CMS Issues Regulations Requiring Nursing Homes to Offer Vaccinations and Report
The Centers for Medicare and Medicaid Services (CMS) issued regulations last week requiring nursing homes to educate staff and residents about the COVID-19 vaccine, offer the vaccine to staff and residents, and maintain documentation of the education, offer, and vaccination status of staff and residents. The requirements also apply to intermediate care facilities for individuals with developmental disabilities (ICFs). In addition to these requirements, the regulations mandate that nursing homes report the vaccination status of their staff and residents, doses administered, adverse vaccine events, and therapeutics administered for treatment of COVID-19 on a weekly basis via the Centers for Disease Control and Prevention's (CDC) National Healthcare Safety Network (NHSN) system. The regulations take effect on May 21st, but nursing homes have until June 13th to begin reporting vaccination and COVID-19 therapeutics data. To accompany the regulations, CMS issued a QSO Memorandum detailing the requirements and the survey procedures to monitor and enforce compliance.
Education, Offer, and Documentation Requirements
The QSO Memorandum describes the steps that facilities must take to comply with the regulations. Specifically, nursing homes and ICFs must:
- Provide education to staff and residents or resident representatives regarding the benefits, risks, and potential side effects associated with the vaccine;
- Offer each resident and staff member the COVID-19 vaccine unless the immunization is medically contraindicated or the resident or staff member has already been immunized;
- When COVID-19 vaccination requires multiple doses, provide the resident or staff member 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;
- Provide the resident, resident representative, or staff member with the opportunity to accept or refuse a COVID-19 vaccine and change their decision;
- Include in the resident's medical record that the resident or resident representative was provided education regarding the benefits and potential risks associated with the COVID-19 vaccine, and 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;
- Maintain documentation of the education provided to staff regarding the benefits and potential risks associated with the COVID-19 vaccine, of the offer to staff of the COVID-19 vaccine or information on obtaining the COVID-19 vaccine, and the COVID-19 vaccine status of staff and related information as indicated by NHSN.
The education offered must include the provision of the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) Fact Sheet and information concerning the benefits and potential side effects of the vaccine. This should include common reactions such as aches or fever and rare reactions such as anaphylaxis. Individuals should be screened prior to offering the vaccination for prior immunization, medical precautions, and contraindications to determine whether they are appropriate candidates for vaccination at any given time.
Staff members who are covered by these requirements are defined as "individuals who work in the facility on a regular (that is, at least once a week) basis, including individuals who may not be physically in the LTC facility for a period of time due to illness, disability, or scheduled time off, but who are expected to return to work. This also includes individuals under contract or arrangement, including hospice and dialysis staff, physical therapists, occupational therapists, mental health professionals, or volunteers, who are in the facility on a regular basis, as the vaccine is available."
Members are urged to review the QSO Memorandum in its entirety for documentation requirements and investigative and survey procedures.
NHSN Reporting Requirement
The regulations add a new requirement that nursing homes report the COVID-19 vaccination status of residents and staff on a weekly basis through NHSN. Providers must report cumulative counts (i.e., since December 2020) indicating how many of their total workers and residents received the vaccine (by dose and type), for how many the vaccine was medically contraindicated, and whether the facility has sufficient access to vaccine to offer it to staff during the reporting week. Vaccination status must be listed for all staff and residents, whether they received their vaccination at the facility or elsewhere.
Data must be reported for any health care personnel (employee, contractor, student, trainee) who were eligible to have worked at least one day during the reporting week. Data must be reported for any resident (old enough to be eligible for vaccination) who was in the facility for at least one 24-hour day during the data collection week. Detailed reporting instructions and the list of reporting items are posted here in the “Data Collection Forms and Instructions” section. Note that there are some reporting items that are optional (e.g., reporting by job category).
To assist providers in tracking vaccination status, the CDC has developed Excel files designed to accumulate and output the data in a way that is ready for NHSN entry. These files (one for residents, one for staff) are posted here in the “Supporting Materials” section. Also on the CDC COVID-19 Vaccination site are links to a reporting training presentation as well as a helpful set of Frequently Asked Questions (FAQs). The CDC will rebroadcast a recorded training presentation with live question and answer sessions on May 18th, 20th, 25th, and 27th. Registration is required and available here.
Providers are encouraged to begin reporting as soon as possible, but no later than the week ending June 13th. The same deficiency citation (F884) and penalties that apply for failure to comply with current NHSN COVID-19 reporting requirements will be imposed for failure to report complete vaccination status information, with CMS starting to review for compliance on June 14th.
The rule also makes mandatory the reporting of COVID-19 therapeutics administered to residents for treatment of COVID-19. Instructions for that pathway are on the main Long Term Care Facility (LTCF) COVID-19 Module page under “Therapeutics.”
The regulations were published as an Interim Final Rule, which takes effect prior to completion of the comment period. However, comments may be submitted prior to July, and we will be working on comments with LeadingAge National. Notably, the preamble to the regulations solicits comments on the feasibility of applying these regulations to assisted living facilities.
Educational Resources
LeadingAge National has compiled an array of resources about the vaccine and strategies to improve acceptance rates. They are available here. In particular, members may be interested in a COVID-19 vaccination conversation guide for managers and a conversation infographic with specific phrases that work better than others. The CDC's LTCF Vaccination Toolkit is available here, with an Answers to Common Questions for LTCF Staff document here. The CDC's Vaccination Communication Toolkit is available here.
Contact: Karen Lipson, klipson@leadingageny.org, 518-867-8838