In early September, the Biden administration announced its “Path out of the Pandemic” which, among other components of the Plan, included a vaccination mandate for certain health care settings. On November 4, 2021, the Centers for Medicare & Medicaid Services (“CMS”) announced the publication of the Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule (“IFR”). The IFR will be formally published in the Federal Register on November 5, 2021. Because CMS issued the emergency regulation as an Interim Final Rule, the rule will become effective upon publication.
Unlike the OSHA COVID-19 Vaccination and Testing Emergency Temporary Standard, also announced on November 4th, the CMS IFR is more narrow in application in that it only applies to Medicare and Medicaid-certified providers and suppliers (collectively “facilities”) that are regulated under the Medicare Conditions of Participation, Conditions for Coverage or Requirements for Participation for 21 types of providers and suppliers. Specifically, the IFR directly regulates the following facilities:
- Ambulatory surgery centers;
- Psychiatric residential treatment facilities;
- Programs of All-Inclusive Care for the Elderly;
- Long Term Care Facilities;
- Intermediate Care Facilities for Individuals with Intellectual Disabilities;
- Home Health Agencies;
- Comprehensive Outpatient Rehabilitation Facilities;
- Clinics, rehabilitation agencies, and public health agencies as providers of outpatient PT and Speech services;
- Community Mental Health Centers;
- Home Infusion Therapy suppliers;
- Rural Health Clinics/Federally Qualified Health Centers; and
- End Stage Renal Disease Facilities
The IFR does not directly apply to other health care entities, such as physician offices, that are not regulated by CMS. However, depending on the number of employees, physician offices could possibly be covered by the OSHA ETS.
The IFR vaccination requirement essentially applies to all staff regardless of clinical responsibility or patient contact. In addition to employees at a facility, the requirements would also apply to licensed practitioners providing care at the facility, students, trainees, volunteers, and persons that provide care, treatment, or other services to the facility under contract or by other arrangement. It should be noted that there are some exceptions for persons providing services to a facility under arrangement (for example a repair person providing periodic services to a facility); however, such exceptions should be evaluated on a case-by-case basis. Additionally, facility staff that perform services exclusively (100%) outside of the facility setting would not be required to receive the vaccination. Finally, the IFR also allows for exemptions for staff members with recognized medical conditions for which vaccines are contraindicated and staff members with sincere religious beliefs. Medical and religious exemptions would be analyzed under well-known employment law concepts set forth in Federal law. Interestingly, in FAQs to the IFR, CMS specifically, points out that exemptions should not be provided to staff for the sole purpose of evading vaccination.
From a timing perspective, the IFR requires covered facilities to establish a process to fulfill the applicable staff vaccination requirements in two, 30-day, phases. Phase 1 will begin upon publication of the IFR in the Federal Register (November 5, 2021) and will require all staff at covered facilities to receive the first dose of a multi-dose vaccine (Pfizer and/or Moderna) or a single dose of the Johnson & Johnson vaccine on or before December 5, 2021. Staff receiving a multi-dose vaccine must receive their second vaccination on or before January 4, 2022.
Covered facilities falling to comply with all the requirements of the IFR are subject to civil monetary penalties, denial of payment and possibly termination from the Medicare and Medicaid programs. CMS does point out, however, that termination would only occur after the providing the facility in question with an opportunity to make corrections and come into compliance.
Finally, with regard to the IFR’s interaction with state laws that might prohibit vaccine mandates, CMS points to the Supremacy Clause of the U.S. Constitution as pre-empting any contrary state law. As to potential conflicts with other Federal regulations, such as the OSHA ETS, CMS indicates that covered facilities should look to the requirements of the IFR.
Covered facilities should promptly review the guidance put out by CMS and seek the assistance of qualified legal counsel as necessary.
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This publication is for general information only. It is not legal advice, and legal counsel should be contacted before any action is taken that might be influenced by this publication.
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