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. Learn more at http://petrieflom.law.harvard.edu/events/details/2016-annual-conference.

1. 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

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
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4. VERMONT ALL-­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)

5. 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.”

6. GOBEILLE V. LIBERTY MUTUAL
(2016)
AN EXPANSIVE PREEMPTIVE DECISION
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7. 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

8. 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”
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
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10. 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

11. 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)

12. 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

13. POTENTIAL SOLUTIONS
CREATIVE MEASURES TO SAVE APCDS
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14. 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 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
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Voluntary data contributions by payers
– Health Care Cost Institute dataset – Aetna, Humana,
UnitedHealthcare

16. 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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