Category: Health Law Policy

Twitter Round-Up (11/18-11/24)

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By Casey Thomson

After what we hope was a hearty meal (or at least a restful, happy holiday) this past Thanksgiving for all of our readers, we are back with this week’s Twitter round-up – just a few days behind schedule.

  • Daniel Goldberg (@prof_goldberg) tweeted an article by Stefan Fatsis on the different perspectives regarding child participation in tackle football. As Goldberg noted in his tweet, from the perspective of neuroethics, the choice is clear: tackle football (or American football) is harmful for kids. (11/19)
  • Frank Pasquale (@FrankPasquale) included a link to a piece describing why data from all clinical trials should be readily accessible to doctors, or the origins of the BMJ Open Data Campaign. The article used the case of the Tamiflu anti-flu drug as an example, where the article authors described their hurdles in communicating with the drug’s producers concerning drug test results while trying to review the efficacy of the drug through Cochrane Collaboration. (11/21)
  • Kevin Outterson (@koutterson) posted his article, published in the New England Journal of Medicine, concerning the path for new federal regulations for compounding pharmacies in the wake of the meningitis outbreak and the New England Compounding Center (NECC). (11/23)
  • Arthur Caplan (@ArthurCaplan) brought up a recent post concerning the American College of Obstetricians and Gynecologists (ACOG) and their declaration that making birth control pills over-the-counter (OTC), rather than prescription, could reduce the rate of unplanned pregnancies in the United States (which has not changed in 20 years). While the change would not occur overnight, there are many consequences that remain unclear – including changes in price and insurance coverage. (11/23)
  • Michelle Meyer (@MichelleNMeyer) retweeted a link to David Shaywitz’s article, which noted the increased criticism and distrust facing industry studies as compared to those of university scientists. Shaywitz encouraged contextualization of industry criticism to recognize that such critiques often plague medical science in general, not just industry. (11/24)

Note: As a reminder from the last post, retweeting should not be read as an endorsement of or agreement with the content of the original tweet.

The New Diagnostic Scan for Alzheimer’s Disease

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[Ed. Note: We’re happy to announce that after a great month of guest blogging, Chris Robertson will be joining Bill of Health as a regular contributor.]

By Christopher Robertson

The New York Times brings us an interesting story about a new brain scan technology that allows the diagnosis of Alzheimer’s Disease.  Below the fold, I sketch a few interesting themes for health law, including the FDA’s authority over the practice of medicine, the use of blinding to improve clinical decision making, the value of a clinical diagnosis for an untreatable condition, and the problems of pre-existing conditions clauses in long-term care insurance. Read More

Another Contraceptives Mandate Case

Holly Fernandez Lynch Leave a comment

Following up on Chris Robertson’s and Kevin Outterson’s posts below (here and here), I just wanted to draw your attention to another federal district court opinion on the contraceptives coverage mandate.  This one is from Nov. 19 and involves the owners of Hobby Lobby.  The court denied their motion for a preliminary injunction on the following grounds:

Plaintiffs have not demonstrated a probability of success on their First Amendment claims. Hobby Lobby and Mardel, secular, for-profit corporations, do not have free exercise rights. The Greens [the individual owners] do have such rights, but are unlikely to prevail as to their constitutional claims because the preventive care coverage regulations they challenge are neutral laws of general applicability which are rationally related to a legitimate governmental objective.

Plaintiffs also have failed to demonstrate a probability of success on their Religious Freedom Restoration Act claims. Hobby Lobby and Mardel are not “persons” for purposes of the RFRA and the Greens have not established that compliance with the preventive care coverage regulations would “substantially burden” their religious exercise, as the term “substantially burdened” is used in the statute. Therefore, plaintiffs have not met their prima facie burden under RFRA and have not demonstrated a probability of success as to their RFRA claims.

There are tens of cases challenging the contraceptives mandate pending at the moment, and several have already been dismissed on procedural grounds.  But my current count of the substantive cases is 3 preliminary injunctions granted (Newland, Weingartz Supply, and Tyndale House Publishers), 1 denied (Hobby Lobby), and 1 case holding outright that the mandate violates neither the First Amendment nor RFRA (O’Brien).  Have I missed any?

Connecting National Policy and Local Experience to Reverse Diabetes Disparities

The Petrie-Flom Center Staff Leave a comment

[Ed. Note: Today we’re happy to provide you with a guest post by Noreen M. Clark, PhD, Myron E. Wegman Distinguished University Professor, Director, Center for Managing Chronic Disease, University of Michigan]

Health care disparities are perhaps among the most vexing problems in medicine, public health and health policy.  Despite broad public- and private-sector attention to the problem, disparities continue to grow.  At the Alliance to Reduce Disparities in Diabetes, a national program launched and supported by The Merck Company Foundation, we are working to reverse this trend and are finding that it’s critical that national policies aimed at reversing diabetes disparities consider the on-the-ground experience of those working to improve health outcomes for those most affected.

Too often national policies are developed that work well in theory but are divorced from the reality of what’s happening at the community level.  This makes enacting changes to reduce disparities in diabetes difficult, but the work of those on-the-ground is shedding light on ways to overcome the systemic and structural barriers to providing effective diabetes care to those most in need.  For example, the Alliance’s five health care delivery sites have implemented multifaceted evidence-based approaches designed to eliminate gaps produced by inequity and lack of targeted attention to those adults and their families who are most likely to be severely burdened by diabetes.

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Overdose Update: Celebrity Edition

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By Scott Burris

You’ve probably heard about the good news/bad news experience of Stephanie Bongiovi, daughter of rocker Jon Bon Jovi. A college student, she ODed on heroin, but help was summoned and she’s going to be fine. The (temporary) bad news for her (and longer term for others in her plight) is that she and a companion were arrested IN SPITE of a recent New York Good Samaritan 911 law passed explicitly to encourage people to call for help.

There are some technicalities and prerequisites, so if you want to see the law it’s available on LawAtlas. But if she or her companion sought help, and absent a hyper-technical reading of the statute (it literally does not protect a victim unable to seek help), the charges should never have been filed and should be dropped. The problem for the rest of us is that these laws only work if people at an OD scene know about them and trust them. High profile arrests like this are — and for once I think there might be some truth to this claim — sending a message not to seek help.

Meanwhile, Leo Beletsky, Jody Rich and Alex Walley have a fine little piece in JAMA that thoroughly catalogues the removable barriers to OD prevention. The table alone is worth thousands of words, which is nice because JAMA’s editors were pretty tight on the word limit despite the importance of the topic.

Opinion granting preliminary injunction on contraceptive coverage mandate

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By Christopher Robertson

Yesterday (Friday Nov 16), U.S. District Judge Reggie Walton granted a preliminary injunction barring enforcement of the contraceptive coverage mandate that was part of the regulations implementing the Affordable Care Act (ACA).  There is lots of news coverage (e.g., HuffPo and WaPo), but as usual, the news organizations do not link to the opinion.  For your convenience, I’ve linked to it in the prior sentence, and provide some very preliminary observations below the fold.

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Roundup of State Ballot Initiatives on Health Issues

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By Katie Booth

This November, voters weighed in on an array of state ballot initiatives on health issues from medical marijuana to health care reform. Ballot outcomes by state are listed below (more after the jump).

Voters in Alabama, Montana, and Wyoming passed initiatives expressing disapproval of the Affordable Care Act, while a similar initiative in Florida garnered a majority of the vote but failed to pass under the state’s supermajority voting requirement. Missouri voters passed a ballot initiative prohibiting the state executive branch from establishing a health insurance exchange, leaving this task to the federal government or state legislature. Florida voters defeated a measure that would have prohibited the use of state funds for abortions, while Montana voters passed a parental notification requirement for minors seeking abortions (with a judicial waiver provision). Perhaps surprisingly, California voters failed to pass a law requiring mandatory labeling of genetically engineered food. Several states legalized medical marijuana, while Arkansas voters struck down a medical marijuana initiative and Montana voters made existing medical marijuana laws more restrictive. Colorado and Washington legalized all marijuana use, while a similar measure failed in Oregon. Physician-assisted suicide was barely defeated in Massachusetts (51% to 49%), while North Dakotans banned smoking in indoor workplaces. Michigan voters failed to pass an initiative increasing the regulation of home health workers, while Louisiana voters prohibited the appropriation of state Medicaid trust funds for other purposes.

Affordable Care Act:

  • Alabama Health Care Amendment, Amendment 6: Approved 59.52% to 40.48% (prohibits mandatory participation in any health care system)
  • Florida Health Care Amendment, Amendment 1: Defeated 51.46% to 48.54% (required 60% support to pass) (would have prohibited passing laws compelling the purchase of health insurance)
  • Missouri Health Care Exchange Question, Proposition E: Approved 61.8% to 38.2% (“prohibit[s] the Governor or any state agency, from establishing or operating state-based health insurance exchanges unless authorized by a vote of the people or the legislature”)
  • Montana Health Care Measure, LR-122: Approved 66.83% to 33.17% (prohibits “the state or federal government from mandating the purchase of health insurance coverage or imposing penalties for decisions related to the purchase of health insurance coverage”)
  • Wyoming Health Care Amendment, Amendment A: Approved 76.98% to 23.02% (stating that “the right to make health care decisions is reserved to the citizens of the state of Wyoming”)

Drug Law Factoids for Your Consideration

Temple University Center for Public Health Law Research Leave a comment

By Scott Burris

This is a succinct paragraph from the weekly newsletter of U. Maryland’s Center for Substance Abuse Research. Seems relevant both to the conference on law  enforcement and public health I reported on earlier this week, and the election results on marijuana:

There were an estimated 12,408,899 arrests in the United States in 2011, according to data from the national Uniform Crime Reporting (UCR) Program. The highest number of arrests were for drug abuse violations—selling, manufacturing, or possessing drugs, followed by larceny-theft and driving under the influence. The majority (82%) of these arrests were for possession and one-half of these drug abuse violations involved marijuana. A poll conducted in 2011 found that one-half of U.S. residents think that marijuana should be legalized (see CESAR FAX, Volume 21, Issue 19).

An International Meeting of Public Health and Law Enforcement

Temple University Center for Public Health Law Research 1 Comment

By Scott Burris

We know, and now most people acknowledge, that police activity has some clear, and in some instances intentional, effects on health.  To start with the obvious, police are instrumental in reducing the number of people who are murdered, assaulted, raped, or otherwise terrorized. Policing – like any form of social intervention – can also have unintended consequences. There is, for example, considerable evidence that criminal law and legal practices can increase risks of HIV and other harms among drug users.

These facts are well-established and pretty well recognized. So now the question is not whether policing has health consequences, but rather whether social and health work is to be seen as an integral element of law enforcement in the 21st century.  In much of their day to day work, police are engaged in far more than the prevention of crime or the maintenance of social order.  This is something we all know, something that has probably always been true of police work, something that is shaping a lot of programs around the world, and yet something we need to talk more openly about.

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Bill of Health Interview with Einer Elhauge on Health Care Reform

Holly Fernandez Lynch Leave a comment

As you have already heard a few times on this blog, Professor Einer Elhauge, the Petrie-Flom Center’s Founding Faculty Director and Petrie Professor of Law at Harvard Law School, has a new book out on health care reform called Obamacare on Trial.  The book collects various essays that Prof. Elhauge published in popular media outlets, along with several postscripts, and it has received all sorts of glowing praise.

Prof. Elhauge has graciously agreed to answer some questions for us in the first ever Bill of Health e-interview.  Check it out:

Bill of Health: So, first things first, did the Supreme Court get it right in NFIB v. Sebelius?

Prof. Elhauge: The Supreme Court got the tax issue right, and I think the Medicaid expansion as well, but I think the Supreme Court got the commerce clause issue totally wrong.  Worse, the way they got it wrong portends trouble for the future.

Bill of Health: What were you most surprised by in the SCOTUS decision?

Prof. Elhauge: The fact that a majority of the Supreme Court was willing to use a methodology that clearly expanded judicial discretion to overrule the political branches, and that no one really ever called them on it either on the Supreme Court or in the briefing.

Bill of Health: You’ve noted that you didn’t originally take the constitutional challenges to the Affordable Care Act seriously.  Why do you think they were able to gain such traction?

Prof. Elhauge: I think the big problem was that the government never directly rebutted either the claim that purchase mandates were unprecedented or the dreaded broccoli hypothetical.  Instead they tried to evade the question, I guess because they thought it was unfavorable to them, but the iron rule of litigation is that if you don’t discuss your problematic issues, then you leave your opponents to be the only one that discusses them, and they are sure to frame them in the way most unfavorable to you. The government’s unwillingness to engage this issue left the Supreme Court with the entirely false impression that Obamacare fundamentally changed the relationship between the individual and government, and that thus the government faced a heavy burden to justify the health insurance mandate.  I think the government should’ve directly argued that in fact federal purchase mandates were not at all unprecedented, but rather that health insurance mandates went all the way back to the framers, who adopted two health insurance mandates in the 1790s in Congresses that had many framers on them.  The government should’ve also pointed out that the argument that courts can, in the name of “limiting principles”, create brand-new restrictions on congressional power that have no basis in the Constitution in order to restrain the possibility that Congress might exercise a power in a silly way, like adopting a broccoli mandate, amounts to a remarkable usurpation of political power by the judicial branches.  One could equally say that because Congress might pass silly laws like a law prohibiting the purchase of broccoli, the federal courts should impose a new constitutional limit that prevents Congress from ever restricting commerce. Or because Congress might tax 100% of our income to buy broccoli or go to war to get more broccoli, the Supreme Court should invalidate Congress’s power to tax or declare war.  The “limiting principles” argument that was employed here ironically has no limiting principle and looks benign but is actually a wolf in sheep’s clothing.

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