Reproductive Malpractice and the U.S. Military

Check out the new op-ed at HuffPo by Bill of Health bloggers Dov Fox and Alex Stein on the unfair treatment of American servicewomen (and their children) under the Feres doctrine should they fall victim to medical malpractice during their pregnancy or delivery. Fox and Stein call for SCOTUS to fix the loophole it left open in the 1950 case, or for Congress to “set up a fund for compensating children whose disabilities were caused by substandard care at military medical facilities.”  Take a look at the full post here.

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!

Some Thoughts from a Health Lawyer on King v. Burwell

By Joan H. Krause

[Cross-posted from Hamilton and Griffin on Rights]

The long-awaited and much-debated opinion in King v. Burwell is here. In an opinion written by Chief Justice Roberts – who almost single-handedly saved the ACA with his 2012 opinion in N.F.I.B. v. Sebelius – and newly joined by N.F.I.B. dissenter Justice Kennedy as well as the more liberal Justices, the Court agreed with the Fourth Circuit that the ACA’s tax credits (or “subsidies”) are available to individuals who purchase insurance through both State and Federal health insurance Exchanges. The Petitioners, four Virginia residents who did not wish to purchase health insurance, had argued that Virginia’s Federally-run Exchange did not constitute “an Exchange established by the State” under the ACA tax credit provision; because unsubsidized coverage would cost more than 8% of the Petitioners’ incomes, they would be exempt from the Act’s individual mandate and would not be required to purchase health insurance. While acknowledging that the Petitioners’ arguments regarding the “plain meaning” of the phrase were strong, the majority nonetheless sided with the Government, holding that the context and structure of the overall statute led to the conclusion that the statute permitted tax credits for insurance purchased on “any Exchange created under the Act,” whether State or Federal (slip op. at 21). Justice Scalia penned a scathing yet witty dissent (“We should start calling this law SCOTUScare,” slip op., Scalia, J. dissenting, at 21), arguing that the plain meaning of the language made clear that tax credits were available only on State exchanges, and that any flaws in the Act’s design should be left to Congress to fix.

Despite the attention it received, King was something of a stealth ACA case. Lacking the Constitutional controversies of N.F.I.B., it was in many ways a run-of-the mill statutory interpretation case focusing on four words in a massive document containing, in the words of the Chief Justice, “more than a few examples of inartful drafting” (slip op. at 14).   And yet the potential effects of the decision were perhaps even more far-reaching, in large part because of the timing. N.F.I.B.’s Commerce Clause analysis may have more precedential value in the long-run, but far fewer of the Act’s provisions had gone into effect in June of 2012. With approximately 7 million individuals now receiving insurance through the Federal Exchange, and the majority of them (an estimated 87%) receiving subsidies, the decision in King could have led to the devastating loss of insurance for millions of Americans.

While commentators will no doubt parse every sentence of the opinion (including the Court’s refusal to defer to the IRS’s interpretation of the statute under Chevron), as a health lawyer I found two aspects of the opinion notable. First, the Chief Justice drafted a very nuanced (and mercifully succinct) description of the health insurance market flaws the ACA was designed to address. The Chief Justice understood the ACA’s “three key reforms” – guaranteed issue and community rating of insurance policies, the individual mandate, and tax credits – as well as the ways in which the three were “closely intertwined” (slip op. at 3-4). The first few pages cite multiple horror stories from states where some, but not all, of these reforms were enacted; for data, the opinion cites liberally to the Brief for Bipartisan Economic Scholars as Amici.   In its depth (not to mention brevity), the analysis is completely different from the tortured description of health insurance found just a few years ago in N.F.I.B., evincing a far more sophisticated understanding of both the legal issues and the legislation itself.

Continue reading

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.

Proving Decision-Causation

By Alex Stein

Proving decision-causation in a suit for informed-consent violation is never easy. Things get even worse when a trial judge misinterprets the criteria for determining – counterfactually – whether the patient would have agreed to the chosen treatment if she were to receive full information about its benefits, risks, and alternatives. The recent Tennessee Supreme Court decision, White v. Beeks, — S.W.3d —- 2015 WL 2375458 (Tenn. 2015), is a case in point. Continue reading

‘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

Hobby Lobby Fall Out

By David Orentlicher

[cross-posted at HealthLawProfs blog and orentlicher.tumblr.com]

For those who feared that the Supreme Court’s Hobby Lobby decision would open the door for employers to block contraceptive access for women in the workplace, welcome reassurance has come this week from the U.S. Court of Appeals for the Fifth Circuit. According to the Fifth Circuit, when the Affordable Care Act requires that contraception coverage be available for workers at religiously-affiliated institutions, the Act also accommodates the scruples of employers who have religiously-based objections to contraceptive use.

As the Fifth Circuit observed, employers with religious objections to contraception can shift the responsibility for coverage to their insurers or the federal government. Hence, there is no unlawful burden on those employers from the mandate that health care plans cover the costs of contraception. Continue reading

King v. Burwell: Is the ACA Here to Stay?

With Chief Justice Roberts’ remarkably strong decision today for the Supreme Court in King v. Burwell millions of Americans can now rest assured:  affordable health insurance is here to stay.  There may not be a constitutional right to health care in the U.S., and thanks to the Court’s 2012 decision regarding the Affordable Care Act’s Medicaid expansion, millions of citizens (not to mention non-citizens) remain uninsured; but the ACA’s promise of providing affordable coverage to millions of low income Americans is now secure.

The question before the Court in Burwell was whether individuals in the 34 states that rely on a federally-operated health insurance exchange, rather than a state-created exchange, are eligible for the federal tax credits. Without those credits, most people could not afford to buy insurance on the exchanges. Nor would they be subject to the ACA’s mandate to have coverage. As the Court recognized, as healthy people fled the exchanges, the insurance markets in states with federally-operated exchanges would experience a death spiral.

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Affordable Care, the Supreme Court, and the Wisdom of Crowds

By David Orentlicher

[cross-posted at HealthLawProfs blog and orentlicher.tumblr.com]

How will the Supreme Court rule on the challenge to the Affordable Care Act’s subsidies that help millions of lower- and middle-income Americans afford their health care coverage? According to FantasySCOTUS’s court watchers, who have correctly predicted more than 70 percent of Supreme Court decisions so far this year, Obamacare should remain intact.

This result is not surprising. The arguments in favor of the government are much stronger than are those for the challenger. To be sure, the challengers cite to two lines in the Affordable Care Act (ACA) that authorize subsidies for insurance bought on state-operated health insurance exchanges, without mentioning federally-operated state exchanges. Hence, argue the challengers, subsidies should be provided only for insurance purchased on state-operated exchanges, which means in only about 1/3 of states. But other language in ACA indicates that the subsidies are available for insurance purchased on all exchanges. When a statute’s language is ambiguous and there are reasonable alternative interpretations, courts are supposed to defer to the executive branch’s interpretation, not substitute their own interpretation. Continue reading

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

New York Times Op-Ed on the A/B Illusion & the Virtues of Data-Driven Innovation

I have an op-ed with Christopher Chabris that appeared in this past Sunday’s New York Times. It focuses on one theme in my recent law review article on corporate experimentation: the A/B illusion. Despite the rather provocative headline that the Times gave it, our basic argument, made as clearly as we could in 800 words, is this: sometimes, it is more ethical to conduct a nonconsensual A/B experiment than to simply go with one’s intuition and impose A on everyone. Our contrary tendency to see experiments—but not untested innovations foisted on us by powerful people—as involving risk, uncertainty, and power asymmetries is what I call the A/B illusion in my law review article. Here is how the op-ed begins:

Can it ever be ethical for companies or governments to experiment on their employees, customers or citizens without their consent? The conventional answer — of course not! — animated public outrage last year after Facebook published a study in which it manipulated how much emotional content more than half a million of its users saw. Similar indignation followed the revelation by the dating site OkCupid that, as an experiment, it briefly told some pairs of users that they were good matches when its algorithm had predicted otherwise. But this outrage is misguided. Indeed, we believe that it is based on a kind of moral illusion.

After the jump, some clarifications and further thoughts.

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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.

Military Medical Malpractice in Baby Delivery and Prenatal Care

By Alex Stein

When Congress enacted the Federal Tort Claims Act (FTCA) in 1946, it did not envisage that its formulation of the federal government’s liability will allow members of the military forces to sue the United States for service-related noncombatant injuries. The Supreme Court closed this gap in Feres v. United States, 340 U.S. 135 (1950). It held that FTCA did not waive the government’s immunity from tort liability for members of the military and supported that interpretation by a number of reasons. First and most important, FTCA made the government liable in torts according to state laws that do not – and are not authorized to – govern the distinctly federal relationship between the government and its armed forces. Second, Congress has established a uniform compensation scheme for injured and fallen soldiers (the Veterans Benefit Act, 38 U.S.C. §§ 301, et seq.). Four years later, in United States v. Brown, 348 U.S. 110 (1954), the Court rationalized Feres as protecting military discipline as well.

Based on these rationales, the Court subsequently decided that Feres also protects the government against suits for derivative harms sustained by civilians. Specifically, it held that when a military person’s “injury incident to service” is the “genesis” of a civilian’s  harm, the civilian cannot sue the government. Stencel Aero Engineering Corp. v. United States, 431 U.S. 666 (1977).

These decisions did not envision the present-day inflow of women into the military and that pregnant servicewomen will be receiving obstetric care at military facilities. For these women and their newborns, the implications of Feres in the event of medical malpractice are unclear. Continue reading

‘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