Researcher handling test tubes in a laboratory_lab

The Centers for Medicare & Medicaid Services has rescinded a pandemic-era memo that allowed expanded use of point-of-care antigen COVID-19 tests under Clinical Laboratory Improvement Amendments (CLIA) waivers. 

Long-term care facilities must take care to adhere to manufacturers’ use parameters when conducting asymptomatic COVID-19 testing following this change in enforcement discretion, according to the American Health Care Association/National Center for Assisted Living.

Some of these POC tests were originally meant to be used for symptomatic patients only and CMS sought to give facilities latitude to cover their pandemic testing needs. But now testing is approved for both symptomatic patients and serial screening of asymptomatic patients, the AHCA/NCAL stated in a Thursday blog post. The original intent of the CMS policy therefore is no longer compelling, as “tests can be provided within the parameters designed to ensure accuracy,” CMS said in a Monday memo

Compliance and citations

The change in enforcement discretion is effective immediately, and means that skilled nursing facilities and/or assisted living communities with a CLIA Certificate of Waiver must check that they are complying with the manufacturer’s instructions when using these tests, according to the AHCA/NCAL.

“Providers that violate the manufacturer’s use may be subject to enforcement actions related to the facility’s CLIA Certificate of Waiver,” the industry advocate noted.

According to CMS, CLIA surveyors will also cite a laboratory “if it performs SARS-CoV-2 molecular and antigen POC tests on asymptomatic individuals outside the test’s authorization.”

The agency has required that long-term care facilities have a CLIA waiver to perform COVID-19 tests on site during the pandemic. According to CMS data, 90% of skilled nursing facilities in 2020 already had the correct version of the waiver to conduct the tests that were available at that time.

Contact for questions 

AHCA/NCAL suggested that those with further questions contact it at the following address: [email protected].

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