On May 11, 2021, the Centers for Medicare & Medicaid Services (CMS) of the U.S. Department of Health & Human Services published an interim final rule that will effectively increase vaccination rates for those long-term care facilities that participate in Medicare or Medicaid programs.

What the Rules Require

The new federal regulations, which became effective on June 14, 2021, will require long-term care facilities to make weekly reports regarding COVID-19 vaccination status of their residents and staff, including:

1. each dose of vaccine received,
2. any vaccination-related adverse events, and
3. therapeutics administered to residents for the treatment of COVID-19.

CMS will post facility-specific vaccination information on its COVID-19 nursing home data site.

Additionally, the new regulations require facilities to educate residents, resident representatives and staff regarding the benefits and potential side effects associated with the COVID-19 vaccine, including common reactions, such as aches and fever, and rare reactions such as anaphylaxis. Facilities must develop policies and procedures for sharing COVID-19 vaccine information, and such information must be offered in a manner that residents (or their resident representatives) and staff can understand. The Food and Drug Administration (FDA) requires that each COVID-19 vaccine authorized under an Emergency Use Authorization (EUA) provide the vaccine recipients or their caregivers with an EUA Fact Sheet before the vaccine is offered. Facilities must offer the vaccine either directly or through a pharmacy provider.

To assist long-term care facilities in meeting the education requirements, CMS has provided online materials. Fact sheets are available on the Center for Disease Control and Prevention’s COVID-19 Vaccine Emergency Use Authorization (EAU) Fact Sheets for Recipients and Caregivers website. CMS also recommends that staff work with their Long-term care facility’s Medical Director and Infection Prevention team(s), and use the CDC and FDA resources, including the CDC’s LTC Facility Toolkit: Preparing for COVID-19 Vaccination at Your Facility, which is available online, as sources of information when establishing their vaccination education programs.

Residents and their representatives have the right to refuse the COVID-19 vaccine and to change their decision about vaccination at any time. Consequently, facilities cannot take any adverse action against a resident who refuses the vaccine, such as socially isolating the resident, denying outside visitation to the resident or involuntarily discharging the resident. CMS, however, did not promulgate any rules regarding vaccination requirements for staff, noting that facilities should follow state law and facility policies regarding staff refusal of vaccination. This lack of a clear directive may result in inconsistent staff vaccination policies from facility to facility.

Documenting Compliance

In addition to the weekly vaccination status updates, each long-term care facility must maintain documentation of its compliance for potential review by CMS.

For residents, compliance documentation must include, at a minimum:

• The date and name of the resident or resident representative who received vaccine education, which must cover the benefits and potential risks associated with the COVID-19 vaccine;
• The date the vaccine was offered to the resident, and whether the vaccination was received or rejected due to contraindications, prior vaccinations or refusal;
• If there is a contraindication to the resident having the vaccination, appropriate documentation must be made in the resident’s medical record; and
• Samples of the educational materials used to educate residents.

For staff, compliance documentation must include, at a minimum:

• The date each staff member received education regarding the benefits and potential side effects of the COVID-19 vaccine. Compliance can be satisfied by providing a staff roster showing who received the education (e.g., a sign-in sheet with dates) and samples of the educational materials provided;
• Vaccination status of each staff member (i.e., immunized or not), including whether fully immunized (i.e., evidence of completed series of multi-dose vaccines); and
• For staff members immunized outside of the facility, the facility should request vaccination documentation from those staff members to confirm vaccination status.

Facilities failing to satisfy these requirements could face civil monetary penalties starting at $1,000 for the first infraction. For questions about these new requirements, please contact any member of our Senior Living Group.

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