Interim Final Rule: COVID-19 Vaccine Immunization Requirements for Clients and Staff in Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID)

Mary Madison, RN, RAC-CT, CDP
Clinical Consultant – Briggs Healthcare

CMS posted QSO-21-21-ICFIID on August 23, 2021.  This QSO carries the same title as this blog.


On Dec. 1, 2020, the Advisory Committee in Immunization Practices (ACIP) recommended that health care personnel (HCP) and LTC facility residents be offered COVID-19 vaccination first (Phase 1a).  On May 13, 2021, CMS published an IFC codified at 42 CFR Part 483, CMS-3414- IFC, entitled “COVID-19 Vaccine Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff” (86 FR 26306). The new requirements help ensure ICF/IID clients are offered COVID-19 vaccinations and education to help protect people most at risk of severe illness or death from COVID-19.

CMS added new requirements at 42 CFR 483.460(a)(4) directing ICF/IID to develop policies and procedures to educate clients, their representatives, and staff on the benefits and risks, and potential side effects of the COVID-19 vaccine. Further, the ICF/IID must offer the vaccine unless it is medically contraindicated or the client or staff member has already been immunized. Additionally, the facility must maintain appropriate documentation to reflect the provision of the required COVID-19 vaccine education and offering, and whether the client and staff member received the vaccine or did not receive it due to medical contraindications or refusal. The education and offering of the vaccine only needed to be documented once the CMS-3414-IFC rule went into effect on May 21, 2021.

Further, CMS continues to encourage ICF/IID to voluntarily report COVID-19 incidence and vaccination status of clients and staff, each dose of vaccine received, COVID-19 vaccination adverse events, and therapeutics administered to clients to treat COVID-19 on the CDC NHSN website. This reporting will help public health agencies and stakeholders monitor the percentage of clients and staff who are vaccinated and target resources accordingly to improve vaccination rates. Additionally, reporting the use of therapeutics will help agencies and stakeholders monitor the prevalence of these treatments, their effectiveness, and support allocation efforts to ensure that the ICF/IID has access to the supplies (vaccines, personal protective equipment, and COVID-19 tests) they need.

Noncompliance related to the new requirements for educating and offering COVID-19 vaccination to clients and staff will be cited at W-tags 500-507. This QSO memorandum is 7 pages in length.  Be sure to read and share it with your team.  Note the many resources on the last page.