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New CMS Interim Final Rule on Vaccine Requirements: You Are Likely NOT Captured Under the Rule

Health care providers and suppliers have their own new requirements for COVID-19 vaccinations. Last week, the Centers for Medicare & Medicaid Services (CMS) released an interim final rule to require many types of Medicare- and Medicaid-certified providers and suppliers to establish COVID-19 vaccination requirements for their staff. Under the interim final rule, providers must implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19, to provide medical and religious exemptions and related accommodations, and to track and document staff COVID-19 vaccinations. CMS also released guidance in the form of Frequently Asked Questions (FAQs).

The following are excerpts from the FAQs issued with the interim final rule.  As you will see, the regulation does not apply to physician’s offices because they are not subject to CMS health and safety regulations.  Please read further to confirm your office is not captured under the interim final rule.


Basics

Q: When does this take effect?
A: The emergency regulation is effective as of November 5, 2021.

Q: Is this a facility-specific or individual-level requirement?
A: The staff vaccination requirements apply to Medicare and Medicaid-certified provider and supplier types (collectively, “facilities”) that are regulated under the Medicare health and safety standards known as Conditions of Participation (CoPs), Conditions for Coverage (CfCs), or Requirements. Facilities are required to have a process or policy in place ensuring that all applicable staff are vaccinated against COVID-19.


Eligibility

Q: To which provider and supplier types does this apply?
A: The staff vaccination requirement applies to the following Medicare and Medicaid-certified provider and supplier types: Ambulatory Surgery Centers, Community Mental Health Centers, Comprehensive Outpatient Rehabilitation Facilities, Critical Access Hospitals, End-Stage Renal Disease Facilities, Home Health Agencies, Home Infusion Therapy Suppliers, Hospices, Hospitals, Intermediate Care Facilities for Individuals with Intellectual Disabilities, Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services, Psychiatric Residential Treatment Facilities (PRTFs) Programs for All-Inclusive Care for the Elderly Organizations (PACE), Rural Health Clinics/Federally Qualified Health Centers, and Long Term Care facilities.

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. What about Assisted Living Facilities, Group Homes, or other similar settings?
A: This regulation only applies to Medicare and Medicaid-certified facilities. CMS does not have regulatory authority over care settings such as Assisted Living Facilities or Group Homes. This regulation will also not apply to physician’s offices because they are not subject to CMS health and safety regulations.

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 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 under this Act. Citations to the relevant statutory authorities for each specific type of provider and supplier is 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.


Interaction with State Law

Q: What happens if State law prohibits vaccine mandates? How can CMS expect a facility to follow its requirements if its State prevents them from implementing this rule?
A: Under the Supremacy Clause of the U.S. Constitution, this regulation pre-empts any state law to the contrary. U.S. Const. art. VI § 2.

Should you fall into one of the rare chiropractic physician offices covered under the Rule (admitting privileges in a hospital), you should read further in the FAQ sections under Requirements, Exemptions, and Enforcement found here.