Health Care Providers Face Short Deadline to Comply With CMS Vaccine Mandate

The Centers for Medicare and Medicaid Services (CMS) released an Interim Final Rule with comment period on Nov. 4 that mandates the COVID-19 vaccine for eligible staff at most health care facilities. It also published a set of Frequently Asked Questions about the mandate. CMS will accept comments on the final rule until Jan. 4, 2022.

Under the emergency rule, which takes effect Nov. 5, covered facilities must establish a policy ensuring that all eligible staff receive the first dose of a COVID-19 vaccine before providing any care, treatment or other services by Dec. 5. All eligible staff must receive the necessary shots to be fully vaccinated by no later Jan. 4, 2022. CMS will enforce these requirements through its survey and certification process.  

What Types of Facilities are Covered?

The staff vaccination rule 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 (PACE) organizations
• Rural health clinics/federally qualified health centers
• Long-term care facilities

Which Staff Are Covered?    

The vaccine mandate broadly applies to all eligible staff working on- or off-site for a covered facility, regardless of clinical responsibility or patient contact, unless they provide services 100% remotely and do not have any direct contact with patients or other staff members. Those subject to the mandate include:

• Employees
• Individuals who provide care, treatment or other services for the facility or its patients under a contract
• Licensed practitioners
• Students
• Trainees
• Volunteers
• Physicians who admit or treat patients in person within a facility
• All staff who interact with other staff, patients, residents or clients in off-site locations, such as homes, administrative sites or other sites of care

Providers and suppliers must establish exemptions based on medical or religious reasons as a part of their policies and procedures. However, CMS believes that exemptions are only appropriate in limited circumstances. It states that no exemption should be provided to any staff for whom it is not legally required under the Americans with Disability Act or Title VII of the Civil Rights Act, or to any staff member who requests an exemption solely to evade vaccination.  

How Does CMS Define “Fully Vaccinated”?

CMS currently considers staff fully vaccinated if it has been two weeks or more since they completed a primary vaccination series for COVID-19. However, staff who have completed the primary series for the vaccine received by the Phase 2 implementation date are considered to have met these requirements, even if they have not yet completed the 14-day waiting period required for full vaccination. The completion of a primary vaccination series for COVID-19 is defined in the rule as the administration of a single-dose vaccine (such as the Janssen (Johnson & Johnson) COVID-19 vaccine), or the administration of all required doses of a multi-dose vaccine (such as the Pfizer-BioNTech COVID-19 vaccine (interchangeable with the licensed Comirnaty vaccine) or the Moderna COVID-19 vaccine). Staff who receive vaccines listed by the World Health Organization (WHO) for emergency use that are not approved or authorized by the FDA or as a part of a clinical trial are also considered to have completed the vaccination series in accordance with CDC guidelines.

Based on the tight deadlines to comply with this rule, covered providers must act quickly to establish policies and procedures that ensure eligible staff meet the vaccine requirements by Dec. 5. If you have any questions about compliance with the final rule, please contact Blake Adams or another member of Phelps’ Health Care team.