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


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Part of the "2016 Annual Conference: Big Data, Health Law, and Bioethics" held at Harvard Law School on May 6, 2016.

This conference aimed to: (1) identify the various ways in which law and ethics intersect with the use of big data in health care and health research, particularly in the United States; (2) understand the way U.S. law (and potentially other legal systems) currently promotes or stands as an obstacle to these potential uses; (3) determine what might be learned from the legal and ethical treatment of uses of big data in other sectors and countries; and (4) examine potential solutions (industry best practices, common law, legislative, executive, domestic and international) for better use of big data in health care and health research in the U.S.

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School 2016 annual conference was organized in collaboration with the Berkman Center for Internet & Society at Harvard University and the Health Ethics and Policy Lab, University of Zurich.

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

  2. 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. 3. INTRODUCTION PRE-­GOBEILLE ERISA  PREEMPTION AND APCDS Center  for  Health  Law  and  Policy  Innovation 3
  4. 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. 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. 6. GOBEILLE V. LIBERTY MUTUAL (2016) AN EXPANSIVE PREEMPTIVE DECISION Center  for  Health  Law  and  Policy  Innovation 6
  7. 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. 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. 9. POST-GOBEILLE CONCERNS MAJOR IMPACTS ON APCDS Center  for  Health  Law  and  Policy  Innovation 9
  10. 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. 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. 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. 13. POTENTIAL SOLUTIONS CREATIVE MEASURES TO SAVE APCDS Center  for  Health  Law  and  Policy  Innovation 13
  14. 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. 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. 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  
  17. 17. 122  Boylston  Street  Ÿ Jamaica  Plain,  MA  02130 Connect  with  us  online HarvardCHLPI HarvardCHLPI