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September 04, 2020

Health Law Weekly

COVID-19 Updates and Developments (Week of August 31)

  • September 04, 2020

Agency Action

Department of Health and Human Services (HHS)

September 1—HHS is encouraging assisted living facilities (ALF) to apply now for funding under the Provider Relief Fund Phase 2 General Distribution allocation. Nearly one million older adults reside in the nation’s roughly 28,000 ALFs. Because this older population is more vulnerable to COVID-19, many ALFs have implemented public health recommendations that have increased their costs. Eligible ALFs applying for Phase 2 funding will receive 2% of their annual revenue from patient care. The deadline for initiating an application for funding is September 13.

August 31—Licensed health care practitioners who prescribe or administer point-of-care tests to screen for COVID-19 infections in nursing homes, assisted-living facilities, long term care facilities, and other facilities where individuals congregate will now be covered under the Public Readiness and Emergency Preparedness Act (PREP Act), HHS announced. "Today's action will expand the use of rapid point-of-care antigen tests to slow the spread of COVID-19 and continue safely reopening America," said Assistant Secretary for Health, ADM Brett P. Giroir, MD. The PREP Act preempts any state or local law that prohibits individuals from administering Food and Drug Administration (FDA)-authorized COVID-19 tests to symptomatic and asymptomatic individuals at “congregate facilities”—i.e., “facilities where people congregate to receive care or education or to work.”

Food and Drug Administration (FDA)

August 28—FDA revised its emergency use authorization (EUA) for remdesivir to include treating all hospitalized patients with suspected or laboratory confirmed COVID-19. In May, FDA issued the EUA to Gilead Sciences Inc. for use in treating patients with low blood oxygen levels or needing breathing support. The revised EUA allows the drug, which was shown in clinical trials to shorten recovery time for some patients, to be used in treating adult and pediatric hospitalized patients regardless of disease severity.

National Institutes of Health (NIH)

September 2—NIH awarded $129.3 million in contracts to nine companies for new COVID-19 testing technologies. The contract awards are part of the agency’s Rapid Acceleration of Diagnostics initiative to support scale-up and manufacturing of portable point-of-care tests and high-throughput laboratories that can return results within 24 hours. At the end of July, NIH also entered into contracts with seven companies valued at $248.7 million under the initiative.

Other Developments

September 1—The National Academies of Sciences, Engineering, and Medicine today released a draft framework to assist policymakers in planning for equitable allocation of a vaccine against COVID-19. The Committee on Equitable Allocation of Vaccine for the Novel Coronavirus developed the preliminary framework in July at the request of the NIH and Centers for Disease Control and Prevention. The draft draws on lessons learned from past mass vaccination campaigns and guidance from the recent COVID-19 pandemic. The committee recommends a four-phased approach to achieve maximum societal benefit by reducing morbidity and mortality caused by the transmission of novel coronavirus. The draft outlines the phases and rationale for prioritizing groups included in each phase as the supply of vaccine increases. The committee asked for public feedback on the draft between September 1 and September 4, with a final framework expected in the fall.