CMS Rule Requires COVID-19 Vaccine Procedures and Reporting Beginning May 21, 2021

Today, the Centers for Medicare & Medicaid Services (CMS) published an Interim Final Rule on COVID-19 Vaccine Requirements. This rule applies to residents, clients, and staff of nursing facilities (SNF/NF) and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID). CMS also published a QSO memo to state survey agencies on how to operationalize this new requirement.

The Interim Final Rule is effective on May 21, 2021.  Compliance review by the State Survey Agency, Indiana Department of Health (IDH) regarding the COVID-19 vaccine reporting requirements to NHSN will begin June 14, 2021.

The Interim Final Rule specifies that LTC facilities must develop and implement policies and procedures to:

• Educate all residents and staff about COVID-19 vaccines;
• Offer vaccination to all residents and staff; and
• Report to the CDC via NHSN certain data regarding vaccination status for residents and staff as well as any therapeutic treatments (e.g., monoclonal antibody) use.
  • Note that this requires additional reporting via NHSN modules: reporting the Resident Therapeutics Pathway found on COVID-19 LTCF Module, as well as reporting via the Weekly HCP and Resident COVID-19 Vaccination Module.

In implementing the Interim Final Rule, the CMS QSO memo requires:

• Policy and Procedure – development and implementation of policy and procedure to meet resident’s and staff’s informational needs regarding COVID-19 vaccinations and to provide COVID-19 vaccines to residents and staff that request them.
• Education – all residents and staff must be educated on the vaccine they are offered and receive the FDA COVID-19 EUA Fact Sheet before being offered the vaccine (click here for COVID-19 EUA Fact Sheets).  Education must cover benefits and potential side effects – full informed consent is required.  If a vaccine requires multiple doses then education and consent is required again prior to the additional dose.
• Offering Vaccine – When COVID-19 vaccine supply is available to the facility, facilities must offer residents and staff COVID-19 vaccine.  The vaccine may be offered directly by the facility or indirectly through an external partner (pharmacy, government agency, other health entity).  The offer of vaccination is not required for those entering the facility for a limited time and specific purpose (delivery/repair personnel, volunteers that are present less than once weekly).
  • If vaccine is not available in the facility CMS expects facilities to provide information to staff and residents on external vaccination opportunities (such as health department clinics) and that the facility will have evidence of these efforts.
  • If there is any delay in manufacturing that is preventing acquisition of COVID-19 vaccine, CMS expects the facility to document this (similar to influenza).
• Administration – vaccination must be conducted in accordance with CDC, ACIP, FDA, and manufacturer guidelines, including appropriate monitoring of recipients for adverse reactions, and long-term care facilities must have strategies in place to appropriately evaluate and manage post-vaccination adverse reactions among their residents and staff, per 483.45(d), F757.
• Adverse Event Reporting – selected adverse events from COVID-19 vaccination must be reported to VAERS (https://vaers.hhs.gov/)
• Resident Refusal – Residents have the right to refuse the vaccine and no adverse action against the resident for refusal may occur.
• Documentation – facilities must maintain documentation of their efforts for both residents and staff as follows:
  • Resident Documentation must include:
    • Education to the resident/resident representative, including date and time and name of the representative (as applicable);
    • Date and time the offering of the vaccine took place;
    • Acceptance or refusal of the vaccine;
    • If contraindicated for the vaccine, appropriate documentation of such in the medical record; and
    • Maintain and provide samples of the educational materials used to educate residents.
  • Staff Documentation must include:
    • Education of each staff member and offering of COVID-19 vaccine to each staff member.  Compliance can be achieved by a maintaining a roster with sign-in sheet, date/time of the education, and samples of materials used to educate staff.
    • The vaccination status of each staff members (immunized or not) and whether fully immunized (if a multi-doze series).
    • If a staff member was immunized at a previous location or outside the facility the facility should request documentation from the staff member to verify vaccination status.

IHCA will engage IDH survey leadership as to the implementation of this requirement and continue to communicate with IHCA members as this rule is implemented.  Please contact Lori Davenport (ldavenport@ihca.org) or Zach Cattell (zcattell@ihca.org) with questions.