Carl Ameringer on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

This week features a first time visit from Carl Ameringer, professor of health policy and politics at Virginia Commonwealth University in Richmond, Virginia. A lawyer with a PhD in political science, he is an expert on issues surrounding our national debate on health care reform. We discuss his latest book “US Health Policy and Health Care Delivery: Doctors, Reformers, and Entrepreneurs,” published by Cambridge University Press. Our conversation connects the past and future of American health care, from 19th century development to the ACOs of the ACA. We close with some reflections on path-dependence: is American exceptionalism a permanent impediment to health sector rationalization, or does it provide some models for improvement? Muddling through history, policy, and law has rarely been more edifying, and we hope you enjoy the conversation as much as we did.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher Radio Tunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of January. The selections feature topics ranging from the savings possible from greater generic substitution in Medicare; to proposed federal right to try legislation; to the characteristics of interim publications and final publications from RCTs. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Egilman AC, Wallach JD, Ross JS, Dhruva SS. Medicare Spending and Potential Savings on Brand-Name Drugs with Available Generic Substitutes Excluded by 2 Large Pharmacy Benefit Managers, 2012 Through 2015. JAMA Intern Med. 2018 Jan 16. [Epub ahead of print]
  2. Fuse Brown EC, Sarpatwari A. Removing ERISA’s Impediment to State Health Reform. N Eng J Med. 2018 Jan 4;378(1):5-7.
  3. Joffe S, Lynch HF. Federal Right-to-Try Legislation—Threatening the FDA’s Public Health Mission. N Eng J Med. 2018 Jan 10. [Epub ahead of print]
  4. Sinha MS, Freifeld CC, Brownstein JS, Donneyong MM, Rausch P, Lappin BM, Zhou EH, Dal Pan GJ, Pawar AM, Hwang TJ, Avorn J, Kesselheim AS. Social Media Impact of the Food and Drug Administration’s Drug Safety Communication Messaging About Zolpidem: Mixed-Methods Analysis. JMIR Public Health Surveill. 2018 Jan 5;4(1).
  5. Sommers BD, Kesselheim AS. Massachusetts’ Proposed Medicaid Reforms – Cheaper Drugs and Better Coverage? N Engl J Med. 2018 Jan 11;378(2):109-111.
  6. Woloshin S, Schwartz LM, Bagley PJ, Blunt HB, White B. Characteristics of Interim Publications of Randomized Clinical Trials and Comparison with Final Publications. JAMA. 2018 Jan 23;319(4):404-406.

The cat is now truly amongst the pigeons in the debate about the high cost of clinical negligence in the NHS

By John Tingle

UK national and social media have been buzzing all last week about a letter sent on Monday 29th January 2018 by the NHS Confederation to the Justice Secretary and copying in the Secretary of State for Health.BBC  news set the scene under the banner headline, ‘Curb rising NHS negligence pay-outs, health leaders urge’.

The NHS Confederation is a charity and membership body that brings together and speaks on behalf of all organisations that plan, commission and provide NHS services. Members are drawn from every part of the health and care system. The letter coordinated by them had several co-signatories in the medical establishment including the Chief Executives of the doctor’s defence organisations, the British Medical Association (BMA), The Academy of Medical Royal Colleges. The letter said that the current level of NHS compensation pay-outs is unsustainable and is diverting significant amounts of funding away from front line care services. Last year the NHS spent £1.7 billion on clinical negligence claims, representing 1.5 % of front line health services spending. This annual cost has almost doubled since 2010/11 with an average 11.5 % increase every year:

Continue reading

REGISTER NOW! Will Value-based Care Save the Health Care System?

Will Value-based Care Save the Health Care System?
March 2, 2018 9:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Value-based health care is one of the most pressing topics in health care finance and policy today. Value-based payment structures are widely touted as critical to controlling runaway health care costs, but are often difficult for health care entities to incorporate into their existing infrastructures. Because value-based health care initiatives have bipartisan support, it is likely that these programs will continue to play a major role in both the public and private health insurance systems. As such, there is a pressing need to evaluate the implementation of these initiatives thus far and to discuss the direction that American health care financing will take in the coming years.

To explore this important issue, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is collaborating with Ropes & Gray LLP to host a one-day conference on value-based health care. This event will bring together scholars, health law practitioners, and health care entities to evaluate the impact of value-based health care on the American health care system.

This event is free and open to the public, but seating is limited and registration is required. Register now!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School with support from the Oswald DeN. Cammann Fund and Ropes & Gray LLP.

You can love the brain and football, too

Check out the new op-ed from Francis X. Shen, Senior Fellow in Law and Neuroscience at the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behaviorat Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

From the op-ed:

As final preparations are made for the Super Bowl Sunday, traditional excitement for the game is being countered by criticism about player safety.

In both Illinois and New York, for instance, legislators have proposed banning youth tackle football. Football legend Brett Favre has made headlines telling reporters he prefers his grandchildren play golf instead of football.

Typical criticism of youth football points out that given advances in our knowledge about the brain, it is dangerous to let your kids play football, and unethical to enjoy watching such a barbaric sport.

As a professor whose research is devoted to the intersection of neuroscience and law, I have often found myself at the heart of these football debates. I have testified multiple times in front of the state Legislature, and teach a seminar devoted entirely to “sports concussions and the law.”

Given this background, I often get surprised looks when I defend the value of collision sports. Some find it hard to reconcile my love of the brain with a policy stance that they think promotes brain damage. But I think you can embrace neuroscience and the NFL.

Read more here!

Carl Coleman on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

Seton Hall Law Professor Carl Coleman leads our deep dive into human subjects research, the revised common rule, and the future of data and biospecimen use. We discuss the reasons for the continued delays of the revised common rule, and debate some of its merits. We also add some comparative perspective as we explore researchers’ objections to aspects of both the original and revised rules. Carl has previously written on “rationalizing risk assessment” in research, and brings a wealth of experience to the discussion.

Carl has served as Bioethics and Law Adviser at the World Health Organization (WHO) in Geneva, Switzerland, where he was one of the primary authors of the report, Ethical Considerations in Developing a Public Health Response to Pandemic Influenza. He has contributed to WHO reports on capacity building for research ethics committees, ethical issues in tuberculosis prevention, care, and control, research ethics in epidemic response efforts, standards and operational guidance for research ethics committees, and key issues in global health ethics. From 2010-2013, Carl was a member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), which is charged with providing expert advice to the Office for Human Research Protections of the U.S. Department of Health and Human Services.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher Radio Tunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.

Crimes of Passion: New Neuroscience vs. Old Doctrine

Crimes of Passion: New Neuroscience vs. Old Doctrine
February 14, 2018 12:00 PM
Wasserstein Hall, Milstein West (2019)
Harvard Law School, Cambridge, MA

On Valentine’s Day we celebrate love. But the criminal law often sees love and passion turned into violence. How does this happen? And how should law respond? Many doctrines, most notably the “heat of passion” defense – which historically has been used disproportionately to excuse the crimes of men against women – rely on a distinction between defendants who acted “emotionally” instead of “rationally.” But modern neuroscience has debunked the idea that reason and emotion are two entirely different mental states. This panel will explore how law should respond to this neuroscientific challenge to long-held doctrine.

Panelists:

  • Lisa Feldman-Barrett, PhD, University Distinguished Professor of Psychology and Director of the Interdisciplinary Affective Science Laboratory at Northeastern University; Research Scientist, Department of Psychiatry, Northeastern University; Research Neuroscientist, Department of Radiology, Massachusetts General Hospital; Lecturer in Psychiatry, Harvard Medical School; Faculty Affiliate, the Center for Law, Brain & Behavior, Massachusetts General Hospital
  • Judge Nancy Gertner (ret.), Senior Lecturer on Law, Harvard Law School and Managing Director, Center for Law, Brain & Behavior, Massachusetts General Hospital
  • Moderator: Francis X. Shen, PhD, JD, Senior Fellow in Law and Applied Neuroscience, the Petrie-Flom Center in Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Law, Brain & Behavior at Massachusetts General Hospital; Associate Professor of Law and McKnight Land-Grant Professor, University of Minnesota Law School; Executive Director of Education and Outreach, the MacArthur Foundation Research Network on Law and Neuroscience

Part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

How to “Lower Drug Prices” Without Lowering Drug Prices

Yesterday, Alex Azar was sworn in as the Secretary for the Department of Health and Human Services. A key question is whether Azar will take action against high drug prices, and if so, what he will do. At his confirmation hearing, Azar stated clearly that “drug prices are too high.” And during Azar’s swearing-in ceremony, the President stated that Azar was “going to get those prescription drug prices way down.” But I’m skeptical that Secretary Azar will do much to address the problem in the near term.

To be clear, I’m skeptical for a host of reasons, none of which are necessarily reflective of Secretary Azar. Much like health care, drug pricing is complicated. HHS should (and will) worry about potential unintended consequences of drug pricing proposals, proceeding cautiously and taking concerns seriously. HHS’ ability to act may be limited without Congressional involvement, and Congress has thus far been unable to act on this issue. Other proposals may take years to develop or implement, leaving patients without relief in the interim.

As a former President of Eli Lilly, Secretary Azar understands the drug pricing system deeply. He’s absolutely right that “there’s not one action that all of a sudden fixes this.” But if Azar is under pressure to deliver drug pricing changes in the short term, I’d expect to see focus in three main areas. Here’s the problem, though: at least two of these would not necessarily lower drug prices individually or drug spending overall. They might well increase overall spending. Importantly, that may not be a bad thing (as I’ll explain). But they won’t hurt the bottom line of the drug companies the President believes are “getting away with murder,” and they may well bolster it. The third area may lower prices – but it wouldn’t be Azar’s accomplishment.

Continue reading

Innovation Gaps on Life Science Frontiers

Join us in wonderful Copenhagen at our CeBIL Kick-Off Conference: ”Innovation Gaps on Life Science Frontiers? From Antimicrobial Resistance & the Bad Bugs to New Uses, AI & the Black Box”. The  Conference marks the start of the Novo Nordisk Foundation’s Collaborative Research Programme in Biomedical Innovation Law which is carried out within a unique network of international core partners, including internationally renowned experts at Harvard Law School’s Petrie Flom Center, Harvard Medical School/Brigham & Women’s Hospital, University of Cambridge, University of Michigan, and UCPH’s Department of Food and Resource Economics (IFRO).

Leading international experts, including i.a. our distinguished Bill of Health colleagues Glenn Cohen, Aaron Kesselheim; Nicholson Price, and Kevin Outterson, will discuss legal, economic, societal and scientific aspects of selected Life Science areas.

Time: Monday, 5 March 2018 09:00 – 18:00 (followed by a reception in the Gobelin Hall)

Venue: The Ceremonial Hall (Festsalen), University of Copenhagen, Main Building, Frue Plads 4, DK-1168 Copenhagen K

More information on  speakers, agenda and registration is available here and here.

Extended background:

Biomedical innovation is experiencing changes of epic proportions. Rapid progress in many scientific areas, such as gene editing, pharmacogenomics, artificial intelligence and big data-driven precision medicine, has greatly advanced the promises and opportunities of the health and life sciences. Nevertheless, the total number of truly new and innovative drugs receiving market approval is unsatisfactory. At the same time, some of the more innovative therapies that actually could reach patients have become extremely expensive or ethically problematic. These new technological possibilities raise many complex scientific, legal and ethical issues affecting many stakeholders, such as medical practitioners, regulators, patients and the industry.

To support the in depth study of these developments, the Novo Nordisk Foundation has awarded a grant of DKK 35 million for a new Collaborative Research Programme in Biomedical Innovation Law (CeBIL). CeBIL’s overall aim is to help translate ground-breaking biomedical research into affordable and accessible therapies by scrutinizing the most significant legal challenges to biomedical innovation and public health from a holistic cross-disciplinary perspective. CeBIL is hosted by a new Centre for Advanced Studies at the University of Copenhagen’s Faculty of Law. The research is carried out within a unique network of international core partners, including internationally renowned experts at Harvard Law School, Harvard Medical School, University of Cambridge, University of Michigan, and UCPH’s Department of Food and Resource Economics (IFRO). Moreover, CeBIL will collaborate with a broad network of stakeholder organizations and international experts within law, economics, life science, medicine, sociology and pharmacy.

This Kick-Off Conference marks the start of CeBIL which opened its’ doors on January 1st, 2018. Reflecting the research projects that will be at the focus CeBIL’s research during the first 5 years, leading international experts will discuss legal, economic, societal and scientific aspects of selected life science areas and debate future challenges and opportunities.

 

.

 

EVENT: Punishing Disease: HIV and the Criminalization of Sickness

Punishing Disease: HIV and the Criminalization of Sickness
January 29, 2018, 12:00 PM
Wasserstein Hall, Room 3007
1585 Massachusetts Ave., Cambridge, MA

Please join us for a talk with Trevor Hoppe on his book, Punishing Disease: HIV and the Criminalization of Sickness. The book examines how and why US policymakers and public health systems have adopted coercive and punitive responses to stop the spread of HIV/AIDS. It also looks at how others diseases have been punished throughout history, and cautions against the extension of criminalization to diseases such as hepatitis and meningitis.

Trevor Hoppe is Assistant Professor of Sociology at the University at Albany, SUNY. He was previously a postdoctoral fellow in the Criminology, Law andSocietyDepartment at the University of California at Irvine. Hoppe’s research examines how punishment came to be a legitimate response to controlling HIV and disease more generally. In 2017, Hoppe published The War on Sex, a collection of essays co-edited with David Halperin analyzing the criminalization of sex, and Punishing Disease a monograph explaining the rise of punitive responses to HIV and other infectious diseases.

This talk is part of the Human Rights Program’s year-long speaker series examining the criminalization of human rights concerning gender, sexuality, and reproduction. It is co-sponsored by the Petrie-Flom Center for Health Law, Policy, Biotechnology and Bioethics, the Criminal Justice Policy Program, and the Center for Health Law Policy Innovation at Harvard Law School. 

 

Graduate Students, ACA Section 2714, and Medical Debt

Special guest post by Marissa Lawall 

Arguably the most popular provision of the Affordable Care Act (ACA), section 2714 (42 U.S.C. § 300gg-14) provides that individuals may stay on their parent’s insurance plan until they are twenty-six years of age. A 2013 Commonwealth Fund survey found 7.8 young adults gained new or better insurance through this ACA provision, and a repeat survey in 2016 found the uninsured rate for young adults, ages 19-34, dropped from 28% to 18%. On its face, it is difficult to find any harm caused by this provision. Healthy young people have insurance, despite continuing education or lack of gainful employment, and are presumably lowering costs by being in the risk pool. However, this provision can lead to unforeseen pitfalls, including medical debt, because of the way it interacts with the growing trend of increased cost sharing and narrow networks.  These trends acutely impact students in higher education, because students who study even a modest distance from their parents’ home are unlikely to have access to nearby “in-network” providers, and because students’ medical needs more often tend to come in the form of unexpected emergencies.  In this post, I will highlight my personal experience with Section 2714, as a graduate student, and explore policy and possibilities for reform.

An Emergency and a Choice: Applying Section 2714

Like many young adults, I remained on my parents’ insurance when I went to college. Specifically, I remained on my mom’s insurance because I was in law school and continue to be an advocate for the ACA program. But when my mom began a new job at a different hospital her insurance changed and so did the medical network. The only “in network” coverage was through the hospital that employed her, and that was hour and forty-five minutes away. I didn’t view this as an issue until the unexpected happened. Continue reading

Illness, Disability, and Dignity

By Yusuf Lenfest

Medicine is meant to heal our ailments and treat our illnesses. Our deep knowledge of the body and the numerous mechanisms that contribute or correlate to good health is considered a triumph of the medical sciences. We can now perform transplants with relative ease, offer prosthetics to those who require them, and even cure some forms of blindness. But so much of modern medicine today is built around quantitative data—family histories, success and morbidity rates, pathologization, statistical analyses—without much conscious consideration of how one understands, copes, or derives meaning from their experience. True, such data is gathered for the purposes of more accurate diagnoses and as the first defense against an illness or medical condition; but physicians are taught to concentrate on the cure, and while few would dispute that that is certainly a good thing, we also ought to keep in mind that excessive focus on a default measure of “normal” does not necessarily allow us to express the diverse ways of being in the world nor adequately account for the ways in which people embrace their conditions.

Some autistic individuals, for example, believe that autism should be accepted as a difference and not as a disorder. That the autism spectrum is precisely that—a spectrum—is important: on the one hand, statistical analysis may reveal that these individuals are in the minority versus the average population, only 1%; but on the other hand, to take a different perspective, it means merely that the characteristics of these individuals manifest in a way that is atypical with how the institution and culture of medicine classifies them. Lest we forget, medicine is part of the dynamic structure of society and social norms—in the background and the foreground—of knowledge-making, and it is imbedded in place and society, as part of the structures existing in institutions. It is not possible to consider theoretical or epistemological claims apart from practical knowledge and applied sciences. Continue reading

The Conduct of Clinical Trials of Treatments during Public Health Emergencies: A Health Policy and Bioethics Consortium

The Conduct of Clinical Trials of Treatments during Public Health Emergencies: A Health Policy and Bioethics Consortium
February 9, 2018, 12:00 PM
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

In the past several years, the United States has struggled to respond to viral outbreaks, such as Ebola and Zika.  There is now an awareness of the need to rapidly develop vaccines and treatments for epidemics that can quickly spread from country to country. But questions remain as how to best conduct clinical trials and development of vaccines in the context of an epidemic or outbreak.

Join two health policy experts in examining the appropriate conduct of clinical trials during public health emergencies.

Panelists

  • Susan Ellenberg, Professor Of Biostatistics, Biostatistics And Epidemiology, the Hospital of the University Of Pennsylvania and Director, Biostatistics And Data Management Core, Penn Center For AIDS Research
  • Jason Schwartz, Assistant Professor of Public Health (Health Policy), Yale School of Public Health and Assistant Professor, Program in the History of Science and Medicine, Yale University
  • Moderator: Carmel Shachar, Executive Director, the Petrie-Flom Center, and Lecturer on Law, Harvard Law School

Lunch will be provided. This event is free and open to the public.

Learn more about the Health Policy and Bioethics Consortia.

The Health Policy and Bioethics Consortia is a monthly series that convenes two international experts from different fields or vantage points to discuss how biomedical innovation and health care delivery are affected by various ethical norms, laws, and regulations. They are organized by the Center for Bioethics at Harvard Medical School and the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women’s Hospital, in collaboration with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Support provided by the Oswald DeN. Cammann Fund at Harvard University.

NEW EVENT (1/29)! Punishing Disease: HIV and the Criminalization of Sickness

Punishing Disease: HIV and the Criminalization of Sickness
January 29, 2018, 12:00 PM
Wasserstein Hall, Room 3007
1585 Massachusetts Ave., Cambridge, MA

Please join us for a talk with Trevor Hoppe on his book, Punishing Disease: HIV and the Criminalization of Sickness. The book examines how and why US policymakers and public health systems have adopted coercive and punitive responses to stop the spread of HIV/AIDS. It also looks at how others diseases have been punished throughout history, and cautions against the extension of criminalization to diseases such as hepatitis and meningitis.

Trevor Hoppe is Assistant Professor of Sociology at the University at Albany, SUNY. He was previously a postdoctoral fellow in the Criminology, Law andSocietyDepartment at the University of California at Irvine. Hoppe’s research examines how punishment came to be a legitimate response to controlling HIV and disease more generally. In 2017, Hoppe published The War on Sex, a collection of essays co-edited with David Halperin analyzing the criminalization of sex, and Punishing Disease a monograph explaining the rise of punitive responses to HIV and other infectious diseases.

This talk is part of the Human Rights Program’s year-long speaker series examining the criminalization of human rights concerning gender, sexuality, and reproduction. It is co-sponsored by the Petrie-Flom Center for Health Law, Policy, Biotechnology and Bioethics, the Criminal Justice Policy Program, and the Center for Health Law Policy Innovation at Harvard Law School. 

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School with support from the Oswald DeN. Cammann Fund and Ropes & Gray LLP.

Prenatal Testing and Human Capabilities

By Aobo Dong

According to Vardit Ravitsky’s paper on “Shifting Landscape of Prenatal Testing,” there exist two competing rationales for prenatal screenings for severe disabling conditions like Down syndrome. The “reproductive-autonomy” rationale justifies screening by invoking a woman’s individual autonomy. In contrast, the “public health rationale” justifies pre-natal screening and termination due to a Down syndrome diagnosis by invoking the costly public health expenditures that must be spent on children born with these disabilities – resembling a utilitarian calculation that minimizes pain and maximizes pleasure for society as a whole. According to Ravisky, the public health rationale creates social pressure that incentivizes women and their families to make the decision to terminate. Thus, the public health rationale is heavily pro-termination, while the individual autonomy rationale could lead women to make decisions in either way. What she proposes as a solution is to combat the public health rationale to allow women to make autonomous decisions free of social pressures, and establish a stronger “informed consent” procedure that better informs the implications of pre-natal screenings and Down syndrome so that women could make the best possible decision for themselves. This blog post will shed more light on this issue by invoking Martha Nussbaum’s capabilities approach to human rights.

A central feature of the capabilities approach is “adaptive preference” that measures the relative success in achieving the 10 core capabilities cross nation-states and social classes. Nussbaum is aware of the fact that “individuals vary greatly in their need for resources and in their ability to convert resources into valuable functioning.” Therefore, it is not even adequate to provide an equal amount of educational resources for one student with Down syndrome and another without any learning disability. Nussbaum would argue that the child needs something even more than a formal education, a proposal that could be much more costly than a regular education alone. She would not assume that a student with the condition must have a low self-worth; instead, she would consider the factors in the child’s social environment that may have caused such low self-esteem, and direct resources to improve the child’s own sense of worth and maximize her future potentials in living a fully human life. This is consistent with capability 7B (respect), which stresses their ability to “be treated as a dignified being whose worth is equal to that of others.” Continue reading

Why Are So Many American Women Dying in Childbirth?

By Clíodhna Ní Chéileachair

In November Serena Williams, indisputably one of the greatest – if not the greatest – tennis player in history gave birth to her daughter by emergency Caesarean section. After the surgery, Williams reported to an attending nurse that she was experiencing shortness of breath and immediately assumed she was experiencing pulmonary embolism. The star athlete has a history of blood clots and had discontinued blood thinners before the surgical delivery. Contrary to William’s requests for a CT scan and blood thinners, medical staff assumed that pain medication had made her confused. A later CT scan confirmed Williams’ self-diagnosis. Stripping out the fact of Williams’ identity turns this near-miss into a terrifyingly common story in US maternal care, albeit one with a happier ending than many. The global trend in maternal death rates – the rate of women dying in childbirth and post-childbirth – has rapidly decreased over the past 15 years. At the same time, the US, despite recording one of the highest per capita income levels in the world, has one of the highest maternal mortality rates in the developed world.

Continue reading

What The Great Divide Over IVF Coverage Can Tell Us About The Future Of Other High-Tech Interventions

This new post by Eli Adashi appears on the Health Affairs Blog as part of a series stemming from the Sixth Annual Health Law Year in P/Review event held at Harvard Law School on Tuesday, December 12, 2017.

One is hard pressed to conjure up a more fundamental right than the right to procreate. It is a right “baked” into human DNA, a right inherent to the very existence of the species, and a right enshrined now 70 years ago in the Universal Declaration of Human Rights of the United Nations. In principle then, the precept of procreative liberty is all that is necessary and sufficient to undergird the right to infertility care in general and to in vitro fertilization (IVF) in particular. In support of this premise, the World Health Organization (WHO) defined infertility as a disease. Just as importantly, the WHO included Infertility in its International Classification of Diseases replete with the billing codes thereof.

However, the promise of procreative liberty and all that flows from it has yet to be fully realized. For one, the aforementioned principles have not been uniformly embraced by all member states of the United Nations including the United States. For another, access to IVF remains compromised by high procedural costs, widening income disparities, extensive underwriting gaps in both the public and private sectors, deep-seated sociocultural clefts, and fundamental moral discords. To those seeking to build a family, the confluence of these hindrances is nothing short of prohibitive with the net effect being access all but denied. None of this is surprising of course. Access, after all, equals affordability, which is unlikely to improve anytime soon given growing price pressures and widening income disparities. […]

Read the full article here!

Dystopian Memes on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

It’s a stormy healthcare landscape out there, so this show is all lightning round. We cover several areas:

Litigation: Nic provides the Ariadne’s thread through a labyrinthine pharma-tort judgment out of California. The metal on metal hip litigation has resulted in a big judgment, but medical device regulation is still fundamentally broken. Disgruntled Centene enrollees are suing the ACA insurer of last resort for ultra-narrow networks (and Washington state is not happy, either). Washington may lead the way for future narrow network regulation or consent decrees. We followed up on the duodenoscope superbug litigation saga, focusing on duties to translate foreign language emails in discovery.

Regulation: We discussed a crisis in long-term care, following up on last week’s discussion with Paul Osterman. Medicare is not making it any easier for many who qualify for help. We reviewed the new priorities of HHS’s Conscience Rights, er, Civil Rights Division (and potential responses to conscience claims). The rise of Medicaid work requirements is a hot topic, as Kentucky Governor Bevin imposed them last week. Continue reading

On Sex Discrimination In Health Care, The Pendulum Swings With Severity

This new post by Kevin Costello and Maryanne Tomazic appears on the Health Affairs Blog as part of a series stemming from the Sixth Annual Health Law Year in P/Review event held at Harvard Law School on Tuesday, December 12, 2017.

Like many other areas of law, protections against sex discrimination experienced dramatic fluctuation in 2017. Safeguards and norms thought to be firmly planted by the Obama administration were reversed. And because the field of anti-discrimination law tends toward cross-disciplinary borrowing of standards and interpretations, the effect of a single change—in employment or education, for example—is amplified in others, like health care. The year in sex discrimination proved to be a paradigmatic example of progressive advocates wanting badly for things to be one way, but it’s the other way (See Note 1).

In 2017, the apple of discord here involved interpretation of Title IX’s prohibition of discrimination “on the basis of sex.” Progressive advocates understand that phrase expansively, to encompass at least discrimination that occurs because of sex, gender identity, sexual stereotyping, and sexual orientation. Conservatives, unsurprisingly, interpret the language as narrowly delimited to distinctions made only on the basis of biological sex assigned at birth. We all bore witness to a severe swing of this pendulum in 2017. […]

Read the full post here!