Source: http://blogs.harvard.edu/billofhealth/2016/03/page/2/
Timestamp: 2018-06-21 02:26:52
Document Index: 50420824

Matched Legal Cases: ['art 3', 'art 1', 'art 2', 'art 4', 'art 5', 'art 6', 'art 2', 'art 1', 'art 3', 'art 4', 'art 5', 'art 6']

March | 2016 | Bill of Health | Page 2
Posted on March 21, 2016 by Greg Lipper
Flickr/Creative Commons—Women’s eNews
Posted in Affordable Care Act, Contraceptive Coverage, Gregory Lipper	| Tagged Religious Freedom Restoration Act, Supreme Court, Zubik
Posted on March 21, 2016 by jrobertson
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 →
Posted in Bioethics, Biotechnology, Health Law Policy, John A. Robertson, Organs, Reproductive Technology
Zubik v. Burwell, Part 3: Birth Control Is Not Abortion
Posted on March 19, 2016 by Greg Lipper
Flickr/Creative Commons—Irina Ivanova
(Read Part 1, Part 2, Part 4, Part 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?
Posted in Affordable Care Act, FDA, Gregory Lipper, Health Law Policy, Insurance	| Tagged Contraception, Religious Freedom Restoration Act, Supreme Court, Zubik
Zubik v. Burwell, Part 2: The Religious Objectors Who Cried Wolf
Posted on March 17, 2016 by Greg Lipper
Flickr/Creative Commons—Luke Jones
(Read Part 1, Part 3, Part 4, Part 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.
The EEOC’s Role In Reshaping Wellness Programs
Posted on March 17, 2016 by Petrie-Flom Center
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. […]
Posted in Affordable Care Act, Bioethics, Disability, Events, Health Law Policy, Petrie-Flom Center
Posted on March 17, 2016 by Center for Public Health Law Research
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 →
Posted in Bioethics, Health Law Policy, Mental Health, Public Health Law Research	| Tagged drug overdose, drug testing, Opioids, Substance Abuse
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. […]
Posted in Bioethics, Biotechnology, Events, FDA, Health Law Policy, Intellectual Property, Petrie-Flom Center, Pharmaceuticals
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 →
Posted on March 16, 2016 by acaplan
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. […]
Posted in Arthur Caplan, Bioethics, Biotechnology, Global Health, Health Law Policy, International, Public Health
Posted on March 16, 2016 by Petrie-Flom Center
Posted in Bioethics, Events, Health Care Finance, Health Care Reform, Health Law Policy, Medical Quality, Medicare/Medicaid, Petrie-Flom Center, Pharmaceuticals, Public Health, Resource Allocation
Posted on March 15, 2016 by npterry
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.
Breaking Good? The Arc Of Antitrust Policy In The Health Sector
Posted on March 15, 2016 by Petrie-Flom Center
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. […]
Posted in Events, FDA, Health Care Reform, Health Law Policy, Insurance, Petrie-Flom Center, Pharmaceuticals, Public Health
Medicaid Expansion Through Section 1115 Waivers: Evaluating The Tradeoffs
Posted on March 15, 2016 by rachelsachs
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. […]
Posted in Events, Health Care Reform, Health Law Policy, Medicare/Medicaid, Petrie-Flom Center, Rachel Sachs
Posted on March 15, 2016 by John Tingle
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 →
Posted in Bioethics, Global Health, Health Care Reform, Health Law Policy, John Tingle, Medical Quality, Public Health, Resource Allocation	| Tagged Global Health, Health Law, Health Quality, International, John Tingle, Medical Malpractice, Medical Safety, Patient Safety, public health, Resource Allocation
Can Negligent Providers of Medical Care Use the Patient’s Self-Destructive Behavior to Fend Off Liability?
Posted on March 14, 2016 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 →
Posted in Alex Stein	| Tagged Colorado, Comparative Fault, Defenses, Hospitals, Medical Malpractice
Taking A Data-Driven, Patient-Centric Approach To Pharmaceutical Company Communication With Health Care Professionals
Posted on March 11, 2016 by Petrie-Flom Center
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. […]
Posted in Events, FDA, Health Law Policy, Off-Label Use, Petrie-Flom Center, Pharmaceuticals, Public Health
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.
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. […]
Posted in Events, FDA, Health Law Policy, Off-Label Use, Pharmaceuticals, Public Health
Yale Bioethics Newsletter: 3/11/16