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.

Justice Breyer and Wheaton College v. Burwell

By Gregory Curfman

Tom Goldstein, Publisher of SCOTUSblog, has opined on why Justice Stephen Breyer apparently joined the majority opinion in Wheaton College v. Burwell, which the Court released last Thursday. The majority granted Wheaton a temporary injunction exempting the College from the contraceptive mandate, which was spawned by the Affordable Care Act and which the College claimed violates its religious principles. The vote was 6 to 3, with Justice Scalia filing a concurrence (agreeing “in the result”) and Justices Sotomayor, Ginsburg, and Kagan issuing a forceful dissent. The opinion was unsigned, leaving ambiguous whether Justice Breyer actually did join the majority, though the numbers leave little doubt that he did.

Tom Goldstein believes that Justice Breyer joined the majority because, in doing so, he gained more than he lost. In addition to granting the College an injunction, the majority opinion also states that nothing in the opinion prohibits the government from taking steps to provide women access to contraceptive agents without a copayment. The specific language in the opinion is:

“Nothing in this order precludes the Government from relying on this notice, to the extent it considers it necessary, to facilitate the provision of full contraceptive coverage under the Act.”

Thus, Tom Goldstein believes that in joining the majority, Justice Breyer accomplished the pragmatic objective of preventing the loss of contraceptive coverage for the nation’s women who are employed by nonprofit organizations.

Without comment from Justice Breyer himself, we of course cannot know why he (presumably) joined the majority in Wheaton College v. Burwell, despite the fact he dissented when the Court granted Wheaton College a brief (two-day) injunction earlier in the week. And despite the fact that he also joined Justices Ginsburg, Sotomayor, and Kagan in issuing a very strong dissent in Hobby Lobby v. Burwell. Continue reading

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

SCOTUSfrontCheck 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!

On Agency Accommodations and Least Restrictive Alternatives

Nadia N. Sawicki

Did HHS shoot itself in the foot by providing an accommodation to religious non-profits?

In holding that the contraceptive mandate imposed by HHS on Hobby Lobby and Conestoga Wood was not the “least restrictive alternative” for providing no-cost contraceptive coverage to women, the Supreme Court pointed to the accommodation HHS recently provided to religiously-affiliated non-profit corporations. Under the accommodation, “eligible organizations” such as religiously-affiliated hospitals and universities can avoid funding insurance coverage for contraceptives if they certify that they have a religious objection to providing such coverage. In such cases, the eligible organization’s insurance issuer must exclude contraception from the organization’s group health insurance plan, and instead provide a separate issuer-funded contraceptive plan directly to employees. Given that such an accommodation is already in place for some employers, the Supreme Court noted, “HHS itself has demonstrated that it has at its disposal an approach that is less restrictive than requiring employers to fund contraceptive methods that violate their religious beliefs.”

One obvious problem with the Court’s assertion, noted in Justice Ginsburg’s dissent, is that the Court expressly declined to determine whether such an accommodation would in fact be permissible under RFRA. Given the challenges to the accommodation-by-certification requirement already brought by organizations like Little Sisters of the Poor, it is far from clear that the current composition of the Supreme Court would uphold this requirement if faced with a direct challenge.

A second, perhaps less obvious, concern about the Court’s proposal that the eligible employer accommodation be extended to for-profit corporations is that HHS may now regret providing it – and as a result, HHS may refrain from making similar accommodations in the future, which would be a significant loss to defenders of religious freedom.

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Waiting for Hobby Lobby–A brief refresher of the issues

Cross post from healthlawprof blog

Jennifer S. Bard

Since the likelihood is that many readers of this blog will be asked to comment when the Supreme Court, some time this week, announces its decision in Hobby Lobby and Conestoga Wood Specialty cases here’s a brief refresher and some links.  The cases are challenges to the Affordable Care Act’s requirement that employers who choose to offer health insurance to their employees must provide policies that include ten essential benefits-including contraception.  The U.S. Supreme Court has heard oral arguments and read the briefs—it’s likely that whatever opinion is issued will reflect at least some of the arguments presented to the Court.

This case is about the Affordable Care Act’s requirement that employers who offer their employees health insurance must include ten essential benefits, including contraception.  Hobby Lobby and Conestoga Wood are privately held, for-profit companies whose owners have sincerely held religious objections to providing four specific kinds of contraception.  They believe these contraceptives terminate rather than prevent pregnancy.  Many religious organizations and companies have gotten exemptions to these requirements, but this case considers whether private, for-profit companies should qualify as well.

The cases raise three major issues:

  1. Does the Religious Freedom Restoration Act apply to corporations even though it uses the word “person?” (Can companies have religious beliefs?)
  2. Is providing insurance that covers birth control a “substantial burden?” on these two company’s’ religious beliefs?
  3. Does the government have a compelling reason for requiring companies that provide insurance to have it cover birth control?

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Smoke and Mirrors and Women, Oh My

[Guest post by Katherine L. Record, JD, MPH, MA]

Last week the Supreme Court attracted lots of attention when it heard arguments about whether a corporation can exclude mandatory preventive benefits from its employee health plan, based on a religious objection to certain types of healthcare.  This is a tale as old as time; religion has long been the basis for opposition to reproductive (i.e., women’s) health – including the preventive healthcare now in question, contraception.

Yet this argument has nothing to do with government infringement on the practice of religion.

In fact, the corporation, Hobby Lobby, covered two of the four contraceptive devices in dispute until its lawyers were actually arguing the issue in court, apparently to little detriment to the company’s faith in God.  What’s more, Hobby Lobby’s 401(k) includes more than $73 million invested in the companies that produce these objectionable contraceptives (e.g., intrauterine devices, emergency contraception).

This has not stopped Hobby Lobby from arguing that the Affordable Care Act (ACA) is threatening its freedom, as a corporation, to practice religion.

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Who’s the Boss? Why are our employers making our health insurance choices in the first place?

This guest cross-post first appeared on Slate.com.

Margaux J. Hall is the Center for Reproductive Rights Fellow at Columbia Law School. All views expressed are the author’s own.

This week, the Supreme Court hears oral argument in two cases asking whether for-profit business corporations have religious liberty rights. Hobby Lobby, a group of craft stores with 13,000 employees, and Conestoga Wood, a small Mennonite furniture maker, want to be free of the Obamacare requirement that employer-provided health insurance plans need to provide certain forms of birth control. They argue that their religious convictions prohibit them from covering such items. Religious institutions, reproductive-rights advocates, and others have sparred over the conflicting rights claims, but one important part of the conversation has been missing almost completely: Why are American employers deciding the contents of our personal health insurance plans?

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Advance Directives, Rights, and Brain Death Pregnancies

Dr. Jeffrey Ecker, a noted fetal medicine specialist, has an excellent piece on the Munoz case in Texas in a recent NEJM article (“Death in Pregnancy—An American Tragedy”).[1]   He shares the widespread view that brain dead pregnant women should not be maintained over the father or family’s objections.  He does, however, suggest that maintenance may occur with family consent to enable the fetus be born with the best chance of survival.

The burden of his comment is on legal issues and rights.  Because Texas recognizes brain death as legal death, the hospital had acted inappropriately when it relied on the Texas advance directive statute, which limits advance directives when a woman is pregnant, to maintain her over her husband’s wishes. The court ruled that since Ms Munoz was brain dead, the advance directive limitation which applies only to patients who are still alive, did not apply to a pregnant patient who was dead under cardiopulmonary or brain death criteria for death.  His comment deserves laurels for its clear presentation of the statutory conflict and its resolution.

Dr. Ecker, however, like many other commentators, runs into trouble when he says that the hospital’s actions in the Munoz case, even if supported by statute  are “a wrongful usurpation of the rights of individuals,  in this case  … women.”[2]  The problem is his the assumption that there is or should be a constitutional or legal right at Time 1 when competent to issue a legally binding directive at Time 2 when the maker is incompetent and indeed may have a different set of interests or none at all.

But there is no constitutional right to make a directive at Time 1 that binds at Time 2.  Justice Sandra O’Connor concurring in the outcome in Cruzan mentioned a possible 14th Amendment right to appoint a health care proxy to make a decision at Time 2, but no other justice joined her.[3]  Indeed, a constitutional right to make future directives that bind oneself directly or through an agent has no constitutional precedent and poses many problems.

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TOMORROW: Second Annual Health Law Year in P/Review

Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Continue reading

1/31: Second Annual Health Law Year in P/Review

Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Continue reading

1/31: Second Annual Health Law Year in P/Review conference

Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Continue reading

Art Caplan: When Religion Trumps Medicine

Cross-post from bioethics.net

Imagine that you were in a terrible car accident and suffered a huge loss of blood. An ambulance comes and takes you, dazed and in pain, to the only hospital within a hundred mile area of the accident. That hospital happens to be affiliated with the Jehovah’s Witnesses. Everything at the hospital is state of the art. The doctors and nurses are all well trained. There is only one hitch in terms of your medical care. You need blood transfusions or you are going to die. The hospital does not have a blood bank. Nor does it offer transfusions. They believe blood transfusion violates their faith. The doctor suggests you be given a lot of fluids to maintain your ‘volume’ and that you hope for the best. Wouldn’t you demand that the Witness affiliated hospital put aside their faith-based beliefs and do what is medically indicated and either provide a transfusion or try to arrange one? If you did not recover would you expect your family to accept the fact that your death could easily have been prevented but for the hospital’s decision to put theology over medicine?

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Standards of Care and Patient Advocacy in Religiously Affiliated Hospitals

By Nadia N. Sawicki

The New York Times reported today that the ACLU has filed a lawsuit against the United States Conference of Catholic Bishops on behalf of Tamesha Means, a patient at Mercy Health Partners in Michigan.  The suit alleges that Means suffered physical and emotional harm as a result of the Conference of Bishops’ ethical directives relating to pregnancy termination, which Mercy, as a Catholic health institution, is required to follow.

According to the ACLU press release and the Times article, when Means’ water broke 18 weeks into her pregnancy, she rushed to Mercy Health, the only hospital in her county.  According to medical experts, the fetus had “virtually no chance of surviving” and posed a significant risk to Means’ health.  Mercy physicians did not share this information with Means, and discharged her without informing her that terminating the pregnancy and extracting the fetus was the safest course of action from a medical perspective. Means returned to the hospital twice in the next two days, suffering from infection and extreme pain, but it wasn’t until she miscarried that the staff at Mercy attended to her medical needs.   An obstetrician at the University of Wisconsin Medical School quoted in the Times described Mercy’s treatment of Means’ condition as “basic neglect.”

Rather than suing Mercy Health Partners, Means and the ACLU are suing the Conference of Bishops.  They argue that by directing Catholic hospitals to avoid terminating pregnancies or providing referrals (even when a woman’s health is at risk), the Conference of Bishops is ultimately responsible for the harms suffered by Means and other women in her position.  According to Louise Melling, deputy director of the ACLU, “This isn’t about religious freedom, it’s about medical care.”

There are a host of legal, ethical, and religious issues associated with the Tamesha Means case.  But in this post, I’d like to focus on only one - the division of legal responsibility between health care providers and third parties when it comes to patient advocacy and quality of care. Continue reading

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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Caplan on Organs and Inmates

By Art Caplan

Are we ever capable of laying a stupid idea to rest in America?  Apparently not.  The latest tempest in the ever-resurrecting world of solutions to the shortage of organs is donation by executed prisoners.  The Governor of Ohio held up a plan to execute a man on death row when he requested that his organs be donated to his mother and sister each of whom have serious health problems.

According to the AP,

“Ohio Governor John Kasich on Wednesday stayed the execution of convicted killer Ronald Phillips to assess whether Phillips’s non-vital organs or tissues can be donated to his mother or possibly others. Phillips, 40, was scheduled to be executed Thursday for the 1993 murder of 3-year-old Sheila Marie Evans.

“I realize this is a bit of uncharted territory for Ohio, but if another life can be saved by his willingness to donate his organs and tissues, then we should allow for that to happen,” Kasich said in a statement.”

The Governor need not have bothered.  What child rapist and murderer Ron Phillips had in mind was donating his heart and kidneys to his family.  He has shown no interest in helping anyone else nor did he ever mention tissue donation.

Moreover, getting organs from an executed prisoner is both impractical and immoral.

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The contraception mandate decision

From my post at The Incidental Economist:

The Gilardi v. HHS decision is out today (on scribd), blocking the PPACA contraception mandate for the plaintiffs. Two brothers own Freshway Foods and a related company that offer a self-insured health plan to their 400 employees. For non-grandfathered plans with an annual enrollment period starting on or after September 23, 2010, PPACA required zero deductibles and cost sharing for a package of preventative services. One component of that package includes FDA-approved contraception. The Gilardi brothers claimed this requirement violates the Religious Freedom Restoration Act (RFFA). A majority of the Court agreed, sending the case back to the District Court for a reconsideration of the injunction.

This case raises an interesting point about pluralism in our society. When do we get to abstain from generally-applicable laws that violate our moral beliefs? Even more attenuated, when do we get to opt out because other people’s actions violate our beliefs? Can the Freshway companies decide to drop hospice care for their employees as violating their Catholic beliefs? Could a Muslim employer prevent employees from bringing home the bacon with their paychecks? Could a Baptist employer fire employees for watching porn at home on HBO?

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