Public Briefing on Contraceptives Coverage Mandate from KFF

For those of you following the contraceptives coverage mandate litigation:

Later this month, the Supreme Court will hear two cases from for-profit corporations, Hobby Lobby Stores and Conestoga Wood Specialties, challenging the Affordable Care Act’s (ACA) requirement to cover contraceptives on religious grounds. On Tuesday, March 11, two weeks before the hearings, the Kaiser Family Foundation will host a public briefing and panel discussion from 9:30am-11:00am ET in its Washington, DC office to discuss the implications of these court cases on the ACA, corporate and individual religious protections, and civil rights. For those unable to attend, a live webcast will be hosted on

Speakers include:

Welcome and Introduction Alina Salganicoff, Ph.D. (Moderator),Vice President and Director, Women’s Health Policy, Kaiser Family Foundation

An Overview of the Contraceptive Coverage Requirement and Legal Challenges Laurie Sobel, J.D., Senior Policy Analyst, Women’s Health Policy, Kaiser Family Foundation

The Religious Freedom Restoration Act and its Application to These Cases Marci A. Hamilton, J.D., Paul R. Verkuil Chair in Public Law at the Benjamin N. Cardozo School of Law, Yeshiva University

Possible Rulings and Outcomes Tom Goldstein, J.D., Publisher SCOTUSblog, Partner Goldstein & Russell, P.C.

Panel Discussion on Implications

Tuesday, March 11, 9:30am-11:00am ET, (Registration and breakfast beginning at 9:00am)

Where: Barbara Jordan Conference Center, Kaiser Family Foundation Offices, 1330 G Street, NW, Washington, D.C., (one block west of Metro Center)

RSVP: Please register online to attend this event in person.

Live Webcast: A live webcast will be available on

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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Peter Singer on BatKid

This is worth a read, and, in my opinion, absolutely right.  The discussion is relevant to broader questions of identified v. statistical lives, as well as “choice architecture” questions about how charities ought to seek out donations.  Take a look:

Heartwarming causes are nice, but let’s give to charity with our heads

Full disclosure: Several years ago my family took advantage of a Make-A-Wish trip resulting from my younger brother’s leukemia.  He is now a thriving adult and doing great, and the experience was incredible, especially for those families with children facing terminal diagnoses.  But the fact remains that this really has to be seen as a “luxury” charity – and when faced with a stark side-by-side choice of where the dollars could be spent, Peter’s analysis nails it.

A new framework for considering the contraceptives mandate cases?

Just a quick pointer to an interesting new article out by Kara Loewentheil at Yale, When Free Exercise Is a Burden: Protecting ‘Third Parties’ in Religious Accommodation Law.  

Here’s her abstract (posted a few weeks ago before cert was granted):

As of November 2013, over 60 lawsuits have been filed under the First Amendment and the Religious Freedom Restoration Act (“RFRA”), challenging the contraceptive coverage requirement (“CCR”) of The Patient Protection and Affordable Care Act, more than half brought by for-profit employers with religious objections to providing insurance coverage for contraception. The conflict combines questions of the reach of the regulatory state, the nature and purpose of free exercise rights, women’s social and economic equality, and a lightning-rod political debate. No wonder then that these cases have produced a circuit split, and are now primed for a Supreme Court ruling, as two cert petitions in these cases were filed in September 2013. It is no surprise that these cases have produced such divergent results, because the problem lies not with the courts, but with the doctrine, which frames the conflict as being between the State and the religious objector. But as the CCR cases make clear, this relationship is often beside the point entirely. Rather, some religious accommodation cases regulate not only the relationship between the State and the objector, but a variety of conflicts and relationships between the religious objectors and various other rights-holders. The courts and the scholarship have occasionally noticed that such conflicts may exist but have not suggested any systematic way of thinking about or resolving them. To remedy this lacuna, I propose a framework for identifying and analyzing these under-theorized conflicts, elaborating on strands of concern for third parties in the doctrine that have never been fully fleshed out. I argue that once we identify the set of cases in which there are sufficiently weighty third-party interests at stake – whether practical or expressive – to merit deviation from the standard doctrinal framework, the question should be whether the State can provide a solution that respects all the rights in question. If so, it should have an obligation to do so. If not, the group with equality-implicating rights (again, whether practical or expressive) should “win” – with any “tie” going to the third parties, because the purpose of religious accommodation law is to protect the equality of religious objectors, not to privilege religion. The CCR suits present a paradigmatic example in which the State’s most important interest lies in its representation of the rights of third parties, and in which comprehensive solutions respecting all parties’ rights are possible but not doctrinally required, thus providing a clear illustration of why the framework I suggest would be an improvement in religious accommodation law. Nevertheless, there are also ways to better balance the interests involved through use of the existing doctrine, as the last part of this paper demonstrates.

SCOTUS and the Contraceptives Coverage Mandate

As everyone and their brother expected, SCOTUS has just decided to take up two cases challenging the contraceptives coverage mandate: Hobby Lobby, in which the 10th Circuit ruled in favor of the religiously-objecting (but secular, for-profit) employer, and Conestoga, in which the 3rd Circuit went the other direction, maintaining that “for-profit, secular corporations cannot engage in religious exercise.”

I think the First Amendment piece of this is pretty much open-and-shut: the requirement that employers offer health plans that provide contraceptives coverage free of charge is pretty clearly neutral and generally applicable.  Arguments around the Religious Freedom Restoration Act are much more interesting.  For our non-lawyer readers, the basic idea behind RFRA is that the federal government may not (1) substantially burden the right to free exercise of religion, unless it does so (a) in furtherance of a compelling interest, and (2) using the least restrictive means.  This is a high hurdle, otherwise known as strict scrutiny.

You can see several clear decision points under the RFRA analysis, and pretty much any one of them could go either way:

Do for-profit corporations have a right to free exercise?

As a threshold matter, RFRA offers protection only to those entities with free exercise rights.  Citizens United tells us that “corporations are people, my friend.”  So if that analysis applies to both the First Amendment’s free speech rights and free exercise rights, then corporations can at least pass go.  On the other hand, some courts have maintained that religion can only be exercised by individuals or religious organizations, such that RFRA would not apply to secular, for-profit corporations.

Does the contraceptives mandate impose a substantial burden? 

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Fertility and Divorce

In case you missed it, NYT had an interesting Op-Ed on Friday that addressed the inclusion of money for fertility treatments in divorce settlements – and made some suggestions about how to address fertility issues in prenups. Take a look here.

As prices drop, I wonder if/when it will become commonplace for women to start banking some “just in case” eggs in their early twenties as a matter of course. Some eager-to-be grandparents have already started the trend.

More Commentary on Why Patients May Be Discriminated Against

Given my recent piece in the New England Journal on discrimination against patients, particularly obese patients in the context of the Americans with Disabilities Act, I found this NY Times story particularly interesting: Disability and Discrimination at the Doctor’s Office. The Times story focuses on patients who are disabled in more traditional ways, but indicates that the main culprit behind the medical discrimination they may experience is not animus, but rather lack of proper equipment, which can be quite expensive.  Luckily, there may be hope on the horizon, thanks to the ACA.

Tough Advice to Swallow from the NYT Ethicist

Take a look at the answer this physician received about breaking his promise of confidentiality to a patient.  The New York Times’ Ethicist describes this as a modern problem, but it seems to me this is age-old.  And although the confession was not medical, the nature of the doctor-patient relationship and the historical trust it has cultivated can’t be ignored.  The Ethicist says he expects vehement disagreement, and that’s one thing he’s right about for sure.

Live Blogging FDA in the 21st Century Conference, Panel 9 – Addressing the Challenges of and Harnessing New Technologies

Last but not least!  Our final conference panel focused on “Addressing the Challenges of and Harnessing New Technologies,” and was moderated by Fran Miller.

We heard first from Margaret Riley on “Twenty-First Century Technology with Twentieth Century Baggage: FDA Regulation of Regenerative Medicine.”  Riley explained that regenerative medicine (i.e., the use of pluripotent stem cells) has the potential to cure disease, injury, and even remedy organ shortages.  Of course, it is a hugely political issue and the debate is emotional, value-laden, and not necessarily logical.  As a result, the legislation/regulation that results in this area may be far from ideal.

Focusing on FDA specifically, Riley explained that the agency’s approach to stem cell regulation is rooted in its regulation of gene therapy and tissue products, as initiated in the 1990s.  FDA’s regulation of autologous stem cell therapies – in which a person’s own cells are removed, manipulated, and reintroduced – as a drug was recently upheld by the District Court of DC (US v. Regenerative Sciences, 878 F. Supp. 2d 248 (DDC 2012)), but is now on appeal to the DC Circuit. Riley is not sure what the outcome will be on appeal, but noted that getting BLA’s approved on a doctor-by-doctor basis will be very difficult and likely impossible.  One possible outcome of FDA regulation is likely to be off-shoring and stem cell tourism; ironically, strict regulation may end up not protecting patients, who will end up going abroad.

Next up was Nathan Cortez, who asked “Is the FDA Equipped to Regulate Mobile Health Devices?”

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Live Blogging from FDA in the 21st Century Conference, Panel 4: Timing Is Everything

Another great conference session this afternoon: “Timing Is Everything: Balancing Access and Uncertainty.”  This one was moderated by Jeff Skopek, with presentations by Shannon Gibson, Trudo Lemmens, and Efthimios Parasidis.

First, we heard from Gibson and Lemmens on “Overcoming ‘Premarket Syndrome,’” AKA the various problems associated with relying solely on premarket data for safety and efficacy determinations.  These problems include the fact that industry studies have been shown to be more likely to be biased in favor of demonstrating a positive result, and premarket studies also cannot really demonstrate how a product will be used in clinical practice.  Moreover, for niche market drugs (e.g., those for orphan indications or pharmacogenomics), which are becoming more and more popular, there are fewer patients available to serve as clinical trial subjects, thereby inherently limiting the data that may be generated prior to approval and increasing uncertainty around safety and effectiveness.

So what should we do? Develop an improved post-market research agenda, say Gibson and Lemmens, and explore “adaptive licensing,” by which they mean rendering regulatory decisions based on the entire body of evidence collected throughout a product’s life cycle.   They argue that drug access decisions should not be binary, but instead, should be incremental and continually reassessed based on new data, including data that becomes available after a drug has been initially made available to patients. They closed by pointing out the importance of data transparency at all points in drug regulation.

Next, we heard from Efthimios Parasidis on “Innovative Regulating as a Public Health Imperative.”  Parasidis focused on the ways in which FDA can leverage its existing post-market regulatory authorities granted under the Food and Drug Administration Amendments Act of 2007, including requiring post-market studies and imposing Risk Evaluation and Mitigation Strategy requirements (REMS).

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Live Blogging from FDA in the 21st Century Conference – Peter Barton Hutt’s Plenary

We’re well on our way into the Petrie-Flom Center’s Annual Conference, FDA in the 21st Century, and we’ll be live blogging the sessions today and tomorrow here at Bill of Health.

Today’s sessions opened with a fantastic plenary from Peter Barton Hutt, who’s had more than five decades of experience with Food and Drug Law, including 4 years as Chief Counsel to the FDA.

Peter addressed a wide variety of topics in his talk on “Historical Themes and Developments Over the Past 50 Years.”

1.    FDA Management

Peter discussed various management approaches utilized by different FDA commissioners over the years, from Commissioner Edwards in the 1970s who ran the agency like a management consultant, meeting with every Center every week, to Commissioner McClellan who viewed his post through the lens of an economist.  Different management styles have been needed as the agency has grown tremendously, from 6,500 employees in 1976 to a $4 billion appropriation and more than 12,000 employees today.  As a result of that growth, the Commissioner and Center directors necessarily know less and less about what the organization is doing.  This creates tremendous possibilities for inconsistencies, mistakes, and loss of control, and ultimately, policy is now made from the bottom-up.

2.    Rulemaking

Peter described the fundamental shift in FDA’s approach to rulemaking over its history.  Before 1970, the agency relied heavily on a combination of guidance and litigation, primarily as a result of the fact that the four general counsels in that role from 1906 to 1971 were all litigators, and viewed lawsuits as the appropriate way to develop government policy.  It became clear in the 1970s that this approach couldn’t work for everything, and as a result, the agency reinterpreted an obscure provision of the Act allowing it to issue regulations for “efficient enforcement” of the law to permit substantive rulemaking, rather than just procedural rules.   This allowed huge programs to be created administratively, from nutritional labeling to OTC drug review to FOIA regulations.  Equally important was FDA’s approach to developing lengthy explanatory preambles to its regulations.

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Discrimination Against Obese Patients

Following up on a blog post I did here several months ago, take a look at – and a listen to – some additional commentary I have in this week’s New England Journal of Medicine.

The gist?  The law prohibits many, but not all, grounds for discrimination against potential patients.  Race, religion, sex, and disability are among the most uniformly protected categories, whereas less than half of states prohibit health care discrimination based on sexual orientation or gender identity, for example. Moreover, the rejection of patients because they smoke, play contact sports, or engage in other risky behavior is legally within the realm of physician discretion, as is discrimination based on other characteristics not protected by law.

So what about obesity discrimination by healthcare providers?  Perhaps one of the last comparatively socially acceptable bases for discrimination, weight has not traditionally been treated as a protected category under civil rights laws. But one possible strategy is to consider the scope of prohibitions against disability discrimination. This is actually a pretty unsettled area of law – but the bottom line, to the extent there is one, is that rejection of an overweight or obese patient who is neither impaired to the extent of being disabled nor regarded as disabled would be legally permissible under the Americans with Disabilities Act.  Rejection of an obese patient who is disabled could also be permissible, so long as the disability was not the reason for the rejection.  The only problem would come up if a disabled obese patient were to be rejected on that basis, and could prove that to be the case.  So this may not be the most helpful approach to address obesity discrimination in the healthcare context, and in my opinion, reliance on simple medical professionalism and the commitment to caring for those in need has much more to offer.                          

Revisions to the Declaration of Helsinki

On Monday, the World Medical Association opened a 2-month public consultation on proposed revisions to the Declaration of Helsinki.  The Declaration was most recently revised in 2008, and according to the WMA, the current round of proposed changes is intended “to provide for more protection for vulnerable groups and all participants by including the issue of compensation, more precise and specific requirements for post-study arrangements and a more systematic approach to the use of placebos.”

You can see a side by side analysis of the proposed revisions and explanatory comments here.  We’ll see what happens down the road, but a few things are worth noting:

  1. The working group responsible for the revisions explicitly acknowledges that it cannot literally be true that the well-being of the individual research subjects must take precedence over all other interests (new paragraph 8/old para. 6).  Nonetheless, it retains that language for aspirational purposes – a strange choice, IMHO, which could conceivably lead to less respect for the Declaration as a whole.
  2. The revised Declaration would (in line with almost every other ethical body to consider the issue) add a new paragraph indicating that “Adequate compensation and treatment for subjects who are harmed as a result of participating in the research must be ensured” (new para. 15).  The current version (old para. 14) states only that the protocol should include “provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.”  The nature of the Declaration is such that it doesn’t provide much detail, but even this revised statement is a step in the right direction.  Will US regulators ever take the hint?
  3. The revisions would take a harder stance toward research involving disadvantaged or vulnerable populations, permitting research with these groups only when it could not be carried out in a non-vulnerable population (new para. 20/old para. 17).  I understand the sentiment…really I do.  But this approach seems to unduly discount the real benefits that accrue to research participants and communities just by virtue of having the research done there.  And if research is responsive to population/community needs and priorities AND the population/community stands to benefit from the research – two standards that remain in the revised Declaration – why do we need the third criterion that research couldn’t be conducted in an alternative population? Continue reading

More Thoughts on the Preemie Study and IRB Review

By now, most of you have heard about the controversial study that sought to evaluate how much oxygen to give premature newborns to preserve both their lives and their sight.  Below, Laura Stark lays out some of the key details about the study and OHRP’s response, and concludes that part of the problem may have been a result of the difficulties associated with approving multi-site research.

Maybe so, but let me offer a more fundamental challenge: perhaps IRBs are just ineffective – or not as effective as we hope they would be – at protecting human subjects.  In retrospect, it looks like all 23 IRBs that reviewed the study, all of which were applying the same regulatory standards, failed to do what OHRP, many news outlets, and as awareness grows, much of the public thinks they ought to have done to protect the babies and families involved in this study.  How could they all have gotten it wrong?  Are the regulations insufficient?  Are the procedures insufficient? Is it all just a matter of interpretation?

These questions lead to another fundamental issue: the lack of empirical evidence on IRB effectiveness.  We have data on whether IRBs follow the regulations, data on adverse events, data on OHRP warning letters, data on IRB-imposed research burdens and delays – but these all nibble around the edges of the real questions: what are IRBs supposed to be doing, are they doing it well, and how would we know?  The counterfactual – a world without IRB review – is pretty tough to study, but I’m working with a group of colleagues at the Petrie-Flom Center and elsewhere to think through some empirical methods to get at precisely these issues.  And we’d love to hear your thoughts!

Finally, as a side note, one point that seems to be getting lost in coverage of this preemie story is that although there seems to have been some major problems with the consent process, the study question itself was a very important one to ask.

New Paper on Conscience and the ACA

Piggy-backing on Glenn’s post below, I just wanted to point you to my contribution to the same symposium issue of Ethical Perspectives.  The paper, “Religious Liberty, Conscience, and the Affordable Care Act,” can be downloaded here, and copied below is the abstract:

Broadly applicable legal requirements often come into conflict with moral or religious standards that individuals and organizations feel more strongly compelled to obey. Making room for such moral and religious standards in secular society is important, but can be difficult, since any exemptions or accommodations cannot be allowed frustrate the purpose of the general law, and must also be fair to those who remain subject to it without any special arrangements.

This essay briefly surveys the ways in which the Affordable Care Act might come into conflict with moral and religious beliefs held by both individuals and institutions, and describes the government accommodations that have been offered or considered to date. In particular, it focuses on the requirement that employers offer insurance coverage for free contraceptives and the requirement that individuals purchase insurance coverage that may include services they find objectionable. In both cases, I conclude that the proffered accommodations should be altered to enhance fairness as between objectors and non-objectors.

More on Contraceptives Coverage

For an excellent perspective on the legal challenges to the contraceptives coverage mandate being brought by for-profit, secular companies with religious owners, check out Bill Keller’s recent NYT op-ed.  A brief snippet:

“Also, courts tend to distinguish between laws that make you do something and laws that merely require a financial payment. In the days of the draft, conscientious objectors were exempted from conscription. A sincere pacifist could not be obliged to kill. But a pacifist is not excused from paying taxes just because he or she objects to the money being spent on war. Doctors who find abortions morally abhorrent are not obliged to perform them. But you cannot withhold taxes because some of the money goes to Medicaid-financed abortion.”

These analogies are helpful, but I’m not sure I’m totally convinced that the employers here are only being asked to make a financial payment equivalent to a tax.  Certainly they don’t have to take contraceptives themselves, but they aren’t being asked to just pay money to the government – they are being asked to directly arrange coverage for something they find morally objectionable.  So I’m really on the fence here.

Ultimately, I don’t want to be too quick to dismiss the complicity objections raised by these employers as just the same as tax objections that are easily waived off as completely unworkable.  We can’t have every Tom, Dick, and Harry refusing to pay taxes for things they find objectionable – but we could come up with a system for accommodating the religious objections of secular business owners: namely the accommodation being offered to religious employers.  If insurers can bear the burden of handling contraceptives coverage completely on their own for religious employers like hospitals and universities, why couldn’t they do the same across the board?

And let me reiterate once again that all of this just demonstrates that employers really have no place whatsoever in our healthcare system.

India Releases New Rules on Clinical Trial Injury

Last week, the Indian government issued revised rules governing “compensation in case of injury or death during clinical trial.”  You’ve really got to read the whole thing, but some of the provisions are pretty remarkable:

  • “In the case of an injury occurring to the clinical trial subject, he or she shall be given free medical management as long as required.”  Note that this doesn’t say anything about the injury being study-related.
  • If an injury is related, then the subject is also entitled to financial compensation above any medical expenses.
  • If the subject dies as a result of clinical trial participation, his or her “nominees” would be entitled to financial compensation.
  • Injury or death will be considered related to trial participation in a variety of usual circumstances, including adverse effects of the investigational product and protocol violation or negligence.  But here’s the kicker: injury or death will be deemed trial-related, and therefore eligible for care/compensation, if it results from “failure of investigational product to provide intended therapeutic effect” or “use of placebo in a placebo-controlled trial”.  Read that again – if an investigational product doesn’t work, the sponsor will be liable for free medical care and further financial compensation.
Like all of the presidential bioethics commissions and many others that have considered this issue, I’m all for the adoption of reasonable and appropriate compensation systems to make subjects whole in the event of study-related injury.  And I think US policy is woefully inadequate on this score.  But the pendulum can also swing too far in the other direction.  Will sponsors take their trials elsewhere or will research in India still be worth it?
[H/T to Rebecca Li for the head's up re: publication of the new rules.]

Breaking News on Contraceptive Coverage Mandate

News Release

February 1, 2013
Contact: HHS Press Office
(202) 690-6343

Administration issues Notice of Proposed Rulemaking on recommended preventive services policy

The Obama administration today issued proposed rules for public comment regarding contraceptive coverage with no cost sharing under the health care law. The proposed rules provide women with coverage for preventive care that includes contraceptive services with no co-pays, while also respecting the concerns of some religious organizations.

Today’s Notice of Proposed Rulemaking reflects public feedback received through the Advance Notice of Proposed Rulemaking issued in March 2012.  In addition, these proposed rules are open for public comment through April 8, 2013.

“Today, the administration is taking the next step in providing women across the nation with coverage of recommended preventive care at no cost, while respecting religious concerns,” said Health and Human Services Secretary Kathleen Sebelius.  “We will continue to work with faith-based organizations, women’s organizations, insurers and others to achieve these goals.”

The proposed rules lay out how non-profit religious organizations, such as non-profit religious hospitals or institutions of higher education, that object to contraception on religious grounds can receive an accommodation that provides their enrollees separate contraceptive coverage, and with no co-pays, but at no cost to the religious organization.

With respect to insured plans, including student health plans, these religious organizations would provide notice to their insurer.  The insurer would then notify enrollees that it is providing them with no-cost contraceptive coverage through separate individual health insurance policies.

With respect to self-insured plans, as well as student health plans, these religious organizations would provide notice to their third party administrator.  In turn, the third party administrator would work with an insurer to arrange no-cost contraceptive coverage through separate individual health insurance policies.

Insurers and third party administrators would work to ensure a seamless enrollment process. The proposed rules lay out how the costs of both the insurer and the third party administrator would be covered, without any charge to either the religious organization or the enrollees.

Additionally, the proposed rules simplify and clarify the definition of “religious employer” for purposes of the exemption from the contraceptive coverage requirement.  These employers, primarily houses of worship, can exclude contraception coverage from their health plans for their employees.

The proposed rules are available here:

A fact sheet on today’s proposed rules is available here:

For more information on women’s preventive services and the Affordable Care Act, visit: