NPRM Symposium: Privacy and Promises, Promises, Promises

Part Two of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The first blog post in this series probably provided a few surprises, but the surprises are just beginning. Can the NPRM to amend the Common Rule keep its promises?

The NPRM promises that patients will be able to consent to use of their clinical data in research, which is actually two promises, not one. The first is that the consent will be given effect. The second is that the refusal will be given effect.  As to refusal, the NPRM absolutely does not keep its promise.

The NPRM is filled with page after page of exceptions where your consent is not required. These include examples like trailing you and spying on you in public, some tests done on how to affect children’s behavior, and more. Continue reading

NPRM Symposium: Your Privacy or Your Life – Human Research Subjects and the Great Healthdata Giveaway

Part One of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The recent Apple-FBI controversy has highlighted the fact that our government, obligated to protect our privacy in some contexts, actively undermines it in others. The same internal conflict of interest is responsible, at least in part, for the U.S. government’s recent proposal to revise longstanding regulations to protect people who participate in research.

The proposals emerged last September, 2015, and were hailed as the first major reworking of the regulations in several decades, four years after an Advance Notice of Proposed Rulemaking buried somewhat different approaches to the same desired adverse privacy effects in a tome of hundreds of pages. It’s a safe bet that few if any members of the public not professionally involved ever read them. The feds gave themselves four years to consider and devise the current proposal, but they gave the public about four months to consider it and with no evident structured interaction with public opinion. Continue reading

REGISTER NOW! 2016 Annual Conference: Big Data, Health Law, and Bioethics

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2016 Annual Conference:
Big Data, Health Law, and Bioethics
May 6, 2016
Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

“Big Data” is a phrase that has been used pervasively by the media and the lay public in the last several years. While many definitions are possible, the common denominator seems to include the “three V’s” – Volume (vast amounts of data), Variety (significant heterogeneity in the type of data available in the set), and Velocity (speed at which a data scientist or user can access and analyze the data).

Defined as such, health care has become one of the key emerging use cases for big data. For example, Fitbit and Apple’s ResearchKit can provide researchers access to vast stores of biometric data on users from which to test hypotheses on nutrition, fitness, disease progression, treatment success, and the like. The Centers for Medicare & Medicaid Services (CMS) have vast stores of billing data that can be mined to promote high value care and prevent fraud; the same is true of private health insurers.  And hospitals have attempted to reduce re-admission rates by targeting patients that predictive algorithms indicate are at highest risk based on analysis of available data collected from existing patient records. Continue reading

The Unintended Uninsured: The Affordable Care Act’s Coverage Gap

[Cross posted from the Harvard Law and Policy Review]

By Julian Polaris

This is a golden age for access to healthcare in America. In 2015, over 90% of Americans had health coverage, the highest insurance ratein the 50 years the federal government has collected insurance data. This astonishing progress is due in large part to the Affordable Care Act (ACA): President Obama recently announced that 20 million people are covered thanks to the ACA. The victory is bittersweet, however: had the ACA been implemented as designed, an additional three million people would have insurance today. This is the story of the “coverage gap,” a crack in the ACA created by the Supreme Court and left unrepaired in nineteen states. A crack so wide that three million low-income people have fallen through it.

The ACA, as originally passed, aimed to increase access to health coverage in two main ways. First, the Act expanded Medicaid, the public health plan for people with low income. Previously, most states had limited Medicaid eligibility to specific groups like children and pregnant women. The ACA enlarged and standardized the Medicaid program to cover all people who earn up to 138% of the federal poverty level (FPL). The federal government picks up 90% of the cost of healthcare services for newly eligible beneficiaries, whereas costs in traditional Medicaid are split closer to 50-50.

Second, the ACA established the health insurance “exchanges,” portals in each state where consumers can shop for standardized plans that aren’t tied to a particular employer. Federal tax credits are available to subsidize exchange coverage for those earning 100 to 400% of the FPL. Continue reading

The Petrie-Flom Center & Coalition to Transform Advanced Care Launch “The Project on Advanced Care and Health Policy”

The Project on Advanced Care and Health Policy will foster development of improved models of care for individuals with serious advanced illness nearing end-of-life, through interdisciplinary analysis of important health law and policy issues.

March 28, 2016 – The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Coalition to Transform Advanced Care (C-TAC) today announced a new collaboration, The Project on Advanced Care and Health Policy.

This initiative is prompted by the fact that current health law policy and regulation, developed largely in a fee-for service environment with siloed providers, creates barriers that may impede widespread adoption of improved models of care for those with advanced illness. The Project will seek to address this problem through policy and research projects that will identify and analyze these barriers, and propose policy solutions that promote development and growth of successful programs. This may entail developing proposed regulatory approaches for the advanced care delivery model that could be adopted by policymakers at the state and federal levels, as well as exploration of potential payment methodologies for this model of care.  Continue reading

NPRM Symposium: Consent and Consistency in the NPRM

By Luke Gelinas, Guest Blogger

  1.  Interpreting the proposed consent requirement

One of the most discussed and controversial aspects of the Department of Health and Human Services’ recent notice of proposed rule-making (NPRM), which stands to change the federal regulations governing research with human beings, is a new consent requirement for secondary research on bio-specimens.  ‘Secondary research’ involves leftover blood or tissue samples that are re-purposed for research after their original use as clinical samples or in prior research studies has been served.  Whereas the current regulations permit re-purposed samples to be used in research without consent so long as the samples are anonymized or de-identified, the new rule would require individuals to be notified that their samples will be used in research, and to give broad permission or consent for such use, before research using them is permitted.

One possible justification for the new consent requirement is what I will call the ‘rights-violation’ interpretation.  The rights-violation approach maintains that consent for research with biospecimens is ethically required to avoid a rights-violation—which is what, the view claims, using someone’s samples without their consent amounts to.

Defenders of this view face the challenge of saying precisely which right is violated by research with re-purposed specimens.  One idea is that the samples still count as part of the individual’s body, even if they are no longer spatially continuous with it, so that using them without consent infringes a bodily right.  A second possibility is that, even if donated specimens are not part of one’s body in the relevant sense, we yet have ownership interests in and claims to our biological materials, so that  something closer to a property right at stake.  A third view focuses on the personal health information that can be garnered from certain sorts of research with bio-specimens (e.g., research involving whole genome sequencing), claiming that privacy rights stand to be infringed when specimens are used without consent.  Each of these views raises complex ethical (and indeed in some cases metaphysical) issues that defenders of the rights-violation interpretation must work out.  Continue reading

TOMORROW, 3/25 in NYC! Book Talk & Panel: FDA in the 21st Century – The Challenges of Regulating Drugs and New Technologies

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FDA in the 21st Century:
The Challenges of Regulating Drugs and New Technologies

March 25, 2016 12:00 PM

92nd Street Y
1395 Lexington Ave. (at 92nd St.), New York, NY

Join co-editors Holly Fernandez Lynch (Petrie-Flom Executive Director) and I. Glenn Cohen (Petrie-Flom Faculty Director) and contributor Lewis Grossman (American University) for a discussion of FDA in the 21st Century: The Challenges of Regulating Drugs and New Technologies (Columbia University Press, 2015). This volume stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future.

This is a ticketed event. To learn more, visit the 92nd Street Y’s website!

Sponsored by the 92nd Street Young Men’s and Young Women’s Hebrew Association (New York, New York) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

PANEL (4/5): The National Security Implications of the Genetics Revolution

 

Technology Concept

The National Security Implications of the Genetics Revolution
April 5, 2016 12:00 PM
Pound Hall, Room 101
Harvard Law School, 1536 Massachusetts Ave., Cambridge, MA

 

Panelists:

  • Jamie Metzl, JD ’97, Senior Fellow for Technology and National Security of the Atlantic Council. He has served on the U.S. National Security Council, State Department, and Senate Foreign Relations Committee, as Executive Vice President of the Asia Society and with the United Nations in Cambodia. A globally syndicated columnist and regular guest on national and international media, he is the author of a history of the Cambodian genocide and the novels The Depths of the Sea and Genesis Code.

Topic: The National Security Implications of the Genetics Revolution

  • George J. Annas, JD, MPH, William Fairfield Warren Distinguished Professor and Chair of the Department of Health Law, Bioethics & Human Rights, Boston University School of Public Health; Professor in the Boston University School of Medicine, and School of Law

Topic: Post-9/11 Uses of Public Health and Medicine by National Security Agencies 

  • Jonathan D. Moreno, PhD, David and Lyn Silfen University Professor of Ethics, Perelman School of Medicine, University of Pennsylvania

Topic: National Security and Biology

This event is free and open to the public. Lunch will be provided.

Cosponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, the Harvard National Security & Law Association, the Harvard National Security Journal, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

The EEOC’s Role In Reshaping Wellness Programs

This new post by Kristin Madison appears on the Health Affairs Blog concludes the blog series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

Wellness programs remain a popular feature of the employer landscape, but the legal environment surrounding them has long been uncertain. In April 2015, the Equal Employment Opportunity Commission took a significant step toward resolving this uncertainty by formally proposing a ruleclarifying the applicability Americans with Disabilities Act of 1990 (ADA) to wellness programs.

In doing so, it staked out middle ground between an approach that would have sharply limited the use of incentives in wellness programs, and a more permissive approach consistent with regulations already in place under the Affordable Care Act (ACA). The proposed rule has the potential to shape, or reshape, future wellness programs. The extent to which it will do so, however, remains uncertain. […]

Read the full post here.

One Patent Law, Two Economic Sectors: Is The One-Size-Fits-All Patent Law Still Workable?

This new post by Claire Laporte appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

Ever since the first patent was issued in 1790, the United States has had a single patent law to protect inventions in all fields. Over the past three decades, that law has been strained to the breaking point in covering both the life sciences and other technologies.

On the life sciences side, patents protect platform technologies as well as specific products and are important at every stage of a product’s life cycle. Many scientific breakthroughs arise from federally funded research in universities and other institutions. Under the Bayh-Dole Act, these institutions license the resulting patents to companies, often start-ups, which develop the technology until it is ready to be marketed.

During the many years of the development process, companies need to attract investment, and investors often assess the merits of the patent portfolio as an indicator of the ultimate strength of the company. Once a product is released to the market, patents still matter; each day of patent protection for a blockbuster drug is worth millions. Patent litigation in the life sciences is typically between competitors and reflects an effort by one of those competitors to maintain its exclusivity. […]

Read the full post here.

Bioethicist Arthur Caplan: Using Genetically Modified Mosquitoes To Fight Zika Is The Right Thing To Do

A new piece by Bill of Health contributor Art Caplan on Forbes:

When most of us think of mosquito control, we think of repellent, sprays and DEET. You might think long sleeves, window screens or mosquito control trucks, too. We’ve gotten pretty used to the idea that mosquitoes live around and among us–even when those mosquitoes carry diseases like West Nile, dengue, malaria and Zika. The best we can do to avoid their pesky, and sometimes lethal, bites is make our bodies unreachable or unappetizing.

The Zika outbreak sweeping through South America, Central America, Mexico and the Caribbean–and steadily moving north–has made mosquito control a top priority for national and international leaders, including the CDC and WHO. Transmitted primarily by the bite of the female Aedes aegypti mosquito, Zika has been linked to microcephaly in babies born to mothers infected during their pregnancies, as well as Guillain-Barré syndrome, which causes paralysis and even respiratory failure. Zika can get into the blood supply. A few cases of Zika appear to have been sexually transmitted. […]

Read the full article here.

The Economics Of Paying For Value

This new post by Nancy Beaulieu, Michael Chernew, Soren Kristensen, and Meredith Rosenthal appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

The notion that the American health care system should transition from paying for volume to paying for value has become nearly ubiquitous. There is a broad consensus that health care providers should be paid more if they deliver higher value care (i.e. care that results in substantial health gains per dollar spent).

These beliefs have led to a proliferation of value-based payment programs in both public and private sectors. For example, at the beginning of 2015, Sylvia Burwell announced the federal government’s commitment to tie 90 percent of fee-for-service Medicare payments to quality or value measures by 2018. In January of 2015, a newly formed alliance of health care providers, insurers, and employers called the Health Care Transformation Task Force committed to shifting 75 percent of their business to contracts that provide incentives for quality and efficiency by 2020.

The details of existing value or quality-based payment programs vary enormously and without regard to any conceptual framework. For example, they vary in the size of incentives and the measures used. They also vary in whether quality payments are contingent on financial savings and whether the value-based payment model is budget neutral. Even the term value is inconsistently defined. […]

Read the full post here.

Breaking Good? The Arc Of Antitrust Policy In The Health Sector

This new post by Barak Richman appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

It appears that 2016 will follow 2015 as another year of massive consolidation in the health care sector. It therefore follows that 2016 will, also like 2015, be another year in which assorted health care industries receive significant antitrust scrutiny. Against this backdrop, it is timely and revealing to examine the current state and trajectory of antitrust law as it intersects and shapes health care policy.

Beginning in the late 1980s, when hospitals and hospital systems started an intense consolidation trend that continues today, many were challenged by the Federal Trade Commission (FTC) for creating anticompetitive and therefore illegal pricing power. Yet the FTC was unsuccessful in convincing courts that this was a harmful trend, and the Commission earned a costly, long losing streak, suffering defeats in each of six landmark cases between 1994 and 1999 (Note 1). The district courts reasoned that the hospitals’ mergers would provide better and more efficient care, that patients would travel to obtain cheaper care, and in any event, because the hospitals were nonprofit, they would not exercise market power to increase prices.

All these predictions have been proven incorrect. Hospital mergers (including those involving nonprofits) have significantly increased prices, and there has been no evidence of increased efficiencies. In fact, evidence suggests that, because the administration of health insurance both reduces the impact of marginal price increases and limits demand in close substitutes, hospital monopolists are even more costly than “typical” monopolies. One significant development in 2015 is new research which revealed that cost variation in the US is largely determined by hospitals market power. The string of FTC losses and the consequent wave of hospital consolidations can only be described as a collective and massive failure of antitrust policy. […]

Read the full post here.

Medicaid Expansion Through Section 1115 Waivers: Evaluating The Tradeoffs

This new post by Rachel Sachs appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

Nearly six years after the passage of the Affordable Care Act (ACA), health law and policy experts continue to painstakingly track the progress of the Act’s Medicaid expansion. The original intention of the ACA was to expand Medicaid in every state, leading to gains in coverage by all individuals below a certain income.

However, the Supreme Court’s 2012 ruling in National Federation of Independent Business v. Sebelius(NFIB) invalidated the original expansion as unconstitutionally coercive, effectively making the Medicaid expansion voluntary for states. As of this blog post, just 32 states including DC have expanded Medicaid pursuant to the ACA.

Most of the states that have expanded Medicaid thus far have done so through the standard procedure, following the statutory guidelines set forth by the ACA and the Centers for Medicare & Medicaid Services (CMS) and incorporating the newly eligible enrollees into their existing programs as a new beneficiary group. But some states have successfully negotiated customized expansions with CMS through the use of the Section 1115 waiver process, seeking to expand Medicaid only on their terms. […]

Read the full post here.