Los Angeles, California, United States. June 23, 2021: #FreeBritney rally at LA Downtown Grand Park during a conservatorship hearing for Britney Spears.

There’s More to Decision-Making Capacity than Cognitive Function

The Health Law, Policy, Bioethics, and Biotechnology Workshop provides a forum for discussion of new scholarship in these fields from the world’s leading experts. Though the Workshop is typically open to the public, it is not currently, due to the COVID-19 pandemic. However, many of our presenters will contribute blog posts summarizing their work, which we are happy to share here on Bill of Health.

By James Toomey

The doctrine of capacity is a mess.

From Britney Spears’s high-profile struggles to establish her own capacity to the countless, quiet challenges of so many older adults, the doctrine of capacity, which requires people to have the cognitive functioning to understand the nature and consequences of a decision in order for it to be recognized in law, is vague, normatively and medically challenging, and inconsistently applied.

This is a big deal — at stake in every capacity case is whether, on the one hand, an individual may access the legal rights most of us take for granted, to enter into contracts, buy or transfer property, or get married or divorced; or, on the other, whether the legal system will ratify a decision the “real person” never would have made.

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Scales of justice and gavel on table.

Symposium Introduction: Health Justice: Engaging Critical Perspectives in Health Law and Policy

By Ruqaiijah Yearby and Lindsay F. Wiley

Public health scholars, advocates, and officials have long recognized that factors outside an individual’s control act as barriers to individual and community health.

To strive for health equity, in which everyone “has the opportunity to attain . . . full health potential and no one is disadvantaged from achieving this potential because of social position or any other socially defined circumstance,” many have adopted the social determinants of health (SDOH) model, which identifies social and economic factors that shape health. Yet, health equity has remained elusive in the United States, in part because the frameworks that most prominently guide health reform do not adequately address subordination as the root cause of health inequity, focus too much on individuals, and fail to center community voices and perspectives.

The health justice movement seeks to fill these gaps. Based in part on principles from the reproductive justice, environmental justice, food justice, and civil rights movements, the health justice movement rejects the notion that health inequity is an individual phenomenon best explained and addressed by focusing on health-related behaviors and access to health care. Instead it focuses on health inequity as a social phenomenon demanding wide-ranging structural interventions.

This digital symposium, part of the Health Justice: Engaging Critical Perspectives in Health Law & Policy Initiative launched in 2020, seeks to further define the contours of and debates within the health justice movement and explore how scholars, activists, communities, and public health officials can use health justice frameworks to achieve health equity.

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Picture of Ivermectin tablets.

Legal and Ethical Analysis of Court-Ordered Ivermectin Treatment for COVID-19

By Jennifer S. Bard

A judge in Ohio ruled on Monday that a hospital in the region must administer ivermectin to a patient very sick with COVID-19 in their ICU, despite the decision by the medical staff, in agreement with recent statements by the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), that ivermectin is not an appropriate treatment, as it has been shown not to work against COVID.

The patient’s prescription came from a doctor who has no authority to treat patients at this particular hospital, although he is licensed to prescribe medicine in Ohio.

This case tracks a swelling interest, which some ascribe to the efforts of a group called America’s Front Line Doctors, among people for the anti-parasitic medication as both a treatment and prophylactic for COVID-19 — despite warnings from the medical establishment that it doesn’t work, and, if taken in the form normally given to farm animals or at the dosages being suggested, can be harmful.

The Ohio ruling is just the latest of several successful law suits (see similar cases in New York and Illinois) to order hospitals to administer ivermectin to hospitalized COVID-19 patients, despite the objections of the treating physicians.

There is also evidence of a global trend, as evidenced by the order of a court in South Africa to allow the prescription of ivermectin for COVID-19, something that was previously not permitted by the country’s drug regulatory agency.

This trend of courts ordering that treatments requested by hospitalized patients be made available by that hospital — so long as they are prescribed by a physician — opens the door to substantial administrative, legal, and ethical chaos. This post analyzes some of the most pressing legal, regulatory, and ethical concerns.

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Abortion rights protest following the Supreme Court decision for Whole Women's Health in 2016

How Social Movements Have Facilitated Access to Abortion During the Pandemic

By Rachel Rebouché

Before the end of 2021, the U.S. Food and Drug Administration (FDA) will reconsider its restrictions on medication abortion. The FDA’s decision could make a critical difference to the availability of medication abortion, especially if the Supreme Court abandons or continues to erode constitutional abortion rights.

Under that scenario of hostile judicial precedents, a broad movement for abortion access — including providers, researchers, advocates, and lawyers — will be immensely important to securing the availability of remote, early abortion care.

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LONDON, UNITED KINGDOM- 1 APRIL 2015: A newspaper rack holding several international newspapers, such as The International New York Times, USA Today, Irish Times, Londra Sera and Corriere Della Sera.

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

By Ameet SarpatwariBeatrice Brown, Alexander EgilmanAviva Wang, 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.

Below are the citations for papers identified from the month of July. The selections feature topics ranging from a discussion of issues related to FDA’s approval of aducanumab for the treatment of Alzheimer’s disease, to an analysis of the communication of survival data in cancer drug labels, to an evaluation of public-sector contributions to novel biologic drugs. A full posting of abstracts/summaries of these articles may be found on our website.

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Map of remote execution requirements for advance directives.

Advance Care Planning in an Online World: State Law Activity and Challenges Since COVID-19

By Nikol Nesterenko, Jonathan Chernoguz, and Sarah Hooper

Advance care planning — the process by which an individual documents their wishes for health care in the event that they become incapacitated — has become particularly urgent during the COVID-19 pandemic.

However, individuals that wish to engage in advance care planning, and specifically to document their plans in a written form (i.e., advance directives), have faced significant hurdles due to legal execution requirements. State advance directive law often requires or presumes live, in-person witnessing or notarization, actions which were prohibited by social distancing orders or simply unsafe during the pandemic.

In this piece, we summarize the state of remote execution requirements for advance directives before and during the COVID-19 pandemic. Broadly speaking, while many states took some action in this regard, most did not enact comprehensive changes, and therefore failed to meaningfully facilitate remote execution of advance directives.

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illustration of person tracking his health condition with smart bracelet, mobile application and cloud services.

Reforming How Medicare Pays for Digital Health

By Robert Horne and Lucia Savage

The Fourth Industrial Revolution, also known as the digital revolution, leverages technology to blur the lines between products and services. In the health insurance sector, this revolution offers policymakers unique opportunities to improve coverage and payment efficiencies while providing meaningful benefits to beneficiaries.

Medicare could lead this charge. Congress has an opportunity to reform Medicare in 2024, when the Trust Fund will become insolvent. Policymakers expect Congress to address this problem legislatively to prevent interruptions in coverage for seniors.

If past behavior is any indication, the legislation will also include reforms to improve how the program operates and spends money. Reforms to Medicare’s traditional coverage and reimbursement approaches that harness the digital revolution can help the program secure additional value. We know this because other sectors of the U.S. economy that have fully embraced this revolution have realized additional value.

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Gloved hand holding medical rapid test labeled COVID-19 over sheet of paper listing the test result as negative.

How Long COVID Is Forcing a Reckoning with the Neglect of Post-Infectious Chronic Illnesses

By Colleen Campbell

While post-viral illnesses are not new, they have been considerably neglected by the public health, medical, and scientific communities. This invisibility has, in many ways, been constructed by institutional neglect and medical sexism.

The COVID-19 pandemic is now causing a reckoning with this institutional neglect. This is because COVID Long Haulers and patient advocates for the chronically ill are forcing an unprecedented recognition for these chronic complex diseases.

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Doctor working with modern computer interface.

To Set the Price Tag for Telehealth, First Understand Its Value

By Mary Witkowski, Susanna Gallani, and David N. Bernstein

As the economy reopens, a debate has emerged about whether to continue supporting telehealth and digital practices, or whether to return to pre-pandemic practices, practically relegating telehealth solutions and digital interactions to lower-value exceptions to traditional medical care.

The next set of regulatory and payment policies will likely set the trajectory for how digital health is integrated into the overall care model. We suggest that rather than making these policy decisions based on incremental thinking relative to historical pricing of in-person care, they ought to be based on an assessment of how they generate value for patients.

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