PREP-Act Coverage – COVID Screening Tests

Angie SzumlinskiCompliance, Health

The United States Department of Health and Human Services (HHS) is the lead agency for the federal government’s response to the COVID-19 pandemic and on January 31, 2020, declared the 2019 novel coronavirus (COVID-19) a public-health emergency for the United States.

A key component of that response is rapidly expanding COVID-19 testing across America. Within HHS, the Office of the Assistant Secretary for Health leads federal efforts to support that expansion. 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. Testing for COVID-19, including those who are asymptomatic, is a key part of that effort.

Therefore, as an Authority Having Jurisdiction under the Secretary’s March 10, 2020 declaration under the Public Readiness and Emergency Preparedness Act (PREP Act), Assistant Secretary for Health, Admiral Brett P. Giroir, M.D., extends coverage under the 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. Such tests must be authorized, approved or cleared by the FDA (collectively, FDA-authorized COVID-19 tests).

Click below to read the guidance:

Guidance for PREP Act Coverage for COVID-19 Screening Tests at Nursing Homes, Assisted Living Facilities, Long Term Care Facilities, and other Congregate Facilities

Stay safe, stay well, and stay tuned!