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Volume 21.14

CMS is issuing an Interim Final Rule requiring most Medicare and Medicaid certified providers and suppliers to establish a policy ensuring that all eligible staff have received the first dose of a two-dose vaccine or a one-dose vaccine prior to providing any care, treatment, or other services by December 5, 2021.  All staff must be fully vaccinated by December 5, 2021.  The regulation does provide for exemptions for employees based on medical conditions, or religious beliefs, observances, or practices.

The requirements apply to: Ambulatory Surgical Centers, Hospices, Programs of All-Inclusive Care for the Elderly, Hospitals, Long Term Care facilities, Psychiatric Residential Treatment Facilities, Intermediate Care Facilities for Individuals with Intellectual Disabilities, Home Health Agencies, Comprehensive Outpatient Rehabilitation Facilities, Critical Access HospitalsClinics (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/Federally Qualified Health Centers, and End-Stage Renal Disease Facilities.  The interim rule does not directly apply to other health care entities including physician offices, which are outside of the regulatory oversight of CMS.

The Conditions of Participation (“CoP”) for each provider type will be updated to reflect these regulatory changes.

The CMS press release is available here.  The entire interim rule is available here

According to the interim rule, “In order to best protect patients, families, caregivers, and staff, we are not limiting the vaccination requirements of this IFC 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, including 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. This includes administrative staff, facility leadership, volunteer, or other fiduciary board members, housekeeping and food services, and others. We considered excluding individual staff members who are present at the site of care less frequently than once per week from these vaccination requirements but were concerned that this might lead to confusion or fragmented care. Therefore, any individual that performs their duties at any site of care or has the potential to have contact with anyone at the site of care, including staff or patients, must be fully vaccinated to reduce the risks of transmission of SARSCoV-2 and spread of COVID-19.”

Comments to the interim rule can be sent by regular mail to Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3415-IFC, P.O. Box 8016, Baltimore, MD 21244-8016, or by overnight mail to Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3415-IFC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

The interim final rule will be discussed today at 2:00 p.m. ET.  You must register here to attend this briefing (discussion) by 12:00 p.m. ET.   

Questions can be submitted in advance with the subject heading “IFC-6 Stakeholder Call Question” to Partnership@cms.hhs.gov.