Insight | December 2, 2021
The Centers for Medicare and Medicaid Services’ (CMS) vaccination requirement for health care workers is set forth by a CMS interim final rule with comment period, CMS-3415-IFC (IFC). Although an injunction of nationwide effect was recently issued by a Louisiana Court that prohibits the enforcement of the IFC, it is prudent to assess whether or not the IFC applies to your health care workers, and prepare accordingly in case the injunction is lifted.
The IFC directly applies only to enumerated Medicare and Medicaid-certified providers and suppliers. The IFC states the following:
"Specifically, this IFC 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)
This 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."
The IFC requirements apply to Medicare and Medicaid-certified provider and supplier types regulated under the Medicare health and safety standards, known as Conditions of Participation (CoPs), Conditions for Coverage (CfCs), or Requirements. If you bill for Medicare and Medicaid, this by itself is not enough to establish you as applicable providers under the IFC. Rather, the IFC further states it "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."
If you are not the type of providers and suppliers that the IFC directly regulates then the IFC does not directly apply to you, and you are not required to implement new vaccination requirements for your health care workers under this rule. In addition to the IFC’s exact language, the CMS’s FAQ regarding the IFC also answers this question (last question, page 1).
Nevertheless, the IFC may indirectly apply to you via arrangements with any IFC applicable providers and suppliers (see Section II.A.I of the IFC). Per this section, applicable providers’ and suppliers’ "…COVID-19 vaccination policies and procedures must apply to the following facility staff, regardless of clinical responsibility or patient contact, and including all current staff as well as any new staff, who provide any care, treatment, or other services for the facility and/or its patients: 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."
To note, the CMS IFC is separate from the Occupational Safety and Health Administration (OSHA) Vaccination Requirement for Employers with 100 or more employees, known as the COVID-19 Vaccination and Testing Emergency Temporary Standard (ETS). The OSHA ETS was to be effective January 4, 2022; however, its enforcement is temporarily stayed via a court order issued by the U.S. Court of Appeals for the Fifth Circuit.
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