Elevating the Post-Acute and
Long Term Care Profession

May 11, 2021

CMS Mandates SNFs Report Vaccinations. Today, the Centers for Medicare and Medicaid Services (CMS) issued both an interim final rule with comment period (IFC) and a new QSO-21-19-NH addressing vaccinations. The QSO begins by explaining the rule change and repeating the text, then gives guidance on the two F-tags involved, F887 (immunization) and F884 (reporting). Under F887, CMS explains the IFC's requirements for SNFs to provide education to residents, their representatives, and staff on the vaccine, to offer and to administer vaccinations (which can be through others such as pharmacies), and to report adverse events. The QSO spells out documentation requirements and clarifies that residents have the right to refuse vaccination. It leaves whether staff can refuse to state law and facility policy. Last, the QSO gives survey procedures for F887. It does not specify an effective date for the F887 requirements, but in the IFC, CMS states it is effective 10 days after being displayed in the Federal Register.

Under F884, CMS states that the IFC "requires LTC facilities report, on a weekly basis, 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 [the National Healthcare Safety Network's] NHSN's LTCF COVID-19 Module." CMS gives brief instructions, explaining that these items will become part of the regular weekly reporting, like aggregate COVID-19 test results. It is not line-level reporting as with point-of-care test results. As noted, therapeutics (e.g., monoclonal antibodies) also must be reported. The first report must be made by 11:59 p.m. on June 13, 2021. In a detailed enforcement section, CMS confirms that the vaccination reporting will be policed like the test result reporting - through citations and civil money penalties starting at $1,000.

CMS clarifies their goal for the required reporting, writing in the IFC, "NHSN provides the long-term means to collect these data now that the Pharmacy Partnership has finished and will allow for calculation of percentages of residents and staff vaccinated in every facility." CMS adds, '[w]e anticipate that the additional reporting burden to LTC facilities will be minimal." They intend to publish data from the vaccination reporting on its COVID-19 Nursing Home Data page, as it does with other data from NHSN.

Vaccination Requirements Also Apply to ICFs - HCBS Next? In an unusual twist, CMS in the IFC also revised the ICF/IID regulations at 42 CFR 483.430 and 483.460 to require ICFs to educate staff and residents about vaccination, to offer the vaccine, and to document compliance. See pages 96-98 of the IFC. These requirements do not include reporting vaccination data to NHSN, as ICFs are not mandatory NHSN users. In addition, QSO-21-19-NH does not apply to ICFs.

Even more unusually, CMS suggests it is considering exercising its authority over Medicaid funding to extend vaccination requirements to other provider types, including congregate home and community-based services (HCBS), both services for seniors (such as assisted living) and services for people with disabilities (waiver homes). In an extensive discussion at pages 4-9 of the IFC, CMS lays out its thoughts on this question, including encouraging providers and states to vaccinate individuals in these settings. CMS wrote specifically:

CMS is seeking public comment on the feasibility of implementing vaccination policies for other Medicare/Medicaid participating shared residences in which one or more people reside such as but not limited to the following: psychiatric residential treatment facilities (PRTFs), psychiatric hospitals, forensic hospitals, adult foster care homes (AFC homes), group homes, assisted living facilities (ALFs), supervised apartments, and inpatient hospice facilities.

CMS also mentions non-residential congregate settings such as "day habilitation sites [and] adult day health providers" and asks a number of specific questions about these settings on which it requests comment.