Month: May 2016

Radical Redesign of Health Care and Its Implications for Policy: A Lecture by Donald Berwick, MD, Administrator of the Centers for Medicare and Medicaid Services (2010-2011)

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stethoscope with puzzleSpecial Lecture to Open ASLME’s 39th Annual Health Law Professors Conference

June 2, 2016, 6:00pm

Wasserstein Hall, Milstein East (2036), Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Reception to follow.

Free and open to the public, but seating is limited. Please register for the lecture and reception here.

Introduction by Martha Minow, Morgan and Helen Chu Dean and Professor, Harvard Law School

Moderator: I. Glenn Cohen, Professor of Law and Faculty Director of the Petrie-Flom Center, Harvard Law School

MAGAZINE- 12/17/03; Boston- Dr. Donald Berwick poses for a portrait at his Boston organization The Institute of Healthcare Improvement. Photo by Laurie Swope (DIGITAL IMAGE)

Donald Berwick, MD, is one of the United States’ leading advocates for high-quality healthcare. From July 2010 to December 2011, he served as the Administrator of the Centers for Medicare and Medicaid Services. For 22 years prior to that, he was the founding CEO – and now President Emeritus and Senior Fellow – of the Institute for Healthcare Improvement, a nonprofit dedicated to improving healthcare around the world. A pediatrician by background, he has also served on the faculties of the Harvard Medical School and the Harvard School of Public Health.

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TWIHL Special: Wendy Mariner Analyzes the New Wellness Regulations

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By Nicolas Terry and Frank Pasquale

twihl 5x5A special TWIHL episode with analysis of the new EEOC regulations under the ADA and GINA on Employer Wellness Plans. Nic is joined by Professor Wendy Mariner. Professor Mariner is the Edward R. Utley Professor of Health Law at Boston University School of Public Health, Professor of Law at Boston University School of Law, Professor at Boston University School of Medicine, and Co-Director of the J.D.-M.P.H. joint degree program, and a member of the faculty of the Center for Health Law, Ethics and Human Rights at BUSPH. Professor Mariner’s research focuses on laws governing health risks, including social and personal responsibility for risk creation, health insurance systems, implementation of the Affordable Care Act, ERISA, health information privacy, and population health policy.

Our discussion concentrated on the ADA regulation and examined how the agency responded to comments (including ours), the concept of voluntariness, the status of EEOC v. Flambeau, Inc., data protection (including issues raised when  employers research the health of their employees), and the policy flaws in the wellness space.The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy.

Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

FDA Gets Serious about Regulating E-Cigarettes

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By Elizabeth Guo

Last Tuesday, FDA published in the Federal Register the final version of its “Deeming Regulation.” The final rule, like the proposed rule, subjects all tobacco products to FDA regulation. Under the Family Smoking Prevention and Tobacco Control Act (FSPTCA), a “tobacco product” is “any product made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.” The final Deeming Regulations gives FDA control over previously unregulated products such as electronic cigarettes (e-cigarettes), cigars, pipe tobacco, hookah tobacco, and gels. FDA’s proposed rule had provided an option that would have exempted premium cigars from regulation, but FDA’s final rule adopted the broader option, subjecting all cigars to FDA regulation.

The 499-page rule responded to a number of challenges posed to FDA’s regulation of previously unregulated tobacco products. Many of these challenges were directed at e-cigarettes (“electronic nicotine delivery systems,” or “ENDS”). FDA responded to these challenges by articulating its view of its authority to regulate ENDS. Specifically, FDA believes:

E-cigarette regulation will benefit the public health, though it is unclear whether e-cigarettes benefit the public health

FDA’s authority to regulate ENDS does not require the agency to establish that regulating ENDS will benefit the public health. The ENDS industry had argued that FDA was required to quantify the health risks of certain products before subjecting them to regulation. FDA argued that section 901, which gives FDA authority to deem products, did not have a public health standard. Read More

The Importance of Transparency in Scientific Innovation

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The health technology company Theranos once received enthusiastic media coverage for its promises of radical innovation in clinical laboratory testing and its eye-catching valuation of $9 billion. Now the company can’t seem to stop the unending stream of bad news. In addition to Theranos’ previous troubles (discussed here and here), the company is now under investigation by both the U.S. Securities and Exchange Commission and the U.S. Attorney’s Office for the Northern District of California. Recently, Sunny Balwani, the company’s president and chief operating officer, departed Theranos.

Many of Theranos’ problems ultimately reflect systemic issues within medical technology innovation. Multiple articles have begun to discuss Theranos as a cautionary tale for innovators and investors. With the advantages of hindsight, a clear theme emerges from the morass Theranos finds itself in: the company’s lack of transparency about its science is at the root of many of its problems. Theranos’ refusal to allow scrutiny about its science and claims prevented effective oversight and earlier checks on the company’s grandiose claims. This negatively impacted the company’s relationships with regulators, its own board, and its business partners, and has dramatically undermined the company’s claims.

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What to Expect When You’re Expecting at Least Another Year of Contraception Litigation

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Photo: Zubik Rally
Tim Ritz/Americans United for Separation of Church and State

By Gregory M. Lipper

In a unanimous, unsigned order hailed as “an almost hilariously brazen punt,” the Supreme Court sent Zubik v. Burwell and the other contraception cases back to the lower courts for further consideration. The order states that, in light of the supplemental briefs submitted at the Court’s request, the parties should have “an opportunity to arrive at an approach going forward that accommodates petitioners’ religious exercise while at the same time ensuring that women covered by petitioners’ health plans ‘receive full and equal health coverage, including contraceptive coverage.’”

That, of course, describes the current accommodation, which the Court in 2014 touted as a compromise that protected women’s interests while relieving religious objectors’ of any burdens created by the previous requirement that they provide and pay for the coverage themselves. But the Court, likely split 4–4 on whether even that accommodation complies with the Religious Freedom Restoration Act, wants the parties to see if they can compromise further without subjecting women to second-class care.

These cases will almost certainly return to the Supreme Court, which may or may not have nine members by that time. But in the meantime, things are up in the air—especially for affected women:

1. The Court decided—nothing. Although objectors’ lawyers claimed victory, even the most nimble of advocates would struggle to identify an actual victory from an order that “expresses no view on the merits of the cases.” Lest any misunderstanding persist, the Court reiterated that it took no position on any of the underlying legal questions:

In particular, the court does not decide [1] whether petitioners’ religious exercise has been substantially burdened, [2] whether the Government has a compelling interest, or [3] whether the current regulations are the least restrictive means of serving that interest.

Those questions will be decided again by the Courts of Appeals, all but one of which has already ruled against the objectors. A victory this is not.

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SCOTUS and More Surprises on Zubik

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After the 2014 SCOTUS decision in Hobby Lobby, in which a closely-held for-profit employer won the argument that the federal Religious Freedom Restoration Act protected it against enforcement of the government’s contraceptives coverage mandate, all eyes have been on what SCOTUS would do in response to a challenge to the very same accommodation it toyed with as a less restrictive alternative in that case.  The Court agreed to hear a consolidated set of challenges to the accommodation brought by several religious non-profit employers who seek outright exemption from the mandate (under the case name Zubik et al.) – but then Justice Scalia passed away, leaving the Court with the unpalatable prospect of a 4-4 decision.

SCOTUS has pulled a few tricks out of its hat to avoid that possibility.  First, it surprised us by seeking supplemental briefs on a possible compromise solution, which would ostensibly allow women to access contraceptives (as the government desires) while not burdening the religious employers (as they desire).  The parties basically responded, as politely as would be expected, that some compromise was indeed possible – but not on terms the other could or would actually accept.  Nonetheless, today, SCOTUS surprised us again – seeing enough glimmer of a possible compromise to decline to decide the cases on the merits, instead returning them to the lower courts to work something out.

So what does that mean?  In my view, count it as a win for the government.  Eight out of nine circuit courts ruled in the government’s favor below, holding that the accommodation it had already offered did not substantially burden employers’ religious beliefs – which means that RFRA’s further protection, demanding a compelling government interest satisfied in the least restrictive way, does not even get triggered. These courts have no reason to change that determination now.  Even if there is a compromise that would be less burdensome on religious employers (which I don’t think there is), such a compromise is not required under RFRA unless there is a substantial burden.  And SCOTUS hasn’t said there is.

What we have here is, ironically, precisely the same result we’d have had if SCOTUS had issued a 4-4 decision.  The lower court opinions will almost certainly stand, and we’ll likely still have a bit of a circuit split. So now, we wait on a new president.  The Donald would presumably destroy the ACA/mandate entirely, whereas Hillary would hopefully be able to deliver a ninth justice that will recognize RFRA’s reasonable limits.  Religious freedom is critically important, but so too is accepting the government’s dramatic efforts to be accommodating, short of letting every religious believer be an island unto himself.

How Not to Debate Health Care Reform

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Editor’s Note: This post was originally published on May 12 with portions of the essay missing. The corrected text is below.

By Ted Marmor

Presidential campaigns in the United States are not typically fought over competing manifestos, with policy details set out in reasonably clear language. Rather they are disputes among candidates about the state of the country and what values—or aspirational visions—they endorse.  And, for at least a century, most American debates about health care reform have been dominated by ideological slogans, misleading claims about financing, and mystifying labels. Republicans have exemplified the mystification this year, repeatedly mislabeling Obamacare as socialized medicine and falsely claiming it a “takeover of American medicine.”

In fairness, the Democratic primaries have generated their own version of mystification. The two candidates do agree on the goals of universal health insurance. But clarity ends there. The Clinton campaign has emphasized incremental reform possibilities and criticized Senator Sanders’ proposal of Medicare for All as unrealistic. Sanders, by contrast, has offered a compelling conception of a fairer and less expensive version of what Americans want, but no incremental steps to get to it.

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NPRM Symposium: Consent, Causality, and Castles in the Air

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

Reading the NPRM and its government commentary, one is subtly, slowly led to a sense of inevitability.  Arguments from abstract principles emerge, leave a footprint and then, in the wake of another tide of interests and arguments, another principal supplants them.  But we are to believe that each previous  footprint endures intact.  There’s “autonomy,” said to require expanding opportunity to consent to honor individual preferences, overtrodden by scientific convenience, which demands just one-time consent, and suggests that world-changing choices to be privacy-bare may be irrevocable.  There’s privacy demanding that information meet HIPAA deidentification standards at least some of the time; but there is some undisclosed vector requiring that there is no limit on who government may share your medical information with.  Surrender to the illusion that these are not inconsistent,  and the proposal is the best of all possible worlds, in which every inconsistent good is maximized and every tradeoff ignored.  Surrender the illusion itself and one sees a mix of juxtaposed  partial-prints going different directions, each incomplete.

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Elizabeth Sepper on ‘The Week in Health Law’ Podcast

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By Nicolas Terry and Frank Pasquale

 

This week we interviewed Elizabeth Sepper, Associatetwihl 5x5 Professor of Law at Washington University. Elizabeth’s work explores the interaction of morality, professional ethics, and law in health care and insurance. She has written extensively on conscientious refusals to provide reproductive and end-of-life healthcare In recent work, Elizabeth has argued that, in resisting compliance with antidiscrimination laws, pharmacy regulations, and insurance mandates (most prominently, the Affordable Care Act’s contraceptive mandate), businesses make claims more reminiscent of market libertarianism than of religious freedom.

Our conversation covered many aspects of conscience claims by contemporary health providers. Our timing was perfect, since HHS just finalized a rule on one of Elizabeth’s areas of expertise: prohibitions on discrimination based on race, color, national origin, sex, age or disability. Elizabeth weighed in on the rule and its implications for the future of health care.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

When Global Health Norms Meet Medicaid

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Special guest post by Nicholas J. Diamond

Medicaid is currently facing a timely, although largely underappreciated, challenge: rebalancing Medicaid long-term services and supports (LTSS). For context, LTSS refer to a broad range of paid and unpaid medical and personal care assistance for individuals who experience difficulty completing self-care tasks due to aging, chronic illness, or disability. According to 2013 estimates, there are approximately 12 million individuals in the U.S. who rely on LTSS, mostly paid for through Medicaid, with a projected increase to approximately 27 million individuals by 2050.

Medicaid has a historical structural bias toward institutional care, such as nursing homes, as opposed to home and community-based services (HCBS), such as home health aides, personal care, chore services, supported employment, rent and food for live-in caregiver, and nonmedical transportation, among many others. Medicaid LTSS rebalancing, therefore, shifts spending away from institutional settings and toward HCBS, which is less expensive and generally preferred by beneficiaries. States may provide HCBS through a complex panoply of federal statutory authorities, including waiver authorities, which afford states wide latitude in designing programs. As you might imagine, with flexibility comes significant variations in how states provide HCBS, which specific types of HCBS they provide, and whether, for instance, cost containment strategies available under certain authorities negatively impact access to needed services. Read More