Last Year Was A Wild One For Health Law — What’s On The Docket For 2015?

A new blog post by Greg Curfman, Holly Fernandez Lynch and I. Glenn Cohen on the Health Affairs Blog:

Everywhere we look, we see the tremendous impact of new legal developments—whether regulatory or statutory, federal or state—on health and health care. These topics range from insurance to intellectual property to religion to professionalism to civil rights. They remain among the most important questions facing Americans today.

This post is the first in a series that will stem from the Third Annual Health Law Year in P/Review event to be held at Harvard Law School on Friday, January 30, 2015. The conference, which is free and open to the public, brings together leading experts to review major developments in health law over the previous year, and preview what is to come.

Read the full post here, and register for the Third Annual Health Law Year in P/Review for free here.

Next Friday (1/30): Third Annual Health Law Year in P/Review

P-Review_2015_poster_with_borderJanuary 30, 2015 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East AB
1585 Massachusetts Avenue, Cambridge, MA

Please join us for the Third Annual Health Law Year in P/Review symposium, with leading experts discussing major developments during 2014 and what to watch out for in 2015. The discussion at this day long event will cover hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients.

The full agenda with speakers is available on our website.

Attendance is free and open to the public, but space is limited and registration is required. Please register here. Contact petrie-flom@law.harvard.edu with questions.

Federal Newborn Screening Law Emphasizes Informed Consent

Allison M. Whelan, J.D.
Senior Fellow, Center for Bioethics and Global Health Policy, University of Minnesota 
Guest Blogger

On December 18, 2014, President Obama signed into law the Newborn Screening Saves Lives Reauthorization Act of 2014. The Act includes new timeliness and tracking measures to ensure newborn babies with deadly yet treatable disorders are diagnosed quickly. These changes responded to a Milwaukee Journal Sentinel investigation that found thousands of hospitals delayed sending babies’ blood samples to state labs.  A primary purpose of newborn screening is to detect disorders quickly, so any delays increase the risk of illness, disability, and even death.

Although a major reason for the Act’s amendments is to address these problematic delays, another important addition to the Act establishes a parental consent requirement before residual newborn blood spots (NBS) are used in federally-funded research. The Act directs the Department of Health and Human Services (HHS) to update the Federal Policy for the Protection of Human Subjects (the “Common Rule”) to recognize federally-funded research on NBS as “human subjects” research. It also eliminates the ability of an institutional review board to waive informed consent requirements for NBS research.

Continue reading

Concussion laws lead to increase in health care utilization

By Christine Baugh

Between 2009 and 2014 all U.S. States and the District of Columbia implemented concussion legislation. Generally modeled after Washington State’s Zachery Lystedt Law, most of these statutes require that youth and adolescent athletes are provided with information about concussions prior to sports participation, that they are removed from play if they are suspected of having sustained a concussion, and that they receive clearance from a medical professional prior to returning to sports participation. One of the main purposes of the Zachery Lystedt Law, and presumably those laws modeled after it, is to prevent the catastrophic neurological injury that can occur when a youth athlete returns to play too quickly following a concussion.

Gibson and colleagues recently published their study “Analyzing the effect of state legislation on health care utilization for children with concussion,” in JAMA Pediatrics. This study compared concussion care utilization for adolescents age 12 to 18 in states with and without concussion legislation using an insurance claims database. After controlling for potentially confounding factors such as median income and number of insured individuals per state, Gibson et al. found that states that had implemented concussion legislation had increased concussion care utilization (92% increase) compared to those without legislation (75% increase). The increases in care utilization were driven primarily by increases in visits to the doctor’s office and to a neurologist, not through increases in emergency department care, which the authors described as encouraging.

Continue reading

The People of the State of New York v. Actavis: Making a Hard-Switch Procompetitive

Actavis is back in the spotlight regarding its allegedly anticompetitive behavior. Last month, the U.S. District Court for the Southern District of New York issued an injunction against Actavis and its subsidiary, Forest Laboratories LLC based on the New York Attorney General’s “product hopping” suit.

The suit concerns Actavis’ attempt to extend monopoly protection for its drug Namenda. Namenda is one of only a few FDA approved drugs to treat Alzheimer’s disease, and the only approved drug in a class of medications that act on the glutamatergic system by blocking NMDA receptors. Namenda is also Actavis’ largest revenue generating drug; it brought in $1.5 billion in sales last year. Unfortunately for Actavis, Namenda’s patent protection is due to expire in 2015. Once the patent protection for Namenda has expired, Actavis should ordinarily expect to see a dramatic reduction in sales revenue, as much as 90% in the first year, as consumers switch to a lower-cost generic version.

Continue reading

Access to Drinking-Water as a Fundamental Human Right

by Martín Hevia

Access to drinking-water is obviously necessary to lead a healthy life. However, in Latin America, many lack access to this vital resource.

Very recently, in December 2, the Argentine Supreme Court discussed the legal status of access to drinking-water in the Argentine legal system (the case is “Kersich, Juan Gabriel y otros c/Aguas Bonaerenses y otros s/amparo”). The Argentine Constitution does not explicitly recognize a right to have access to drinking-water. The Court discussed the claim of citizens of 9 de Julio against “Aguas Argentinas,” which was allegedly providing water with levels of arsenic higher than those allowed by Argentine law. In deciding the case, with the vote of 4 of the 5 Supreme Court judges, the Court reached two important conclusions.

First, invoking General Comment 15 on the right to water of the UN Committee on Economic, Social, and Cultural Rights, the Court concluded that Access to drinking water is a fundamental human right: it is necessary to lead a life with dignity, as well as necessary to fulfill other human rights, mainly, the right to health. The Court also invoked human rights treaties incorporated to the Argentine Constitution such as the Convention on the Rights of the Child - its Article 24.2.c mandates providing clean drinking water to combat disease.

Second, the Court held that the provision of drinking-water is a community interest. Thus, the right to access to drinking water is a “collective right” (the Spanish term is “derecho de incidencia colectiva”): drinking water is one of the elements of the environment, which is collective good under Section 41 of the Argentine National Constitution.

Although the Court discussed the particular claim of the inhabitants of 9 de Julio, and it ordered lower courts to analyze again the case on the basis of the aforementioned two conclusions, it is worth asking about the legal implications of this decision for the Argentine legal system. The decision of the Court expressly recognizes access to drinking water a collective constitutional right. This means that, from now on, inhabitants of Argentina will be able to file collective claims to demand both the Federal and the Provintial States that they make access to drinking-water a priority. Not doing so will entail not taking the Constitution seriously.

Do hospitals have a role in population health?

Population health advocates have identified health care providers, and hospitals in particular, as key allies in the effort to create better health and longer lives for Americans nationwide. Despite a growing interest in “community-based’ models of care, hospitals remain the most visible component of the US health care system. What’s more, hospitals are where the money, not to mention many of leading brains and cultural authority, reside. Of the 17.4% of GDP that the United States invests in health care, roughly 30% goes to hospitals – more than any other spending category. Hence why people interested in population health wish to have hospitals on board as they aim to address the always-challenging social, behavior and environmental determinants of health.

But the question remains open: do hospitals really have a role in the pursuit of population health?  Continue reading

The Beginning of the Broccoli Mandate?

By Deborah Cho

In National Federation of Independent Businesses v. Sebelius, 132 S. Ct. 2566  (2012), the Court famously struck down the “individual mandate” of the ACA under the Commerce Clause.  The Chief Justice noted that the Government’s argument for regulation under the Commerce Clause — that individuals were participating in interstate commerce by not purchasing health insurance and were thereby subject to regulation — “would justify a mandatory purchase to solve almost any problem.”  He continued, “To consider a different example in the health care market, many Americans do not eat a balanced diet.  [The] failure of that group to have a healthy diet increases health care costs, to a greater extent than the failure of the uninsured to purchase insurance . . . Under the Government’s theory, Congress could address the diet problem by ordering everyone to buy vegetables.”

This hypothetical was raised as an example of a potential absurd result of accepting the Government’s line of reasoning in this case.  It was provided as an extreme outcome to catch the reader’s attention.  Justice Ginsburg even responded to this “broccoli horrible” hypothetical by stating that the Court would have to accept a lengthy chain of inferences, something that the Court has refused to do in the past, to find that a vegetable-purchase mandate would affect health-care costs.  Some of those inferences included accepting that individuals would eat the vegetables rather than throw them away once purchased, that they would cut back on other unhealthy foods, and that the healthy diet would not be offset by an individual’s lack of exercise.  In addition to this piling of inferences, Justice Ginsburg noted that the democratic process would serve as a “formidable check” to prevent a situation such as the broccoli horrible.   Discussions about this broccoli mandate outside the courtroom were framed similarly.  One article from 2012 stated that Congress would need to be “crazy” to pass such legislation and that “absurd bills like a broccoli mandate are likely to fail other constitutional tests.”

Yet, here we are, just a couple years later, and it seems that some of the weakest and most vulnerable in our population have indeed found themselves in the midst of the broccoli horrible.  Continue reading

College Athletic Trainers Report Being Bullied

By Christine Baugh

A recent study indicates that college athletic trainers feel bullied on the job. The study, published in the Journal of Athletic Training, surveyed 723 collegiate athletic trainers, and found that approximately 15% of them felt that they were the victim of workplace harassment and about 20% had witnessed an instance of workplace bullying. Although there were no differences found in who was bullied, the bullies were identified as predominantly male and were most often coaches. A related examination of the perceptions of bullying in this environment, consisting of semi-structured qualitative interviews with select collegiate athletic trainers, identified structural factors associated with increased bullying and suggested workplace training as a potential solution.

The findings of these studies are in line with previous work describing the college sports medicine working environment as fraught with conflicts of interest (discussed in a previous blog post: here). However, the prevalence of bullying found in this study is actually lower than found in other studies examining bullying in other medical workplaces. That said, NCAA guidance suggests that medical professionals, including athletic trainers, should be given “unchallengeable authority” with regards to medical decision-making in the college sports medicine setting. Bullying in the college sports medicine setting occurred more frequently, according to the recent studies, when there was administrative indifference that allowed individuals who “lack respect for the athletic training professional” to act on his feelings.

Given the primary role of the athletic trainers as healthcare providers in the college sports medicine setting, it is possible that the hostility experienced in the workplace ultimately affects collegiate athlete health outcomes. Future research examining the interaction between athletic trainer workplace experience and athlete health outcomes is needed, as are interventions to ensure that athletic trainers are allowed to provide healthcare to collegiate athletes without external impediment.

The Ethics of Using Placebo Controls in Ebola Clinical Trials

[Blogger's Note: I am very pleased to share this post by my colleague at Seton Hall Law, Carl Coleman. This post was cross-posted at Health Reform Watch.]

By Carl H. Coleman

With well over 5,000 global deaths from Ebola already reported, drug developers are working fast to begin human clinical trials of promising experimental treatments.  Earlier this month, US government officials announced plans to launch a study of multiple Ebola interventions at the NIH Clinical Center, Emory University, and the University of Nebraska.  Shortly thereafter, the international relief organization Médecins sans Frontières (MSF) announced that it would soon begin testing of three experimental interventions at its treatment centers in West Africa, in collaboration with a coalition of European partners and the World Health Organization.

As predicted in an earlier blog post, a major area of contention in these trials involves the ethical acceptability of using placebo controls.  Plans for the US study are to give some participants the experimental drugs and others placebos, with everyone receiving the best supportive care available, such as fluid replacement and medications to fight off other infections.  In the MSF trials, by contrast, none of the participants will be given placebos; instead, everyone will receive one of three different experimental interventions.

From a methodological perspective, it is easy to see why the designers of the US study have chosen to use placebos.  Placebo-controlled trials are widely considered the “gold standard” of clinical research.  Using placebos makes it possible to identify the extent to which observed outcomes in participants are the result of the experimental intervention, as opposed to factors such as access to better health care facilities, receipt of supportive care, or psychological expectations (the so-called “placebo effect”).  Continue reading

Protect Those Who Protect Our Food

Check out a new op-ed by our friends, Jacob E. Gersen and Benjamin I. Sachs at Harvard Law School!

CAMBRIDGE, Mass. — EVERY year, 5.5 million people are sickened by norovirus, a highly contagious gastrointestinal bug. According to the Centers for Disease Control and Prevention, norovirus is the leading cause of food-borne illness in the United States and is spread primarily by “infected food workers.” Last year cooks, waiters and other workers were involved in about 70 percent of the outbreaks.

This is just one example of the critical role that food workers play in our nation’s economic and public health systems. And yet, while we often tailor employment rules for work that has a special impact on the public, the law has yet to recognize food workers as a distinct class — an approach that harms consumers, the economy and the workers themselves.

Sick restaurant workers provide a particularly vivid example of the kind of legal reform that’s needed. Until recently, very few restaurant workers had the legal right to paid sick time, which meant that many of them went to work very ill (last week voters in Massachusetts and three cities passed paid-sick-leave laws). Federal law can fix this problem by requiring employers to provide their workers with paid time off. [...]

To read the full op-ed, please click here.

Health and Wealth

By David Orentlicher
[Cross-posted at Health Law Profs blog]

A number of studies have suggested that education, wealth, and other socioeconomic factors are more important than health care in promoting a person’s health. Earlier this week, NPR reported on a study of welfare payments that reinforces the link between income and health. Researchers studied children whose families received benefits through the Mothers Pension Program between 1911 and 1935. Compared to children in families that did not receive program benefits, the children of recipients lived longer, and their longer lives might reflect the fact that they stayed in school longer and earned higher incomes during their working days.

European Responses to the Ebola Crisis, Part I: Initiatives at the European Medicines Agency (EMA)

By Timo Minssen

The current Ebola outbreak already attracted much attention on “Bill of Health” resulting in some excellent blogs on a horrible topic.

While it is evident that the current health crisis requires both immediate responses and more sustainable changes in health care policy, research and regulation, medicines regulators are collaborating internationally to find innovative solutions enhancing evaluation of and access to potential new medicines to fight Ebola outbreaks. In a statement announced by the International Coalition of Medicines Regulatory Authorities (ICMRA) in September 2014, regulators around the world led by the FDA and the EMA have vowed to collaborate in supporting accelerated evaluation of experimental new drugs to treat Ebola virus infections and say they will encourage submission of regulatory dossiers. This clearly backs up the World Health Organization’s (WHO) decision to test experimental Ebola treatments in infected patients in the current outbreak region in West Africa and to speed up the development of vaccines.

In the following I would like to summarize and discuss some of the recent European responses to the current crisis starting with an overview on recent initiatives at the EMA.

Like its US counterpart, the EMA leads a close and consistent dialogue with public and private developers of Ebola products and spends much effort in reviewing available information on the various experimental Ebola treatments currently under development. These experimental drugs range from experimental antivirals or vaccines based on the adenovirus or stomatitis vaccine to experimental therapies based on mono- and polyclonal antibody technologies. One of these unapproved antibody combination drugs – MAPP Biologicals’  ZMapp – has already been used in some care workers affected by Ebola. Other experimental drugs that are currently reviewed by the EMA include Biocryst’s BCX 4430, Fab’entech’s Hyperimmune horse sera, Sarepta’s AVI-7537, Toyama Chemicals and MediVector’s Favipiravir and Tekmira’s TKM-Ebola.

Other companies such as Bavarian Nordic  and the Russian Mikrogen are close to follow.

In addition to monitoring experimental drugs and enhancing global collaboration, the European Medicines Agency has like the FDA initiated several activities in order to support and speed up the development of these drugs towards market approval.  Continue reading

Call for Proposals: The 2016 Brocher Foundation Residencies

By Timo Minssen

I have just been informed that a new call for proposals for the 2016 Brocher Foundation residencies has been launched. I can warmly recommend this splendid opportunity to any researcher or group of researchers in the fields of Bioethics, Medical Anthropology, Health Economics, Health Policy, Health Law, Philosophy of Medicine and Health, Medical Humanities, Social Science Perspectives on Health, Medical Ethics, or History of Medicine.

A grant by the Brocher Foundation enables international researchers to carry out their projects for a 1-4 month period at one of the most beautiful places in Europe. The Brocher Foundation’s seat is located in Switzerland at the shores of the beautiful Lake Geneva. The location is very close to the French border and to international organisations particularly relevant to the health sector, such as WHO, WTO, WIPO, UNHCR, ILO, WMA, ICRC, and others.

The following information has been extracted from the webpage of the Brocher Foundation:  Continue reading

Addressing the Dearth of Data on Fetal Death: The Role of Hospitals*

By Kate Greenwood
[Cross-posted at Health Reform Watch]

As I have blogged about before, including last year here, research and public health interventions aimed at preventing stillbirth are stymied by a dearth of data. In an article in this month’s Maternal and Child Health Journal, Erica Lee and colleagues at New York City’s Bureau of Vital Statistics evaluate data collection by New York City hospitals before and after the city’s implementation, in 2011, of the 2003 United States Standard Report of Fetal Death. The Standard Report aids reporters by setting forth “a series of checkboxes for potentially fatal fetal and maternal conditions.” Unfortunately, Lee’s research reveals a persistent and widespread failure to collect basic information when a baby dies in utero.

In New York City, Lee found, “fetal death reports frequently supplied ‘intrauterine fetal demise’, ‘stillbirth’, or other inadequate terms as causes of death.” As Lee points out, words and phrases like this, which merely describe what happened without assigning a cause to it, do not inform public health research. In many cases, of course, what caused a stillbirth truly is unknown. Prior research suggests that this is true 10-40% of the time. In New York City, though, even after the implementation in 2011 of the Standard Report, the percentage of reports with ill-defined causes of fetal death remained troublingly high, at 61%. There was also substantial variation from hospital to hospital. The hospitals that were the best reporters assigned a specific cause 87% of the time, while the worst assigned a specific cause 0% of the time.

As Lee and her colleagues explain,

“public health research aimed at preventing fetal deaths is substantially limited by the data available, particularly poorly-defined and nonspecific causes of fetal death. These data quality concerns have forced researchers to conduct resource intensive cohort studies and/or time consuming chart audits to fully understand the causes behind fetal deaths rather than relying on the more readily-available and routinely collected fetal death records.”

Lee suggests that the variation that exists between hospitals represents an opportunity for improvement, which leads to the question of what policy levers could be used to bring all hospitals up the level of the top performers.  Continue reading

Will the Real Evidence-Based Ebola Policy Please Stand Up? Seven Takeaways From Maine DHHS v. Hickox

By Michelle Meyer

Ebola pic

The case I mentioned in my last post, Maine Department of Health and Human Services v. Kaci Hickox is no more. Hickox and public health officials agreed to stipulate to a final court order imposing on Hickox the terms that the court had imposed on her in an earlier, temporary order. Until Nov. 10, when the 21-day incubation period for Ebola ends, Hickox will submit to “direct active monitoring” and coordinate her travel with Maine public health authorities to ensure that such monitoring occurs uninterrupted. She has since said that she will not venture into town or other public places, although she is free to do so.

In a new post at The Faculty Lounge,* I offer a detailed account of the case, which suggests the following lessons:

  1. As Hickox herself described it, the result of her case is a “compromise,” reflecting neither what Hickox nor what Maine initially wanted.
  2. That compromise was achieved by the parties availing themselves of the legal process, not through Hickox’s civil disobedience.
  3. The compromise is not easily described, as it has been, as a victory of science-based federal policy over fear-based state demagoguery. By the time the parties got to court, and perhaps even before then, what Maine requested was consistent with U.S. CDC Guidance, albeit a strict application of it. What Hickox had initially offered to do, by contrast, fell below even the most relaxed application of those guidelines, although by the time the parties reached court, she had agreed to comply with that minimum.
  4. The compromise applies only to Hickox, and was based on a stipulation by the parties to agree to the terms that the court had temporarily imposed after reviewing a limited evidentiary record. Additional evidence and legal arguments that the state might have raised in the now-cancelled two-day hearing could have resulted in a different outcome.
  5. A substantially different outcome, however, would have been unlikely under Maine’s public health statute. Indeed, it is not clear that Maine’s public health statute allows public health authorities to compel asymptomatic people at-risk of developing Ebola to do anything, including complying with minimum CDC recommendations.
  6. “Quarantine” is a charged, but ambiguous, term. It allows us to talk past one another, to shorthand and needlessly politicize a much-needed debate about appropriate policy, and to miss the fact that the CDC Guidance in some cases recommends what could be fairly described as a “quarantine” for people like Hickox and requires it for asymptomatic people with stronger exposure to Ebola (but who are still probably less likely to get sick than not).
  7. It’s not clear who has bragging rights to Ebola policy “grounded in science,” or what that policy looks like.

* The piece is quite long, and I cannot bear the fight with the WordPress formatting demons that it would require to cross-post it here.

From Harvard Effective Altruism: Upcoming (Nov. 17): Steven Pinker on “The Past, Present, and Future of Violence”

Harvard College Effective Altruism presents:

The Past, Present, and Future of Violence
with Steven Pinker

Monday, November 17th, 7 PM
Science Center D
RSVP here.

Pinker

Contact Harvard College Effective Altruism at harvardea@gmail.com.

The Constitutional Implications of Ebola: Civil Liberties and Civil Rights In Times of Health Crises

Join us for an important public forum:

Constitutional Implications of Ebola:
Civil Liberties & Civil Rights In Times of Health Crises

This public forum addresses the constitutional and public health implications of Ebola response in the United States.  According to state and federal laws, patient information is deemed private and is to be held in strict confidentiality.  However, in the wake of Ebola, well-established protocols to guard patient privacy have been neglected or suspended without public debate.  At this forum, a panel of experts raise questions not only about how to contain the disease, but also to what extent Americans value their healthcare privacy, civil liberties, and civil rights.  To what extent are Americans’ Ebola fears influenced by the origins of the disease?  What liberties are Americans willing to sacrifice to calm their fears?  How to balance the concern for public welfare with legal and ethical privacy principles?

Speakers: Reverend Jesse L. Jackson, Sr.;  Michele Goodwin, Chancellor’s Chair, UC Irvine School of Law;  Professor Andrew Noymer, UC Irvine School of Public Health; and Dr. George Woods, American Psychiatric Association.

This Forum intervenes in the current national and international discourse on Ebola by probing law’s role in addressing public health crises.  This forum is free and open to the public.

WHEN: Wednesday, November 19, 2014, 3.30pm-5.30pm

WHERE: University of California Irvine, School of Law; ROOM EDU 1111, 401 E Peltason Dr, Irvine, CA 92612