The ACA Survives — But With A Note Of Caution For The Future?

Academic Fellow Rachel Sachs has a new piece up at the Health Affairs Blog discussing the Supreme Court’s decision in King v. Burwell. From the piece: 

Chief Justice Roberts has once again saved a core provision of the Affordable Care Act (ACA). In King v Burwell, a majority of six Justices upheld the validity of an Internal Revenue Service (IRS) rule interpreting the text of the ACA to permit tax credits to be distributed through both state and federal insurance exchanges. As a result, the millions of Americans receiving subsidies through federally established exchanges in the states that have not chosen to establish their own exchanges will continue to receive them.

Much of the briefing and argument in King involved the legal principle known as Chevron deference, in which courts generally defer to agencies’ reasonable interpretations of statutes if the statutory language is ambiguous. In this case, the government first argued that the statutory language clearly permitted tax credits to be made available on federally established exchanges. But even if the statute was ambiguous, it contended, Chevron counseled deference to the IRS’ reasonable interpretation of the statute.

Read the full piece on the Health Affairs Blog!

Happy about the Supreme Court’s ACA decision? Thank a law professor

By Rachel Sachs

[Originally published on The Conversation].

The core of the Affordable Care Act (ACA) has now survived its second trip to the Supreme Court.

Chief Justice John Roberts wrote for the majority in King v Burwell, holding that the federal government may provide subsidies for citizens to purchase health insurance on exchanges that were established by the federal government, rather than by their own state.

A ruling for the challengers (the “King” in King v Burwell) would not only have stopped the flow of subsidies to 6.4 million people currently receiving them, but it would also have disrupted the functioning of the individual insurance markets in the 34 states that have not established their own exchanges. Continue reading

‘The Week in Health Law’ Podcast (Special “Jiggery-Pokery” Edition)

By Nicolas Terry

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Completing our special coverage of the Supreme Court decision in King v. Burwell we are joined by Wendy Mariner. We discuss Chevron Zero, healthcare exceptionalism, and health insurance consolidation & regulation.

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 or 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

King v. Burwell And A Right To Health Care

Bill of Health contributor Gregory Curfman has a new piece up at the Health Affairs Blog discussing the Supreme Court’s decision in King v. Burwell in the broader context of Americans’ right to care. From the piece:

Do Americans have a fundamental right to health care? This oft-debated question is timely given the Supreme Court’s stunning ruling yesterday in King v. Burwell, in which health insurance subsidies on the federal exchange were upheld in a 6-3 decision.

Here I will place the King v. Burwell opinion in the larger context of to what extent Americans are provided a right to care. The Constitution itself does not stipulate a general right to health care, but a patchwork of rights to certain aspects of health care have emerged over time from both constitutional and statutory law.

Read the full piece at the Health Affairs Blog!

Health Law Year in P/Review: Until Next Year

This new post by Holly F. Lynch, I. Glenn Cohen, and Gregory Curfman appears on the Health Affairs Blog as the final entry in a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

It’s been our great pleasure to collaborate with the Health Affairs Blog on this series stemming from theThird Annual Health Law Year in P/Review symposium at Harvard Law School. This annual event takes a look back over the prior year and previews the year to come with regard to hot topics in health law.

After the symposium, we asked our speakers to keep the conversation going online by expanding on their topics from different angles or by honing in on particularly intriguing features. These pieces were published on the Health Affairs Blog through the spring and into summer.

We heard more from Kevin Outterson on how to promote innovation in the development of new antibiotics, from Rachel Sachs on whether the Food and Drug Administration’s proposal to regulate laboratory-developed tests will really stifle innovation, and from Claire Laporte on the impact of recent Supreme Court decisions on bio-IP.

George Annas weighed in on the Ebola outbreak, which has already almost faded from public consciousness but offers important public health lessons, while Wendy Parmet and Andrew Sussman tackled important developments in tobacco control. […]

Read the full post here.

Check out the latest news from the Petrie-Flom Center!

Check out the June 26th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:
PFC_Logo_300x300APPLICATIONS OPEN!
2015-2016 Petrie-Flom Center Student Fellowship

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics.

The Petrie-Flom Center Student Fellowship is a competitive one-year program designed to support Harvard graduate students interested in pursuing independent scholarly projects related to health law policy, biotechnology, and bioethics. With intensive mentorship from Petrie-Flom Center affiliates, student fellows are expected to produce a piece of publishable scholarship by the end of the academic year, at which point they are awarded a modest stipend. Student fellows blog regularly at Bill of Health, the Center’s blog, where their work receives substantial public exposure; participate in and organize Center events; and enroll in the Health Law Policy and Bioethics Workshop, which provides the opportunity to interact with leading scholars in the field.

Applications will be accepted on a rolling basis until 9AM, Friday, August 7, 2015. Notifications of awards will be made by August 21, 2015. For more information, please visit our website.

For further questions, contact Administrative Director Cristine Hutchison-Jones, chutchisonjones@law.harvard.edu.

For more on news and events at Petrie-Flom, see the full newsletter.

‘The Week in Health Law’ Podcast (Special “Apple Sauce” Edition)

By Nicolas Terry

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A special, alas Frank-less edition, with some first impressions on the Supreme Court decision in King v. Burwell from the terrific Nicole Huberfeld.

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 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

The FDA’s Determination On Artificial Trans Fat: A Long Time Coming

By Diana R. H. Winters

[cross-posted at Health Affairs Blog]
On June 16, 2015, the Food and Drug Administration (FDA) released its final determination withdrawing the generally recognized as safe (GRAS) designation for partially hydrogenated oils (PHOs), which are the main source of artificial trans fat in processed foods. The agency gave the food industry three years, until June 18, 2018, to phase out the use of PHOs. The FDA’s order was expected based on the agency’s tentative determination that PHOs were no longer GRAS, published in November 2013.

This action is a milestone in — although perhaps not the culmination of — the FDA’s decades-long attempt to grapple with increasing scientific recognition that trans fat poses a serious health risk to consumers. The action is also unusual, in that it is quite rare for the FDA to withdraw GRAS status from a food product, a move that most likely will mean the ingredient is no longer used in foods.

What is not unusual, unfortunately, is the lengthy timeframe of this regulatory trajectory in the context of FDA action. To be sure, this action will lead to a dramatic reduction in the use of PHOs in processed foods, which in turn, will lead Americans to eat less trans fat – a good thing. What this regulatory action does not do, however, is speak to problems with the GRAS process as a whole.

Continue reading

Human Rights Tribunal Upholds France’s Policies on Ending Life Support for Permanently Unaware Patients

By Norman L. Cantor

France recently confronted its version of America’s 2005 Schiavo case (in which the Florida Supreme Court upheld a spouse’s determination to end life support to a permanently unconscious patient despite the patient’s parents’ objections). In 2014, France’s Conseil d’Etat ruled that artificial nutrition and hydration (ANH) could be withdrawn from a permanently vegetative patient based on oral statements that the patient had made, while competent, indicating unwillingness to be medically sustained in such a condition. The patient’s objecting parents then sought a declaration from the European Court of Human Rights (ECHR) that such termination of life support would violate the European Convention on Human Rights. On June 5, 2015, the ECHR rejected the objecting parents’ contention, finding that France’s approach met human rights standards both in the process and the criteria followed by medical personnel in deciding to end life support.   Lambert v. France, #46043/14 (ECHR 2015).

Vincent Lambert, then 32 years old, was grievously injured in a 2008 traffic accident. He suffered massive brain trauma and was hospitalized for the next 7 years at Reims University Hospital. His precise medical status was initially uncertain. In July 2011, a medical evaluation found him to be “minimally conscious plus.” Over the next year and a half, he underwent 87 speech therapy sessions which failed to establish any code of communication between Mr. Lambert and his surroundings. In early 2013, the attending physician, Dr. Kariger, initiated a process to review Mr. Lambert’s condition and to determine whether the ANH sustaining Mr. Lambert should be withdrawn.

The process that followed was extensive. During 2013, Dr. Kariger consulted with 6 physicians concerning the patient’s mental status and held 2 family meetings at which Mr. Lambert’s wife, Rachel, his parents, and 8 siblings were present. In January 2014, Dr. Kariger announced his determination to end artificial nutrition and reduce hydration. Dr. Kariger’s written report explained that Mr. Lambert had become permanently unaware of his environment and, according to accounts of Mr. Lambert’s prior oral expressions, he would not wish to be medically sustained in such a debilitated condition. Five of the six medical consultants agreed, as did the patient’s wife and 6 of his 8 siblings.

Continue reading

Tackling Medicaid In Massachusetts

This new post by Jeffrey Sánchez appears on the Health Affairs Blog as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

The Affordable Care Act (ACA) provides a number of tools to address longstanding problems in our fragmented health care system. At the national level, the Centers for Medicare and Medicaid Services (CMS) are redefining Medicare through initiatives that promote payment and delivery reform, such as Shared Savings and Value-Based Purchasing. States are also seeking their own opportunities to move away from inefficient systems that reward volume over quality. In particular, state Medicaid programs have the potential to play a major role in these efforts.

Given the number of individuals Medicaid covers, it has the biggest potential impact in improving health care. Medicaid covers more than 1 in 5 Americans, funding more than 16 percent of total personal health spending in the United States. With ACA Medicaid expansion, enrollment increased in 2014 by 8.3 percent and led to an increased overall Medicaid spending growth of 10.2 percent. Total Medicaid spending growth in 2015 is expected to be 14.3 percent with a 13.2 percent enrollment growth. This is not an insignificant portion of both state and federal health care dollars. Thoughtful and concerted reforms to Medicaid have the potential to reduce spending and improve care quality. […]

Read the full article here.

‘The Week in Health Law’ Podcast

By Nicolas Terry

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This week we are joined by Nick Bagley. Nick reminds us how King v. Burwell should be decided before we discuss his fascinating new article on public utility regulation of healthcare. We end with some brief updates on 21st Century Cures, TPP, and the EU privacy regulation. It’s a fun-packed 40 minutes!

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 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

Mini-conference on antibiotic incentives

If you will be in DC on Thursday, we have a great meeting about economic incentives for antibiotic innovation. Location is Capitol Hill. Register here.

Panelists include Rep. Peter Roskam (House Ways & Means), Sir Jim O’Neill, head of the UK AMR Review, Dr. Susan Coller Monarez, National Security Council and Christine Ardal, coordinator of WP2 (economic incentives) in DRIVE-AB.  I will present the first look at the long-awaited Chatham House report.

@koutterson

How law professors helped the Supreme Court understand the Affordable Care Act

By Rachel Sachs

[Originally published on The Conversation].

In March, the Supreme Court heard oral arguments in King v Burwell, a case that could broadly impact the functioning of the Affordable Care Act (ACA). The central question in King v Burwell is whether the federal government may provide subsidies for citizens to purchase health insurance on exchanges that were established by the federal government, rather than by their own state. If the court rules for the government, these subsidies will remain in place. If the court rules against the government, subsidies may no longer be provided to people living in states that have not established their own exchanges.

A decision is expected by the end of June, and a ruling against the government could harm not only the 6.4 million people receiving these subsidies, but also the individual insurance markets in the 34 states that have not established their own exchanges. These markets would likely descend into an actuarial “death spiral,” in which healthier people exit the market in cycles, leaving sicker patients to pay ever-higher premiums. Continue reading

The South Dakota Effect: A Potential Blow to Abortion Rights

By Alex Stein

Many of us are familiar with the “California Effect.” California’s hydrocarbon and nitrogen oxide emission standards for cars are more stringent than the federal EPA standards and more costly to comply with. Yet, California’s emission standards have become the national standard since automobile manufacturers have found it too expensive to produce cars with different emission systems – one for California and another for other states – and, obviously, did not want to pass up on California, the biggest car market in the nation.

Such regulatory spillover may also occur in the abortion regulation area as a consequence of the legislative reforms implemented by South Dakota and thirteen other states. These reforms include statutory enactments that require doctors to tell patients that abortion might lead to depression, suicidal thoughts and even to suicide. Failure to give this warning to a patient violates the patient’s right to informed consent and makes the doctor liable in torts. Continue reading

Black Lives Matter To Human Research–Lessons From ‘On The Run’

On-the-Run-w-GoffmanIn her recent publication, On The Run, University of Wisconsin sociology professor, Alice Goffman writes about embedded research from 2002-2007 in a “ghetto” community she names 6th Street (located in Philadelphia).  The African American residents of this community are mostly poor and tethered to the  criminal justice system as parolees, on probation, and in and out of jail.  Goffman’s human research subjects comprised the jailed, imprisoned, and minors–IRBs generally describe these populations as “vulnerable.”

On The Run is hailed as original, creative, and transgressive because of Goffman’s lengthy stay in such a descriptively chilling, dangerous, and Black neighborhood–where frequent gun battles teach kids to dive for cover, the women are teen mothers or crack addicted, and law enforcement incessantly polices the community. Indeed, she moves into the neighborhood and lives with three of the 6th Street boys.  Much could be gained from documenting the challenges in such a community, particularly given the troubling patterns of mass incarceration in the U.S.  However, the book raises questions about what represents credibility, quality, and rigor in social science research; the book lacks an index, bibliography, and meaningful citations.  I write about these concerns and more in a forthcoming Texas Law Review essay, which can be found here.

Reviewers lauded the rigor and ignored ethics of the book, agreeing with Goffman’s Princeton advisor, Professor Mitchell Duneier, and his NY Times assessment that  “[t]he level of immersion is really unusual,” because “[s]he got access to the life of the ghetto and came to understand aspects of it we don’t ever get to see.”  Yet, therein resides a significant problem. Fascination with the ghetto and perceptions that life in inner-cities is so bad that researchers can’t possibly expose those human subjects to risks and harms may have blinded the book’s many reviewers to the fact that Black lives matter, including in human research.  It might have also implied a lower standard for rigor; it is rare that an academic book lacks a bibliography and index.  Goffman also destroyed her field notes. These concerns becomes starkly relevant when she writes about her desire and collaboration with “Mike” to kill a man from the neighboring 4th Street.

Continue reading

Check out the latest news from the Petrie-Flom Center!

Check out the June 12th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

NOW HIRING!

Petrie-Flom Center/Harvard Catalyst Fellow in Clinical Research Ethics

This is a newly created full-time position for a post-doctoral employee fellow in clinical research ethics to support the work of the Petrie-Flom Center at Harvard Law School in its collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst, Harvard’s Clinical and Translational Science Center. The fellow must have strong knowledge of clinical research and its regulation, with particular interest in the regulatory, ethical, and practical aspects associated with recruitment and retention of research participants. The position will provide the opportunity to interact with a wide range of stakeholders, such as IRB members, administrators, investigators, institutional leadership, patient advocates, and other community members. This position allows for a maximum of 10% effort in furtherance of the fellow’s own research agenda(s) in related fields. Illustrative projects include the following:

  • Defining the clinical trials recruitment problem, including cataloguing various barriers to recruitment, outstanding data needs, and possible solutions, and developing a research agenda
  • Evaluating whether there are ways to prioritize trials and allocate research participants as a scarce resource
  • Considering innovative trial designs as a potential mechanism to address the recruitment problem
  • Developing a recruitment/retention toolkit to help investigators develop successful recruitment/retention plans
  • Addressing the proper parameters of remuneration to subjects
  • Developing surveys to learn more about participant motivations, expectations, and concerns
  • Conducting additional empirical research to develop knowledge that can improve clinical trial recruitment/retention

For more information and to apply, view the full job description!

For more on news and events at Petrie-Flom, see the full newsletter.

A Test For Overpayment Liability

By Zack Buck

The eyes of practitioners, compliance officers, and providers have been trained on the Southern District of New York as many await a decision on a motion to dismiss in Kane v. Continuum Health Partners, No. 11-2325. Kane has grabbed recent attention because of what it could represent: a new era in fraud enforcement.

The facts are straightforward. Throughout 2009 and 2010, three hospitals operating under the Continuum Health Partners umbrella (which is now Mount Sinai Health System) submitted erroneous Medicaid claims seeking reimbursement due to what has been described as a “computer glitch.” The New York Comptroller’s Office notified Continuum of the incorrect claims in the fall of 2010, and Continuum launched an internal investigation.

Relator Robert Kane was asked to investigate any erroneously submitted claims. By early 2011, he had created a spreadsheet containing around 900 claims he thought were erroneously submitted. He emailed the spreadsheet to superiors on February 4, 2011. On February 8, 2011, Kane’s employment was terminated.

Continue reading

‘The Week in Health Law’ Podcast

By Nicolas Terry

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This week we are joined by Leslie Francis for a wide-ranging discussion of Privacy, Big Data and EU Law. Check out some of Leslie’s publications here and here.

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 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