Another Opinion Upholding the Contraceptives Coverage Accommodation

Today, the 10th Circuit issued its opinion in the Little Sisters of the Poor case, holding that the accommodation offered to religious nonprofits – and now also to certain closely-held for-profits – is legally acceptable under the standard imposed by the Religious Freedom Restoration Act (RFRA).  The accommodation, just recently finalized in its current form, allows eligible employers to avoid covering contraceptives for their employees so long as they notify their insurer or the government of their religious objection to doing so. Importantly, employees are still legally guaranteed access to free contraceptives through alternate mechanisms, usually the via insurer directly.

The 10th Circuit’s opinion represents the fifth win for the administration on the accommodation issue following Hobby Lobby. (Note that Hobby Lobby was about an employer who was not previously eligible for the accommodation.)  The RFRA standard provides that the government “may substantially burden a person’s exercise of religion only if it demonstrates that application of the burden to the person—(1) is in furtherance of a compelling governmental interest; and (2) is the least restrictive means of furthering that compelling governmental interest.”

In Little Sisters, the 10th Circuit dispensed with the RFRA claim by holding that there was no substantial burden, one of the threshold questions in the RFRA analysis.  It explained that the fact of the employer’s opt-out does not *cause* contraceptives coverage (i.e., by requiring another party to provide coverage in their stead), which instead is mandated by federal law.  It also determined that there is no substantial burden from complicity in the overall scheme to deliver contraceptive coverage, i.e., by delivering notice of objection, because their only involvement in the scheme is the act of opting out.  Thus, RFRA’s protections were not implicated, and the accommodation can stand.

I fully agree with the result in this case, but would have gotten there another way.

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Patent Law, Expertise, and the Court of Appeals for the Federal Circuit

by Zachary Shapiro

Since its creation in 1982, the Court of Appeals for the Federal Circuit (CAFC) has been a magnet for controversy and criticism. While I do not align myself with those critics, it would be foolish to not acknowledge the problems that are present with the CAFC. For instance, for the vast majority of federal law, when law develops differently in different circuits, the Supreme Court is able to observe those developments, and decide which interpretation is most desirable. Because the CAFC has sole jurisdiction over patent law appeals, patent law is not subject to these circuit splits. While splits temporarily hamper uniform justice, they do allow for experimentation, enabling different legal interpretations to be tested in real life. In this way, splits can allow an appellate body to make a more informed decision regarding which interpretation should be followed.

The lack of circuit splits in patent law can be problematic, given accusations that the CAFC has succumbed to a form of institutional capture by the patent lobby.[1] Critics highlight the CAFC’s decision in Amazon[2] and eBay[3] as evidence of this capture. In Amazon, the CAFC found a broad presumption of irreparable harm, allowing for broad extension of preliminary injunctions in future cases of patent infringement (even though they overturned the injunction at issue in the case). This patent-holder-friendly standard was ultimately overruled in eBay,[4] after the CAFC applied its nearly automatic injunction standard. The Supreme Court overturned this decision, and dialed back the presumption, in large part because it was seen as too favorable to patent holders.

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House Passes 21st Century Cures Act, Including a New NIH Innovation Prize Fund

This morning, the House of Representatives passed the 21st Century Cures Act by a vote of 344-77, achieving a truly bipartisan result in a difficult political environment.  (I’ve blogged about the Act several times now, and the House Energy & Commerce Committee has a clear section-by-section summary here.)  There is much to like in the bill (such as the increased NIH funding), much to be concerned about (such as some of the provisions abbreviating FDA review of drugs and devices), and much whose value will depend on implementation.  It’s also not certain that any of these provisions will ultimately become law – the Senate has yet to even introduce its own draft bill, let alone vote on it or achieve a consensus with the House.  But I wanted to use this post to draw attention to a new amendment to the Act that was introduced a few days ago and approved by the House this morning prior to the vote on the full bill.

Representatives Todd Young (R-IN) and Andy Harris (R-MD) introduced an amendment creating an Innovation Prize Program within the NIH.  As the text stood on Wednesday (speakers on the floor of the House today suggested that some of this language is likely to change, if it has not already changed), it instructed the Director of the NIH to create the fund in service of one or both of these two goals: 1) “Identifying and funding areas of biomedical science that could realize significant advancements through the creation of a prize competition” and 2) “Improving health outcomes, particularly with respect to human diseases and conditions for which public and private investment in research is disproportionately small relative to Federal Government expenditures on prevention and treatment activities, thereby reducing Federal expenditures on health programs.”  The Director is also given wide discretion to design prize competitions, including whether they involve a lump-sum award at the end or are parceled out in milestone payments along the way.

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New HHS Rules on Contraceptive Coverage

Today, HHS released new final regulations further clarifying the contraceptives coverage mandate.  I have not had the chance to fully digest these, but you can read them here.

Key nuggets, pulled straight from the text:

  • These final regulations continue to allow eligible organizations to choose between using EBSA Form 700 or the alternative process consistent with the Wheaton interim order. The alternative process provides that an eligible organization may notify HHS in writing of its religious objection to covering all or a subset of contraceptive services. The notice must include the name of the eligible organization and the basis on which it qualifies for an accommodation; its objection based on sincerely held religious beliefs to covering some or all contraceptive services, as applicable (including an identification of the subset of contraceptive services to which coverage the eligible organization objects, if applicable); the plan name and type (that is, whether it is a student health insurance plan within the meaning of 45 CFR 147.145(a) or a church plan within the meaning of ERISA section 3(33)); and the name and contact information for any of the plan’s third party administrators and health insurance issuers.
  • [T]hese final regulations extend the [existing] accommodation to a for-profit entity that is not publicly traded, is majority-owned by a relatively small number of individuals, and objects to providing contraceptive coverage based on its owners’ religious beliefs. This definition includes for-profit entities that are controlled and operated by individual owners who are likely to have associational ties, are personally identified with the entity, and can be regarded as conducting personal business affairs through the entity. . . . Based on the information available, it appears that the definition of closely held for-profit entity set forth in these final regulations includes all the for-profit corporations that have filed lawsuits alleging that the contraceptive coverage requirement, absent an accommodation, violates RFRA.

The upshot(s):

  • The extended accommodation allowing eligible objecting employers to notify the government rather than their insurer directly has simply been changed from an interim to a final rule.  This won’t make the pending non-profit litigation go away because these employers still object to two things: (1) having to provide their insurer’s contact information to the government so the government can notify the insurers of their obligations to provide free contraceptives; and (2) having to continue to maintain relationships with insurers who will provide contraceptives.
  • The extension of the accommodation’s eligibility criteria to include closely-held for-profit employers has now been made official following proposed regulation in the wake of Hobby Lobby. In the interim period after Hobby Lobby, objecting for-profits could simply object and avoid the mandate – and their insurers did not have to step in because the accommodation did not yet apply. Now it does, and these employers will likely raise similar objections to the accommodation as have already been raised by their non-profit counterparts.

Let’s just face it – litigation stemming from the ACA will never go away…

Worth Reading This Week

By Nicolas Terry

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

Check out the July 10th 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:
AGENDA NOW AVAILABLE!
Specimen Science: Ethics and Policy Implications

November 16, 2015
8:00 AM – 5:00 PM

Harvard Law School
Room TBD 

Many important advances in human health depend on the effective collection, storage, use, and sharing of biological specimens and their associated data. However, recent controversies involving specimen-based research have raised important questions about ownership, data-sharing, privacy considerations, group harms, and standards for responsible specimen stewardship.

Please join us for a symposium to discuss the key ethical and policy issues raised by genetics and other research involving human biological materials, covering the entire trajectory from specimen source to new discovery. The experts at this day-long event will cover key topics, such as historical, legal, and international perspectives; donor attitudes, researcher perspectives, and institutional considerations; broad vs. specific informed consent; privacy, ownership, and control; use of specimens collected through mandatory newborn screening; research with discrete and insular populations; and others. Conference papers eventually will be published as an edited volume with a major academic press.

For a full agenda and to register for this event, visit our website

This event is a collaboration between Case Western Reserve University, the Petrie-Flom Center at Harvard Law School, and the Multi-Regional Clinical Trials Center at Harvard. It is supported by funding from the National Human Genome Research Institute.

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

Medical Device Tax: Back in the News Post-King

By Gregory Curfman

Just when the Affordable Care Act (ACA) has won a second major Supreme Court victory in King v. Burwell, conservative critics of the ACA are back on the attack, this time directing their ire towards the medical device tax. Having lost the battle on subsidies, they are now focusing on the device tax as the prime target in their attempt to overturn parts of the ACA. This 2.3% excise tax levied on the medical device industry is stipulated as one of the tax provisions in the ACA. The rationale is that since the ACA provides coverage for many more people, thus bringing more business to the industry, it is reasonable to ask the industry to pay something back to support the programmatic mission of the ACA.

From the beginning, the medical device industry has strongly objected to the excise tax, claiming it will stifle innovation by taking away funds that would otherwise be used for new product research and development. For example, Dr. Thomas Stossel of Harvard Medical School, a conservative voice on health issues, recently wrote: “A 2.3 percent tax on sales can easily mean the difference between commercial success and bankruptcy: borderline profits become losses and investors flee to less risky ventures. Brute force taxes destabilize the fragile innovation ecosystem.” Continue reading

Onward And Upward For The ACA After King v. Burwell

Christie Hager, a speaker at the Petrie-Flom Center’s “King v. Burwell and the Future of the Affordable Care Act” conference on April 1 has a new piece up at the Health Affairs Blog discussing the Supreme Court’s decision. From the piece: 

Chief Justice Roberts, in the majority opinion in King v. Burwell, confirmed that the only insurance spiral now is one onward and upward for the millions of Americans who will benefit from the peace of mind and protections of the Affordable Care Act (ACA) as passed by Congress and signed by President Obama.

Among the many benefits of the ACA, Exchanges have been operating in some form to increase coverage in every state since 2013. Millions of lives have been changed or saved as a result. Many legal theorists and Supreme Court observers are rightly praising the sound legal reasoning and Constitutional principles in action that led to upholding key aspects of the Affordable Care Act (again).

It is a stark example of the relationship among the three branches created by the Constitution: Legislative drafting and passage, Executive implementation, and Judicial interpretation of language that in this case may have been less than clear. Additionally, the practical implications of the Court’s decision also are particularly salient. […]

Read the full piece here.

The Argument That Wasn’t

Guest Blogger Abigail R. Moncrieff of the Boston University School of Law and a speaker at the Petrie-Flom Center’s “King v. Burwell and the Future of the Affordable Care Act” conference on April 1 has a new piece up at the Health Affairs Blog discussing the Supreme Court’s decision. From the piece: 

Last Christmas, I spent a somewhat panicky inter-semester break writing an amicus brief for King v. Burwell. I was worried that five Supreme Court justices were going to be too tempted by the plaintiffs’ legalistic interpretation of Obamacare’s text, despite ample evidence beyond the text that Congressnever intended to deprive citizens in 34 states of health insurance subsidies.

In a seminar I taught at Boston University, one of my students had proposed a legalistic version of the common sense point that Congress could not possibly have intended the plaintiffs’ result—a legalistic argument that could be fatal to the plaintiffs’ case but that the government could not make—and I decided to spend my break writing and submitting it. […]

Read the full piece here.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of June. The selections feature topics ranging from the merits of the proposed 21st Century Cures Act and Trans-Pacific Partnership, to discrepancies between non-public FDA complete response letters and sponsor press releases, to the status of pediatric post-approval safety systems in North America. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Avorn J. In Opposition to Liberty: We Need a “Sovereign” to Govern Drug Claims. Ann Intern Med. 2015 June 30. [Epub ahead of print]
  2. Avorn J and Kesselheim AS. The 21st Century Cures Act – Will It Take Us Back in Time? New Engl J Med. 2015 June 25;372(26):2473-2475.
  3. Doshi P. FDA drug summaries: a simplification too far? 2015 June 12; 350:h3135.
  4. Kapczynski, A. (2015). The Trans-Pacific Partnership – Is It Bad for Your Health? N Engl J Med.2015 June 10. [Epub ahead of print]
  5. Lanini S, Zumla A, Ioannidis JPA, et al. Are adaptive randomised trials or non-randomised studies the best way to address the Ebola outbreak in west Africa? The Lancet Infectious Diseases. 2015 June;15(6):738-745.
  6. Lurie P, Chahal HS, Sigelman DW, Stacy S, Sclar J, Ddamulira B.Comparison of content of FDA letters not approving applications for new drugs and associated public announcement from sponsors: cross sectional study.  2015 June 10;350:h2758.
  7. McMahon AW, Wharton GT, Bonnel R, et al. Pediatric post-marketing safety systems in North America: assessment of the current status. Pharmacoepidemiol Drug Saf. 2015 June 22. [Epub ahead of print]
  8. Ruger JP, Ruger TW, Annas GJ. The Elusive Right to Health Care under U.S. Law. New Engl J Med. 2015 June 25;372(26):2558-2563.

 

Bioethicist Art Caplan: Why Jim Carrey is Wrong About Vaccines

A new opinion piece by contributor Art Caplan on NBC News:

California has decided one large epidemic scare is enough. After the frightening outbreak of measles that started at Disneyland and sickened 147 people, Californians rejected the irrationality of anti-vaccine zealots and decided to restrict parents’ ability to exempt their children from school vaccinations.

The new law signed by Governor Jerry Brown throws out religious and philosophical reasons to exempt. Only health concerns will be permitted and those must be verified by a physician. If you simply don’t want to vaccinate your kids, you will have to home school.

The new law is all to the good. No major religions have heartburn over vaccination. Most see it as an obligation in order to help the community. And philosophical exemptions were nothing but an open door for those who are ill-informed, addicted to misinformation on the internet or just plain selfish. […]

Read the full article here.

‘The Week in Health Law’ Podcast

By Nicolas Terry

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This week we discussed the law of genetic privacy (and health data in general) with Ifeoma Ajunwa, a law professor at UDC and researcher with Microsoft Research. GINA was big news last month as a “landmark case” resulted in a verdict of “$2.25 million to two men whose employer tested their DNA.” Ajunwa’s original, compelling work on GINA includes this article on genetics & civil rights.

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 RadioTunein 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

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.

King v. Burwell And The Importance Of State Politics

David K. Jones of the Boston University School of Public Health and a speaker at the Petrie-Flom Center’s “King v. Burwell and the Future of the Affordable Care Act” conference on April 1, has a new piece up at the Health Affairs Blog discussing the Supreme Court’s decision. From the piece: 

The Supreme Court’s decision in King v. Burwell brings an important chapter of the Affordable Care Act’s (ACA) implementation to a close. The fight about health reform is not over, with Republican presidential candidates promising to repeal the law while supporters of the law push for Medicaid expansion and the development of Accountable Care Organizations.

But it is important to pause and reflect on what we have learned the last five years. This is uncharted territory for supporters of comprehensive health reform who for so many decades studied why legislation was so difficult to enact rather than how complicated it is to implement. […]

Read the full piece 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.

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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.