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Center for Health Law and Policy Innovation
[email protected] www.chlpi.org
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
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
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 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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