Oxygen mask as part of artificial lungs ventilation machine in surgery room, closeup.

Arizona’s Crisis Standards of Care and Fair Allocation of Resources During COVID-19

By Govind Persad

As COVID-19 cases spiked in Arizona, the state activated its crisis standards of care, which provide triage guidelines if absolute scarcity arises.

Arizona has done the right thing by adopting crisis standards of care instead of leaving these decisions about ventilators to be made ad hoc by medical staff, which presents the risk both of arbitrary and biased decisions and of greater distress for clinical staff who are forced to make decisions without a guidance framework.

Arizona’s activation of its crisis standards of care stands in contrast to most other states’ response to the pandemic, including New York, which ultimately did not activate its crisis standards of care. Even though Arizona and other states have not yet reached the stage of absolute scarcity where triage policies are invoked—and hopefully will take steps to avoid reaching it—the move has prompted discussions about fair triage policies and criticisms from some community organizations.

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a stethoscope tied around a dollar bill, with a bottle of pills nearby

What Ever Happened to NIH’s “Fair Pricing” Clause?

By Jorge L. Contreras

In the midst of the COVID-19 pandemic, calls have been made for “fair” and “reasonable” pricing of the vaccines and therapeutics that will eventually be approved to address the virus. A range of proposals in this regard have been made by members of Congress, the Trump Administration, various states, academics and civil society.

Amid this current debate, it is worth remembering the brief period from 1989 to 1995 when the U.S. National Institutes of Health (NIH) did impose reasonable pricing constraints on drugs that were developed as part of cooperative R&D agreements (“CRADAs”) between federal agencies and private industry.

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Health care workers in personal protective equipment attend to a patient.

Value-Based Reimbursement Can Decrease Spending on Medicare During COVID-19

By Sravya Chary

Since the start of the COVID-19 pandemic, the virus’ disproportionate threat to the Medicare patient population has been widely discussed and acknowledged. In light of the public health crisis and an increasing financial burden placed on entities involved in Medicare cost sharing, a value-based Medicare system would not only reduce costs, but also better protect the elderly and chronically ill during the pandemic.

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New TWIHL: Ethical Issues in Development of a COVID-19 Vaccine

This episode is the first of a series of shows dealing with health care and research ethics related to COVID-19.

Here, Tara Sklar from The University of Arizona James E. Rogers College of Law introduces Arthur Caplan, the Drs. William F. and Virginia Connolly Mitty Professor, Founding Head of the Division of Medical Ethics, and Co-Chair of the Working Group on Compassionate Use and Preapproval Access (CUPA) at NYU Grossman School of Medicine. Dr. Caplan discusses ethical issues in development of a COVID-19 vaccine.

The series is co-sponsored by the NYU Grossman School of Medicine Division of Medical Ethics and the University of Arizona Health Law and Policy Program.

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, SpotifyTunein or Podbean.

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 me on Twitter @nicolasterry or @WeekInHealthLaw.

Journal of Law and the Biosciences Continues to Have an Impact

The COVID-19 pandemic has underscored the importance of the biosciences in our world, as well as the legal, ethical, and regulatory choices that shape the development and implementation of innovations from the biosciences.

The Journal of Law and the Biosciences (JLB) offers high-quality, open-access scholarship at the intersection of the biosciences and law as the first fully open-access, peer-reviewed, legal journal to focus on these issues.

Recently, the Journal of Law and the Biosciences received an updated impact factor of 2.275, highlighting its relevance and influence in law, medicine, and ethics. JLB ranks 25th out of 154 law journals, second of sixteen legal medicine journals, and third out of sixteen medical ethics journals.

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hospital equipment

Taking Control During COVID-19 Through Advance Care Planning

By Stephanie Anderson and Carole Montgomery

A deep divide exists in the American health care system between patients’ values and the care they receive.

Let’s start with a story – Marcus was in his mid-40’s when he underwent high-risk heart surgery during which he suffered a brain injury. Afterward, the surgeons at first reassured his family that the surgery itself was successful (his heart was working fine) in spite of his brain injury.

Unfortunately, after many days in the ICU he remained unconscious and was not able to get off the ventilator. Specialists told the family that his brain injury was severe, and he would likely not be able to carry on a meaningful conversation or live independently ever again.

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TWIHL 212: Substance Use Privacy Before and After CARES

By Nicolas Terry

In this episode, I welcome back Kirk Nahra, a partner and Co-Chair of the Cybersecurity and Privacy Practice at Wilmer Hale in DC. He has been a leading authority on privacy and cybersecurity matters for more than two decades. Mr. Nahra counsels clients across industries, from Fortune 500 companies to startups, on implementing the requirements of privacy and data security laws across the country and internationally.

And, after all this time, finally I welcome Melissa Goldstein, Associate Professor in the Department of Health Policy and Management at the Milken Institute School of Public Health at the George Washington University, where she teaches courses in bioethics (including genomics, reproductive ethics, end-of-life, and research ethics issues), health information technology policy, and public health law and conducts research on health information privacy and the legal and policy aspects of health information technology. Our excuse for getting together is that we recently co-authored a piece on the Health Affairs blog titled COVID-19: Substance Use Disorder, Privacy, And The CARES Act.

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, SpotifyTunein or Podbean.

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 me on Twitter @nicolasterry or @WeekInHealthLaw.

Young male doctor in telehealth concept

Call for Abstracts: Looking Forward to a Post-Pandemic Landscape

By Carmel Shachar and Katie Kraschel

The COVID-19 pandemic has disrupted virtually every facet of day-to-day life.

This disruption has forced us to examine baseline choices and assumptions about how to deliver health care, participate in public discourse, provide access to education, and support the workforce. This “great revision” will continue in several iterative stages: an immediate response to the crisis, a modulation as the pandemic continues, and a resolution into a “new normal.”

The Petrie-Flom Center and the Solomon Center for Health Law Policy are interested in tracking when crisis settles into the new normal and articulating how public policy and law should respond to that evolution.

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a crowd of people shuffling through a sidewalk

The SSTAR Initiative: A Policy Proposal for a Full, Equitable Recovery from COVID-19

By Sara E. Abiola and Zohn Rosen

Full recovery from the COVID-19 pandemic in the U.S. will require new policy that promotes equity and streamlines access to social services while supporting small businesses

Unprecedented job loss due to COVID-19 has led to an economic crisis for families of all backgrounds and income levels.

Current health and social services programs are ill-equipped to handle this need. Moreover, long-standing racial health inequities and the stigma associated with using social services will persist in the absence of significant systems-level change.

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Task force on coronavirus and equity report card.

The Health Equity Failures of Massachusetts’ COVID-19 Reopening Plan

By Charlene Galarneau

Massachusetts began Phase III of its reopening plan this week. Reopening unquestionably involves disproportionate risks to the health of some residents relative to others, and the State’s push forward fails to adequately address these risks.

Phase III of Governor Baker’s Reopening Massachusetts Plan began on July 6, with the exception of Boston, which will begin Phase III on July 13. The first step of Phase III focuses on the reopening of recreational activities: gyms, movie theaters, museums, casinos, and professional sports teams, with specific rules for each type of operation.

In its May 2020 report, “Reopening Massachusetts,” the State’s Reopening Advisory Board asserts that “key public health metrics will determine if and when it is appropriate to proceed through reopening phases.” It references six indicators, including the COVID-19 positive test rate, deaths, hospitalizations, health care system readiness, testing capacity, and contact tracing capabilities.

But these state-wide metrics are inadequate, in both public health and ethics terms. Missing from these metrics in particular, and this Reopening Plan in general, is recognition of, not to mention accountability for, the predictably disproportionate negative impacts that reopening has on the lives of Black and Latinx residents, low-wage workers, and other groups already disparately harmed by COVID-19.

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