Mary Madison, RN, RAC-CT, CDP
Clinical Consultant – Briggs Healthcare
On August 31, 2020, HHS (Department of Health and Human Services) announced Guidance for PREP Act Coverage for COVID-19 Screening Tests at Nursing Homes, Assisted Living Facilities, Long-Term-Care Facilities, and other Congregate Facilities. This extends 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.
Both the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have issued guidance and provided other information regarding screening asymptomatic individuals, including in congregate settings.
According to FDA, For health care providers who are ordering an authorized SARS-CoV-2 diagnostic test to be used off-label (outside the authorization) to screen asymptomatic individuals not suspected of having COVID-19, we recommend they consider the information below. Although the current available literature suggests that symptomatic individuals with COVID-19 and asymptomatic individuals without known exposure may have similar levels of viral genetic material, there is limited data on the distribution of viral loads in individuals with and without symptoms across demographics, different settings, and specimen types. Therefore, when screening asymptomatic individuals, health care providers should consider using a highly sensitive test, especially if rapid turnaround times are available. If highly sensitive tests are not feasible, or if turnaround times are prolonged, health care providers may consider use of less sensitive point-of-care tests, even if they are not specifically authorized for this indication (commonly referred to as “off-label”). For congregate care settings, like nursing homes or similar settings, repeated use of rapid point-of-care testing may be superior for overall infection control compared to less frequent, highly sensitive tests with prolonged turnaround times.
CMS has concluded that [it] requires facilities with a CLIA Certificate of Waiver to follow the manufacturer’s instructions (Instructions for Use) when performing laboratory testing. The FDA has granted Emergency Use Authorizations (EUA) to certain antigen tests for testing specimens from individuals who are suspected of COVID-19 by their healthcare provider within a number of days after the onset of symptoms, specific to each authorized test’s validated performance. The FDA has provided recommendations for health care providers who are ordering authorized tests outside their authorization (e.g., antigen tests for asymptomatic individuals)— see FDA’s FAQ on Testing for SARS-CoV-2 (“Q: Does the FDA have recommendations for health care providers using SARS-CoV-2 diagnostic tests for screening asymptomatic individuals for COVID-19?”) for further information. CMS will temporarily exercise enforcement discretion for the duration of the COVID-19 public health emergency under CLIA for the use of SARS-CoV-2 POC antigen tests on asymptomatic individuals. Specifically, CMS will not cite facilities with a CLIA Certificate of Waiver when SARS-CoV-2 POC antigen tests are performed on asymptomatic individuals, as described in the FDA FAQ.