To avoid new citations of COVID tests, refer to manufacturers’ instructions for use –

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

According to the American Health Care Association/National Center for Assisted Living, long-term care facilities must be careful to adhere to manufacturers’ usage parameters when performing asymptomatic COVID-19 testing after this change in enforcement discretion.

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

Conformity and Quotations

The change in enforcement discretion is effective immediately and means that qualified nursing facilities and/or assisted living communities with a CLIA clearance certificate must verify with AHCA/NCAL that they are following the manufacturer’s instructions when using these tests.

“Vendors violating manufacturer use may be subject to enforcement actions related to the facility’s CLIA clearance certificate,” the industry advocate noted.

According to CMS, CLIA experts will also cite a lab “when it performs SARS-CoV-2 molecular and antigen POC testing on asymptomatic individuals outside of testing authorization.”

The agency has required long-term care facilities to have a CLIA waiver to conduct on-site COVID-19 testing during the pandemic. According to CMS data, by 2020, 90% of qualified care facilities already had the correct version of the exemption to administer the tests available at the time.

Contact for questions

AHCA/NCAL suggested that those who have additional questions should contact them at [email protected]

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