CMS releases Long Term Care Facility COVID-19 Testing Requirements

On August 25 the Centers for Medicare and Medicaid Services (CMS) released an interim final rule related to additional policy and regulatory provisions in response to the COVID-19 Public Health Emergency. The interim final rule adds mandatory conditions of participation at 42 CFR 483.80(h) requiring facilities to test all residents and staff for COVID-19.

CMS has released state survey guidance and a revised COVID-19 Focused Survey Tool to assess compliance with the new requirements. CMS will cite noncompliance related to the new requirements under tag F886. Facilities may either use rapid point-of-care (POC) diagnostic testing devices or make arrangements with an offsite laboratory. Facilities who plan to use POC devices, including devices provided by the Department of Health and Human Services, with their own staff must have a CLIA Certificate of Waiver.

CMS’s guidance includes requirements regarding symptomatic, outbreak, and routine testing of staff and residents. Routine testing of staff is based on the county positivity rate in the past week and ranges from once a month in areas of low (<5%) community COVID-19 activity to twice a week in areas of high (>10%) community COVID-19 activity. Testing requires an order from a physician, physician assistant, nurse practitioner, or clinical nurse specialist and must be obtained through use of standing orders or other means. Facilities conducting their own testing under a CLIA certificate of waiver must comply with data reporting requirements. CMS has developed a frequently asked questions document for COVID-19 testing at Skilled Nursing Facilities/Nursing Homes. Facilities must demonstrate compliance with the testing requirements through documentation regarding each test performed in response to symptomatic, outbreak and routine testing.

In addition, the new COVID-19 Focused Survey Tool includes additional survey questions related to infection prevention controls including the use of face masks by staff, residents, visitors, and others, use of Transmission-Based Precautions, and the designation and training of one or more individuals as infection preventionists.

The full guidance document and survey tool is available here.