Obama Administration to Revise Contraceptives Coverage Accommodation

In response to the SCOTUS decision granting Wheaton College a preliminary injunction against having to comply with the terms of the HHS accommodation available to non-profit religious organizations who object to covering contraceptives for their employees (i.e., submitting a form to their insurance providers), the Obama Administration has announced that it will revise the terms of that accommodation. Instead of requiring objecting employers to provide the form and notice to insurers or third party administrators of self-insured health plans so that they can jump in to provide free coverage directly to employees, HHS will issue new regulations in short order, the details of which remain to be worked out, but will likely allow nonprofit institutions to write a letter stating their objections, rather than filling out the form (see the WSJ story here). This will leave the government to make sure employees are not left without contraceptives coverage.

I may be oversimplifying things, but I think this extended accommodation really isn’t such a big deal.  It seems to just add the government in as a middleman between the objecting employer and the insurer or third party administrator that was responsible for providing coverage under the original accommodation.  In other words, before, nonprofit religious employers with an objection had to fill out the form and give it directly to their insurers; after the modification, those employers could just let the government know, and presumably the government will notify their insurers.  A bit more bureaucracy, but shouldn’t be too big of a problem – probably just a drop in the bucket of the massive ACA bureaucracy, and potentially unnoticeable by the women seeking free contraceptives.  That is unless the employers claim that even this approach leaves them complicit in violation of their religious beliefs.

Since SCOTUS’s substantial burden test as applied in Hobby Lobby focused on the hefty fines for noncompliance, rather than the extent to which the employers’ religious beliefs were directly v. indirectly burdened, the complicity point is an important one to keep an eye on.  Will religious employers be satisfied with simply adding another link to the causal chain?  Perhaps (and I hope).  Technically, all they would be asked to do is announce to the world that they have a religious objection.  What the government does with that information is beyond their control.  If this works out, the revised accommodation could also be extended to the closely held for-profit corporations with religious objections to contraceptives coverage that SCOTUS determined could not be forced to comply with the mandate, such that their employees too could retain access.

So let’s see what HHS can come up with.  Haters gonna hate, as they say, so I’m sure there will be more litigation on this, but hopefully we’re nearing a solution – and I think a good compromise.  The bigger issue will be dealing with all those other services that must be included as essential benefits or preventive services to which religious employers may object, and to which insurers are likely to object to providing free coverage.  But let’s see if the ACA lives to die another day after Halbig and King.

Petrie-Flom Center Launches New Book on Human Subjects Research Regulation

Human Subjects Research Regulations Book CoverThe Petrie-Flom Center is pleased to announce publication of Human Subjects Research Regulation: Perspectives on the Future (MIT Press 2014), co-edited by Petrie-Flom Center Faculty Director, I. Glenn Cohen, and Executive Director, Holly Fernandez Lynch.  This edited volume stems from the Center’s 2012 annual conference, which brought together leading experts in a conversation about whether and how the current system of human subjects research regulation in the U.S. ought to change to fit evolving trends, fill substantial gaps, and respond to identified shortcomings.

The book is currently available from MIT Press and Amazon, in hardcover and paperback.  We will be hosting a book discussion at Harvard Law School on October 22, and in Baltimore on December 5 at Public Responsibility in Medicine and Research (PRIMR)’s annual Advancing Ethical Research Conference.  Details will be announced shortly.

 From the book jacket:

 The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the Tuskegee syphilis study, conducted by U.S. government researchers from 1932 to 1972. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, as this book documents, it has significant flaws—including its potential to burden important research, overprotect some subjects and inadequately protect others, generate inconsistent results, and lag behind developments in how research is conducted. Invigorated by the U.S. government’s first steps toward change in over twenty years, Human Subjects Research Regulation brings together the leading thinkers in this field from ethics, law, medicine, and public policy to discuss how to make the system better. The result is a collection of novel ideas—some incremental, some radical—for the future of research oversight and human subject protection.

After reviewing the history of U.S. research regulations, the contributors consider such topics as risk-based regulation; research involving vulnerable populations (including military personnel, children, and prisoners); the relationships among subjects, investigators, sponsors, and institutional review boards; privacy, especially regarding biospecimens and tissue banking; and the possibility of fundamental paradigm shifts.

Contributors
 Adam Braddock, Alexander Morgan Capron, Ellen Wright Clayton, I. Glenn Cohen, Susan Cox, Amy L. Davis, Hilary Eckert, Barbara J. Evans, Nir Eyal, Heidi Li Feldman, Benjamin Fombonne, Elisa A. Hurley, Ana S. Iltis, Gail H. Javitt, Greg Koski, Nicole Lockhart, Holly Fernandez Lynch, Michael McDonald, Michelle N. Meyer, Osagie K. Obasogie, Efthimios Parasidis, Govind Persad, Rosamond Rhodes, Suzanne M. Rivera, Zachary M. Schrag, Seema K. Shah, Jeffrey Skopek, Laura Stark, Patrick Taylor, Anne Townsend, Carol Weil, Brett A. Williams, Leslie E. Wolf

For a more information, including the full table of contents, check out the book on the MIT Press website

In the Aftermath of Hobby Lobby

By Gregory Curfman and Holly Fernandez Lynch

[A quick follow up to our recent NEJM Perspective on the case, with I. Glenn Cohen]

Immediately after Justice Samuel Alito’s announcement on June 30 of the majority opinion in Burwell v. Hobby Lobby, the Supreme Court took further actions on the contraceptive mandate, and both supporters and opponents of the opinion were furiously assessing the implications and impact of what has proved to be a wild week for women’s access to contraception.

A report from the IMS Institute last April found that 24 million more prescriptions for oral contraceptives without a copayment were written in 2013 (when the contraceptive mandate was in full effect) than in 2012 (when it was not). This translates into a savings of $483 million for women (on average $269 per person). The percentage of women with no out-of-pocket costs for contraceptives increased from 14% to 56%. What will be the impact of the Supreme Court’s decision in Hobby Lobby on these trends?

The Hobby Lobby opinion is quite clear that the contraceptive mandate, spawned by the Affordable Care Act, may not be enforced against closely held, for-profit companies with religious objections to paying for contraceptives coverage. In other words, such companies will not face the hefty fines for noncompliance that would otherwise be imposed by the Department of Health and Human Services.

Nonprofit Organizations

The opinion does not, however, apply to religious-affiliated, nonprofit organizations, such as Catholic schools or religious charities. For such organizations that object to paying for contraceptives coverage, the applicable regulation provided an accommodation by which the entities themselves were off the hook, but instead their insurers (or in the case of self-insured organizations, a third party administrator) would be required to provide free contraceptives coverage without cost to either the employee or the employer.  In order to be eligible for this accommodation, the nonprofit entity must complete a form designating its objection and provide a copy to its health insurance issuer or a third party administrator. A number of nonprofits filed lawsuits asking that they be exempt from even this requirement, on the grounds that they were still being required to violate their religious beliefs by deputizing someone else to provide the objectionable services. One such group, the Little Sisters of the Poor in Colorado, a group of nuns who perform charity work, was granted an injunction by the Supreme Court last January.

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Religious Freedom and Access to Health Care

SCOTUSfront

By I. Glenn Cohen, Holly Fernandez Lynch, and Gregory Curfman

Check out the “hot off the press” New England Journal of Medicine Perspectives piece “When Religious Freedom Clashes with Access to Care” by Petrie-Flom Faculty Director I. Glenn Cohen, Executive Director Holly Fernandez Lynch, and NEJM Executive Editor (and PFC Faculty Affiliate), Gregory Curfman.  We review the legal background for SCOTUS’ Hobby Lobby decision, summarize the majority and dissenting opinions, and clarify some key implications of the case, including further problematization of the employer-based health insurance system, reduced likelihood of future attempts to offer religious exemptions to health care mandates, and expanded religious challenges in the health care space.  We close by noting that although the public’s ire and praise has been directed at the Justices, they were applying Congress’ statute – and Congress could (but is very unlikely to) amend the Religious Freedom Restoration Act to be less stringent, or otherwise intervene to ensure that women have affordable access to contraceptive services regardless of their employer’s beliefs.

Take a look and let us know what you think!

Vaccines and Spying

The NY Times is reporting that the CIA has banned its “operational use” of vaccination programs, which came to light in the context of the hunt for Osama bin Laden. As if it weren’t already hard enough to launch successful vaccination campaigns (domestically and globally), this vaccination+spying taint has surely added further obstacles. And while it’s great to have an affirmative statement that the program has been stopped, significant damage has already been done – trust has already been lost, and it will be incredibly difficult to get skeptical populations back on board. Unfortunately, a statement from the spy promising not to spy anymore isn’t likely to do much. We’ve seen lasting impact of the Wakefield paper linking vaccines to autism, despite its retraction and extensive repudiation – the long term global impact of the CIA’s program could be even worse, with refusal to participate in vaccination programs compounded by violence against public health workers accused of covert activity. Put this alongside physician involvement in executions under the heading: “Ways Not to Mix Medical and Non-Medical Objectives.”

TOMORROW: Hot Topics at Presidential Commission on Bioethics

Hot Topics at the Presidential Commission for the Study of Bioethical Issues: Plus Q&A on Careers in Law and Bioethics!

Friday, April 11, 2014, 12:00pm

Pound Hall 100, Harvard Law School, 1563 Massachusetts Ave.

Please join us for an update from the Presidential Commission for the Study of Bioethical Issues, delivered by Michelle Groman (HLS ’05), Associate Director at the Bioethics Commission.  Since its inception in 2009, President Obama’s Commission has issued reports on synthetic biology, human subjects research, whole genome sequencing, pediatric medical countermeasure research, and incidental findings. Currently, the Commission is examining the ethical implications of neuroscience research and the application of neuroscience research findings as part of the federal government’s BRAIN Initiative.  The Commission also has developed educational materials to support teaching of bioethics ideas, principles, and theories in traditional and non-traditional settings.

This final half-hour of this event will feature a discussion of career opportunities in law and bioethics, led by Ms. Groman and Holly Fernandez Lynch, Petrie-Flom Center Executive Director.  Bring your questions!

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

For questions, contact petrie-flom@law.harvard.edu, or 617-496-4662.

Cosponsored by the Office of Career Services at Harvard Law School. This event is supported by the Oswald DeN. Cammann Fund.

RESCHEDULED: 4/11, Hot Topics at Presidential Commission on Bioethics

Hot Topics at the Presidential Commission for the Study of Bioethical Issues: Plus Q&A on Careers in Law and Bioethics!

Friday, April 11, 2014, 12:00pm

Pound Hall 100, Harvard Law School, 1563 Massachusetts Ave.

Please join us for an update from the Presidential Commission for the Study of Bioethical Issues, delivered by Michelle Groman (HLS ’05), Associate Director at the Bioethics Commission.  Since its inception in 2009, President Obama’s Commission has issued reports on synthetic biology, human subjects research, whole genome sequencing, pediatric medical countermeasure research, and incidental findings. Currently, the Commission is examining the ethical implications of neuroscience research and the application of neuroscience research findings as part of the federal government’s BRAIN Initiative.  The Commission also has developed educational materials to support teaching of bioethics ideas, principles, and theories in traditional and non-traditional settings.

This final half-hour of this event will feature a discussion of career opportunities in law and bioethics, led by Ms. Groman and Holly Fernandez Lynch, Petrie-Flom Center Executive Director.  Bring your questions!

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

For questions, contact petrie-flom@law.harvard.edu, or 617-496-4662.

Cosponsored by the Office of Career Services at Harvard Law School. This event is supported by the Oswald DeN. Cammann Fund.

CANCELED: 3/3 Panel on Presidential Commission for Study of Bioethical Issues

UPDATE, 3/1: DUE TO THE STORM THAT IS CURRENTLY AFFECTING THE EAST COAST, OUR SPEAKER MICHELLE GROMAN HAS HAD TO CANCEL HER TRAVEL FOR MONDAY, 3/3. THE EVENT WILL BE RESCHEDULED FOR LATER IN THE SPRING.

CANCELED: Hot Topics at the Presidential Commission for the Study of Bioethical Issues: Plus Q&A on Careers in Law and Bioethics!

TO BE RESCHEDULED

Austin Hall West (111), Harvard Law School

Please join us for an update from the Presidential Commission for the Study of Bioethical Issues, delivered by Michelle Groman (HLS ’05), Associate Director at the Bioethics Commission.  Since its inception in 2009, President Obama’s Commission has issued reports on synthetic biology, human subjects research, whole genome sequencing, pediatric medical countermeasure research, and incidental findings. Currently, the Commission is examining the ethical implications of neuroscience research and the application of neuroscience research findings as part of the federal government’s BRAIN Initiative.  The Commission also has developed educational materials to support teaching of bioethics ideas, principles, and theories in traditional and non-traditional settings.

This final half-hour of this event will feature a discussion of career opportunities in law and bioethics, led by Ms. Groman and Holly Fernandez Lynch, Petrie-Flom Center Executive Director.  Bring your questions!

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

For questions, contact petrie-flom@law.harvard.edu, or 617-496-4662.

Cosponsored by the Office of Career Services at Harvard Law School. This event is supported by the Oswald DeN. Cammann Fund.

A solution to the contraceptives coverage mess?

While prepping for a guest lecture on the contraceptives coverage mandate currently before SCOTUS, I had the opportunity today to review the merits briefs filed in the Hobby Lobby case.  I think both petitioners and respondents put out their absolute strongest arguments, as one would expect at this highest level of review.  The government asserts a fairly convincing case that for-profit corporations were not meant to be covered by the Religious Freedom Restoration Act (RFRA) and that individual shareholders are not burdened by the mandate, and the respondents convincingly argue that RFRA does indeed apply and the numerous exemptions already offered by the government have eviscerated any claim that refusing religious exemptions to for-profit corporations is necessary to achieve a compelling government interest.

The respondents, Hobby Lobby and its family owners, articulate a variety of less restrictive alternative methods to achieve the government’s interest in promoting public health and gender equality, including having the government provide free access to contraceptives rather than demanding that employers do so. Interestingly, however, the respondents do not suggest simply extending the existing accommodation available to religious non-profits to for-profit corporations with religious objections.  This accommodation allows a religious non-profit that objects to contraceptives to sidestep the mandate, instead requiring that its insurance company exclude contraceptives from the employer’s plan and itself bear responsibility to provide preventive services without cost-sharing.   The rationale is that it should be at least cost-neutral for insurance companies to provide this coverage, on the grounds that preventing pregnancy is cheaper than covering new dependents.  (And for self-insured plans, there is a similar approach by which third party administrators bear the burden, and are compensated via adjustments to Exchange user fees.)

I can’t be certain why the respondents omitted this obvious alternative, but one possibility has to do with the fact that the accommodation is currently being challenged (e.g., by the Little Sisters of the Poor) as insufficient because objecting employers argue that they are still being required to facilitate access to objectionable services, even if they do not have to pay for them.

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