On May 13, 2021, the Centers for Medicare and Medicaid Services (“CMS”) published an interim final rule with comment period addressing COVID vaccine education, administration, and reporting requirements for nursing homes. Designed to reduce the spread of COVID-19, the rule updates the existing infection control requirements that nursing homes must meet to participate in the Medicare program, found at 42 C.F.R § 483.80. The effective date for the new rule is May 21, 2021, and Michigan’s state survey and certification staff have advised that they will begin enforcement of the new rule on June 14, 2021.

Facility Policies and Procedures.
Under the new rule, nursing homes must develop and implement policies and procedures to ensure that all the following occur in the facility:

  1. Offer the COVID-19 Vaccine. When the COVID-19 vaccine is available to the facility, it must offer each resident and staff member the COVID-19 vaccine, unless contraindicated or the resident or staff member has already been immunized. Here CMS permits, but does not require, the facility to offer the vaccine directly.
  2. Education. Before offering the COVID-19 vaccine, the facility must provide education to all staff members and residents (or resident representative) regarding the benefits and risks and potential side effects associated with the vaccine. “Staff” is defined as individuals who work at the facility regularly (at least weekly).  This is a less inclusive definition of staff than applies to COVID-19  testing of staff.
  3. Additional Doses. In situations where COVID-19 vaccination requires multiple doses, the facility must provide the resident, resident representative, or staff member with current information regarding those additional doses, including any changes in the benefits or risks and potential side effects, before requesting consent.
  4. Individual Choice. The resident, resident representative, or staff member has the opportunity to accept or refuse a COVID-19 vaccine, and to change their decision. Note, because this requirement appears to preclude a mandatory staff vaccination policy, we expect CMS will receive comments and push back on this requirement as it pertains to staff. Look for more information to come from CMS on this issue.
  5. Resident Record Documentation. The resident’s medical record must document:(a) That the resident/resident representative was provided education regarding the benefits and potential risks associated with COVID-19 vaccine; and(b) Each dose of COVID-19 vaccine administered to the resident, or if the resident did not receive the COVID-19 vaccine due to medical contraindications or refusal.
  6. Facility DocumentationThe facility must maintain documentation related to staff COVID-19 vaccination that includes:

(a) That staff were provided education regarding the benefits and potential risks associated with COVID-19 vaccine;

(b) Staff were offered the COVID-19 vaccine or information on obtaining COVID-19 vaccine; and

(c) The COVID-19 vaccine status of staff and related information as indicated by the Centers for Disease Control and Prevention’s National Healthcare Safety Network (NHSN)

Facility ReportingNursing homes will also be required to report to NHSN the COVID-19 vaccine status of residents and staff, including total numbers of residents and staff, numbers of residents and staff vaccinated, numbers of each dose of COVID-19 vaccine received, COVID-19 vaccination adverse events, and therapeutics administered to residents for treatment of COVID-19. Given the May 21, 2021 effective date of the new rule, a facility’s first data submission should occur by June 13, 2021.

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