Centers for Medicare and Medicaid Services Issues COVID-19 Vaccine Mandate

NOTE: On January 13, 2022, the United States Supreme Court stayed the preliminary injunctions issued by the United States District Courts for the Eastern District of Missouri and Western District of Louisiana. For more information, see Supreme Court Blocks OSHA’s Emergency Temporary Standard, Allows CMS Mandate to Move Forward.

On November 4, 2021, the Centers for Medicare and Medicaid Services (“CMS”) released its “Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule” (“IFR”). The IFR requires employees of Medicare and Medicaid-participating health care facilities to become fully vaccinated against COVID-19 by January 4, 2022. This Alert provides an overview of some of the obligations the IFR imposes on covered facilities.

Covered Facilities

The IFR only applies to Medicare and Medicaid-certified provider and supplier entities that have Conditions or Requirements of Participation. Specifically, the IFR applies to: Ambulatory Surgical Centers; Hospices; Psychiatric Residential Treatment Facilities; Programs of All-Inclusive Care for the Elderly; Hospitals; Long Term Care Facilities, including Skilled Nursing Facilities and Nursing Facilities; Intermediate Care Facilities for Individuals with Intellectual Disabilities; Home Health Agencies; Comprehensive Outpatient Rehabilitation Facilities; Critical Access Hospitals; Clinics, rehabilitation agencies and public health agencies as providers of outpatient physical therapy and speech-language pathology services; Community Mental Health Centers; Home Infusion Therapy suppliers; Rural Health Clinics; Federally Qualified Health Centers; and End-Stage Renal Disease Facilities.

Notably, the IFR does not apply to other health care entities that are not Medicare or Medicaid-certified facilities. This includes physician’s offices, Assisted Living Facilities, Group Homes, and Home and Community-based Services.  Facilities that are not covered by the IFR may, however, be covered under the Occupational Safety and Health Administration’s (“OSHA”) Emergency Temporary Standard for employers with 100 or more employees. See OSHA ETS Client Alert.

Mandatory Vaccination Requirement

The IFR requires covered facilities to develop and implement policies and procedures to ensure that all staff become fully vaccinated. Unlike OSHA’s Emergency Temporary Standard, the IFR does not give employees an option to engage in regular COVID-19 testing in lieu of becoming fully vaccinated. Certain employees may be entitled to a reasonable accommodation from the vaccine requirement if such an accommodation does not present a direct threat to the safety or an undue burden to the facility, including those employees for whom a vaccine is medically contraindicated, for whom medical necessity requires a delay in vaccination, or who are legally entitled to a reasonable accommodation under civil rights laws because they have a disability or sincerely held religious beliefs that conflict with the vaccination requirement.

By December 5, 2021, all staff must have either received at least the first dose of a COVID-19 vaccine or requested a lawful exemption. By January 4, 2022, all staff must be fully vaccinated unless they have been granted a lawful exemption.

The vaccination requirement applies to all facility staff, regardless of clinical responsibility or patient contact. The requirement includes all current and new staff who provide any care, treatment, or other services for the facility or its patients. This includes facility employees, licensed practitioners, students, trainees, and volunteers.  Also included are individuals who provide care, treatment, or other services for the facility or its patients under a contract or other arrangement. 

Additionally, individuals who work in a covered facility but are not employed by the facility may also be required to comply with the mandatory vaccination requirement. When assessing whether a particular individual is covered by the IFR, covered facilities should consider frequency of presence, services provided, and proximity to patients and staff. Examples of covered individuals include independent medical staff members, allied health professionals, surgical implant representatives, clergy, and health plan representatives who evaluate medical necessity on-site.    

The IFR also applies to staff who routinely care for patients outside of a covered facility, but who may come into contact with employees who enter a covered facility for their job responsibilities. Some examples include home health services, home infusion therapy, and hospice. Conversely, individuals who provide services 100 percent remotely are not subject to the vaccination requirement. 

Facilities are Required to Track and Document Certain Records

Facilities must track and securely document the vaccination status of each staff member, including documenting the status of staff who have received booster doses as recommended by the Centers for Disease Control and Prevention (“CDC”). Acceptable forms of proof of vaccination include: COVID-19 vaccination cards, documentation from a health care provider or electronic health record, or a state immunization system record.

The facility must also document vaccine exemption requests and whether those exemption requests were granted or denied. If vaccination must be delayed for a staff member based on CDC recommendations, the facility must track and document this as well. 

Next Steps for Covered Facilities

With the December 5th deadline requiring staff to have received at least one dose quickly approaching, covered facilities should begin informing staff of the mandatory vaccination requirement. Covered facilities should also begin putting together a system for documenting the vaccination status of its staff as well as documenting exemption requests.

If you have any questions about complying with the IFR or would like to discuss how the IFR may impact your facility, please contact a Lewis Rice Labor & Employment attorney.