On November 4, the federal government announced new vaccine requirements for health care workers issued by the Centers for Medicare & Medicaid Services (CMS). Here is what health care employers need to know.

What Is Required?

• Covered facilities are required to develop and implement policies and procedures to ensure their staff and all covered people are vaccinated for COVID-19 and track and maintain documentation of their vaccination status. 
   
• Covered facilities are required to make contingency plans in consideration of staff that are not fully vaccinated to ensure that they will soon be vaccinated and will not provide care, treatment, or other services for the provider or its patients until such time as such staff are considered fully vaccinated, or, at a minimum, have received a single-dose COVID-19 vaccine or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine. This planning should also address the safe provision of services by individuals who have requested an exemption from vaccination while their request is being considered.
   
• This regulation does not include testing requirements. Covered facilities (such as long term care facilities) that are subject to testing requirements under other regulations must continue to comply with those testing requirements.

What Is a Covered Facility?

• The vaccination requirements apply to Medicare and Medicaid-certified provider and supplier types that are regulated under the Medicare health and safety standards known as Conditions of Participation (CoPs), Conditions for Coverage (CfCs), or Requirements for Participation.
   
• The staff vaccination requirement applies to the following Medicare and Medicaid-certified provider and supplier types: community mental health centers; ambulatory surgery centers (ASCs); 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. The requirement applies to Indian Health Service facilities, too.
   
• The regulation does not apply to assisted living facilities, group homes, or physician offices. However, these facilities are still subject to other applicable state and federal COVID-19 vaccination requirements, including the Occupational Safety and Health Administration’s COVID-19 emergency temporary standard (currently stayed and on hold), which requires certain facilities that employ 100 or more employees to mandate vaccinations or testing and masking for those employees. In addition, if an ASC is located in a physician office, that physician office must then comply with the vaccination requirements as its physician office staff shares common areas (and often overlaps staff) with ASC staff, patients, and visitors.
   
• The vaccination requirement also does not apply to religious nonmedical health care institutions, organ procurement organizations (OPOs), or portable x-ray suppliers. OPO and portable x-ray suppliers are indirectly subject to the vaccination requirements under their contracts with covered facilities, however, as OPO and portable x-ray supplier employees and contractors would be included in the universe of individuals that covered facilities must require to be vaccinated.

Who Is a Covered Person?

• The CMS rule applies to all covered facility staff – regardless of clinical responsibility or patient contact – and includes all current staff as well as any new staff who provide any care, treatment, or other services for the covered facility and/or its patients. 
   
• This includes, but is not limited to: facility employees; licensed practitioners; students, trainees, and volunteers; and individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement. These requirements are not limited to those staff who perform their duties within a formal clinical setting and apply to staff that care for patients or clients outside of the covered facility’s physical location. This means that staff who interact with other staff, patients, residents, clients, or PACE program participants in locations such as homes, clinics, administrative offices, or at off-site meeting locations, for example, are required to be vaccinated.
   
• The CMS rule includes administrative staff, individuals on a covered facility’s medical staff or who have admitting privileges, facility leadership, volunteer or other fiduciary board members, and housekeeping and food services.
   
• The CMS rule does not include staff who telework full-time (i.e., 100% remote) and do not come in contact with the public, patients, clients, or other staff by means of their position with the covered facility.
   
• Covered facilities are not required to mandate vaccination for all vendors that enter a covered facility on an ad hoc basis (e.g., an annual elevator inspector) or for vendors that provide services to the Covered Facility off-site (e.g., remote accounting or human resources professionals). But covered facilities have to require vaccination for long-term on-site vendors, such as a construction crew working on a project whose members use shared facilities during their breaks, since they are using the same common areas used by staff, patients, and visitors.

Are There Exemptions for Covered People?

• Yes. The only exemptions are those applicable under federal law. Any state or local law that attempts to narrow or eliminate these minimum vaccination requirements are deemed inapplicable and superseded.
   
• Certain allergies, recognized medical conditions, or religious beliefs, observances, or practices may provide grounds for exemption. Each covered facility should establish exemptions as part of its policies and procedures and ensure that such exemptions align with federal law and do not provide for exemptions that are not legally required under the Americans with Disabilities Act or other federal law.

What Are the Documentation Requirements?

• The CMS rule requires that covered facilities track and securely document the vaccination status of each staff member, including those for whom there is a temporary delay in vaccination.
   
• Covered facilities must also document vaccine exemption requests and outcomes.
   
• All medical records, including vaccine documentation, must be kept confidential and stored separately from an employer’s personnel files.

What Is the Timing?

• The CMS rule is broken into two phases for implementation.
   
  • Phase 1, effective December 6, 2021, includes nearly all provisions of the rule, including the requirements that all staff have received, at a minimum, the first dose of a COVID-19 vaccine or requested and/or been granted a lawful exemption prior to providing any care, treatment, or other services for the facility and/or its patients. Phase 1 also requires that covered facilities have appropriate policies and procedures developed and implemented.
     
  • Phase 2, effective January 4, 2022, consists of the requirement that all covered people are fully vaccinated for COVID-19, except for those staff who have been granted exemptions.
     
• Although an individual is not considered fully vaccinated until 14 days after the final dose, covered people who have received the final dose of a multi-dose vaccination series by the Phase 2 effective date are considered to have met the individual vaccination requirements, even if they have not yet completed the 14-day waiting period.

How Is Compliance Monitored?

• As a federal regulation, this vaccination requirement pre-empts any state law that prohibits vaccines or is otherwise contrary to the regulation.
   
• State survey agencies will monitor compliance with these vaccination requirements through standard recertification surveys and all complaint surveys. Accreditation agencies will also assess compliance.

What Are the Penalties?

• Covered facilities that are cited for noncompliance may be subject to enforcement remedies imposed by the federal government depending on the level of noncompliance and the remedies available under federal law. Examples include civil money penalties, denial of payment for new admissions, or termination of the Medicare/Medicaid provider agreement.

Will the Standard Survive Legal Challenges?

• The rule will likely be challenged in court. OSHA’s COVID-19 vaccinate-or-test-and-mask policy, which was released the same day as the CMS rule, has already been put on hold because of a lawsuit. But the CMS rule remains in effect, and health care employers should keep a close eye on legal developments as they plan their response to the standard.