Zubik v. Burwell, Part 4: The Compelling Interest in Contraceptive Coverage

Photo: Birth Control Rally

Flickr/Creative Commons—Women’s eNews

By Gregory M. Lipper

(Read Part 1, Part 2Part 3Part 5, and Part 6 of this series.)

If the Supreme Court were to conclude that the plantiffs in Zubik v. Burwell plaintiffs have established a substantial burden on religious exercise, the case is not over. Under the Religious Freedom Restoration Act, the government may enforce even a law that substantially burdens religious exercise if that law advances a compelling governmental interest and is the least-restrictive means of advancing that interest. In the 2014 Hobby Lobby decision, the Supreme Court majority assumed, without deciding, that the coverage regulations advanced a compelling interest. And in his concurring opinion, Justice Kennedy went further: It was “important to confirm,” he wrote, that “a premise of the Court’s opinion is its assumption that the HHS regulation here at issue furthers a legitimate and compelling interest in the health of female employees.”

The government’s interest in ensuring that women have contraceptive coverage is compelling indeed. Access to contraception has many benefits—some of them obvious, others less so. And these benefits explain why the CDC has listed family planning as one of the 10 most important public-health advances of the 20th century.

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Uterus Transplants: Challenges and Potential

[Cross posted at the OUPBlog]

By John A. Robertson

The birth of a healthy child in Sweden in October, 2014 after a uterus transplant from a living donor marked the advent of a new technique to help women with absent or non-functional uteruses to bear genetic offspring. The Cleveland Clinic has now led American doctors into this space, performing the first US uterine transplant in February, 2016 as part of an Institutional Review Board (IRB)-approved series of ten transplants using cadaveric donors. Dallas and Boston medical centers have also been approved for this program, as will other programs as progress continues. An estimate of 50,000 American women are potential clients.

The path to womb transplants, however, will not be easy. On 7 March, the Cleveland Clinic celebrated its transplant with a media announcement full of joy and celebration. Two days later in a decidedly different key, the Clinic informed the world that the organ was surgically removed because the recipient had “suddenly developed a serious complication.” One can only imagine the disappointment of the patient and medical team, who had smiled so happily in media coverage. Of course, early failure is not surprising with innovative surgery, and no doubt the Cleveland clinic will proceed with other patients. The case is a reminder that the road to success is long, and initial steps should be closely monitored by IRBs, as is occurring in Cleveland, Sweden, and elsewhere. Continue reading

Zubik v. Burwell, Part 3: Birth Control Is Not Abortion

Photo: Plan B

Flickr/Creative Commons—Irina Ivanova

By Gregory M. Lipper

(Read Part 1Part 2Part 4Part 5, and Part 6 of this series)

Pay attention to the Supreme Court’s upcoming contraceptive-coverage cases and you’ll hear horror stories from religious-right groups about an “abortion-pill mandate” (here’s ADF and ACLJ). These groups know that contraception is popular and that, to most people, campaigns to block birth control would seem Jurassic. With abortion more controversial, claims about compulsory distribution of “abortion pills” sound much scarier. Indeed, the plaintiffs’ briefs in Zubik claim that the accommodation would make the plaintiffs complicit in the provision of coverage for, among other things, “abortifacients.”

But neither surgical abortion nor the abortion pill (known as RU–486) are part of the Affordable Care Act’s coverage requirements. So why are courts, websites, and inboxes awash in complaints about the termination of pregnancies?

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Medicare’s Coming Battle Over Drug Reimbursement

By Zack Buck

Following months of news coverage highlighting how American drug prices are “out of control,” the Centers for Medicare and Medicaid Services (CMS) seems to have been spurred into action. Last week, CMS proposed a new reimbursement regime for drugs paid for by Medicare Part B (drugs administered on an outpatient basis).

Addressing the concerns that the existing reimbursement formula may encourage physicians to rely on more expensive drugs, the proposal calls for testing new payment models designed to save money. The most striking of these changes calls for altering the “average sales price plus 6 percent” reimbursement formula (the amount Medicare pays doctors to reimburse them for drugs) to a formula which would pay doctors the average sales price plus 2.5 percent, plus a fee of $16.80 per drug per day. Further, the proposal also calls for testing indications-based and reference pricing. If implemented, all of these tools would be likely to produce cost savings for Medicare Part B, which spends $20 billion annually on drugs.

According to the New York Times, the proposal “touched off a tempest,” as physicians, politicians, and drug manufacturers criticized  the proposed changes. The American Society of Clinical Oncologists decried the “heavy-handed” government intervention that would adversely affect seniors’ quality of care. Senator Orrin G. Hatch (R-UT) implied that the change would allow “unelected bureaucrats” to usurp medical judgment, with negative effects on access to care. And a statement from the Pharmaceutical Research and Manufacturers of America (PhRMA) noted that the proposal “puts Medicare patients who rely on these medicines at risk.”

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Zubik v. Burwell, Part 2: The Religious Objectors Who Cried Wolf

Photo: wolf

Flickr/Creative Commons—Luke Jones

By Gregory M. Lipper

(Read Part 1, Part 3Part 4Part 5, and Part 6 of this series)

Yesterday, I evaluated the unprecedented arguments, by the plaintiffs in Zubik v. Burwell and its companion cases, that the process for seeking a religious exemption from the contraceptive-coverage regulations itself burdened the objectors’ religious exericse. Today, I move to a more basic question: Are these idiosyncratic claims sincere?

Like all free-exercise provisions, the Religious Freedom Restoration Act protects only sincere religious beliefs; it does not permit challengers to cloak ideological or financial objections in religious garb. Insincerity can reveal itself in several ways: prior inconsistent conduct, claims that are suspiciously timed, or outright admissions of an ulterior motive. The RFRA challenges to the contraceptive coverage regulations—and especially the accommodation—have presented several of these elements. But the government, in resisting these RFRA challenges, has not challenged the plaintiffs’ sincerity.

That said, there are several reasons to doubt the sincerity of several plaintiffs’ claims, and to see these lawsuits as an exercise in politics arising from broader conservative and religious opposition to the Obama administration’s positions on issues such as healthcare reform, stem cell research, abortion, and marriage equality. This apparent insincerity provides yet another reason to reject the latest round of RFRA challenges to the contraceptive accommodation.

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The EEOC’s Role In Reshaping Wellness Programs

This new post by Kristin Madison appears on the Health Affairs Blog concludes the blog series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

Wellness programs remain a popular feature of the employer landscape, but the legal environment surrounding them has long been uncertain. In April 2015, the Equal Employment Opportunity Commission took a significant step toward resolving this uncertainty by formally proposing a ruleclarifying the applicability Americans with Disabilities Act of 1990 (ADA) to wellness programs.

In doing so, it staked out middle ground between an approach that would have sharply limited the use of incentives in wellness programs, and a more permissive approach consistent with regulations already in place under the Affordable Care Act (ACA). The proposed rule has the potential to shape, or reshape, future wellness programs. The extent to which it will do so, however, remains uncertain. […]

Read the full post here.

New Federal Employee Drug Screening Guidelines to Include Opioid Testing

By Jonathan K. Larsen, JD, MPP

There is no denying that the United States is experiencing an opioid overdose epidemic. Drug overdose deaths generally in the United States have been associated, at least in part, with increasing mortality rates among white non-Hispanics, which is counter to trends in other wealthy nations. The Urban Institute’s Laudan Aron recently posted about the underlying causes of our current epidemic, paying special attention to aggressive marketing of painkillers, the related spike in opioid prescriptions, and the closely correlated increase in opioid abuse. The issue has even made it into the current Presidential campaign, however briefly. President Obama has sought increased funding to address the issue, as well as a focused private, state, and local effort to tackle prescription drug abuse. While opioid abuse has been on the rise, it is not typically part of employee drug testing, when employers choose or are required to test. This may be changing.

The Substance Abuse and Mental Health Services Administration (SAMHSA), the federal agency responsible for drug testing standards for federal agencies, is poised to release drug screening guidelines (see page 4 (28104 in the Federal Register) that would expand drug screening for opioid abuse to federal employees, and could influence employee drug testing policies across the nation. The US Department of Defense has been testing for hydrocodone and benzodiazepines (used to treat anxiety and seizures among other things) since May 1, 2012. SAMHSA cites sobering statistics about opioid-related deaths now outnumbering deaths from illicit drugs, as it prepares to test for oxycodone, oxymorphone, hydrocodone, and hydromorphone, all classified as Schedule II drugs, or drugs with high risk of abuse, by the United States Food and Drug Administration (FDA). The proposed guidelines were released May 15, 2015, so the final rules should be coming soon. Continue reading

One Patent Law, Two Economic Sectors: Is The One-Size-Fits-All Patent Law Still Workable?

This new post by Claire Laporte appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

Ever since the first patent was issued in 1790, the United States has had a single patent law to protect inventions in all fields. Over the past three decades, that law has been strained to the breaking point in covering both the life sciences and other technologies.

On the life sciences side, patents protect platform technologies as well as specific products and are important at every stage of a product’s life cycle. Many scientific breakthroughs arise from federally funded research in universities and other institutions. Under the Bayh-Dole Act, these institutions license the resulting patents to companies, often start-ups, which develop the technology until it is ready to be marketed.

During the many years of the development process, companies need to attract investment, and investors often assess the merits of the patent portfolio as an indicator of the ultimate strength of the company. Once a product is released to the market, patents still matter; each day of patent protection for a blockbuster drug is worth millions. Patent litigation in the life sciences is typically between competitors and reflects an effort by one of those competitors to maintain its exclusivity. […]

Read the full post here.

Zubik v. Burwell, Part 1: Why Paperwork Does Not Burden Religious Exercise

Photo: IUD

Flickr/Creative Commons—mara

By Gregory M. Lipper

(Read Part 2, Part 3Part 4Part 5, and Part 6 of this series)

Birth control is back at the high court. On March 23, the Supreme Court will hear oral argument in Zubik v. Burwell and its six companion cases. Despite what you may have heard, religious objectors—whether they are nuns or Notre Dame—are not required to distribute birth control. On the contrary, an accommodation enables religious objectors to opt out of offering contraceptive coverage to their employees; once the objectors request the accommodation, the government arranges for the objectors’ insurance companies or plan administrators to provide the coverage—at no cost to either the objectors or their students and employees. But does this accommodation itself violate objectors’ free-exercise rights under the Religious Freedom Restoration Act?

No, say eight of the nine federal appeals courts to consider the question. These courts have rejected the argument that by opting out of providing contraceptive coverage, objectors’ religious exercise is substantially burdened because the government arranges for a third party to pick up the slack. Continue reading

Bioethicist Arthur Caplan: Using Genetically Modified Mosquitoes To Fight Zika Is The Right Thing To Do

A new piece by Bill of Health contributor Art Caplan on Forbes:

When most of us think of mosquito control, we think of repellent, sprays and DEET. You might think long sleeves, window screens or mosquito control trucks, too. We’ve gotten pretty used to the idea that mosquitoes live around and among us–even when those mosquitoes carry diseases like West Nile, dengue, malaria and Zika. The best we can do to avoid their pesky, and sometimes lethal, bites is make our bodies unreachable or unappetizing.

The Zika outbreak sweeping through South America, Central America, Mexico and the Caribbean–and steadily moving north–has made mosquito control a top priority for national and international leaders, including the CDC and WHO. Transmitted primarily by the bite of the female Aedes aegypti mosquito, Zika has been linked to microcephaly in babies born to mothers infected during their pregnancies, as well as Guillain-Barré syndrome, which causes paralysis and even respiratory failure. Zika can get into the blood supply. A few cases of Zika appear to have been sexually transmitted. […]

Read the full article here.

The Economics Of Paying For Value

This new post by Nancy Beaulieu, Michael Chernew, Soren Kristensen, and Meredith Rosenthal appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

The notion that the American health care system should transition from paying for volume to paying for value has become nearly ubiquitous. There is a broad consensus that health care providers should be paid more if they deliver higher value care (i.e. care that results in substantial health gains per dollar spent).

These beliefs have led to a proliferation of value-based payment programs in both public and private sectors. For example, at the beginning of 2015, Sylvia Burwell announced the federal government’s commitment to tie 90 percent of fee-for-service Medicare payments to quality or value measures by 2018. In January of 2015, a newly formed alliance of health care providers, insurers, and employers called the Health Care Transformation Task Force committed to shifting 75 percent of their business to contracts that provide incentives for quality and efficiency by 2020.

The details of existing value or quality-based payment programs vary enormously and without regard to any conceptual framework. For example, they vary in the size of incentives and the measures used. They also vary in whether quality payments are contingent on financial savings and whether the value-based payment model is budget neutral. Even the term value is inconsistently defined. […]

Read the full post here.

‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

twihl 5x5

This week we talked to Professor Erin C. Fuse Brown of Georgia State University’s College of Law (a previous guest on episodes 5 and 22!).  We discussed her fascinating work on the law & policy of health care pricing, including work on cost-control and consolidation (with Jaime S. King). Be sure to check out her SSRN Page for other important work on ongoing efforts to bend the cost curve in health care and assure more universal access to care.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Breaking Good? The Arc Of Antitrust Policy In The Health Sector

This new post by Barak Richman appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

It appears that 2016 will follow 2015 as another year of massive consolidation in the health care sector. It therefore follows that 2016 will, also like 2015, be another year in which assorted health care industries receive significant antitrust scrutiny. Against this backdrop, it is timely and revealing to examine the current state and trajectory of antitrust law as it intersects and shapes health care policy.

Beginning in the late 1980s, when hospitals and hospital systems started an intense consolidation trend that continues today, many were challenged by the Federal Trade Commission (FTC) for creating anticompetitive and therefore illegal pricing power. Yet the FTC was unsuccessful in convincing courts that this was a harmful trend, and the Commission earned a costly, long losing streak, suffering defeats in each of six landmark cases between 1994 and 1999 (Note 1). The district courts reasoned that the hospitals’ mergers would provide better and more efficient care, that patients would travel to obtain cheaper care, and in any event, because the hospitals were nonprofit, they would not exercise market power to increase prices.

All these predictions have been proven incorrect. Hospital mergers (including those involving nonprofits) have significantly increased prices, and there has been no evidence of increased efficiencies. In fact, evidence suggests that, because the administration of health insurance both reduces the impact of marginal price increases and limits demand in close substitutes, hospital monopolists are even more costly than “typical” monopolies. One significant development in 2015 is new research which revealed that cost variation in the US is largely determined by hospitals market power. The string of FTC losses and the consequent wave of hospital consolidations can only be described as a collective and massive failure of antitrust policy. […]

Read the full post here.

Medicaid Expansion Through Section 1115 Waivers: Evaluating The Tradeoffs

This new post by Rachel Sachs appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

Nearly six years after the passage of the Affordable Care Act (ACA), health law and policy experts continue to painstakingly track the progress of the Act’s Medicaid expansion. The original intention of the ACA was to expand Medicaid in every state, leading to gains in coverage by all individuals below a certain income.

However, the Supreme Court’s 2012 ruling in National Federation of Independent Business v. Sebelius(NFIB) invalidated the original expansion as unconstitutionally coercive, effectively making the Medicaid expansion voluntary for states. As of this blog post, just 32 states including DC have expanded Medicaid pursuant to the ACA.

Most of the states that have expanded Medicaid thus far have done so through the standard procedure, following the statutory guidelines set forth by the ACA and the Centers for Medicare & Medicaid Services (CMS) and incorporating the newly eligible enrollees into their existing programs as a new beneficiary group. But some states have successfully negotiated customized expansions with CMS through the use of the Section 1115 waiver process, seeking to expand Medicaid only on their terms. […]

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Intelligent Transparency and Patient Safety: New UK Government Patient Safety Plans Launched

By John Tingle

One thing is clear when commentating on patient safety developments in the UK is that there is hardly ever a dull moment or a lapse of activity in patient safety policy development .Something always appears to be happening somewhere and it’s generally a very significant something. Things are happening at a pace with patient safety here.

On the 3rd March 2016 the Secretary of State for Health,The Rt Honourable Jeremy Hunt announced a major change to the patient safety infrastructure in the NHS with the setting  up from the 1st April 2016 of the independent Healthcare Safety Investigation Branch. In a speech in London to the Global Patient Safety Summit on improving standards in healthcare he also reflected on current patient safety initiatives.This new organisation has been modelled on the Air Accident Investigation Branch which has operated successfully in the airline industry. It will undertake, ‘timely, no-blame investigations’.

The Aviation and Health Industries
The airline industry has provided some very useful thinking in patient safety policy development when the literature on patient safety in the UK is considered. The way the airline industry changed its culture regarding accidents is mentioned by the Secretary of State in glowing terms. Pilots attending training programmes with engineers and flight attendants discussing communications and teamwork. There was a dramatic and immediate reduction in aviation fatalities which he wants to see happening now in the NHS. Continue reading

Can Negligent Providers of Medical Care Use the Patient’s Self-Destructive Behavior to Fend Off Liability?

By Alex Stein

The Colorado Supreme Court recently delivered an important decision on medical malpractice, P.W. v. Children’s Hospital Colorado, — P.3d —- (Colo. 2016), 2016 WL 297287. This decision denied a hospital the comparative negligence and assumption of risk defenses that purported to shift to the patient the duty to eliminate or reduce the risk that the hospital was obligated to guard against.

The defendant hospital admitted a known suicidal patient to its secure mental health unit and placed him under high suicide-risk precautions. The hospital’s staff failed to follow those precautions by allowing the patient to be alone in a bathroom for twenty minutes. During these twenty minutes, the patient hanged himself with his scrub pants and suffered a devastating anoxic brain injury. Continue reading

Taking A Data-Driven, Patient-Centric Approach To Pharmaceutical Company Communication With Health Care Professionals

This new post by James M. “Mit” Spears appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

This post is based in part on a debate which took place between Jerry Avorn and Mit Spears. After reading this piece, check out the counter argument. You can also watch a video of the debate.

The ability of pharmaceutical companies to provide information about medicines to health care professionals beyond that which is contained in the Food and Drug Administration (FDA)-approved labeling is a topic that has generated a great deal of discussion, particularly in light of the August 2015 Amarin decision rendered by a US District Court in the Southern District of New York, and the FDA’s recent settlement of the case.

In Amarin, Judge Paul Engelmayer ruled that the FDA’s regulation of information provided by pharmaceutical companies violated the First Amendment’s Commercial Speech doctrine to the extent that they prohibited the communication of truthful and non-misleading speech, even where the information provided went beyond the FDA-approved labeling. On March 8, FDA and Amarin settled the case in a way that preserves Amarin’s ability to share truthful, non-misleading information about its medicine. In fact, the FDA even agreed to provide advisory review of two such communications per year with a 60-day timeline.

This case followed on the heels of the Second Circuit’s 2013 decision in Caronia and the Supreme Court’s 2011 ruling in Sorrell v. IMS Health, Inc., in which the Courts affirmed that the First Amendment’s protections of commercial speech extended to pharmaceutical companies and their employees. […]

Read the full post here.

The First Amendment And Pharmaceutical Promotion

This new post by Jerry Avorn appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

This post is based in part on a debate which took place between Jerry Avorn and Mit Spears. After reading this piece, check out the counter argument. You can also watch a video of the debate.

Traditionally, communication about medications has been granted a privileged status different from that accorded to other forms of communication. This makes sense for several reasons.

Unlike other marketplace transactions, most consumers are not able to acquire all the information they need to make appropriate purchasing decisions. This is obviously true of patients, but it is also true of doctors. Most physicians simply do not have the expertise or the time to review the voluminous information that a manufacturer submits to the Food and Drug Administration when it applies for approval of a new product. Even more important, a great deal of information provided to the FDA by a manufacturer is considered proprietary to that company. As a result, although this data is evaluated by FDA scientists, it is simply not accessible to physicians or patients outside of the agency.

Large teams of FDA scientists with expertise in pharmacology, clinical trials, epidemiology, statistics, and several other disciplines take six to 10 months to review the massive dossiers submitted by manufacturers to win drug approval. The idea that unfettered “commercial free speech” would make it possible for prescribers to come up with equally useful determinations on their own is simply implausible. […]

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The Amarin Settlement: Watershed or Sinkhole?

By Joan H. Krause

The latest development in the simmering war over off-label drug promotion came on March 8, when Amarin Pharma reached a proposed settlement with the FDA that would allow the company to market its cardiovascular drug, Vascepa, for certain unapproved uses.  While the settlement must be approved by the district court, it already has fueled speculation about ever-broader challenges to off-label restrictions.  The unique set of facts at issue in Amarin, however, likely will limit the ability of other pharmaceutical companies to follow suit, at least in the short term.

Amarin sued the FDA in May 2015, relying on the Second Circuit’s 2012 opinion in United States v. Caronia, which held that the Food, Drug and Cosmetic Act did not prohibit a pharmaceutical sales representative’s truthful statements about off-label use of his company’s drug, Xyrem.  Procedurally, the Amarin dispute was unusual.  Vascepa was approved in 2011 for the treatment of patients with very high triglyceride levels.  Before the approval, Amarin entered into a special protocol assessment (SPA) with the FDA under which Vascepa would be studied (the ANCHOR study) in patients with slightly lower triglyceride levels, with the expectation of additional approval if the drug met study benchmarks.  In 2013, Amarin filed for such approval.

Subsequent to the SPA, however, studies of other cardiovascular products suggested that reducing triglyceride levels in high-risk patients did not lead to real clinical benefits for patients in terms of reducing events such as heart attack and stroke.  An FDA Advisory Committee found “substantial uncertainty” as to whether Vascepa would reduce such real-life risks, and the agency rescinded the SPA.  While acknowledging that the drug had met the ANCHOR study goals, the agency refused to approve the new indication until a second study confirmed Vascepa was able to reduce major cardiac events in such patients.  The FDA refused to allow Amarin to add the ANCHOR study results to Vascepa’s label, and warned that the drug might be misbranded if marketed for the new use.

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