On November 5, 2021, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule (the “IFC”) establishing COVID-19 vaccination requirements for staff at certain Medicare- and Medicaid-approved facilities.
The IFC applies to staff of ambulatory surgical centers, hospices, psychiatric residential treatment facilities, hospitals, long-term and intermediate-care facilities, home health agencies, comprehensive outpatient rehabilitation facilities, critical access hospital, clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services, community mental health centers, home infusion therapy suppliers, rural health clinics and federally qualified health centers, and end-stage renal disease facilities. The IFC does not directly apply to other healthcare entities not listed above. Staff includes “facility employees; licensed practitioners; students, trainees, and volunteers; and individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement.”
The IFC outlines phases for compliance with the new vaccination requirement. Phase 1, which is effective on December 6, 2021, includes the requirement that all staff at certain Medicare- and Medicaid-approved facilities received the first dose (or only dose, if applicable) of a COVID-19 vaccination, or have requested or been granted an exemption to the requirements.
Phase 2, which takes effect on January 4, 2022, requires that the first vaccination be completed, and that staff are fully vaccinated (i.e., with a second dose, as applicable), except for those staff that have been granted an exemption or have been forced to delay for an approved reason.
The IFC also requires facilities to establish and implement a process by which staff can request an exemption. Potential exemptions under the IFC may include allergies, documented medical conditions, or religious beliefs.
To ensure compliance with the vaccination requirements of the IFC, CMS also requires facilities to track and securely document vaccination status of all staff. Vaccination exemption requests and the outcome must also be documented.
Approved facilities must also develop a process for ensuring that they will follow nationally recognized infection prevention and control guidelines to mitigate the spread of COVID-19, particularly for those staff members that do not receive a vaccination due to an approved exemption.
State surveyors will assess compliance with the IFC. Facilities that are cited for noncompliance may be subject to penalties depending on the nature of the noncompliance, but may include civil money penalties, denial of payment for new admissions, or termination of the Medicare/Medicaid provider agreement. CMS is set to issue interpretive guidelines on enforcement.