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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Empty hospital bed.

New Data Reignites Concerns over COVID-19 and Nursing Homes in New York State

By James W. Lytle 

Concerns over New York State’s response to the COVID-19 pandemic, particularly with respect to its treatment of nursing homes, have recently re-emerged in light of a new report and court ruling related to the matter.

Almost from the outset of the pandemic, the State faced scrutiny as to whether it was accurately reporting deaths of nursing home patients.

After nursing homes complained in April about the lack of PPE and other resources to combat the pandemic, Governor Andrew Cuomo responded that it was not the state’s responsibility, and asked the Department of Health and the Attorney General to launch investigations into nursing homes’ response to the pandemic.

Nine months later, in late January 2021, the report by New York State Attorney General Letitia James of the nursing home investigation was released.

Among the report’s headlines, the Attorney General’s preliminary analysis found that the Department of Health had undercounted deaths of nursing home residents due to COVID-19 by about 50%, largely because of the failure of the State to count the deaths of those residents who were transferred to hospitals immediately prior to their deaths. No other state excluded patients who had been transferred before death to hospitals from their nursing home fatality reports.

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Adult and child holding kidney shaped paper on textured blue background.

New Regulation Aims at Accountability for Organ Procurement Organizations

By James W. Lytle and Abe Sutton

Facing a looming deadline for the adoption of pending proposed rules, the Trump Administration finalized a host of healthcare regulations, including highly anticipated regulations addressing drug pricing and Stark Law/anti-kickback rules. Within this flurry of regulatory activity, the Centers for Medicare & Medicaid Services (CMS) also finalized an important, but not as widely discussed, proposal that seeks to hold Organ Procurement Organizations (OPOs) more accountable for their performance.

While some of these last-minute actions by the outgoing administration may ultimately be reversed or revised by the Biden Administration, this rule was associated with a well-regarded Advancing American Kidney Health initiative that has been “widely hailed by health care groups, patient advocacy organizations and Democrats,” making it “the most broadly popular health initiative of Trump’s presidency.” While its fate is not entirely certain, the recently issued final rule may be one of the few last-minute legacies of the Trump Administration likely to be more warmly received by its successor.

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