The Centers for Medicare and Medicaid Services (CMS) has published an interim final rule that changed the conditions of participation in Medicare and Medicaid to require vaccination of certain healthcare workers. The rule, title “Omnibus COVID-19 Health Care Staff Vaccination Rule” was published in the Federal Register on November 5, 2021.

The rule requires all employees of certain health care entities that are regulated by CMS to obtain their first vaccination shot or apply for a religious or other health or disability related exemption by December 6, 2021. Additionally, the rule requires either completed vaccination series or approved exemption by January 4, 2022.

Covered Entities and Individuals

The rule is not a blanket vaccine mandate for all health care workers and Medicare sites of service as had been speculated in various media reports. Instead the rule is limited to only those entities who are surveyed by CMS and have Conditions of Participation, Conditions for Coverage, or Requirements for Participation in the Medicare and Medicaid programs.

The list of covered entities includes four major groups of health care providers and suppliers:

(1) residential congregate care facilities (Long Term Care facilities (LTC), intermediate care facilities for individuals with intellectual disabilities (ICFs-IID), and psychiatric residential treatment facilities for individuals under 21 years of age (PRTFs));

(2) acute care settings (hospitals, critical access hospitals (CAHs), and ambulatory surgical centers (ASCs));

(3) outpatient clinical care and services (End-Stage Renal Disease (ESRD) Facilities, Community Mental Health Centers (CMHCs), Comprehensive Outpatient Rehabilitation Facilities (CORFs), Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs), and Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services); and

(4) home-based care (Home Health Agencies (HHAs), Hospice, and Programs of All-Inclusive Care for the Elderly (PACE) Organizations).

Notably absent from these groups are physicians and physician offices, which are not surveyed by CMS. Organ Procurement Organizations and Portable X-Ray suppliers are also not covered by the rule. However, organizations that are not subject to this rule may still be subject to the OSHA Emergency Temporary Standard that requires vaccination or regular testing and masking for all corporations with 100 or more employees

As for which employees are covered by the rule, the CMS has indicated that only employees who perform their work on a 100% remote basis would be exempt from the requirements of the rule. Everyone else, regardless of the extent of their interaction with patients or the clinical nature of their job would be subject to the rule’s requirements.

Additionally, CMS has indicated that this rule is preeminent above any other federal vaccination requirement for covered entities. Therefore, if your facility is included within the covered group, then this applies to your staff, regardless of whether you are also a Federal Contractor and would otherwise be subject to the executive order on federal contracting workforce safety.


The rule is subject to religious and health or disability related exemptions and employers are directed by the rule to establish a procedure by which their employees may apply for such an exemption. The CMS directs employers to resources provided by the Centers for Disease Control and Prevention and the Equal Employment opportunity Commission to establish those policies and procedures.

Proof Requirements and Vaccines

The rule allows for any of the FDA authorized vaccines or the vaccines approved by the World Health Organization to fulfill the mandate. However, should a health care entity have an employee who received a non-approved vaccine, they will not be judged to have fulfilled the mandate and will instead be required (at least 28 days after their non-approved vaccination) to re-vaccinate with one of the authorized vaccines.

For proof of vaccination, a health care entity must keep any of the following forms of documentation, separate and apart from the employee’s personnel file: CDC COVID-19 vaccination record card (or a legible photo of the card); Documentation of vaccination from a health care provider or electronic health record; State immunization information system record; or, if vaccinated outside of the U.S., a reasonable equivalent of any of those.

Enforcement and Penalties

Initial compliance is required on December 5, 2021 and by that time covered health care entities must either have all of their employees (and volunteers) vaccinated with the first dose of the primary series of Covid-19 vaccines or have unvaccinated employees in the process of applying for a religious or health and disability exemption.

The second phase of the rule takes effect January 4, 2022. By that date covered entities must have their staff fully vaccinated or fully approved for some form of exemption. For the purposes of this rule, fully vaccinated means that the individual has had both doses of the vaccine, not that they have waited the full 14 days after the final dose for full immunity to have taken effect.

The rule will be enforced by the state survey agencies that currently evaluate health care entities for compliance with Medicare and Medicaid requirements. Those agencies will be directed to examine the policies and procedures of the entities and to see the vaccination records of all staff.

The rule specifically identifies that it is supreme to any state or local restrictions on vaccine mandates. Punishment for failure to comply could result in civil monetary penalties, refusal to pay for services or even termination from Medicare and Medicaid.

Interaction with OSHA Standard

As noted earlier, the CMS rule is preeminent over any other federal rule for entities and facilities that are enumerated as covered by it. However, the rule identifies that there may be some situations in which a company that has some staff are covered by the CMS rule while others may be covered by the Emergency Temporary Standard issued by the Occupational Safety and Health Administration on the same day.

Check out this post from Reed Smith’s Employment Law Watch Blog for more information about the application of the OSHA standard.

Should you have any questions related to this CMS rule, or any other health care compliance issues, please do not hesitate to reach out to the health care attorneys at Reed Smith.