Wilson Sonsini Goodrich & Rosati

On November 5, 2021, the Centers for Medicare and Medicaid Services (CMS) issued an Interim Final Rule (IFR) with Comment Period, 86 Fed. Reg. 61555 (Nov. 5, 2021), requiring mandatory COVID-19 vaccination of staff of many Medicare and Medicaid-certified healthcare providers and suppliers. Citing its broad statutory authority to develop health and safety requirements through its Conditions of Participation, Conditions for Coverage, and Requirements for Participation, CMS has set a January 4, 2022 deadline for those staff to be fully vaccinated.

Healthcare workers are the front line of the COVID-19 pandemic. CMS asserts the importance of vaccination of healthcare staff, not only to protect against COVID-19 exposure in the workplace, but because patients are less likely to access the healthcare system when staff are unvaccinated. Workplace exposure leads to absenteeism and inadequate staffing levels to meet demand. The threat of interacting with unvaccinated staff results in patients forgoing care and treatment, which disproportionately affects the elderly, impoverished, communities with social risk factors, and minorities.

CMS's vaccine mandate will affect staff at only certain enumerated Medicare and Medicaid-certified healthcare providers and suppliers:

  • ambulatory surgical centers
  • hospices
  • psychiatric residential treatment facilities
  • programs of all-inclusive care for the elderly
  • hospitals (acute care hospitals, psychiatric hospitals, long term care hospitals, children's hospitals, hospital swing beds, transplant centers, cancer hospitals, and rehabilitation 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
  • end-stage renal disease facilities

CMS's vaccine mandate does not apply to staff of physicians' offices. CMS states that physicians' offices are not subject to Medicare's health and safety regulations; however, they may face state vaccine regulations or other federal vaccine mandates such as those issued by Occupational Safety and Health Administration (OSHA).

CMS defines the term "staff" to mean all current, and newly hired, individuals who provide any care, treatment, or other services for the facility or its patients regardless of clinical responsibility or patient contact. Those individuals include facility employees; licensed practitioners; students; trainees; volunteers; and individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement. Those staff must receive a single dose COVID–19 vaccine or the initial dose of a primary series by December 6, 2021. Staff must be fully vaccinated by January 4, 2022. Fully vaccinated means that it has been two weeks or more since completion of a primary vaccination series. Providers and suppliers must track and securely document the vaccination status of each staff member, including those for whom there is a temporary delay in vaccination, such as recent receipt of monoclonal antibodies or convalescent plasma.

CMS also allows for certain staff exemptions from the vaccine mandate. Healthcare providers and suppliers must establish and implement a process by which staff may request an exemption from COVID–19 vaccination requirements based upon federal law such as allergies, recognized medical conditions, or religious beliefs, observances, or practices. CMS requires that healthcare providers and suppliers document all staff exemption requests and outcomes.

The IFR is the first time CMS will mandate the vaccination of healthcare staff. Previously, vaccination requirements were left to the discretion of individual providers or state boards of health. Interested parties may submit comments on the IFR by January 4, 2022.