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CMS Issues New Testing Regulations and Guidance

The Centers for Medicare and Medicaid Services (CMS) has published new COVID-19 testing regulations and guidance memos, QSO-20-38-NH and QSO-20-37-CLIA,NH, for nursing homes that took effect on Sept. 2, 2020. Members are advised that to the extent New York State testing requirements are more stringent, the State requirements continue to apply. Members should take note of federal testing requirements applicable to an "outbreak," defined as a single confirmed case among staff or a single nursing home-onset confirmed case among residents. The new federal testing requirements cover:

  • facility-wide testing in the event of an outbreak;
  • routine testing of staff based on community prevalence;
  • procedures for staff or residents who refuse testing, and documentation; and
  • documentation and reporting of testing.

In addition, the COVID-19 Focused Survey Tool has been updated to incorporate the new requirements.

The new regulations and associated guidance include the following requirements:

  • Testing of all staff and residents who show symptoms consistent with COVID-19.
  • Facility-wide testing in the event of an “outbreak,” which is defined as a single new COVID infection among staff or a single  “nursing home-onset” COVID infection among residents. A resident admitted with COVID-19 is not a “nursing home-onset” case. Testing must continue every three to seven days until at least 14 days elapse without a positive result.
  • Routine testing of all staff, volunteers, and those who provide services under an arrangement with a nursing home, including certified nursing assistant (CNA) trainees, at a minimum frequency based on county positivity rates. New York State facilities must continue to comply with New York’s more stringent weekly staff testing requirements, unless the positivity rate of the county in which the facility is located rises above 10 percent. If the positivity rate exceeds 10 percent, staff testing must be conducted twice weekly under the federal regulations. There are no counties in New York with a positivity rate of greater than 10 percent at this time.
  • Monitoring of the county positivity rate every other week to adjust the frequency of staff testing as needed. The guidance includes a table specifying the testing frequency associated with various positivity rates. If the county positivity rate increases to require a higher frequency level, the facility should begin testing staff at the higher frequency as soon as the criteria for the higher activity are met. If the county positivity rate decreases to require a lower frequency, the facility should continue testing staff at the higher frequency level until the county positivity rate has remained at the lower activity level for at least two weeks before reducing testing frequency. County positivity rates are available here, under the heading "COVID-19 Testing."
  • Facilities that are not using point-of-care testing are directed to select labs that can quickly process tests and report results within 48 hours. If a facility cannot meet requirements due to lack of supplies or inability of labs to deliver results within 48 hours, it should document its efforts to obtain quick test results with the identified laboratory or laboratories and its contact with the local and state health departments.
  • Only antigen or nucleic acid testing will satisfy testing requirements, not antibody testing. Point-of-care and off-site laboratory analysis are both acceptable.
  • Documentation of testing in the resident’s medical record or staff personnel file, including data elements specified in the guidance.
  • Reporting of all point-of-care test results within 24 hours in accordance with Clinical Laboratory Improvement Amendment (CLIA) (or New York State limited service laboratory) COVID-19 reporting requirements. In addition, COVID-19 data must be reported to the National Healthcare Safety Network (NHSN) weekly.
  • An order from a health care professional or pharmacist, in accordance with State law, to perform a COVID-19 test on an individual.

LeadingAge National will be submitting comments on the regulations, although they are in effect as an interim final rule. Members are urged to submit comments as well. LeadingAge National has provided a tip sheet for drafting comments on the regulations. Comments are due Mon., Nov. 2nd by 5 p.m.

Concerns have been raised about the sensitivity of the rapid point-of-care antigen tests and whether confirmatory PCR tests are required for negative results. The Centers for Disease Control and Prevention's (CDC) “Considerations for Interpreting Antigen Test Results in Nursing Homes” guidance document is available here. LeadingAge National’s antigen testing memo is available here.

Contact: Karen Lipson, klipson@leadingageny.org, 518-867-8838