On November 5, 2021, CMS published an interim final rule regarding vaccination requirements for staff working for Medicare and/or Medicaid certified Skilled Nursing Facilities ("SNFs"). On December 28, 2021, CMS issued QSO 22-07-ALL covering the guidance and survey process related to these new regulatory requirements.  This QSO is specifically applicable to California.¹ QSO 22-07's Attachment A also introduced the F-tag associated with this vaccination requirement for SNFs—F888. As of January 27, 2022, CMS began enforcing F888 through its survey process during recertification and complaint visits.

By January 27, 2022, providers were federally required to ensure100% of their staff had at least one dose of a vaccination series or a pending/granted exemption (i.e. medical necessity or religious belief). Providers must also have demonstrated that they had developed and implemented policies and procedures ensuring staff vaccination (including the specific requirements enumerated in 42 CFR 483.80 and F888's survey guidance, such as additional precautions related to unvaccinated staff members) in order to be compliant with F888.

By February 27, 2022, in order to remain compliant with F888, providers will be required to:

1. Demonstrate development and implementation of appropriate policies and procedures related to staff vaccination and
2. Ensure 100% of staff have completed all required doses of a vaccine series or been granted an exemption.

Providers at less than 100% staff vaccination rate, but more than 90% with a plan to achieve 100% staff vaccination rate within 30 days will not be subject to enforcement action. Otherwise, facilities at less than 100% vaccination rate could be subject to an imposition of remedies by CMS, including but not limited to civil money penalties ("CMP"), denial of payment, and/or termination.

By March 27, 2022, any facility that fails to maintain 100% compliance could be subjected to federal enforcement action.

Along with working to meet these significant regulatory requirements regarding mandatory vaccination, providers would do well to specifically prepare for these F888 survey visits. During recertification and complaint visits, surveyors will now request the following documentation related to F888:

• the facility's COVID-19 vaccination policies and procedures,
• the number of resident and staff cases of COVID-19 over the last four weeks,
• a list of all staff and their vaccination status, including other specific information. (CMS created the COVID-19 Staff Vaccination Matrix available at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Nursing-Homes through the link titled "Survey Resources with Staff Vaccine Documents (01-28-2022)" for the purposes of fulfilling this requirement.)

Facilities should consider having a point person assigned to update and maintain this information in one easily accessible location in preparation for survey visits. Facilities should also consider designating the same staff member to review the Matrix and its requirements prior to survey to ensure the accuracy of any information submitted during a survey.

According to CMS's recently updated Infection Prevention, Control & Immunizations critical element pathway (CMS-20054)² when surveying for F888 surveyors will randomly select 8 staff members from the Matrix (2 vaccinated staff and 6 unvaccinated staff). Surveyors are guided to focus on staff members who regularly work at the facility. It is clear from the CMS guidance that surveyors are to focus more attention on unvaccinated staff members, including review of unvaccinated staff's specific understanding of infection prevention practices and the facility's vaccination policies, whether they've been placed on modified duty, and specific observation for violation of infection prevention requirements by unvaccinated staff.

Based on the Scope and Severity Grid for F888 deficiencies published by CMS it is also clear that facilities that fail to meet the F888 requirements and are experiencing a COVID-19 outbreak are at higher risk of a severe scope and severity such as an immediate jeopardy. Although CMS can, as always, impose remedies for violations at F888, it has at least built in a moderator for facilities to lower the scope and severity of a violation. To convince CMS to lower the scope and severity, the facility must show (1) it had no or limited access to the vaccine or (2) it took aggressive steps to have all staff vaccinated, such as advertising for new staff or hosting vaccine clinics. In the event facilities can show a lack of access to vaccines or an aggressive push for staff vaccinations, CMS may lower the scope and severity cited for any noncompliance at F888. As usual, documentation will be key in any survey related to F888 and in the ultimate determination of scope and severity.

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¹ As a result of litigation regarding the vaccine mandate, CMS also issued QSO's 22-09 and 22-11 applicable to specific other states.

² This critical element pathway is also located in the ZIP file link titled "Survey Resources with Staff Vaccine Documents (01-28-2022)" at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Nursing-Homes.