On Tuesday, May 11, 2021, The Centers for Medicare & Medicaid Services (CMS) announced an interim final rule, with comment period, that revises the infection control requirements that long-term care (LTC) facilities and intermediate care facilities for individuals with intellectual disabilities (ICFs-IID) must meet to participate in the Medicare and Medicaid programs. The new rule aims to reduce the spread of COVID-19 by requiring LTC facilities and ICFs-IID to educate their residents, clients, and staff about COVID-19 vaccines and by requiring that such facilities offer COVID-19 vaccines, when available, to all residents, clients, and staff. Under this rule, LTC facilities and ICFs-IID may provide the vaccines directly or indirectly, such as through arrangements with pharmacy partners or local health departments.
In addition to the currently required reporting of COVID-19 testing, case, and mortality data, this new rule requires LTC facilities to report the vaccination status and related data elements of all residents and staff to the Centers for Disease Control and Prevention’s (CDC) National Healthcare Safety Network (NHSN) on a weekly basis. LTC facilities must also report any COVID-19 therapeutics administered to residents. This increased reporting is required to help the CDC understand the impact of vaccination on transmission in LTC facilities and to help the CDC make changes to guidance to better protect such facilities’ residents and staff. The data will further allow the CDC to identify and alert CMS to facilities that may need additional support related to vaccine education and administration.
CMS notes in its announcement that many facilities are already educating their residents, clients, and staff, and are voluntarily reporting vaccine administration data. Participation in these efforts on a voluntary basis has not been universal, however, and CMS is concerned that many high-risk groups, including residents and clients at LTC facilities and ICFs-IID are not able to access COVID-19 vaccinations. Further, while the CDC’s previously-established Pharmacy Partnership for Long-Term Care Program had much success in timely vaccinating many LTC facility residents and staff, CDC data shows that approximately 2,500 (or 16% of) CMS-certified skilled nursing facilities did not participate in the program.
CMS announces this rule out of recognition that individuals residing in congregate settings, regardless of health or medical conditions, are at greater risk of infections, and many residents and clients of LTC facilities and ICFs-IID face higher risk of severe illness due to age, disability, or underlying health conditions. With that in mind, CMS is also considering extending the requirements included in the new rule to other congregate living settings over which it has regulatory authority, including inpatient psychiatric hospitals and psychiatric residential treatment facilities, but CMS has not included such facilities in this rule because it believes that such requirements are not feasible at this time. Specifically, individuals in psychiatric hospitals may only be inpatients for a short period, making appropriate provision of two-dose vaccine series challenging, and such hospitals cannot yet guarantee sufficient availability of single-dose vaccine product.
CMS is also seeking comment on the feasibility of adding appropriate COVID-19 vaccine requirements for residents, clients, and staff of all congregate living facilities over which CMS has regulatory authority and pays for some portion of the care and services provided. Specifically, CMS is interested in comments on potential barriers such facilities may face in meeting these requirements, such as staffing issues or characteristics of the resident or client population, and potential unintended consequences of such requirements.
The announced rule will be published in the Federal Register on Thursday, May 13, 2021, and will be effective on Friday May 21, 2021. Comments must be received by no later than 5 p.m. on Monday, July 12, 2021.
 The CDC defines “therapeutics” for the purposes of NHSN as a “treatment, therapy, or drug” and states that monoclonal antibodies are examples of anti-SARS-CoV-2 antibody-based therapeutics used to help the immune system recognize and respond more effectively to the SARS-CoV-2 virus.