Reed Smith Client Alerts

On November 5, 2021, the Centers for Medicare & Medicaid Services (“CMS”) published an interim final rule (the “IFR” or “Rule”) that changes Medicare regulations to require vaccination of certain health care workers against SARS-CoV-2. The Rule, titled “Omnibus COVID-19 Health Care Staff Vaccination Rule” requires compliance by covered entities in two stages based on the series of vaccinations.

Compliance Dates

  • Phase 1 of the Rule will take effect December 6, 2021.
  • Phase 2 of the Rule will take effect January 4, 2022.
  • The Rule will be open for comment. Comments are due on January 4, 2022, by 5 p.m.

Severability

According to its terms, the Rule is fully severable and if any portion of the Rule is held invalid by a court, the remainder of the Rule will remain in effect in its entirety.

Authority

Sections 1102 and 1807 of the Social Security Act (42 USC 1302 and 42 USC 1395hh, respectively). The Rule is issued as a mandatory requirement of participation/enrollment in the Medicare and Medicaid programs.

Overview of Regulation

CMS has implemented health and safety standards for 21 types of providers and suppliers.  These requirements are known variously as the Conditions of Participation, Conditions for Coverage, or Requirements for Participation and are general obligations for enrollment in Medicare. The Rule amends these safety standards to create a SARS-CoV-2 vaccination obligation for employees and staff, with relted tracking and documentation requirements, and an obligation to follow nationally recognized infection prevention and control guidelines to mitigate the transmission and spread of SARS-CoV-2. Compliance is enforced by state survey agencies.

The Rule applies to the following list of Medicare providers and suppliers (listed with the relevant section of Title 42 of the CFR):

  • 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)

Entities that are not listed above are not directly subject to the Rule, and this includes some notable exceptions.  For example, physicians and physician offices are not subject to the Rule directly because they do not have CMS Conditions for Coverage (physicians are classified as “suppliers” under Medicare law) and are not surveyed by state survey agencies.  That said, a physician who has staff privileges at a hospital would be subject to the Rule by virtue of its application to the hospital. DMEPOS suppliers, such as pharmacies, are another example of a Medicare enrollment that is not directly subject to the Rule.  Organ Procurement Organizations and Portable X-Ray suppliers are a further example.

With regard to Long Term Care facilities, the rule specifically removes the ability of staff to refuse vaccination, a provision that was included in earlier rules applicable to LTC facilities.

Of note, however, affected providers and suppliers can approve exemptions subject to rules addressing evaluating and documenting those requests.

Organizations that are not subject to the Rule may still be subject to the OSHA Emergency Temporary Standard that requires vaccination or regular testing and masking for all corporations with 100 or more employees. (See here for more information on the OHSA Emergency Temporary Standard for Workplace Vaccination Policies.)

The CMS Rule applies to eligible staff working at a facility that participates in the Medicare and Medicaid programs, regardless of clinical responsibility or patient contact. The requirement includes 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 also includes individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangements.

However, employees who work in a 100% remote setting through telework are not covered by the Rule. The Rule contemplates certain other fact-specific circumstances under which ad hoc service providers, such as annual elevator inspection personnel, may not be covered by the Rule.