New federal regulations now require long term care (LTC) facilities to report weekly concerning the vaccination status of their staff and residents, further increasing the pressure on those facilities with low vaccination rates.

Nursing homes already self-report COVID-19 testing, case and mortality data for staff and residents. The new requirements attempt to address the low vaccination rates at some nursing facilities, particularly among staff.

The Centers for Medicare & Medicaid Services of the U.S. Department of Health and Human Services (DHHS) published an interim final rule on May 11 to increase COVID-19 vaccination rates for those facilities that participate in the Medicare or Medicaid programs.

The new rule requires facilities to educate staff and residents (or resident representatives) regarding the benefits and potential side effects associated with the COVID-19 vaccine, to offer the vaccine to those unvaccinated (directly or through a pharmacy partner), and to report the COVID-19 status of staff and residents to the Center for Disease Control and Prevention’s National Healthcare Safety Network. CMS will post facility-specific vaccination information on its COVID-19 nursing home data website.

The new rule also requires all staff and residents to be educated about the COVID-19 vaccine and receive the FDA COVID-19 EUA Fact Sheet before being offered the vaccine. CMS has provided online training materials that facilities can utilize for this purpose.

CMS believes that more education will encourage higher vaccination rates. Still, the new rule allows residents to refuse the vaccine, and takes no position with respect to staff, deferring instead to state agencies and their vaccination requirements for health care workers, if any. This leaves many facilities with little guidance to enforce a clear and consistent vaccination policy for their staff. To complicate matters further, the new rule defines “staff” broadly to include any individuals who work in the facility at least once a week, including independent contractors, such as physical therapists.

Finally, facilities must maintain documentation of their compliance with the new rule.

For residents, documentation includes:

• The date and name of the resident (or representative) who received vaccine education, including the benefits and potential side effects.
• The date that the vaccine was offered to the resident, and whether accepted or refused due to contraindication or prior vaccination.
• If contraindicated for the vaccine, appropriate documentation of such in the resident’s medical record.
• Samples of the educational materials used to educate residents.

For staff, documentation includes:

• The date that each staff member was educated about the benefits and potential side effects of the vaccine. Compliance can be achieved by a maintaining a roster with a sign-in sheet, date/time of the education and samples of materials used to educate staff.
• The vaccination status of each staff member and whether fully immunized (if a multi-dose series).
• If a staff member was immunized outside the facility, the facility should request documentation from the staff member to verify vaccination status.

CMS enforcement of the new rule begins June 14, so facilities should begin now to address the additional regulatory requirements or risk civil monetary penalties starting at $1,000 for the first violation. For questions about the new requirements, please contact me or any member of the Senior Living Industry Group.

DISCLAIMER: The information in this alert should not be construed as legal advice to be relied upon nor to create an attorney/client relationship. Please note that the reader’s or an industry’s specific situation or circumstances will vary and, thus, for example, an approach that is advisable in one industry may not be appropriate in another industry. If you have questions about your situation or about how to apply information contained in this alert to your situation or industry, you should reach out to an attorney.

The views expressed in this alert are those of the individual author and do not necessarily reflect the views of the firm or the firm’s clients. The response to the COVID-19 pandemic is particularly challenging, evolving and, in many cases, can be controversial. Any views expressed in this alert are not intended to advocate for or endorse a particular governmental response to the pandemic.