Month: December 2013


Uncertain Future for the Same-Specialty Law in Florida

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By Alex Stein

Florida statute, § 766.102(12) (2012), lays down a strict same-specialty requirement for expert witnesses supporting medical malpractice allegations. Specifically, it provides that “If a physician licensed under chapter 458 or chapter 459 or a dentist licensed under chapter 466 is the party against whom, or on whose behalf, expert testimony about the prevailing professional standard of care is offered, the expert witness must be licensed under chapter 458, chapter 459, or chapter 466 or possess a valid expert witness certificate issued under s. 458.3175, s. 459.0066, or s. 466.005.”

The Florida Bar Code and Rules of Evidence Committee recommended the Florida Supreme Court to adopt this statutory provision “as a rule of procedure to the extent that it is procedural.”

The Board of Governors recommended the Court to reject the Committee’s proposal “on the grounds that the provision is unconstitutional, will have a chilling effect on the ability to obtain expert witnesses, and is prejudicial to the administration of justice.”

The Court declined to follow the Committee’s recommendation due to the concerns raised. See here. The Court had another good reason for declining to adopt this recommendation: the provision in question is substantive rather than procedural. See here. 

Sleep versus Training: The NY Times on Surgical Work Hours

I. Glenn Cohen Leave a comment

Pauline Chen at the NY Times Blog has an article on cut backs on the number of hours of training for young surgeons.

According to her story:

“For the past decade, in response to increasing pressure from politicians, unions and sleep experts, the Accreditation Council for Graduate Medical Education, the organization responsible for accrediting American medical and surgical training programs, has been working to cap the hours that residents work. In 2011 the council passed the strictest limits yet. To maintain their accreditation, residency training programs had to abide by a 22-page set of scheduling rules that limited all in-hospital work including any elective “moonlighting” jobs to 80 hours per week, mandated the number of hours “free of duty” after different “duty periods” (eight hours off after 16-hour duty periods and 14 hours off after 24-hour duty periods) and even specified the timing of “strategic napping” in no uncertain terms (after 16 hours of continuous duty and between the hours of 10 p.m. and 8 a.m.).

While most residency programs chafed under the exhaustively detailed regulations, surgical training programs had particular difficulty adopting the new mandates. For nearly a century, surgical residency had been a period of both intensive experience and increasing responsibility under the guidance of more experienced surgeons. More recent research has affirmed that approach, demonstrating the strong link between a surgeon’s operative skill, the number of operations performed and patient outcomes. With limits set on their time at the hospital, young surgeons-in-training had fewer opportunities to care for patients or scrub in on operations. While previous generations of trainees had the luxury of participating in at least one operation a day, new trainees had only enough time to be involved in two or maybe three operations each week.

Calculating the number of hours “lost” by cutting back on in-hospital time, surgical leaders estimated that young surgeons-to-be were now missing out on as much as a year’s worth of experience”

She relies heavily on an new Annals of Surgery Article, wherein, as Chen reports,

“Researchers sent questionnaires to the directors of subspecialty fellowship training programs and asked them to comment on the bedside and operating skills of the young surgeons enrolling in their programs. These fellowships are a kind of high-level and often prestigious surgical “gap year” where young surgeons who have completed the basic five-year surgery residency can delay independent practice to pursue an additional year or two of training.

The results were abysmal. Fewer than half of the young surgeons could operate or make clinical decisions on their own. Nearly a third of them were incapable of performing even the most basic operations like a gallbladder removal on their own. And a quarter were unable to recognize the early signs of complications.

Even in areas of surgery where the young surgeons had had supplementary online learning modules during their residency, they performed poorly, with more than half unable to perform basic maneuvers.”

While acknowledging that “some observers have criticized the study for being self-serving – most respondents also noted that the young surgeons’ deficiencies resolved after additional training under their auspices —” Chen’s article reads largely as an attack on these new residency work hour rules.

Since I have written on the subject of these residency work hour rules with sleep specialists earlier this year in the Journal of Law, Medicine, and Ethics, it may be unsurprising that I take a somewhat different view.

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Down with Antipaternalism!

Scott Burris 2 Comments

As the holidays approach, I have a chance to catch up on reading.  The Sept-Oct issue of the Hastings Center Report had a paper by Larry Gostin on Michael Bloomberg’s health policy career in New York, and I have seen some of a series of responses by other scholars that will appear in due course. With his usual facility, Gostin recounts the story of Bloomberg’s health department and its innovations in policy – it’s a great piece for a health law class.  The piece is also typical Gostin in its framing of the issue of paternalism as a key driver of opposition to many of Bloomberg’s initiatives.  And if it is typical Gostin, it is really representative of our field, since Gostin has both drawn on and helped reinforce a widely held belief that the politics of public health are strongly driven by a tension between individual liberty (inscribed legally in civil rights and culturally in individualism and antipaternalism) and public health.

In this framework, paternalism is a premise, not a hypothesis. Gostin writes, “The societal discomfort with Bloomberg’s agenda is grounded, at its core, in distrust of government influence on how autonomous adults conduct their lives.” He describes how health policy-makers are driven to rely on the harm principle to justify policies by “American antipathy toward paternalism.”  Yet, and this is also typical of the discourse in our field, he also follows the Sunstein-Thaler line that ultimately denies the empirical assumptions upon which anti-paternalist claims depend: “The public health approach rejects the idea that there is such a thing as unfettered free will, recognizing instead that the built environment, social networks, marketing, and a range of situational cues drive complex behaviors.”

Public health law has been stuck here for a while, accepting that public health policy has and always will be subject to the arbitrary dominion of a mass delusion of autonomy.  I think this log-jam is starting to break – and that proponents of effective health laws should be doing all they can to properly discredit and abandon this old trope.  A few signs:

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Two Pills: “That Will Be $307,000, please.”

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By Christopher Robertson

So reads the cover of the MIT Technology Review this month.  The article is available for free online.  The article begins with the story of Kalydeco, which is priced at $294,000 per year.

The company also pledged to provide it free to any patient in the United States who is uninsured or whose insurance won’t cover it. Doctors and patients enthusiastically welcomed the drug because it offers life-saving health benefits and there is no other treatment. Insurers and governments readily paid the cost.

Hold on.  If patients can get the medicine for free even when their insurers decline to pay the cost, why would insurers “readily pay the cost?”

Petrie-Flom Intern’s Weekly Round-Up: 12/9-12/16

The Petrie-Flom Center Staff 2 Comments

By Chloe Reichel

1) In developing nations, tobacco companies are trying to prevent regulation of their products. They claim that tobacco laws are in violation of trade treaties.

2) In a report released on Thursday, researchers found that gun violence is most effectively addressed as a public health issue. Suggested policies include school programs on conflict resolution and better background checks.

3) In the past year, 36 states have dedicated more funding to mental health issues. While Congress hasn’t passed any legislation on mental health, the Obama administration has published a set of mental health parity rules.

4) Children five and under living in New York City and attending city-licensed preschools and day care centers are required by law to receive a flu vaccination. The Autism Action Network is already planning to sue over this bill.

5) This Wednesday, the FDA approved recommendations that limit the use of specific antibiotics in raising livestock. According to these recommendations, manufacturers of these antibiotics can voluntarily change the uses on the labels of the drugs, so that they cannot be prescribed to speed up animal growth.

6) Testifying in front of Congress, Kathleen Sebelius, Secretary of Health and Human Services, said that an investigation into the failure of Healthcare.gov has been launched. In her testimony, she emphasized that the problems of the website are no longer occurring, and encouraged people to use the site.

A new framework for considering the contraceptives mandate cases?

Holly Fernandez Lynch Leave a comment

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

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

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

Managing All Care

The Petrie-Flom Center Staff Leave a comment

By Nathaniel Counts

Health insurers are beginning to realize the importance of downstream cost-saving.  By paying to keep people healthy now, health insurers avoid major expenditures later when they must cover chronic conditions and hospitalizations.  For example, by paying for nutrition counseling and fitness programs for prediabetics, health insurers can reduce the rate of transition to diabetes for their clients, which both saves the insurer thousands of dollars and keeps their clients happier and healthier.   This type of innovation is possible because the law requires certain expenditures, i.e. doctors must treat individuals at the emergency room, and these expenditures tend to be quite large if incurred.

Social services in general could enjoy this type of innovation if funding were pooled between government services, and healthcare, housing, food, and direct welfare were all managed together.  Currently, each is conceived as a separate welfare program, so one can only recognize reduction within a program, not how the programs interact.  For example, it may be that the expansion of SNAP benefits would decrease emergency room visits and end up being cost-saving overall.  It may also be that certain types of subsidized housing reduce the need for other services and are more cost-saving than others, but this is hard to recognize when each program is segregated.  One could imagine that subsidized housing built in areas with better access to quality food and jobs would be more expensive upfront, but could save in money overall by reducing the need for other benefits.  Because social services currently have a system of mandatory spending in the form of entitlements, there is an incentive to ensure that individuals transition away from use of the more expensive services.

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Conflicts of Interests and the Goals of Translational Medicine

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By Matthew L Baum

There are many ways to drive medicine forward. One is to work to remove economic, political, or geographic barriers to accessing care, and thus aid those whose suffering can be assuaged but is not being so. Another is to work to develop treatments for types of suffering poorly eased (or addressed) by current care. Both are important. Serious pursuit of the second strategy, however, requires the participation of industry; to translate bench science into benefits for real people will usually require manufacture of new medicines or devices, a function that universities and public institutions do not do but industry does well.

But for those students, like myself, currently training in MD-PhD programs in hopes of pursuing this goal of translational medicine, it is not at all clear what attitude we should take towards industry. On the one hand, the vision to move science from bench to bedside would seem best served by those clinician-scientists who do not see publication as the end result but are devoted to responsibly guiding their discoveries into the industrial setting and propelling them to patients. On the other hand, connections between industry and academia are often described categorically as “conflicts of interest” that must be disclosed and ideally divested. I will not attempt to comment here on the events that have led to a prima facie (pharma facie?) negative valence of academic-industrial connections; I was struck to hear, however, one of the panelists (an academic) on a recent panel discussion on translational medicine open with a slow and measured statement affirming her belief that collaborations between academics and industry can be a “good thing.” She then paused, as if to let the shock of the statement permeate the audience.

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