On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) issued an Interim Final Rule with Comment Period (IFC) requiring all healthcare workers in CMS-regulated settings to be fully vaccinated against COVID-19 by January 4, 2022. The new rule applies to approximately 76,000 providers and covers over 17 million health care workers across the country.
The IFC comes nearly two months after President Biden announced the CMS rule as part of a five-pronged plan targeted at increasing the number of people vaccinated against COVID-19. The IFC takes effect immediately.
Importantly, the IFC, unlike the new OSHA ETS, does not provide weekly COVID-19 testing as an alternative to mandatory vaccination. The CMS rule will preempt any inconsistent state or local laws, including laws that ban or limit an employer’s authority to require vaccination, masks, or testing.
Who is Covered by IFC?
The following Medicare- and Medicaid-certified providers and suppliers must ensure that all applicable staff are vaccinated for COVID-19:
- Ambulatory Surgical Centers
- Hospices
- Psychiatric residential treatment facilities
- Programs for All-Inclusive Care for the Elderly (PACE)
- Hospitals
- Long Term Care Facilities and nursing homes
- Intermediate Care Facilities for Individuals with Intellectual Disabilities
- Home Health Agencies
- Comprehensive Outpatient Rehabilitation Facilities
- Critical Access Hospitals
- Clinics, rehabilitation agencies, and public health agencies
- Community Mental Health Centers
- Home Infusion Therapy suppliers
- Rural Health Clinics/Federally Qualified Health Centers
- End-Stage Renal Disease Facilities
The IFC explains that all staff at these CMS-regulated facilities are subject to mandatory vaccination, “regardless of clinical responsibility or patient contact,” as long as they interact with other staff, patients, residents, or clients. For instance, the IFC covers licensed practitioners, students, trainees, volunteers, and individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement. The vaccine mandate further applies to administrative staff, facility leadership, and housekeeping and food services.
Individuals who provide services 100% remotely, such as fully remote telehealth or payroll services, are not subject to the vaccination requirements of the IFC.
Who is Not Covered by the IFC?
As outlined above, the IFC applies only to Medicare and Medicaid-certified facilities. The rule does not apply to Assisted Living Facilities, Group Homes, or similar settings because CMS does not have regulatory authority over them.
Similarly, the IFC does not apply to physician’s offices because they are not subject to CMS health and safety regulations. The IFC also does not apply to Medicaid home services, such as Home and Community-Based Services, because they are not covered by CMS’s health and safety regulations.
The IFC does not apply to all health care settings because CMS’s authority to make and publish rules and regulations is limited by the Social Security Act. The Secretary of Health and Human Services does not have authority to regulate certain types of health care facilities, such as those mentioned above, or independent physicians/clinicians.
When Must Employees Be Fully Vaccinated?
Within 30 days of the IFC’s publication, covered individuals must have received the first dose, or only dose as applicable, of a COVID-19 vaccine (or have requested or been granted an exemption to the vaccination requirement). The IFC requires that individuals who have not been granted an exemption be “fully vaccinated” within 60 days of the IFC’s publication.
Under the IFC, an individual is considered “fully vaccinated” two weeks after completion of a primary vaccination series, i.e., two weeks after receiving a dose of a single-dose vaccine and two weeks after receiving the final dose of a multi-dose vaccine.
Additional Requirements for Infection Prevention and Control
All facilities covered by the IFC must have a process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated.
CMS acknowledged that many facilities covered by the IFC are already subject to meeting specific infection prevention and control requirements on an ongoing basis. The IFC mandates that these facilities “have a process for ensuring the implementation of additional precautions” to mitigate the spread of COVID-19 for unvaccinated staff.
Documentation of Vaccinations
In order to ensure compliance with the vaccination requirements of the IFC, covered facilities are required to “track and securely document the vaccination status of each staff member, including those for whom there is a temporary delay in vaccination, such as receipt of monoclonal antibodies or convalescent plasma.” In addition, vaccine exemption requests and outcomes must also be documented. This documentation requirement will be an ongoing process as new staff are onboarded.
Pursuant to the ADA and the Rehabilitation Act, all medical records, including vaccine documentation, must be kept confidential and stored separately from an employer’s personnel files.
Vaccine Exemptions
The IFC makes clear that covered individuals must be able to request an exemption from the vaccination requirement based on an applicable Federal law, such as the ADA or Title VII of the Civil Rights Act. Facilities must have a process for collecting and evaluating such requests. As mentioned above, facilities must also track and document exemption requests, as well as the facility’s decision on the request, and any accommodations that are provided.
For individuals requesting a medical exemption from vaccination, all documentation confirming recognized clinical contraindications of COVID-19 vaccines, and which supports the individual’s request, “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.” Such documentation “must contain all information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications.” The documentation must also include a “statement by the authenticating practitioner recommending that the staff member be exempted from the facility’s COVID-19 vaccination requirements based on the recognized clinical contraindications.”
Vaccine exemption requests based on medical condition or sincerely held religious belief should be evaluated in accordance with the facility’s established policies and procedures. Potentially relevant here, the IFC states that it “preempts the applicability of any State or local law providing for exemptions to the extent such law provides broader exemptions than provided for by Federal law and are inconsistent with this IFC.”
Additional Planning
Due to likely unforeseen circumstances, CMS requires that facilities make “contingency plans” in consideration of staff that are not fully vaccinated to ensure that they will soon be vaccinated and will not provide care, treatment, or other services for the facility or its patients until such time as the staff member becomes vaccinated. This planning should also address the safe provision of services by individuals who have requested an exemption from vaccination while their request is being considered.
Bottom Line
Publication of the IFC is a major step in the Biden Administration’s efforts to curb the continued spread of COVID-19. However, the rule may not be in its final form. Those affected by the rule have 60 days to submit comments on it, after which the CMS could post an updated final rule. We will continue to monitor the situation and update accordingly.