The White House, Washington, DC.

The Years of Magical Thinking: Pandemic Necrosecurity Under Trump and Biden

By Martha Lincoln

From spring 2020 through the present day, Americans have endured levels of sickness and death that are outliers among not only wealthy democracies, but around the world. No other country has recorded as many total COVID-19 casualties as the United States — indeed, no other country comes close.

This situation is not happenstance. From early moments in 2020, the concept of a right to health — and indeed, even a right to life — has been discounted in American policy, discourse, and practice. Quite mainstream and influential individuals and institutions — physicians, economists, and think tanks — have urged leaders to shed public health protections — particularly masking — and “move away” from the pandemic. Over the past two years in the United States, leaders in both political parties have capitulated to — if not embraced — the doxa that a certain amount of death and suffering is inevitable in our efforts to overcome (or “live with”) the pandemic. In a piece written during the first months of COVID under Trump, I called this dangerous yet influential outlook necrosecurity: “the cultural idea that mass death among less grievable subjects plays an essential role in maintaining social welfare and public order.”

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Washington DC 09 20 2021. More than 600,000 white flags honor lives lost to COVID, on the National Mall. The art installation " In America: Remember" was created by Suzanne Brennan Firstenberg.

Introduction to the Symposium: Health Law and Policy in an Era of Mass Suffering

By Chloe Reichel and Benjamin A. Barsky

Last spring, the United States crossed the bleak and preventable 1,000,000-death mark for lives lost during the COVID-19 pandemic. In this symposium, our hope is to acknowledge — and mourn — this current era of mass suffering and death.

In particular, we want to reckon with the role of health law and policy in shaping, and at times catalyzing, the impact that the pandemic has had on our loved ones and communities.

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Nov 22, 2019 Palo Alto / CA / USA - Close up of Amazon logo and Smile symbol at one of their corporate offices located in Silicon Valley, San Francisco bay area.

One Medical Acquisition: The Path Forward

This piece has been adapted slightly from its original form, which was published at On the Flying Bridge on July 24, 2022.

By Michael Greeley

Last week’s $3.9 billion acquisition of One Medical (NASDAQ: ONEM) by Amazon triggered significant hyperventilating about the transformative and immediate impact of this transaction on the health care industry. Interestingly, Amazon’s market capitalization increased 1.4% or $18.3 billion on the day of the announcement, paying for the purchase a few times over. Undoubtedly there could be exciting near-term benefits for the 750,000 ONEM members as their Amazon Prime accounts are linked to their ONEM memberships, facilitating targeted Whole Food and Amazon Pharmacy coupons. But what we might expect to see over time is a provocative debate with powerful implications for how each of us manage the arc of our health care journeys.
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Tax forms with laptop, glasses, pen, and calculator.

The Tax Code Needs to Do More for Public Health

By Bailey Kennedy

With the pain of tax day now a month behind us, it’s worth talking about something that we don’t often associate with the tax code: health. It’s not easy to imagine that the tax code could truly do much to make Americans happier and healthier — but there are ways that it could. Federal and state tax codes could both be reformed in small ways that might encourage Americans to make healthier decisions.

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Female hand writing signature on the paper document.

How to Construct Better Organ Donation Policy and Achieve Health Equity

By James R. Jolin

The United States is facing an organ donation crisis, with massive gaps between supply and demand.

Per estimates from the Department of Health and Human Services (HHS), over 106,000 Americans are currently awaiting this life-saving medical treatment. Further, the burden of this shortage falls unequally:  in 2020, while approximately 48% of white patients in need of transplants received an organ, only 27% of Black patients secured one.

The stakes are too high to allow the organ donation crisis to proceed in the U.S. without bold intervention. But with many policy options on the table, unresolved ethical concerns, and a patchwork of organ donation laws across the country, the proper path forward is not immediately clear.

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Doctor or surgeon with organ transport after organ donation for surgery in front of the clinic in protective clothing.

Pig Hearts for Humans and the FDA

By Jacob Balamut

David Bennett, a man who recently underwent the world’s first successful xenotransplantation organ surgery, died last month after a sudden and as yet unexplained period of rapid deterioration.

Bennett, who was 57 years old, had been suffering from end-stage heart disease. With limited options for treatment, he underwent an experimental emergency procedure to replace his damaged heart with a genetically modified pig’s heart. The pig was genetically modified to limit the likelihood that Bennett’s immune system would reject the heart.

Many researchers and clinicians alike see the potential for genetically modified animal organs to serve as a solution to our organ transplant and supply issues. The Health Resources and Services Administration estimates that 17 people die per day on the candidate waiting list. These deaths are the result of a lack of supply of organs, which has been a longstanding issue within the United States.

However, currently, the U.S. Food and Drug Administration (FDA) has not approved any genetically modified or pure animal organs for xenotransplantation in humans. For the surgery to go forward in Bennett’s case, the team had to submit a request to the FDA seeking to use the pig heart in the emergency procedure (so-called “compassionate use”). The lack of approved xenotransplantation products stems from a lack of safety data and concerns regarding the potential for cross-species infections to occur.

In 2016, the FDA updated previously existing guidance for xenotransplantation. The purpose of the guidance was to inform the industry of how the FDA would be handling xenotransplantation applications and to provide recommendations.  In order for xenotransplantation products to be approved, the following process must occur.

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Waiting area in a doctor's office

Churntables: A Look at the Record on Medicaid Redetermination Plans

By Cathy Zhang

The COVID-19 Public Health Emergency (PHE) expires at the end of this week, with Department of Health and Human Services (HHS) Secretary Xavier Becerra expected to renew the PHE once more to extend through mid-July.

When the PHE ultimately expires, this will also trigger the end of the Medicaid continuous enrollment requirement, under which states must provide continuous Medicaid coverage for enrollees through the end of the last month of the PHE in order to receive enhanced federal funding. This policy improves coverage and helps reduce churn, which is associated with poor health outcomes.

After the PHE, states can facilitate smooth transitions for those no longer eligible for Medicaid by taking advantage of the full 12- to 14- month period that the Centers for Medicare & Medicaid Services (CMS) has established for redetermining eligibility.

In August 2021, CMS released guidance giving states up to 12 months following the end of the PHE to redetermine whether Medicaid enrollees were still eligible and renew coverage. Last month, CMS released new guidance specifying that states must initiate redeterminations and renewals within 12 months of the PHE ending, but have up to 14 months to complete them. The agency is encouraging states to spread its renewals over the course of the full 12-month unwinding period, processing no more than 1/9th of their caseloads in a month, in order to reduce the risk of inappropriate terminations.

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Emergency room.

Hospitals in Poor Rural Counties Face the Greatest Financial Threat from COVID

By Robert I. Field and Anthony W. Orlando

The latest wave of COVID cases and hospitalizations has raised concerns about the financial resilience of many hospitals in the United States. Throughout the pandemic, we have witnessed shortages of medical supplies, exhaustion of frontline workers, and the overflow of patients beyond the physical capacity of hospital beds and buildings. Now, after nearly two years of repeated COVID surges, there is a real danger that some institutions might run so low on funding that they will need to downsize or close altogether.

Large hospitals in metropolitan areas have, for the most part, weathered the storm. Ample financial resources enabled them to survive with fewer lucrative elective procedures and sudden overwhelming demand for less profitable intensive care for COVID patients. But in many parts of the country, especially rural regions, smaller hospitals lack such financial cushions. For them, COVID could be an existential threat.

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Bill of Health - Globe and vaccine, covid vaccine

COVID ‘Compromise’ on International IP Underscores Need for New Approach

By Cynthia M. Ho

The leaked compromise regarding a “waiver” of international intellectual property (IP) obligations under the TRIPS Agreement for World Trade Organization (WTO) members has met harsh criticism as a shadow of the original proposal to waive international obligations regarding patent, trade secret, and copyright obligations relating to any COVID vaccine, treatment, diagnostic, or personal protective equipment (PPE).

The compromise excludes diagnostics, treatments, and PPE. It only narrowly modifies compulsory licenses of patents covering COVID vaccines. Moreover, it imposes additional restrictions on use of compulsory licenses. But still, multinational pharmaceutical manufacturers have protested even these modest changes from the status quo, arguing that there is no IP problem that needs to be fixed.

Clearly there is a problem. It has taken 18 months since the original Indian and South African proposal to get to this limited compromise, while gross vaccine inequity between wealthy and poor countries continues. In addition, the leaked compromise between four WTO members is still being debated — and even if agreement can be reached, it needs agreement of over 100 other WTO members. We need a new approach.

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Melbourne, Australia - 1st November 2021: A person wearing full PPE holds a vial of sotrovimab medicine covid-19 virus treatment. It is under an emergency use authorization to treat covid in Australia.

Litigation Challenges Prioritization of Race or Ethnicity in Allocating COVID-19 Therapies

By James Lytle

Recent guidance from the U.S. Food & Drug Administration (FDA) encouraged several states to adopt policies that prioritized race or ethnicity in the allocation of monoclonal antibody treatments and oral antivirals for the treatment of SARS-CoV-2.

The guidance proved to be highly controversial, prompting two states, Utah and Minnesota, to withdraw their guidance, and leading a third state, New York, to become the subject of two federal lawsuits that challenge the guidance’s legality: one (Jacobson v. Bassett) brought by a white, non-Hispanic Cornell Law Professor, William Jacobson, in the Northern District of New York (“Jacobson”) and a second (Roberts v. Bassett) initiated by Jonathan Roberts and Charles Vavruska, two white, non-Hispanic residents of New York City in the Eastern District (“Roberts”).

Public health and policy experts have published commentaries on the challenging issues underlying New York’s COVID treatment guidelines and others have offered more detailed guidance, including on this blog, on what criteria should be used in allocating scarce COVID treatments. What follows is focused on the litigation pending in New York and its potential impact on the broader issues at the intersection of the pandemic response and racial equity.

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