On November 5, 2021, the Centers for Medicaid and Medicare Services (CMS) published the Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule with public comment period (IFC). The IFC requires COVID-19 vaccination for staff in specified workplaces. Shortly thereafter, legal challenges were filed, implementation temporary halted by a preliminary injunction, implementation reinstated for some states, and ultimately reinstated for the remaining states following the Supreme Court’s decision on January 13, 2022. These challenges and injunctions, along with mixed messaging, have created a great deal of confusion over who must comply with the vaccination requirement.
It is important to note, even though physicians may participate with Medicare and Medicaid and provide services similar to one or more of the facilities listed below, independent physicians and medical practices are not subject to the CMS health care staff vaccination rule. Regarding the applicability of the IFC, CMS states, “It does not directly apply to other health care entities, such as physician offices, that are not regulated by CMS.” Although independent medical practices are not subject to this rule, individual physicians or staff members may be required to be vaccinated if they have admitting or clinical privileges at a facility impacted by the Rule (see FAQ below) or if they provide services at one of the below CMS certified facilities (whether by contract or other arrangement) or if they have the potential to have contact with anyone at one of the above CMS-certified facilities as part of their services for the facility.
The CMS IFC requires Medicare- and Medicaid-certified providers and suppliers (“facilities”) regulated under the health and safety standards known as Conditions of Participation, Conditions for Coverage, or Requirements for Participation in Medicare and Medicaid to establish processes or policies for vaccinating all applicable staff against COVID-19. These facility types are as follows:
- Ambulatory Surgery Centers
- Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services
- Community Mental Health Centers
- Comprehensive Outpatient Rehabilitation Facilities
- Critical Access Hospitals
- End-Stage Renal Disease Facilities
- Home Health Agencies
- Home Infusion Therapy Suppliers
- Intermediate Care Facilities for Individuals with Intellectual Disabilities
- Long Term Care facilities
- Programs for All-Inclusive Care for the Elderly Organizations
- Psychiatric Residential Treatment Facilities
- Rural Health Clinics/Federally Qualified Health Centers
Clinical and non-clinical staff at the above-mentioned facilities, including employees, students, trainees, and volunteers, are required to be vaccinated. This also includes individuals who provide care, treatment, or other services for the facility and/or its patients under contract and to physicians admitting and/or treating patients in a facility. And, until further guidance clarifies otherwise, all staff of medical practices owned by a hospital (or a hospital-affiliated entity). According to CMS, individuals who provide services 100 percent remotely and who do not have any direct contact with patients and other staff, such as fully remote telehealth or payroll services, are not subject to the vaccination requirements outlined in this regulation.
The processes or policies must recognize reasonable accommodations to “individuals who are legally entitled to them because they have a disability or sincerely held religious beliefs, practices, or observations that conflict with the vaccination requirement.” The IFC and resulting guidance (QSO-22-07) specifies a timeline by which all facilities’ staff, who are not otherwise exempted, must have received the appropriate number of doses. The Phase 1 deadline for Michigan was January 27, 2022, and the Phase 2 deadline is February 28, 2022.
FAQs from CMS:
Q: Why didn’t CMS include all health care settings?
A: CMS is using the authority established by Congress under the Social Security Act to regulate Medicare and Medicaid-certified health facilities. Sections 1102 and 1871 of the Social Security Act (the Act) grant the Secretary of Health and Human Services general authority to make and publish such rules and regulations, not inconsistent with the Act, as may be necessary to the efficient administration of the functions with which the Secretary is charged. Citations to the relevant statutory authorities for each specific type of provider and supplier are set out in the discussion of each provider- and supplier-specific provision of the regulation. This authority does not extend to certain facilities nor independent physicians/clinicians.
Q: Would a physician with admitting privileges in a hospital be covered under this requirement?
A: Yes, a physician admitting and/or treating patients in-person within a facility subject to the CMS health and safety regulations and included as a part of this requirement must be vaccinated so that the facility is compliant.
Q: How quickly must staff be vaccinated in order for the facility to remain compliant with the regulation?
A: The regulation requires health care providers to establish a process or policy to fulfill the staff vaccination requirements over two phases. For Phase 1, within 30 days after the guidance is posted, staff at all health care facilities included within the regulation must have received, at a minimum, the first dose of a primary series or a single dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the facility and/or its patients. For Phase 2, within 60 days after the guidance is posted, staff at all health care provider and supplier types included in the regulation must complete the primary vaccination series (except for those who have been granted exemptions from the COVID-19 vaccine or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by CDC). If the deadline falls on a weekend or federal holiday, it will be effective on the next business day. View the CMS
Omnibus COVID-19 Health Care Staff Vaccination rule implementation and enforcement timeline on the CMS Emergencies Page.