On April 27, 2021, the Center for Medicare & Medicaid Services (CMS) announced revised guidance for Interim Final Rule, CMS-3401-IFC related to Long-Term Care Facility Testing Requirements and the COVID-19 Focused Survey Tool. CMS published the initial interim final rule with comment period on Aug. 25, 2020. Under the original Interim Final Rule, “[f]acilities are required to test residents and staff, including individuals providing services under arrangement and volunteers, for COVID-19 based on parameters set forth by the HHS Secretary”. As vaccination rates have increased, CMS has revised the testing requirements to be in line with the increased vaccination rate.
Under the revised Interim Final Rule, two new definitions are introduced that are important to understanding the revisions. The first definition is “fully vaccinated,” which is defined as, “[a] person who is greater than two weeks following receipt of the second dose in a two-dose series, or greater than two weeks following receipt of one dose of a single-dose vaccine.” The second definition is “unvaccinated,” which is defined as “[a] person who does not fit the definition of ‘fully vaccinated,’ including people whose vaccination status is not known, for the purposes of this guidance.” In the revised guidance, there are no changes to the testing requirements for trigger events involving a “symptomatic individual identified” and “outbreaks (any new case arises in facility),” other than the introduction of the new definitions.
For both of the above triggers, all individuals impacted, whether staff or residents, must be tested under these scenarios. Specifically, CMS has stated that for “[o]utbreak testing, all staff and residents should be tested, regardless of vaccination status, and all staff and residents that tested negative should be retested every three days to seven days until testing identifies no new cases of COVID-19 infection among staff or residents for a period of at least 14 days since the most recent positive result.” Additionally, if a staff member or resident shows signs or symptoms of COVID-19, regardless of vaccination status, the individual must be immediately tested.
Where the guidance has changed is for testing of staff and residents with an exposure to COVID-19 and routine testing of staff, where CMS is following CDC’s Updated Healthcare Infection Prevention and Control Recommendations in Response to COVID-19 Vaccination. Under the CDC’s guidance: (1) fully vaccinated health care professionals who have high risk exposure, but who are asymptomatic do not need to be restricted from work for 14 days following their exposure; (ii) fully vaccinated residents who have prolonged close contact (within six feet for a cumulative total of 15 minutes or more over a 24-hour period) should quarantine following that close contact; and (iii) residents being admitted to a post-acute care facility do not need to quarantine upon being admitted if they are fully vaccinated and have not had prolonged close contact with someone with COVID-19 in the prior 14 days.
Finally, CMS has revised its guidance for routine testing for staff. Under the revision, vaccinated staff do not need to be routinely tested. Only unvaccinated staff will need to be routinely test based on the county positivity rate for the past week.
Finally, CMS has revised the COVID-19 Focused Survey for Nursing Homes tool to reflect the new testing requirements implemented under the interim rule. The revised guidance can be found in Control Immunization Pathway (CMS-20054)at https://www.cms.gov/Medicare/Provider-Enrollment-andCertification/GuidanceforLawsAndRegulations/Downloads/LTC-Survey-Pathways.zip.
If you or your organization may be impacted by these changes, revised requirements or are interested in learning how to comply with these changes, please contact Dinsmore’s health care practice attorneys.