DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Medicare & Medicaid Services
7500 Security Boulevard, Mail Stop C2-21-16 Baltimore,
Maryland 21244-1850
Center for Clinical Standards and Quality
DATE: December 2, 2021
Ref: QSO-22-04-ALL
TO: State Survey Agency Directors
FROM: Directors,
Quality, Safety & Oversight Group (QSOG) and Survey & Operations Group (SOG)

SUBJECT: Vaccination Regulation: Enforcement of Rule Imposing Vaccine Requirement for
Health Care Staff in Medicare- and Medicaid-certified Providers and Suppliers is
Suspended so Long as Court Ordered Injunctions Remain in Effect
Memorandum Summary
Survey and Enforcement of the Vaccine Requirement for Health Care Staff in
Medicare- and Medicaid-certified Providers and Suppliers Suspended While Court
Ordered Injunctions are in Effect: The Centers for Medicare & Medicaid Services
(CMS) will not enforce the new rule regarding vaccination of health care workers or
requirements for policies and procedures in certified Medicare/Medicaid providers and
suppliers (including nursing facilities, hospitals, dialysis facilities and all other provider
types covered by the rule) while there are court-ordered injunctions in place prohibiting
enforcement of this provision.

Background
On November 4, 2021, the Federal Register posted the notice of the CMS interim final rule with
comment revising the requirements that most Medicare- and Medicaid-certified providers and
suppliers must meet to participate in Medicare and Medicaid programs. See Interim Final Rule with
comment period, “Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff
Vaccination,” 86 Fed. Reg. 61,555 (Nov. 5, 2021). The published rule requires staff working in
Medicare- or Medicaid-certified providers to have the shots necessary to be fully vaccinated against
COVID-19 by January 4, 2022, and to receive their first shot prior to December 6, 2021. The rule
allows for medical and religious exemptions and requires that providers have policies and procedures
to operationalize these requirements.

On November 29 and November 30, 2021, the United States District Court for the Eastern District of
Missouri and United States District Court for the Western District of Louisiana issued preliminary
injunctions against the implementation and enforcement of the Interim Final Rule against Medicare and Medicaid-certified providers and suppliers. Between the two of them, these injunctions cover all
states, the District of Columbia and the US Territories. CMS has appealed both of these decisions, and
has filed motions for stays of these orders. While CMS remains confident in its authority to protect the
health and safety of patients in facilities certified by the Medicare and Medicaid programs, it has
suspended activities related to the implementation and enforcement of this rule pending future
developments in the litigation. Accordingly, while these preliminary injunctions are in effect,
surveyors must not survey providers for compliance with the requirements of the Interim Final
Rule. Health care facilities, of course, may voluntarily choose to comply with the Interim Final Rule.
Contact: Questions about this memorandum should be addressed to your CMS Location.

 

Karen L. Tritz David R. Wright
Director, Survey & Operations Group Director, Quality, Safety & Oversight Group
cc: Survey and Operations Group Management