On Thursday, November 4, the Centers for Medicare & Medicaid Services (CMS) announced an Interim Final Rule requiring that all staff employed by covered Medicare- and Medicaid-certified providers must receive a first COVID-19 vaccine dose by December 5 and have received both doses of a two-vaccine series by January 4 unless they have been granted a medical or religious exemption. The requirement applies to all employees, licensed practitioners, students, trainees, volunteers, and any individual who provides care, treatment, or other services for a covered provider and/or its patients, regardless of clinical responsibility or patient contact. The only individuals exempt from the requirement are those exempted by the ADA and Title VII and those providing services performed exclusively offsite and who do not have any contact with any patients or other staff (i.e., people who work 100% remotely).

The vaccination requirement applies to the following Medicare and Medicaid-certified provider and supplier types: Ambulatory Surgery Centers, Community Mental Health Centers, Comprehensive Outpatient Rehabilitation Facilities, Critical Access Hospitals, End-Stage Renal Disease Facilities, Home Health Agencies, Home Infusion Therapy Suppliers, Hospices, Hospitals, Intermediate Care Facilities for Individuals with Intellectual Disabilities, Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services, Psychiatric Residential Treatment Facilities (PRTFs), Programs for All-Inclusive Care for the Elderly Organizations (PACE), Rural Health Clinics/Federally Qualified Health Centers, and Long Term Care facilities.

Rule does permit a delay of the requirement for people who cannot be vaccinated due to clinical precautions (e.g., people who have recently tested positive for COVID-19).  Staff who have COVID-19 antibodies are not exempted.  The facility’s medical exemption process must ensure that requests for medical exemption are supported by documentation that meets the following requirements:  it is signed and dated by a licensed practitioner, who is not the individual requesting the exemption and is acting within their respective scope of practice based on applicable state and local laws; it specifies which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive; and identifies the recognized clinical reasons for the contraindications. Additionally, CMS has stated that a statement by the authenticating practitioner recommending that the staff member be exempted from the facility’s COVID-19 vaccination requirements is also expected.  The Rule does not require testing for those granted an accommodation or any specific additional requirements, leaving it to the facility to determine what additional measures are necessary to minimize the risk of COVID-19 transmission.

In addition, the Rule requires providers to develop processes for the following:

  • Processing exemption requests based on recognized medical conditions, or religious beliefs, observances, or practices;
  • Ensuring that all covered staff receive, at a minimum, a single-dose COVID-19 vaccine, or the first dose of a multi-dose COVID-19 vaccine, prior to providing any care, treatment, or other services for the center and/or its patients;
  • Ensuring that all staff are fully vaccinated;
  • Implementing additional precautions to mitigate the transmission of COVID-19 for all staff who are not fully vaccinated (i.e., those exempted from vaccination for medical or religious reasons);
  • Tracking and securely documenting employee vaccination status; and
  • Tracking and securely documenting exemption requests and accommodations.

CMS has also issued FAQs that aid in interpreting the new Rule, including a discussion of how the CMS Rule interacts with the existing OSHA health care ETS and the OSHA general ETS also issued on November 4, 2021 discussed here.

Ballard Spahr’s labor and employment team is ready to assist any employers seeking to roll out a mandatory vaccination program that complies with the requirements of the Rule.