net capital costs for hospitals would be $23.5 billion ($24.5 billion -

$0.9 billion of Medicare incentives - $0.1 billion of Medicaid incentives) under the low scenario,

and $21.4 billion ($23.8 billion - $2.1 billion of Medicare incentives - $0.3 billion of Medicaid
CMS-0033-F 654

incentives) under the high scenario.

Comment: Some commenters believed that CMS grossly underestimated the cost and

hour burden for EPs, eligible hospitals and CAHs to comply with meaningful use Set A and Set

B measures. Some commenters stated that we should take into consideration all the time

required to prepare all attestation of meaningful use measures, including the manual counting of

numerators and denominators in our burden estimates.

Response: Prior to and after the publication of the proposed rule, we have worked with

ONC to ensure that our meaningful use objectives/measures are well aligned with certified EHR

technology. In the final rule, we only require meaningful use measures that can be achieved by

the functionality and capability of certified EHR technology. Furthermore, based on comments,

we have explained in section II.A.2.d. of this final rule that we are including a substantial amount

of flexibility in the final rule to lower the burden for EPs, eligible hospitals and CAHs in meeting

the attestation and demonstration of meaningful use criteria. Some examples of such flexibility

are the categorization of Stage 1 meaningful use core and menu (optional) criteria, reducing the

number of meaningful use objectives/measures for 2011 and 2012, limiting the denominators, in

certain cases, only to patients whose records are maintained using certified EHR technology, and

lowering thresholds for many of the meaningful use measures. We believe these changes reduce

burden without compromising the intent of the Congress, and the ability of EHR technology to

begin to improve health care quality, efficiency, and outcomes. We have considered the

comments and we have made some revisions on our previous burden estimates. While this

requirement is subject to PRA, we have no way of accurately quantifying the burden. We will

continue to monitor the burden associated with the implementation of EHR technology as our

experience continues to grow and as EHR technology continues to evolve.

CMS-0033-F 655

Comment: CMS received numerous comments regarding the burden (economic and

other) of reporting on the large number of measures and the overall quality reporting burden this

will add to EPs and other healthcare providers. Others suggested reporting on significantly

smaller set of measures.

Response: As we have explained in section II.A.3.(d) of this final rule, we have reduced

the reporting burden by decreasing the number of required clinical quality measures and limiting

measures to those that can be automatically calculated by a certified EHR. We believe that the

proposed burden estimate, which was estimated to be an additional 0.5 hours in 2011 and 2012,

is reasonable and we are finalizing it.

Table 20 below lists the objectives and associated measures in which we estimate the

burden to fulfill “core set,” “menu set”, and clinical quality measures requirements. Estimates of

total capital costs at the bottom of Table 20 are derived from the estimates used in the “Industry

Costs” section in Section V.G.4. of this final rule.

 CMS-0033-F 656

TABLE 20: Burden and Capital Costs associated with Meaningful Use Objectives and Associated Measures

Stage 1 Objectives (EPs) Stage 1 Objectives Burden Estimate

(Hospitals) per Respondent Burden Estimate per
Stage 1 Measures (EPs) Respondent (Hospitals) Capital Costs
CORE SET
Use CPOE for medication Use CPOE for More than 30 percent of 10 minutes 10 minutes TBD - cost of a CPOE
orders directly entered by medication orders all unique patients with at module; additionally, the
any licensed healthcare directly entered by any least one medication in cost of extra functionality
professional who can licensed healthcare their medication list seen to generate numerator
enter orders into the professional who can by the EP or admitted to and denominator
medical record per state, enter orders into the the eligible hospital or information automatically
local and professional medical record per CAH’s inpatient or
guidelines state, local and emergency department
professional guidelines (POS 21or 23)have at
least one medication order
entered using CPOE
Implement drug-drug and Implement drug-drug The EP/eligible 1 minute 1 minute TBD - cost of associated
drug-allergy checks and drug-allergy hospital/CAH has enabled with medication error e-
checks this functionality for the prescribing functions
entire EHR reporting
period

Generate and transmit More than 40 percent of 10 minutes TBD - cost of an e-

permissible prescriptions all permissible prescribing system;
electronically (eRx) prescriptions written by additionally, the cost of
the EP are transmitted extra functionality to
electronically using generate numerator and
certified EHR technology denominator information
automatically
 CMS-0033-F 657

Record Demographics Record Demographics More than 50 percent of 10 minutes 10 minutes TBD – cost of
• Preferred language • Preferred all unique patients seen functionality that can
• Gender language by the EP or admitted to incorporate this
• Race • Gender the eligible hospital’s or information is coded
• Ethnicity • Race CAH’s inpatient or
• Date of birth • Ethnicity emergency department
• Date of birth (POS 21 or 23) have
• Date and demographics recorded
preliminary cause as structured data
of death in the
event of mortality
in the eligible
hospital or CAH
Maintain an up-to-date Maintain an up-to-date More than 80 percent of 10 minutes 10 minutes TBD - cost of
problem list of current and problem list of current all unique patients seen functionality that can
active diagnoses and active diagnoses by the EP or admitted to incorporate diagnoses in
the eligible hospital’s or coded format
CAH’s inpatient or
emergency department
(POS 21 or 23) have at
least one entry or an
indication that no
problems are known for
the patient recorded as
structured data.
Maintain active medication Maintain active More than 80 percentof all 10 minutes 10 minutes TBD - cost of
list medication list unique patients seen by functionality that can
the EP or admitted to the incorporate medication
eligible hospital’s or information in coded
CAH’s inpatient or format
emergency department
(POS 21 or 23) have at
least one entry (or an
indication that the patient
is not currently prescribed
any medication) recorded
as structured data
 CMS-0033-F 658

Maintain active medication Maintain active More than 80 percent of 10 minutes 10 minutes TBD - cost of
allergy list medication allergy list all unique patients seen functionality that can
by the EP or admitted to incorporate medication
the eligible hospital’s or allergy information in
CAH’s inpatient or coded format
emergency department
(POS 21 or 23) have at
least one entry (or an
indication that the patient
has no known medication
allergies) recorded as
structured data
Record and chart changes Record and chart For more than 50 percent 10 minutes 10 minutes TBD - cost of
in vital signs: changes in vital signs: of all unique patients age functionality that can
• Height • Height 2 and over seen by the EP incorporate this
• Weight • Weight or admitted to eligible information in coded
• Blood pressure • Blood pressure hospital’s or CAH’s format
• Calculate and display • Calculate and inpatient or emergency
BMI display BMI department (POS 21 or
• Plot and display growth • Plot and display 23), height, weight and
charts for children 2-20 growth charts for blood pressure are
years, including BMI children 2-20 recorded as structure data
years, including
BMI
Record smoking status for Record smoking status More than 50 percentof all 10 minutes 10 minutes TBD - cost of
patients 13 years old or for patients 13 years unique patients 13 years functionality that can
older old or older old or older seen by the incorporate this
EP or admitted to the information in coded
eligible hospital’s or format
CAH’s inpatient or
emergency department
(POS 21 or 23) have
“smoking status” recorded
Implement one clinical Implement one clinical Implement one clinical 1 minute 1 minute TBD - cost associated
decision support rule decision support rule decision support rule with clinical decision
relevant to specialty or relevant to specialty or support functionality
high clinical priority with high clinical priority
the ability to track with the ability to track
compliance to that rule compliance to that rule
 CMS-0033-F 659

Report ambulatory quality Report hospital quality For 2011, provide 10 minutes 10 minutes
measures to CMS or the measures to CMS or aggregate numerator and
States the States denominator through
attestation as discussed in TBD - cost of the
section II(A)(3) of the final functionality to capture
rule and report on quality
For 2012, electronically measures
submit the measures as
discussed in section
II(A)(3) of the final rule

Provide patients with an Provide patients with More than 50 percentof all 10 minutes 10 minutes
electronic copy of their an electronic copy of patients of the EP or the
health information their health information inpatient or emergency
(including diagnostic test (including diagnostic departments of the eligible
results, problem list, test results, problem hospital or CAH (POS 21
medication lists, allergies), list, medication lists, or 23) who request an
upon request allergies, discharge electronic copy of their
summary, health information are
procedures), upon provided it within 3
request business days
Provide patients with More than 50 percent of 10 minutes
an electronic copy of all patients who are
their discharge discharged from an TBD - cost an EHR
instructions at time of eligible hospital or CAH’s system capable of
discharge, upon inpatient or emergency storing this information
request department (POS 21 or and transmitting it to
23) and who request an patients
electronic copy of their
discharge instructions are
provided it
 CMS-0033-F 660

Provide clinical summaries Clinical summaries 10 minutes TBD - cost an EHR

for patients for each office provided to patients for systems capable of
visit more than 50 percent of storing this information
all office visits within 3 and transmitting to
business days patients

Capability to exchange Capability to exchange Performed at least one 1 hour 1 hour TBD - cost an EHR
key clinical information (for key clinical information test of certified EHR system capable of
example, problem list, (for example, technology's capacity to storing this information
medication list, allergies, discharge summary, electronically exchange and transmitting to
diagnostic test results), procedures, problem key clinical information providers and patient
among providers of care list, medication list, authorized entities
and patient authorized allergies, diagnostic
entities electronically test results), among
providers of care and
patient authorized
entities electronically
*Protect electronic health *Protect electronic Conduct or review a 6 hours 6 hours N/A as conducting or
information created or health information security risk analysis per reviewing a security risk
maintained by the certified created or maintained 45 CFR 164.308 (a)(1) analysis does not
EHR technology through by the certified EHR and implement security necessarily hinge on the
the implementation of technology through the updates as necessary and purchase
appropriate technical implementation of correct identified security
capabilities appropriate technical deficiencies as part of its
capabilities risk management process
CORE SET BURDEN 9 hours 2 minutes 8 hours 42 minutes

MENU SET
 CMS-0033-F 661

Implement drug-formulary Implement drug- The EP/eligible 1 minute 1 minute TBD - cost of associated
checks formulary checks hospital/CAH has with medication error e-
enabled this prescribing functions
functionality and has
access to at least one
internal or external
drug formulary for the
entire EHR reporting
period
Record advance More than 50 percentof 1 minute
directives for patient all unique patients 65
65 years old or older years old or older
admitted to the eligible
hospital’s or CAH’s
inpatient department
(POS 21) have an
indication of an
advance directive
status recorded
Incorporate clinical lab-test Incorporate clinical More than 40 percentof 10 minutes 10 minutes TBD - cost of extra
results into EHR as lab-test results into all clinical lab tests functionality to generate
structured data EHR as structured results ordered by the numerator and
data EP or by an authorized denominator information
provider of the eligible automatically
hospital or CAH for
patients admitted to its
inpatient or emergency
department (POS 21
or 23) during the EHR
reporting period whose
results are either in a
positive/negative or
numerical format are
incorporated in certified
EHR technology as
structured data
 CMS-0033-F 662

Generate lists of patients by Generate lists of Generate at least one 10 minutes 10 minutes TBD – cost of having an
specific conditions to use patients by specific report listing patients of EHR registry function
for quality improvement, conditions to use for the EP, eligible
reduction of disparities, quality improvement, hospital, or CAH with a
research or outreach reduction of specific condition.
disparities, research
or outreach

Send reminders to patients More than 20 percentof 1 minute TBD - cost of

per patient preference for all unique patients 65 functionality to send
preventive/ follow up care years or older or 5 reminders to patients
years old or younger
were sent an
appropriate reminder
during the EHR
reporting period
 CMS-0033-F 663

Provide patients with timely More than 10 percentof 10 minutes TBD - cost an EHR
electronic access to their all unique patients seen system capable of
health information (including by the EP are provided storing this information
lab results, problem list, timely (available to the and making it
medication lists, allergies) patient within four continuously available to
within four business days of business days of being patients
the information being updated in the certified
available to the EP EHR technology)
electronic access to
their health information
subject to the EP’s
discretion to withhold
certain information
Use certified EHR Use certified EHR More than 10 percentof 10 Minutes 10 Minutes
technology to identify technology to identify all unique patients seen
patient-specific education patient-specific by the EP or admitted
resources and provide education resources to the eligible hospital’s
those resources to the and provide those or CAH’s inpatient or
patient if appropriate resources to the emergency department
patient if appropriate (POS 21 or 23) are
provided patient-
specific education
resources
The EP, eligible hospital or The EP, eligible The EP, eligible 10 minutes 10 minutes TBD - cost an e-
CAH who receives a patient hospital or CAH who hospital or CAH prescribing system
from another setting of care receives a patient performs medication capable of medication
or provider of care or from another setting reconciliation for more reconciliation
believes an encounter is of care or provider of than 50 percent of
relevant should perform care or believes an transitions of care in
medication reconciliation encounter is relevant which the patient is
should perform transitioned into the
medication care of the EP or
reconciliation admitted to the eligible
hospital’s or CAH’s
inpatient or emergency
department (POS 21 or
23)
 CMS-0033-F 664

The EP, eligible hospital or The EP, eligible The EP, eligible 10 minutes 10 minutes
CAH who transitions their hospital or CAH who hospital or CAH who
patient to another setting of transitions their transitions or refers
care or refers their patient patient to another their patient to another
to another provider of care setting of care or setting of care or
should provide summary refers their patient to provider of care should TBD - cost an EHR
care record for each another provider of provides summary of system capable of
transition of care and care should provide care record for more storing this information
referral summary care record than 50 percent of and transmitting it to
for each transition of transitions of care and patients
care and referral referrals
Capability to submit Capability to submit Performed at least one 1 hour 1 hour TBD - cost associated
electronic data to electronic data to test of certified EHR with functionality that can
immunization registries or immunization technology's capacity capture immunization
Immunization Information registries or to submit electronic information and submit
Systems and actual Immunization data to immunization that information to
submission according to Information Systems registries and follow up immunization registries
applicable law and practice and actual submission if the test is
submission successful (unless
according to none of the
applicable law and immunization registries
practice to which the EP,
eligible hospital or CAH
submits such
information have the
capacity to receive the
information
electronically)
 CMS-0033-F 665

Capability to provide Performed at least one 1 hour TBD - cost associated

electronic submission test of certified EHR with functionality that can
of reportable (as technology’s capacity capture lab results
required by state or to provide electronic information and submit
local law) lab results submission of that information to public
to public health reportable lab results to health agencies
agencies and actual public health agencies
submission and follow-up
according to submission if the test is
applicable law and successful (unless
practice none of the public
health agencies to
which eligible hospital
or CAH submits such
information have the
capacity to receive the
information
electronically)
Capability to provide Capability to provide Performed at least one 1 hour 1 hour TBD - cost associated
electronic syndromic electronic syndromic test of certified EHR with functionality that can
surveillance data to public surveillance data to technology's capacity capture syndromic
health agencies and actual public health to provide electronic surveillance data and
transmission according to agencies and actual syndromic surveillance submit that information
applicable law and practice transmission data to public health to public health agencies
according to agencies and follow-up
applicable law and submission if the test is
practice successful (unless
none of the public
health agencies to
which an EP. eligible
hospital or CAH
submits such
information have the
capacity to receive the
information
electronically)
Hospital: $5 million to
MENU SET LEAST BURDENSOME CRITERIA 42 minutes 42 minutes install; $1 million annual
maintenance/
training costs
 CMS-0033-F 666

MENU SET MOST BURENSOME CRITERIA 2 hours 40 minutes 3 hours 30 minutes

Time to Attest to & Report CQM 30 minutes 30 minutes

TOTAL – CORE SET (including CQM) + LEAST BURDENSOME MENU

10 hours 14 minutes 9 hours 54 minutes
SET CRITERIA

TOTAL – CORE SET(including CQM) + MOST BURENSOME MENU SET

12 hours 12 minutes 12 hours 42 minutes
CRITERIA
*This burden estimate assumes that covered entities are already conducting and reviewing these risk analyses under current HIPAA regulations. Therefore, we
have not accounted for additional burden associated with the conduct or review of such analyses.
CMS-0033-F 667

B. ICRs Regarding Participation Requirements for EPs, Eligible Hospitals, and CAHs (§495.10)

Since the EHR incentive payment program is new, we do not have enough information to

estimate the information collection requirements burden beyond the first payment year for an EP,

eligible hospital, or CAH for this provision. Furthermore, the EPs, eligible hospitals, and CAHs

can enroll any time during the first 5 years; therefore, it is difficult to predict with certainty the

burden beyond the first payment year as the burden depends on the number of participants.

Therefore, we provide a best estimate of what we believe the burden associated with this

provision might be.

For the proposed rule, §495.10 (a) through (c), we estimated that all 442,600 non-

hospital-based Medicare, and Medicaid EPs would register in 2011 to receive an EHR incentive

payment, and that it would take no more than 0.5 hours to complete the registration, resulting in

a total estimated annual registration burden for all EPs of 221,300 hours (442,600 EPs x

0.5 hours). As we could not predict whether an EP or a medical secretary (on the EP’s behalf)

would register, we did one high-end and one low-end burden estimate. The cost burden for an

EP who chose to register in the EHR incentive payment program himself or herself was $39.67

(0.5 hours x $79.33 (mean hourly rate for physicians based on the May 2008 Bureau of Labor

Statistics)), with a total estimated annual cost burden for all EPs of $17,555,729 (221,300 hours

x $79.33). Similarly, the cost burden for an EP who chose to use a medical secretary to register

on their behalf was $7.41 (0.5 hours x $14.81), with a total estimated annual cost burden for all

EPs of $3,277,453 (221,300 hours x $14.81). We used the average of the two estimates in the

tally in Table 34 of the proposed rule. We invited comments on whether we should use the

higher cost burden estimate ($17,555,729) or the lower cost burden estimate ($3,277,453), but

we did not receive any comments on this issue. We invited public comments on the
CMS-0033-F 668

estimated percentages or the numbers of EPs that will register in CY 2011 and subsequent years,

but we did not receive any comments on this issue.

We are finalizing both the lower cost estimate using the medical secretary as the

personnel registering for the EP and the high cost estimate of the EP registering him or herself.

Due to the revised estimates of non-hospital-based EPs eligible for the EHR incentive program,

we are revising our burden estimates to reflect this change. In the final rule, we estimate that

521,600 non-hospital-based Medicare, and Medicaid EPs may register in CY 2011 to receive an

EHR incentive payment. We believe that an EP may use a medical secretary to register on

his/her behalf (low burden) or the EP may register him or herself (high burden). We estimate

that it would take no more than 0.5 hours to complete the registration. The low cost burden for a

medical secretary to register an EP is $7.41 (0.5 hours x $14.81 (mean hourly rate of medical

secretaries based on the May 2008 Bureau of Labor statistics)). The total estimated annual

registration burden hours for the low cost estimate is 260,800 (521,600 EPs x 0.5 hours) in the

first payment year. The total estimated low cost burden for all EPs to register in CY 2011 is

$3,862,448 (260,800 hours x $14.81). The high cost burden for an EP to register him or herself

is $39.67 (0.5 hours x $79.33 (mean hourly rate for physicians based on the May 2008 Bureau of

Labor Statistics)). In the first payment year, the total estimated annual registration burden hours

for the high cost estimate is 260,800 (521,600 EPs x 0.5 hours). The total estimated high cost

burden for all EPs to register in CY 2011 is $20,689,264 (260,800 hours x $79.33). We only use

the average of the two estimates in the tally in Table 34.

Section 495.10(d) proposed that if there were subsequent changes in the initial registration

information, the EP was responsible for providing us with updated changes in the manner

specified by us. Based on our experience with provider enrollment, we estimated that about
CMS-0033-F 669

11 percent of the Medicare and Medicaid EPs might need to update their registration information

during a 1-year period. We estimated that 49,214 EPs (11 percent) might only have one occasion

that required updating of information in a given year. For each occasion, we estimated that it

would take no more than 0.5 hours to notify us of the changes. With that, we estimated that the

annual total burden hours for 49,214 EPs to update changes were 24,607. However, we could

not predict if the EP would update the registration information himself or herself or assign a

medical secretary to do it. Therefore, we did two burden estimates for an EP and his/her medical

secretary. The cost burden for an EP who chose to update the registration information himself or

herself was $39.67. The total estimated annual cost burden for all 49,214 EPs to update

registration information themselves was $1,952,073. Similarly, the cost burden for the EP who

chose to use a medical secretary to update registration information on his/her behalf was $7.41.

The total estimated annual cost burden for 49,214 EPs who chose to use medical secretaries to

update registration information on their behalf was $364,429. We used the average of the two

estimates in the tally in Table 34. We invited comments on whether we should use the higher

cost burden estimate ($1,952,073) or the lower cost burden estimate ($364,429) but we did not

receive any comments on this issue. We also invited public comments on the

estimated percentages and the numbers of EPs that will need to submit subsequent registration

changes to us over the course of the EHR incentive payment program but we did not receive any

comments on this issue.

We are finalizing both the lower cost estimate using the medical secretary as the

personnel to update registration information for the EP and the high cost estimate of the EP

updating their registration information. Due to the revised estimates of non-hospital-based EPs

eligible for the EHR incentive program pursuant to legislative inclusion of EPs who practice in
CMS-0033-F 670

outpatient hospital setting, we are revising our burden estimate for this requirement to reflect this

change. In the final rule, we estimate that about 11 percent of the Medicare and Medicaid EPs

may need to update their registration information during a 1-year period. We estimate that

57,998 EPs (527,254 (revised estimated number of EPs for CY 2012) x 11 percent) may only

have one occasion that requires them to update their information in a given year. For each

occasion, we estimate that it will take no more than 0.5 hours to notify us of the changes. With

that, we estimate that the annual total burden hours for 57,998 EPs to update registration changes

are 28,999. The lower cost burden estimate for a medical secretary to update an EP’s registration

is $7.41 ($14.81 (mean hourly rate for medical secretary based on the May 2008 Bureau of Labor

Statistics) x 0.5 hours). The total lower cost burden for all EPs to update registration information

is $429,475 (28,999 hours x $14.81). The high cost burden for an EP to update their own

registration information is $39.67 (0.5 hours x $79.33 (mean hourly rate for physicians based on

May 2008 Bureau of Labor Statistics)). The total estimated annual high cost burden to update

registration information is $2,300,491 (28,999 hours x $79.33). We only use the average of the

two estimates in the tally in Table 34.

In § 495.10(a) and (b), we estimate that in FY 2011, there are 5,011 Medicare and

Medicaid eligible hospitals, and CAHs that may be qualified to receive EHR incentive payment.

Since we cannot predict how many eligible hospitals, and CAHs will participate in the EHR

incentive payment program, we estimate that all 5,011 hospitals may register for the incentive

program for burden estimate purposes. We estimate that it would take no more than 0.5 hours

for an eligible hospital or CAH to register. We estimate the total annual burden hours for

registration will be 2,506 (5,011 hospitals x 0.5 hours). Once the decision to participate in the

incentive program is made, we believe eligible hospitals or CAHs may assign a medical
CMS-0033-F 671

secretary to submit the registration information. The cost burden for an eligible hospital or CAH

to register is $7.41 (0.5 hours x $14.81 (mean hourly rate for medical secretaries based on the

May 2008 Bureau of Labor Statistics)). We estimate that the total annual cost burden for eligible

hospitals and CAHs to register is $37,106 (5,011 hospitals x 0.5 hours x $14.81) (mean hourly

rate for medical secretaries based on the May 2008 Bureau of Labor Statistics)). We invited

public comments on the estimated percentages or the number of eligible hospitals and CAHs that

will register for the EHR incentive payment program in 2011 and subsequent years but we did

not receive any comments on this issue. We are finalizing the burden estimates as proposed.

In §495.10(d), we proposed that if there were subsequent changes in the initial

registration information, the eligible hospital or CAH was responsible for providing us with

updated information in the manner specified by us. Based on our experience with provider

enrollment, we estimated that about 8 percent of the Medicare and Medicaid eligible hospitals

and CAHs (5,011 hospitals and CAHs x 8 percent = 401 hospitals) might need to update their

registration information during a 1-year period. We estimated that eligible hospitals in this

8 percent pool might only have 1 occasion that required updating of registration information in a

given year. For each occasion, we estimated that it would take no more than 0.5 hours to notify

us of the changes. With that, we estimated that the total annual burden hours for eligible

hospitals and CAHs to update CMS of registration changes were 201 (401 hospitals and CAHs x

0.5 hours). We believe that eligible hospitals or CAHs might assign a medical secretary to

update the registration information. We estimated the total annual cost burden for eligible

hospitals and CAHs to update CMS of registration changes is $2,969 (401 hospitals and CAHs x

0.5 hours x $14.81) (mean hourly rate for medical secretaries based on the May 2008 Bureau of

Labor Statistics)). We invited public comments on the estimated percentages and the numbers of
CMS-0033-F 672

eligible hospitals and CAHs that will submit subsequent registration changes to us over the

course of the EHR incentive payment program but we did not receive any comments on this

issue. We are finalizing the estimated burden for hospital and CAHs that will be making

subsequent registration changes for FY 2012 as proposed.

In §495.10 (e)(1), we proposed that for participation in the EHR incentive payment

programs, prior to the first payment year, an EP must notify us in a specified manner as to

whether he or she elects to participate in the Medicare or Medicaid EHR incentive program. We

estimated that in 2011, there would be about 80,900 dual Medicare/Medicaid EPs who might

make the initial Medicare and Medicaid program selection. The standard full amount of

Medicaid incentive payments that an EP could receive is larger than the standard full amount for

the Medicare EP incentive payments. Therefore, for burden estimate purposes, we believed that

all of the 80,900 dual Medicare/Medicaid EPs might make the Medicaid program selection. We

estimated that it would take no more than 0.5 hours to submit the initial Medicare or Medicaid

selection notification to us. We could not predict if the EP would submit the notification to CMS

himself or herself or assign a secretary to do it. Therefore, we did one high end estimate and one

low end burden estimate for an EP and a medical secretary respectively. The total estimated

burden hours for all the dual Medicare/Medicaid EPs to notify CMS of program selection were

40,450 in the first payment year. The cost burden for these EPs who notify CMS of Medicare or

Medicaid program selection himself or herself was $39.67. The total estimated annual cost

burden for all dual Medicare/Medicaid EPs to notify CMS of program selection themselves was

$3,208,899. Similarly, the cost burden for an EP who chose to use a medical secretary to notify

CMS of program selection was $7.41. The total estimated annual cost burden for all dual

Medicare/Medicaid EPs who use medical secretaries to notify CMS of program selection was
CMS-0033-F 673

$599,065. We used the average of the two estimates in the tally in Table 34. We invited

comments on whether we should use the higher cost burden estimate ($3,208,899) or the lower

cost burden estimate ($599,065), but we did not receive any comments on this issue. We also

invited public comments on the estimated percentages and the number of dual

Medicare/Medicaid EPs that would submit initial Medicare or Medicaid program selection in

2011, 2012, 2013, or 2014 but we did not receive any comments.

In the final rule, we are finalizing both the low burden cost estimate using a medical

secretary for dual-Medicare/Medicaid EPs to notify CMS of program selection and the high

burden cost estimate of an EP who may do this him or herself. We have revised the total number

of dual-Medicare/Medicaid EPs and the associated burden estimates pursuant to the legislative

inclusion of EPs, who practice in outpatient hospital, in the incentive program. We estimate that

in CY 2011, there will be 95,500 dual Medicare/Medicaid EPs who may use a medical secretary

to notify CMS of the initial Medicare and Medicaid program selection. We estimate that it

would take no more than 0.5 hours to submit the initial Medicare or Medicaid selection

notification to us. The estimated burden for all the dual-Medicare/Medicaid EPs to comply with

this requirement is 47,750 hours (95,500 EPs x 0.5 hours). The associated low cost burden for a

dual-Medicare/Medicaid EP is $7.41 (0.5 hours x $14.81 (mean hourly rate for medical

secretaries based on May 2008 Bureau of Labor Statistics) and the total low cost burden for all

the dual-Medicare/Medicaid EPs is $707,178 (47,750 hours x $14.81). The associated high cost

burden for a dual-Medicare/Medicaid EP is $39.67 (0.5 hourss x $79.33 (mean hourly rate for

physicians based on the May 2008 Bureau of Labor Statistics)) and the total high cost burden

estimate for all dual-Medicare/Medicaid EPs is $3,788,008 (47,750 hours x $79.33). We only

use the average of the two estimates in the tally in Table 34.
CMS-0033-F 674

In §495.10(e)(2) we proposed that EPs might switch from Medicare to Medicaid EHR

incentive program or vice versa one time, and only for payment year 2014 or earlier. The burden

associated with this requirement was the time required for the EP to make the

Medicare/Medicaid program selection. Since we had no knowledge of how many EPs will make

the subsequent changes in program selection, we assumed that all 81,700 (estimated number of

dual-Medicare/Medicaid EPs for CY 2012) dual Medicare/Medicaid EPs might make subsequent

program selection changes for burden estimate purposes. We estimated that it would take no

more than 0.5 hours to submit the Medicare/Medicaid selection change to us. We could not

predict if the EP would submit the change to CMS himself or herself or assign a secretary to do

it. Therefore, we did one high end burden estimate for an EP and one low end estimate for a

medical secretary. We used the average of the two estimates in the tally in Table 34. The total

estimated burden hours for all dual-Medicare/Medicaid EPs to notify CMS of program changes

were 40,850 in a given year. The higher cost burden for the EP who chose to notify CMS of

Medicare/Medicaid program change him or herself was $39.67. The total estimated annual cost

burden for all dual Medicare/Medicaid EPs to notify CMS of program changes themselves was

$3,240,630. Similarly, the lower cost burden for an EP who chose to use a medical secretary to

notify CMS of program changes was $7.41. The total estimated annual cost burden for all dual-

Medicare/Medicaid EPs who use medical secretaries to notify CMS of program changes was

$604,989. We invited comments on whether we should use the higher cost burden estimate

($3,240,630) or the lower cost burden estimate ($604,989) but we did not received any

comments on this issue. We also invited comments on the estimated percentages and the number

of dual-Medicare/Medicaid EPs that would submit initial Medicare or Medicaid program

changes in 2012, 2013, or 2014 but we did not receive any comments on this issue.
CMS-0033-F 675

We are finalizing both the lower cost burden for EPs for may assign medical secretaries

as the personnel to submit Medicare/Medicaid program selection changes to CMS and the high

cost burden for EPs who may do this him or herself. We revised our burden estimates and the

number of dual-Medicare/Medicaid EPs, pursuant to legislative inclusion of EPs who practice at

outpatient hospital setting in the incentive program. For CY 2012, we estimate that there will be

96,500 dual-Medicare/Medicaid EPs. The notification will take 0.5 hours and the total burden

for all dual-Medicare/Medicaid EPs will be 48,250 hours (96,500 EPs x 0.5 hours). The lower

cost burden for each EP is $7.41 (0.5 hours x $14.81 (mean hourly rate for medical secretaries

based on the May 2008 Bureau of Labor Statistics) and the total lower cost burden for all the

dual-Medicare/Medicaid EPs will be $714,583 (48,250 hours x $14.81). The high cost burden

for each EP is $39.67 (0.5 hours x $79.33 (mean hourly rate for physicians based on the

May 2008 Bureau of Labor Statistics)) and the total high cost burden for all dual-

Medicare/Medicaid EPs is $3,827,673 (48,250 hours x $79.33). We only use the average of the

two estimates in the tally in Table 34.

C. ICRs Regarding Identification of Qualifying MA Organizations, MA-EPs and MA-affiliated

Eligible Hospitals (§495.202)

Section 495.202(a)(1) states that beginning with bids due in June 2011 (for plan

year 2012), MA organizations seeking reimbursement for qualifying MA EPs and qualifying

MA-affiliated eligible hospitals under the MA EHR incentive program are required to identify

themselves to CMS in a form an manner specified by CMS, as part of submissions of initial bids

under section 1854(a)(1)(A) of the Act. There is no burden associated with this requirement for

qualifying MA organizations offering MA HMO plans, since they are deemed to meet the

definition of HMO in 42 U.S.C. 300gg-91(b)(3) of the PHS Act in accordance with

CMS-0033-F 676

§495.202(a)(2). However, per §495.202(a)(3), for MA organizations offering types of MA plans

other than HMOs, the burden is the amount of time it will take them to attest to the fact that they

meet the definition of HMO in 42 U.S.C. 300gg-91(b)(3). We believe the burden associated

with this requirement for MA organizations not offering HMO type plans would be

approximately 1 hour per MA organization. We do not believe that there are any MA

organizations that are not offering MA HMO type plans that will request reimbursement for

qualifying MA EPs or MA-affiliated eligible hospitals under the MA EHR incentive payment

program. Although the timeframe goes beyond the effective date of the proposed information

collection period (3 years from the effective date of the final rule), we do not believe there are

any MA organizations with potentially qualifying MA EPs or potentially qualifying

MA-affiliated eligible hospitals that will need to report to us beginning in 2014 (for plan year

2015) per §495.202(a)(4). Therefore, we believe there will be no burden associated with

identification of qualifying MA organizations per §495.202(a)(1) through (4).

Section 495.202(b)(1) and (2) require a qualifying MA organization, as part of its initial

bid starting with its bid for plan year 2012, to make preliminary identification of potentially

qualifying MA EPs and potentially qualifying MA-affiliated eligible hospitals for which the

organization is seeking incentive payments for the current plan year (2011). The burden

associated with this requirement would be the time required for a MA organization to identify

their MA-affiliated hospitals to CMS. In the proposed rule, we explained that when MAOs

identify amounts of compensation per §422.204(b)(2) and (5) they will also be identifying MA

EPs per this requirement, and therefore there is will be no additional burden related to this

requirement with respect to MA EPs. There are approximately 29 MA-affiliated eligible

hospitals and approximately 12 MA organizations, or an average of 2.42 eligible hospitals for

CMS-0033-F 677

each MA organization. In the proposed rule, we estimated that the total burden hours for all MA

organizations to identify their affiliated hospitals to CMS would be 3 hours. We believe a MA

organization may use a billing clerk to identify the eligible hospital to us. The total cost burden

for all MA organizations to identify their eligible hospitals to us would be $46.32.

Sections 495.202(b)(1) and (2), state that a MA organization, as part of its initial bid

starting with plan year 2012, must make a preliminary identification of potentially qualifying

MA EPs and potentially qualifying MA-affiliated eligible hospitals for which the organization is

seeking incentive payments for the current plan year. A qualifying MA organization must

provide the following information on their MA-affiliated EPs and eligible hospitals: (A) name of

the EP or eligible hospital; (B) address of the EP’s practice or eligible hospital’s location; and

(C) NPI. We believe that it is within the customary business practices of an MA organization to

keep the information in (A), (B), and (C) on file. The burden associated with this requirement

would be the time required to provide this information to CMS along with an attestation that the

MA EPs or MA-affiliated eligible hospitals meet the eligibility criteria. In the proposed rule, we

estimated that it would take 0.5 hours for a MA organization to comply with this attestation

requirement. We estimated that the total burden for all MA organizations to attest would be

6 hours. We believe that MA organizations may use an attorney to attest on their behalf. In the

proposed rule, we estimated that the cost burden for a MA organization to attest is $29.99 and

the total estimated cost burden for all MA organizations to attest would be $359.88.

Section 495.202(b)(4) states that all qualifying MA organizations, as part of their initial

bids in June 2015 for plan year 2016, must identify potentially qualifying MA EPs and

potentially qualifying MA-affiliated eligible hospitals. An attestation that each professional or

hospital either meets or does not meet the eligibility criteria must be included as part of the
CMS-0033-F 678

identification submission. We cannot estimate the collection burden for this requirement as the

timeframe goes beyond the scope of the effective date of the proposed information collection

period (3 years from the effective date of the final rule).

D. ICRs Regarding Incentive Payments to Qualifying MA Organizations for MA-EPs and

Hospitals (§495.204)

Section 495.204(b)(2) requires a qualifying MA organization to report to CMS within 60

days of the close of the calendar year, the aggregate annual amount of revenue attributable to

providing services that would otherwise be covered as professional services under Part B

received by each qualifying MA EP for enrollees in MA plans of the MA organization in the

payment year. Since the tracking of salaries or compensation for MA EPs constitutes usual and

customary business practices, the only burden associated with this requirement would be the time

required to submit the aggregated annual amount of revenue received by each qualifying MA EP

for enrollees in MA plans of the MA organization. In the proposed rule, we estimated that there

were 12 MA organizations and 28,000 MA EPs. We believe that it will take a MA organization

40 hours annually to report the required aggregate revenue data for all its salaried MA EPs, given

that all the data are readily available. The total estimated annual burden hours for all MA

organizations to comply with this requirement would be 480. We believe MA organizations may

involve a billing clerk to report the required data to CMS. We estimated that the cost burden for

a MA organization to report was $617.6 (40 hours x $15.44 (mean hourly rate of billing clerk

based on the May 2008 Bureau of Labor Statistics)) and we estimated the total annual cost

burden for all MA organizations to comply with this requirement would be $7,411.

Section 495.204(b)(4) states that for qualifying MA EPs who are compensated on a

salaried basis, CMS requires the qualifying MA organization to develop a methodology for
CMS-0033-F 679

estimating the portion of each qualifying MA EP’s salary attributable to providing services that

would otherwise be covered under Part B to MA plan enrollees of the MA organization. The

methodology: (i) must be approved by CMS; (ii) may include an additional amount related to

overhead, where appropriate, estimated to account for the MA-enrollee related Part B practice

costs of the salaried qualifying MA EP; and (iii) methodological proposals must be submitted to

CMS by June of the payment year and must be auditable by an independent third party. CMS

will review and approve or disapprove such proposals in a timely manner. In the proposed rule,

we estimated that it might take a MA organization one and a half hour to develop the

methodology. We estimated that there are about two MA organizations that may have the need

to develop the methodology. We estimated the total burden hours for the two MA organizations

to develop the methodology would be 3 hours. We believed that a MA organization may use an

accountant to develop the methodology. We estimated the cost burden for a MA organization

was $47.48 (1.5 hours x $31.65 (mean hourly rate for accountants based on the May 2008

Bureau of Labor Statistics)), and the total cost burden for the two MA organizations to develop

the methodology would be $94.95 (47.48 x 2 MA organizations).

Section 495.204(b)(5) states that for qualifying MA EPs who are not salaried, qualifying

MA organizations may obtain and submit to CMS, attestations from such qualifying MA EPs as

to the amount of compensation received by such EPs for MA plan enrollees of the MA

organization. We estimate that about 10 percent of the MA EPs were not salaried and that was

an average of 233 non-salaried EPs in each MA organization. Further, we estimate that it might

take 0.25 hour to electronically obtain and compile each attestation into a document for

transmission to CMS. We estimate the total burden hours for a MA organization would be 58.3,

and the total estimated burden hours for all MA organizations would be 699.6 (58.3 hours x 12
CMS-0033-F 680

MA organizations). We believe an MA organization may involve a billing clerk to compile and

submit the compensation information from such attestations. We estimate the cost burden for a

MA organizations to comply with this requirement would be $900.15 (58.3 hours x $15.44

(mean salary of a billing clerk based on the May 2008 Bureau of Labor Statistics)). We estimate

the total annual cost burden for all MA organizations to comply with this requirement would be

$10,801.82 ($900.15 x 12 MA organizations).

Section 495.204(b)(6) states that for qualifying MA EPs who are not salaried, qualified

MA organizations may also have qualifying MA EPs send MA organization compensation

information directly to CMS. We estimated the burden associated with this requirement is the

time it would take the MA EP to send the information directly to CMS. However, we believe

that the non-salaried MA EPS are employed by a third-party physician group which will be

responsible for sending the required information to CMS. Again, we estimate that about

10 percent of the MA EPs are not salaried and that there is an average of 233 non-salaried EPs in

each of the third-party physician groups. Further, we estimate that it might take 0.25 hour to

electronically obtain and compile the information into a document for transmission to CMS. We

estimate the total burden hours for a third-party physician group will be 58.3, and the total

estimated burden hours for all third-party physician groups will be 699.6(58.3 hours x 12

third-party physician group). We believe a third-party physician group may involve a billing

clerk to compile and submit the compensation information. We estimate the cost burden for a

third-party physician group to comply with this requirement will be $900.15 (58.3 hours x

$15.44 (mean salary of a billing clerk based on the May 2008 Bureau of Labor Statistics)). We

estimate the total annual cost burden for all third-party physician groups to comply with this

requirement will be $10,801.82 ($900.15 x 12 third-party physician groups). Note that this is the
CMS-0033-F 681

same burden we estimate with respect to §422.204(b)(5). Further, an MAO will either submit

non-salary information directly to CMS, or it will have someone else do it on behalf of the MA

EPs with respect to that MAO. We believe the burden related to §422.204(b)(6) is counted in the

burden we already projected with respect to §422.204(b)(5). We do not believe any MAO will

submit under both §422.204(b)(5) and (6).

E. ICRs Regarding Meaningful User Attestation (§495.210)

Section 495.210(b) requires qualifying MA organizations to attest within 60 days after

the close of a calendar year whether each qualifying MA EP is a meaningful EHR user. We

anticipate that the adopted EHR technology will capture the data for determination whether each

qualifying MA EP is a meaningful EHR user. We estimate the burden associated with this

requirement would be the time necessary to attest to the required information. We estimated that

there were approximately 12 MA organizations and approximately 28,000 MA EPs, or an

average of approximately 2,333 MA EPs affiliated with each qualifying MA organization. We

believe that it would take a MA organization about 40 hours annually to attest whether each

qualifying MA EP is a meaningful user, given that all the data are captured in the certified EHR

technology and that meaningful use will be demonstrated through the continued reporting of

HEDIS data. We estimate the total estimated annual burden hours for all MA organizations to

comply with this requirement will be 480. We believe MA organizations might involve an

attorney to attest on their behalf. We estimate the cost burden for a MA organization to attest

will be $2,399 (40 hours x $59.98 (mean hourly rate of attorney based on the May 2008 Bureau

of Labor Statistics)). We estimate the total annual cost burden for all MA organizations to

comply with attestation for MA EPs will be $28,790.

CMS-0033-F 682

Section 495.204(c)(2) states that to the extent data are available, qualifying MA

organizations must receive hospital incentive payments through their affiliated hospitals under

the Medicare FFS EHR hospital incentive program, rather than through the MA EHR hospital

incentive program. Under §495.210(c), we proposed that qualifying MA organizations be

required to attest within 60 days after the close of a calendar year whether each qualifying MA-

affiliated eligible hospital is a meaningful EHR user. While the EHR incentive payments for

Medicare FFS and MA-affiliated hospitals are treated the same as all Medicare-certified MA

affiliated hospitals they will demonstrate clinical quality measures through the continued

reporting of HEDIS data. This means that §495.210(c) generally applies to a MA-affiliated

hospital that is not Medicare certified, and such a type of hospitals does not exist currently. We

do not expect there to be any MA-affiliated hospitals that will not be covered under the Medicare

FFS EHR hospital incentive program because section 1852(a)(1)(A) of the Act requires MA

organizations to provide Part A inpatient services solely through providers that meet applicable

requirements of the Medicare program. We have already addressed the attestation burden on

hospitals, including MA-affiliated hospitals under §495.10 (b)(2)(i)(ii) and through our existing

PRA package related to HEDIS reporting by MA organizations – OMB control number 0938-

NEW.

F. ICRs Regarding Establishing Patient Volume (§495.306)

This section of the final rule contains patient volume requirements, and requires EPs and

certain hospitals to attest to meeting such requirement using representative periods in order to

qualify for a Medicaid EHR incentive. The minimum patient volume requirements are as

follows: 30 percent Medicaid patient volume for most EPs, 20 percent Medicaid patient volume

for pediatricians, 30 percent needy individual patient volume for EPs practicing predominantly in
CMS-0033-F 683

an FQHC or RHC, and 10 percent Medicaid patient volume for acute-care hospitals. The burden

associated with the requirements in this section is the time and effort necessary to submit the

information to CMS. In the proposed rule, in each instance, we estimated it would take no

longer than 0.5 hours to submit the necessary information to CMS. We estimated that 119,000

entities would submit the required information to meet 30 percent (or 20 percent pediatrician)

requirements for most EPs. We estimated the total annual burden to be 59,500 hours, with total

labor cost amounting to $4,720,135 (assuming that physicians (rather than staff assistants)

establish patient volume ($79.33 mean hourly rate for physicians based on May 2008 Bureau of

Labor Statistics).

For hospitals to attest to patient volume, we estimated that 3,631 entities would submit

required information, and estimated a total burden of 1,815.50 hours (3,631 entities x .5 hours).

The total labor cost associated with this requirement is $25,617. This cost burden was based on

a secretary reporting patient volume on behalf of the acute care hospital at $14.11 (mean hourly

rate for secretaries based on May 2008 Bureau of Labor Statistics).

We received no comments on this section; however, since we have revised our definition

of hospital-based EP, the burden is revised to account for the additional number of Medicaid EPs

that could now be eligible to receive Medicaid incentive payments. We currently estimate that

there are an additional Medicare/Medicaid 75,700 EPs that could be eligible for an incentive

payment because of the new definition of hospital-based EP. We believe there are 553,200

Medicare EPs of which 86 percent are non-hospital based or 477,500. We believe 20 percent or

95,500 will meet patient volume requirements, and therefore, potentially qualify for Medicaid

EHR incentive payments. Additionally, there are 44,100 Medicaid-only EPs (nurse practitioners,

certified nurse-midwives, dentists, and physician assistants) that we believe will meet patient
CMS-0033-F 684

volume. Specifically, we believe that 139,600 EPs (95,500 + 44,100) could be reporting patient

volume information. Thus, the updated annual burden associated with the requirements in

§495.306at 0.5 hours for EPs is 69,800.

The total labor cost associated with the requirement is (69,800 X 79.33) $5,537,234. The total

labor cost associated with the each requirement is $5,537,234.

For hospitals reporting patient volume, we have updated the burden to account for the

additional CAHs that meet the definition of acute care hospital. Specifically, there are 3,620

acute care hospitals, 11 cancer hospitals, and 1,302 CAHs that must report 10 percent Medicaid

patient volume, or 4,933 entities. The updated annual burden associated with the requirement, at

0.5 hours is 2,466.5 (4,933 X .05). The total labor cost is $34,803.30.

G. ICRs Regarding Process for Payments (§495.312)

Section 495.312(b) states that in order to receive a Medicaid EHR incentive payment, a

provider must report all necessary data (including data required by subpart A of the regulations,

such as meaningful use data) within the EHR reporting period. We believe the information

collections associated with this requirement are discussed in the relevant sections discussing each

particular requirement that would necessitate data reporting (for example, the burden for

demonstrating meaningful use is discussed in the information collection section on meaningful

use.) Therefore, we have not calculated a separate information collection burden for this

requirement.

H. ICRs Regarding Activities Required to Receive an Incentive Payment (§495.314)

Section 495.314(a)(1) states that in the first payment year, to receive an incentive

payment, the Medicaid EP or eligible hospital must meet one of the following criteria. The

Medicaid EP or eligible hospital must demonstrate that during the EHR reporting period for a
CMS-0033-F 685

payment year, it has adopted, implemented, or upgraded certified EHR technology, as defined in

§495.302; or, the Medicaid EP or eligible hospital must demonstrate that during the EHR

reporting period for a payment year it is a meaningful user of certified EHR technology as

defined in §495.4.

The burden associated with the requirements in proposed §495.314(a)(1) is the time and

effort necessary for a Medicaid EP or eligible hospital to demonstrate that it meets one of the

criteria in §495.314(a)(1)(i) through (ii). We believe we already accounted for this burden in the

earlier discussion of the burden associated with §495.8.

Section 495.314(a)(2) states that a provider may notify the State of its nonbinding

intention to participate in the incentives program prior to having fulfilled all of the eligibility

criteria. This requirement constitutes a third-party disclosure. The burden associated with this

requirement is the time and effort necessary for a provider to send notification to the State. We

estimated that this burden will be the same burden associated with §495.10 since the information

necessary to notify the State of the providers non-binding intention to participate in the program

could be the same information as submitted by those providers that have committed to

participating in the program, that is, the National Provider Identifier, the tax identification

number, etc.

Section 495.314(b)(1) states that in the second, third, fourth, fifth, and sixth payment

years, to receive an incentive payment, the Medicaid EP or eligible hospital must demonstrate

that during the EHR reporting period for the applicable payment year, it is a meaningful user of

certified EHR technology, as defined in §495.4. The burden associated with this requirement is

the time and effort necessary for a Medicaid EP or eligible hospital to demonstrate that it is a
CMS-0033-F 686

meaningful user of certified EHR technology. We discussed the burden associated with this

requirement in our discussion of the burden associated with §495.6 and 495.8.

We did not receive any comments on the information collection burdens we estimated for the

proposed rule.

I. ICRs Regarding State Monitoring and Reporting Regarding Activities Required to Receive an

Incentive Payment (§495.316)

Section 495.316(a) requires States to be responsible for tracking and verifying the

activities necessary for a Medicaid EP or eligible hospital to receive an incentive payment for

each payment year, as described in §495.314. Burden is calculated for each State's process for

the administration of the Medicaid incentive payments, including tracking of attestations and

oversight, and the process for approving, processing, and making timely payments.

For the proposed rule, we estimated that it would take 5 hours per State to accomplish

this. The estimated annual burden for States associated with the aforementioned submission

requirements is 280 hours (56 States-Territories x 5.0 hours/State-Territory). The cost burden

was estimated based on an employee contracting with the State Agency. The burden associated

with §495.316 is already in the OMB approval process. We announced the information

collection in a Federal Register notice that published on September 11, 2009 (74 FR 467330).

Comment: Some commenters asked CMS to clarify if States are responsible for

collecting the MU measure data or if providers will report data directly to CMS. If the collection

and reporting of MU data are States’ responsibility, this would create tremendous burden on

States. The commenters also asked CMS to clarify if States are responsible for validating

attestations by eligible providers.

Response: For EPs and some hospitals, States are responsible for collecting the MU
CMS-0033-F 687

measure data; for hospitals that are eligible for both the Medicare and Medicaid incentives,

hospitals that meet the Medicare MU objectives are deemed to have met MU for Medicaid; thus,

since hospitals are required to report MU data to CMS for the Medicare EHR incentives program

, these hospitals do not, in addition, have to report MU data to States. States are required to

submit a State Medicaid HIT plan to CMS for review and approval outlining their methodology

for collecting MU measure data and other required information outlined in this final rule. States

are also responsible for validating attestations by providers. We do not believe collecting data or

validating attestations is a tremendous burden on States as noted by our estimates. States can

receive 90 percent FFP for administering the incentive payments to providers and for conducting

adequate monitoring and oversight. In addition, it should be noted that States voluntarily

participate in the Medicaid EHR incentive program.

J. ICRs Regarding State Responsibilities for Receiving FFP (§495.318)

Section 495.318 states that in order to be provided FFP under section 1903(a)(3)(F) of the

Act, a State must demonstrate to the satisfaction of the Department, that the State is conducting

the activities listed at §495.318(a) through (c). This burden is the same as that listed above in the

burden discussion for §495.316.

K. ICRs Regarding Prior Approval Conditions (§495.324)

Section 495.324(a) requires a State to obtain prior written approval from the Department

as specified in paragraph (b) of this section, when the State plans to initiate planning and

implementation activities in support of Medicaid provider incentive payments encouraging the

adoption and use of certified EHR technology with proposed Federal financial participation

(FFP). Specifically, §495.324(b) states that to receive 90 percent match, each State must receive

prior approval for all of the requirements listed in §495.324(b)(1) through (3).
CMS-0033-F 688

Section 495.324(c) requires a State to obtain prior written approval from the Department

of its justification for a sole source acquisition, when it plans to acquire non-competitively from

a nongovernmental source HIT equipment or services, with proposed FFP under subpart D of

Part 495 in the regulations, if the total State and Federal acquisition cost is more than $100,000.

Burden must be calculated for State Medicaid Agencies to submit the planning and

implementation documents and the SMHP to CMS. This burden is the same as that listed above

in the burden discussion for §495.316.

L. ICRs Regarding Termination of Federal Financial Participation (FFP) for Failure to Provide

Access to Information (§495.330)

Section 495.330(a) states that the Department can terminate FFP at any time if the

Medicaid agency fails to provide State and Federal representatives with full access to records

relating to HIT planning and implementation efforts, and the systems used to interoperate with

electronic HIT, including on-site inspection. Section 495.330(b) states that the Department may

request such access at any time to determine whether the conditions in this subpart are being met.

The burden associated with the requirements in this section is the time and effort necessary to

make the information available to the Department upon request so it can monitor compliance.

The Department estimated that it will make 1 request per State/Territory per year for information

and that it will take each State 5 hours to compile and furnish the information. For States to

collect and submit the information required, we estimated it would take 5 hours per State. The

estimated annual burden for States associated with the aforementioned submission requirements

is 280 hours (56 States-Territories x 5.0 hours/State-Territory).

The annual cost burden for a State employee to provide the above information is $9,904

(280 hours x $35.37 (mean hourly rate for a management analyst based on the May 2008 Bureau
CMS-0033-F 689

of Labor Statistics)). We believe that a secretary may compile State information and provide the

information to the Department. In that case the annual cost burden for the secretary to provide

this information is $3,951 (280 hours x $14.11 (mean hourly rate for secretaries based on the

May 2008 Bureau of Labor Statistics)).

M. ICRs Regarding State Medicaid Agency and Medicaid EP and Hospital Activities (§495.332

through §495.344)

The burden associated with this section is the time and effort associated with completing

the single provider election repository and each State's process for the administration of the

Medicaid incentive payments, including tracking of attestations and oversight; the submission of

the State Medicaid HIT Plan and the additional planning and implementation documents;

enrollment or reenrollment of providers, and collection and submission of the data for providers

to demonstrate that they have adopted, implemented, or upgraded certified EHR technology or

that they are meaningful users of such technology. We believe much of the burden associated

with these requirements has already been accounted for in our discussion of the burden for

§495.316.

N. ICRs Regarding Access to Systems and Records (§495.346)

Section 495.346 states that the State agency must allow the Department access to all

records and systems operated by the State in support of this program, including cost records

associated with approved administrative funding and incentive payments to Medicaid providers.

State records related to contractors employed for the purpose of assisting with implementation or

oversight activities or providing assistance, at such intervals as are deemed necessary by the

Department to determine whether the conditions for approval are being met and to determine the

efficiency, economy, and effectiveness of the program.

CMS-0033-F 690

The Department believes that the burden associated with maintaining the records is

exempt under 5 CFR 1320.3(b)(2) as this burden is part of a usual and customary business

practice; the time, effort, and financial resources necessary to comply with a collection of

information that would be incurred by persons in the normal course of their activities (for

example, in compiling and maintaining business records) will be excluded from the ‘‘burden’’ if

the agency demonstrates that the reporting, recordkeeping, or disclosure activities needed to

comply are usual and customary.

However, there is burden associated with making the information available to the

Department upon request. This burden is described in the burden discussion for §495.330.

O. ICRs Regarding Procurement Standards (§495.348)

Section 495.348 (c) states that a grantee must maintain written standards of conduct

governing the performance of its employees engaged in the award and administration of

contracts. Although most States may already have these written standards of conduct, we have

estimated the burden associated with this requirement as the time and effort necessary for a

grantee to develop and maintain written standards of conduct. We estimate it will take each of

the 56 grantees 0.5 hourss to develop and maintain standards of conduct. The total estimated

annual burden is 28 hours (56 grantees x 0.5 hourss). The annual cost burden for a grantee to

develop and maintain standards of conduct is $990 (28 hours x $35.37 (mean hourly rate for a

management analyst based on the May 2008 Bureau of Labor Statistics)).

Section 495.348(e) requires that all grantees establish written procurement procedures.

At a minimum, the standards must provide for the information listed in §495.348(e)(1) through

(13). The burden associated with this requirement is the time and effort necessary for a grantee

to develop and maintain written procurement procedures. Although most States probably have
CMS-0033-F 691

these procedures already, we estimate that it will take each of the 56 grantees 0.5 hourss to

develop and maintain written procurement procedures. The total estimated annual burden is

28 hours (56 grantees x 0.5 hours). The annual cost burden for a grantee to develop and maintain

written procurement procedures is $990 (28 hours x $35.37 (mean hourly rate for a management

analyst based on the May 2008 Bureau of Labor Statistics)).

Section 495.348(f) imposes recordkeeping requirements. This section states that a

system for contract administration must be maintained to ensure contractor performance with the

terms, conditions and specifications of the contract and to ensure adequate and timely follow up

on all purchases. The burden associated with this requirement is the time and effort necessary to

develop and maintain a system for contract administration. We estimate that it will take each of

the 56 grantees 5 hours to develop and maintain a system for contract administration. The total

estimated annual burden is 280 hours (56 grantees x 5 hours). The annual cost burden for a

grantee to develop and maintain a system for contract administration is $9904 (280 hours x

$35.37 (mean hourly rate for a management analyst based on the May 2008 Bureau of Labor

Statistics)).

P. ICRs Regarding State Medicaid Agency Attestations (§495.350)

Section 495.350 requires States to provide assurances to the Department that amounts

received with respect to sums expended that are attributable to payments to a Medicaid provider

for the adoption of EHR are paid directly to such provider, or to an employer or facility to which

such provider has assigned payments, without any deduction or rebate. The burden associated

with this requirement is the time and effort necessary for a State to verify that the sums expended

are attributable to payments to a Medicaid provider for the adoption of EHR are paid directly to

such provider, or to an employer or facility to which such provider has assigned payments,
CMS-0033-F 692

without any deduction or rebate. Additionally, there is burden associated with submitting an

attestation to the Department to that effect. The estimated burden associated with these

requirements is 0.5 hours to verify the information and 0.5 hours to submit the attestation to the

Department, for a total of 1 hour. The estimated annual burden for States associated with the

aforementioned submission requirements is 56 hours (56 States-Territories x 1 hours State-

Territory). The annual cost burden for a State employee to provide the above information is

$1,981 (56 hours x $35.37 (mean hourly rate for a management analyst based on the May 2008

Bureau of Labor Statistics)). We believe that that a secretary may compile State information and

provide the information to the Department. In that case the annual cost burden for the secretary

to provide this information is $790 (56 hours x $14.11 (mean hourly rate for secretaries based on

the May 2008 Bureau of Labor Statistics)).

Q. ICRs Regarding Reporting Requirements (§495.352)

Section 495.352 requires each State to submit to the Department on a quarterly basis a

progress report documenting specific implementation and oversight activities performed during

the quarter, including progress in implementing the State's approved Medicaid HIT plan. The

burden associated with this requirement is the time and effort necessary for a State to draft and

submit quarterly progress reports to the Department. For States to collect and submit the

information required, we estimate it will take 5 hours per State. The estimated annual burden for

States associated with the aforementioned submission requirements is 280 hours (56 States-

Territories x 5 hours/State-Territory).

The annual cost burden for a State employee to provide the above information is $9,904

(280 hours x $35.37 (mean hourly rate for a management analyst based on the May 2008 Bureau

of Labor Statistics)). We believe that a secretary may compile State information and provide the
CMS-0033-F 693

information to the Department. In that case the annual cost burden for the secretary to provide

this information is $3,951 (280 hours x $14.11 (mean hourly rate for secretaries based on the

May 2008 Bureau of Labor Statistics)).

R. ICRs Regarding Retroactive Approval of FFP with an Effective Date of February 18, 2009

(§495.362)

Section 495.362 states that for administrative activities performed by a State, without

obtaining prior approval, which are in support of planning for incentive payments to providers, a

State may request consideration of FFP by recorded request in a HIT planning advance planning

document or implementation advance planning document update. While this requirement is

subject to the PRA, we believe the burden is already covered in the discussion of proposed

§495.332 through §495.344.

S. ICRs Regarding Financial Oversight and Monitoring Expenditures (§495.366)

Section 495.366(a)(2) requires a State to have a process in place to report actual

expenditures for the Medicaid EHR incentive program using the Medicaid Budget Expenditure

System. Since States already have to report Medicaid expenditures to the Medicaid Budget and

Expenditure System, there is no need for States to develop and implement a reporting process.

However, States will need to estimate and report the expenditures related to the provider

incentive payments and the cost of the administration of the incentive payments. The estimated

annual burden for States associated with the aforementioned requirements is 280 hours (56

States-Territories x 5 hours State-Territory).

The annual cost burden for a State employee to provide the above information is $9,904

(280 hours x $35.37 (mean hourly rate for a management analyst based on the May 2008 Bureau

of Labor Statistics)). We believe that a secretary may compile State information and provide the
CMS-0033-F 694

information to the Department. In that case the annual cost burden for the secretary to provide

this information is $3,951 (280 hours x $14.11 (mean hourly rate for secretaries based on the

May 2008 Bureau of Labor Statistics)).

Section 495.366(a)(3) requires a State to have an automated payment and information

retrieval mechanized system, (Medicaid Management Information System) to make EHR

payment incentives, to ensure Medicaid provider eligibility, to ensure the accuracy of payment

incentives, and to identify potential improper payments. Since States already have an automated

payment and information retrieval system, there is no need to estimate this burden.

Section 495.366(b) lists the information collection requirements associated with provider

eligibility as a basis for making payment. States must, subject to §495.332, collect and verify

information on Medicaid providers. This burden is the same as that listed above in the

discussion of §495.316.

Section §495.366(c)(1) states that subject to §495.332, the State must annually collect

and verify information regarding the efforts to adopt, implement, or upgrade certified EHR

technology and the meaningful use of said technology before making any payments to providers.

This burden has already been discussed in our burden explanation for §495.8.

Section 495.366(d)(1) states that subject to paragraph §495.332, the State must assure

that State expenditures are claimed in accordance with, including but not limited to, applicable

Federal laws, regulations and policy guidance. Section 495.366(d)(2) specifies that subject to

§495.332, the State must have a process in place to assure that expenditures for administering the

Medicaid EHR incentive payment program will not be claimed at amounts higher than

90 percent of the cost of such administration. Section 495.366(d)(3) states that subject to

§495.332, the State must have a process in place to assure that expenditures for payment of
CMS-0033-F 695

Medicaid EHR incentive payments will not be claimed at amounts higher than 100 percent of the

cost of such payments to Medicaid providers. This burden is the same as that listed above in the

discussion of §495.316.

Section 495.366(e) discusses the information collection requirements associated with

improper Medicaid electronic health record payment incentives. The burden associated with the

requirements listed in proposed §495.366(e)(1) through (7) is the time and effort necessary to

develop processes to provide the necessary assurances discussed in this section. This burden is

the same as that listed above in the discussion of §495.316.

T. ICRs Regarding Appeals Process for a Medicaid Provider Receiving Electronic Health

Record Incentive Payments (§495.370)

Section 495.370(a) requires states to have a process in place consistent with the

requirements established in §447.253(e) for a provider or entity to appeal incentive payments,

incentive payment amounts, provider eligibility determinations, and the demonstration of

adopting, implementing, or upgrading and meaningful use of certified EHR technology. This

burden is the same as that listed above in the discussion of §495.316.

We continue to believe that these numbers are subject to a substantial amount of

uncertainty and actual experience may be significantly different. The range of possible

experience is greater than under most other rules for the following reason; specifically, this rule

provides the option for States to participate in the Medicaid certified electronic health record

technology incentive payment program. To the extent that States participate more or less than

assumed here (that is, the number of States, EPs and hospitals) the burden associated may be

greater than or less than estimated.

CMS-0033-F 696

U. General Comments Regarding the Information Collection Requirements

Comment: Some commenters recommended that EPs and eligible hospitals should start

tracking time and resources estimates on their overall cost for complying with all the required

data collection to achieve meaningful use during the reporting period. They believed the

information is beneficial for CMS in developing and assessing future meaningful use objectives

and measures.

Response: We welcome provider input on the required resources to comply with the

meaningful use requirements. We believe the information would help us to fine-tune burden

estimates for future rulemaking for subsequent stages of meaningful use demonstration.
 CMS-0033-F 697

TABLE 21: Burden and Cost Estimates Associated with Information Collection Requirements

Total Hourly Total

OMB Burden per Annual Labor Cost Total Cost of Capital/Maintenance
Control Response Burden of Reporting Reporting Costs Total Costs
Reg Section No. Respondents Responses (in hours) (in hours) (in $) (in $) (in $) (in $)
§495.8 (a)(1)- EHR
Technology Used, core Set
Objectives/Measures &
Quality Measures (EPs) 0938-
(2011) New 521,600 521,600 9.367 4,885,827 79.33 387,592,672 0 387,592,672
§495.8 (a)(1)- menu Set
Objectives/Measures high 0938-
(EPs) (2011) New 521,600 521,600 2.666 1,390,586 79.33 110,315,156 21,700,000,000 21,810,315,156
§495.8 (a)(1)- menu Set
Objectives/Measures low 0938-
(EPs) (2011) New 521,600 521,600 0.700 365,120 79.33 28,964,970 21,700,000,000 21,728,964,970
§495.8 (a)(1)- menu Set
Objectives/Measures average 0938-
(EPs) (2011) New 521,600 521,600 1.683 877,853 79.33 69,640,063 21,700,000,000 21,769,640,063
§495.8(a)(2) - EHR
Technology Used & core Set
Objectives/Measures (EPs) 0938-
(2012) New 527,254 527,254 8.867 4,675,161 79.33 370,880,539 0 370,880,539
§495.8 (a)(2)- menu Set
Objectives/ Measures high 0938-
(EPs) (2012) New 527,254 527,254 2.666 1,405,659 79.33 111,510,941 4,500,000,000 4,611,510,941
§495.8 (a)(2)- menu Set
Objectives/ Measures low 0938-
(EPs) (2012) New 527,254 527,254 0.700 369,078 79.33 29,278,942 4,500,000,000 4,529,278,942
§495.8 (a)(2)- menu Set
Objectives/ Measures 0938-
average (EPs) (2012) New 527,254 527,254 1.683 887,368 79.33 70,394,942 4,500,000,000 4,570,394,942
§495.8 (a)(2)- Ambulatory
Quality Measures (EPs) 0938-
(2012) New 527,254 527,254 0.500 263,627 14.81 3,904,316 0 3,904,316
§495.8 (b)(1)-- EHR
Technology Used, core Set
Objectives/Measures &
Quality Measures 0938-
(hospitals/CAHs) (2011) New 5,011 5,011 9.200 46,101 59.98 2,765,150 0 2,765,150
 CMS-0033-F 698

Total Hourly Total

OMB Burden per Annual Labor Cost Total Cost of Capital/Maintenance
Control Response Burden of Reporting Reporting Costs Total Costs
Reg Section No. Respondents Responses (in hours) (in hours) (in $) (in $) (in $) (in $)
§495.8(b)(1) - menu Set
Objectives/ Measures low 0938-
(hospitals/CAHs) (2011) New 5,011 5,011 0.700 3,508 59.98 210,392 20,600,000,000 20,600,210,392
§495.8(b)(1) - menu Set
Objectives/ Measures high 0938-
(hospitals/CAHs) (2011) New 5,011 5,011 3.500 17,539 59.98 1,051,959 20,600,000,000 20,601,051,959
§495.8(b)(1) - menu Set
Objectives/ Measures
average (hospitals/CAHs) 0938-
(2011) New 5,011 5,011 2.100 10,523 59.98 631,176 20,600,000,000 20,600,631,176
§495.8 (b)(2)-- EHR
Technology Used & core Set
Objectives/Measures 0938-
(hospitals/CAHs) (2012) New 5,011 5,011 8.700 43,596 59.98 2,614,870 0 2,614,870
§495.8 (b)(2)- menu Set
Objectives/ Measures low 0938-
(hospitals/CAHs) (2012) New 5,011 5,011 0.700 3,508 59.98 210,392 5,000,000,000 5,000,210,392
§495.8 (b)(2)- menu Set
Objectives/ Measures high 0938-
(hospitals/CAHs) (2012) New 5,011 5,011 3.500 17,539 59.98 1,051,959 5,000,000,000 5,001,051,959
§495.8 (b)(2)- menu Set
Objectives/ Measures
average (hospitals/CAHs) 0938-
(2012) New 5,011 5,011 2.100 10,523 59.98 631,176 5,000,000,000 5,000,631,176
§495.8 (b)(2)- Hospital
Quality Measures 0938-
(hospitals/CAHs) (2012) New 5,011 5,011 0.500 2,506 14.81 37,106 0 37,106
§495.10(a)-(c) -- (EPs) 0938-
(2011) low New 521,600 521,600 0.500 260,800 14.81 3,862,448 0 3,862,448
§495.10(a)-(c) -- (EPs) 0938-
(2011) high New 521,600 521,600 0.500 260,800 79.33 20,689,264 0 20,689,264
§495.10(a)-(c) -- (EPs)
(2011) average 521,600 521,600 0.500 260,800 47 12,275,856 0 12,275,856
0938-
§495.10(d) - (EPs) (2012) low New 57,998 57,998 0.500 28,999 14.81 429,475 0 429,475
§495.10(d) - (EPs) (2012) 0938-
high New 57,998 57,998 0.500 28,999 79.33 2,300,491 0 2,300,491
§495.10(d) - (EPs) (2012)
average 57,998 57,998 0.500 28,999 47 1,364,983 0 1,364,983
 CMS-0033-F 699

Total Hourly Total

OMB Burden per Annual Labor Cost Total Cost of Capital/Maintenance
Control Response Burden of Reporting Reporting Costs Total Costs
Reg Section No. Respondents Responses (in hours) (in hours) (in $) (in $) (in $) (in $)
§495.10(e)(1) - (EPs) (2011) 0938-
low New 95,500 95,500 0.500 47,750 14.81 707,178 0 707,178
§495.10(e)(1) - (EPs) (2011) 0938-
high New 95,500 95,500 0.500 47,750 79.33 3,788,008 0 3,788,008
§495.10(e)(1) - (EPs) (2011)
average 95,500 95,500 0.500 47,750 47 2,247,593 0 2,247,593
§495.10(e)(2) - (EPs) (2012) 0938-
low New 96,500 96,500 0.500 48,250 14.81 714,583 0 714,583
§495.10(e)(2) - (EPs) (2012) 0938-
high New 96,500 96,500 0.500 48,250 79.33 3,827,673 0 3,827,673
§495.10(e)(2) - (EPs) (2012)
average 96,500 96,500 0.500 48,250 47 2,271,128 0 2,271,128
§495.10(a) (b) (hospital) 0938-
(2011) New 5,011 5,011 0.500 2,506 14.81 37,106 0 37,106
0938-
§495.10(d) - (hospital) (2012) New 401 401 0.500 201 14.81 2,969 0 2,969
§495.202(b)(2) (2012) 0938-
EPs-preliminary ID New 12 12 0.500 6 59.98 360 0 360
§495.202(b)(2) (2012)
MA-affiliated hospitals- 0938-
preliminary ID New 12 12 0.250 3 15.44 46 0 46
§495.202(b)(2) (2012) EPs- 0938-
final ID New 12 12 0.500 6 59.98 360 0 360
§495.202(b)(2) (2012) MA- 0938-
affiliated hospitals-final ID New 12 12 0.250 3 15.44 46 0 46
§495.204(b)(2) (2012) 0938-
Revenue reporting New 12 12 40.000 480 15.44 7,411 0 7,411
§495.204(b)(4) (2012) EPs- 0938-
method New 2 2 1.500 3 31.65 95 0 95
§495.204(b)(5) or 0938-
(b)(6)(2012) EPs-salary New 12 12 58.300 700 15.44 10,802 0 10,802
§495.210(b) (2012) EPs- 0938-
attestation New 12 12 40.000 480 59.98 28,790 0 28,790
0938-
§495.306(a)(1)(i) New 139,600 139,600 0.500 69,800 79.33 5,537,234 0 5,537,234
0938-
§495.306(a)(1)(ii)(A) New 139,600 139,600 0.500 69,800 79.33 5,537,234 0 5,537,234
0938-
§495.306(a)(1)(ii)(B) New 139,600 139,600 0.500 69,800 79.33 5,537,234 0 5,537,234
 CMS-0033-F 700

Total Hourly Total

OMB Burden per Annual Labor Cost Total Cost of Capital/Maintenance
Control Response Burden of Reporting Reporting Costs Total Costs
Reg Section No. Respondents Responses (in hours) (in hours) (in $) (in $) (in $) (in $)
0938-
§495.306(a)(2) New 4,933 4,933 0.500 2,467 14.11 34,802 0 34,802
0938-
§495.316 New 56 56 5.000 280 100 28,000 0 28,000
0938-
§495.330(a) - high New 56 56 5.000 280 35.37 9,904 0 9,904
0938-
§495.330(a) - low New 56 56 5.000 280 14.11 3,951 0 3,951
§495.330(a) - average 56 56 5.000 280 24.74 6,927 0 6,927
0938-
§495.348(c) New 28 56 0.500 28 35.37 990 0 990
0938-
§495.348(e) New 28 56 0.500 28 35.37 990 0 990
0938-
§495.348(f) New 28 56 5.000 280 35.37 9,904 0 9,904
0938-
§495.350--high New 56 56 1.000 56 35.37 1,981 0 1,981
0938-
§495.350--low New 56 56 1.000 56 14.11 790 0 790
§495.350--average 56 56 1.000 56 24.74 1,385 0 1,385
0938-
§495.352--high New 56 56 5.000 280 35.37 9,904 0 9,904
0938-
§495.352--low New 56 56 5.000 280 14.11 3,951 0 3,951
§495.352--average 56 56 5.000 280 24.74 6,927 0 6,927
0938-
§495.366--high New 56 56 5.000 280 35.37 9,904 0 9,904
0938-
§495.366--low New 56 56 5.000 280 14.11 3,951 0 3,951
§495.366--average 56 56 5.000 280 24.74 6,927 0 6,927

Total 2011* 6,344,458 481,944,348 42,781,944,348

Total 2012* 6,175,290 466,366,443 9,966,366,443

Note: Where there are low, high, and average estimates listed for the provisions, only the average figures are used for the purpose of burden calculation
* Burden not otherwise designated by year, that is, 2011, 2012, or 2011-2012, is considered to be annual burden and is included in the sum total burden for both 2011 and 2012.
CMS-0033-F 701

We will accept comments on the aforementioned information collection requirements for

60 days from the date of display for this final rule. At the conclusion of the 60-day comment

period, we will publish an additional notice announcing the submission of the information

collection request associated with this final rule for OMB approval. At that time, the public will

have an additional 30 days to submit public comments to OMB for consideration.

To obtain copies of the supporting statement associated with the information collection

requirements contained herein, access CMS’ Web Site at

http://www.cms.hhs.gov/PaperworkReductionActof1995, or E-mail your request, including your

address, phone number, OMB number, and CMS document identifier, to

[email protected], or call the Reports Clearance Office on (410) 786-1326.

In commenting on the information collection requirements, please reference the

information collection request identifier (CMS-10336). To be assured consideration, comments

and recommendations must be submitted in one of the following ways by [OFR—insert date 60

days after date of display at the Federal Register]:

1. Electronically. You may submit your comments electronically to

http://www.regulations.gov. Follow the instructions for "Comment or Submission" or "More

Search Options" to find the information collection document(s) accepting comments.

2. By regular mail. You may mail written comments to the following address:

CMS, Office of Strategic Operations and Regulatory Affairs

Division of Regulations Development

Attention: Document Identifier/OMB Control Number

Room C4-26-05

7500 Security Boulevard

CMS-0033-F 702

Baltimore, Maryland 21244-1850.

IV. Regulatory Impact Analysis

A. Overall Impact

We have examined the final impacts of this rule as required by Executive Order 12866,

the Regulatory Flexibility Act, section 1102(b) of the Social Security Act regarding rural hospital

impacts, the Unfunded Mandates Reform Act, Executive Order 13132 on Federalism, and the

Congressional Review Act.

Executive Order 12866 directs agencies to assess all costs and benefits of available

regulatory alternatives and, if regulation is necessary, to select regulatory approaches that

maximize net benefits (including potential economic, environmental, public health and safety

effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared

for rules with economically significant effects ($100 million or more in any 1 year). This final

rule is anticipated to have an annual effect on the economy of $100 million or more, making it an

economically significant rule under the Executive Order and a major rule under the

Congressional Review Act. Accordingly, we have prepared a RIA that to the best of our ability

presents the costs and benefits of the final rule.

This final rule is one of three coordinated rulemakings undertaken to implement the goals

and objectives of the HITECH Act related to the adoption and meaningful use of certified EHR

technology. The other two are HHS's interim final rule establishing certification criteria,

standards, and implementation specifications for certification of EHR systems, and HHS' final

rule on EHR certification programs. Each rule assessed the direct economic effects of its

provisions. This final rule on Medicare and Medicaid EHR Incentive Programs addresses the

impacts related to the actions taken by EPs or eligible hospitals, or CAHs to demonstrate
CMS-0033-F 703

meaningful use of certified EHR technology, including purchasing or developing in-house

certified EHR technology or EHR technology modules.

A number of factors will affect the adoption of EHR systems and demonstration of

meaningful use. Many of these are addressed in this final analysis, but also the final provisions

of the other rules. Readers should understand that these forecasts are also subject to substantial

uncertainty since demonstration of meaningful use will depend not only on the standards and

requirements for FYs 2011 and 2012 for eligible hospitals and CYs 2011 and 2012 for EPs, but

on future rulemakings issued by the HHS.

The HITECH Act provides Medicare and Medicaid incentive payments for the

meaningful use of certified EHR technology. Additionally, the Medicaid program also provides

incentives for the adoption, implementation, and upgrade of certified EHR technology. Payment

adjustments are incorporated into the Medicare program for providers unable to demonstrate

meaningful use. The absolute and relative strength of these is unclear. For example, a provider

with relatively small Medicare billings will be less disadvantaged by payment adjustments than

one with relatively large Medicare billings. Another uncertainty arises because there are likely

to be "bandwagon"effects as the number of providers using EHRs rises, thereby inducing more

participation in the incentives program, as well as greater adoption by entities (for example,

clinical laboratories) that are not eligible for incentives or subject to penalties, but do business

with EHR adopters. It is impossible to predict exactly if and when such effects may take hold.

One legislative uncertainty arises because under current law, physicians are scheduled for

payment reductions under the sustainable growth rate (SGR) formula for determining Medicare

payments. Under the current law, physician payments were reduced by 23 percent beginning

December 1, 2010, and are scheduled for further reductions in CY 2011. Such reductions could
CMS-0033-F 704

cause major changes in physician behavior, enrollee care, and other Medicare provider

payments, but the specific nature of these changes is exceptionally uncertain. Under a current

law scenario, the EHR incentives or payment adjustments would exert only a minor influence on

physician behavior relative to these very large payment reductions. However, the Congress has

legislatively avoided physician payment reductions in each of the past 7 years. Behavioral

changes resulting from these scheduled Medicare physician payment reductions are not included

in our estimate and likewise we do not assume any additional behavioral changes from EHR

incentive payments for Medicare physicians.

All of these factors taken together make it impossible to predict with precision the timing

or rates of adoption and ultimately meaningful use. Therefore, we show two scenarios, which

illustrate how different scenarios would impact overall costs. Our "high"scenario of meaningful

use demonstration assumes that roughly a decade from now, nearly 100 percent of hospitals and

70 percent of EPs will be "meaningful users." This estimate is based on the substantial economic

incentives created by the combined direct and indirect factors affecting providers. We appreciate

that in the real world nothing is ever 100 percent, and can even identify factors that would

certainly lead providers to forego implementing an EHR. For example, a physician nearing

retirement with a low Medicare caseload might well decide to accept the relatively low adverse

consequences of declining to demonstrate meaningful use of certified EHR technology.

Alternatively, EPs, eligible hospitals and CAHs may choose not to adopt and meaningfully use

EHRs if the total costs of purchasing certified EHRs and the total costs of complying with this

rule are higher than the value of the total EHR incentive payments (and adjustments, if

applicable). However, we have no reliable basis for estimating the rate of such "holdouts." To

emphasize the uncertainties involved, we have also created a "low" scenario estimate for the
CMS-0033-F 705

demonstration of meaningful use each year, which assumes less robust adoption and meaningful

use. Our "low"scenario of meaningful use demonstration assumes that roughly a decade from

now, nearly 95.6 percent of hospitals and 36 percent of EPs will be "meaningful users."

Both the high and low scenario estimates are based on current law, which includes a

scheduled physician payment cut of 23 percent on December 1, 2010. Such a reduction could

cause major changes in physician behavior, enrollee care, and other Medicare provider

payments, but the specific nature of these changes is exceptionally uncertain. In our estimates,

we did not assume changes in physician behavior as a result of these payment cuts, as this

reflects the standard practice used in forecasts of government spending (including effects on the

private sector) by the Boards of Trustees for the Hospital Insurance and Supplementary Medical

Insurance Trust Funds, and the Office of the Actuary in HHS.

Since this RIA was published in the proposed rule, legislation has been enacted that

increases the number of EPs that may be eligible to receive an incentive payment by changing

the determination of hospital-based. A complete discussion of the issue, including comments

and responses are available section 2 of this rule stated. The determination of whether an EP is

hospital-based will be based upon whether substantially all of the EP’s services are furnished in

Places of service classified under place of service codes 21 (Inpatient Hospital) or 23

(Emergency Room, Hospital). Previously under the old definition, CMS estimated that 27

percent of EPs would meet the definition of hospital-based, however, now, under this final

definition of hospital-based EPs, about 14 percent of Medicare EPs would be considered

hospital-based and thus not eligible to receive any incentive payments.

There are many estimates of current EHR adoption and usage rates. There is one EHR

function—e-prescribing—for which adoption and usage rates for both physicians and hospitals
CMS-0033-F 706

may exceed 50 percent. However, high estimates are misleading because they focus on

particular elements, not on comprehensive systems that provide a full range of functions, similar

in scope to those established in ONC’s final rule that adopts standards, implementation

specifications, and certification criteria for the technical requirements and capabilities that EHR

systems will need to meet in order to be certified. Based on several peer-reviewed studies, only

a small proportion of physicians and hospitals have invested in EHR technology that

encompasses such a broad range of functions. For example, a study entitled "Electronic Health

Records in Ambulatory Care—A National Survey of Physicians"(Catherine DesRoches et al.,

New England Journal of Medicine, July 3, 2008), found that in 2007 only "four percent of

physicians reported having an extensive, fully functional electronic-records system, and 13

percent reported having a basic system." (Additional results from the same survey can be found

at the Department's Health IT Adoption Initiative Web site at

http://healthit.hhs.gov/portal/server.pt?open=512&mode=2&cached=true&objID=1152.)

Another study entitled "Use of Electronic Health Records in U.S. Hospitals"(Ashish Jha et al.,

New England Journal of Medicine, April 16, 2009) found that in 2007 "only 1.5 percent of U.S.

hospitals have a comprehensive electronic-records system … and an additional 7.6 percent have

a basic system." Computerized order entry (CPOE) for drugs was fully implemented in only 17

percent of hospitals.

Most physicians and hospitals have not yet invested in the hardware, software, testing

and training to implement advanced EHRs for a number of reasons – lack of standards, lack of

interoperability, limited physician acceptance, fear of maintenance costs, and lack of capital.

Perhaps most importantly, adoption of EHR technology necessitates major changes in business

processes and practices throughout a provider's office or facility. Business process reengineering
CMS-0033-F 707

on such a scale is not undertaken lightly. However, the availability of the HITECH Act

incentives, grants for technical support, more consistent use of standards and specified

certification criteria, and other factors addressed in this RIA are likely to increase the adoption of

EHR technology very substantially over the next 10 years—perhaps approaching complete

adoption for physicians, hospitals, and many other types of providers, despite, as those providers

have commented, not being included in this final rule.

Overall, we expect spending under the EHR incentive program for transfer payments to

Medicare and Medicaid providers over 10 years to be $9.7 billion under the low scenario, and

$27.4 billion under the high scenario (these estimates include net payment adjustments for

Medicare providers who do not achieve meaningful use in 2015 and beyond in the amount of

$3.9 billion under the high scenario and $8.1 billion under the low scenario). We have also

estimated "per entity" costs for EPs, eligible hospitals, and CAHs. We estimate also that

adopting entities will achieve dollar savings at least equal to their total costs, and that there will

be additional benefits to society. We remain persuaded after consideration of the public

comments that implementation costs will be significant for each participating entity because

providers who would like to qualify as meaningful users of EHRs will need to purchase certified

EHR technology. We further acknowledge that certified EHRs may differ in many important

respects from the types of EHRs noted in these comments and the functionalities they contain

may differ. However, we still anticipate that the short-term costs to demonstrate meaningful use

of certified EHR technology will be outweighed by the long-term benefits, including practice

efficiencies and improvements in medical outcomes. Thus it remains that although both cost and

benefit estimates are highly uncertain, the RIA that we have prepared to the best of our ability

presents the costs and benefits of the final rulemaking.

CMS-0033-F 708

B. Regulatory Flexibility Analysis

The Regulatory Flexibility Act requires agencies to prepare an Initial Regulatory

Flexibility Analysis to describe and analyze the impact of the final rule on small entities unless

the Secretary can certify that the regulation will not have a significant impact on a substantial

number of small entities. In the healthcare sector, Small Business Administration size standards

define a small entity as one with between $7 million and $34 million in annual revenues. For the

purposes of the Regulatory Flexibility Act, essentially all non-profit organizations are considered

small entities, regardless of size. Individuals and States are not included in the definition of a

small entity. Since the vast majority of Medicare providers (well over 90 percent) are small

entities within the Regulatory Flexibility Act's definitions, it is the normal practice of HHS

simply to assume that all affected providers are "small" under the Regulatory Flexibility Act. In

this case, most EPs, eligible hospitals, and CAHs are either non-profit or meet the SBA's size

standard for small business. We also believe that the effects of the incentives program on many

and probably most of these affected entities will be economically significant. Accordingly, this

RIA section, in conjunction with the remainder of the preamble, constitutes the required Initial

Regulatory Flexibility Analysis. We believe that the adoption and meaningful use of EHRs will

have an impact on virtually every EP and eligible hospital, as well as CAHs and some EPs and

hospitals affiliated with MA organizations. While the program is voluntary, in the first 5 years it

carries substantial positive incentives that will make it attractive to virtually all eligible entities.

Furthermore, entities that do not demonstrate meaningful use of EHR technology will be subject

to significant Medicare payment reductions after the fifth year. The anticipation of these

Medicare payment adjustments will also motivate EPs, eligible hospitals, and CAHs to adopt and

meaningfully use certified EHR technology.

CMS-0033-F 709

For some EPs, CAHs and eligible hospitals the EHR technology that they have in place

before the HITECH requirements will be able to be upgraded to meet the criteria for certified

EHR technology as defined for this program. These costs may be minimal, involving no more

than a software upgrade. "Home-grown" EHR systems that might exist may also require an

upgrade to meet the HITECH certification requirements.

We believe that most EPs using EHR systems will require significant changes to achieve

certification and that EPs, CAHs and eligible hospitals will have to make process changes to

achieve meaningful use. Further, given what we know about the current low levels of EHR

adoption we believe that the majority of EPs will need to purchase certified EHR technology,

implement this new technology, and train their staff on its use. The costs for implementation and

complying with the criteria of meaningful use could lead to higher operational expenses.

However, we believe that the combination of payment incentives and long-term overall gains in

efficiency will compensate for the initial expenditures.

1. Number of Small Entities

In total, we estimate that there are approximately 624,000 healthcare organizations (EPs,

eligible hospitals, or CAHs that will be affected by the incentive program. These include

hospitals and physician practices as well as doctors of medicine or osteopathy, dental surgery or

dental medicine, podiatric medicine, optometry or a chiropractor. Additionally, eligible

nonphysicians (such as certified nurse-midwives, etc) will be eligible to receive the Medicaid

incentive payments.

Of the 624,000 healthcare organizations we estimate will be affected by the incentive

program, we estimate that 94.71 percent will be EPs, 0.8 percent will be hospitals, and 4.47

percent will be MAO physicians or hospitals. We further estimate that EPs will spend
CMS-0033-F 710

approximately $54,000 to purchase and implement a certified EHR and $10,000 annually for

ongoing maintenance according to the CBO. In that paper, Evidence on the Costs and Benefits

of Health Information Technology, May 2008, in attempting to estimate the total cost of

implementing health IT systems in office-based medical practices, recognized the complicating

factors of EHR types, available features and differences in characteristics of the practices that are

adopting them. The CBO estimated a cost range of $25,000 to $45,000 per physician. For all

eligible hospitals, the range is from $1 million to $100 million. Though reports vary widely, we

anticipate that the average would be $5 million to achieve meaningful use. We estimate

$1 million for maintenance, upgrades, and training each year. See the Costs of EHR adoption in

section a under Background and Assumptions portion of this analysis for a discussion regarding

the costs of adoption and variation by size and details on our estimates for the number of entities

that are eligible for the incentive within each eligibility type category.

Comment: One commenter suggested that the Regulatory Flexibility Act analysis did not

include an assessment of the cost to implement the rule at state and local health departments.

State and local health departments do operate clinics and provide care to the public. Some state

and local health departments would be considered small businesses under the Regulatory

Flexibility Act and an assessment of the implementation costs for these entities would allow us

to work together to identify possible funding sources and cost savings strategies.

Response: Under Medicaid, clinics such as rural health clinics or FQHCs are not eligible

providers that can receive incentive payments. However, EPs within these clinics can receive

incentive payments if they meet all other eligibility requirements. The Federal costs and

payments associated with EHR implementation for EPs are captured on in Tables 32 and 33.
CMS-0033-F 711

2. Alternatives Considered

This final rule implements new provisions of the Act for providing incentives for EPs,

eligible hospitals, and CAHs that adopt and demonstrate meaningful use of certified EHR

technology. HHS has no discretion to change the incentive payments or Medicare payment

reductions specified in the statute for providers that adopt or fail to adopt EHR and achieve

meaningful use of EHR technology. The only substantial alternatives within the discretion of the

Department revolve around how best to meet the requirements of the HITECH Act through the

definition of meaningful use for FY 2011 and beyond. Requirements that are too stringent could

have the adverse effect of preventing many EPs, eligible hospitals, and CAHs from achieving

meaningful use and thus preventing them from receiving an incentive payment. Our meaningful

use requirements for 2011 are designed to encourage more widespread adoption of certified EHR

technology and allow more EPs, eligible hospitals, and CAHs to qualify for incentives while they

are also adjusting their practice patterns and training staff to operate the EHR technology in

preparation for more stringent meaningful use requirements over time. We recognize that there

may be incremental costs that result from requiring additional functionality over the base level

defined in the HITECH Act. We note that with regard to reporting of clinical quality measures

for purposes of demonstrating meaningful use, we initially considered requiring EPs, eligible

hospitals, and CAHs to report quality measures electronically in the initial year of the program;

however, ultimately we determined that many providers would not be able to comply with a

requirement to report all quality measures at the beginning of the program. The alternative

approach, consistent with the requirements of this final rule, is to require reporting of quality

measures in phases. In 2011, there will be a requirement to report clinical quality measures

through attestation with a numerator, denominator, and exclusions. Electronic clinical quality
CMS-0033-F 712

measure reporting will begin in FY 2012 for hospitals and CY 2012 for EPs. We expect that

additional clinical quality measure reporting will be added in later years.

Under Medicaid, we considered numerous alternatives regarding how to demonstrate

eligibility for the incentive payments as well as adoption and meaningful use of the certified

EHR technology. These alternatives, including the time period for demonstrating adequate

patient volume, and the requirements and methods for demonstrating meaningful use are

discussed in section II.D. of this final rule.

3. Conclusion

As discussed later in this analysis, we believe that there are many positive effects of

adopting EHR on health care providers, quite apart from the incentive payments to be provided

under this rule. While economically significant, we do not believe that the net effect on

individual providers will be negative over time except in very rare cases. (The statute provides

for hardship exemption in such cases.) Accordingly, we believe that the object of the Regulatory

Flexibility Act to minimize burden on small entities are met by this rule as final.

Comment: Commenters cited the variation in the costs of EHR adoption across EP

settings. For example, smaller practices believe their costs of EHR adoption to be higher per

physician than larger counterparts. They believe they cannot realize the staff reductions and

related cost savings from EHR adoption due to greater cross-functionality for their staff.

Response: We acknowledge the different experiences EPs have with EHR adoption and

implementation. Two additional studies relating to the costs of adoption among small practices

(Miller et al. (2005) "The Value Of Electronic Health Records In Solo Or Small Group

Practices" Health Affairs 24(5): 1127-1137, and Zaroukian and Sierra (2006) "Benefiting from

Ambulatory EHR Implementation: Solidarity, Six Sigma, and Willingness to Strive" The Journal
CMS-0033-F 713

of Healthcare Information Management 20(1): 53-60) estimate the cost per physician to be

$44,000 per year with roughly $8,500 to $13,000 in ongoing maintenance. However, even

among these studies there was still variation in experience. The per provider design of

meaningful use incentive payments and orientation of other government health IT grant

programs is to facilitate adoption and positive return on investment across health care settings.

Thus we continue to hold that our cost estimates are reasonable estimations of provider

experience while acknowledging that variations in experiences will be inevitable.

C. Small Rural Hospitals

Section 1102(b) of the Act requires us to prepare a RIA if a rule would have a significant

impact on the operations of a substantial number of small rural hospitals. This analysis must

conform to the provisions of section 604 of the Regulatory Flexibility Act. For purposes of

section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of

a metropolitan statistical area and has fewer than 100 beds. This final rule would affect the

operations of a substantial number of small rural hospitals because they are required to adopt

certified EHR technology by 2015, or face adjusted Medicare payments. As stated above, we

have determined that this final rule would create a significant impact on a substantial number of

small entities, and have prepared a Regulatory Flexibility Analysis as required by the Regulatory

Flexibility Act and, for small rural hospitals, section 1102(b) of the Act. Furthermore, any

impacts that would arise from the implementation of certified EHR technology in a rural eligible

hospital would be positive, with respect to the streamlining of care and the ease of sharing

information with other EPs to avoid delays, duplication, or errors.

Comment: Several commenters have disagreed with our assessment, noting that the

unique circumstances of small rural hospitals will not lead to efficiency and lower costs as it
CMS-0033-F 714

might with urban hospitals, but would lead to increased costs related to loss of productivity

among the staff for implementing and learning an EHR system, and in later years, Medicare

payment adjustments because of the lack of broadband access in these areas among other

reasons.

Response: Although we agree that small rural hospitals will have challenges inherent in

their location, size and staffing complexity, we also acknowledge that smaller, more rural

hospitals could experience added burden in achieving meaningful use. Supplemental funding to

Regional Extension Centers to assist CAHs will work to lessen disparity between urban and rural

hospitals. We also believe that the presence of incentive payments, market demands and rewards

for data exchange, and future cost savings resulting from meaningful use will increase hospital

adoption and meaningful use of EHRs.

D. Unfunded Mandates Reform Act

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that

agencies assess anticipated costs and benefits before issuing any rule whose mandates would

require spending in any 1 year $100 million in 1995 dollars, updated annually for inflation. In

2010, that threshold is approximately $135 million. UMRA does not address the total cost of a

rule. Rather, it focuses on certain categories of cost, mainly those "Federal mandate" costs

resulting from--(1) imposing enforceable duties on State, local, or tribal governments, or on the

private sector, or (2) increasing the stringency of conditions in, or decreasing the funding of,

State, local, or tribal governments under entitlement programs.

This rule imposes no substantial mandates on States. This program is voluntary for

States and States offer the incentives at their option. The State role in the incentive program is

essentially to administer the Medicaid incentive program. While this entails certain procedural
CMS-0033-F 715

responsibilities, these do not involve substantial State expense. In general, each State Medicaid

Agency that participates in the incentive program will be required to invest in systems and

technology to comply - States will have to identify and educate providers, evaluate their

attestations and pay the incentive. However, the Federal government will fund 90 percent of the

State’s related administrative costs, providing controls on the total State outlay.

The investments needed to meet the meaningful use standards and obtain incentive

funding are voluntary, and hence not "mandates" within the meaning of the statute. However,

the potential reductions in Medicare reimbursement after FY 2015 are effectively mandates. We

note that we have no discretion as to those potential payment reductions. Private sector EPs that

voluntarily choose not to participate in the program may anticipate potential costs in the

aggregate that may exceed $135 million; however, because EPs may choose for various reasons

not to participate in the program, we do not have firm data for the percentage of participation

within the private sector.

This RIA, taken together with the remainder of the preamble, constitutes the analysis

required by UMRA.

E. Federalism

Executive Order 13132 establishes certain requirements that an agency must meet when it

promulgates a final rule that imposes substantial direct requirement costs on State and local

governments, preempts State law, or otherwise has Federalism implications. This final rule

would not have a substantial direct effect on State or local governments, preempt State law, or

otherwise have a Federalism implication. Importantly, State Medicaid agencies are receiving

100 percent match from the Federal government for incentives paid and a 90 percent match for

expenses associated with administering the program. As previously stated, we believe that State
CMS-0033-F 716

administrative costs are minimal. We note that this final rule does add a new business

requirement for States, because of the systems that will need to be implemented to track and

report on provider attestations, applications, and payments. States will also expend funds on the

systems that must be built to conduct the tracking and reporting activities. States will interface

with the NLR since registration of providers will be stored in the NLR. For tracking and making

payments, we believe that most States will use their current MMIS system to make payments.

States must inform us of their plans for payments, systems, etc, via the SMHP, PAPD and IAPD;

additionally, States will indicate the costs associated with these activities in their PAPD and

IAPD. CMS is providing 90 percent FFP to States for building the interface and/or for updates

to the MMIS related to EHR incentive payment administration. We believe the Federal share of

the 90 percent match will protect the States from burdensome financial outlays and, as noted

above, States offer the Medicaid EHR incentive program at their option.

F. Anticipated Effects

The objective of the remainder of this RIA is to summarize the costs and benefits of the

HITECH incentive program for the Medicare FFS, Medicaid, and Medicare Advantage (MA)

programs. We also provide assumptions and a narrative addressing the potential costs to the

industry for implementation of this technology.

G. HITECH Impact Analysis

1. Need for Regulation

This final rule would implement the provisions of the American Recovery and

Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) that provide incentive payments to EPs,

eligible hospitals, and CAHs participating in Medicare and Medicaid programs that adopt and

meaningfully use certified EHR technology. The final rule specifies the initial criteria that an
CMS-0033-F 717

EP, eligible hospital, or CAH must meet in order to qualify for the incentive payment;

calculation of the incentive payment amounts; payment adjustments under Medicare for covered

professional services and inpatient hospital services provided by EPs, and eligible hospitals

failing to meaningfully use certified EHR technology; and other program participation

requirements. As noted earlier in this RIA, changes both in legislation and policy based on

comments from the public have been taken into account for the preparation of this final impact

analysis.

2. Alternatives Considered

As previously discussed in the alternatives section of the regulatory flexibility analysis,

HHS has no discretion to change the incentive payments or payment reductions specified in the

statute for providers that adopt or fail to adopt EHR and demonstrate meaningful use of certified

EHR technology. However, we have discretion around how best to meet the HITECH Act

requirements for meaningful use for FY 2011 and beyond, which we have exercised in this final

rule. Additionally, we have used our discretion to appropriately time the registration, attestation

and payment requirements to allow EPs and eligible organizations as much time as possible in

coordination with the anticipated certification of EHR technology to obtain and meaningfully use

certified EHRs. We recognize that there may be additional costs that result from various

discretionary policy choices such as requiring additional functionality over the base level defined

in the HITECH Act, however, those costs cannot be estimated and are not captured in this

analysis.

3. Background and Assumptions

The principal costs of this final rule are the additional expenditures that will be

undertaken by eligible entities in order to obtain the Medicare and Medicaid incentive payments
CMS-0033-F 718

to adopt, implement or upgrade and/or demonstrate meaningful use of certified EHR technology,

and to avoid the Medicare payment adjustments that will ensue if they fail to do so. The

estimates for the provisions affecting Medicare and Medicaid EPs, eligible hospitals, and CAHs

are somewhat uncertain for several reasons: (1) the program is voluntary although payment

adjustments will be imposed on Medicare providers who are unable to demonstrate meaningful

use starting in 2015; (2) the criteria for the demonstration of meaningful use of certified EHR

technology has been finalized for stage one but will change over time; (3) the HHS certification

process although defined, has yet to be implemented;, and, (4) the impact of the financial

incentives and payment adjustments on the rate of adoption of certified EHR technology by EPs,

eligible hospitals, and CAHs is difficult to predict. The net costs and savings shown for this

program represent two possible scenarios and actual impacts could differ substantially.

As written in the preamble, this final rule describes the incentive payments for EPs,

eligible hospitals, and CAHs for adopting and demonstrating meaningful use of certified EHR

technology. This impact analysis addresses the costs and benefits to the Medicare and Medicaid

programs, as well as general implementation costs for eligible hospitals, CAHs and EPs.

Detailed information about the incentive program, the specific payment amounts and how

those payments will be paid, is provided in section II.of this final rule. Based on input from a

number of internal and external sources, including the Government Accountability Office (GAO)

and CBO, we calculated the numbers of EPs and eligible hospitals, including CAHs under

Medicare, Medicaid, and MA and used them throughout the analysis.

● About 553,200 Medicare FFS EPs in 2011 (some of which will also be Medicaid EPs).

● About 14 percent of the total EPs are hospital-based Medicare EPs, and are not eligible

for the program. This leaves approximately 477,500 nonhospital-based Medicare EPs in 2011.
CMS-0033-F 719

● Twenty percent of the nonhospital-based Medicare EPs (approximately 95,500

Medicare EPs in 2011) are also eligible for Medicaid (meet the 30 percent Medicaid patient

volume criteria), but can only be paid under one program. We assume that any EP in this

situation will choose to receive the Medicaid incentive payment, because it is larger.

● About 44,100 non-Medicare eligible EPs (such as dentists, pediatricians, and eligible

non-physicians such as certified nurse-midwives, nurse practitioners and physicians assistants)

will be eligible to receive the Medicaid incentive payments.

● 5,011 eligible hospitals comprised of the following:

++ 3,620 acute care hospitals.

++ 1,302 CAHs

++ 78 children's hospitals (Medicaid only).

++ 11 cancer hospitals (Medicaid only).

● All eligible hospitals, except for children's and cancer hospitals, may qualify and apply

for both Medicare and Medicaid incentive payments.

● 12 MA Organizations (about 28,000 EPs, and 29 hospitals) would be eligible for

incentive payments.

● Payments can begin as early as third quarter FY 2011.

4. Industry Costs and Adoption Rates

To estimate the impact on healthcare providers we used information from four studies

cited previously. Based on these studies, we continue to estimate for EPs, the average

adopt/implement/upgrade cost is $54,000 per physician FTE, while annual maintenance costs

average $10,000 per physician FTE.

CMS-0033-F 720

For all eligible hospitals, the range is from $1 million to $100 million. Although reports

vary widely, we anticipate that the average would be $5 million to achieve meaningful use,

because providers who would like to qualify as meaningful users of EHRs will need to purchase

certified EHRs. We further acknowledge that "certified EHRs" may differ in many important

respects from the EHRs currently in use and may differ in the functionalities they contain. We

estimate $1 million for maintenance, upgrades, and training each year. Industry costs are

important, in part, because EHR adoption rates will be a function of these industry costs and the

extent to which the costs of "certified EHRs" are higher than the total value of EHR incentive

payments available to EPs and eligible hospitals (as well as adjustments, in the case of the

Medicare EHR incentive program) and any perceived benefits including societal benefits.

Because of the uncertainties surrounding industry cost estimates, we have made various

assumptions about adoption rates in the following analysis in order to estimate the budgetary

impact on the Medicare and Medicaid programs.

For an eligible Medicaid EP, the first year incentive can be based on adoption,

implementation, and upgrade costs. Previously, we noted that section 1903(t)(4)(C) of the Act

gives the Secretary the authority to determine average allowable costs for certified EHR

technology. The Secretary studied average costs associated with the purchase, initial

implementation, and upgrade of certified EHR technology, including support services and initial

training.

Sections 1903(t)(1)(A) and 1903(t)(4) of the Act specify that EPs may not receive

incentive payments in excess of 85 percent of the net average allowable costs of certified EHR

technology, with such net average allowable costs capped at $25,000 in the first year (and

$10,000 in each of the subsequent years.

CMS-0033-F 721

a. Costs of EHR Adoption for EPs

Previously, we described four studies used to estimate costs of implementation including

the purchase and installation of hardware and software, training, as well as productivity losses

associated with implementation and training. Each of these studies was conducted several years

ago, and did not control for type of EHR, functionality, physician practice type or size.

Furthermore, EHRs were not being built against any particular consensus standard, nor was the

concept of "meaningful use" a factor. Thus, the cost of implementing and maintaining certified

EHR technology which meets the requirements established in this regulation might exceed the

estimates from these studies.

One average estimate of the cost per physician for implementation is around $35,000. A

similar study of community health centers estimated costs to average $54,000 per physician FTE.

In this study, the authors explained that implementation costs varied between entities for

hardware, software, installation, and training. After implementation, there were ongoing

operating costs estimated at $21,000 per year for a practice of four physicians. The CBO paper,

Evidence on the Costs and Benefits of Health Information Technology, May 2008, in attempting

to estimate the total cost of implementing health IT systems in office-based medical practices,

recognized the complicating factors of EHR types, available features and differences in

characteristics of the practices that are adopting them. The CBO estimated a cost range of

$25,000 to $45,000 per physician. In the CBO study, operating costs added $3,000 to $9,000 per

physician per year. Finally, a 2005 paper from AHRQ stated that the average purchase and

implementation cost of an EHR could be $32,606 per FTE physician. Maintenance costs were

an additional $1,500 per physician, per month, or $18,000 per year. Smaller practices had the

highest implementation costs per physician at $37,204. Based on the studies cited, eligible
CMS-0033-F 722

providers will be eligible to receive the maximum incentive permitted under the statute, because

the implementation and maintenance costs we have estimated exceed the caps for net average

allowable costs set in the statute.

In calculating the impact of the EHR incentive program for Medicaid EPs, we assumed

that approximately 20 percent of the EPs eligible for the Medicare incentive payment program

are also eligible for Medicaid EHR incentive payments (about 95,500 in 2011). Since the

Medicaid incentive payments are higher than those for Medicare and EPs can only receive

payments from one program, we assume the dually eligible EPs will receive their payments

through the Medicaid program. It is also important to note that just as there is overall variation

in state Medicaid programs, we anticipate there will be variation in the design and timing of state

Medicaid EHR incentive programs. New data on the pace of state planning for meaningful use

was used to adjust Medicaid adoption scenarios. Thus, how and when providers apply for

meaningful use through Medicaid will likely differ by state. Medicaid also offers incentive

payments for dentists, certified nurse-midwives, nurse practitioners and certain physicians'

assistants. While minimal, we have incorporated the sum of these groups in Table 51. We have

estimated a range of Medicaid EPs that will be meaningful users each calendar year. The last

line represents the range of predicted meaningful EHR users each calendar year. The Medicaid

penetration rate for EPs is consistent with the analysis that was used for the Medicare EPs, but

without the behavioral limitations imposed by the Medicare current statute SGR payment

reductions. We assumed a modest behavioral response by Medicaid EPs to the Medicaid

incentive payments resulting in an increase over baseline participation.

b. Costs of EHR Adoption for Eligible Hospitals

The American Hospital Association (AHA) conducts annual surveys that among other
CMS-0033-F 723

measures, track hospital spending. We have updated these data to reflect the latest figures from

the 2008 AHA Survey. Costs at these levels of adoption were significantly higher in 2008 than

2007. This may better reflect the costs of implementing additional functionalities. We have also

updated the number of discharges using the most recent cost report data available. The range in

yearly information technology spending among hospitals is large – from $36,000 to over

$32 million based on 2007 and 2008 AHA data. EHR system costs specifically were reported by

experts to run as high as $20 million to $100 million; HHS discussions with experts led to cost

ranges for adoption that varied by hospital size and level of EHR system sophistication.

Research to date has shown that adoption of comprehensive EHR systems is limited. In the

aforementioned AHA study, 1.5 percent of these organizations had comprehensive systems,

which were defined as hospital-wide clinical documentation of cases, test results, prescription

and test ordering, plus support for decision-making that included treatment guidelines. Some

10.9 percent have a basic system that does not include physician and nursing notes, and can only

be used in one area of the hospital. Applying a similar standard to the 2008 AHA data, results in

roughly 3-4 percent of hospitals having comprehensive systems and 12 to 13 percent having

basic systems. According to hospital CEOs, the main barrier to adoption is the cost of the

systems, and the lack of capital. Hospitals have been concerned that they will not be able to

recoup their investment, and they are already operating on the smallest of margins. Because

uptake of advanced systems is low, it is difficult to get a solid average estimate for

implementation and maintenance costs that can be applied across the industry. In addition, we

recognize that there are additional industry costs associated with adoption and implementation of

EHR technology that are not captured in our estimates that eligible entities will incur. Because

the impact of those activities, such as reduced staff productivity related to learning how to use
CMS-0033-F 724

the EHR technology, the need to add additional staff to work with HIT issues, administrative

costs related to reporting, and the like are unknown at this time and difficult to quantify.

5. Medicare Incentive Program Costs

a. Medicare Eligible Professionals (EPs)

In the proposed rule, CMS said that an EP would be a hospital- based EP and therefore

ineligible to receive a Medicare or Medicaid EHR incentive payment if more than 90 percent of

their services are provided in the following place of service (POS) codes for HIPAA standard

transactions: 21—Inpatient Hospital, 22 – Outpatient Hospital, 23 – Emergency Room.

However, as previously noted here and discussed elsewhere in this final rule, Congress

amended the law to include only POS codes 21 (inpatient) and 23 (emergency room), excluding

22 (outpatient hospital), thereby permitting some hospital-based EPs to qualify for the incentive

payment. Accordingly we have updated our tables to reflect the increased number of EPs that

may now qualify for the incentive payments, and those revisions to the numbers flow throughout

these updated tables.

To determine the estimated costs of the Medicare incentives for EPs we first needed to

determine the EPs with Medicare claims. Then, we calculated that about 14 percent of those EPs

are hospital-based based on the definition final in §495.4, and therefore, do not qualify for

incentive payments. This percent of EPs were subtracted from the total number of EPs who

have claims with Medicare. These numbers were tabulated from Medicare claims data.

We have also estimated that about 20 percent of EPs that are not hospital-based will

qualify for Medicaid incentive payments and will choose that program because the payments are

higher. Of the remaining EPs, we have estimated the percentage which will be meaningful users

each calendar year. As discussed previously our estimates for the number of EPs that will
CMS-0033-F 725

successfully demonstrate meaningful use of certified EHR technology are uncertain, so we

established high and low scenarios to account for high and low rates of demonstration of

meaningful use.

The percentage of Medicare EPs who will satisfy the criteria for demonstrating

meaningful use of certified EHR technology and will qualify for incentive payments is a key, but

a highly uncertain factor. Our Medicare EHR adoption assumptions for EPs are also affected by

the current situation with Medicare physician fee schedule payment rates. As noted previously,

under current law (that is, the SGR system formulas), physician payments will be reduced by

21.3 percent beginning June 1, 2010, and are scheduled to be further reduced beginning in

CY 2011. Such reductions would almost certainly cause major changes in physician behavior,

enrollee care, and other Medicare provider payments, but the specific nature of these changes is

exceptionally uncertain. Under a current law scenario, the EHR incentives or Medicare payment

adjustments would exert only a minor influence on physician behavior relative to these very

large payment reductions. Behavioral changes resulting from these scheduled payment

reductions are not included in our estimate and likewise do not assume any additional behavioral

changes from EHR incentive payments. Accordingly, the estimated number of non-hospital

based Medicare EPs, (including those additional EPs who may now qualify under the revised

definition), who will demonstrate meaningful use of certified EHR technology over the period

CYs 2011 through 2019 is as shown in Table 22 .

TABLE 22: Medicare EPs Demonstrating Meaningful Use of Certified EHR Technology,
High and Low Scenario

Calendar Year
2011 2012 2013 2014 2015 2016 2017 2018 2019
EPs who have claims with 553.2 558.9 564.6 570.3 576.0 581.7 587.5 593.3 599.0
Medicare (thousands)
Non-Hospital Based EPs 477.5 482.4 487.3 492.2 497.1 502.1 507.1 512.0 517.0
CMS-0033-F 726

Calendar Year
2011 2012 2013 2014 2015 2016 2017 2018 2019
(thousands)
EPs that are both Medicare and 95.5 96.5 97.5 98.4 99.4 100.4 101.4 102.4 103.4
Medicaid EPs (thousands)
Low Scenario:
Percent of EPs who are 10 13 15 18 21 24 28 32 36
Meaningful Users
Meaningful Users (thousands) 39.9 48.7 58.8 70.2 83.1 97.3 112.9 129.9 148.1
High Scenario:
Percent of EPs who are 36 40 44 49 53 58 62 66 70
Meaningful Users
Meaningful Users (thousands) 136.8 154.7 173.3 192.6 212.2 231.9 251.3 270.4 288.8

Under the HITECH Act, EPs can receive up to 5 years of Medicare incentive payments

for the demonstration of meaningful use of certified EHR technology. These payments are the

lesser of 75 percent of the physician's allowed charges for the year or a specified maximum

amount, which declines from a possible $18,000 incentive payment for the first payment year

(2011 or 2012) to a $2,000 incentive payment for the fifth payment year. EPs in HPSAs receive

incentives that are 10 percent higher than the maximum amounts. Hospital-based EPs are not

eligible for the Medicare EP incentive payments. EPs may choose to receive incentive payments

from either Medicare or Medicaid, (with some limitations on switching programs) but not from

both.

The standard full amount of Medicaid incentive payments that an EP could receive is

larger than the standard full amount for the Medicare EP incentive payments: of $63,750 versus

$44,000 for Medicare. Medicare incentive payments can first be paid to EPs in CY 2011; and

2012 is the last year that an EP can start to receive incentives and obtain the full 5 years of

payments. EPs who first qualify in CY 2013 would be limited to an incentive of $15,000 for the

first year, and may be eligible to receive 4 years of incentive payments. EPs who first qualify in

CY 2014 would be limited to an incentive of $12,000 for the first year and may be eligible to
CMS-0033-F 727

receive 3 years of incentive payments. For the Medicare program, incentives are not payable

after CY 2016, and EPs who first demonstrate meaningful use in CY 2015 or later are not

eligible for EHR incentive payments.

Medicare payment adjustments will apply in CY 2015 and later to EPs who cannot

demonstrate meaningful use of certified EHR technology, regardless of whether they received an

EHR incentive payment or not. Specifically, the Medicare Physician Fee Schedule payments for

an EP who cannot demonstrate meaningful use of certified EHR technology would be reduced by

1 percentage point in CY 2015, two percentage points in CY 2016, and 3 percentage points in

CY 2017, and between 3 and 5 percentage points in starting in CY 2018. The HITECH Act

gives the Secretary the authority, beginning in CY 2018, to increase these reductions by 1

percentage point each year, but not more than 5 percentage points overall, if the Secretary finds

the proportion of EPs who are meaningful EHR users is less than 75 percent.

Each year a transfer will be made between the general fund of the Treasury and the Part

B account of the Supplemental Medical Insurance (SMI) trust fund to offset the incentives paid

or payment adjustments made during the year. In this way, the Part B beneficiary premium will

not be affected by the EP payment incentives.

We estimate that there are 12 MA organizations that might be eligible to participate in the

EHR incentive program. Those plans have about 28,000 EPs.

Our estimates of the incentive payment costs and payment adjustment savings reflect our

assumptions about the proportion of EPs who will demonstrate meaningful use of certified EHR

technology. These assumptions were developed based on a review of recent studies and

discussions with subject matter experts. We project that a growing proportion of EPs will adopt

certified EHR technology that meets the standards even in the absence of the legislated
CMS-0033-F 728

incentives. This number could be higher or lower depending on the final meaningful use

definition adopted, physicians' access to capital and implementation expertise, the success of the

other HITECH programs in reaching physicians, and other factors.

Specifically, our assumptions are based on literature estimating current rates of physician

EHR adoption and rates of diffusion of EHRs and similar technologies. There are a number of

studies that have attempted to measure the rate of adoption of electronic medical records (EMR)

among physicians prior to the enactment of the HITECH Act (see, for example, Funky and

Taylor (2005) The State and Pattern of Health Information Technology Adoption. RAND

Monograph MG-409. Santa Monica: The RAND Corporation; Ford, E.W., Menachemi, N.,

Peterson, L.T., Huerta, T.R. (2009) "Resistance is Futile: But it is Slowing the Pace of EHR

Adoption Nonetheless" Journal of the American Informatics Association 16(3): 274-281). We

started with the estimated rate of EHR adoption from the study with the most rigorous definition,

but note that the meaningful criteria are not equivalent to a fully functional system as defined in

this study. (DesRoches, CM, Campbell, EG, Rao, SR et al (2008) "Electronic Health Records in

Ambulatory Care-A National Survey of Physicians" New England Journal of Medicine 359(1):

50-60). For the low scenario, we then inflated that number (4 percent) to a 2011 baseline using

the numbers of physicians reporting in that survey that they had EHR implementation underway.

We assumed that the same proportion of them would be implementing fully-functional EHRs as

in the baseline (30 percent of those with basic systems.) We then trended this number forward

using the trajectory mapped out by Ford et al. using the data from the period prior to FY 2004

since the slower rate of adoption during the FY 2005 through 2007 period was thought to be

caused by policy uncertainty which this regulation should resolve.

CMS-0033-F 729

Given the revisions to the meaningful use criteria in this final rule and the nationwide

implementation of the Regional Extension Center Program, the likelihood of reaching the high

scenario has increased. However, actual adoption trends could be significantly different from

these assumptions, given the elements of uncertainty we describe throughout this analysis.

Net costs for the low scenario of the Medicare EP portion of the HITECH Act are shown

in Table 23.

TABLE 23: Estimated Costs (+) and Savings (–) for Medicare EPs Demonstrating
Meaningful Use of Certified EHR Technology, Low Scenario
(in billions)

Payment
Incentive Benefit
Fiscal Year Adjustment Net Total
Payments Payments
Receipts
2009 — — — —
2010 — — — —
2011 $0.2 — — $0.2
2012 $1.0 — — $1.0
2013 $0.9 — — $0.9
2014 $0.6 — — $0.6
2015 $0.5 –$0.6 — –$0.1
2016 $0.3 –$1.0 — –$0.6
2017 $0.1 –$1.4 — –$1.3
2018 — –$1.6 — –$1.6
2019 — –$1.6 — –$1.6
Total, 2009-2014 $2.6 — — $2.6
Total, 2009-2019 $3.6 –$6.1 — –$2.5

The estimated net costs for the high scenario of the Medicare EP portion of the HITECH

Act are shown in Table 24.

TABLE 24: Estimated Costs (+) and Savings (–) for Medicare EPs Demonstrating
Meaningful Use of Certified EHR Technology, High Scenario
(in billions)

Payment
Incentive Benefit
Fiscal Year Adjustment Net Total
Payments Payments
Receipts
2009 — — — —
CMS-0033-F 730

Payment
Incentive Benefit
Fiscal Year Adjustment Net Total
Payments Payments
Receipts
2010 — — — —
2011 $0.6 — — $0.6
2012 $2.3 — — $2.3
2013 $2.0 — — $2.0
2014 $1.3 — — $1.3
2015 $1.1 –$0.4 — $0.7
2016 $0.7 –$0.6 — $0.1
2017 $0.3 –$0.8 — –$0.5
2018 — –$0.8 — –$0.8
2019 — –$0.8 — –$0.8
Total, 2009-2014 $6.2 — — $6.2
Total, 2009-2019 $8.3 –$3.4 — $5.0

b. Medicare Eligible Hospitals and CAHs

In brief, the estimates of hospital adoption were developed by calculating projected

incentive payments (which are driven by discharges), comparing them to projected costs of

attaining meaningful use, and then making assumptions about how rapidly hospitals would adopt

given the fraction of their costs that were covered. In addition, our estimates have been updated

to reflect that the additional challenges likely to be experienced in the adoption of EHRs among

CAHs will be partially ameliorated by supplements to Regional Extension Center funding to

assist CAHs with EHR adoption.

Specifically, the first step in preparing estimates of Medicare program costs for eligible

hospitals was to determine the amount of Medicare incentive payments that each hospital in the

country could potentially receive under the statutory formula, based on its admission numbers

(total patients and Medicare patients). The total incentive payments potentially payable over a

4-year period vary significantly by hospitals' inpatient caseloads, ranging from a low of about

$11,000 to a high of $12.9 million, with the median being $3.8 million. The potential Medicare

incentive payments for each eligible hospital were compared with the hospital's expected cost of
 CMS-0033-F 731

purchasing and operating certified EHR technology. Costs of adoption for each hospital were

estimated using data from the 2008 AHA annual survey and IT supplement. Estimated costs

varied by size of hospital and by the likely status of EHR adoption in that class of hospitals.

Hospitals were grouped first by size (CAHs, non-CAH hospitals under 400 beds, and hospitals

with 400 or more beds) because EHR adoption costs do vary by size: namely, larger hospitals

with more diverse service offerings and powerful physician staffs generally implement more

customized systems than smaller hospitals that might purchase off-the-shelf products. We then

calculated the proportion of hospitals within each class that were at one of three levels of EHR

adoption: (1) hospitals which had already implemented relatively advanced systems that

included CPOE systems for medications; (2) hospitals which had implemented more basic

systems through which lab results could be shared, but not CPOE for medications; and (3)

hospitals starting from a base level either neither CPOE or lab reporting. The CPOE for

medication standard was chosen because expert input indicated that the CPOE standard in the

final meaningful use definition will be the hardest one for hospitals to meet. Table 25 provides

these proportions.

TABLE 25: Hospital IT Capabilities By Hospital Size

Levels of Adoption
Any CPOE Meds Lab Results Neither Total
Number Number Number Number
of of of of
Hospital Size Hospitals Percentage Hospitals Percentage Hospitals Percentage Hospitals Percentage
CAHs 176 19% 440 48% 293 32% 909 23%
Small/Medium 817 31% 1,352 51% 462 18% 2,631 67%
Large (400+beds) 216 54% 163 41% 18 5% 397 10%
Total 1209 31% 1955 50% 773 20% 3,937 100%

We then calculated the costs of moving from these stages to meaningful use for each

class of hospital, assuming that even for hospitals with CPOE systems they would incur
CMS-0033-F 732

additional costs of at least 10 percent of their IT budgets. These costs were based on

cross-sectional data from the AHA survey and thus do not likely represent the true costs of

implementing systems. We have updated these data to reflect the latest figures from the 2008

AHA Survey. Costs at these levels of adoption were significantly higher in 2008 than 2007.

This may better reflect the costs of implementing additional functionalities. We have also

updated the number of discharges using the most recent cost report data available. Under the

HITECH Act, an eligible hospital can receive up to 4 years of Medicare incentive payments for

the demonstration of meaningful use of certified EHR technology. These payments reflect the

ratio of Medicare inpatient days to total inpatient days and are adjusted by transition factors of

100, 75, 50, and 25 percent for the first through fourth implementation years respectively.

[Medicare incentive payments can first be paid to hospitals in FY 2011, and FY 2013 is the last

year that a hospital can start to receive incentives and obtain the full 4-year transition rates].

Eligible hospitals that first qualify in FY 2014 or FY 2015 will only receive the transition

portions that apply to eligible hospitals who implement their EHR in FY 2013 (for example, 75

percent in FY 2014 and 50 percent in FY 2015). Eligible hospitals first demonstrating

meaningful use in FY 2016 or later are not eligible for incentive payments. Medicare payment

adjustments will be applied beginning in FY 2015 to eligible hospitals that cannot demonstrate

meaningful use of certified EHR technology. Special rules apply to CAHs.

We estimate that there are 12 MAOs that might be eligible to participate in the incentive

program. Those plans have 29 eligible hospitals. The costs for the MA program have been

included in the overall Medicare estimates.

Again to illustrate the uncertainty, we are providing two scenarios for our estimates. Our

high scenario estimated net costs for section 4102 of the HITECH Act are shown in Table 26:
CMS-0033-F 733

Estimated costs (+) and savings (–) for eligible hospitals adopting certified EHRs. This

provision is estimated to increase Medicare hospital expenditures by a net total of $10.1 billion

during FYs -2011 through 2019.

TABLE 26: Estimated Costs (+) and Savings (–) for Medicare Eligible Hospitals
Demonstrating Meaningful Use of Certified EHR Technology, High Scenario
(in billions)

Fiscal Year Incentive Payment Benefit

Payments Adjustment Payments Net Total
Receipts
2009 — — — —
2010 — — — —
2011 $0.5 — (¹) $0.5
2012 $2.1 — (¹) $2.1
2013 $2.2 — (¹) $2.2
2014 $1.9 — (¹) $1.9
2015 $2.1 -$0.3 (¹) $1.8
2016 $1.3 -$0.1 (¹) $1.2
2017 $0.5 -$0.1 (¹) $0.5
2018 — (¹) (¹) (¹)
2019 — — (¹) (¹)
Total, 2009-2014 $6.7 — –$0.1 $6.7
Total, 2009-2019 $10.7 –$0.5 –$0.2 $10.1
1
Savings of less than $50 million.

We are also providing the estimates for a low scenario in Table 27.

TABLE 27: Estimated Costs (+) and Savings (–) for Medicare Eligible Hospitals
Demonstrating Meaningful Use of Certified EHR Technology, Low Scenario
(in billions)

Fiscal Year Incentive Payment Benefit Net Total

Payments Adjustment Payments
Receipts
2009 — — — —
2010 — — — —
2011 $0.2 — (¹) $0.2
2012 $0.9 — (¹) $0.9
2013 $1.1 — (¹) $1.1
2014 $1.2 — (¹) $1.2
2015 $1.4 –$0.9 (¹) $0.5
2016 $1.2 –$0.6 (¹) $0.6
CMS-0033-F 734

Fiscal Year Incentive Payment Benefit Net Total

Payments Adjustment Payments
Receipts
2017 $0.6 -$0.3 (¹) $0.3
2018 — -$0.2 (¹) -$0.2
2019 — -$0.1 (¹) -$0.1
Total, 2009-2014 $3.5 — –$0.1 $3.5
Total, 2009-2019 $6.7 –$2.0 –$0.2 $4.6
1
Savings of less than $50 million.

Based on the comparison of Medicare incentive payments and implementation/operating

costs for each eligible hospital, (described above), we made the assumptions shown in Table 28,

related to the prevalence of certified EHR technology for FY 2011 through 2018. As indicated,

eligible hospitals that could cover the full cost of an EHR system through Medicare incentive

payments were assumed to implement them relatively rapidly, and vice-versa. In other words,

eligible hospitals will have an incentive to purchase and implement an EHR system if they

perceive that a large portion of the costs will be covered by the incentive payments. Table 28

shows the high scenario estimates:

TABLE 28: Assumed Proportion of Eligible Hospitals with Certified EHR Technology, by
Percentage of System Cost Covered by Medicare Incentive Payments, High Scenario

Incentive Payments as Percentage of EHR

Fiscal
Technology Cost
Year
100+% 75-100% 50-75% 25-50% 0-25%
2011 0.8 0.5 0.3 0.2 0.1
2012 0.95 0.65 0.5 0.35 0.2
2013 1.0 0.8 0.7 0.6 0.4
2014 1.0 0.95 0.85 0.75 0.6
2015 1.0 1.0 0.95 0.9 0.8
2016 1.0 1.0 1.0 0.95 0.9
2017 1.0 1.0 1.0 1.0 0.95
2018 1.0 1.0 1.0 1.0 1.0

For instance, under the high scenario 50 percent of eligible hospitals whose incentive

payments would cover between 75 percent and 100 percent of the cost of a certified EHR system
CMS-0033-F 735

were assumed to have a certified system in FY 2011. In FY 2012, 65 percent of those hospitals

were assumed to have a certified EHR system. All such hospitals were assumed to have a

certified EHR system in FY 2015 and thereafter.

High rates of EHR adoption are anticipated prior to FY 2015 due to the large payment

adjustments that will be imposed on eligible hospitals that are unable to demonstrate meaningful

use beginning in FY 2015. Specifically, the Medicare "market basket" payment updates would

be reduced (on a noncumulative basis) by one-fourth, one-half, and three-fourths for FYs 2015,

2016, and 2017 and later, respectively, for eligible hospitals that were not meaningful users of

certified EHR technology. However, we heard from industry experts that issues surrounding the

capacity of vendors and expert consultants to support implementation, issues of access to capital,

and competing priorities in responding to payer demand will limit the number of hospitals that

can adopt advanced systems in the short-term. Therefore, we cannot be certain of the adoption

rate for hospitals due to these factors and others previously outlined in this preamble, and so we

provide two scenarios which are examples of what we believe are possible low rates and high

rates of adoption.

Table 29 shows the low scenario estimates.

TABLE 29: Assumed Proportion of Eligible Hospitals with Certified EHR Technology, by
Percentage of System Cost Covered by Medicare Incentive Payments, Low Scenario

Incentive Payments as Percentage of EHR

Fiscal Technology Cost
Year 100+% 75-100% 50-75% 25-50% 0-25%
2011 0.6 0.35 0.2 0.1 0.05
2012 0.65 0.4 0.25 0.15 0.1
2013 0.75 0.55 0.4 0.25 0.15
2014 0.9 0.75 0.55 0.4 0.3
2015 1.0 0.9 0.75 0.6 0.5
2016 1.0 1.0 0.9 0.85 0.75
2017 1.0 1.0 0.95 0.9 0.85
2018 1.0 1.0 1.0 0.95 0.9
CMS-0033-F 736

Incentive Payments as Percentage of EHR

Fiscal Technology Cost
Year 100+% 75-100% 50-75% 25-50% 0-25%
2019 1.0 1.0 1.0 1.0 1.0

For large, organized facilities such as hospitals, we believe that the revenue losses caused

by these payment adjustments would be a substantial incentive to adopt certified EHR

technology, even in instances where the Medicare incentive payments would cover only a

portion of the costs of purchasing, installing, populating, and operating the EHR system. Based

on the assumptions about incentive payments as percentages of EHR technology costs in Table

29, we estimated that the great majority of eligible hospitals would qualify for at least a portion

of the Medicare incentive payments that they could potentially receive, and only a modest

number would incur penalties. Nearly all eligible hospitals are projected to have implemented

certified EHR technology by FY 2019. Table 30 shows our high scenario estimated percentages

of the total potential incentive payments associated with eligible hospitals that could demonstrate

meaningful use of EHR systems. Also shown are the estimated percentages of potential

incentives that would actually be paid each year.

TABLE 30: Estimated Percentage of Medicare Incentives Which Could be Paid for
Meaningful Use of Certified EHR Technology Associated with Eligible Hospitals and
Estimated Percentage Payable in Year, High Scenario

Fiscal Percent Associated Percent Payable

Year with Eligible Hospitals in Year
2011 38.4% 38.4%
2012 53.5% 53.5%
2013 70.2% 70.2%
2014 82.6% 82.6%
2015 92.6% 54.2%
2016 96.9% 43.4%
2017 99.0% —
2018 100.0% —
CMS-0033-F 737

For instance in FY 2012 under the high scenario, 53.5 percent of the total amount of

incentive payments which could be payable in that year would be for eligible hospitals who have

demonstrated meaningful use of certified EHR technology and therefore will be paid. In

FY 2015 under the high scenario, 92.6 percent of the total amount of incentive payments which

could be payable will be for hospitals who have certified EHR systems, but some of those

eligible hospitals would have already received 4 years of incentive payments, and therefore

54.2 percent of all possible incentive payments actually paid in that year.

Table 31 shows the low scenario estimates.

TABLE 31: Estimated Percentage of Medicare Incentives Which could be paid for the
Meaningful Use of Certified EHR Technology Associated with Eligible Hospitals and
Estimated Percentage Payable in Year, Low Scenario

Fiscal Percent Associated with Percent Payable in

Year Eligible Hospitals Year
2011 16.8% 16.8%
2012 21.8 % 21.8%
2013 32.1% 32.1%
2014 47.6% 47.6%
2015 66.4 % 49.6%
2016 85.9% 64.1%
2017 91.4% —
2018 95.6 % —

The estimated payments to eligible hospitals were calculated based on the hospitals'

qualifying status and individual incentive amounts under the statutory formula. Similarly, the

estimated penalties for nonqualifying hospitals were based on the market basket reductions and

Medicare revenues. The estimated savings in Medicare eligible hospital benefit expenditures

resulting from the use of hospital certified EHR systems are discussed under "general

considerations" at the end of this section. We assumed no future growth in the total number of

hospitals in the U.S. because growth in acute care hospitals has been minimal in recent years.
CMS-0033-F 738

Comment: The AHA surveyed 795 hospitals in January 2010 asking whether their EHR

systems could meet each of the meaningful use objectives now and in coming years: 45 percent

reported they could meet all Stage 1 objectives by 2015 meaning that the remainder might be

subject to penalties.

Response: Their survey was based on our proposed definition of meaningful use. The

definition of meaningful use in this final rule offers more flexibility and lower thresholds which

we believe will make it easier for eligible hospitals to qualify for incentives. However we do

acknowledge that the meaningful use criteria described in this final rule may still challenge

hospitals to use their IT in ways that improve patient care and outcomes. We also acknowledge

that smaller, more rural hospitals could experience added burden in achieving meaningful use

related to timing and costs of implementation. Supplemental funding to Regional Extension

Centers to assist CAHs will work to lessen disparity between urban and rural hospitals. We also

believe that the presence of incentive payments, market demands and rewards for data exchange,

and future cost savings resulting from meaningful use will increase hospital adoption and

meaningful use of EHRs.

c. Critical Access Hospitals (CAHs)

We estimate that there are 1,302 CAHs eligible to receive EHR incentive payments.

Given the financial assistance available under HITECH for Regional Extension Centers, whose

priorities include assisting CAHs in EHR adoption, we estimate that the 19 percent of CAHs

with relatively advanced EHR systems will achieve meaningful use before 2016. We also

estimate that most of the remaining CAHs that have already adopted some kind of EHR system

(48 percent of CAHs) will also achieve meaningful use by 2016. Our estimates regarding the
CMS-0033-F 739

incentives that will be paid to CAHs are incorporated into the overall Medicare and Medicaid

program costs.

We note that in response to comments this final rule amends the definition of acute care

hospital for purposes of the Medicaid EHR incentive payment program to generally include

critical access hospitals that meet the Medicaid patient volume criteria. Thus, the change in the

definition has required that we update our tables to reflect the increased number of hospitals that

now may qualify for the Medicaid EHR incentive payment program under this new definition.

The numbers and percentages from the revised tables are reflected throughout this final impact

analysis. Additionally, EHR adoption rates have been adjusted now that CAHs will be eligible

for both Medicare and Medicaid EHR incentive payments.

6. Medicaid Incentive Program Costs

Under section 4201 of the HITECH Act, States can voluntarily participate in the

Medicaid incentive payment program and we have based our Medicaid incentive program costs

on all States participating. Eligible hospitals and EPs can qualify for a Medicaid incentive

payment for adopting, implementing, or upgrading in their first participation year, or for

meaningful use, and up to an additional 5 years of incentive payments for demonstrating

meaningful use of certified EHR technology. Under Medicaid, EPs include physicians

(including pediatricians), dentists, certified nurse-midwives, nurse practitioners, and certain

physician assistants. Initial incentive payments are available through 2016, and incentive

payments cannot be made after 2021. The Medicaid hospital incentives are similar to those

specified in section 4102 of the HITECH Act for Medicare, except that they must be paid out

over at least 3 years and are spread out over a maximum of 6 years, are based on the ratio of

Medicaid inpatient days to total days, and are not phased down as quickly as the Medicare
CMS-0033-F 740

payments based on the first year of payment. Medicaid hospitals can begin incentive payments

through 2016, and incentive payments cannot be made after 2021. There are also additional

hospitals, such as children's and cancer hospitals that are only eligible for Medicaid incentives.

EPs may qualify for Medicaid incentive payments if at least 30 percent of their patient

volume is from Medicaid. (Separate rules apply for pediatricians.) As mentioned above, the

Medicaid maximum incentive payments are larger than the corresponding Medicare payments.

Various maximums are specified for eligible hospital and EP incentive payments. There are no

Medicaid penalties for non-adoption of EHR systems or for failing to demonstrate meaningful

use. The Federal costs for Medicaid incentive payments to providers who can demonstrate

meaningful use of EHR technology were estimated similarly to the estimates for Medicare

eligible hospital and EP. Table 32 shows our high estimates for the net Medicaid costs for

eligible hospitals and EP.

TABLE 32: Estimated Federal Costs (+) and Savings (–) under Medicaid, High Scenario
(in $billions)

Incentive payments
Eligible Benefit
Fiscal year Hospitals professionals payments Net total
2009 — — — —
2010 — — — —
2011 0.8 0.9 (¹) 1.7
2012 0.3 1.1 (¹) 1.4
2013 0.9 1.0 (¹) 1.9
2014 0.7 0.9 (¹) 1.6
2015 0.6 1.1 (¹) 1.7
2016 0.5 1.1 (¹) 1.7
2017 0.4 0.9 (¹) 1.3
2018 0.2 0.6 (¹) 0.7
2019 0.0 0.3 (¹) 0.3
Total, 2009-14 2.5 4.0 0.0 6.5
Total, 2009-19 4.3 8.0 -0.1 12.2
1
Less than $50 million impact
CMS-0033-F 741

Table 33 shows the low estimates for Medicaid costs and savings.

TABLE 33: Estimated Federal Costs (+) and Savings (–) under Medicaid, Low Scenario
(in $billions)

Incentive Payments Benefit

Eligible Payments
Fiscal Year Hospitals Professionals Net Total
2009 — — — —
2010 — — — —
2011 0.4 0.2 (¹) 0.6
2012 0.1 0.4 (¹) 0.5
2013 0.4 0.4 (¹) 0.8
2014 0.4 0.4 (¹) 0.8
2015 0.5 0.5 (¹) 1.0
2016 0.7 0.6 (¹) 1.3
2017 0.8 0.5 (¹) 1.3
2018 0.4 0.4 (¹) 0.9
2019 0.1 0.3 (¹) 0.4
Total, 2009-14 1.3 1.4 0.0 2.7
Total, 2009-19 3.8 3.8 0.0 7.6
1
Less than $50 million impact.

a. Medicaid EPs

To determine the Medicaid EP incentive payments, we first determined the number of

qualifying EPs. As indicated above, we assumed that 20 percent of the non-hospital-based

Medicare EPs would meet the requirements for Medicaid incentive payments (30 percent of

patient volume from Medicaid). All of these EPs were assumed to choose the Medicaid

incentive payments, as they are larger. In addition, the total number of Medicaid EPs was

adjusted to include EPs who qualify for the Medicaid incentive payments but not for the

Medicare incentive payments, such as most pediatricians, dentists, certified nurse-midwives,

nurse practitioners and physicians assistants. As noted previously there is much uncertainty

about the rates of demonstration of meaningful use that will be achieved. Therefore, as we

estimated for the Medicare EPs, we are providing high and low scenario estimates for Medicaid

EPs.
 CMS-0033-F 742

Our high scenario estimates are listed in the Table 34.

TABLE 34: Assumed Number of Nonhospital Based Medicaid EPs Who Will Be
Meaningful Users of Certified EHR Technology, High Scenario
(All population figures are in thousands)

2011 2012 2013 2014 2015 2016 2017 2018 2019

EPs who have claims with Medicare 553.2 558.9 564.6 570.3 576.0 581.7 587.5 593.3 599.0
Non-Hospital based EPs 477.5 482.4 487.3 492.2 497.1 502.1 507.1 512.0 517.0
EPs who meet the Medicaid patient Volume
Threshold 95.5 96.5 97.5 98.4 99.4 100.4 101.4 102.4 103.4
Medicaid Only EPs1 44.1 44.8 45.5 46.3 47.1 47.8 48.6 49.3 50.1
Total Medicaid 139.6 141.3 143.0 144.7 146.5 148.2 150.0 151.7 153.5
Percent of EPs receiving incentive
payments during year 47.3% 66.3% 76.6% 82.2% 85.6% 88.8% 43.8% 25.0% 14.4%
Number of EPs receiving incentive payment
during year 66.0 93.7 109.6 119.0 125.4 131.7 65.7 38.0 22.1
Percent of EPs who have ever received
incentive payment 47.3% 66.3% 76.6% 82.2% 85.6% 88.8% 91.9% 94.7% 95.9%
Number of EPs who have ever received
incentive payment 66.0 93.7 109.6 119.0 125.4 131.7 137.7 143.6 147.2
1\
Includes non hospital-based eligible pediatricians, dentists, certified nurse-midwives, nurse practitioners and physicians
assistants. These numbers were not based on tabulated Medicaid data. Rather, a different methodology was used to estimate the
EP counts for each group.

It should be noted that since the Medicaid EHR incentive payment program provides that

a Medicaid EP can receive an incentive payment in their first year because he or she has

demonstrated a meaningful use or because he or she has adopted, implemented, or upgraded

certified EHR technology, these participation rates include not only meaningful users but eligible

providers implementing certified EHR technology as well. Table 35 shows our low scenario

estimates.

TABLE 35: Assumed Number of Nonhospital Based Medicaid EPs Who Will Be
Meaningful Users of Certified EHR Technology, Low Scenario
(All population figures are in thousands)

2011 2012 2013 2014 2015 2016 2017 2018 2019

EPs who have claims with Medicare 553.2 558.9 564.6 570.3 576.0 581.7 587.5 593.3 599.0
Non-Hospital based EPs 477.5 482.4 487.3 492.2 497.1 502.1 507.1 512.0 517.0
EPs who meet the Medicaid patient Volume 95.5 96.5 97.5 98.4 99.4 100.4 101.4 102.4 103.4
Threshold
Medicaid Only EPs1 44.1 44.8 45.5 46.3 47.1 47.8 48.6 49.3 50.1
Total Medicaid 139.6 141.3 143.0 144.7 146.5 148.2 150.0 151.7 153.5
Percent of EPs receiving incentive payments 15.1% 24.0% 30.8% 36.0% 40.5% 45.3% 30.7% 21.9% 15.1%
during year
 CMS-0033-F 743

2011 2012 2013 2014 2015 2016 2017 2018 2019

Number of EPs receiving incentive payment 21.1 34.0 44.0 52.1 59.4 67.2 46.0 33.2 23.1
during year
Percent of EPs who have ever received 15.1% 24.0% 30.8% 36.0% 40.5% 45.3% 50.4% 55.7% 59.9%
incentive payment
Number of EPs who have ever received 21.1 34.0 44.0 52.1 59.4 67.2 75.5 84.4 91.9
incentive payment
1
Includes non hospital-based eligible pediatricians, dentists, certified nurse-midwives, nurse practitioners, and physicians assistants.
These numbers were not based on tabulated Medicaid data. Rather, a different methodology was used to estimate the EP counts for
each group.

b. Medicaid Hospitals

Medicaid incentive payments to most acute-care hospitals were estimated using the same

adoption assumptions and methodology as described previously for Medicare eligible hospitals

and shown in Table 36. Because hospitals' Medicare and Medicaid patient loads differ, we

separately calculated the range of percentage of total potential incentives that could be associated

with qualifying hospitals, year by year, and the corresponding actual percentages payable each

year. Acute care hospitals and children's hospitals can spread aggregate Medicaid incentive

payments over no less than 3 years, but no more than 6 years of payments, and acute care

hospitals may qualify to receive both the Medicare and Medicaid incentive payments.

As stated previously, the estimated eligible hospital incentive payments were calculated

based on the hospitals' qualifying status and individual incentive amounts payable under the

statutory formula. The estimated savings in Medicaid benefit expenditures resulting from the use

of certified EHR technology are discussed under "general considerations." We estimated the

Medicaid incentives payable to children's hospitals as an add-on to the base estimate, using data

on the number of children's hospitals compared to non-children's hospitals.

TABLE 36: Estimated Percentage of Potential Medicaid Incentives Associated with

Eligible Hospitals and Estimated Percentage Payable Each Year, High Scenario

Fiscal Percent Associated Percent Payable

Year with Eligible Hospitals in Year
2011 39.1% 39.1%
CMS-0033-F 744

Fiscal Percent Associated Percent Payable

Year with Eligible Hospitals in Year
2012 54.4% 54.4%
2013 70.9% 70.9%
2014 83.1% 44.0%
2015 92.9% 38.5%
2016 97.1% 26.2%
2017 99.0% 14.0%
2018 100.0% 4.2%
2019 100.0% 0.0%

Table 37 shows our low scenario estimates.

TABLE 37: Estimated Percentage of Potential Medicaid Incentives Associated with

Eligible Hospitals and Estimated Percentage Payable Each Year, Low Scenario

Fiscal Percent Associated with Percent Payable

Year Eligible Hospitals in Year
2011 18.3% 18.3%
2012 23.3% 23.3%
2013 33.7% 33.7%
2014 49.2% 30.9%
2015 67.8% 44.5%
2016 86.5% 52.8%
2017 91.8% 37.3%
2018 95.9% 18.7%
2019 100.0% 0.0%

7. Benefits for all EPs and all Eligible Hospitals

In this final rule we have not quantified the overall benefits to the industry, nor to eligible

hospitals, or EPs in the Medicare, Medicaid, or MA programs. We believe that the first 5 years

of the incentive program will be dedicated to implementation activities, from installation of the

technology to training to operational and behavioral changes. Information on the costs and

benefits of adopting systems specifically meeting the requirements in this rule does not yet exist

– and information on costs and benefits overall is limited (Goldzweig et al. 2009 "Costs and

Benefits of Health Information Technology: New Trends from the Literature" Health Affairs.)
CMS-0033-F 745

Nonetheless, we believe there are benefits that can be obtained by eligible hospitals and

EPs, including: reductions in medical record-keeping costs, reductions in repeat tests, decreases

in length of stay, and reduced errors. Furthermore, there is limited but growing evidence to

support the cost-saving benefits anticipated from wider adoption of EHRs. For example, at one

hospital emergency room in Delaware, the ability to download and create a file with a patient's

medical history saved the ER $545 per use, mostly on reduced waiting times. A pilot study of

ambulatory practices found a positive ROI within 16 months and annual savings thereafter

(Greiger et al. 2007, A Pilot Study to Document the Return on Investment for Implementing an

Ambulatory Electronic Health Record at an Academic Medical Center

http://www.journalacs.org/article/S1072-7515%2807%2900390-0/abstract - article-footnote-1s.)

Some vendors have estimated that EHRs could result in cost savings of between $100 and $200

per patient per year. As adoption increases, there will be more opportunities to capture and

report on cost savings and benefits. A number of relevant studies are required in the HITECH

Act for this specific purpose, and the results will be made public, as they are available.

8. Benefits to Society

According to the recent CBO study "Evidence on the Costs and Benefits of Health

Information Technology" http://www.cbo.gov//ftpdocs/91xx/doc9168/05-20-HealthIT.pdf when

used effectively, EHRs can enable providers to deliver health care more efficiently. For

example, the study states that EHRs can reduce the duplication of diagnostic tests, prompt

providers to prescribe cost-effective generic medications, remind patients about preventive care

reduce unnecessary office visits and assist in managing complex care. Further, the report claims

that there is a potential to gain both internal and external savings from widespread adoption of

health IT, noting that internal savings would likely be in the reductions in the cost of providing
CMS-0033-F 746

care, and that external savings could accrue to the health insurance plan or even the patient, such

as the ability to exchange information more efficiently. The benefits resulting specifically from

this final regulation are even harder to quantify because they represent, in many cases, adding

functionality to existing systems and reaping the network externalities created by larger numbers

of providers participating in information exchange.

Since the CBO study, additional research has emerged documenting the association of

EHRs with improved outcomes among diabetics (Hunt, JS et al. (2009) "The impact of a

physician-directed health information technology system on diabetes outcomes in primary care: a

pre- and post-implementation study" Informatics in Primary Care 17(3):165-74; Pollard, C et al.

(2009) "Electronic patient registries improve diabetes care and clinical outcomes in rural

community health centers" Journal of Rural Health 25(1):77-84) and trauma patients

(Deckelbaum, D. et al. (2009) "Electronic medical records and mortality in trauma patients "The

Journal of Trauma: Injury, Infection, and Critical Care 67(3): 634-636), enhanced efficiencies in

ambulatory care settings (Chen, C et al. (2009) "The Kaiser Permanente Electronic Health

Record: Transforming and Streamlining Modalities Of Care."Health Affairs 28(2):323-333), and

improved outcomes and lower costs in hospitals (Amarasingham, R. et al. (2009) "Clinical

information technologies and inpatient outcomes: a multiple hospital study" Archives of Internal

Medicine 169(2):108–14).

9. General Considerations

The estimates for the HITECH Act provisions were based on the economic assumptions

underlying the President's 2011 Budget. Under the statute, Medicare incentive payments for

certified EHR technology are excluded from the determination of MA capitation benchmarks.

As noted previously, there is considerable uncertainty about the rate at which eligible hospitals,
CMS-0033-F 747

CAHs and EPs will adopt EHRs and other HIT. Nonetheless, we believe that the Medicare

incentive payments and the prospect of significant payment penalties for not demonstrating

meaningful use will result in the great majority of hospitals implementing certified EHR

technology in the early years of the Medicare EHR incentive program. We expect that a steadily

growing proportion of practices will implement certified EHR technology over the next 10 years,

even in the absence of the Medicare incentives. Actual future Medicare and Medicaid costs for

eligible hospital and EP incentives will depend in part on the standards developed and applied

for assessing meaningful use of certified EHR technology. We expect to administer the

requirements in such a way as to encourage adoption of certified EHR technology and facilitate

qualification for incentive payments, and expect to adopt progressively demanding standards at

each stage year. Certified EHR technology has the potential to help reduce medical costs

through efficiency improvements, such as prompter treatments, avoidance of duplicate or

otherwise unnecessary services, and reduced administrative costs (once systems are in place),

with most of these savings being realized by the providers rather than by Medicare or Medicaid.

To the extent that this technology will have a net positive effect on efficiency, then more rapid

adoption of such EHR systems would achieve these efficiencies sooner than would otherwise

occur, without the EHR incentives.

The CBO has estimated a modest level of such savings attributable to EHRs, with much

of the amount associated with reductions in adverse drug-to-drug interactions. We expect a

negligible impact on benefit payments to hospitals and EPs from Medicare and Medicaid as a

result of the implementation of EHR technology.

In the process of preparing the estimates for this rule, we consulted with and/or relied on

internal CMS sources, as well as the following sources:

CMS-0033-F 748

● Congressional Budget Office (staff and publications).

● American Medical Association (staff and unpublished data).

● American Hospital Association.

● Actuarial Research Corporation.

● RAND Health studies on:

++ "The State and Pattern of Health Information Technology Adoption"(Fonkych &

Taylor, 2005);

++ "Extrapolating Evidence of Health Information Technology Savings and

Costs"(Girosi, Meili, & Scoville, 2005); and

++ "The Diffusion and Value of Healthcare Information Technology"(Bower, 2005).

● Kaiser Permanente (staff and publications).

● Miscellaneous other sources (Health Affairs, American Enterprise Institute, news

articles and perspectives).

As noted at the beginning of this analysis, it is difficult to predict the actual impacts of

the HITECH Act with much certainty at this time. We believe the assumptions and methods

described herein are reasonable for estimating the financial impact of the provisions on the

Medicare and Medicaid programs, but acknowledge the wide range of possible outcomes.

All financial analysis is calculated over a 10-year planning horizon, because though the

incentive payments for Medicare EPs, CAHs and eligible hospitals will only be paid for 5 years,

the Medicaid incentives will cease in CY 2021. Starting in CY 2015, Medicare payment

adjustments will begin.

CMS-0033-F 749

10. Summary

The total cost to the Medicare and Medicaid programs is estimated to be $9.7 billion in

transfers under the low scenario, and $27.4 billion under the high scenario, over a 10-year

timeframe. The main reasons for the changes from the proposed rule are revised definitions of

hospital-based eligible professional and Medicaid acute care hospitals, and updated data on

discharges and costs of adoption among hospitals. We do not estimate total costs to the provider

industry, but rather provide a possible per EP and per eligible hospital outlay for implementation

and maintenance operations.

TABLE 51: Estimated EHR Incentive Payments and Benefits Impacts on the Medicare and
Medicaid Programs of the HITECH EHR Incentive Program. (Fiscal Year) – (in billions)
Low Scenario

Fiscal Medicare Eligible Medicaid Eligible Total

Year Hospitals Professionals Hospitals Professionals
2011 $0.2 $0.2 $0.4 $0.2 $1.0
2012 $0.9 $1.0 $0.1 $0.4 $2.4
2013 $1.1 $0.9 $0.4 $0.4 $2.8
2014 $1.2 $0.6 $0.4 $0.4 $2.6
2015 $0.5 -$0.1 $0.5 $0.5 $1.4
2016 $0.6 -$0.6 $0.7 $0.6 $1.3
2017 $0.3 -$1.3 $0.8 $0.5 $0.3
2018 -$0.2 -$1.6 $0.4 $0.4 -$1.0
2019 -$0.1 -$1.6 $0.1 $0.3 -$1.3
TOTAL $4.6 -$2.5 $3.8 $3.8 $9.7

Table 39 shows the total costs from 2011 through 2019 for the high scenario after which

the payment adjustments will be invoked.

CMS-0033-F 750

Table 39: Estimated EHR Incentive Payments and Benefits Impacts on the Medicare and
Medicaid Programs of the HITECH EHR Incentive Program. (Fiscal Year) – (in billions)
High Scenario

Medicare Eligible Medicaid Eligible

Fiscal Year Hospitals Professionals Hospitals Professionals Total
2011 $0.5 $0.6 $0.8 $0.9 $2.8
2012 $2.1 $2.3 $0.3 $1.1 $5.8
2013 $2.2 $2.0 $0.9 $1.0 $6.1
2014 $1.9 $1.3 $0.7 $0.9 $4.8
2015 $1.8 $0.7 $0.6 $1.1 $4.2
2016 $1.2 $0.1 $0.5 $1.1 $2.9
2017 $0.5 -$0.5 $0.4 $0.9 $1.3
2018 — -$0.8 $0.2 $0.6 0.0
2019 — -$0.8 — $0.3 -$0.5
TOTAL $10.1 $5.0 $4.3 $8.0 $27.4

11. Explanation of Benefits and Savings Calculations

In our analysis, we assume that benefits to the program would accrue in the form of

savings to Medicare, through the Medicare EP payment adjustments. Expected qualitative

benefits, such as improved quality of care, better health outcomes, and the like, are still unable to

be quantified at this time.

H. Accounting Statement

Whenever a rule is considered a significant rule under Executive Order 12866, we are

required to develop an Accounting Statement indicating the classification of the expenditures

associated with the provisions of this final rule. Monetary annualized benefits and nonbudgetary

costs are presented as discounted flows using 3 percent and 7 percent factors. Additional

expenditures that will be undertaken by eligible entities in order to obtain the Medicare and

Medicaid incentive payments to adopt and demonstrate meaningful use of certified EHR

technology, and to avoid the Medicare payment adjustments that will ensue if they fail to do so

are noted by a placeholder in the accounting statement. We are not able to explicitly define the
 CMS-0033-F 751

universe of those additional costs, nor specify what the high or low range might be to implement

EHR technology in this final rule.

Expected qualitative benefits include improved quality of care, better health outcomes,

reduced errors and the like. Private industry costs would include the impact of EHR activities

such as temporary reduced staff productivity related to learning how to use the EHR, the need for

additional staff to work with HIT issues, and administrative costs related to reporting.

TABLE 40: Accounting Statement: Classification of Estimated Expenditures

CYs 2010 through 2019

Category: Transfers
Annualized Monetized Low Estimate High Estimate
7% 1,147.9 million 3,102.2 million
3% 1,038.7 million 2,902.4 million
From Whom to Whom Federal government to eligible professionals and hospitals.
Category: Industry Costs Associated with Reporting
Requirements
Low Estimate High Estimate
626.62 million 652.35 million
From Whom to Whom Private industry.
Category: Other Industry Costs
Annualized Monetized Low Estimate High Estimate
7% TBD TBD
3% TBD TBD
From Whom to Whom Private industry.

In accordance with the provisions of Executive Order 12866, this final rule was reviewed

by the Office of Management and Budget.

CMS-0033-F 752

List of Subjects

42 CFR Part 412

Administrative practice and procedure, Health facilities, Medicare, Puerto Rico, Reporting and

recordkeeping requirements.

42 CFR Part 413

Health facilities, Kidney diseases, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 422

Administrative practice and procedure, Health facilities, Health maintenance organizations

(HMO), Medicare, Penalties, Privacy, Reporting and recordkeeping requirements.

42 CFR Part 495

Administrative practice and procedure, Electronic health records, Health facilities, Health

professions, Health maintenance organizations (HMO), Medicaid, Medicare, Penalties, Privacy,

Reporting and recordkeeping requirements.

CMS-0033-F 753

For the reasons set forth in the preamble, the Centers for Medicare & Medicare Services amends

42 CFR Chapter IV as follows:

PART 412—PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL

SERVICES

1. The authority citation for part 412 continues to read as follows:

Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).

Subpart D—Basic Methodology for Determining Prospective Payment Federal Rates for

Inpatient Operating Costs

2. Section 412.64 is amended as follows:

A. Revising paragraph (d)(2)(i)(B).

B. Adding new paragraphs (d)(2)(i)(C) and (d)(3).

The revision and additions read as follows:

§412.64 Federal rates for inpatient operating costs for Federal fiscal year 2005 and

subsequent fiscal years.

* * * * *

(d) * * *

(2) * * *

(i) * * *

(B) For fiscal year 2007 through 2014, by 2 percentage points.

(C) For fiscal year 2015 and subsequent fiscal years, by one-fourth.

* * * * *

(3) Beginning in fiscal year 2015, in the case of a “subsection (d) hospital,” as defined

under section 1886(d)(1)(B) of the Act, that is not a meaningful electronic health record (EHR)
CMS-0033-F 754

user as defined in part 495 of this chapter, three-fourths of the applicable percentage change

specified in paragraph (d)(1) of this section is reduced--

(i) For fiscal year 2015, by 33 1/3 percent;

(ii) For fiscal year 2016, by 66 2/3 percent; and

(iii) For fiscal year 2017 and subsequent fiscal years, by 100 percent.

* * * * *

PART 413—PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT

FOR END–STAGE RENAL DISEASE SERVICES; OPTIONAL PROSPECTIVELY

DETERMINED PAYMENT RATES FOR SKILLED NURSING FACILITIES

3. The authority citation for part 413 continues to read as follows:

Authority: Secs. 1102, 1812(d), 1814(b), 1815, 1833(a), (i), and (n), 1861(v), 1871,

1881, 1883, and 1886 of the Social Security Act (42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g,

1395l(a), (i), and (n), 1395x(v), 1395hh, 1395rr, 1395tt, and 1395ww); and sec. 124 of Public

Law 106–133 (113 Stat. 1501A–332).

Subpart E--Payments to Providers

4. Section 413.70 is amended as follows:

A. Revising paragraph (a)(1).

B. Adding new paragraphs (a)(5), (a)(6) and (a)(7).

The revision and additions read as follows:

§413.70 Payment for services of a CAH.

(a) Payment for inpatient services furnished by a CAH (other than services of distinct

part units). (1) Effective for cost reporting periods beginning on or after January 1, 2004,

payment for inpatient services of a CAH, other than services of a distinct part unit of the CAH
CMS-0033-F 755

and other than the items included in the incentive payment described in paragraph (a)(5) of this

section and subject to the adjustments described in paragraph (a)(6) of this section, is 101 percent

of the reasonable costs of the CAH in providing CAH services to its inpatients, as determined in

accordance with section 1861(v)(1)(A) of the Act and the applicable principles of cost

reimbursement in this part and in part 415 of this chapter, except that the following payment

principles are excluded when determining payment for CAH inpatient services:

(i) Lesser of cost or charges;

(ii) Ceilings on hospital operating costs;

(iii) Reasonable compensation equivalent (RCE) limits for physician services to

providers; and

(iv) The payment window provisions for preadmission services, specified in §412.2(c)(5)

of this subchapter and §413.40(c)(2) of this part.

* * * * *

(5) A qualifying CAH receives an incentive payment for the reasonable costs of

purchasing certified EHR technology in a cost reporting period during a payment year as

determined under §495.106 of this chapter in lieu of payment for such reasonable costs under

paragraph (a)(1) of this section.

(6)(i) For cost reporting periods beginning in or after FY 2015, if a CAH is not a

qualifying CAH, as defined in §495.106(a) of this chapter, then notwithstanding the percentage

applicable in paragraph (a)(1) of this section, the reasonable costs of the CAH in providing CAH

services to its inpatients are adjusted, by the following applicable percentage:

(A) For cost reporting periods beginning in FY 2015, 100.66 percent.

(B) For cost reporting periods beginning in FY 2016, 100.33 percent.

CMS-0033-F 756

(C) For cost reporting periods beginning in FY 2017 and each subsequent fiscal year,

100 percent.

(ii) A CAH may, on a case-by case basis, be exempt from the application of the

adjustments made under this paragraph, if CMS or its Medicare contractors determine, on an

annual basis, that requiring the CAH to become a qualifying CAH under §495.106 of this chapter

would result in a significant hardship, such as in the case of a CAH in a rural area without

sufficient Internet access.

(iii) In no case may a CAH be granted an exemption under this paragraph (a)(6) for more

than 5 years.

(7) There is no administrative or judicial review under section s1869 and 1878 of the

Actor otherwise of the following:

(i) The methodology and standards for determining the amount of payment under

paragraph (a)(5) of this section, including the calculation of reasonable costs under §495.106(c)

of this chapter.

(ii) The methodology and standards for determining the amount of payment adjustments

made under paragraph (a)(6).

(iii) The methodology and standards for determining a CAH to be a qualifying CAH

under §495.106 of this chapter.

(iv) The methodology and standards for determining if the hardship exemption applies to

a CAH under paragraph (a)(6)(ii) of this section.

(v) The specification of the cost reporting periods, payment years, or fiscal years as applied

under this paragraph.

* * * * *
CMS-0033-F 757

PART 422—MEDICARE ADVANTAGE PROGRAM

5. The authority citation for part 422 continues to read as follows:

Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).

Subpart G--Payments to Medicare Advantage Organizations

6. Section 422.304 is amended by adding a new paragraph (f) to read as follows:

§422.304 Monthly payments.

* * * * *

(f) Separate payment for meaningful use of certified EHRs. In the case of qualifying

MA organizations, as defined in §495.200 of this chapter, entitled to MA EHR incentive

payments per §495.220 of this chapter, such payments are made in accordance with sections

1853(l) and (m) of the Act and subpart C of Part 495 of this chapter.

7. Section 422.306 is amended as follows:

A. Removing “and” from the end of paragraph (b)(2)(ii).

B. Removing the period at the end of paragraph (b)(2)(iii) and adding “; and” in its

place.

C. Adding a new paragraph (b)(2)(iv).

The addition reads as follows:

§422.306 Annual MA capitation rates.

* * * * *

(b) * * *

(2) * * *
CMS-0033-F 758

(iv) Adjusted to exclude costs attributable to payments under sections 1848(o) and

1886(n) of the Act of Medicare FFS incentive payments for meaningful use of electronic health

records.

* * * * *

8. Section 422.308 is amended as follows:

A. Redesignating paragraph (a) as paragraph (a)(1).

B. Adding a new paragraph (a)(2).

The addition reads as follows:

§422.308 Adjustments to capitation rates, benchmarks, bids, and payments.

* * * * *

(a) * * *

(2) The amount calculated in paragraph (a)(1) of this section must exclude expenditures

attributable to sections 1848(a)(7) and (o) and sections 1886(b)(3)(B)(ix) and (n) of the Act.

* * * * *

9. Section 422.322 is amended as follows:

A. Adding paragraph (a)(3).

B. Revising paragraph (b).

The addition and revision read as follows:

§422.322 Source of payment and effect of MA plan election on payment.

(a) * * *

(3) Payments under subpart C of part 495 of this chapter for meaningful use of

certified EHR technology are made from the Federal Hospital Insurance Trust Fund or

the Supplementary Medical Insurance Trust Fund. In applying section 1848(o) of the Act
CMS-0033-F 759

under sections 1853(l) and 1886(n)(2)of the Act under section 1853(m) of the Act, CMS

determines the amount to the extent feasible and practical to be similar to the estimated

amount in the aggregate that would be payable for services furnished by professionals

and hospitals under Parts B and A, respectively, under title XVIII of the Act.

(b) Payments to the MA organization. Subject to §412.105(g), §413.86(d), and

§495.204 of this chapter and §§422.109, 422.316, and 422.320, CMS' payments under a

contract with an MA organization (described in §422.304) with respect to an individual

electing an MA plan offered by the organization are instead of the amounts which (in the

absence of the contract) would otherwise be payable under original Medicare for items

and services furnished to the individual.

* * * * *

SUBCHAPTER G--STANDARDS AND CERTIFICATIONS

10. A new part 495 is added to read as follows:

PART 495--STANDARDS FOR THE ELECTRONIC HEALTH RECORD

TECHNOLOGY INCENTIVE PROGRAM

Subpart A--General Provisions

Secs.

495.2 Basis and purpose.

495.4 Definitions.

495.6 Meaningful use objectives measures for EPs, eligible hospitals, and CAHs.

495.8 Demonstration of meaningful use criteria.

495.10 Participation requirements for EPs, eligible hospitals, and CAHs.

CMS-0033-F 760

Secs.

Subpart B--Requirements Specific to the Medicare Program

495.100 Definitions.

495.102 Incentive payments to EPs.

495.104 Incentive payments to eligible hospitals.

495.106 Incentive payments to CAHs.

495.108 Posting of required information.

§495.110 Preclusion on administrative and judicial review.

Subpart C--Requirements Specific to Medicare Advantage (MA) Organizations

495.200 Definitions.

495.202 Identification of qualifying MA organizations, MA-EPs, and MA-affiliated eligible

hospitals.

495.204 Incentive payments to qualifying MA organizations for MA-EPs and MA-affiliated

eligible hospitals.

495.206 Timeframe for payment to qualifying MA organizations.

495.208 Avoiding duplicate payment.

495.210 Meaningful EHR user attestation.

495.212 Limitation on review.

Secs.

Subpart D--Requirements Specific to the Medicaid Program

495.300 Basis and purpose.

495.302 Definitions.

495.304 Medicaid provider scope and eligibility.

CMS-0033-F 761

495.306 Establishing patient volume.

495.308 Net average allowable costs as the basis for determining the incentive payment.

495.310 Medicaid provider incentive payments.

495.312 Process for payments.

495.314 Activities required to receive an incentive payment.

495.316 State monitoring and reporting regarding activities required to receive an incentive

payment.

495.318 State responsibilities for receiving FFP.

495.320 FFP for payments to Medicaid providers.

495.322 FFP for reasonable administrative expenses.

495.324 Prior approval conditions.

495.326 Disallowance of FFP.

495.328 Request for reconsideration of adverse determination.

495.330 Termination of FFP for failure to provide access to information.

Secs.

495.332 State Medicaid health information technology (HIT) plan requirements.

495.334 Reserved.

495.336 Health information technology planning advance planning document requirements

(HIT PAPD).

495.338 Health information technology implementation advance planning document

requirements (HIT IAPD).

495.340 As-needed HIT PAPD update and as-needed HIT IAPD update requirements.

495.342 Annual HIT IAPD requirements.

CMS-0033-F 762

495.344 Approval of the State Medicaid HIT plan, the HIT PAPD and update, the HIT IAPD

and update, and the annual HIT IAPD.

495.346 Access to systems and records.

495.348 Procurement standards.

495.350 State Medicaid agency attestations.

495.352 Reporting requirements.

495.354 Rules for charging equipment.

495.356 Nondiscrimination requirements.

495.358 Cost allocation plans.

495.360 Software and ownership rights.

495.362 Retroactive approval of FFP with an effective date of February 18, 2009.

495.364 Review and assessment of administrative activities and expenses of Medicaid provider

health information technology adoption and operation.

495.366 Financial oversight and monitoring of expenditures.

495.368 Combating fraud and abuse.

495.370 Appeals process for a Medicaid provider receiving electronic health record incentive

payments.

Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and

1395hh).

Subpart A--General Provisions

§495.2 Basis and purpose.

This part implements the following:

CMS-0033-F 763

(a) Section 1848(o) of the Act by establishing payment incentives under Medicare Part B

for eligible professionals who adopt and meaningfully use certified electronic health record

(EHR) technology.

(b) Section 1853(1) of the Act to provide incentive payments to Medicare Advantage

organizations for certain affiliated professionals who meaningfully use certified EHR technology

and meet certain other requirements.

(c) Section 1886(n) of the Act by establishing incentives payments for the meaningful

use of certified EHR technology by subsection (d) hospitals, as defined under section

1886(d)(1)(B) of the Act, participating in the Medicare FFS program.

(d) Section 1814(l) of the Act to provide an incentive payment to critical access hospitals

that meaningfully use certified EHR technology based on the hospitals' reasonable costs.

(e) Section 1853(m) of the Act to provide incentive payments to MA organizations for

certain affiliated hospitals that meaningfully use certified EHR technology.

(f) Sections 1903(a)(3)(F) and 1903(t) of the Act to provide 100 percent Federal

financial participation (FFP) to States for incentive payments to certain eligible providers

participating in the Medicaid program to purchase, implement, and operate (including support

services and training for staff) certified EHR technology and 90 percent FFP for State

administrative expenses related to such incentive payments.

(g) Sections 1848(a)(7), 1853(l)(4), 1886(b)(3)(B)(ix)(I), and 1853(m)(4) of the Act,

providing for payment reductions for inpatient services furnished on or after October 1, 2014 to

Medicare beneficiaries by hospitals that are not meaningful users of certified EHR technology,

and for covered professional services furnished on or after January 1, 2015 to Medicare
CMS-0033-F 764

beneficiaries by certain professionals who are not meaningful users of certified EHR

technology.

§495. 4 Definitions.

In this part, unless otherwise indicated--

Certified electronic health record technology has the same definition as this term is

defined at 45 CFR 170.102.

Critical access hospital (CAH) means a facility that has been certified as a critical access

hospital under section 1820(e) of the Act and for which Medicare payment is made under section

1814(l) of the Act for inpatient services and under section 1834(g) of the Act for outpatient

services.

EHR reporting period means either of the following:

(1) For an eligible professional (EP)--

(i) For the first payment year, any continuous 90-day period within a calendar year;

(ii)(A) Except as specified in paragraph (1)(ii)(B) of this definition, for the second, third,

fourth, fifth, or sixth payment year, the calendar year.

(B) For Medicaid providers who are demonstrating they are meaningful EHR users for

the first time in their second payment year, the EHR reporting period during such second

payment year is any continuous 90-day period within the calendar year.

(2) For an eligible hospital or a CAH--

(i) For the first payment year, any continuous 90-day period within a federal fiscal year;

and

(ii)(A) Except as specified in paragraph (2)(ii)(B) of this definition, for the second, third,

fourth, fifth, or sixth payment year, the Federal fiscal year.

CMS-0033-F 765

(B) For Medicaid providers who are demonstrating they are meaningful EHR users for

the first time in their second payment year, the EHR reporting period during such second

payment year is any continuous 90-day period within the Federal fiscal year.

Eligible hospital means an eligible hospital as defined under §495.100 or Medicaid

eligible hospital under subpart D of this part.

Eligible professional (EP) means an eligible professional as defined under §495.100 or a

Medicaid eligible professional under subpart D of this part.

Hospital-based EP is an EP (as defined under this section) who furnishes 90 percent or

more of his or her covered professional services in a hospital setting in the year preceding the

payment year. For Medicare, this will be calculated based on the Federal FY prior to the

payment year. For Medicaid, it is at the State’s discretion if the data is gathered on the Federal

FY or CY prior to the payment year. A setting is considered a hospital setting if it is a site of

service that would be identified by the codes used in the HIPAA standard transactions as an

inpatient hospital, or emergency room setting.

Meaningful EHR user means:

(1) Subject to paragraph (3) of this definition, an EP, eligible hospital or CAH that, for

an EHR reporting period for a payment year, demonstrates in accordance with §495.8

meaningful use of certified EHR technology by meeting the applicable objectives and

associated measures under §495.6; and

(2)(i) Except as specified in paragraph (2)(ii) of this definition, a Medicaid EP or

Medicaid eligible hospital, that meets the requirements of paragraph (1) of this definition and

any additional criteria for meaningful use imposed by the State and approved by CMS under

§495.316 and §495.332.

CMS-0033-F 766

(ii) An eligible hospital or CAH is deemed to be a meaningful EHR user for purposes of

receiving an incentive payment under subpart D of this Part, if the hospital participates in both

the Medicare and Medicaid EHR incentive programs, and the hospital meets the requirements of

paragraph (1) of this definition.

(3) To be considered a meaningful EHR user, at least 50 percent of an EP’s patient

encounters during the EHR reporting period during the payment year must occur at a

practice/location or practices/locations equipped with certified EHR technology.

Payment year means:

(1) For an EP, a calendar year beginning with CY 2011; and

(2) For a CAH or an eligible hospital, a Federal fiscal year beginning with FY 2011.

Qualified EHR has the same definition as this term is defined at 45 CFR 170.102.

First, second, third, fourth, fifth, or sixth payment years mean as follows:

(1) The first payment year is: with respect to an EP, the first calendar year for which the

EP receives an incentive payment under this part; and with respect to an eligible hospital or

CAH, the first FY for which the hospital receives an incentive payment under this part.

(2) The second, third, fourth, fifth, or sixth payment year is:

(i) With respect to a Medicare EP, the second, third, fourth or fifth successive

CY immediately following the first payment year; and with respect to a Medicare eligible

hospital or CAH, the second, third, or fourth successive Federal FY immediately following the

first payment year. (Note: Medicare EPs are not eligible for a sixth payment year and Medicare

eligible hospitals are not eligible for a fifth or sixth payment year.)
CMS-0033-F 767

(ii) (A) With respect to a Medicaid EP, the second, third, fourth, fifth, or sixth CY for

which the EP receives an incentive payment under subpart D, regardless of whether the year

immediately follows the prior payment year; and

(B) With respect to a Medicaid eligible hospital, for years prior to FY 2017, the second,

third, fourth, fifth, or sixth Federal FY for which the hospital receives an incentive payment

under subpart D of this part, regardless of whether the year immediately follows the prior

payment year. Beginning with FY 2017, payments to Medicaid eligible hospitals must be

consecutive, and the hospital is not eligible for an incentive payment under subpart D of this part

unless it received such incentive payment for the prior fiscal year.

§495.6 Meaningful use objectives and measures for EPs, eligible hospitals, and CAHs.

(a) Stage 1 criteria for EPs. (1) General rule regarding Stage 1 criteria for meaningful

use for EPs. Except as specified in paragraphs (a)(2) and (a)(3) of this section, EPs must meet all

objectives and associated measures of the Stage 1 criteria specified in paragraph (d) of this

section and five objectives of the EP’s choice from paragraph (e) of this section to meet the

definition of a meaningful EHR user.

(2) Exclusion for non-applicable objectives. (i) An EP may exclude a particular

objective contained in paragraphs (d) or (e) of this section, if the EP meets all of the following

requirements:

(A) Must ensure that the objective in paragraph (d) or (e) of this section includes an

option for the EP to attest that the objective is not applicable.

(B) Meets the criteria in the applicable objective that would permit the attestation.

(C) Attests.
CMS-0033-F 768

(ii) An exclusion will reduce (by the number of exclusions applicable) the number of

objectives that would otherwise apply. For example, an EP that has an exclusion from one of the

objectives in paragraph (e) of this section must meet four (and not five) objectives of the EP’s

choice from such paragraph to meet the definition of a meaningful EHR user.

(3) Exception for Medicaid EPs who adopt, implement or upgrade in their first payment

year. For Medicaid EPs who adopt, implement, or upgrade certified EHR technology in their

first payment year, the meaningful use objectives and associated measures of the Stage 1 criteria

specified in paragraphs (d) and (e) apply beginning with the second payment year, and do not

apply to the first payment year.

(b) Stage 1 criteria for eligible hospitals and CAHs. (1) General rule regarding Stage 1

criteria for meaningful use for eligible hospitals or CAHs. Except as specified in paragraphs

(b)(2) and (b)(3) of this section, eligible hospitals and CAHs must meet all objectives and

associated measures of the Stage 1 criteria specified in paragraph (f) of this section and five

objectives of the eligible hospital’s or CAH’s choice from paragraph (g) of this section to meet

the definition of a meaningful EHR user.

(2) Exclusions for nonapplicable objectives. (i) An eligible hospital or CAH may

exclude a particular objective that includes an option for exclusion contained in paragraphs (f) or

(g) of this section, if the hospital meets all of the following requirements:

(A) The hospital meets the criteria in the applicable objective that would permit an

exclusion.

(B) The hospital so attests.

(ii) An exclusion will reduce (by the number of exclusions received) the number of

objectives that would otherwise apply. For example, an eligible hospital that is excluded from
CMS-0033-F 769

one of the objectives in paragraph (g) of this section must meet four (and not five) objectives of

the hospital’s choice from such paragraph to meet the definition of a meaningful EHR user.

(3) Exception for Medicaid eligible hospitals that adopt, implement or upgrade in their

first payment year. For Medicaid eligible hospitals that adopt, implement, or upgrade certified

EHR technology in their first payment year, the meaningful use objectives and associated

measures of the Stage 1 criteria specified in paragraphs (f) and (g) of this section apply

beginning with the second payment year, and do not apply to the first payment year.

(c) Many of the objective and associated measures in paragraphs (d) through (g) of this

section rely on measures that count unique patients or actions.

(1) If a measure (or associated objective) in paragraphs (d) through (g) of this section

references paragraph (c) of this section, then the measure may be calculated by reviewing only

the actions for patients whose records are maintained using certified EHR technology. A

patient’s record is maintained using certified EHR technology if sufficient data was entered in

the certified EHR technology to allow the record to be saved, and not rejected due to incomplete

data.

(2) If the objective and associated measure does not reference this paragraph (c) of this

section, then the measure must be calculated by reviewing all patient records, not just those

maintained using certified EHR technology.

(d) Stage 1 core criteria for EPs. An EP must satisfy the following objectives and

associated measures, except those objectives and associated measures for which an EP qualifies

for an exclusion under paragraph (a)(2) of this section specified in this paragraph :
CMS-0033-F 770

(1)(i) Objective. Use computerized provider order entry (CPOE) for medication orders

directly entered by any licensed healthcare professional who can enter orders into the medical

record per state, local and professional guidelines.

(ii) Measure. Subject to paragraph (c) of this section, more than 30 percent of all unique

patients with at least one medication in their medication list seen by the EP have at least one

medication order entered using CPOE.

(iii) Exclusion in accordance with paragraph (a)(2) of this section Any EP who writes

fewer than 100 prescriptions during the EHR reporting period.

(2)(i) Objective. Implement drug-drug and drug-allergy interaction checks.

(ii) Measure. The EP has enabled this functionality for the entire EHR reporting period.

(3)(i) Objective. Maintain an up-to-date problem list of current and active diagnoses.

(ii) Measure. More than 80 percent of all unique patients seen by the EP have at least

one entry or an indication that no problems are known for the patient recorded as structured data.

(4)(i) Objective. Generate and transmit permissible prescriptions electronically (eRx).

(ii) Measure. Subject to paragraph (c) of this section, more than 40 percent of all

permissible prescriptions written by the EP are transmitted electronically using certified EHR

technology.

(iii) Exclusion in accordance with paragraph (a)(2) of this section Any EP who writes

fewer than 100 prescriptions during the EHR reporting period.

(5)(i) Objective. Maintain active medication list.

(ii) Measure. More than 80 percent of all unique patients seen by the EP have at least

one entry (or an indication that the patient is not currently prescribed any medication) recorded

as structured data.
CMS-0033-F 771

(6)(i) Objective. Maintain active medication allergy list.

(ii) Measure. More than 80 percent of all unique patients seen by the EP have at least

one entry (or an indication that the patient has no known medication allergies) recorded as

structured data.

(7) (i) Objective. Record all of the following demographics:

(A) Preferred language.

(B) Gender.

(C) Race.

(D) Ethnicity.

(E) Date of birth.

(ii) Measure. More than 50 percent of all unique patients seen by the EP have

demographics recorded as structured data.

(8)(i) Objective. Record and chart changes in the following vital signs:

(A) Height.

(B) Weight.

(C) Blood pressure.

(D) Calculate and display body mass index (BMI).

(E) Plot and display growth charts for children 2 - 20 years, including BMI.

(ii) Measure. Subject to paragraph (c) of this section, more than 50 percent of all unique

patients age 2 and over seen by the EP, height, weight and blood pressure are recorded as

structured data.
CMS-0033-F 772

(iii) Exclusion in accordance with paragraph (a)(2) of this section. Any EP who either

see no patients 2 years or older, or who believes that all three vital signs of height, weight, and

blood pressure of their patients have no relevance to their scope of practice.

(9)(i) Objective. Record smoking status for patients 13 years old or older.

(ii) Measure. Subject to paragraph (c) of this section, more than 50 percent of all unique

patients 13 years old or older seen by the EP have smoking status recorded as structured data.

(iii) Exclusion in accordance with paragraph (a)(2) of this section. Any EP who sees no

patients 13 years or older.

(10)(i) Objective. Report ambulatory clinical quality measures to CMS or, in the case of

Medicaid EPs, the States.

(ii) Measure. Subject to paragraph (c) of this section, successfully report to CMS (or, in

the case of Medicaid EPs, the States) ambulatory clinical quality measures selected by CMS in

the manner specified by CMS (or in the case of Medicaid EPs, the States).

(11)(i) Objective. Implement one clinical decision support rules relevant to specialty or

high clinical priority along with the ability to track compliance with that rule.

(ii) Measure. Implement one clinical decision support rule.

(12)(i) Objective. Provide patients with an electronic copy of their health information

(including diagnostics test results, problem list, medication lists, medication allergies) upon

request.

(ii) Measure. Subject to paragraph (c) of this section, more than 50 percent of all

patients who request an electronic copy of their health information are provided it within 3

business days.
CMS-0033-F 773

(iii) Exclusion in accordance with paragraph (a)(2) of this section. Any EP that has no

requests from patients or their agents for an electronic copy of patient health information during

the EHR reporting period.

(13)(i) Objective. Provide clinical summaries for patients for each office visit.

(ii) Measure. Subject to paragraph (c) of this section, clinical summaries provided to

patients for more than 50 percent of all office visits within 3 business days.

(iii) Exclusion in accordance with paragraph (a)(2) of this section. Any EP who has no

office visits during the EHR reporting period.

(14)(i) Objective. Capability to exchange key clinical information (for example,

problem list, medication list, allergies, and diagnostic test results), among providers of care and

patient authorized entities electronically.

(ii) Measure. Performed at least one test of certified EHR technology's capacity to

electronically exchange key clinical information.

(15)(i) Objective. Protect electronic health information created or maintained by the

certified EHR technology through the implementation of appropriate technical capabilities.

(ii) Measure. Conduct or review a security risk analysis in accordance with the

requirements under 45 CFR 164.308(a)(1) and implement security updates as necessary and

correct identified security deficiencies as part of its risk management process.

(e) Stage 1 menu set criteria for EPs. An EP must meet five of the following objectives

and associated measures, one of which must be either paragraph (e)(9) or (e)(10) of this section,

except that the required number of objectives and associated measures is reduced by an EP’s

paragraph (a)(2) of this section exclusions specified in this paragraph:

(1)(i) Objective. Implement drug-formulary checks.

CMS-0033-F 774

(ii) Measure. The EP has enabled this functionality and has access to at least one

internal or external formulary for the entire EHR reporting period.

(2)(i) Objective. Incorporate clinical lab-test results into EHR as structured data.

(ii) Measure. Subject to paragraph (c) of this section, more than 40 percent of all clinical

lab tests results ordered by the EP during the EHR reporting period whose results are either in a

positive/negative or numerical format are incorporated in certified EHR technology as structured

data.

(iii) Exclusion in accordance with paragraph (a)(2) of this section. An EP who orders no

lab tests whose results are either in a positive/negative or numeric format during the EHR

reporting period.

(3)(i) Objective. Generate lists of patients by specific conditions to use for quality

improvement, reduction of disparities, research, or outreach.

(ii) Measure. Subject to paragraph (c) of this section, generate at least one report listing

patients of the EP with a specific condition.

(4)(i) Objective. Send reminders to patients per patient preference for preventive/follow-

up care.

(ii) Measure. Subject to paragraph (c) of this section, more than 20 percent of all

patients 65 years or older or 5 years old or younger were sent an appropriate reminder during the

EHR reporting period.

(iii) Exclusion in accordance with paragraph (a)(2) of this section. An EP who has no

patients 65 years old or older or 5 years old or younger with records maintained using certified

EHR technology.
CMS-0033-F 775

(5)(i) Objective. Provide patients with timely electronic access to their health

information (including lab results, problem list, medication lists, and allergies) within 4 business

days of the information being available to the EP.

(ii) Measure. At least 10 percent of all unique patients seen by the EP are provided

timely (available to the patient within four business days of being updated in the certified EHR

technology) electronic access to their health information subject to the EP’s discretion to

withhold certain information.

(iii) Exclusion in accordance with paragraph (a)(2) of this section. Any EP that neither

orders nor creates any of the information listed at 45 CFR 170.304(g) during the EHR reporting

period.

(6)(i) Objective. Use certified EHR technology to identify patient-specific education

resources and provide those resources to the patient if appropriate.

(ii) Measure. More than 10 percent of all unique patients seen by the EP are provided

patient-specific education resources.

(7)(i) Objective. The EP who receives a patient from another setting of care or provider

of care or believes an encounter is relevant should perform medication reconciliation.

(ii) Measure. Subject to paragraph (c) of this section, the EP performs medication

reconciliation for more than 50 percent of transitions of care in which the patient is transitioned

into the care of the EP.

(iii) Exclusion in accordance with paragraph (a)(2) of this section. An EP who was not

the recipient of any transitions of care during the EHR reporting period.
CMS-0033-F 776

(8)(i) Objective. The EP who transitions their patient to another setting of care or

provider of care or refers their patient to another provider of care should provide summary care

record for each transition of care or referral.

(ii) Measure. Subject to paragraph (c) of this section, the EP who transitions or refers

their patient to another setting of care or provider of care provides a summary of care record for

more than 50 percent of transitions of care and referrals.

(iii) Exclusion in accordance with paragraph (a)(2) of this section. An EP who neither

transfers a patient to another setting nor refers a patient to another provider during the EHR

reporting period.

(9)(i) Objective. Capability to submit electronic data to immunization registries or

immunization information systems and actual submission according to applicable law and

practice.

(ii) Measure. Performed at least one test of certified EHR technology's capacity to

submit electronic data to immunization registries and follow up submission if the test is

successful (unless none of the immunization registries to which the EP submits such information

has the capacity to receive the information electronically).

(iii) Exclusion in accordance with paragraph (a)(2) of this section. An EP who

administers no immunizations during the EHR reporting period or where no immunization

registry has the capacity to receive the information electronically.

(10)(i) Objective. Capability to submit electronic syndromic surveillance data to public

health agencies and actual submission according to applicable law and practice.

(ii) Measure. Performed at least one test of certified EHR technology's capacity to

provide electronic syndromic surveillance data to public health agencies and follow-up
CMS-0033-F 777

submission if the test is successful (unless none of the public health agencies to which an EP

submits such information has the capacity to receive the information electronically).

(iii) Exclusion in accordance with paragraph (a)(2) of this section. An EP who does not

collect any reportable syndromic information on their patients during the EHR reporting period

or does not submit such information to any public health agency that has the capacity to receive

the information electronically.

(f) Stage 1 core criteria for eligible hospitals or CAHs. An eligible hospital or CAH

must meet the following objectives and associated measures except those objectives and

associated measures for which an eligible hospital or CAH qualifies for a paragraph (b)(2) of this

section exclusion specified in this paragraph:

(1)(i) Objective. Use CPOE for medication orders directly entered by any licensed

healthcare professional who can enter orders into the medical record per State, local, and

professional guidelines.

(ii) Measure. Subject to paragraph (c) of this section, more than 30 percent of all unique

patients with at least one medication in their medication list admitted to the eligible hospital’s or

CAH’s inpatient or emergency department (POS 21 or 23) have at least one medication order

entered using CPOE.

(2)(i) Objective. Implement drug-drug and drug-allergy interaction checks.

(ii) Measure. The eligible hospital or CAH has enabled this functionality for the entire

EHR reporting period.

(3)(i) Objective. Maintain an up-to-date problem list of current and active diagnoses.
CMS-0033-F 778

(ii) Measure. More than 80 percent of all unique patients admitted to the eligible

hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) have at least one entry or

an indication that no problems are known for the patient recorded as structured data.

(4)(i) Objective. Maintain active medication list.

(ii) Measure. More than 80 percent of all unique patients admitted to the eligible

hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) have at least one entry

(or an indication that the patient is not currently prescribed any medication) recorded as

structured data.

(5)(i) Objective. Maintain active medication allergy list.

(ii) Measure. More than 80 percent of all unique patients admitted to the eligible

hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) have at least one entry

(or an indication that the patient has no known medication allergies) recorded as structured data.

(6)(i) Objective. Record all of the following demographics;

(A) Preferred language.

(B) Gender.

(C) Race.

(D) Ethnicity.

(E) Date of birth.

(F) Date and preliminary cause of death in the event of mortality in the eligible hospital

or CAH.

(ii) Measure. More than 50 percent of all unique patients admitted to the eligible

hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) have demographics

recorded as structured data.

CMS-0033-F 779

(7)(i) Objective. Record and chart changes in the following vital signs:

(A) Height.

(B) Weight.

(C) Blood pressure.

(D) Calculate and display body mass index (BMI).

(E) Plot and display growth charts for children 2 - 20 years, including BMI.

(ii) Measure. Subject to paragraph (c) of this section, for more than 50 percent of all

unique patients age 2 and over admitted to the eligible hospital’s or CAH’s inpatient or

emergency department (POS 21 or 23), height, weight, and blood pressure are recorded as

structured data.

(8)(i) Objective. Record smoking for patients 13 years old or older.

(ii) Measure. Subject to paragraph (c) of this section, more than 50 percent of all unique

patients 13 years old or older or admitted to the eligible hospital’s inpatient or emergency

department (POS 21 or 23) have smoking status recorded as structured data.

(iii) Exclusion in accordance with paragraph (b)(2) of this section. Any eligible hospital

or CAH that admits no patients 13 years or older to their inpatient or emergency department

(POS 21 or 23).

(9)(i) Objective. Report hospital clinical quality measures to CMS or, in the case of

Medicaid eligible hospitals, the States.

(ii) Measure. Subject to paragraph (c) of this section, successfully report to CMS (or, in

the case of Medicaid eligible hospitals or CAHs, the States) hospital clinical quality measures

selected by CMS in the manner specified by CMS (or, in the case of Medicaid eligible hospitals

or CAHs, the States).

CMS-0033-F 780

(10)(i) Objective. Implement one clinical decision support rule related to a high priority

hospital condition along with the ability to track compliance with that rule.

(ii) Measure. Implement one clinical decision support rule.

(11)(i) Objective. Provide patients with an electronic copy of their health information

(including diagnostic test results, problem list, medication lists, medication allergies, discharge

summary, procedures), upon request.

(ii) Measure. Subject to paragraph (c) of this section, more than 50 percent of all

patients of the inpatient or emergency departments of the eligible hospital or CAH (POS 21 or

23) who request an electronic copy of their health information are provided it within 3 business

days.

(iii) Exclusion in accordance with paragraph (b)(2) of this section. Any eligible hospital

or CAH that has no requests from patients or their agents for an electronic copy of patient health

information during the EHR reporting period.

(12)(i) Objective. Provide patients with an electronic copy of their discharge instructions

at time of discharge, upon request.

(ii) Measure. Subject to paragraph (c) of this section, more than 50 percent of all

patients who are discharged from an eligible hospital or CAH’s inpatient or emergency

department (POS 21 or 23) and who request an electronic copy of their discharge instructions are

provided it.

(iii) Exclusion in accordance with paragraph (b)(2) of this section. Any eligible hospital

or CAH that has no requests from patients or their agents for an electronic copy of the discharge

instructions during the EHR reporting period.

CMS-0033-F 781

(13)(i) Objective. Capability to exchange key clinical information (for example,

problem list, medication list, medication allergies, and diagnostic test results), among providers

of care and patient authorized entities electronically.

(ii) Measure. Performed at least one test of certified EHR technology's capacity to

electronically exchange key clinical information.

(14)(i) Objective. Protect electronic health information created or maintained by the

certified EHR technology through the implementation of appropriate technical capabilities

(ii) Measure. Conduct or review a security risk analysis in accordance with the

requirements under 45 CFR 164.308 (a)(1) and implement security updates as necessary and

correct identified security deficiencies as part of its risk management process.

(g) Stage 1 menu set criteria for eligible hospitals or CAHs. Eligible hospitals or CAHs

must meet five of the following objectives and associated measures, one which must be specified

in paragraph (g)(8), (g)(9), or (g)(10) of this section, except that the required number of

objectives and associated measures is reduced by a hospital’s paragraph (b)(2) of this section

exclusions specified in this paragraph:

(1)(i) Objective. Implement drug-formulary checks.

(ii) Measure. The eligible hospital or CAH has enabled this functionality and has access

to at least one internal or external formulary for the entire EHR reporting period.

(2)(i) Objective. Record advance directives for patient 65 years old or older.

(ii) Measure. Subject to paragraph (c) of this section, more than 50 percent of all unique

patients 65 years old or older admitted to the eligible hospital’s or CAH’s inpatient (POS 21)

have an indication of an advance directive status recorded as structured data.

CMS-0033-F 782

(iii) Exclusion in accordance with paragraph (b)(2) of this section. An eligible hospital or

CAH that admits no patients age 65 years old or older during the EHR reporting period.

(3)(i) Objective. Incorporate clinical lab-test results into EHR as structured data.

(ii) Measure. Subject to paragraph (c) of this section, more than 40 percent of all clinical

lab tests results ordered by an authorized provider of the eligible hospital or CAH for patients

admitted to its inpatient or emergency department (POS 21 and 23) during the EHR reporting

period whose results are either in a positive/negative or numerical format are incorporated in

certified EHR technology as structured data.

(4)(i) Objective. Generate lists of patients by specific conditions to use for quality

improvement, reduction of disparities, research, or outreach.

(ii) Measure. Subject to paragraph (c) of this section, generate at least one report listing

patients of the eligible hospital or CAH with a specific condition.

(5)(i) Objective. Use certified EHR technology to identify patient-specific education

resources and provide those resources to the patient if appropriate.

(ii) Measure. More than 10 percent of all unique patients admitted to the eligible

hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) are provided patient-

specific education resources.

(6)(i) Objective. The eligible hospital or CAH who receives a patient from another

setting of care or provider of care or believes an encounter is relevant should perform medication

reconciliation.

(ii) Measure. Subject to paragraph (c) of this section, the eligible hospital or CAH

performs medication reconciliation for more than 50 percent of transitions of care in which the
CMS-0033-F 783

patient is admitted to the eligible hospital’s or CAH’s inpatient or emergency department (POS

21 or 23).

(7)(i) Objective. The eligible hospital or CAH that transitions their patient to another

setting of care or provider of care or refers their patient to another provider of care should

provide summary care record for each transition of care or referral.

(ii) Measure. Subject to paragraph (c) of this section, the eligible hospital or CAH that

transitions or refers their patient to another setting of care or provider of care provides a

summary of care record for more than 50 percent of transitions of care and referrals.

(8)(i) Objective. Capability to submit electronic data to immunization registries or

immunization information systems and actual submission according to applicable law and

practice.

(ii) Measure. Performed at least one test of certified EHR technology's capacity to

submit electronic data to immunization registries and follow up submission if the test is

successful (unless none of the immunization registries to which the eligible hospital or CAH

submits such information has the capacity to receive the information electronically).

(iii) Exclusion in accordance with paragraph (b)(2) of this section. An eligible hospital or

CAH that administers no immunizations during the EHR reporting period or where no

immunization registry has the capacity to receive the information electronically.

(9)(i) Objective. Capability to submit electronic data on reportable (as required by State

or local law) lab results to public health agencies and actual submission according to applicable

law and practice.

(ii) Measure. Performed at least one test of certified EHR technology’s capacity to

provide electronic submission of reportable lab results to public health agencies and follow-up
CMS-0033-F 784

submission if the test is successful (unless none of the public health agencies to which an eligible

hospital or CAH submits such information has the capacity to receive the information

electronically).

(iii) Exclusion in accordance with paragraph (b)(2) of this section. No public health

agency to which the eligible hospital or CAH submits such information has the capacity to

receive the information electronically.

(10)(i) Objective. Capability to submit electronic syndromic surveillance data to public

health agencies and actual submission according to applicable law and practice.

(ii) Measure. Performed at least one test of certified EHR technology's capacity to

provide electronic syndromic surveillance data to public health agencies and follow-up

submission if the test is successful (unless none of the public health agencies to which an eligible

hospital or CAH submits information has the capacity to receive the information electronically).

(iii) Exclusion in accordance with paragraph (a)(2) of this section. No public health

agency to which the eligible hospital or CAH submits information has the capacity to receive the

information electronically.

(h) Stage 2 criteria for EPs. Beginning when final regulations for Stage 2 are effective,

an EP must satisfy the following objectives and associated measures:

(1)(i) Objective. Use computerized provider order entry (CPOE) for medication orders

directly entered by any licensed healthcare professional who can enter orders into the medical

record per state, local and professional guidelines.

(ii) Measure. More than 60 percent of all unique patients with at least one medication in

their medication list seen by the EP have at least one medication order entered using CPOE.
CMS-0033-F 785

(iii) Exclusion. Any EP who writes fewer than 100 prescriptions during the EHR

reporting period.

(2) [Reserved].

(i) Stage 2 criteria for eligible hospitals or CAHs. Beginning when final regulations for

Stage 2 are effective, an eligible hospital or CAH must satisfy the following objectives and

associated measures:

(1)(i) Objective. Use computerized provider order entry (CPOE) for medication orders

directly entered by any licensed healthcare professional who can enter orders into the medical

record per state, local and professional guidelines.

(ii) Measure. More than 60 percent of all unique patients with at least one medication in

their medication list admitted to the eligible hospital's or CAH's inpatient or emergency

department (POS 21 or 23) have at least one medication order entered using CPOE.

(2) [Reserved].

§495.8 Demonstration of meaningful use criteria.

(a) Demonstration by EPs. An EP must demonstrate that he or she satisfies each of the

applicable objectives and associated measures under §495.6 of this subpart as follows:

(1) For CY 2011--(i) Attestation. Attest, through a secure mechanism, in a manner

specified by CMS (or for a Medicaid EP, in a manner specified by the State), that during the

EHR reporting period, the EP--

(A) Used certified EHR technology, and specify the technology used;

(B) Satisfied the required objectives and associated measures under §495.6(d) and

§495.6(e) of this subpart;

CMS-0033-F 786

(C) Must specify the EHR reporting period and provide the result of each applicable

measure for all patients seen during the EHR reporting period for which aselected measure is

applicable;

(ii) Additional requirements for Medicaid EPs. For Medicaid EPs, if, in accordance with

§495.316 and §495.332, CMS has approved a State's revised definition for meaningful use, in

addition to meeting paragraphs (a)(1)(i) through (ii) of this section, the EP must also demonstrate

meeting the State revised definition using the method approved by CMS; and

(iii) Exception for Medicaid EPs. If a Medicaid EP has adopted, implemented or

upgraded certified EHR technology in the first payment year, the EP need not demonstrate

meaningful use until the second payment year, as described in §495.6 and §495.8 of this subpart.

(2) For CY 2012 and subsequent years--

(i) Attestation. Attest, through a secure mechanism, in a manner specified by CMS (or

for a Medicaid EP, in a manner specified by the State) that during the EHR reporting period, the

EP--

(A) Used certified EHR technology and specify the technology used.

(B) Satisfied the required objectives and associated measures under §495.6(d) and

§495.6(e), except §495.6(d)(10) “Report ambulatory clinical quality measures to CMS or, in the

case of Medicaid EPs, the States.”

(C) Must specify the EHR reporting period and provide the result of each applicable

measure for all patients seen during the EHR reporting period for which a selected measure is

applicable.

(ii) Reporting of clinical quality information. For §495.6(d)(10), “Report ambulatory

clinical quality measures to CMS or, in the case of Medicaid EPs, the States,” report the
CMS-0033-F 787

ambulatory clinical quality measures selected by CMS electronically to CMS (or in the case of

Medicaid EPs, the States) in the manner specified by CMS (or in the case of Medicaid EPs, the

States).

(iii) Additional requirements for Medicaid EPs. For Medicaid EPs, if, in accordance

with §495.316 and §495.332, CMS has approved a State's additional criteria for meaningful use,

in addition to meeting paragraphs (a)(2)(i) through (iii), the EP must also demonstrate meeting

such additional criteria using the method approved by CMS.

(iv) Exception for Medicaid EPs. If a Medicaid EP has adopted, implemented, or

upgrade certified EHR technology in the first payment year, the EP need not demonstrate that it

is a meaningful EHR user until the second payment year, as described in §495.6 and §495.8 of

this subpart.

(3) For all CYs, an EP who practices in multiple physical locations, not all of which have

certified EHR technology available, will demonstrate meaningful use using only the locations

where the EP has certified EHR technology available. (See also §495.4 regarding the definition

of meaningful EHR user).

(b) Demonstration by eligible hospitals and CAHs. To successfully demonstrate that it is

a meaningful EHR user, an eligible hospital or CAH must the following requirements:

(1) For FY 2011--

(i) Attestation. Attest, through a secure mechanism, in a manner specified by CMS (or

for a Medicaid eligible hospital, in a manner specified by the State), that during the EHR

reporting period, the eligible hospital or CAH--

(A) Used certified EHR and specify the technology used.

CMS-0033-F 788

(B) Satisfied the required objectives and associated measures under §495.6(f) and

§495.6(g).

(C) Must specify the EHR reporting period and provide the result of each applicable

measure for all patients admitted to the inpatient or emergency department (POS 21 or 23) of the

hospital during the EHR reporting period for which a selected measure is applicable.

(ii) Additional requirements for Medicaid eligible hospitals. For Medicaid eligible

hospitals, if, in accordance with §495.316 and §495.332, CMS has approved a State’s revised

definition for meaningful use, in addition to meeting paragraphs (b)(1)(i) through (ii) of this

section, the eligible hospital must also demonstrate meeting the State’s revised definition using

the method approved by CMS.

(iv) Exception for Medicaid eligible hospitals. If a Medicaid eligible hospital has

adopted, implemented or upgraded certified EHR technology in the first payment year, the

eligible hospital need not demonstrate meaningful use until the second payment year, as

described in §495.6 and §495.8 of this subpart.

(2) For FY 2012 and subsequent years--

(i) Attestation. Attest, through a secure mechanism, in a manner specified by CMS (or

for a Medicaid eligible hospital, in a manner specified by the State), that during the EHR

reporting period, the eligible hospital or CAH--

(A) Used certified EHR and specify the technology used;

(B) Satisfied the required objectives and associated measures under §495.6(f) and

§495.6(g), except §495.6(f)(9) “Report hospital clinical quality measures to CMS or, in the case

of Medicaid eligible hospitals, the States;”

CMS-0033-F 789

(C) Must specify the EHR reporting period and provide the result of each applicable

measure for all patients admitted to the inpatient or emergency department (POS 21 or 23) of the

hospital during the EHR reporting period for which a selected measure is applicable.

(ii) Reporting clinical quality information. For §495.6(f)(9) “Report hospital clinical

quality measures to CMS or, in the case of Medicaid eligible hospitals, the States,” report the

hospital quality measures selected by CMS electronically to CMS (or in the case of Medicaid

eligible hospitals, the States), in the manner specified by CMS (or in the case of Medicaid

eligible hospitals, the States).

(iv) Additional requirements for Medicaid eligible hospitals. For Medicaid eligible

hospitals if, in accordance with §495.316 and §495.332, CMS has approved a State's revised

definition for meaningful use, in addition to meeting paragraphs (b)(2)(i) through (iii) of this

section, the eligible hospital must also demonstrate meeting the State’s revised definition using

the method approved by CMS.

(v) Exception for Medicaid eligible hospitals. If a Medicaid eligible hospital has

adopted, implemented, or upgraded certified EHR technology in the first payment year, the

eligible hospital need not demonstrate that it is a meaningful EHR user until the second payment

year, as described in §495.6 and §495.8 of this subpart.

(c) Review of meaningful use. (1) CMS (and in the case of Medicaid EPs and eligible

hospitals, States) may review an EP, eligible hospital or CAH's demonstration of meaningful use.

(2) All EPs, eligible hospitals, and CAHs must keep documentation supporting their

demonstration of meaningful use for 6 years.

§495.10 Participation requirements for EPs, eligible hospitals, and CAHs.

CMS-0033-F 790

(a) An eligible hospital, CAH or EP must submit in a manner specified by CMS the

following information in the first payment year:

(1) Name of the EP, eligible hospital or CAH.

(2) National Provider Identifier (NPI).

(3) Business address and phone number.

(4) Such other information as specified by CMS.

(b) In addition to the information submitted under paragraph (a) of this section, an

eligible hospital or CAH, must, in the first payment year, submit in a manner specified by CMS

its CMS Certification Number (CCN) and its Taxpayer Identification Number (TIN).

(c) Subject to paragraph (f) of this section, in addition to the information submitted under

paragraph (a) of this section, an EP must submit in a manner specified by CMS, the Taxpayer

Identification Number (TIN) which may be the EP’s Social Security Number (SSN) to which the

EP's incentive payment should be made.

(d) In the event the information specified in paragraphs (a) through (c) of this section as

previously submitted to CMS is no longer accurate, the EP, eligible hospital or CAH must

provide updated information to CMS or the State on a timely basis in the manner specified by

CMS or the State.

(e) An EP that qualifies as both a Medicaid EP and Medicare EP--

(1) Must notify CMS in the manner specified by CMS as to whether he or she elects to

participate in the Medicare or the Medicaid EHR incentive program;

(2) After receiving at least one EHR incentive payment, may switch between the two

EHR incentive programs only one time, and only for a payment year before 2015;
CMS-0033-F 791

(3) Must, for each payment year, meet all of the applicable requirements, including

applicable patient volume requirements, for the program in which he or she chooses to

participate (Medicare or Medicaid);

(4) Is limited to receiving, in total, the maximum payments the EP would receive under

the Medicaid EHR program, as described in subpart D of this part; and

(5) Is placed in the payment year the EP would have been in had the EP begun in and

remained in the program to which he or she has switched. For example, an EP that begins

receiving Medicaid incentive payments in 2011, and then switches to the Medicare program for

2012, is in his or her second payment year in 2012.

(f) Limitations on incentive payment reassignments. (1) EPs are permitted to reassign

their incentive payments to their employer or to an entity with which they have a contractual

arrangement allowing the employer or entity to bill and receive payment for the EP's covered

professional services.

(2) (i) Assignments in Medicare must be consistent with Section 1842(b)(6)(A) of the

Act and 42 CFR part 424 subpart F.

(ii) Medicaid EPs may also assign their incentive payments to a TIN for an entity

promoting the adoption of EHR technology, consistent with subpart D of this part.

(3) Each EP may reassign the entire amount of the incentive payment to only one

employer or entity.

Subpart B--Requirements Specific to the Medicare Program

§ 495.100 Definitions.

In this subpart unless otherwise indicated--

CMS-0033-F 792

Covered professional services means (as specified in section 1848(k)(3) of the Act)

services furnished by an EP for which payment is made under, or is based on, the Medicare

physician fee schedule.

Eligible hospital means a hospital subject to the prospective payment system specified in

§412.1(a)(1) of this chapter, excluding those hospitals specified in §412.23 of this chapter , and

excluding those hospital units specified in §412.25 of this chapter..

Eligible professional (EP) means a physician as defined in section 1861(r) of the Act,

which includes, with certain limitations, all of the following types of professionals:

(1) A doctor of medicine or osteopathy.

(2) A doctor of dental surgery or medicine.

(3) A doctor of podiatric medicine.

(4) A doctor of optometry.

(5) A chiropractor.

Geographic health professional shortage area (HPSA) means a geographic area that is

designated by the Secretary under section 332(a)(1)(A) of the PHS Act as of December 31 of the

year prior to the payment year as having a shortage of health professionals.

Qualifying CAH means a CAH that is a meaningful EHR user for the EHR reporting

period for a cost reporting period beginning during a payment year.

Qualifying eligible professional (qualifying EP) means an EP who is a meaningful EHR

user for the EHR reporting period for a payment year and who is not a hospital-based EP, as

determined for that payment year.

Qualifying hospital means an eligible hospital that is a meaningful EHR user for the EHR

reporting period for a payment year.

CMS-0033-F 793

§ 495.102 Incentive payments to EPs.

(a) General rules. (1) Subject to paragraph (b) of this section, in addition to the amount

otherwise paid under section 1848 of the Act, there must be paid to a qualifying EP (or to an

employer or entity in the cases described in section 1842(b)(6)(A) of the Act) for a payment year

an amount equal to 75 percent of the estimated allowed charges for covered professional services

furnished by the EP during the payment year.

(2) For purposes of this paragraph (a) of this section, the estimated allowed charges for

the qualifying EP’s covered professional services during the payment year are determined based

on claims submitted no later than 2 months after the end of the payment year, and, in the case of

a qualifying EP who furnishes covered professional services in more than one practice, are

determined based on claims submitted for the EP's covered professional services across all such

practices.

(b) Limitations on amounts of incentive payments.

(1) Except as otherwise provided in paragraphs (b)(2) and (c) of this section, the amount

of the incentive payment under paragraph (a) of this section for each payment year is limited to

the following amounts:

(i) For the first payment year, $15,000 (or, if the first payment year for such qualifying

EP is 2011 or 2012, $18,000).

(ii) For the second payment year, $12,000.

(iii) For the third payment year, $8,000.

(iv) For the fourth payment year, $4,000.

(v) For the fifth payment year, $2,000.

(vi) For any succeeding payment year for such professional, $0.
CMS-0033-F 794

(2)(i) If the first payment year for a qualifying EP is 2014, then the payment limit for a

payment year for the qualifying EP is the same as the amount specified in paragraph (b)(1) of

this section for such payment year for a qualifying EP whose first payment year is 2013.

(ii) If the first payment year for a qualifying EP is after 2014, then the payment limit

specified in this paragraph for such EP for such year and any subsequent year is $0.

(c) Increase in incentive payment limit for EPs who predominantly furnish services in a

geographic HPSA. In the case of a qualifying EP who in the year prior to the payment year

furnishes more than 50 percent of his or her covered professional services in a geographic HPSA

that is designated as of December 31 of such year, the incentive payment limit determined under

paragraph (b) of this section is to be increased by 10 percent.

(d) Payment adjustment effective in CY 2015 and subsequent years for nonqualifying

EPs.

(1) Subject to paragraph (d)(3) of this section, beginning in 2015, for covered

professional services furnished by an EP who is not a qualifying EP or a hospital-based EP for

the year, the payment amount for such services is equal the product of the applicable percent

specified in paragraph (d)(2) of this section and the Medicare physician fee schedule amount for

such services.

(2) Applicable percent. Applicable percent is as follows:

(i) For 2015, 99 percent if the EP is not subject to the payment adjustment for an EP who

is not a successful electronic prescriber under section 1848(a)(5) of the Act, or 98 percent if the

EP is subject to the payment adjustment for an EP who is not a successful electronic prescriber

under section 1848(a)(5) of the Act).

(ii) For 2016, 98 percent.

CMS-0033-F 795

(iii) For 2017 and each subsequent year, 97 percent.

(3) Significant hardship exception. (i) The Secretary may, on a case-by-case basis,

exempt an EP who is not a qualifying EP from the application of the payment adjustment under

paragraph (d)(1) of this section if the Secretary determines that compliance with the requirement

for being a meaningful EHR user would result in a significant hardship for the EP.

(ii) The Secretary's determination to grant an EP an exemption under paragraph (d)(3)(i)

of this section may be renewed on an annual basis, provided that in no case may an EP be

granted an exemption under paragraph (d)(3)(i) of this section for more than 5 years.

§ 495.104 Incentive payments to eligible hospitals.

(a) General rule. A qualifying hospital (as defined in this subpart) must receive the

special incentive payment as determined under the formulas described in paragraph (c) of this

section for the period specified in paragraph (b) of this section.

(b) Transition periods. Subject to paragraph (d) of this section and the payment formula

specified in paragraph (c) of this section, qualifying hospitals may receive incentive payments

during transition periods which comprise the following fiscal years:

(1) Hospitals whose first payment year is FY 2011 may receive such payments for FYs

2011 through 2014.

(2) Hospitals whose first payment year is FY 2012 may receive such payments for FYs

2012 through 2015.

(3) Hospitals whose first payment year is FY 2013 may receive such payments for FYs

2013 through 2016.

(4) Hospitals whose first payment year is FY 2014 may receive such payments for FY

2014 through 2016.

CMS-0033-F 796

(5) Hospitals whose first payment year is FY 2015 may receive such payments for FY

2015 through 2016.

(c) Payment methodology. (1) The incentive payment for each payment year is

calculated as the product of the following:

(i) The initial amount determined under paragraph (c)(3) of this section.

(ii) The Medicare share fraction determined under paragraph (c)(4) of this section.

(iii) The transition factor determined under paragraph (c)(5) of this section.

(2) Interim and final payments. CMS uses data on hospital acute care inpatient

discharges, Medicare Part A acute care inpatient-bed-days, Medicare Part C acute care inpatient-

bed-days, and total acute care inpatient-bed-days, from the latest submitted 12-month hospital

cost report as the basis for making preliminary incentive payments. Final payments are

determined at the time of settling the first 12-month hospital cost report for the hospital fiscal

year that begins on or after the first day of the payment year, and settled on the basis of data from

that cost reporting period.

(3) Initial amount. The initial amount is equal to one of the following:

(i) For each hospital with 1,149 acute care inpatient discharges or fewer, $2,000,000.

(ii) For each hospital with at least 1,150 but no more than 23,000 acute care inpatient

discharges, $2,000,000 + [$200 x (n – 1,149)], where n is the number of discharges for the

hospital.

(iii) For each hospital with more than 23,000 acute care inpatient discharges, $6,370,200.

(4) Medicare share fraction. (i) General. (A) CMS determines the Medicare share

fraction for an eligible hospital by using the number of Medicare Part A, Medicare Part C, and
CMS-0033-F 797

total acute care inpatient-bed-days using data from the Medicare cost report as specified by

CMS.

(B) CMS computes the denominator of the Medicare share fraction using the charity care

charges reported on the hospital's Medicare cost report.

(ii) The Medicare share fraction is the ratio of--

(A) A numerator which is the sum of--

(1) The number of inpatient-bed-days which are attributable to individuals with respect

to whom payment may be made under Part A, including individuals enrolled in section 1876

Medicare cost plans; and

(2) The number of inpatient-bed-days which are attributable to individuals who are

enrolled with a Medicare Advantage organization (as defined in §422.2 of this chapter).

(B) A denominator which is the product of--

(1) The total number of acute care inpatient-bed-days; and

(2) The total amount of the eligible hospital's charges, not including any charges that are

attributable to charity care, divided by the estimated total amount of the hospitals charges.

(5) Transition factor. For purposes of the payment formula, the transition factor is as

follows:

(i) For hospitals whose first payment year is FY 2011--

(A) 1 for FY 2011;

(B) ¾ for FY 2012;

(C) ½ for FY 2013; and

(D) ¼ for FY 2014.

(ii) For hospitals whose first payment year is FY 2012--

CMS-0033-F 798

(A) 1 for FY 2012;

(B) ¾ for FY 2013;

(C) ½ for FY 2014; and

(D) ¼ for FY 2015;

(iii) For hospitals whose first payment year is FY 2013--

(A) 1 for FY 2013;

(B) ¾ for FY 2014;

(C) ½ for FY 2015; and

(D) ¼ for FY 2016.

(iv) For hospitals whose first payment year is FY 2014--

(A) ¾ for FY 2014;

(B) ½ for FY 2015; and

(C) ¼ for FY 2016.

(v) For hospitals whose first payment year is FY 2015--

(A) ½ for FY 2015; and

(B) ¼ for FY 2016.

(d) No incentive payment for nonqualifying hospitals. After the first payment year, an

eligible hospital will not receive an incentive payment for any payment year during which it is

not a qualifying hospital.

§495.106 Incentive payments to CAHs.

(a) Definitions. In this section, unless otherwise indicated--

Payment year means a Federal fiscal year beginning after FY 2010 but before FY 2016.
CMS-0033-F 799

Qualifying CAH means a CAH that would meet the definition of a meaningful EHR user

at §495.4, if it were an eligible hospital.

Reasonable costs incurred for the purchase of certified EHR technology for a qualifying

CAH means the reasonable acquisition costs incurred for the purchase of depreciable assets as

described in part 413 subpart G of this chapter, such as computers and associated hardware and

software, necessary to administer certified EHR technology as defined in §495.4, excluding any

depreciation and interest expenses associated with the acquisition.

(b) General rule. A qualifying CAH receives an incentive payment for its reasonable

costs incurred for the purchase of certified EHR technology, as defined in paragraph (a) of this

section, in the manner described in paragraph (c) of this section for a cost reporting period

beginning during a payment year as defined in paragraph (a) of this section.

(c) Payment methodology. (1) Payment amount. A qualifying CAH receives an

incentive payment amount equal to the product of its reasonable costs incurred for the purchase

of certified EHR technology and the Medicare share percentage.

(2) Calculation of reasonable costs. CMS or its Medicare contractor computes a

qualifying CAH's reasonable costs incurred for the purchase of certified EHR technology, as

defined in paragraph (a) of this section, as the sum of--

(i) The reasonable costs incurred for the purchase of certified EHR technology during the

cost reporting period that begins in a payment year; and

(ii) Any reasonable costs incurred for the purchase of certified EHR technology in cost

reporting periods beginning in years prior to the payment year which have not been fully

depreciated as of the cost reporting period beginning in the payment year.

CMS-0033-F 800

(3) Medicare share percentage. Notwithstanding the percentage applicable under

§413.70(a)(1) of this chapter, the Medicare share percentage equals the lesser of—

(i) 100 percent; or

(ii) The sum of the Medicare share fraction for the CAH as calculated under

§495.104(c)(4) of this subpart and 20 percentage points.

(d) Incentive payments made to CAHs. (1) The amount of the incentive payment made

to a qualifying CAH under this section represents the expensing and payment of the reasonable

costs computed in paragraph (c) of this section in a single payment year and, as specified in

§413.70(a)(5) of this chapter, such payment is made in lieu of payment that would have been

made under §413.70(a)(1) of this chapter for the reasonable costs of the purchase of certified

EHR technology including depreciation and interest expenses associated with the acquisition.

(2) The amount of the incentive payment made to a qualifying CAH under this section is

paid through a prompt interim payment for the applicable payment year after--

(i) The CAH submits the necessary documentation, as specified by CMS or its Medicare

contractors, to support the computation of the incentive payment amount under this section; and

(ii) CMS or its Medicare contractor reviews such documentation and determines the

interim amount of the incentive payment.

(3) The interim incentive payment made under this paragraph is subject to a

reconciliation process as specified by CMS and the final incentive payment as determined by

CMS or its Medicare contractor is considered payment in full for the reasonable costs incurred

for the purchase of certified EHR technology in a single payment year.

(4) In no case may an incentive payment be made with respect to a cost reporting period

beginning during a payment year before FY 2011 or after FY 2015 and in no case may a CAH
CMS-0033-F 801

receive an incentive payment under this section with respect to more than 4 consecutive payment

years.

(e) Reductions in payment to CAHs. For cost reporting periods beginning in

FY 2015, if a CAH is not a qualifying CAH for a payment year, then the payment for

inpatient services furnished by a CAH under §413.70(a) of this chapter is adjusted by the

applicable percentage described in §413.70(a)(6) of this chapter unless otherwise exempt

from such adjustment.

(f) Administrative or judicial review. There is no administrative or judicial review under

sections 1869 or 1878 of the Act, or otherwise, of the --

(1) Methodology and standards for determining the amount of payment, the reasonable

cost, and adjustments described in this section including selection of periods for determining,

and making estimates or using proxies of, inpatient-bed-days, hospital charges, charity charges,

and the Medicare share percentage as described in this section;

(2) Methodology and standards for determining if a CAH is a qualifying CAH under this

section;

(3) Specification of EHR reporting periods, cost reporting periods, payment years, and

fiscal years used to compute the CAH incentive payment as specified in this section; and

(4) Identification of the reasonable costs used to compute the CAH incentive payment

under paragraph (c) of this section including any reconciliation of the CAH incentive payment

amount made under paragraph (d) of this section.

§495.108 Posting of required information

CMS-0033-F 802

(a) CMS posts, on its Internet website, the following information regarding EPs,

eligible hospitals, and CAHs receiving an incentive payment under subparts B and C of this part:

(1) Name.

(2) Business addressee.

(3) Business phone number.

(4) Such other information as specified by CMS.

(b) CMS posts, on its Internet website, the following information for qualifying MA

organizations that receive an incentive payment under subpart C of this part--

(1) The information specified in paragraph (a) of this section for each of the qualifying

MA organization's MA plan information; and

(2) The information specified in paragraph (a) of this section for each of the qualifying

MA organization's MA EPs and MA-affiliated eligible hospitals.

§495.110 Preclusion on administrative and judicial review.

There is no administrative or judicial review under sections 1869 or 1878 of the Act, or

otherwise, of the following:

(a) For EPs--

(1) The methodology and standards for determining EP incentive payment amounts;

(2) The methodology and standards for determining the payment adjustments that apply

to EPs beginning with 2015;

(3) The methodology and standards for determining whether an EP is a meaningful EHR

user, including--

(i) The selection of clinical quality measures; and

(ii) The means of demonstrating meaningful EHR use.

CMS-0033-F 803

(4) The methodology and standards for determining the hardship exception to the

payment adjustments;

(5) The methodology and standards for determining whether an EP is hospital-based; and

(6) The specification of the EHR reporting period, as well as whether payment will be

made only once, in a single consolidated payment, or in periodic installments.

(b) For eligible hospitals--

(1) The methodology and standards for determining the incentive payment amounts

made to eligible hospitals, including--

(i) The estimates or proxies for determining discharges, inpatient-bed-days, hospital

charges, charity charges, and Medicare share; and

(ii) The period used to determine such estimate or proxy;

(2) The methodology and standards for determining the payment adjustments that apply

to eligible hospitals beginning with FY 2015;

(3) The methodology and standards for determining whether an eligible hospital is a

meaningful EHR user, including--

(i) The selection of clinical quality measures; and

(ii) The means of demonstrating meaningful EHR use.

(4) The methodology and standards for determining the hardship exception to the

payment adjustments; and

(5) The specification of the EHR reporting period, as well as whether payment will be

made only once, in a single consolidated payment, or in periodic installments.

Subpart C--Requirements Specific to Medicare Advantage (MA) Organizations

§ 495.200 Definitions.
CMS-0033-F 804

As used in this subpart:

First payment year means with respect to--

(1) Covered professional services furnished by a qualifying MA EP, the first calendar

year for which an incentive payment is made for such services under this subsection to a

qualifying MA organization.

(2) Qualifying MA-affiliated eligible hospitals, the first fiscal year for which an

incentive payment is made for qualifying MA-affiliated eligible hospitals under this section to a

qualifying MA organization.

Inpatient-bed-days is defined in the same manner and is used in the same manner as that

term is defined and used for purposes of implementing section 4201(a) of the American

Recovery and Reinvestment Act of 2009 with respect to the Medicare FFS hospital EHR

incentive program in §495.104 of this part.

Patient care services means health care services for which payment would be made under,

or for which payment would be based on, the fee schedule established under Medicare Part B if

they were furnished by an EP to a Medicare beneficiary.

Payment year means –

(1) For a qualifying MA EP, a calendar year (CY) beginning with CY 2011 and ending

with CY 2016; and

(2) For an eligible hospital, a Federal fiscal year (FY) beginning with FY 2011 and

ending with FY 2016.

Qualifying MA-affiliated eligible hospital means an eligible hospital under section

1886(n)(6) of the Act that is under common corporate governance with a qualifying MA

organization , for which at least two thirds of the Medicare hospital discharges (or bed-days) are
CMS-0033-F 805

of (or for) are Medicare individuals enrolled under MA plans, and that is a meaningful user of

certified EHR technology as defined by §495.4 of this part. In the case of a hospital for which at

least one-third of whose Medicare bed-days for the year are covered under Part A rather than

Part C, payment for that payment year must only be made under section 1886(n) of the Act and

not under this section.

Qualifying MA EP means all of the following:

(1) A physician (as described in section 1861(r) of the Act), including a doctor of

medicine or osteopathy who is either of the following:

(i) Employed by a qualifying MA organization.

(ii) Employed by, or is a partner of, an entity that through a contract with a qualifying

MA organization furnishes at least 80 percent of the entity's Medicare patient care services to

enrollees of such organization.

(2) Furnishes at least 80 percent of his or her professional services covered under Title

XVIII to enrollees of the qualifying MA organization.

(3) Furnishes, on average, at least 20 hours per week of patient care services to enrollees

of the qualifying MA organization during the EHR reporting period.

(4) Is a meaningful user of certified EHR technology in accordance with §495.4 of this

part.

(5) Is not a “hospital-based EP” as that term is defined in §495.4of this Part.

Qualifying MA organization means a MA organization that is organized as a health

maintenance organization (HMO) as defined in section 2791(b)(3) of the Public Health Service

(PHS) Act which includes a Federally qualified HMO, an organization recognized as an HMO
CMS-0033-F 806

under State law, or a similar organization regulated for solvency under State law in the same

manner and to the same extent as an HMO.

Second, third, fourth, and fifth payment year means with respect to incentive payments

for qualifying--

(1) MA EPs to a qualifying MA organization, each successive calendar year immediately

following the first payment year for the qualifying MA organization. The first payment year and

each successive year immediately following the first payment year, for the qualifying MA

organizations, through 2016, is the same for all qualifying MA EPs with respect to any specific

qualifying MA organization.

(2) MA-affiliated eligible hospitals to a qualifying MA organization, each successive

fiscal year immediately following the first payment year for the qualifying MA organization.

Under common corporate governance means that a qualifying MA organization and a

qualifying MA-affiliated eligible hospital have a common parent corporation, that one is a

subsidiary of the other, or that the organization and the hospital have a common board of

directors.

§ 495.202 Identification of qualifying MA organizations, MA-EPs and MA-affiliated

eligible hospitals.

(a) Identification of qualifying MA organizations. (1) Beginning with bids due in June

2011 (for plan year 2012), MA organizations seeking reimbursement for qualifying MA EPs and

qualifying MA-affiliated eligible hospitals under the MA EHR incentive program are required to

identify themselves to CMS in a form and manner specified by CMS, as part of submissions of

initial bids under section 1854(a)(1)(A) of the Act.

CMS-0033-F 807

(2) Qualifying MA organizations offering MA HMO plans, absent evidence to the

contrary, are deemed to meet the definition of HMO in 42 U.S.C. 300gg-91(b)(3) - section

2791(b)(3) of the PHS Act.

(3) Qualifying MA organizations offering MA plan types other than HMOs, must attest

to the fact that they meet the definition of HMO in 42 U.S.C. 300gg-91(b)(3) - section

2791(b)(3) of the PHS Act.

(4) Beginning with bids due in June 2014 (for plan year 2015), all MA organizations

with potentially qualifying MA EPs or potentially qualifying MA-affiliated eligible hospitals

under the MA EHR incentive program must identify themselves to CMS in a form and manner

specified by CMS, as part of submissions of initial bids under section 1854(a)(1)(A) of the Act.

“Potentially qualifying MA EPs” and “potentially qualifying MA-affiliated eligible hospitals”

are those EPs and hospitals that meet the respective definitions of “qualifying MA EP” and

“qualifying MA-affiliated eligible hospital” in §495.200 but who (or which) are not meaningful

users of certified EHR technology.

(b) Identification of qualifying MA EPs and qualifying MA-affiliated eligible

hospitals.

(1) A qualifying MA organization, as part of its initial bid starting with plan year 2012,

must make a preliminary identification of potentially qualifying MA EPs and potentially

qualifying MA-affiliated eligible hospitals for which the organization is seeking incentive

payments for the current plan year.

(2) A qualifying MA organization must provide CMS with the following for each MA

EP or eligible hospital when reporting under either paragraph (b)(1) or (b)(3) of thissection:

(i) The MA EP's or MA-affiliated eligible hospital's name.

CMS-0033-F 808

(ii) The address of the MA EP's practice or MA-affiliated eligible hospital's location.

(iii) NPI.

(iv) An attestation by MA organization specifying that the MA EP or MA-affiliated

eligible hospital meets the eligibility criteria.

(3) Final identification of potentially qualifying MA EP or MA-affiliated eligible

hospital must be made within 60 days of the close of the payment year as defined in §495.200

for which MA EHR incentive payments are being sought.

(4) Beginning plan year 2015 and for subsequent plan years, all qualifying MA

organizations, as part of their initial bids in June for the following plan year must--

(i) Identify potentially qualifying MA EPs and potentially qualifying MA-affiliated

eligible hospitals;

(ii) Include information specified in paragraph (b)(2)(i)(A) through (C) of this section for

each professional and hospital.

(iii) Include an attestation that each professional and hospital either meets or does not

meet the EHR incentive payment eligibility criteria.

§ 495.204 Incentive payments to qualifying MA organizations for MA-EPs and MA-

affiliated eligible hospitals.

(a) General rule. A qualifying MA organization receives an incentive payment for its

qualifying MA-EPs and its qualifying MA-eligible hospitals. The incentive payment amount

paid to a qualifying MA organization for a--

(1) Qualifying MA-EP is the amount determined under paragraph (b) of this section; and

(2) Qualifying MA-eligible hospital is the amount determined under paragraph (c) of this

section.
CMS-0033-F 809

(b) Amount payable to qualifying MA organization for qualifying MA EPs.

(1) CMS substitutes an amount determined to be equivalent to the amount computed

under §495.102 of this part.

(2) The qualifying MA organization must report to CMS within 60 days of the close of

the calendar year, the aggregate annual amount of revenue attributable to providing services that

would otherwise be covered as professional services under Part B received by each qualifying

MA EP for enrollees in MA plans of the MA organization in the payment year.

(3) CMS calculates the incentive amount for the MA organization for each qualifying

MA EP as an amount equal to 75 percent of the reported annual revenue specified in paragraph

(b)(2) of this section, up to the maximum amounts specified under section 1848 (o)(1)(B) of the

Act.

(4) For qualifying MA EPs who are compensated on a salaried basis, CMS requires the

qualifying MA organization to develop a methodology for estimating the portion of each

qualifying MA EP's salary attributable to providing services that would otherwise be covered as

professional services under Part B to MA plan enrollees of the MA organization in the payment

year. The methodology--

(i) Must be approved by CMS; and

(ii) May include an additional amount related to overhead, where appropriate, estimated

to account for the MA-enrollee related Part B practice costs of the salaried qualifying MA EP.

(iii) Methodological proposals must be submitted to CMS by June of the payment year

and must be auditable by an independent third-party. CMS will review and approve or

disapprove such proposals in a timely manner.

CMS-0033-F 810

(5) For qualifying MA EPs who are not salaried, qualifying MA organizations may

obtain attestations from such qualifying MA EPs (or from entities that the MA EPs are employed

by or with which they have a partnership interest) as to the amount of compensation received by

such EPs for MA plan enrollees of the MA organization. The organizations may submit to CMS

compensation information for each such MA EP based on such attestations.

(6) For qualifying MA EPs who are not salaried, qualified MA organizations may have

qualifying MA EPs (or from entities that the MA EPs are employed by or with which they have a

partnership interest) send MA organization compensation information directly to CMS. CMS

will use the information provided in this subparagraph or paragraph (b)(5) of this section for no

other purpose than to compute the amount of EHR incentive payment due the MA organization.

(c) Amount payable to qualifying MA organization for qualifying MA-affiliated eligible

hospitals. (1)(i) CMS substitutes an amount determined to be equivalent to the amount

computed under §495.104, to the extent data are not available to compute payments for

qualifying MA-affiliated eligible hospitals under the Medicare FFS EHR hospital incentive

program.

(ii) CMS uses the same methodology and defines "inpatient-bed-days" and other terms

as used under the Medicare FFS EHR hospital incentive program in §495.104 of this part in

computing amounts due qualifying MA organizations for MA-affiliated eligible hospitals.

(2) To the extent data are available, qualifying MA organizations must receive hospital

incentive payments through their affiliated hospitals under the Medicare FFS EHR hospital

incentive program, rather than through the MA EHR hospital incentive program.

(d) Payment to qualifying MA organizations. CMS makes payment to qualifying MA

organizations for qualifying MA EPs only under the MA EHR incentive program and not under
CMS-0033-F 811

the Medicare FFS EHR incentive program to the extent an EP has earned less than the maximum

incentive payment for the same period under the Medicare FFS EHR incentive program.

(e) Payment review under MA. To ensure the accuracy of the incentive payments, CMS

conducts selected compliance reviews of qualifying MA organizations to ensure that EPs and

eligible hospitals for which such qualifying organizations received incentive payments were

meaningful EHR users in accordance with §422.504 of this chapter.

(1) The reviews include validation of the status of the organization as a qualifying MA

organization, verification of meaningful use and review of data used to calculate incentive

payments.

(2) MA organizations are required to maintain evidence of their qualification to receive

incentive payments and the data necessary to accurately calculate incentive payments.

(3) Documents and records must be maintained for 6 years from the date such payments

are made with respect to a given payment year.

(4) Payments that result from incorrect or fraudulent attestations, cost data, or any other

submission required to establish eligibility or to qualify for such payment, will be recouped by

CMS from the MA organization.

§ 495.206 Timeframe for payment to qualifying MA organizations.

(a) CMS makes payment to qualifying MA organizations for qualifying MA EPs under

the MA EHR incentive program after computing incentive payments due under the Medicare

FFS EHR incentive program according to §495.102.

(b) Payments to qualifying MA organizations for qualifying MA-affiliated eligible

hospitals under common corporate governance are made under the Medicare FFS EHR incentive

program, following the timeline in specified in §495.104 of this part. To the extent sufficient
CMS-0033-F 812

data do not exist to pay qualifying MA-affiliated eligible hospitals under common corporate

governance under the Medicare FFS EHR incentive program, payment is made under the MA

EHR incentive program, following the same timeline in §495.104 of this part.

§ 495.208 Avoiding duplicate payment.

(a) Unless a qualifying MA EP is entitled to a maximum payment for a year under the

Medicare FFS EHR incentive program, payment for such an individual is only made under the

MA EHR incentive program to a qualifying MA organization.

(b) Payment to qualifying MA organizations for a qualifying MA-affiliated eligible

hospital under common governance only occurs under the MA EHR incentive program to the

extent that sufficient data does not exist to pay such hospital under the Medicare FFS hospital

incentive program under §495.104 of this part. In no event are EHR incentive payments made

for a hospital for a payment year under this section to the extent they have been made for the

same hospital for the same payment year under §495.104 of this part.

(c) Each qualifying MA organization must ensure that all potentially qualifying MA EPs

are enumerated through the NPI system and that other identifying information required under

§495.202(b) is provided to CMS.

§ 495.210 Meaningful EHR user attestation.

(a) Qualifying MA organizations are required to attest, in a form and manner specified

by CMS, that each qualifying MA EP and qualifying MA-affiliated eligible hospitals is a

meaningful EHR user.

(b) Qualifying MA organizations are required to attest within 60 days after the close of a

calendar year whether each qualifying MA EP is a meaningful EHR user.

CMS-0033-F 813

(c) Qualifying MA organizations are required to attest within 60 days after close of the

FY whether each qualifying MA-affiliated eligible hospital is a meaningful EHR user.

§ 495.212 Limitation on review.

(a) There is no administrative or judicial review under section 1869 or 1878 of the Act,

or otherwise of the methodology and standards for determining payment amounts and payment

adjustments under the MA EHR EP incentive program. This includes provisions related to

duplication of payment avoidance and rules developed related to the fixed schedule for

application of limitation on incentive payments for all qualifying MA EPs related to a specific

qualifying MA organization. It also includes the methodology and standards developed for

determining qualifying MA EPs and the methodology and standards for determining a

meaningful EHR user, including the means of demonstrating meaningful use and the selection of

measures.

(b) There is no administrative or judicial review under sections 1869 or 1878 of the Act,

or otherwise, of the methodology and standards for determining payment amounts and payment

adjustments under the MA EHR hospital incentive program. This includes provisions related to

duplication of payment avoidance. It also includes the methodology and standards developed for

determining qualifying MA-affiliated eligible hospitals and the methodology and standards for

determining a meaningful EHR user, including the means of demonstrating meaningful use and

the selection of measures.

Subpart D--Requirements Specific to the Medicaid Program

§495.300 Basis and purpose.

This subpart implements section 4201 of the American Reinvestment and Recovery Act

of 2009 and sections 1903(a)(3)(F) and 1903(t) of the Act, which authorize States, at their
CMS-0033-F 814

option, to provide for incentive payments to Medicaid providers for adopting, implementing, or

upgrading certified EHR technology or for meaningful use of such technology. This subpart also

provides enhanced Federal financial participation (FFP) to States to administer these incentive

payments.

§495.302 Definitions.

As used in this subpart--

Acceptance documents mean written evidence of satisfactory completion of an approved

phase of work or contract and acceptance thereof by the State agency.

Acquisition means to acquire health information technology (HIT) equipment or services

for the purpose of implementation and administration under this part from commercial sources or

from State or local government resources.

Acute care hospital means a health care facility--

(1) Where the average length of patient stay is 25 days or fewer; and

(2) With a CMS certification number (previously known as the Medicare provider

number) that has the last four digits in the series 0001 – 0879 or 1300 – 1399

Adopt, implement or upgrade means--

(1) Acquire, purchase, or secure access to certified EHR technology;

(2) Install or commence utilization of certified EHR technology capable of meeting

meaningful use requirements; or

(3) Expand the available functionality of certified EHR technology capable of meeting

meaningful use requirements at the practice site, including staffing, maintenance, and training, or

upgrade from existing EHR technology to certified EHR technology per the ONC EHR

certification criteria.
CMS-0033-F 815

Children's hospital means a separately certified children's hospital, either freestanding or

hospital-within-hospital that--

(1) Has a CMS certification number, (previously known as the Medicare provider

number), that has the last 4 digits in the series 3300-3399; and

(2) Predominantly treats individuals under 21 years of age.

Entities promoting the adoption of certified electronic health record technology means

the State-designated entities that are promoting the adoption of certified EHR technology by

enabling oversight of the business, operational and legal issues involved in the adoption and

implementation of certified EHR technology or by enabling the exchange and use of electronic

clinical and administrative data between participating providers, in a secure manner, including

maintaining the physical and organizational relationship integral to the adoption of certified EHR

technology by eligible providers.

Health information technology planning advance planning document (HIT PAPD) means

a plan of action that requests FFP and approval to accomplish the planning necessary for a State

agency to determine the need for and plan the acquisition of HIT equipment or services or both

and to acquire information necessary to prepare a HIT implementation advanced planning

document or request for proposal to implement the State Medicaid HIT plan.

HIT implementation advance planning document (HIT IAPD) means a plan of action that

requests FFP and approval to acquire and implement the proposed State Medicaid HIT plan

services or equipment or both.

Medicaid information technology architecture (MITA) is both an initiative and a

framework. It is a national framework to support improved systems development and health care

management for the Medicaid enterprise. It is an initiative to establish national guidelines for
CMS-0033-F 816

technologies and processes that enable improved program administration for the Medicaid

enterprise. The MITA initiative includes an architecture framework, models, processes, and

planning guidelines for enabling State Medicaid enterprises to meet common objectives with the

framework while supporting unique local needs.

Medicaid management information system (MMIS) means a mechanized claims

processing and information retrieval system--referred to as Medicaid Management Information

Systems (MMIS)--that meets specified requirements and that the Department has found (among

other things) is compatible with the claims processing and information retrieval systems used in

the administration of the Medicare program. The objectives of the MMIS are to include claims

processing and retrieval of utilization and management information necessary for program

administration and audit and must coordinate with other mechanized systems and subsystems

that perform other functions, such as eligibility determination.

Needy individuals mean individuals that meet one of following:

(1) Received medical assistance from Medicaid or the Children's Health Insurance

Program. (or a Medicaid or CHIP demonstration project approved under section 1115 of the

Act).

(2) Were furnished uncompensated care by the provider.

(3) Were furnished services at either no cost or reduced cost based on a sliding scale

determined by the individuals' ability to pay.

Patient volume means the minimum participation threshold (as described at §495.304(c)

through (e)) that is estimated through a numerator and denominator, consistent with the SMHP,

and that meets the requirements of §495.306.

CMS-0033-F 817

Practices predominantly means an EP for whom the clinical location for over 50 percent

of his or her total patient encounters over a period of 6 months in the most recent calendar year

occurs at a federally qualified health center or rural health clinic.

Service oriented architecture or service component based architecture means organizing

and developing information technology capabilities as collaborating services that interact with

each other based on open standards.

State Medicaid health information technology plan (SMHP) means a document that

describes the State's current and future HIT activities.

State self-assessment means a process that a State uses to review its strategic goals and

objectives, measure its current business processes and capabilities against the (MITA) business

capabilities and ultimately develops target capabilities to transform its Medicaid enterprise to be

consistent with the MITA principles.

§495.304 Medicaid provider scope and eligibility.

(a) General rule. The following Medicaid providers are eligible to participate in the HIT

incentives program:

(1) Medicaid EPs.

(2) Acute care hospitals.

(3) Children's hospitals.

(b) Medicaid EP. The Medicaid professional eligible for an EHR incentive payment is

limited to the following when consistent with the scope of practice regulations, as applicable for

each professional (§440.50, §440.60, §440.100; §440.165, and §440.166):

(1) A physician.

(2) A dentist.
CMS-0033-F 818

(3) A certified nurse-midwife.

(4) A nurse practitioner.

(5) A physician assistant practicing in a Federally qualified health center (FQHC) led by

a physician assistant or a rural health clinic (RHC),that is so led by a physician assistant.

(c) Additional requirements for the Medicaid EP. To qualify for an EHR incentive

payment, a Medicaid EP must, for each year for which the EP seeks an EHR incentive payment,

not be hospital-based as defined at §495.4 of this subpart, and meet one of the following criteria:

(1) Have a minimum 30 percent patient volume attributable to individuals receiving

Medicaid.

(2) Have a minimum 20 percent patient volume attributable to individuals receiving

Medicaid, and be a pediatrician.

(3) Practice predominantly in a FQHC or RHC and have a minimum 30 percent patient

volume attributable to needy individuals, as defined at §495.302.

(d) Exception. The hospital-based exclusion in paragraph (c) of this section does not

apply to the Medicaid-EP qualifying based on practicing predominantly at a FQHC or RHC.

(e) Additional requirement for the eligible hospital. To be eligible for an EHR incentive

payment for each year for which the eligible hospital seeks an EHR incentive payment the

eligible hospital must meet the following criteria:

(1) An acute care hospital must have at least a 10 percent Medicaid patient volume for

each year for which the hospital seeks an EHR incentive payment.

(2) A children's hospital is exempt from meeting a patient volume threshold.

§ 495.306 Establishing patient volume.

(a) General rule. A Medicaid provider must annually meet patient volume requirements
CMS-0033-F 819

of §495.304, as these requirements are established through the State’s SMHP in accordance with

the remainder of this section.

(b) State option(s) through SMHP. A State must submit through the SMHP the option or

options it has selected for measuring patient volume. A State must select the methodology

described in either paragraph (c) or paragraph (d) of section (or both methodologies). In

addition, or as an alternative, a State may select the methodology described in paragraph (g) of

this section.

(c) Methodology, patient encounter.

(1) EPs. To calculate Medicaid patient volume, an EP must divide:

(i) The total Medicaid patient encounters in any representative, continuous 90-day period

in the preceding calendar year; by

(ii) The total patient encounters in the same 90-day period.

(2) Eligible hospitals. To calculate Medicaid patient volume, an eligible hospital must

divide--

(i) The total Medicaid encounters in any representative, continuous 90-day period in the

preceding fiscal year; by

(ii) The total encounters in the same 90-day period.

(3) Needy individual patient volume. To calculate needy individual patient volume, an

EP must divide--

(i) The total needy individual patient encounters in any representative, continuous 90-

day period in the preceding calendar year; by

(ii) The total patient encounters in the same 90-day period.

(d) Methodology, patient panel.

CMS-0033-F 820

(1) EPs. To calculate Medicaid patient volume, an EP must divide:

(i) (A) The total Medicaid patients assigned to the EP’s panel in any representative,

continuous 90-day period in the preceding calendar year when at least one Medicaid encounter

took place with the Medicaid patient in the year prior to the 90-day period; plus

(B) Unduplicated Medicaid encounters in the same 90-day period; by

(ii)(A) The total patients assigned to the provider in that same 90-day period with at least

one encounter taking place with the patient during the year prior to the 90-day period;plus

(B) All unduplicated patient encounters in the same 90-day period.

(2) Needy individual patient volume. To calculate needy individual patient volume an

EP must divide--

(i)(A) The total Needy Individual patients assigned to the EP’s panel in any

representative, continuous 90-day period in the preceding calendar year when at least one Needy

Individual encounter took place with the Medicaid patient in the year prior to the 90-day period;

plus

(B) Unduplicated Needy Individual encounters in the same 90-day period, by

(ii)(A) The total patients assigned to the provider in that same 90-day period with at least

one encounter taking place with the patient during the year prior to the 90-day period, plus

(B) All unduplicated patient encounters in the same 90-day period.

(e) For purposes of this section, the following rules apply:

(1) For purposes of calculating EP patient volume, a Medicaid encounter means services

rendered to an individual on any one day where--

(i) Medicaid (or a Medicaid demonstration project approved under section 1115 of the

Act) paid for part or all of the service; or

CMS-0033-F 821

(ii) Medicaid (or a Medicaid demonstration project approved under section 1115 of the

Act) paid all or part of the individual’s premiums, co-payments, and cost-sharing.

(2) For purposes of calculating hospital patient volume, both of the following definitions

in paragraphs (e)(2)(i) and (e)(2)(ii) of this section may apply:

(i) A Medicaid encounter means services rendered to an individual per inpatient

discharge where--

(A) Medicaid (or a Medicaid demonstration project approved under section 1115 of the

Act) paid for part or all of the service; or

(B) Medicaid (or a Medicaid demonstration project approved under section 1115 of the

Act) paid all or part of the individual’s premiums, co-payments, and/or cost-sharing.

(ii) A Medicaid encounter means services rendered in an emergency department on any

one day where--

(A) Medicaid (or a Medicaid demonstration project approved under section 1115 of the

Act) paid for part or all of the service; or

(B) Medicaid (or a Medicaid demonstration project approved under section 1115of the

Act) paid all or part of the individual’s premiums, co-payments, and cost-sharing.

(3) For purposes of calculating needy individual patient volume, a needy patient

encounter means services rendered to an individual on any one day where--

(i) Medicaid or CHIP (or a Medicaid or CHIP demonstration project approved under

section 1115 of the Act) paid for part or all of the service;

(ii) Medicaid or CHIP (or a Medicaid or CHIP demonstration project approved under

section 1115 of the Act) paid all or part of the individual’s premiums, co-payments, or cost-

sharing;
CMS-0033-F 822

(iii) The services were furnished at no cost; and calculated consistent with §495.310(h);

or

(iv) The services were paid for at a reduced cost based on a sliding scale determined by

the individual's ability to pay.

(f) Exception. A children’s hospital is not required to meet Medicaid patient

volume requirements.

(g) Establishing an alternative methodology. A State may submit to CMS for review and

approval through the SMHP an alternative from the options included in paragraphs (c) and (d) of

this section, so long as it meets the following requirements:

(1) It is submitted consistent with all rules governing the SMHP at §495.332.

(2) Has an auditable data source.

(3) Has received input from the relevant stakeholder group.

(4) It does not result, in the aggregate, in fewer providers becoming eligible than the

methodologies in either paragraphs (c) and (d) of this section.

(h) Group practices. Clinics or group practices will be permitted to calculate patient

volume at the group practice/clinic level, but only in accordance with all of the following

limitations:

(1) The clinic or group practice's patient volume is appropriate as a patient volume

methodology calculation for the EP.

(2) There is an auditable data source to support the clinic's or group practice’s patient

volume determination.

(3) All EPs in the group practice or clinic must use the same methodology for the

payment year.
CMS-0033-F 823

(4) The clinic or group practice uses the entire practice or clinic’s patient volume and

does not limit patient volume in any way.

(5) If an EP works inside and outside of the clinic or practice, then the patient volume

calculation includes only those encounters associated with the clinic or group practice, and not

the EP’s outside encounters.

§ 495.308 Net average allowable costs as the basis for determining the incentive payment.

(a) The first year of payment. (1) The incentive is intended to offset the costs associated

with the initial adoption, implementation or upgrade of certified electronic health records

technology.

(2) The maximum net average allowable costs for the first year are $25,000.

(b) Subsequent payment years. (1) The incentive is intended to offset maintenance and

operation of certified EHR technology.

(2) The maximum net average allowable costs for each subsequent year are $10,000.

§495.310 Medicaid provider incentive payments.

(a) Rules for Medicaid EPs. The Medicaid EP's incentive payments are subject to all of

the following limitations:

(1) First payment year. (i) For the first payment year, payment under this subpart may

not exceed 85 percent of the maximum threshold of $25,000, which equals $21,250.

(ii) Medicaid EPs are responsible for payment for the remaining 15 percent of the net

average allowable cost of certified EHR technology, or $3,750 for the first payment year.

(iii) An EP may not begin receiving payments any later than CY 2016.

(2) Subsequent annual payment years.

CMS-0033-F 824

(i) For subsequent payment years, payment may not exceed 85 percent of the maximum

threshold of $10,000, which equals $8,500.

(ii) Medicaid EPs are responsible for payment for the remaining 15 percent of the net

average allowable cost of certified EHR technology, or $1,500 per payment year.

(iii) Payments after the first payment year may continue for a maximum of 5 years.

(iv) Medicaid EPs may receive payments on a non-consecutive, annual basis.

(v) No payments may be made after CY 2021.

(3) Maximum incentives. In no case may a Medicaid EP participate for more than a total

of 6 years, and in no case will the maximum incentive over a 6-year period exceed $63,750.

(4) Limitation. For a Medicaid EP who is a pediatrician described in paragraph (b) of

this section payment is limited as follows:

(i) The maximum payment in the first payment year is further reduced by two-thirds,

which equals $14,167.

(ii) The maximum payment in subsequent payment years is further reduced by two-

thirds, which equals $5,667.

(iii) In no case will the maximum incentive payment to a pediatrician under this

limitation exceed $42,500 over a 6-year period.

(b) Optional exception for pediatricians. A pediatrician described in this paragraph is a

Medicaid EP who does not meet the 30 percent patient volume requirements described in

§495.304 and §495.306, but who meets the 20 percent patient volume requirements described in

such sections.

(c) Limitation to only one EHR incentive program. An EP may only receive an

incentive payment from either Medicare or Medicaid in a payment year, but not both.
CMS-0033-F 825

(d) Exception for EPs to switch programs. An EP may change his or her EHR incentive

payment program election once, consistent with §495.10 of this part.

(e) Limitation to one State only. A Medicaid EP or eligible hospital may receive an

incentive payment from only one State in a payment year.

(f) Incentive payments to hospitals. Incentive payments to an eligible hospital under this

subpart are subject to all of the following conditions:

(1) The payment is provided over a minimum of a 3-year period and maximum of a 6-

year period.

(2) The total incentive payment received over all payment years of the program is not

greater than the aggregate EHR incentive amount, as calculated under paragraph (g) of this

section.

(3) No single incentive payment for a payment year may exceed 50 percent of the

aggregate EHR hospital incentive amount calculated under paragraph (g) of this section for an

individual hospital.

(4) No incentive payments over a 2-year period may exceed 90 percent of the aggregate

EHR hospital incentive amount calculated under paragraph (g) of this section for an individual

hospital.

(5) No hospital may begin receiving incentive payments for any year after FY 2016, and

after FY 2016, a hospital may not receive an incentive payment unless it received an incentive

payment in the prior fiscal year.

(6) Prior to FY 2016, payments can be made to an eligible hospital on a non-consecutive,

annual basis for the fiscal year.

CMS-0033-F 826

(7) A multi-site hospital with one CMS Certification Number is considered one hospital

for purposes of calculating payment.

(g) Calculation of the aggregate EHR hospital incentive amount. The aggregate EHR

hospital incentive amount is calculated as the product of the (overall EHR amount) times (the

Medicaid Share).

(1) Overall EHR amount. The overall EHR amount for an eligible hospital is based upon

a theoretical 4 years of payment the hospital would receive based, for each of such 4 years, upon

the product of the following:

(i) Initial amount. The initial amount is equal to the sum of--

(A) The base amount which is set at $2,000,000 for each of the theoretical 4 years; plus

(B) The discharge related amount for a 12-month period selected by the State, but ending

in the Federal fiscal year before the hospital's fiscal year that serves as the first payment year.

The discharge related amount is the sum of the following, with discharges over the 12-month

period and based upon the total discharges for the eligible hospital (regardless of any source of

payment):

(1) For the first through 1,149th discharge, $0.

(2) For the 1,150th through the 23,000th discharge, $200.

(3) For any discharge greater than the 23,000th, $0.

(C) For purposes of calculating the discharge-related amount under paragraph

(g)(1)(i)(B) of this section, for the last 3 of the theoretical 4 years of payment, discharges are

assumed to increase by the provider's average annual rate of growth for the most recent 3 years

for which data are available per year. Negative rates of growth must be applied as such.

(ii) Medicare share. The Medicare share, which equals 1.

CMS-0033-F 827

(iii) Transition factor. The transition factor which equals as follows:

(A) For the first of the theoretical 4 years, 1.

(B) For the second of the theoretical 4 years, 3/4.

(C) For the third of the theoretical 4 years, 1/2.

(D) For the fourth of the theoretical 4 years, 1/4.

(2) Medicaid share. The Medicaid share specified under this paragraph for an eligible

hospital is equal to a fraction--

(i) The numerator of which is the sum (for the 12 month period selected by the State and

with respect to the eligible hospital) of--

(A) The estimated number of inpatient-bed-days which are attributable to Medicaid

individuals; and

(B) The estimated number of inpatient-bed-days which are attributable to individuals

who are enrolled in a managed care organization, a pre-paid inpatient health plan, or a pre-paid

ambulatory health plan under part 438 of this chapter; and

(ii) The denominator of which is the product of--

(A) The estimated total number of inpatient-bed-days with respect to the eligible hospital

during such period; and

(B) The estimated total amount of the eligible hospital's charges during such period, not

including any charges that are attributable to charity care, divided by the estimated total amount

of the hospital's charges during such period.

(iii) In computing inpatient-bed-days under paragraph (g)(2)(i) of this section, a State

may not include estimated inpatient-bed-days attributable to individuals with respect to whom
CMS-0033-F 828

payment may be made under Medicare Part A, or inpatient-bed-days attributable to individuals

who are enrolled with a Medicare Advantage organization under Medicare Part C.

(h) Approximate proxy for charity care. If the State determines that an eligible

provider's data are not available on charity care necessary to calculate the portion of the formula

specified in paragraph (g)(2)(ii)(B) of this section, the State may use that provider's data on

uncompensated care to determine an appropriate proxy for charity care, but must include a

downward adjustment to eliminate bad debt from uncompensated care data. The State must use

auditable data sources.

(i) Deeming. In the absence of the data necessary, with respect to an eligible hospital the

amount described in paragraph (g)(2)(ii)(B) of this section must be deemed to be 1. In the

absence of data, with respect to an eligible hospital, necessary to compute the amount described

in paragraph (g)(2)(i)(B) of this section, the amount under such clause must be deemed to be 0.

(j) Dual eligibility for incentives payments. A hospital may receive incentive payments

from both Medicare and Medicaid if it meets all eligibility criteria in the payment year.

(k) Payments to State-designated entities. Payments to entities promoting the adoption

of certified EHR technology as designated by the State must meet the following requirements:

(l) A Medicaid EP may reassign his or her incentive payment to an entity promoting the

adoption of certified EHR technology, as defined in §495.302, and as designated by the State,

only under the following conditions:

(i) The State has established a method to designate entities promoting the adoption of

EHR technology that comports with the Federal definition in §495.302.

(ii) The State publishes and makes available to all EPs a voluntary mechanism for

reassigning annual payments and includes information about the verification mechanism the
CMS-0033-F 829

State will use to ensure that the reassignment is voluntary and that no more than 5 percent of the

annual payment is retained by the entity for costs not related to certified EHR technology.

(2) [Reserved].

§ 495.312 Process for payments.

(a) General rule. States must have a process for making payments consistent with the

requirements in subparts A and D of this part.

(b) Reporting data consistent with this subpart. In order to receive a payment under this

part, a provider must report the required data under subpart A and this subpart within the EHR

reporting period described in §495.4.

(c) State role. The State determines the provider's eligibility for the EHR incentive

payment under subpart A and this subpart and approves, processes, and makes timely payments

using a process approved by CMS.

(d) State disbursement. The State disburses an incentive payment to the provider based

on the criteria described in subpart A and this subpart.

(e) Timeframes. Payments are disbursed consistent with the following timeframes for

each type of Medicaid eligible provider:

(1) Medicaid EPs. States disburse payments consistent with the calendar year on a

rolling basis following verification of eligibility for the payment year.

(2) Medicaid eligible hospitals. States disburse payments consistent with the Federal

fiscal year on a rolling basis following verification of eligibility for the payment year.

§495.314 Activities required to receive an incentive payment.

(a) First payment year. (1) In the first payment year, to receive an incentive payment,

the Medicaid EP or eligible hospital must meet one of the following:

CMS-0033-F 830

(i) Demonstrate that during the payment year, it has adopted, implemented, or upgraded

certified EHR technology, as defined in §495.302.

(ii) Demonstrate that during the EHR reporting period for a payment year, it is a

meaningful EHR user as defined in §495.4.

(2) A provider may notify the State of its non-binding intention to participate in the

incentives program prior to having fulfilled all of the eligibility criteria.

(b) Subsequent payment years. (1) In the second, third, fourth, fifth, and sixth payment

years, to receive an incentive payment, the Medicaid EP or eligible hospital must demonstrate

that during the EHR reporting period for the applicable payment year, it is a meaningful EHR

user, as defined in §495.4.

(2) The automated reporting of the clinical quality measures will be accomplished using

certified EHR technology interoperable with the system designated by the State to receive the

data.

§495.316 State monitoring and reporting regarding activities required to receive an

incentive payment.

(a) Subject to §495.332 the State is responsible for tracking and verifying the activities

necessary for a Medicaid EP or eligible hospital to receive an incentive payment for each

payment year, as described in §495.314.

(b) Subject to §495.332, the State must submit a State Medicaid HIT Plan to CMS that

includes--

(1) A detailed plan for monitoring, verifying and periodic auditing of the requirements

for receiving incentive payments, as described in §495.314; and

CMS-0033-F 831

(2) A description of the how the State will collect and report on provider meaningful use

of certified EHR technology.

(c) Subject to §495.332 and §495.352 the State is required to submit to CMS annual

reports on the following:

(1) Provider adoption, implementation, or upgrade of certified EHR technology activities

and payments; and

(2) Aggregated, de-identified meaningful use data.

(d)(1) The annual report described in paragraph (c) of this section must include, but is

not limited to the following:

(i) The number, type, and practice location(s) of providers who qualified for an incentive

payment on the basis of having adopted, implemented, or upgraded certified EHR technology.

(ii) Aggregated data tables representing the provider adoption, implementation, or

upgrade of certified EHR technology.

(iii) The number, type, and practice location(s) of providers who qualified for an

incentive payment on the basis of demonstrating that they are meaningful users of certified EHR

technology;

(iv) Aggregated data tables representing the provider's clinical quality measures data;

and

(v) A description and quantitative data on how its incentive payment program addressed

individuals with unique needs such as children.

(2) Subject to §495.332, The State may propose a revised definition of meaningful use of

certified EHR technology, subject to CMS prior approval, but only with respect to the following

objectives:
CMS-0033-F 832

(i) Generate lists of patients by specific conditions to use for quality improvement,

reduction of disparities, research or outreach.

(ii) Capability to submit electronic data to immunization registries or immunization

information systems and actual submission in accordance with applicable law and practice.

(iii) Capability to provide electronic submission of reportable (as required by State or

local law) lab results to public health agencies and actual submission in accordance with

applicable law and practice; and

(iv) Capability to provide electronic syndromic surveillance data to public health

agencies and actual transmission in accordance with applicable law and practice.

(e) State failure to submit the required reports to CMS may result in discontinued or

disallowed funding.

§495.318 State responsibilities for receiving FFP.

In order to be provided FFP under section 1903(a)(3)(F) of the Act, a State must

demonstrate to the satisfaction of HHS, that the State is--

(a) Using the funds provided for the purposes of administering incentive payments to

providers under this program, including tracking of meaningful use by Medicaid providers of

EHR technology;

(b) Conducting adequate oversight of the program, including routine tracking of

meaningful use attestations and reporting mechanisms; and

(c) Is pursuing initiatives to encourage the adoption of certified EHR technology to

promote health care quality and the exchange of health care information, subject to applicable

laws and regulations governing such exchange.

§495.320 FFP for payments to Medicaid providers.

CMS-0033-F 833

Subject to the requirements outlined in this subpart, FFP is available at 100 percent of

State expenditures for payments to Medicaid eligible providers to encourage the adoption and

meaningful use of certified EHR technology.

§495.322 FFP for reasonable administrative expenses.

Subject to prior approval conditions at §495.324 of this subpart, FFP is available at 90

percent in State expenditures for administrative activities in support of implementing incentive

payments to Medicaid eligible providers.

§495.324 Prior approval conditions.

(a) A State must obtain prior written approval as specified in paragraph (b) of this

section, when the State plans to initiate planning and implementation activities in support of

Medicaid provider incentive payments encouraging the adoption and meaningful use of certified

EHR technology with proposed Federal financial participation.

(b) To receive 90 percent match, each State must receive prior approval for all of the

following:

(1) The HIT planning advance planning document and the implementation advance

planning document.

(2) A request for proposal and any contract that a State may utilize to complete activities

under this subpart, unless specifically exempted by the Department of Health and Human

Services, prior to release of the request for proposal or prior to execution of a contract.

(3) For contract amendments, unless specifically exempted by HHS, before execution of

the contract amendment, involving contract cost increases exceeding $100,000 or contract time

extensions of more than 60 days.

(4) The State Medicaid HIT plan.

CMS-0033-F 834

(c) Failure to submit any of the information specified in paragraph (b) of this section to

the satisfaction of HHS may result in disapproval or suspension of project funding.

(d) A State must obtain prior written approval from HHS of its justification for a sole

source acquisition, when it plans to acquire non-competitively from a nongovernmental source

HIT equipment or services, with proposed FFP under this subpart if the total State and Federal

acquisition cost is more than $100,000.

§495.326 Disallowance of FFP.

If the HHS finds that any acquisition approved or modified under the provisions of this

subpart fails to comply with the criteria, requirements, and other undertakings described in the

approved HIT planning advance planning document and HIT implementation advance planning

document to the detriment of the proper and efficient operation of the Medicaid program,

payment of FFP may be disallowed. In the case of a suspension of approval of a HIT planning

advance planning document and HIT implementation advance planning document, suspension

would occur in the same manner as 45 CFR 205.37(c) and 307.40(a).

§495.328 Request for reconsideration of adverse determination.

If CMS disapproves a State request for any elements of a State's advance planning

document or State Medicaid HIT Plan under this subpart, or determines that requirements are

met for approval on a date later than the date requested, the decision notice includes the

following:

(a) The finding of fact upon which the determination was made.

(b) The procedures for appeal of the determination in the form of a request for

reconsideration.

§495.330 Termination of FFP for failure to provide access to information.

CMS-0033-F 835

(a) HHS terminates FFP at any time if the Medicaid agency fails to provide State and

Federal representatives with full access to records relating to HIT planning and implementation

efforts, and the systems used to interoperate with electronic HIT, including on-site inspection.

(b) The Department may request such access at any time to determine whether the

conditions in this subpart are being met.

§495.332 State Medicaid health information technology (HIT) plan requirements.

Each State Medicaid HIT plan must include all of the following elements:

(a) State systems. For State systems, interoperability, and the current and future visions:

(1) A baseline assessment of the current HIT landscape environment in the State

including the inventory of existing HIT in the State. The assessment must include a

comprehensive--

(i) Description of the HIT “as-is” landscape;

(ii) Description of the HIT “to-be” landscape; and

(iii) HIT roadmap and strategic plan for the next 5 years.

(2) A description of how the State Medicaid HIT plan will be planned, designed,

developed and implemented, including how it will be implemented in accordance with the

Medicaid Information Technology Architecture (MITA) principles as described in the Medicaid

Information Technology Framework 2.0. The MITA initiative--

(i) Establishes national guidelines for technologies and processes that enable improved

program administration for the Medicaid enterprise;

(ii) Includes business, information and technology architectures that provide an overall

framework for interoperability, as well as processes and planning guidelines for enabling State
CMS-0033-F 836

Medicaid enterprises to meet common objectives within the framework while supporting unique

local needs; and

(iii) Is important to the design and development of State EHR incentive payment systems.

(3) A description of how intrastate systems, including the Medicaid Management

Information System (MMIS) and other automated mechanized claims processing and

information retrieval systems--

(i) Have been considered in developing a HIT solution; and

(ii) A plan that incorporates the design, development, and implementation phases for

interoperability of such State systems with a description of how any planned systems

enhancements support overall State and Medicaid goals.

(4) A description of data-sharing components of HIT solutions.

(5) A description of how each State will promote secure data exchange, where

permissible under the Health Insurance Portability and Accountability Act (HIPAA) and other

requirements included in ARRA.

(6) A description of how each State will promote the use of data and technical standards

to enhance data consistency and data sharing through common data-access mechanisms.

(7) A description of how each State will support integration of clinical and

administrative data.

(8) A description of the process in place for ensuring improvements in health outcomes,

clinical quality, or efficiency resulting from the adoption of certified EHR technology by

recipients of Medicaid incentive payments and a methodology for verifying such information.

(9) A description of the process in place for ensuring that any certified EHR technology

used as the basis for a payment incentive to Medicaid providers is compatible with State or
CMS-0033-F 837

Federal administrative management systems, including the MMIS or other automated claims

processing system or information retrieval system and a methodology for verifying such

information.

(10) A description of how each State will adopt national data standards for health and

data exchange and open standards for technical solutions as they become available.

(11) A description of how the State intends to address the needs of underserved and

vulnerable populations such as children, individuals with chronic conditions, Title IV-E foster

care children, individuals in long-term care settings and the aged, blind, and disabled. This

description must address the following:

(i) Person centered goals and objectives and shared decision-making;

(ii) Coordination of care across multiple service providers, funding sources, settings, and

patient conditions--

(iii) Universal design to ensure access by people with disabilities and older Americans;

and

(iv) Institutional discharge planning and diversion activities that are tied to community

based service availability.

(b) Eligibility. For eligibility, a description of the process in place for all of the

following:

(1) For ensuring that each EP and eligible hospital meets all provider enrollment

eligibility criteria upon enrollment and re-enrollment to the Medicaid EHR payment incentive

program.

(2) For ensuring patient volume consistent with the criteria in §495.304 and §495.306 for

each EP who practices predominantly in a FQHC or RHC and for each Medicaid EP who is a
CMS-0033-F 838

physician, pediatrician, nurse practitioner, certified nurse midwife or dentist and a methodology

in place used to verify such information.

(3) For ensuring that the EP or eligible hospital is a provider who meets patient volume

consistent with the criteria in §495.304 and §495.306 and a methodology in place used to verify

such information.

(4) For ensuring that each Medicaid EP is not hospital-based and a methodology in place

used to verify such information.

(5) To ensure that a hospital eligible for incentive payments has demonstrated an average

length of stay of 25 days or less and a methodology for verifying such information.

(c) Monitoring and validation. For monitoring and validation of information, States

must include the following:

(1) A description of the process in place for ensuring that, because of CMS' and the

States' oversight responsibilities, all provider information for attestations including meaningful

use, efforts to adopt, implement, or upgrade and any information added to the CMS Single

Provider Repository including all information related to patient volume, NPI, Tax identification

number (TIN), are all true and accurate and that any concealment or falsification of a material

fact related to the attestation may result in prosecution under Federal and State laws and a

methodology in place used to verify such information.

(2) A description of the process in place for ensuring that the EP or eligible hospital is

eligible to receive an incentive payment consistent with the criteria outlined in §495.314 and a

methodology in place used to verify such information.

(3) A description of the process in place for capturing attestations from each EP or

eligible hospital that they have meaningfully used certified EHR technology during the EHR
CMS-0033-F 839

reporting period, and that they have adopted, implemented, or upgraded certified EHR

technology and a description of the methodology in place used to verify such information.

(4) A description of the process in place for capturing clinical quality data from each EP

or eligible hospital and a description of the methodology in place used to verify such

information.

(5) A description of the process in place for monitoring the compliance of providers

coming onto the program with different requirements depending upon their participation year

and a methodology for verifying such information.

(6) A list of the specific actions planned to implement the EHR incentive program,

including a description and organizational charts for workgroups within State government

including external partners.

(7) A description of the process in place to ensure that no amounts higher than 100

percent of FFP will be claimed by the State for reimbursement of expenditures for State

payments to Medicaid eligible providers for the certified EHR technology incentive payment

program and a methodology for verifying such information.

(8) A description of the process in place to ensure that no amounts higher than 90

percent of FFP will be claimed by the State for administrative expenses in administering the

certified EHR technology incentive payment program and a methodology for verifying such

information.

(9) A description of the process and methodology for ensuring and verifying the

following:
CMS-0033-F 840

(i) Amounts received under section 1903 (a)(3)(F) of the Act with respect to payments to

a Medicaid EP or eligible hospital are paid directly to such provider (or to an employer or facility

to which such provider has assigned payments) without any deduction or rebate.

(ii) All incentive payment reassignments to an entity promoting the adoption of certified

EHR technology, as designated by the State, are voluntary for the Medicaid EP involved.

(iii) Entities promoting the adoption of certified EHR technology do not retain more than

5 percent of such payments for costs not related to certified EHR technology (and support

services including maintenance and training) that is for, or is necessary for the operation of, such

technology.

(10) A description of the process in place for ensuring that each Medicaid EP or eligible

hospital that collects an EHR payment incentive has collected a payment incentive from only one

State even if the provider is licensed to practice in multiple States and a methodology for

verifying such information.

(11)(i) A description of the process in place for ensuring that each EP or eligible hospital

that wishes to participate in the EHR incentive payment program will receive a NPI; and

(ii) A description of how the NPI will be used to coordinate with the CMS so that the EP

will choose only one program from which to receive the incentive payment and the hospital

payments are tracked accordingly.

(12) A description of the process in place for ensuring that each EP or eligible hospital

who wishes to participate in the EHR incentive payment program will provide a TIN to the State

for purposes of the incentive payment.

(d) Payments. For payments, States must provide descriptions of the following

processes that are in place:

CMS-0033-F 841

(1) The process in place for ensuring that there is no duplication of Medicare and

Medicaid incentive payments to EPs and a methodology for verifying such information.

(2) The process in place to ensure that any existing fiscal relationships with providers to

disburse the incentive payments through Medicaid managed care plans does not result in

payments that exceed 105 percent of the capitation rate, in order to comply with the Medicaid

managed care incentive payment rules at §438.6(v)(5)(iii) of this chapter and a methodology for

verifying such information.

(3) The process in place to ensure that only appropriate funding sources are used to make

Medicaid EHR incentive payments and the methodology for verifying such information.

(4) The process in place and the methodology for verifying that information is available

in order to ensure that Medicaid EHR incentive payments are made for no more than a total of 6

years; that no EP or eligible hospital begins receiving payments after 2016; that incentive

payments cease after 2021; and that an eligible hospital does not receive incentive payments after

FY 2016 unless the hospital received an incentive payment in the prior fiscal year.

(5) The process in place to ensure that Medicaid EHR incentive payments are not paid at

amounts higher than 85 percent of the net average allowable cost of certified EHR technology

and the yearly maximum allowable payment thresholds and a methodology for verifying such

information..

(6) The process in place to ensure that all hospital calculations and hospital payment

incentives are made consistent with the requirements of this part and a methodology for verifying

such information.
CMS-0033-F 842

(7) The process in place to provide for the timely and accurate payment of incentive

payments to EPs and eligible hospitals, including the time frame specified by the State to meet

the timely payment requirement.

(8) The process in place and a methodology for verifying such information to provide

that any monies that have been paid inappropriately as an improper payment or otherwise not in

compliance with this subpart will be recouped and FFP will be repaid.

(9) The process in place and the methodology for verifying that EPs meet their

responsibility for 15 percent of the net average allowable cost for certified EHR technology.

(e) For combating fraud and abuse and for provider appeals. (1) A description of the

process in place for a provider to appeal consistent with the criteria described in §495.370 and a

methodology for verifying the following related to the EHR incentives payment program:

(i) Incentive payments.

(ii) Provider eligibility determinations.

(iii) Demonstration of efforts to adopt, implement or upgrade and meaningful use

eligibility for incentive payments under this part.

(2) A description of the process in place, and a methodology for verifying such

information, to address Federal laws and regulations designed to prevent fraud, waste, and abuse,

including, but not limited to applicable provisions of Federal criminal law, the False Claims Act

(32 U.S.C. 3729 et seq.), and the anti-kickback statute (section 1128B(b) of the Act).

(f) Optional--proposed alternatives. A State may choose to propose any of the following,

but they must be included as an element in the State Medicaid HIT Plan for review and approval:

(1) An alternative methodology for measuring patient volume, consistent with

§495.306(g).
CMS-0033-F 843

(2) (i) A revised definition of meaningful use of certified EHR technology consistent

with §495.4 and §495.316(d)(2) of this part.

(ii) Any revised definition of meaningful use may not require additional functionality

beyond that of certified EHR technology and conform with CMS guidance on Stage 1. See also

§495.316(d)(2).

§ 495.334 [Reserved]

§ 495.336 Health information technology planning advance planning document

requirements (HIT PAPD).

Each State's HIT PAPD must contain the following:

(a) A statement of need and objective which clearly state the purpose and objectives of

the project to be accomplished and the necessity for the project.

(b) A project management plan which addresses the following:

(1) The planning project organization.

(2) Planning activities and deliverables.

(3) State and contractor resource needs.

(4) Planning project procurement activities and schedule.

(c) A specific budget for the planning of the project.

(d) An estimated total project cost and a prospective State and Federal cost distribution,

including planning and implementation.

(e) A commitment to submit a HIT implementation advance planning document.

(f) A commitment to conduct and complete activities which will result in the production

of the State Medicaid HIT plan that includes conduct of the following activities:

(1) A statewide HIT environmental baseline self-assessment.

CMS-0033-F 844

(2) An assessment of desired HIT future environment.

(3) Development of benchmarks and transition strategies to move from the current

environment to the desired future environment.

(g) A commitment to submit the plan to CMS for approval.

§495.338 Health information technology implementation advance planning document

requirements (HIT IAPD).

Each State's HIT IAPD must contain the following:

(a) The results of the activities conducted as a result of the HIT planning advance

planning document, including the approved state Medicaid HIT plan.

(b) A statement of needs and objectives.

(c) A statement of alternative considerations.

(d) A personnel resource statement indicating availability of qualified and adequate staff,

including a project director to accomplish the project objectives.

(e) A detailed description of the nature and scope of the activities to be undertaken and

the methods to be used to accomplish the project.

(f) The proposed activity schedule for the project.

(g) A proposed budget including a consideration of all HIT implementation advance

planning document activity costs, including but not limited to the following:

(1) The cost to implement and administer incentive payments.

(2) Procurement or acquisition.

(3) State personnel.

(4) Contractor services.

(5) Hardware, software, and licensing.

CMS-0033-F 845

(6) Equipment and supplies.

(7) Training and outreach.

(8) Travel.

(9) Administrative operations.

(10) Miscellaneous expenses for the project.

(h) An estimate of prospective cost distribution to the various State and Federal funding

sources and the proposed procedures for distributing costs including:

(1) Planned annual payment amounts;

(2) Total of planned payment amounts; and

(3) Calendar year of each planned annual payment amount.

(4) A statement setting forth the security and interface requirements to be employed for

all State HIT systems, and related systems, and the system failure and disaster recovery

procedures available.

§495.340 As-needed HIT PAPD update and as-needed HIT IAPD update requirements.

Each State must submit a HIT PAPD update or a HIT IAPD no later than 60 days after

the occurrence of project changes including but not limited to any of the following:

(a) A projected cost increase of $100,000 or more.

(b) A schedule extension of more than 60 days for major milestones.

(c) A significant change in planning approach or implementation approach, or scope of

activities beyond that approved in the HIT planning advance planning document or the HIT

implementation advance planning document.

(d) A change in implementation concept or a change to the scope of the project.

(e) A change to the approved cost allocation methodology.

CMS-0033-F 846

§495.342 Annual HIT IAPD requirements.

Each State's annual HIT IAPD is due 60 days from the HIT IAPD approved anniversary

date and must contain the following:

(a) A reference to the approved HIT PAPD/IAPD and all approved changes.

(b) A project activity status which reports the status of the past year's major project tasks

and milestones, addressing the degree of completion and tasks/milestones remaining to be

completed and discusses past and anticipated problems or delays in meeting target dates in the

approved HIT technology PAPD/IAPD and approved changes to it.

(c) A report of all project deliverables completed in the past year and degree of

completion for unfinished products.

(d) A project activity schedule for the remainder of the project.

(e) A project expenditure status which consists of a detailed accounting of all

expenditures for project development over the past year and an explanation of the differences

between projected expenses in the approved HIT PAPD/IAPD and actual expenditures for the

past year.

(f) A report of any approved or anticipated changes to the allocation basis in the advance

planning document's approved cost methodology.

§495.344 Approval of the State Medicaid HIT plan, the HIT PAPD and update, the HIT

IAPD and update, and the annual HIT IAPD.

HHS will not approve the State Medicaid HIT plan, HIT PAPD and update, HIT-IAPD

and update, or annual IAPD if any of these documents do not include all of the information

required under this subpart.

§495.346 Access to systems and records.

CMS-0033-F 847

The State agency must allow HHS access to all records and systems operated by the State

in support of this program, including cost records associated with approved administrative

funding and incentive payments to Medicaid providers. State records related to contractors

employed for the purpose of assisting with implementation or oversight activities or providing

assistance, at such intervals as are deemed necessary by the Department to determine whether the

conditions for approval are being met and to determine the efficiency, economy, and

effectiveness of the program.

§495.348 Procurement standards.

(a) General rule. Procurements of HIT equipment and services are subject to the

following procurement standards in paragraphs (b) through (f) of this section regardless of any

conditions for prior approval. These standards--

(1) Include a requirement for maximum practical open and free competition regardless of

whether the procurement is formally advertised or negotiated.

(2) Are established to ensure that such materials and services are obtained in a cost

effective manner and in compliance with the provisions of applicable Federal statutes and

executive orders.

(3) Apply when the cost of the procurement is treated as a direct cost of an award.

(b) Grantee responsibilities. The standards contained in this section do not relieve the

Grantee of the contractual responsibilities arising under its contract(s).

(1) The grantee is the responsible authority, without recourse to the Departmental

awarding agency, regarding the settlement and satisfaction of all contractual and administrative

issues arising out of procurements entered into in support of an award or other agreement. This
CMS-0033-F 848

includes disputes, claims, and protests of award, source evaluation or other matters of a

contractual nature.

(2) Matters concerning violation of statute are to be referred to such Federal, State or

local authority as may have proper jurisdiction.

(c) Codes of conduct. The grantee must maintain written standards of conduct governing

the performance of its employees engaged in the award and administration of contracts.

(1) No employee, officer, or agent must participate in the selection, award, or

administration of a contract supported by Federal funds if a real or apparent conflict of interest

would be involved.

(2) Such a conflict would arise when the employee, officer, or agent, or any member of

his or her immediate family, his or her partner, or an organization which employs or is about to

employ any of the parties indicated herein, has a financial or other interest in the firm selected

for an award.

(3) The officers, employees, and agents of the grantee must neither solicit nor accept

gratuities, favors, or anything of monetary value from contractors, or parties to sub agreements.

(4) Grantees may set standards for situations in which the financial interest is not

substantial or the gift is an unsolicited item of nominal value.

(5) The standards of conduct provide for disciplinary actions to be applied for violations

of such standards by officers, employers, or agents of the grantees.

(d) Competition. All procurement transactions must be conducted in a manner to

provide, to the maximum extent practical, open and free competition.

CMS-0033-F 849

(1) The grantee must be alert to organizational conflicts of interest as well as

noncompetitive practices among contractors that may restrict or eliminate competition or

otherwise restrain trade.

(2) In order to ensure objective contractor performance and eliminate unfair competitive

advantage, contractors that develop or draft grant applications, or contract specifications,

requirements, statements of work, invitations for bids and requests for proposals must be

excluded from competing for such procurements.

(3) Awards must be made to the bidder or offer or whose bid or offer is responsive to the

solicitation and is most advantageous to the grantee, price, quality, and other factors considered.

(4) Solicitations must clearly set forth all requirements that the bidder or offer or must

fulfill in order for the bid or offer to be evaluated by the grantee.

(5) Any and all bids or offers may be rejected when it is in the grantee's interest to do so.

(e) Procurement procedures. All grantees must establish written procurement

procedures. These procedures must provide, at a minimum, the following:

(1) Grantees avoid purchasing unnecessary items.

(2) When appropriate, an analysis is made of lease and purchase alternatives to

determine which would be the most economical and practical procurement for the grantee and

the Federal government.

(3) Solicitations for goods and services provide for all of the following:

(i) A clear and accurate description of the technical requirements for the material,

product or service to be procured. In competitive procurements, such a description must not

contain features which unduly restrict competition.

CMS-0033-F 850

(ii) Requirements which the bidder or offer must fulfill and all other factors to be used in

evaluating bids or proposals.

(iii) A description, whenever practicable, of technical requirements in terms of functions

to be performed or performance required, including the range of acceptable characteristics or

minimum acceptable standards.

(iv) The specific features of brand name or equal descriptions that bidders are required to

meet when such items are included in the solicitation.

(v) The acceptance, to the extent practicable and economically feasible, of products and

services dimensioned in the metric system of measurement.

(vi) Preference, to the extent practicable and economically feasible, for products and

services that conserve natural resources and protect the environment and are energy efficient.

(4) Positive efforts must be made by grantees to utilize small businesses, minority-owned

firms, and women's business enterprises, whenever possible. Grantees of Departmental awards

must take all of the following steps to further this goal:

(i) Ensure that small businesses, minority-owned firms, and women's business

enterprises are used to the fullest extent practicable.

(ii) Make information on forthcoming opportunities available and arrange time frames

for purchases and contracts to encourage and facilitate participation by small businesses,

minority-owned firms, and women's business enterprises.

(iii) Consider in the contract process whether firms competing for larger contracts intend

to subcontract with small businesses, minority-owned firms, and women's business enterprises.
CMS-0033-F 851

(iv) Encourage contracting with consortia of small businesses, minority-owned firms and

women's business enterprises when a contract is too large for one of these firms to handle

individually.

(v) Use the services and assistance, as appropriate, of such organizations as the Small

Business Administration and the Department of Commerce's Minority Business Development

Agency in the solicitation and utilization of small businesses, minority-owned firms and

women's business enterprises.

(5) The type of procuring instruments used (for example, fixed price contracts, cost

reimbursable contracts, purchase orders, and incentive contracts) must be determined by the

grantee but must be appropriate for the particular procurement and for promoting the best interest

of the program or project involved.

(6) The “cost-plus-a-percentage-of-cost” or “percentage of construction cost” methods of

contracting must not be used.

(7) Contracts must be made only with responsible contractors who possess the potential

ability to perform successfully under the terms and conditions of the proposed procurement.

(8) Consideration must be given to such matters as contractor integrity, record of past

performance, financial and technical resources or accessibility to other necessary resources.

(9) In certain circumstances, contracts with certain parties are restricted by agencies'

implementation of Executive Orders 12549 and 12689, “Debarment and Suspension” as

described in 2 CFR part 376.

(10) Some form of cost or price analysis must be made and documented in the

procurement files in connection with every procurement action.

CMS-0033-F 852

(11) Price analysis may be accomplished in various ways, including the comparison of

price quotations submitted, market prices, and similar indicia, together with discounts.

(12) Cost analysis is the review and evaluation of each element of cost to determine

reasonableness, allocability, and allowability.

(13) Procurement records and files for purchases in excess of the simplified acquisition

threshold must include the following at a minimum:

(i) Basis for contractor selection.

(ii) Justification for lack of competition when competitive bids or offers are not obtained.

(iii) Basis for award cost or price.

(f) Contract administration. A system for contract administration must be maintained to

ensure contractor conformance with the terms, conditions and specifications of the contract and

to ensure adequate and timely follow up of all purchases. Grantees must evaluate contractor

performance and document, as appropriate, whether contractors have met the terms, conditions,

and specifications of the contract.

(g) Additional contract requirements. The grantee must include, in addition to

provisions to define a sound and complete agreement, the following provisions in all contracts,

which must also be applied to subcontracts:

(1) Contracts in excess of the simplified acquisition threshold must contain contractual

provisions or conditions that allow for administrative, contractual, or legal remedies in instances

in which a contractor violates or breaches the contract terms, and provide for such remedial

actions as may be appropriate.

CMS-0033-F 853

(2) All contracts in excess of the simplified acquisition threshold (currently $100,000)

must contain suitable provisions for termination by the grantee, including the manner by which

termination must be effected and the basis for settlement.

(h) Conditions for default or termination. Such contracts must describe conditions under

which the contract may be terminated for default as well as conditions where the contract may be

terminated because of circumstances beyond the control of the contractor.

(i) Access to contract materials and staff. All negotiated contracts (except those for less

than the simplified acquisition threshold) awarded by grantees must include a provision to the

effect that the grantee, the Departmental awarding agency, the U.S. Comptroller General, or any

of their duly authorized representatives, must have access to any books, documents, papers and

records and staff of the contractor which are directly pertinent to a specific program for the

purpose of making audits, examinations, excerpts and transcriptions.

§495.350 State Medicaid agency attestations.

(a) The State must provide assurances to HHS that amounts received with respect to

sums expended that are attributable to payments to a Medicaid provider for the adoption of EHR

are paid directly to such provider, or to an employer or facility to which such provider has

assigned payments, without any deduction or rebate.

§495.352 Reporting requirements.

Each State must submit to HHS on a quarterly basis a progress report documenting

specific implementation and oversight activities performed during the quarter, including progress

in implementing the State's approved Medicaid HIT plan.

CMS-0033-F 854

§495.354 Rules for charging equipment.

Equipment acquired under this subpart is subject to the public assistance program

requirements concerning the computation of claims for Federal financial participation in

accordance with the provisions of 45 CFR part 95, subpart G.

§495.356 Nondiscrimination requirements.

State agencies and any other recipients or subrecipients of Federal financial assistance

provided under this subpart are subject to the nondiscrimination requirements in 45 CFR parts

80, 84, and 91.

(a) These regulations in 45 CFR parts 80, 84, and 91 prohibit individuals from being

excluded from participation in, being denied the benefits of, or being otherwise subjected to

discrimination under any program or activity which received Federal financial assistance.

(b) Specifically, 45 CFR part 80 prohibits discrimination on the basis of race, color, or

national origin; 45 CFR part 84 prohibits discrimination on the basis of disability; and 45 CFR

part 91 prohibits discrimination on the basis of age.

§495.358 Cost allocation plans.

State agencies that acquire HIT equipment and services under this subpart are subject to

cost allocation plan requirements in 45 CFR part 95.

§495.360 Software and ownership rights.

(a) General rule. The State or local government must include a clause in all procurement

instruments that provides that the State or local government will have all ownership rights in

software or modifications thereof and associated documentation designed, developed or installed

with FFP under this Subpart.

CMS-0033-F 855

(b) Federal license. HHS reserves a royalty-free, non-exclusive, and irrevocable license

to reproduce, publish or otherwise use and to authorize others to use for Federal government

purposes, the software, modifications, and documentation designed, developed or installed with

FFP under this Subpart..

(c) Proprietary software. Proprietary operating/vendor software packages such as

software that is owned and licensed for use by third parties, which are provided at established

catalog or market prices and sold or leased to the general public must not be subject to the

ownership provisions in paragraphs (a) and (b) of this section.

(d) Limitation. Federal financial participation is not available for proprietary

applications software developed specifically for the public assistance programs covered under

this subpart.

§495.362 Retroactive approval of FFP with an effective date of February 18, 2009.

For administrative activities performed by a State, without obtaining prior approval,

which are in support of planning for incentive payments to providers, a State may request

consideration of FFP by recorded request in a HIT advance planning document or

implementation advance planning document update. In such a consideration, the agency takes

into consideration overall Federal interests which may include any of the following:

(a) The acquisition must not be before February 18, 2009.

(b) The acquisition must be reasonable, useful, and necessary.

(c) The acquisition must be attributable to payments for reasonable administrative

expenses under section 1903(a)(3)(F)(ii) of the Act.

§495.364 Review and assessment of administrative activities and expenses of Medicaid

provider health information technology adoption and operation.

CMS-0033-F 856

(a) CMS conducts periodic reviews on an as needed basis to assess the State's progress

described in its approved HIT planning advance planning document and health information

technology implementation advance planning document.

(b) During planning, development, and implementation, these reviews will generally be

limited to the overall progress, work performance, expenditure reports, project deliverables, and

supporting documentation.

(c) CMS assesses the State's overall compliance with the approved advance planning

document and provide technical assistance and information sharing from other State projects.

(d) CMS will, on a continuing basis, review, assess and inspect the planning, design,

development, implementation, and operation of activities and payments for reasonable

administrative expenses related to the administration of payment for Medicaid provider HIT

adoption and operation payments to determine the extent to which such activities meet the

following:

(1) All requirements of this subpart.

(2) The goals and objectives stated in the approved HIT implementation advance

planning document and State Medicaid HIT plan.

(3) The schedule, budget, and other conditions of the approved HIT implementation

advance planning document and State Medicaid HIT plan.

§495.366 Financial oversight and monitoring of expenditures.

(a) General rule. (1) The State must have a process in place to estimate expenditures for

the Medicaid EHR payment incentive program using the Medicaid Budget Expenditure System.

(2) The State must have a process in place to report actual expenditures for the Medicaid

EHR payment incentive program using the Medicaid Budget Expenditure System.
CMS-0033-F 857

(3) The State must have an automated payment and information retrieval mechanized

system, (Medicaid Management Information System) to make EHR payment incentives, to

ensure Medicaid provider eligibility, to ensure the accuracy of payment incentives, and to

identify potential improper payments.

(b) Provider eligibility as basis for making payment. Subject to §495.332, the State must

do all of the following:

(1) Collect and verify basic information on Medicaid providers to assure provider

enrollment eligibility upon enrollment or re-enrollment to the Medicaid EHR payment incentive

program.

(2) Collect and verify basic information on Medicaid providers to assure patient volume.

(3) Collect and verify basic information on Medicaid providers to assure that EPs are not

hospital-based including the determination that substantially all health care services are not

furnished in a hospital setting, either inpatient or outpatient.

(4) Collect and verify basic information on Medicaid providers to assure that EPs are

practicing predominantly in a Federally-qualified health center or rural health clinic.

(5) Have a process in place to assure that Medicaid providers who wish to participate in

the EHR incentive payment program has or will have a NPI and will choose only one program

from which to receive the incentive payment using the NPI, a TIN, and CMS' national provider

election database.

(c) Meaningful use and efforts to adopt, implement, or upgrade to certified electronic

health record technology to make payment. Subject to §495.312, 495.314, and §495.332, the

State must annually collect and verify information regarding the efforts to adopt, implement, or
CMS-0033-F 858

upgrade certified EHR technology and the meaningful use of said technology before making any

payments to providers.

(d) Claiming Federal reimbursement for State expenditures. Subject to §495.332, the

State must do the following:

(1) Assure that State expenditures are claimed in accordance with, including but not

limited to, applicable Federal laws, regulations, and policy guidance.

(2) Have a process in place to assure that expenditures for administering the Medicaid

EHR incentive payment program will not be claimed at amounts higher than 90 percent of the

cost of such administration.

(3) Have a process in place to assure that expenditures for payment of Medicaid EHR

incentive payments will not be claimed at amounts higher than 100 percent of the cost of such

payments to Medicaid providers.

(e) Improper Medicaid electronic health record payment incentives.

(1) Subject to §495.332, the State must have a process in place to assure that no

duplicate Medicaid EHR payment incentives are paid between the Medicare and Medicaid

programs, or paid by more than one State even if the provider is licensed to practice in multiple

States, or paid within more than one area of a State.

(2) Subject to §495.332, the State must have a process in place to assure that Medicaid

EHR incentive payments are made without reduction or rebate, have been paid directly to an

eligible provider or to an employer, a facility, or an eligible third-party entity to which the

Medicaid eligible provider has assigned payments.

(3) Subject to §495.332, the State must have a process in place to assure that that

Medicaid EHR incentive payments are made for no more than 6 years; that no EP or eligible
CMS-0033-F 859

hospital begins receiving payments after 2016; that incentive payments cease after 2021; and that

an eligible hospital does not receive incentive payments after FY 2016 unless the hospital

received an incentive payment in the prior fiscal year.

(4) Subject to §495.332, the State must have a process in place to assure that only

appropriate funding sources are used to make Medicaid EHR incentive payments.

(5) Subject to §495.332, the State must have a process in place to assure that Medicaid

EHR incentive payments are not paid at amounts higher than 85 percent of the net average

allowable cost of certified EHR technology and the yearly maximum allowable payment

thresholds.

(6) Subject to §495.332, the State must have a process in place to assure that for those

entities promoting the adoption of EHR technology, the Medicaid EHR incentive payments are

paid on a voluntary basis and that these entities do not retain more than 5 percent of such

payments for costs not related to certified EHR technology.

(7) Subject to §495.332, the State must have a process in place to assure that any existing

fiscal relationships with providers to disburse the incentive through Medicaid managed care

plans does not exceed 105 percent of the capitation rate, in order to comply with the Medicaid

managed care incentive payment rules at §438.6(c)(5)(iii) of this chapter and a methodology for

verifying such information.

(8) The State must not request reimbursement for Federal financial participation unless

all requirements of this subpart have been satisfied.

§495.368 Combating fraud and abuse.

(a) General rule. (1) The State must comply with Federal requirements to--
CMS-0033-F 860

(i) Ensure the qualifications of the providers who request Medicaid EHR incentive

payments;

(ii) Detect improper payments; and

(iii) In accordance with §455.15 and §455.21 of this chapter, refer suspected cases of

fraud and abuse to the Medicaid Fraud Control Unit.

(2) The State must take corrective action in the case of improper EHR payment

incentives to Medicaid providers.

(b) Providers' statements regarding submission of documentation containing falsification

or concealment of a material fact on EHR incentive payment documentation. For any forms on

which a provider submits information necessary to the determination of eligibility to receive

EHR payments, the State must obtain a statement that meets the following requirements:

(1) Is signed by the provider and contains the following statement: ”This is to certify

that the foregoing information is true, accurate, and complete. I understand that Medicaid EHR

incentive payments submitted under this provider number will be from Federal funds, and that

any falsification, or concealment of a material fact may be prosecuted under Federal and State

laws.”

(2) Appears directly above the claimant's signature, or if it is printed on the reverse of

the form, a reference to the statements must appear immediately preceding the provider's

signature.

(3) Is resubmitted upon a change in provider representative.

(4) Is updated as needed.

(c) Overpayments. States must repay to CMS all Federal financial participation received

by providers identified as an overpayment regardless of recoupment from such providers, within

CMS-0033-F 861

60 days of discovery of the overpayment, in accordance with sections 1903(a)(1), (d)(2), and

(d)(3) of the Act and part 433 subpart F of the regulations.

(d) Complying with Federal laws and regulations. States must comply with all Federal

laws and regulations designed to prevent fraud, waste, and abuse, including, but not limited to

applicable provisions of Federal criminal law, the False Claims Act (32 U.S.C. 3729 et seq.), and

the anti-kickback statute (section 1128B(b) of the Act).

§495.370 Appeals process for a Medicaid provider receiving electronic health record

incentive payments.

(a) The State must have a process in place consistent with the requirements established

in §447.253(e) of this chapter for a provider or entity to appeal the following issues related to the

HIT incentives payment program:

(1) Incentive payments.

(2) Incentive payment amounts.

(3) Provider eligibility determinations.

(4) Demonstration of adopting, implementing, and upgrading, and meaningful use

eligibility for incentives under this subpart.

(b) Subject to paragraph (a) of this section, the State's process must ensure the following:

(1) That the provider (whether an individual or an entity) has an opportunity to challenge

the State's determination under this Part by submitting documents or data or both to support the

provider's claim.

(2) That such process employs methods for conducting an appeal that are consistent with

the State's Administrative Procedure law(s).

CMS-0033-F 862

(c) The State must provide that the provider (whether individual or entity) is also given

any additional appeals rights that would otherwise be available under procedures established by

the State.
CMS-0033-F

Authority: Catalog of Federal Domestic Assistance Program No. 93.773, Medicare--

Hospital Insurance; and Program No. 93.774, Medicare--Supplementary Medical

Insurance Program, Program No. 93.778, Medical Assistance Program.

Dated: June 16, 2010.

__________________________________

Marilyn Tavenner,

Acting Administrator,

Centers for Medicare & Medicaid Services.

Approved: July 9, 2010.

_________________________________

Kathleen Sebelius,

Secretary.

BILLING CODE 4120-01-P

CMS-0033-F

[FR Doc. 2010-17207 Filed 07/13/2010 at 8:45 am; Publication Date: 07/28/2010]