Centers for Medicare & Medicaid Services Releases Interim Final Rule on COVID-19 Vaccination for Eligible Staff

The Centers for Medicare & Medicaid Service has released an interim final rule on COVID-19 vaccination for health care staff participating in Medicare and Medicaid programs, and the Occupation Safety and Health Administration has released an Emergency Temporary Standard for employers with 100 or more staff members.

An interim final rule was release by the Centers for Medicare & Medicaid Service (CMS) regarding COVID-19 vaccination for health care staff who participate in Medicare and Medicaid programs, according to a press release from the American Society of Clinical Oncology. Additionally, the Occupation Safety and Health Administration (OSHA) issued an Emergency Temporary Standard that detailed a COVID-19 vaccination policy for employers with 100 or more staff members.

Centers for Medicare & Medicaid Interim Final Rule

By December 5, 2021, all eligible staff will be required to have received the first dose of a 1- or 2-dose COVID-19 vaccine before providing any care or treatment to patients. Additionally, all staff are expected to be fully vaccinated by January 4, 2022. Institutions will be considered in compliance with this policy if their staff have been given a vaccine listed by the World Health Organization that has been authorized for emergency use, as well as those who were vaccinated as part of a clinical trial.

The vaccination requirement applies to a number of Medicare- and Medicaid-certified providers and suppliers, including 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. Notably, the rule does not have application in other health care entities, including physician offices without CMS regulations.

Current and new staff of Medicare or Medicaid programs are expected to fulfill the rule regardless of their clinical responsibility of patient contact, including licensed practitioners, students, trainees, and volunteers, as well as those who provide care, treatment, or other services for the facility and/or its patients. However, fully remote individuals who have no direct contact with patients and other staff will not be subjected to the vaccine requirements.

However, the rule does allow for exemptions in staff members with medical conditions in whom the vaccines are counter indicated, as well as individuals with sincerely held religious beliefs, observances, or practices. It is expected for facilities to include exemptions in their policies and procedures in line with federal law. Exemptions should be applicable, with none provided to individuals for whom it is not legally required or who ask for an exemption for the purpose of avoiding vaccination.

Providers and suppliers who do not meet the rule’s requirements will be cited by a surveyor as being non-compliant and will be presented with the opportunity to resume compliance prior to additional action.

OSHA’s Emergency Temporary Standard

Taking effect on January 2, 2022, OSHA’s emergency temporary standard requires that employers with 100 or more staff members develop and enforce a mandatory COVID-19 vaccination policy or adopt a policy that requires their staff to be vaccinated or undergo regular COVID-19 testing with the accompaniment of face coverings while working. Those who test positive for the virus will be asked to leave the workplace and allowed to return following the Center for Disease Control’s Isolation Guidance. Notably, the rule does not apply to institutions covered by the aforementioned CMS rules.

The written vaccine policy must by consistent with the emergency temporary standard with continuous knowledge of every employee’s vaccination status. Proof of vaccine includes an immunization record from a health care provider or pharmacy, a COVID-19 vaccination card, or another type of official documentation. OSHA also intends on addressing employers with fewer than 100 employees to ensure they comply with requirements.

The organization will consider noncompliance as an egregious violation in which separate penalties will be issues for each instance of noncompliance.


COVID-19 vaccine requirements for Medicare, Medicaid facilities and employers of 100 or more staff released. News release. American Society of Clinical Oncology. November 5, 2021. Accessed November 9, 2021.