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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Dried psilocybe cubensis psilocybin magic mushrooms inside a plastic prescription medicine bottle isolated on white background.

As Cities Decriminalize Psychedelics, Law Enforcement Should Step Back

By Mason Marks

Amid rising rates of depression, suicide, and substance use disorders, drug makers have scaled back investment in mental health research. Psychedelics may fill the growing need for innovative psychiatric drugs, but federal prohibition prevents people from accessing their benefits. Nevertheless, some cities, dissatisfied with the U.S. war on drugs, are decriminalizing psychedelics.

In 2019, Denver became the first U.S. city to decriminalize mushrooms containing psilocybin, a psychedelic the FDA considers a breakthrough therapy for major depressive disorder (MDD) and treatment-resistant depression.

In a historic vote, Denver residents approved Ordinance 301, which made prosecuting adults who possess psilocybin-containing mushrooms for personal use the city’s “lowest law enforcement priority.” Since then, in Oakland and Santa Cruz, California, voters approved their own decriminalization measures.

As a Schedule I controlled substance, psilocybin remains illegal under federal law, and despite ongoing clinical trials, it is unlikely to become FDA approved for several years. Social distancing requirements due to COVID-19 are disrupting medical research causing further delays. But as the November election approaches, other U.S. cities prepare to vote on psychedelics.

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

By Ameet Sarpatwari, Charlie Lee, 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 pharmaceutical law and policy.

Below are the abstracts/summaries for papers identified from the month of June. The selections feature topics ranging from the cost of delayed generic entry in Medicaid, to challenges with false negative tests for SARS-CoV-2 infection, to difficulties in implementing and enforcing state opioid prescribing laws. A full posting of abstracts/summaries of these articles may be found on our website.

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The Week in Health Law podcast logo twihl.com

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.

Masks.

Indiana’s Mask Mandate Debate Raises Public Health Enforcement Questions

By Ross Silverman

On Wednesday, July 22, 2020, Indiana Governor Eric Holcomb announced an Emergency Order to mandate mask wearing in public places beginning July 27, and indicated that violations of the order could potentially result in criminal penalties. Shortly after, Attorney General Curtis Hill issued an opinion questioning the Governor’s authority to criminalize mask violations under the state’s Emergency Management and Disaster Law (EMDL).

Indiana’s Executive Order, while in line with some 30 other states now imposing mask orders, represents a change of positions for the Governor. Holcomb has been an advocate for mask wearing in both word and deed, but, until now, not a mandate. As he indicated at his press conference, there have been “concerning changes” in the state’s trajectory of new COVID-19 cases, and that “By masking up, we can & will save lives & slow the spread of #COVID19.”

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London.UK.June 10th 2017.Anti DUP demonstration takes place in Parliament Square.

The Challenge of Implementing Abortion Law Reform in Northern Ireland During COVID-19

By Fiona Bloomer

As observed in the first two decades of the 21st century, abortion exceptionalism has carried through into 2020, remaining one of the most politicized issues globally.

In Northern Ireland (NI), this exceptionalism is evident in landmark developments to improve access, as well as in concerns over obstructions to services. Read More

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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