Authors

Holly Fernandez Lynch, JD, MBE, is the John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics in the Department of Medical Ethics and Health Policy at Penn’s Perelman School of Medicine. She is also the Assistant Faculty Director of Online Education, helping to lead the university’s first online master’s degree, the Master of Health Care Innovation, and other online offerings.

I Concur with the Dissent (or, More on Little Sisters)

Holly Fernandez Lynch 1 Comment

On September 3, the 10th Circuit declined to rehear en banc several challenges to the contraceptives coverage mandate filed by non-profit organizations, including Little Sisters of the Poor. As SCOTUSBlog explains, these organizations had not themselves asked for en banc review, having already moved on to SCOTUS, but the judges have the option of calling for a vote themselves, which one or more of them must have done.  The vote came down 7-5 in favor of refusal, with the dissenting judges (i.e., those who wanted en banc review) issuing an explanation of their position.  On this issue, I concur with the dissent.  But I still don’t think the objecting non-profits should be off the hook.

When it comes to the contraceptives coverage mandate, non-profits, and now certain for-profits, are accommodated such that they may be relieved of the responsibility to contract, arrange, pay, or refer for contraceptives coverage if they notify the government or their health insurer of their objection to doing so, such that their insurer (or third party administrator of self-insured plans) can provide free contraceptives to their employees, at no cost to and without the involvement of the employer (all further explained here by Greg Lipper).  However, many organizations continue to argue that the accommodation fails to relieve them of complicity in providing contraceptives against their religious beliefs.  They want flat out exemption from the mandate. Read More

Pinker on the “moral imperative” for bioethics

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In his stunning Op-Ed in today’s Boston Globe, Steven Pinker seems to suggest that bioethicists come in only one flavor: conservative. I certainly don’t fit that bill. But there’s a lot I think he gets right in this critically important piece. Why not change the default rules: what if new scientific advances were welcome, unless we had strong reason to worry, rather than the other way around?

Take a look, this is really important.

Update, 8/6/15: Many people have voiced strong objections to Pinker’s piece, taking his admonition that “the primary moral goal for today’s bioethics” should be to “[g]et out of the way” as squarely directed at IRBs.  His statement was definitely overbroad, but I didn’t take him to mean that we don’t need IRBs or human subjects protection at all.  In fact, he explicitly acknowledges that “individuals must be protected from identifiable harms” and recognizes the importance of existing safeguards for subject safety and informed consent. Instead, I read his piece not just with human subjects research in mind, but all of science. At the most basic level, I think he is making a very reasonable call for us to be aware of the risks of overprotection, of trying to imagine everything that could ever go wrong, with blinders on to the consequences of what will happen if we sit still, worrying for too long.

Some other reactions from around the web:

https://alicedreger.com/node/210

https://www.bostonglobe.com/opinion/letters/2015/08/05/pace-research-should-not-barrel-ahead-ethical-safeguards/vwA1TOaKvxRicYh8o3253O/story.html

Another Opinion Upholding the Contraceptives Coverage Accommodation

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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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New HHS Rules on Contraceptive Coverage

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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…

Health Law Year in P/Review: Until Next Year

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

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.

A Mixed Message on Obamacare from Two Federal Circuits

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By Greg Curfman and Holly Fernandez Lynch

It was as if lightning had struck twice in the same place.

On Tuesday two pivotal federal circuit court opinions that could dramatically impact the future of Obamacare were unexpectedly issued within hours of each other. And what’s more, the two opinions reached opposite conclusions on the same question, setting the stage for further appeals and possible Supreme Court review, potentially bringing the Affordable Care Act (ACA) before the high court for the third time since its passage.

At issue in both circuit court cases was the legality of providing subsidies in the form of Internal Revenue Service tax credits for the purchase of health insurance on the federal exchange (Healthcare.gov).

In a decision that stunned Obamacare supporters–but elated opponents–a three-judge panel of the Federal Appeals Court for the DC Circuit ruled in Halbig v. Burwell that the purchase of health insurance on the federal exchange may not be subsidized by IRS tax exemptions. This judgment would leave millions of Americans with earnings between 133% and 400% of the federal poverty level without affordable health insurance, and it would also threaten the viability of the employer mandate.

In contrast, in a unanimous (3-0) opinion in a nearly identical case, King v. Burwell, the Federal Appeals Court for the Fourth Circuit in Richmond, VA, came to the opposite conclusion.

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Obama Administration to Revise Contraceptives Coverage Accommodation

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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.

Vaccines and Spying

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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.”

#BELHP2014 Plenary 3, Michael Hallsworth, UK Behavioral Insights Team

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[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: “Behavioral Economics, Law, and Health Policy.”  This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

Today’s lunchtime plenary, Applying Behavioural Insights in Theory and in Practice, was presented by Michael Hallsworth, Principal Advisor, The Behavioural Insights Team (BIT)

Michael described the BIT as a “social purpose” company, originally founded within the UK government, but separated from it (in part) in February 2014.  The company is now partly owned by government, partly owned by its employees, and partly owned by the innovation charity, Nesta.  Michael indicated that when the Team was started, there was genuine doubt about whether behavioral interventions could make a difference or whether this was just a trendy new fad.  The Team responded by implementing rigorous methods of testing, measuring, and evaluating its proposals.

What does the BIT do?  Michael explained that its goal is to incorporate empirical findings about behavior into policy making. Although it has been colloquially referred to as the “Nudge Unit” and Richard Thaler does indeed advise them, the BIT is not actually a nudge unit.  Its first question is not how to nudge but rather how to solve policy problems.  It is a fact that policy tends (and is intended to) influence behavior.  Behavioral insights can allow governments and other policymakers to enhance and assess policy options, and offer new ones.  Put another way, Michael explained that there is not a distinction between policy-making and influencing behavior, they are one and the same.

Michael also argued that we should use behavioral insights as a lens through which to see all government action.  Moreover, whenever the government has decided to act, it should do so in way that it is actually most effective; there is a moral duty to maximize effectiveness and to spend limited government resources wisely.

Michael then went on to describe seven different ways of applying behavioral analysis to show that the best option is to:

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#BELHP2014 Panel 5, Behavioral Economics and the Doctor-Patient Relationship

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[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: “Behavioral Economics, Law, and Health Policy.”  This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

This session was kicked off by Jennifer Zamzow, Post-Doctoral Fellow, Center for Ethics and Policy, Carnegie Mellon University, with a talk called “Affective Forecasting in Medical Decision-Making: What Do Physicians Owe Their Patients?”  Jennifer began with an example of a recently paralyzed patient requesting termination of life-sustaining care on the grounds that his injury feels like a fate worse than death.  On the one hand, we feel compelled to respect the decisions of competent patients, but on the other hand, given what we know about errors in affective forecasting, we anticipate that the patient would be able to eventually adapt to his new circumstances and lead a happy, full life.  The question, then, is whether physicians have any obligation to help their patients make more accurate affective forecasts.

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