On November 4, CMS released its Interim Final Rule (“IFR”) requiring COVID-19 vaccinations for individuals working in Medicare- and Medicaid-participating facilities, as well as individuals working in certain other settings involving face-to-face interactions with patients. The IFR requires all clinical and non-clinical personnel working within a Medicare and Medicaid participating facility or other applicable setting to have received at least the first dose of a COVID-19 vaccine by December 5, 2021 and complete the vaccine course by January 4, 2022. The IFR specifies available medical and religious exemptions to the mandate, but contrary to what was previously published by CMS, testing is not an express exemption to the vaccine requirement. Facilities and other settings affected by the IFR are not required to ensure separate compliance with the vaccine rule also being issued today by the Department of Labor’s Occupational Safety and Health Administration (“OSHA”), as the deadlines are the same for both rules. Hall Render has a separate article discussing the OSHA Rule.
Effective Date
The effective date of Phase 1 of the CMS IFR is December 5, 2021. Personnel subject to the mandate must have at least one dose of the COVID-19 vaccine by that date. Additionally, facilities must have certain policies in place that will be discussed in an upcoming Hall Render article. The effective date of Phase 2 of the CMS IFR, which requires individuals to have received the entire recommended vaccine course, is January 4, 2022. Personnel subject to the mandate are not required to have completed the 14-day post-vaccination period generally recommended for full vaccine efficacy by the Phase 2 effective date.
Facilities/Suppliers Affected by the IFR
CMS published the following table of the facilities impacted by the IFR. Note that while physician groups are not specifically listed, many personnel within those organizations could be subject to the IFR by virtue of relationships with any of the providers/suppliers listed below.
| Provider/Supplier |
| Ambulatory Surgical Centers (ASCs) |
| Hospices |
| Psychiatric Residential Treatment Facilities (PRTFs) |
| Programs of All-Inclusive Care for the Elderly (PACE) |
| Hospitals |
| Long-Term Care (LTC) Facilities |
| Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) |
| Home Health Agencies (HHAs) |
| Comprehensive Outpatient Rehabilitation Facilities (CORFs) |
| Critical Access Hospitals (CAHs) |
| Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services (Organizations) |
| Community Mental Health Centers (CMHCs) |
| Home Infusion Therapy (HIT) Suppliers |
| Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs) |
| End-Stage Renal Disease (ESRD) Facilities |
Personnel Subject to IFR
The IFR vaccine mandates are largely consistent across all covered settings and apply to the following individuals:
- Facility/provider employees;
- Licensed practitioners;
- Students, trainees and volunteers; and
- Individuals who provide care, treatment or other services for the facility/provider and/or its patients, under contract or other arrangement.
CMS intends to interpret the last category very broadly and cites examples of administrative team members and Organ Procurement Organization team members as individuals subject to the IFR due to the potential for even incidental or irregular contact with patients.
Exemptions
The IFR requires affected entities to establish a process by which individuals may request exemptions to the vaccine requirement based on an “applicable federal law.” There will be both medical and non-medical exemptions available for the IFR.
- A medical exemption will require certification by a licensed practitioner (other than the individual requesting the exemption) operating within the scope of the practitioner’s practice, identifying the specific, recognized clinical reasons for contraindications that form the basis of the exemption request.
- Exemptions will be available under the ADA and Title VII as those laws require an employer to provide reasonable accommodations for employees who, because of a disability or a sincerely held religious belief, practice or observance, do not get vaccinated against COVID-19, unless providing an accommodation would pose an undue hardship on the operation of the employer’s business. Facilities must have a process for handling those requests and be prepared to make “reasonable accommodations” for the personnel requesting this type of exemption.
- In addition to individuals who request and receive exemptions under applicable federal law, the IFR’s vaccine requirements exclude individuals who provide services solely on a remote and/or telehealth basis and who do not have direct contact with patients or with other staff who are required to receive the vaccine. In addition, the IFR’s vaccine requirements exclude staff who provide support services exclusively outside of the affected setting, and who do not have any direct contact with patients or other staff who are required to receive the vaccine.
Enforcement and Preemption
CMS will ensure compliance with these requirements through a survey and enforcement processes. Guidance is forthcoming to surveyors, but the agency provides some examples of that guidance, requiring surveyors to review facility records and interview facility personnel. If a facility does not meet the IFR requirements, the facility will be cited by a surveyor and have an opportunity to return to compliance before additional actions occur. The penalties for non-compliance will depend on the severity of the noncompliance and could include civil money penalties, denial of payment for new admissions or termination of the Medicare/Medicaid provider agreement. A White House Senior Administrative Official noted “CMS’s goal is to bring health care providers into compliance; it is not to punish workers or health care facilities. However, we will not hesitate to use our full enforcement authority to protect the health and safety of patients.”
The IFR will “preempt any inconsistent state or local laws, including laws that ban or limit an employer’s authority to require vaccination, masks or testing.” States with laws against employer mandates are expected to challenge the rule in court. However, legal challenges to vaccine mandates have had little success to date.
Practical Takeaways
- Most individuals working in any capacity at most health care facilities are required to complete a vaccine course by January 4, 2022.
- The vaccine requirements in the CMS IFR and those issued by OSHA do not differ.
- Court challenges are anticipated, but it is unclear how long it will be before there is clarity about the legal validity of the CMS rule.
Hall Render will publish additional resources for both the CMS rule and the OSHA rule. In the interim, if you have any questions about either rule, please contact:
- Jennifer Skeels at jskeels@wp.hallrender.com or (317) 977-1497;
- Liz Elias at eelias@wp.hallrender.com or (317) 977-1468; or
- Your primary Hall Render contact.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer an individual’s questions that may constitute legal advice.
