On Nov. 4, 2021, the Centers for Medicare and Medicaid Services (CMS) released an Interim Final Rule with Comment Period ("IFC" or the "rule") regarding COVID-19 vaccination. The IFC is scheduled to take effect on Nov. 5, 2021. Health care provider and supplier employees, students, and volunteers must be vaccinated or receive an exemption by January 4, 2022. An OSHA federal rule applicable to large employers includes the same deadline.
The CMS rule is expansive in its application to all staff other than workers who are 100% remote. The rule applies to the following providers and suppliers:
- 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).
The IFC directly applies only to the Medicare- and Medicaid-certified providers and suppliers listed above. It does not directly apply to other health care entities, such as physician offices, that are not regulated by CMS.
For those providers and suppliers directly impacted by the rule, the rule applies not just to those staff who perform their duties within a health care facility. CMS explained that there may be times that staff encounter fellow employees, such as in an administrative office or at an off-site staff meeting, who will themselves enter a health care facility or site of care for their job responsibilities. Thus, CMS believes it is necessary to require vaccination for all staff that interact with other staff, patients, residents, or clients, in any location, beyond those that physically enter facilities or other sites of patient care.
The IFC acknowledges that employers may also be required to provide appropriate accommodations, to the extent required by federal law, for employees who request and receive exemption from vaccination because of a disability, medical condition, or sincerely held religious belief, practice, or observance. Accordingly, providers and suppliers included in the rule are required to establish and implement a process by which staff may request an exemption from COVID-19 vaccination requirements based on applicable federal law.
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