The newly released CMS mandate for vaccinations directly applies only to Medicare- and Medicaid-certified providers and suppliers that are regulated under the Medicare health and safety standards known as Conditions of Participation (CoPs), Conditions for Coverage (CfCs), or Requirements for Participation. It does not directly apply to physician offices (unless part of a larger system), because they are not subject to CMS health and safety regulations.
Specifically, the mandate directly regulates the following providers and suppliers, listed in the numerical order of the relevant CFR sections being revised in this rule:
- Ambulatory Surgical Centers (ASCs) (§ 416.51)
- Hospices (§ 418.60)
- Psychiatric residential treatment facilities (PRTFs) (§ 441.151)
- Programs of All-Inclusive Care for the Elderly (PACE) (§ 460.74)
- Hospitals (acute care hospitals, psychiatric hospitals, hospital swing beds, long term care hospitals, children’s hospitals, transplant centers, cancer hospitals, and rehabilitation hospitals/inpatient rehabilitation facilities) (§ 482.42)
- Long Term Care (LTC) Facilities, including Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs), generally referred to as nursing homes (§ 483.80)
- Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) (§ 483.430)
- Home Health Agencies (HHAs) (§ 484.70)
- Comprehensive Outpatient Rehabilitation Facilities (CORFs) (§§ 485.58 and 485.70)
- Critical Access Hospitals (CAHs) (§ 485.640)
- Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services (§ 485.725)
- Community Mental Health Centers (CMHCs) (§ 485.904)
- Home Infusion Therapy (HIT) suppliers (§ 486.525)
- Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs) (§ 491.8)
- End-Stage Renal Disease (ESRD) Facilities (§ 494.30)
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 Dec. 5, 2021. All eligible staff must have received the necessary shots to be fully vaccinated – either two doses of Pfizer or Moderna or one dose of Johnson & Johnson – by Jan. 4, 2022. The regulation provides for exemptions based on recognized medical conditions or religious beliefs, observances or practices. Facilities must develop a similar process or plan for permitting exemptions in alignment with federal law.
The requirement applies to all current staff as well as any new staff who provide any care, treatment or other services for the facility and/or its patients. This includes facility employees, licensed practitioners, students, trainees and volunteers. Additionally, this includes individuals who provide care, treatment or other services for the facility and/or its patients under contract or other arrangements. All staff who interact with other staff, patients, residents, clients or PACE program participants in any location beyond the formal clinical setting (such as homes, clinics, other sites of care, administrative offices, off-site meetings, etc.) also must be vaccinated. Physicians admitting and/or treating patients in-person within a facility subject to the CMS health and safety regulations must also be vaccinated so that the facility is compliant.
Here is a link to the published document outlining the mandate:
https://www.federalregister.gov/documents/2021/11/05/2021-23831/medicare-and-medicaid-programs-omnibus-covid-19-health-care-staff-vaccination
Here is a link to frequently asked questions:
https://www.cms.gov/files/document/cms-omnibus-staff-vax-requirements-2021.pdf