Following the end of the COVID-19 public health emergency (PHE) on May 11, the Centers for Medicare & Medicaid Services (CMS) published guidance clarifying the agency’s enforcement discretion for Clinical Laboratory Improvement Amendments (CLIA) regulatory requirements, including the extended enforcement discretion for remote review of digital slides.

Among other key takeaways from this guidance, CMS no longer has the authority to require reporting of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test results. Additional reporting requirements, such as state requirements, still apply. Surveys for SARS-CoV-2 test results will cease; however, laboratories will still be required by law to retain testing records. In general, CMS will not continue the remote survey process. All CLIA surveys, including those performed by accreditation organizations, will be performed on site.

The enforcement discretion for using molecular and antigen SARS-CoV-2 tests for asymptomatic individuals will not continue post-PHE. All CLIA-certified laboratories are required to follow the manufacturer’s Instructions for Use for SARS-CoV-2 testing. However, CMS would not consider it a modification of the test’s Instructions for Use if a health care provider ordered a test for an asymptomatic patient, suspecting that the individual has COVID-19. In accordance with pre-PHE regulatory requirements, a modification of the test’s Instructions for Use would require the laboratory to establish performance specifications and to meet high-complexity personnel requirements.

Laboratories with a Certificate of Waiver will continue to be eligible to perform COVID-19 testing using U.S. Food and Drug Administration-approved tests for as long as the Emergency Use Authorization (EUA) remains in effect. The assay must go through the full traditional marketing authorization with the FDA to receive a CLIA complexity categorization. Laboratories with a Certificate of Waiver cannot perform a test categorized as moderate- or high-complexity by the FDA. Once notified by the FDA of this categorization, the laboratory would need to either discontinue the use of the test or meet the requirements to perform moderate- or high-complexity testing by applying for a Certificate of Compliance or a Certificate of Accreditation.

A laboratory does not need to reverify an EUA test if it was previously verified for detection of SARS-CoV-2 and if the EUA, approved products, and manufacturer’s instructions for verification remain unchanged. If an authorized EUA sample type is removed from the sample types listed in FDA-approved SARS-CoV-2 tests and if the laboratory previously verified those removed sample types on the EUA test, a laboratory would need to establish performance specifications because those sample types would then be considered a modification of the manufacturer’s Instructions for Use.

 

Source:

https://www.cms.gov/files/document/qso-23-15-clia.pdf