On November 4, 2021, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule requiring that Medicare-certified providers implement policies for vaccination of all health care workers against COVID-19.  Compliance with the requirement will be a Condition of Participation in the Medicare program, and providers may be subject to survey, requests for corrective action, and ultimately termination if not in compliance.

Under the rule, health care workers would be required to receive first vaccine doses by December 5, 2021 and second doses by January 4, 2022.  Workers receiving vaccines requiring only one dose would be in compliance with the rule if that dose is received by January 4, 2022.  While the rule does provide for exemptions for recognized medical conditions or religious beliefs, observances, or practices, each consistent with federal law, the rule does not provide an alternative to vaccination through routine COVID-19 testing.

Staff to whom the vaccination requirement applies include “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” regardless of clinical responsibility or patient contact.  While the rule would not apply to workers providing services one hundred percent remotely, it does apply to the above-referenced individuals having even occasional contact with the facility or other workers that ultimately provide care in regulated facilities.

In order to best protect patients, families, caregivers, and staff, [CMS is] not limiting the vaccination requirements . . . to individuals who are present in the facility or at the physical site of patient care based upon frequency. Regardless of frequency of patient contact, the policies and procedures must apply to all staff, including those providing services in home or community settings, who directly provide any care, treatment, or other services for the facility and/or its patients. . . . This includes administrative staff, facility leadership, volunteer or other fiduciary board members, housekeeping and food services, and others.

CMS does confirm that “suppliers are not required to ensure the vaccination of individuals who infrequently provide ad hoc non-health care services . . . or services that are performed exclusively off-site, not at or adjacent to any site of patient care.”

Along with the vaccination requirements addressed above, CMS will require that providers maintain records of vaccination status for each individual to whom the rule applies, including exemption requests and approvals. Requests for medical exemption, to the extent that they rely on a clinical contraindication to COVID-19 vaccines, “must be signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice.”

A pre-publication copy of the interim final rule is available here, and the expected Federal Register publication date is November 5, 2021.  Comments to the interim final rule must be submitted by January 4, 2022.