October 05, 2022

UPDATE: CMS Reinstates CLIA Enforcement Discretion regarding COVID Testing

BY Jodi Eyigor

On October 7, CMS reversed its September 26 rescission of the 2020 memo regarding testing asymptomatic individuals. The policy now in place, effective immediately, is that CMS will continue to exercise enforcement discretion when COVID-19 tests are utilized outside of the authorizations, including emergency use authorizations (EUAs) granted by the Food and Drug Administration (FDA). This enforcement discretion was initially exercised in 2020 due to testing needs exceeding capacity and this discretion will continue for the duration of the COVID-19 PHE>

While CMS no longer requires routine screening testing based on community transmission rates for asymptomatic nursing home staff who are not up to date with COVID-19 vaccination, asymptomatic screening testing continues to be utilized in many circumstances in the nursing home, including testing staff and residents who have been identified as having had a close contact or high-risk exposure and testing of new nursing home admissions / readmissions in areas of high community transmission. Nursing homes and other providers who are using point of care antigen tests in these or other circumstances may continue to use any test. This reverses the Sept 26 policy that said providers may only use the 31 tests approved within the parameters of an FDA authorization or EUA.

LeadingAge will update this article and members with any additional information from CMS on this reversal in the coming days.