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CMS Issues Interim Final Rule on COVID-19 Testing Requirements for Nursing Home Residents and Staff

September 01, 2020

On August 25, 2020, the Centers for Medicare & Medicaid services (CMS) issued an interim final rule that includes new COVID-19 testing requirements for nursing home residents and staff.  The rule will go into effect when it is published in the Federal Register, on September 2, 2020.  There will be a 60-day comment period after the date of publication.  On August 26, 2020, CMS published accompanying guidance, which prescribes how nursing homes must implement the new rule.

All nursing homes will now be required to test all residents when there is an outbreak of COVID-19 in a facility.  Facilities will be required to test staff members and residents who display symptoms of COVID-19, and facilities will now be required to routinely test all staff members.  Below is a summary of the rule and guidance.

Testing of Staff and Residents with COVID-19 Symptoms or Signs

Residents who have signs or symptoms of COVID-19 must be tested.  While test results are pending, the residents must be placed on transmission based precautions until results are obtained.

The rule requires all staff members with symptoms of COVID-19 to be tested.  Staff members are defined as employees, consultants, contractors, volunteers, and caregivers who provide care and services to residents on behalf of the facility.   While the results of testing are pending, staff may not be allowed in the facility.  If the staff member tests positive, the staff may only return to the facility after meeting the Center for Disease Control and Prevention (CDC) guidelines “Criteria for Return to Work for Healthcare Personnel with SARS-CoV2 Infection.”

Testing of Residents and Staff when there is a COVID-19 Outbreak

Whenever a resident or staff member tests positive for COVID-19, all staff and residents must be tested.  Staff and residents who test negative must be retested every 3 to 7 days until no new cases are identified for at least 14 days after the most recent positive.   Staff and residents who test positive during the outbreak do not need to be tested again during the outbreak, but symptoms must be monitored.

Routine Testing of Staff

Facilities will now be required to routinely test all staff.  Frequency of routine testing will depend on the COVID-19 positivity rate in the county where the facility is located.  CMS has prescribed the following intervals:

  • Low Community COVID-19 Activity:  when the county positivity rate is less than 5%, facilities must test all staff monthly.
  • Medium Community COVID-19 Activity: when the county positivity rate is 5%-10%, facilities must test all staff once per week.
  • High Community COVID-19 Activity: when the county positivity rate is greater than 10%, facilities must test all staff twice per week.

The guidance requires facilities to monitor the positivity rate in its county at least every two weeks, but cannot implement a less frequent testing rate, unless the county’s positivity rate remains lower for two weeks.   County positivity rates may be found at: https://data.cms.gov/stories/s/COVID-19-Nursing-Home-Data/bkwz-xpvg

Refusal of Testing

All facilities must have procedures in place when a staff member or resident refuses testing.  If a resident displays symptom of COVID-19 but refuses testing, the resident must be placed on transmission based precautions.  If there is an outbreak in the facility and a resident refuses testing, the facility must be “extremely vigilant”, and CMS suggests additional monitoring to ensure appropriate distance from other residents, wearing of a face mask, and proper hand hygiene until the facility is no longer experiencing an outbreak.  The guidance makes note that facilities may offer residents alternative means of testing that may be more acceptable to the residents.

Staff that display symptoms of COVID-19 but refuse testing must be excluded from the facility until the return to work criteria are met.  If there is an outbreak and a staff member refuses testing, the staff member may not return to the facility until the facility completes its outbreak testing.

Facilities May Test Onsite or Contract with an Outside Laboratory

The testing requirements can be met by facilities by rapid point-of-care (POC) testing or through an arrangement with an offsite laboratory.  POC testing is done on site with facility staff and equipment.  CMS began shipping POC testing equipment to facilities on July 20 and stated that every facility will have the equipment within 14 weeks of that date.   When facilities contract with an offsite laboratory, CMS is requiring that the turnaround time for testing be less than 48 hours.  If the facility is unable to meet the time frame, it must document its efforts to do so.

Additional Guidance:

  • According to the guidance, residents or staff who have recovered from COVID-19 are not required to be tested for three months after the date of when symptoms first onset
  • All testing results must be kept in resident records and the records for staff.  
  • Facilities will face civil monetary penalties for failing to test in accordance with the rule and guidance.
  • Facilities are financially responsible for testing, but CMS announced it will be using recently released funds from the CARES Act to help support facilities with testing.

Consumer Voice plans to submit comments on the rule and accompanying guidance.  

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