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Center for Health Law
and Policy Innovation
chlpi@law.harvard.edu
www.chlpi.org
POTENTIAL  ROADBLOCKS  
IN  HEALTHCARE  BIG  DATA  
COLLECTION
GOBEILLE V.  LIBERTY MUTUAL,  ERISA,
AND ALL-­PAYER CLAIMS DATABASES
MAY 6,  2016
Overview
• Introduction
• Overview  of  Gobeille v.  Liberty  
Mutual
• Post-­Gobeille Concerns  for  Big  Data
• Potential  Solutions
2Center  for  Health  Law  and  Policy  Innovation
INTRODUCTION
PRE-­GOBEILLE ERISA  PREEMPTION AND APCDS
Center  for  Health  Law  and  Policy  Innovation 3
VERMONT ALL-­PAYER CLAIMS DATABASE
Center  for  Health  Law  and  Policy  Innovation 4
Insurers  required  to  submit:  
medical  claims  data,  pharmacy  
claims  data,  and  other  information  
regarding  health  care  
Compiled  into  a  
publically  accessible  
resource  
Vermont  issued  regulations  to  implement  a  health  care  claims  
reporting  system,  establish  an  All-­Payer  Claims  Database  (APCD)  
ERISA  BACKGROUND
Center  for  Health  Law  and  Policy  Innovation 5
• Employment  Retirement  Income  Security  Act  of  1974  (ERISA)
– Federal  statute  setting  minimum  standards  for  most  voluntarily  
established  pensions  and  other  employee  benefit  plans  
– Regulation  of  ERISA  plans  “exclusively  a  federal  concern.”  
– Standardized  financial  disclosure  and  reporting  requirements,  
standards  of  conduct,  responsibility  and  obligation
– Preemption  clause  – “‘all  state  laws  insofar  as  they  .  .  .  relate  to  
any  employee  benefit  plan”
• Supreme  Court’s  interpretation  of  ERISA  preemption  clause
– State  law  is  preempted  if  “it  has  a  connection  with  or  reference  
to  such  a[n  employee  benefit]  plan.”  
– Preemption  limited  to  “state  statutes  that  mandate[]  employee  
benefit  structures  or  their  administration.”  
GOBEILLE V. LIBERTY MUTUAL
(2016)
AN EXPANSIVE PREEMPTIVE DECISION
Center  for  Health  Law  and  Policy  Innovation 6
GOBEILLE V.  LIBERTY MUTUAL
Center  for  Health  Law  and  Policy  Innovation 7
• Majority  Opinion  (Kennedy,  J.)
– ERISA  preempts  Vermont’s  APCD
– Vermont  law  has  a  “connection  with”  ERISA  plan
ü “governs  .  .  .  a  central  matter  of  plan  administration”  
(reporting,  disclosure,  and  recordkeeping)
ü “interferes  with  nationally  uniform  plan  administration”
• Concurrence  (Breyer,  J.)
– “[S]erious administrative  problems”  
– States  should  work  with  the  Department  of  Labor  or  the  
Department  of  Health  and  Human  Services  
GOBEILLE V.  LIBERTY MUTUAL
Center  for  Health  Law  and  Policy  Innovation 8
• Dissent  (Ginsburg,  J.)  
– ERISA  does  NOT preempt  Vermont’s  APCD
– Vermont  law  did  not  “impermissibly  intrude  on  ERISA’s  
dominion  over  employee  benefit  plans”  
üLaw  does  not  impose  a  “substantial  burden”  on  ERISA
üVermont  law  and  ERISA’s  reporting  requirements  “elicit  
different  information  and  serve  distinct  purposes”
ERISA  reporting  -­
Evaluate  the  
financial  soundness  
of  the  plans  
Vermont  law  -­ Evaluate  
and  improve  the  quality  
and  cost  of  health  care  
provided  in  Vermont  
POST-GOBEILLE CONCERNS
MAJOR IMPACTS ON APCDS
Center  for  Health  Law  and  Policy  Innovation 9
POTENTIAL IMPACT OF GOBEILLE
Center  for  Health  Law  and  Policy  Innovation 10
– 18  states  have  
APCDs,  12  
developing  APCDs  
– Need  proprietary  
data  to  control  the  
growth  of  
healthcare  
spending
Impact  on  states’  programs  and  initiatives
POTENTIAL IMPACT OF GOBEILLE
Center  for  Health  Law  and  Policy  Innovation 11
– Colorado  -­ Price  
transparency,  
competition  for  
maternity  services  
and  hip  and  knee  
replacements  
– New  England  -­
Medicaid  versus  
commercially  
insured  children  
– Maine  – Opioid  
prescription
Impact  on  health  services  research  (examples)
POTENTIAL IMPACT OF GOBEILLE
Center  for  Health  Law  and  Policy  Innovation 12
Reduces  number  of  claims  in  APCDs  
• Undermines  research  that  requires  very  large  datasets
• Example:  Multiple  sclerosis  drug  natalizumab (Tysabri)
Impacts  the  external  validity  of  post-­GobeilleAPCD  data
• Removes  a  key  portion  of  the  population  from  APCDs
• Medicare  and  Medicaid  enrollees  differ  from  privately  insured
Loss  of  a  key  resource  for  gauging  the  health  status  and  
needs  
• Hampers  efforts  to  efficiently  allocate  health  resources
• Difficult  to  draw  actionable  conclusions
• Example:  Danish/Medicaid  data
POTENTIAL SOLUTIONS
CREATIVE MEASURES TO SAVE APCDS
Center  for  Health  Law  and  Policy  Innovation 13
POTENTIAL SOLUTION:  DOL
Center  for  Health  Law  and  Policy  Innovation 14
Department  of  Labor  to  use  ERISA  authority  to  regulate
– Justice  Breyer concurrence  :  DOL  Secretary  “may  be  
authorized  to  require  ERISA  plans  to  report  data”
Concerns  with  DOL
DOL  may  not  be  
able  to  waive  
preemption
• Risk  of  further  
litigation
DOL  cannot  
compel  non-­self-­
insured  plans  to  
deliver  
information  
under  ERISA    
• Incomplete  data  set
Unlikely  that  
DOL  will  pass  
regulations  
anytime  soon  
• Next  administration  
may  take  different  
view
POTENTIAL SOLUTIONS:  VOLUNTARY DATA
Center  for  Health  Law  and  Policy  Innovation 15
Voluntary  data  contributions   by  payers
– Health  Care  Cost  Institute  dataset  – Aetna,  Humana,  
UnitedHealthcare
POTENTIAL SOLUTIONS:  PROVIDING INCENTIVES
Center  for  Health  Law  and  Policy  Innovation 16
Incentives  for  data  
sharing
• Tax  incentives  relating  to  
health  insurance  costs  
• Incentives  to  third-­party  
administrators  
• Offer  incentives  only  to  
employers  and  insurers  
who  meet  certain  
standards  in  scope
Non-­financial  incentives
• State  legislation  to  
protect  employers  that  
disclose  employee  health  
care  information
• Address  HIPAA  
concerns
• Address  NDA  concerns
• Address  other  
confidentiality   concerns  
122  Boylston  Street  Ÿ Jamaica  Plain,  MA  02130
chlpi@law.harvard.edu
Connect  with  us  online
HarvardCHLPI
HarvardCHLPI
www.chlpi.org

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Carmel Shachar, "Potential Roadblocks in Health Care Big Data Collection: Gobeille v. Liberty Mutual, ERISA, and All-Payer Claims Databases"

  • 1. Center for Health Law and Policy Innovation [email protected] www.chlpi.org POTENTIAL  ROADBLOCKS   IN  HEALTHCARE  BIG  DATA   COLLECTION GOBEILLE V.  LIBERTY MUTUAL,  ERISA, AND ALL-­PAYER CLAIMS DATABASES MAY 6,  2016
  • 2. Overview • Introduction • Overview  of  Gobeille v.  Liberty   Mutual • Post-­Gobeille Concerns  for  Big  Data • Potential  Solutions 2Center  for  Health  Law  and  Policy  Innovation
  • 3. INTRODUCTION PRE-­GOBEILLE ERISA  PREEMPTION AND APCDS Center  for  Health  Law  and  Policy  Innovation 3
  • 4. VERMONT ALL-­PAYER CLAIMS DATABASE Center  for  Health  Law  and  Policy  Innovation 4 Insurers  required  to  submit:   medical  claims  data,  pharmacy   claims  data,  and  other  information   regarding  health  care   Compiled  into  a   publically  accessible   resource   Vermont  issued  regulations  to  implement  a  health  care  claims   reporting  system,  establish  an  All-­Payer  Claims  Database  (APCD)  
  • 5. ERISA  BACKGROUND Center  for  Health  Law  and  Policy  Innovation 5 • Employment  Retirement  Income  Security  Act  of  1974  (ERISA) – Federal  statute  setting  minimum  standards  for  most  voluntarily   established  pensions  and  other  employee  benefit  plans   – Regulation  of  ERISA  plans  “exclusively  a  federal  concern.”   – Standardized  financial  disclosure  and  reporting  requirements,   standards  of  conduct,  responsibility  and  obligation – Preemption  clause  – “‘all  state  laws  insofar  as  they  .  .  .  relate  to   any  employee  benefit  plan” • Supreme  Court’s  interpretation  of  ERISA  preemption  clause – State  law  is  preempted  if  “it  has  a  connection  with  or  reference   to  such  a[n  employee  benefit]  plan.”   – Preemption  limited  to  “state  statutes  that  mandate[]  employee   benefit  structures  or  their  administration.”  
  • 6. GOBEILLE V. LIBERTY MUTUAL (2016) AN EXPANSIVE PREEMPTIVE DECISION Center  for  Health  Law  and  Policy  Innovation 6
  • 7. GOBEILLE V.  LIBERTY MUTUAL Center  for  Health  Law  and  Policy  Innovation 7 • Majority  Opinion  (Kennedy,  J.) – ERISA  preempts  Vermont’s  APCD – Vermont  law  has  a  “connection  with”  ERISA  plan ü “governs  .  .  .  a  central  matter  of  plan  administration”   (reporting,  disclosure,  and  recordkeeping) ü “interferes  with  nationally  uniform  plan  administration” • Concurrence  (Breyer,  J.) – “[S]erious administrative  problems”   – States  should  work  with  the  Department  of  Labor  or  the   Department  of  Health  and  Human  Services  
  • 8. GOBEILLE V.  LIBERTY MUTUAL Center  for  Health  Law  and  Policy  Innovation 8 • Dissent  (Ginsburg,  J.)   – ERISA  does  NOT preempt  Vermont’s  APCD – Vermont  law  did  not  “impermissibly  intrude  on  ERISA’s   dominion  over  employee  benefit  plans”   üLaw  does  not  impose  a  “substantial  burden”  on  ERISA üVermont  law  and  ERISA’s  reporting  requirements  “elicit   different  information  and  serve  distinct  purposes” ERISA  reporting  -­ Evaluate  the   financial  soundness   of  the  plans   Vermont  law  -­ Evaluate   and  improve  the  quality   and  cost  of  health  care   provided  in  Vermont  
  • 9. POST-GOBEILLE CONCERNS MAJOR IMPACTS ON APCDS Center  for  Health  Law  and  Policy  Innovation 9
  • 10. POTENTIAL IMPACT OF GOBEILLE Center  for  Health  Law  and  Policy  Innovation 10 – 18  states  have   APCDs,  12   developing  APCDs   – Need  proprietary   data  to  control  the   growth  of   healthcare   spending Impact  on  states’  programs  and  initiatives
  • 11. POTENTIAL IMPACT OF GOBEILLE Center  for  Health  Law  and  Policy  Innovation 11 – Colorado  -­ Price   transparency,   competition  for   maternity  services   and  hip  and  knee   replacements   – New  England  -­ Medicaid  versus   commercially   insured  children   – Maine  – Opioid   prescription Impact  on  health  services  research  (examples)
  • 12. POTENTIAL IMPACT OF GOBEILLE Center  for  Health  Law  and  Policy  Innovation 12 Reduces  number  of  claims  in  APCDs   • Undermines  research  that  requires  very  large  datasets • Example:  Multiple  sclerosis  drug  natalizumab (Tysabri) Impacts  the  external  validity  of  post-­GobeilleAPCD  data • Removes  a  key  portion  of  the  population  from  APCDs • Medicare  and  Medicaid  enrollees  differ  from  privately  insured Loss  of  a  key  resource  for  gauging  the  health  status  and   needs   • Hampers  efforts  to  efficiently  allocate  health  resources • Difficult  to  draw  actionable  conclusions • Example:  Danish/Medicaid  data
  • 13. POTENTIAL SOLUTIONS CREATIVE MEASURES TO SAVE APCDS Center  for  Health  Law  and  Policy  Innovation 13
  • 14. POTENTIAL SOLUTION:  DOL Center  for  Health  Law  and  Policy  Innovation 14 Department  of  Labor  to  use  ERISA  authority  to  regulate – Justice  Breyer concurrence  :  DOL  Secretary  “may  be   authorized  to  require  ERISA  plans  to  report  data” Concerns  with  DOL DOL  may  not  be   able  to  waive   preemption • Risk  of  further   litigation DOL  cannot   compel  non-­self-­ insured  plans  to   deliver   information   under  ERISA     • Incomplete  data  set Unlikely  that   DOL  will  pass   regulations   anytime  soon   • Next  administration   may  take  different   view
  • 15. POTENTIAL SOLUTIONS:  VOLUNTARY DATA Center  for  Health  Law  and  Policy  Innovation 15 Voluntary  data  contributions   by  payers – Health  Care  Cost  Institute  dataset  – Aetna,  Humana,   UnitedHealthcare
  • 16. POTENTIAL SOLUTIONS:  PROVIDING INCENTIVES Center  for  Health  Law  and  Policy  Innovation 16 Incentives  for  data   sharing • Tax  incentives  relating  to   health  insurance  costs   • Incentives  to  third-­party   administrators   • Offer  incentives  only  to   employers  and  insurers   who  meet  certain   standards  in  scope Non-­financial  incentives • State  legislation  to   protect  employers  that   disclose  employee  health   care  information • Address  HIPAA   concerns • Address  NDA  concerns • Address  other   confidentiality   concerns  
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