COVID-19 Vaccine Requirements for Medicare, Medicaid Facilities and Employers of 100 or More Staff Released

November 5, 2021

Update: On November 6, the U.S. Court of Appeals for the 5th Circuit blocked implementation of OSHA’s ETS for COVID-19 vaccination. The order from the 5th Circuit, which consolidates multiple petitions from employers and some states, blocks implementation of the OSHA ETS indefinitely.

On November 4, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule requiring COVID-19 vaccination of eligible staff at health care facilities that participate in the Medicare and Medicaid programs, and the Occupational Safety and Health Administration (OSHA) issued an Emergency Temporary Standard (ETS) as an interim final rule outlining the COVID-19 vaccination policy for employers of 100 or more staff.

The CMS Rule—“Medicare and Medicaid Programs: Omnibus COVID-19 Health Care Staff Vaccination”

Facilities covered by this regulation must establish a policy ensuring all eligible staff have received the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine prior to providing any care, treatment, or other services by December 5, 2021. All eligible staff must have received the necessary shots to be fully vaccinated – either two doses of the Pfizer or Moderna vaccine or one dose of the Johnson & Johnson vaccine – by January 4, 2022. Facilities will also be in compliance if they allow staff to work who received a vaccine listed by the World Health Organization (WHO) for emergency use that is not approved or authorized by the FDA, or who received a vaccine during their participation in a clinical trial.

Provider and Supplier Types

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.

This rule does not directly apply to other health care entities, such as physician offices, that are not regulated by CMS. However, 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.

Staff

This vaccination requirement applies to eligible staff working at a facility that participates in the Medicare and Medicaid programs, regardless of clinical responsibility or patient contact including all current and new staff. This includes facility employees, licensed practitioners, students, trainees, and volunteers. This also includes individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangements and are not limited to those staff who perform their duties solely within a formal clinical setting, as many health care staff routinely care for patients and clients outside of such facilities (e.g., home health, home infusion therapy, etc.). Individuals who provide services 100 percent remotely and who do not have any direct contact with patients and other staff, such as fully remote telehealth or payroll services staff, are not subject to these vaccination requirements.

Exemptions

CMS requires facilities to allow exemptions for staff with recognized medical conditions for whom vaccines are contraindicated, or for sincerely held religious beliefs, observances, or practices. Facilities should establish exceptions as a part of their policies and procedures and in alignment with Federal law. CMS believes that exemptions could be appropriate in certain limited circumstances, but no exemption should be provided to any staff for whom it is not legally required (under the Americans with Disabilities Act or Title VII of the Civil Rights Act of 1964) or who requests an exemption solely to evade vaccination.

  • Religious Exemptions: Facilities have the flexibility to establish their own processes that permit staff to request a religious exemption from COVID-19 vaccination requirements. CMS requires facilities to ensure that requests for religious exemptions are documented and evaluated in accordance with applicable federal law and as a part of a facility’s policies and procedures.
  • Medical Exemptions: Facilities also have the flexibility to establish their own processes that permit staff to request a medical exemption from COVID-19 vaccination requirements. Facilities must ensure that all documentation confirming recognized clinical contraindications to COVID-19 vaccinations for staff seeking a medical exemption are signed and dated by a licensed practitioner.

CMS will ensure compliance with these requirements through established survey and enforcement processes.  If a provider or supplier does not meet the requirements, it will be cited by a surveyor as being non-compliant and have an opportunity to return to compliance before additional actions occur.

This regulation pre-empts state laws prohibiting vaccine mandates. It also takes precedence over the other vaccine regulations for all Medicare-regulated facilities.

The OSHA Rule—“COVID-19 Vaccination and Testing; Emergency Temporary Standard”

The OSHA ETS requires employers of 100 or more staff to develop, implement and enforce a mandatory COVID-19 vaccination policy, unless they adopt a policy requiring employees to either be vaccinated or undergo regular COVID-19 testing and wear a face covering at work. This requirement takes effect January 4, 2022.  Individuals who test positive for COVID-19 must be removed from the workplace and can return after following CDC Isolation Guidance. This rule does not apply to entities covered by the CMS rule outlined above or by the federal contractor rule.

Covered employers must have a written vaccine policy consistent with the ETS and continually know the vaccination status of each of their employees. Acceptable proof of vaccination includes a record of immunization from a health care provider or pharmacy, the Centers for Disease Control and Prevention’s (CDC) COVID-19 vaccination card, or other official documentation. Going forward, OSHA will assess capacity of employers with fewer than 100 employees to comply with requirements. 

OSHA is considering noncompliance with this policy an “egregious violation,” under which it can issue a separate penalty for each instance of noncompliance. OSHA can cite for each instance of noncompliance using a range of enforcement tools available to the agency as appropriate and legally permissible. 

Workplaces not covered by this ETS include workplaces covered under the “Safer Federal Workforce Task Force COVID-19 Workplace Safety: Guidance for Federal Contractors and Subcontractors,” and settings where any employee provides health care services or health care support services while subject to the requirements of the June 2021 COVID-19 health care ETS.

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