New CMS Rule Sets COVID Vaccine Requirements for Nursing Facilities

Posted on May 12, 2021 by Jonathan Lips

On May 11, CMS announced an interim final rule establishing new requirements for nursing facilities. The rule requires care centers to offer COVID-19 vaccine to residents and staff, to educate residents and staff regarding the benefits and potential side effects of the vaccine, and to report COVID-19 vaccine and therapeutics treatment information to the Centers for Disease Control and Prevention's (CDC) National Healthcare Safety Network (NHSN).

CMS details these new requirements in Memorandum QSO-21-19-NH, which also apply to Intermediate Care Facilities for Individuals with Intellectual Disabilities.

CMS typically seeks public comment on a proposed rule before making it effective. However, the agency is making the rule effective on the front end, with a 60-day public comment period to follow.

Reporting to National Healthcare Safety Network
The new rule requires nursing facilities to report the COVID-19 vaccination status of residents and staff, total numbers of residents and staff vaccinated, each dose of vaccine received, COVID-19 vaccination adverse events, and therapeutics administered to residents for treatment of COVID-19 through NHSN's LTCF COVID-19 Module weekly. According to CMS, it will publicly report this information “to support protecting the health and safety of residents, staff, and the general public.”

CMS indicates that facilities must begin including vaccination and therapeutic data reporting in facility NHSN submissions by 11:59 p.m. Sunday, June 13, with enforcement starting June 14. As it has done with NHSN reporting requirements since May 2020, CMS itself (rather than MDH) will evaluate NHSN data for compliance and cite facilities for failure to report under F884.

Details about the COVID-19 Vaccine Reporting module, including a template of the required fields, instructions, and an archived training webinar, are available on the NHSN site. CDC conducted training on May 11 to describe recent updates to the module, and a recording will be re-broadcast four more times: May 18, 20, 25, and 27. Register for the recorded broadcasts.

Vaccine Offers and Education
CMS is also adding new requirements for facilities to offer COVID-19 vaccine to residents and staff and to educate residents and staff regarding the vaccine's benefits and potential side effects. These are actions most facilities have already been taking, though CMS does lay out specific documentation requirements. We are working to confirm the effective date of these new requirements, but we believe it will be May 21 (10 calendar days after CMS filed the rule for public inspection in the Federal Register).

Specifically, facilities must develop and implement policies and procedures to ensure all the following:

• When COVID-19 vaccine is available to the facility, each resident and staff member is offered the COVID-19 vaccine unless the immunization is medically contraindicated or the resident or staff member has already been immunized;
• Before offering COVID-19 vaccine, all staff members are provided with education regarding the benefits and risks and potential side effects associated with the vaccine;
• Before offering COVID-19 vaccine, each resident or the resident representative receives education regarding the benefits and risks and potential side effects associated with the COVID-19 vaccine;
• In situations where COVID-19 vaccination requires multiple doses, the resident, resident representative, or staff member is provided with current information regarding those additional doses, including any changes in the benefits or risks and potential side effects associated with the COVID-19 vaccine, before requesting consent for administration of any additional doses;
• The resident, resident representative, or staff member has the opportunity to accept or refuse a COVID-19 vaccine, and change their decision;
• The resident's medical record includes documentation that indicates, at a minimum: (A) That the resident or 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 (C) If the resident did not receive the COVID-19 vaccine due to medical contraindications or refusal; and
• The facility maintains documentation related to staff COVID-19 vaccination that includes at a minimum: (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).

Next Steps
This is an evolving story, and we will provide additional information for members in the days ahead.

CMS has announced a National Nursing Home Stakeholder call for this Thursday, May 13 at 3 p.m. CT. While the agenda has not been announced, CMS will likely use the time to describe this new rule and, we hope, take some questions. Register for this call.