Center for Health Law and Policy Innovation

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POTENTIAL  ROADBLOCKS  IN  HEALTHCARE  BIG  DATA  

COLLECTIONGOBEILLE V.  LIBERTY MUTUAL,  ERISA,AND ALL-­PAYER CLAIMS DATABASES

MAY 6,  2016

Overview

• Introduction• Overview  of  Gobeille v.  Liberty  Mutual

• Post-­GobeilleConcerns  for  Big  Data• Potential  Solutions

2Center  for  Health  Law  and  Policy  Innovation

INTRODUCTION

PRE-­GOBEILLE ERISA  PREEMPTION AND APCDS

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VERMONTALL-­PAYER CLAIMS DATABASE

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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

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• 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

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GOBEILLE V.  LIBERTY MUTUAL

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• 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

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• Dissent  (Ginsburg,  J.)  – ERISA  does  NOT preempt  Vermont’s  APCD– Vermont  law  did  not  “impermissibly  intrude  on  ERISA’s  dominion  over  employee  benefit  plans”  üLaw  does  not  impose  a  “substantial  burden”  on  ERISAüVermont  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

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POTENTIAL IMPACT OF GOBEILLE

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– 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

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– 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

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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

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POTENTIAL SOLUTION:  DOL

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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  DOLDOL  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

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Voluntary  data  contributions   by  payers– Health  Care  Cost  Institute  dataset  – Aetna,  Humana,  UnitedHealthcare

POTENTIAL SOLUTIONS:  PROVIDING INCENTIVES

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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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