Block Grants: Sound Theory or Doomed to Fail?

Block grants are all the rage. Take the latest G.O.P. proposal to repeal and replace the Affordable Care Act: the Graham-Cassidy bill. It proposes to replace the current system and instead give grants to the states, essentially taking the funds the federal government now spends under the ACA for premium subsidies and Medicaid expansion and give those funds to the states as a lump sum with little regulation.

There is a complicated formula by which the bill proposes divvying up this money among the states. Many think the formula is unfair, that it benefits red states over blue states, and that it just flat isn’t enough money. These are incredibly important concerns. But let’s put them to the side for just a moment and consider the theory behind block granting. Is there any world, for instance assuming that the amount and allocation of the funding could be resolved (probably crazy talk), in which switching to block granting may actually improve upon the status quo?

Proponents of block granting health care make two main arguments. First, it will reduce costs. By block granting Medicaid and the ACA subsidies, we end the blank check open entitlement that these programs have become and give states more skin in the game. Second, these cost savings will come from empowering states to innovate. States will become more efficient, improve quality, and solve their own state-specific problems.

These arguments have an understandable appeal. But how will states really react to providing health care coverage on a budget? Continue reading

Call For Abstracts! Beyond Disadvantage: Disability, Law, and Bioethics – PFC’s 2018 Annual Conference

“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1973).

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2018 annual conference, entitled: “Beyond Disadvantage: Disability, Law, and Bioethics.” This year’s conference is organized in collaboration with the Harvard Law School Project on Disability.

Conference Description

disability-law-bioethics_slideHistorically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood. Continue reading

The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States

The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States
October 4, 2017 12:00 PM
Wasserstein Hall, Milstein East B (2036)
Harvard Law School 

From “Pharma Bro” Martin Shkreli to huge price jumps for the EpiPen to the Hepatitis C treatment that costs $1000 per pill, pharmaceutical pricing is a major issue in the news and in Washington. The regular introduction of new, often expensive therapeutics as well as controversial price increases for familiar drugs attract bipartisan attention and ensure that drug costs will remain an important topic of public policy debate.

This panel of experts will discuss current laws and regulations governing pharmaceutical pricing in the United States, the impact of breakthrough therapeutics on drug pricing, and the future of drug pricing policy in the United States.

Continue reading

What’s Next for the ACA?: A Lecture by Larry Levitt

What’s Next for the ACA?: A Lecture by Larry Levitt
October 3, 2017 12:00 PM
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Join Larry Levitt for a talk about the future of the Affordable Care Act and health care in America.

Larry Levitt is Senior Vice President for Special Initiatives at the Kaiser Family Foundation and Senior Advisor to the President of the Foundation. Prior to joining the Foundation, he served as a Senior Health Policy Advisor to the White House and Department of Health and Human Services. He holds a bachelors degree in economics from the University of California at Berkeley, and a masters degree in public policy from Harvard University’s Kennedy School of Government.

This event is free and open to the public.

Sponsored by the Center for Health Law Policy and Innovation, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, and the Harvard Health Law Society, all at Harvard Law School.

TODAY, 9/18 at 5 PM: Health Law Workshop with Jody Madeira

September 18, 2017, 5-7 PM
Hauser Hall, Room 104

Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: “Terminating the Paper Trail: Evaluating the Efficacy of a Multimedia Informed Consent Application in Reproductive Medicine”

For context, please also read: “Is Informed Consent in Reproductive Medicine in Critical Condition?”

Jody L. Madeira is Professor of Law and Louis F. Niezer Faculty Fellow at the Indiana University Maurer School of Law. Her scholarly interests primarily involve the intersection of law and emotion in criminal and family law. Madeira’s new book, Killing McVeigh: The Death Penalty and the Myth of Closure, applies collective memory to criminal prosecution and sentencing, exploring the ways in which victims’ families and survivors came to comprehend and cope with the Oklahoma City bombing through membership in community groups as well as through attendance and participation in Timothy McVeigh’s prosecution and execution. She is also actively involved in empirical research projects assessing patient decision making and informed consent in assisted reproductive technology (ART).

Additionally, Madeira investigates the effects of legal proceedings, verdicts, and sentences upon victims’ families; the role of empathy in personal injury litigation; and the impact of recent developments in capital victims’ services upon the relationship between victims’ families and the criminal justice system.

Madeira earned her JD magna cum laude from the University of Pennsylvania School of Law, where she was elected to the Order of the Coif and served as Senior Articles Editor for the University of Pennsylvania Journal of Constitutional Law. She clerked for the Hon. Richard D. Cudahy at the U.S. Court of Appeals for the Seventh Circuit. She then came to Harvard as a Climenko Fellow and Lecturer in Law, where she taught legal research and writing as well as a seminar on the cultural life of capital punishment. Madeira also recently served as a Research Associate at the Capital Punishment Research Initiative at the School of Criminal Justice, University at Albany, State University of New York.

The Unsustainable High Costs of Clinical Negligence Litigation in England

By John Tingle

Presently in England clinical negligence costs are high and are set to grow even higher. The National Audit Office (NAO) has recently examined clinical negligence costs and they go into some detail on the costs of claims and make a number of important recommendations in a report. Very useful insights are given on the management of clinical negligence claims in the NHS. There is a focus on clinical negligence claims managed through the NHS Resolution’s indemnity scheme, the Clinical Negligence Scheme for Trusts (CNST). Trusts pay contributions to this scheme which is a risk pool and when a legal claim is made against them NHS Resolution takes over the claim and meets the associated costs. The NAO argue that urgent changes are needed to deal with the problem of the increasing costs of clinical negligence claims.

Continue reading

Precision Medicine for All? The Need for Disability Inclusion

By Maya Sabatello

Stakeholders’ engagement is key to achieving the promises of precision medicine research. It is needed in order to establish a sufficiently powered cohort of diverse groups that will allow tailoring disease diagnosis, treatment, and prevention to individual variability in genes, environment, and lifestyle. It is also needed to ensure that research priorities are in sync with the health needs of participants and for curtailing health disparities in the US.

Cognizant of these issues, precision medicine initiatives, including are increasingly investing time and resources to engage potential participants in their studies. the All of Us Research Program (AoU) is exemplary in this regard, focusing in particular on racial and ethnic minorities as well as Native Americans who have been historically underrepresented in genomic research.

But what about people with disabilities?

This question may seem to be off target. After all, persons with disabilities have long been prime targets of genotyping, and their enrollment in genomic research is ongoing.

Continue reading

Five Years of Bill of Health: Student Fellow Contributions

This month we’re celebrating five years of Bill of Health, the success of which would not have been possible without the great contributions of our Student Fellows. Each year, as part of their Fellowship, these diverse students post regularly on issues related to their areas of research and interest, and several have stayed on as regular contributors after the completion of their Fellowships. We’re excited about this year’s contributions, and thank all of our former Fellows for their excellent work!

Below is a list of the top three Student Fellow posts by year, measured by total unique page views (note: one per author selected if multiple posts; older posts have more weight based on more time online): Continue reading

Adam Gaffney on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!twihl 5x5

Adam Gaffney, physician, writer, public health researcher, and healthcare advocate joins us to discuss the “right to health” in all its manifestations, and the slow crawl of U.S. healthcare toward universalism and single-payer. It’s a broad-ranging discussion, touching on law, human rights, political discourse, and economics.

A brief “lightning” round focuses on the exposure of Facebook’s ethos and healthcare consolidation and concentration, with a brief mention of zombie repeal and replace efforts and the Senate HELP’s September 12th bipartisan exchange stabilization hearing. (Frank was also in the Senate that day, but at a different hearing.)

Adam W. Gaffney is Instructor in Medicine at Harvard Medical School, and a staff physician at the Division of Pulmonary and Critical Care Medicine at the Cambridge Health Alliance (CHA), an organization with a longstanding commitment to community health and the health of the underserved. He is author of To Heal Humankind: The Right to Health in History (Routledge, 2017).

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

The 21st Century Trolley

By Gali Katznelson

Here’s a 21st century twist on the classic ethics trolley dilemma: The trolley is a car, you are the passenger, and the car is driving itself. Should the autonomous car remain on its course, killing five people? Should the car swerve, taking down a different bystander while sparing the original five? Should the car drive off the road, and kill you, the passenger, instead? What if you’re pregnant? What if the bystander is pregnant? Or a child? Or holds the recipe to a cure for cancer?

The MIT Media Lab took this thought experiment out of the philosophy classroom by allowing users to test their moral judgements in a simulation. In this exercise, participants can decide which unavoidable harm an autonomous car must commit in difficult ethical scenarios such as those outlined above. The project is a poignant perversion of Philippa Foot’s famous 1967 trolley dilemma, not because it allows participants to evaluate their own judgements in comparison with other participants, but because it indicates that the thought experiment actually demands a solution. And fast.

Several companies including Google, Lyft, TeslaUber, and Mercedes-Benz are actively developing autonomous vehicles. Just last week the U.S. House of Representatives passed the SELF DRIVE (Safely Ensuring Lives Future Deployment And Research In Vehicle Evolution) Act unanimously. Among several provisions, the act allows the National Highway Traffic Safety Administration to regulate a car’s design and construction, and designates states to regulate insurance, liability and licensing. It also paves the way for the testing by car manufacturers of 25 000 autonomous cars in the first year, and up to 100 000 cars within three years. Continue reading

Medicine and Ethics: Religious or Secular?

By Yusuf Lenfest

There is no lack of controversy when talking about religion and medicine in America today. Medicine is studied, practiced, and firmly rooted in the corporal world while religion draws inspiration from texts, traditions, and the incorporeal. Yet from an historical perspective, religious pasts do shape the present, particularly in the realm of ethics and moral reasoning. Indeed, whatever one’s spiritual or philosophical predilections, religion continues to play a major role in the dialogue on medicine and health care in Western society.

Bioethics in particular has become a topic of growing interest in America, but there has been little critical discussion about its contextual underpinnings, which stem largely from a Western Christian perspective. This is not to say that another religion would arrive at radically different system of morals. While differences do exist amongst religious traditions, across both space and time, experience and common sense tell us that diverse religious traditions do in fact share in much of the same moral principles and foundations. So what might other religious traditions say about, or contribute to, the discourse on bioethics? Should religion even be included in the conversation, especially given that health care and healing belong to the sphere of medicine?

Continue reading

Perspectives on Cancer Drug Development Costs in JAMA

By James Love

Vinay Prasad and Sham Mailankody’s JAMA Internal Medicine study on the costs of research and development (R&D) when bringing a single cancer drug to market has sparked renewed discussion about how to measure R&D costs as well as the relationship between R&D costs and prices. What follows is my perspective on the Prasad/Mailankody (PM) paper, how it compares to DiMasi’s widely quoted 2016 study, and on the debate in general.  Continue reading

IRBs Advise Physician Involvement in Informed Consent

By Nadia N. Sawicki

Much has been written about the Supreme Court of Pennsylvania’s recent decision in Shinal v. Toms, in which the court held that a physician’s duty to obtain informed consent, as codified in Pennsylvania’s MCARE Act, is non-delegable. According to the court, a physician faced with an informed consent suit cannot defend himself on the grounds that the patient was adequately informed of the risks and benefits of treatment by a physician assistant, nurse, or other intermediary acting under the physician’s direction. Pennsylvania is not the first state to adopt this view – courts in other jurisdictions (Connecticut, Louisiana, South Dakota, Texas, New Mexico) have similarly held that the duty to secure informed consent rests with the treating physician alone.

The MCARE (Medical Care Availability and Reduction of Error) Act was passed in 2002 to reform Pennsylvania’s medical malpractice laws, and refers to the duties and rights of “physicians” and “patients.” Shinal, likewise, addressed the issue of informed consent in the context of medical treatment. Thus, I was very surprised to learn that some commercial institutional review boards (IRBs), in reliance on the Pennsylvania Supreme Court’s decision, have been advising clinical trial investigators to revise their consent forms and processes to ensure that physician-investigators – and not recruitment coordinators, nurses, or other study staff – secure the consent of research participants.

Schulman, one of the most well-known commercial IRBs, recently posted about the Shinal case on its website; while noting that the case focused on medical malpractice “and does not address consent in the research context,” it advised investigators to “discuss with their legal counsel the impact of this decision on their consent process.” Sterling IRB had a similar post, advising investigators to “consider drafting consent form updates to clearly require that only physician members of the research team may obtain informed consent from a research subject.” In an e-mail that went directly to investigators and study staff, Sterling also suggested that they submit updated consent forms that “make clear that the only person who can obtain consent is the PI/physician.” A recent article in the Journal of Clinical Research Best Practice, titled “What Impact will the Shinal Case have on Informed Consent in Clinical Research?,” offered a more detailed analysis of the case, and concluded that “there is little to suggest that courts would not uniformly apply the same informed consent standards used in the medical practice to clinical research.” Continue reading

Book Launch: Law, Religion, and Health in the United States

Book Launch: Law, Religion, and Health in the United States
September 27, 2017 12:00 PM
Wasserstein Hall, Milstein West A (2019)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

In July 2017, Cambridge University Press will publish Law, Religion, and Health in the United States, co-edited by outgoing Petrie-Flom Center Executive Director Holly Fernandez Lynch, Faculty Director I. Glenn Cohen, and Elizabeth Sepper, Professor of Law at Washington University School of Law. This edited volume stems from the Center’s 2015 annual conference, which brought together leading experts to identify the various ways in which law intersects with religion and health care in the United States, examine the role of law in creating or mediating conflict between religion and health care, and explore potential legal solutions to allow religion and health care to simultaneously flourish in a culturally diverse nation.

About the book: While the law can create conflict between religion and health, it can also facilitate religious accommodation and protection of conscience. Finding this balance is critical to addressing the most pressing questions at the intersection of law, religion, and health in the United States: should physicians be required to disclose their religious beliefs to patients? How should we think about institutional conscience in the health care setting? How should health care providers deal with families with religious objections to withdrawing treatment? In this timely book, experts from a variety of perspectives and disciplines offer insight on these and other pressing questions, describing what the public discourse gets right and wrong, how policymakers might respond, and what potential conflicts may arise in the future. It should be read by academics, policymakers, and anyone else – patient or physician, secular or devout – interested in how US law interacts with health care and religion.

Continue reading

Introducing new blogger James Love

James Love is joining Bill of Health as a regular contributor.
James Love is the Director of Knowledge Ecology International, where his research focuses on the production, management and access to knowledge resources, and aspects of competition policy. This includes work on the financing of R&D, intellectual property rights, prices for and access to new drugs, vaccines and other medical technologies, as well as related topics for other knowledge goods, including software, other copyrighted works, and data.  He previously worked for the Center for Study of Responsive Law, and before that, as Senior Economist for the Frank Russell Company. He has a MPA from Harvard University’s Kennedy School of Government and an MA from Princeton’s Woodrow Wilson School of Public and International Affairs. James will be blogging about  the policies to grant or revoke exclusive rights to make and sell medical products, as well as drug development costs.

Recent Publications:

Welcome, James!

2017 Petrie-Flom Center Annual Open House

2017 Petrie-Flom Center Annual Open House
September 13, 2017 5:30 PM
HLS Pub, Wasserstein Hall, 1st floor
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Join faculty, colleagues, and students with shared interests in health law policy, biotechnology, and bioethics to learn about what the Petrie-Flom Center does and how people can get involved. Faculty Director I. Glenn Cohen will review our sponsored research portfolio, introduce our staff and fellows, including new Executive Director Carmel Shachar, and describe various opportunities for students and others. In addition, our partners including colleagues from the Center for Bioethics at Harvard Medical School and the Center for Law, Brain & Behavior at Massachusetts General Hospital spoke about their programs and activities, including the Master of Bioethics program in the Center for Bioethics at Harvard Medical School. And of course we will eat, drink, and make merry!

This event is free and open to the public.

The Open House reception will immediately follow the lecture “The Neurolaw Revoltion” by Francis X. Shen, Senior Fellow in Law and Applied Neuroscience, at 4pm. Learn more about the lecture here!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School.

The Neurolaw Revolution: A lecture by Francis X. Shen

The Neurolaw Revolution: A lecture by Francis X. Shen
September 13, 2017 4:00 PM
Wasserstein Hall, Milstein East A (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Rapid advances in the brain sciences offer both promise and peril for the law. In light of these developments, Dr. Francis Shen will explore how neuroscientific analysis of law may revolutionize legal doctrine and practice.

 Dr. Shen is the third Senior Fellow in Law and Neuroscience in 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. Dr. Shen directs the Shen Neurolaw Lab at the University of Minnesota, is co-author of the first Law and Neuroscience casebook, and serves as Executive Director of Education and Outreach for the MacArthur Foundation Research Network on Law and Neuroscience.

This lecture will be followed at 5:30pm by the Petrie-Flom Center’s 2017 Open House reception.

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.

Housing Equity Week in Review

The week of Sept. 4-11, 2017 brought more housing-related news from the southeast in the wake of Harvey and Irma, and a few new resources. The latest in housing equity and the law, below:

  • Matthew Desmond writes a Housing State of the Union for the Stanford Center on Inequality and Poverty’s Pathways Magazine State of the Union issue. The report emphasizes the home-ownership racial gap, the relationship with the affordability crisis, and the reform that is needed for the mortgage interest tax deduction.
  • A report by the Philadelphia Federal Reserve Bank on gentrification sheds light on the fact that gentrification is not a new phenomenon
  • The New York Times ran an op-ed on the impact of land use regulation on economic growth.
  • Paul Krugman of the New York Times writes about the need to find equilibrium between negative sprawl (such as in Houston) and NIMBYism (as experienced in San Francisco). He asks, “Why can’t we get cities right?”
  • Community Land Trust has a tool for community focused development.

Federal “Right to Try” Legislation – Perpetuating a Misguided Skepticism Towards the FDA

Cross-posted from the CRITical Thinking blog.

By Jeanie Kim

The “right to try” (RTT) movement presents a narrative that pits patients against the FDA. Supporters of RTT, powered by the libertarian Goldwater Institute, have pushed for laws that let terminally ill patients bypass regulators to access unapproved treatments.

As of September 2017, 37 states have enacted RTT laws. Earlier this year, the Senate and the House introduced federal RTT bills, and on August 3, 2017, the Senate unanimously passed an amended RTT bill without an opportunity for debate. There is pressure on the House to follow suit, but it is unclear whether the House will consider the originally introduced RTT bill (“RTT 1.0”) or the Senate’s amended version (“RTT 2.0”), or even take up the legislation at all.

Despite the recent legislative backing, RTT is not a new concept. It is a variation on an age-old skepticism towards the FDA that has been around as long as the agency’s inception. At the core of RTT is the previously rejected, yet persistent argument that the FDA’s approval standards for safety and efficacy should not matter for terminally ill patients who have nothing to lose [1]. Continue reading

TODAY, 9/11 at 5 PM: Health Law Workshop with William Sage

September 11, 2017, 5-7 PM
Hauser Hall, Room 104

Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: “Fracking Health Care: The Need to Safely De-Medicalize America and Recover Trapped Value for Its People”

William M. Sage is James R. Dougherty Chair for Faculty Excellence at the University of Texas-Austin Law School and Professor (Department of Surgery and Perioperative Care) in the Dell Medical School.