August 31, 2020
HHS Extends Coverage For COVID-19 Screening Tests at Congregate Facilities during the Pandemic
Today, the U.S. Department of Health and Human Services through the Assistant Secretary for Health, extended coverage under the Public Readiness and Emergency Preparedness Act (PREP Act) to licensed health-care practitioners prescribing or administering point-of-care COVID-19 tests, using anterior nares specimen collection or self-collection, for screening in congregate facilities across the Nation.
Enhancing the safety of nursing homes, assisted-living facilities, long-term-care facilities, and other facilities where people congregate to receive care or education or to work is critical for our Nation's response to the COVID-19 pandemic. Using COVID-19 tests to screen for infections, including in asymptomatic individuals, is a key part of that effort.
"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 coverage preempts any State and local law that prohibits or effectively prohibits such persons from administering FDA-authorized COVID-19 tests to symptomatic and asymptomatic individuals at congregate facilities.
PREP Act coverage encompasses licensed health-care practitioners prescribing or administering FDA-authorized COVID-19 tests, including for off-label (outside the authorization) use to screen asymptomatic individuals in congregate facilities.
To access a copy of the guidance, click here.*
* Persons using assistive technology may not be able to fully access information in this file. For assistance, please contact the Office of the Assistant Secretary for Health at email@example.com.