Another Blow to Nursing Home Arbitration Agreements

By Alex Stein

Most, if not all, nursing homes have their residents sign an agreement to arbitrate any dispute or disagreement arising out of or in connection with the care rendered to the resident by the nursing home, including claims by the resident involving, and/or arising out of conduct committed by the nursing home and/or its agents, employees, or others for whom and/or which the nursing home is, may be, or is asserted to be, legally responsible. Such agreements also stipulate that they will apply to and bind any and all persons and/or entities who and/or which may assert a claim on behalf of, or derived through, the resident, including, without limitation, the resident’s legal representative, guardians, heirs, executors, administrators, estate(s), successors and assigns.

Ostensibly, such agreements compel arbitration on the resident’s survivors who claim that the resident died prematurely as a result of the nursing home’s neglect. The Federal Arbitration Act (FAA), as interpreted in AT&T Mobility LLC v. Concepcion, 131 S. Ct. 1740 (2011), seems to support this observation. This Act requires state and federal courts to enforce arbitration agreements similarly to other contracts. Pursuant to this Act, when a resident’s survivor files a wrongful death suit against the nursing home, the court must stay the proceeding and direct the parties to arbitration.

However, a recent decision of the Oklahoma Supreme Court, Boler v. Security Health Care, L.L.C., — P.3d —- (Okla. 2014), has shown that this appearance is misleading. Continue reading

Should Foreigners Be Allowed to Be Listed for U.S. Organs and Other Questions about Organs Without Borders

 

I have a new paper in a theme issue of Law and Contemporary Problems (one of two, I’ll post the second as well when it is available) titled Organs Without Borders? Allocating Transplant Organs, Foreigners, and the Importance of the Nation State (?) This paper is related to but separate from my work on medical tourism, which has dealt among other things with “transplant tourism,” such as traveling abroad to buy a kidney.  In this work I deal with the legally sanctioned distribution of organs. It will surprise many that in the U.S. a non-resident and non-citizen may be listed on the wait list for an organ for transplantation and if he or she is so listed he or she must, as a matter of law, be given the exact same priority as a similarly situated U.S. citizen-resident. Is that policy just or unjust. These are among the topics I tackle in this article. Here is the full abstract:

Most of the discussion of market or non-market forms of allocating and procuring organs takes as its unit of analysis the nation state, or, less commonly a particular state or province, and asks what should the system look like as to this unit. In this article, the second of two articles I contribute to this issue of Law and Contemporary Problems, I want to expand the viewfinder and examine an issue that has received peculiarly little attention in the scholarly and policy discourse: the desirability of treating the nation state (or its subdivisions) as the right level of distribution for organs, whether through market systems or non-market allocation systems. I will show that when we flirt with using a more global viewfinder, a series of difficult (and thus far largely unexplored) ethical and regulatory questions arise relating the inclusion of “outsiders.” At the very end of this article I explore what relevance this analysis may have to allocation within the nation-state as well.A large number of questions could be discussed under this title, but for this article I largely limit myself to two related questions. For both I will use the U.S. as the “home country” for rhetorical clarity, but the basic issues are the same for any home country. The first issue is: Should the U.S. allow “foreigners” to be on the list of those eligible to receive organs in the U.S. when they become available, and, if so, at what level of priority? Surprisingly the current law allows them to be listed to receive organs and if they are so listed it prohibits any discrimination against them for priority based on their being foreign. Second: should the U.S. maintain its own organ distribution network that is limited to the nation state instead of participating in a more globalized system? I should emphasize that my interest here is organs that come to recipients through typical government-run (or at least government-approved) organ allocation systems rather than foreigners who come to U.S. centers and bring their own living donor.

I first describe the two issues and then offer a normative analysis of each. This cluster of issues applies equally to the current U.S. distribution system with its hostility to markets and any of the potential alterations discussed in other articles in this issue of Law and Contemporary Problems.

Continue reading

Upcoming Medicare Forum on Appeals Backlog, Posts

Next week (on October 29) Medicare’s Office of Medicare Hearings and Appeals (OMHA) is holding another appellant forum to discuss the ongoing backlog of Medicare claims waiting for a hearing.  In one sense, a lot has happened since the last forum in February (I covered that here): OMHA announced pilot projects to try statistical sampling and facilitated settlement in some cases (see here and here); CMS (effectively the “defendant” for settlement purposes in these appeals; functionally independent from OMHA) announced a willingness to settle a subset of pending inpatient hospital billing claims for 68 cents on the dollar (see Nick Bagley’s post at the incidental economist); the backlog came up at a couple congressional hearings; and two lawsuits were filed to challenge it, one by providers (see here) and another by beneficiaries (see here).

In another sense, not that much has happened. Unless Thursday’s forum brings big news—and I know that OMHA and CMS have been working hard on reforms so perhaps it will—there is still a big backlog of Medicare appeals, there is still not a resource fix in sight, and the influx of Medicare appeals seems to still far outstrip OMHA’s capacity to hold hearings.

In advance of the forum, I’m planning a series of posts offering my thoughts, such as they are, on where we are and where we are going. I invite anyone who disagrees or thinks I’ve gotten something wrong to post their own views in the comments. Or you can email me and I will look into sharing your thoughts as an independent posting. You can get all my posts on this subject, including new ones as they come in, by clicking here.

A caveat: I’m approaching these as blog posts—trying to get my educated thoughts based on everything I have read out in a timely way—but I might be missing something. If the upcoming forum or comments reveal that I am–I won’t be there in person but will be watching remotely–I will either post a general update or go add particular updates in the text of my posts as necessary.

And a disclosure: I’ve said this before but want to do it once more again before pontificating—I worked in government until a little over a year ago, so my views on these matters may be biased. (And of course I will not discuss anything I worked on.)  But I’ve done my best to be objective.

Harvard Effective Altruism: George Church this Monday

 

From Harvard College Effective Altruism:

The Risks of Biotechnology, with George Church

 

Genetic manipulations can reintroduce extinct viruses or create viruses much deadlier than ever before. What are the dangers associated with biotechnology? Can a mistake in a lab lead to a global pandemic? Can this technology be used by terrorists? What would be the implications? And is humanity doing enough to avoid these threats?

 

George Church, Professor of Genetics at Harvard Medical School and the world’s leading expert on synthetic biology and security will share his insights on these issues.

 

Monday, Oct. 20, 5.30pm, Sever 102

George Church event_Harvard Effective Altruism

Egg Freezing and Women’s Decision Making

[cross-posted at Health Law Profs and PrawfsBlawg]

By David Orentlicher

The announcement by Apple and Facebook that they will cover the costs of egg freezing predictably provoked some controversy—predictably because it involves reproduction and also because too many people do not trust women to make reproductive decisions.

Interestingly, the challenge to women’s autonomy can come from both sides of the political spectrum, as has happened with several assisted reproductive technologies. Scholars on the left criticized surrogate motherhood on the ground that surrogates were exploited by the couple intending to raise the child, and other new reproductive technologies are criticized on the grounds that women will feel obligated to use them rather than free to use them. Indeed, this concern about coercion drives some of the objections to egg freezing. Continue reading

Legal Personhood in the New Argentine Civil and Commercial Code

By Martín Hevia

The Argentine Congress has just passed a new and unified Civil and Commercial Code. The new Code will be effective as of January 2016. The Code covers topics from torts and contracts to family law and in vitro fertilization. It is a massive volume of almost 2700 articles – it is, however, shorter than the current Code, which includes almost 4000 articles -.

One of the main issues in the new Code is the definition of legal personhood. Article 19 of the new Code states that “Human personhood starts with conception”. This wording has been strongly critized because “conception” has been frequently defined as “fertilization.” Critics argue that Art. 19 may imply an obstacle for assisted reproductive technologies: in vitro embryos may be considered “legal persons”, comparable to a live human person. Thus, they may be taken to have the same right to life. In fact, this argument has been accepted by some courts. For example, in 2002, the Supreme Court of Argentina prohibited the production, distribution, and commercialization of Imediat, an emergency contraceptive because of its perceived abortive effects it is considered to violate the right to life, which is regarded as an absolute right that preempts any other right.  For the Court, life begins with the union of the gametes, namely, with fertilization and before implantation. A similar line of reasoning was followed by the Ecuadorian Constitutional Court in 2004.

In contrast, defenders of the wording of Article 19 argue that it should be read together with Article 20, which states that “time of conception is that between the maximum and the minimum length of pregnancy”. This may mean that there cannot be conception outside a woman´s body. Thus, conception is to be understood as “implantation.”  Continue reading

Introducing Martín Hevia

Profile-HeviaWe are pleased to introduce our newest contributor, Martín Hevia, to Bill of Health.

Martín (SJD, Faculty of Law, University of Toronto; Abogado, Universidad Torcuato Di Tella, Argentina) is the Executive Dean and Director of the Law Programme (J.D. Equivalent) at the School of Law of the Universidad Torcuato Di Tella (Buenos Aires, Argentina), where he is an Associate Professor of Law. His research and teaching interests include comparative constitutional and private law; health law and reproductive rights; and legal theory and political philosophy.

Professor Hevia has acted as a legal consultant to the Argentine National Congress on the reform, actualization, and unification of the Argentine Civil and Commercial Codes, and as an Expert for the World Health Organization Public Health Law Consultation Group. He was Co Editor-In-Chief of the Journal of Law & Equality (2004-2006) and Editor-In-Chief of Revista Argentina de Teoría Jurídica (1999-2000). He has also served as a Global Fellow at the International Reproductive and Sexual Health Law Programme, University of Toronto (2009) and Fellow in Comparative Law and Political Economy at Osgoode Hall, York University (2008).

At the University of Toronto, he was awarded the Alan Marks Medal to the Best Graduate Thesis of 2006-2007, the 2007 Gordon Cressy Student Leadership Award for extraordinary extra-curricular contributions to university life and was President of the Graduate Law Students’ Association.

Representative Publications:  Continue reading

Death at 29 or 75: Are Manifestos Commitments to Die?

By Kelsey Berry

The news media has been reporting on the role and means of one’s own death more frequently recently, buoyed along by manifestos (Ezekiel Emanuel’s “Why I Hope to Die at 75”, Brittany Maynard’s “Compassion and Choices” Campaign) that have caught the attention of a diverse audience. These declarations are perhaps more connected to one another than we may think.

Just last week on this blog, Lauren Taylor authored an excellent post on new public figure Brittany Maynard – the terminally ill 29-year old woman who relocated to Oregon for access to its death with dignity law, and to end her life with a prescription for a fatal medication. Maynard’s story seems to have struck a chord in part due to her youth. She is the youngest advocate currently featured on the website of Compassion and Choices, the largest organization advocating for end-of-life options in the US (the next youngest is 57 years old). She is also a well-educated, well-traveled, well-spoken individual, supported in her choices by her immediate family and physician. When Maynard states that the remainder of her life, if allowed to come to a natural end as a result of her cancer and without the help of medical intervention, will not be of value (and will actually be of great disvalue) to her, we are inclined to believe her evaluation – and perhaps even the normative implications that Maynard claims should follow.

Another public figure recently claimed that a particular part of life is not of (sufficient) value to him in order to keep living it, either. In September, Dr. Ezekiel Emanuel, director of the Clinical Bioethics Department at the U.S. National Institutes of Health and head of the Department of Medical Ethics & Health Policy at the University of Pennsylvania, published his essay “Why I Hope to Die at 75” in The Atlantic. The part of life he wishes to avoid? An old age marred by disability, functional loss, and relinquishment of the values and expectations of a younger individual. He proposes to adopt (for himself only) active rejection of life-sustaining and life-prolonging heath care, beginning at age 75. The effect? Ideally, death from infection untreated by antibiotics — it’s “quick and painless.”  Continue reading

PhRMA Sues HHS (Again) For Trying To Expand 340B Discounts To Orphan Drugs

For all those who have been following the ongoing fight between pharmaceutical companies and HHS over the 340B Program’s coverage of orphan drugs (I know you’re out there), last week PhRMA filed a new complaint challenging HRSA’s interpretive rule on the subject under the APA. For all those who are not (but should be) paying attention to this battle, here’s what’s happening.

The 340B Program allows certain health care organizations (such as disproportionate share hospitals) to purchase drugs for their patients at significant discounts. The Affordable Care Act expanded the number and kind of organizations that can participate in the 340B Program, but it also added an exception stating that most of the covered organizations could not obtain 340B discounts for orphan drugs — or, as the statute puts it, for “a drug designated … for a rare disease or condition.” 42 U.S.C. § 256b(e).

The battle between PhRMA and HHS is over is whether this statutory exclusion applies to orphan drugs or orphan indications. There are many drugs which have received an orphan designation for certain indications but are also FDA-approved and prescribed more generally for non-orphan indications. In such a case, can a 340B facility purchase the drug at a discount if it is being prescribed for a non-orphan indication?  Continue reading

State Concussion Legislation: Variable Implementation

By Christine Baugh

The most recent issue of the Journal of Law Medicine and Ethics (generously made available for free by the American Society of Law Medicine and Ethics) included several articles examining state concussion laws. One theme that arose across the articles is that although concussion-related legislation is on the books in all 50 states and the District of Columbia, the extent to which it is creating an improvement in youth and adolescent athlete health outcomes is unclear.

In their article titled “State experiences implementing youth sports concussion laws: challenges, successes, and lessons for evaluating impact” Kerri McGowan Lowrey and Stephanie Morain interviewed stakeholders (e.g., officials at state departments of public health, state athletic associations) at a majority of states with concussion laws in order to understand how the laws had been implemented. Although previous research in the area (see, for example: Hosea Harvey’s piece in the American Journal of Public Health) presented concussion legislation as relatively homogenous, McGowan Lowrey and Morain’s approach provided critical insight. They found that while the state laws are relatively uniform in their construction, there is substantial variation in their implementation. In particular, McGowan Lowrey and Morain reported variation in compliance with the statutes, variation in how much stakeholders were included during formative stages in the legislation’s composition, and variation in what constituted concussion education.

In another article in the issue, my colleagues Emily Kroshus, Alexandra Bourlas, Kaitlyn Perry, and I specifically examined the concussion education and acknowledgement provisions of state concussion laws. This investigation was conducted in two parts: first we examined what the statute mandated and then we examined what the high school athletic association and/or department of education in that state actually provided for education. Similar to McGowan Lowrey and Morain, we found that implementation did not always match statute. In some promising cases the education provided exceeded the information minimally required by statute. In other situations, the concussion information was provided in such a way that it was required to be returned with a parent signature. In cases like this, compliance with one part of the statute (mandating acknowledgement of receipt of information) may have been compromising another (providing concussion education). Although the education and acknowledgement tenets were relatively similar across states, more heterogeneity was found in the implementation of these aspects of the statutes.

In general, these two studies suggest that the approach for examining statute, and particularly its efficacy, needs to be designed to address implementation stage information. Strict examination of the statutory language obscures critical implementation-level differences. These concussion-related statutes, enacted now in every state, are ostensibly supposed to reduce risk and improve athlete health outcomes. The extent to which they are reliably accomplishing this goal is unclear. What is clear is that implementation of the laws, and enforcement in cases where schools do not abide by statute, are necessary precursors to consistent efficacy. Although it is important that all states have taken steps toward protecting the health and safety of youth and adolescent athletes, approving a statute is not the final step toward this aim. Further research is needed to understand what health effects the current laws are having and critically where improvements can be made in this important area of public health law.

[This post reflects my own views only.  It does not necessarily represent the views of the Petrie-Flom Center or the Football Players Health Study at Harvard University.]

Google Health Chats? Caveat Doctor

By Nicolas Terry

Recent speculation about healthcare disruption seems to have moved away from HIT to mHealth (discussed here). Apple has fueled this trend with its launch of sensor-laden iPhones and the new Apple Watch, iOS 8’s Health app and the HealthKit API framework. The future, we are told, is in mHealth provided by our phones and wearables notwithstanding that we have yet to solve data protection and other issues associated with the new devices.

Over the last few days leaks have suggested that web behemoths Facebook and Google may have their own takes on the future of healthcare. Reuters reports that Facebook is doing, lets face it, what you would expect—creating online “support communities” for patients with similar conditions and diseases.and creating “preventative care” applications. Now, Engadget reports that Google is testing a new service that offers chats with doctors when a user searches for symptoms. The service seems related to Google Healthcare Helpouts, a video telemedicine platform that launched a year ago to some on-line speculation about healthcare disruption but which today seems limited to a small number of mostly non-physician therapists, family counsellors, coaches or other advisors. 
Continue reading

The Response to Brittany Maynard

By Lauren Taylor

29-year old Brittany Maynard has captured national headlines this week by publicly announcing her intention to end her own life on November 1st. She did so in an effort to raise funds for and awareness of the non-profit Compassion and Choices.

Maynard was diagnosed earlier this year with an aggressive brain cancer and has moved to Oregon for access to its death with dignity laws. Those laws have allowed her to be prescribed a fatal dose of medication by a physician to be taken at the time and place of her choosing. Maynard sees the prescription as a means of avoiding a potentially long, painful and de-humanizing decline in her health.

In light of Maynard’s case, virtually every major media outlet has featured a bit of medical ethics this week. Maynard’s own voice first appeared in People Magazine, announcing her intention to end her own life.  Therein, Maynard is clear that she does not consider herself to be planning for suicide.  Continue reading

Organ Transplantation: Legal and Ethical Challenges (EdX Course)

My university has recently joined EdX and is offering four courses starting February 2015. I have had the privilege of being selected as one of the instructors. I, along with Alicia Pérez Blanco (a skillful intensive care physician, wonderful colleague and sharp bioethicist), will be teaching a course on the ethical and legal challenges of organ transplantation. This has been possible partly because both of us, at different moments, could benefit from the extraordinary resources and the intellectual environment of the Petrie Flom and the Division of Medical Ethics at Harvard, where I stayed during my sabbatical year in 2011-2012.

The course will be delivered in Spanish (we will vocalize with utmost care and speak very, very slowly, it will sound almost like English…) but we will provide exercises and reading materials in both languages. We will cover a lot of the hot topics (DCD, death determination, organs’ conscription, nudges in organ donation, opting-out, markets of organs, death penalty and organ donation, transplantation tourism, among others) and (hopefully) will have a lot of fun (in spite of the nature of the topic). We are very excited and, I have to confess, a bit anxious about the final result. For more information please visit the EdX official announcement.

Ebola, Flight Bans, and Politics

By Zachary Shapiro

It seems like the debate over banning flights from West African Ebola stricken countries has become instantly political, with many Conservatives calling for a flight ban. See here. One author, in response to these calls, points to the history of Liberia’s relationship with the United States as a reason that the US should not consider a flight ban. Arguments against a flight ban that are not based on public health principles provide fodder for the talking heads and individuals who want to see this as a political issue.

The real question should be how much good a flight ban would do to halt the spread of Ebola to the United States. Many public health experts, from the CDC to the WHO, do not think a ban would make us safer.

Ebola is only contagious when the patient is symptomatic, and the first symptom is almost always a fever. If a patient does not have a fever, and is asymptomatic, they are not contagious. Thus they do not provide a serious risk of infecting other people, even in the confined quarters of an airplane. This makes temperature screening especially important. This easy screening tool is already in use at airports in Ebola affected Countries.  Continue reading

Happy National Health Observances!

By Emily Largent

Perhaps you already knew that October is National Breast Cancer Awareness Month. Did you also know that it is:

  • Domestic Violence Awareness Month,
  • Eye Injury Prevention Month,
  • Health Literacy Month,
  • Home Eye Safety Month,
  • National Bullying Prevention Month,
  • National Down Syndrome Awareness Month,
  • National Medical Librarians Month,
  • National Physical Therapy Month, and
  • Sudden Infant Death Syndrome (SIDS) Awareness Month?

On top of that, we have (just to name a few): Mental Illness Awareness Week (Oct. 6-10); National Depression Screening Day (Oct. 9); Bone and Joint Health National Awareness Week (Oct. 12-20); World Pediatric Bone and Joint Day (Oct. 19); and World Psoriasis Day (Oct. 29).  Background on what it takes to make it onto the H.H.S. Office of Disease Prevention and Health Promotion’s national health observances (NHOs) calendar can be found here.

These campaigns can have different goals: raising general awareness of a health need; changing behavior–for example, convincing individuals to change risky behaviors or to take steps toward disease prevention; soliciting donations for research;  increasing early detection; enabling patient support groups; or influencing legislators and policy.  It appears that NHOs can make a difference.  They are not, however, free of controversy.

For example, a primary goal of National Breast Cancer Awareness Month (NBCAM) is to encourage regular breast examination so that cancer can be diagnosed at an early stage.  It has been found that the NBCAM campaign was initially effective in increasing diagnoses, but the effect has diminished over time as the movement has matured, and it seems that the benefits of mammography screening programs have been overestimated.  Unsurprisingly, it has been suggested that it is time for NBCAM to shift focus.  Additionally, many have been critical of the commercialization of NBCAM (see, e.g., the NFL’s “A Crucial Catch” campaign).

What do you think of NBCAM?  Of NHOs more broadly?  Personally, I was surprised at how few of the October NHOs I was aware of, even though medical charity is a topic of  personal and academic interest for me.

Worth Reading This Week

By Nicolas Terry