CMS Announces Vaccine Mandate for Healthcare Facilities

By Elizabeth S. Wylie and Paul J. Giancola

On Thursday, November 4, 2021, contemporaneous with the announcement of the new Emergency Temporary Standard (“ETS”) of the Occupational Safety and Health Administration (“OSHA”) requiring COVID-19 vaccination or testing for employers with more than 100 employees (“OSHA Employer ETS”), the Centers for Medicare and Medicaid Services (“CMS”) published its ETS for healthcare staff vaccination (“CMS ETS”).  Like the OSHA Employer ETS, the CMS ETS became effective and therefore enforceable Friday, November 5, 2021.  Essentially, the CMS ETS requires COVID-19 vaccination of all covered, non-exempt staff at healthcare  provider and supplier types (collectively referred to as “facilities”) that participate in Medicare and Medicaid programs regulated under CMS health and safety regulations. Where state law prohibits a vaccine mandate, CMS states that the federal vaccination requirement pre-empts state law that is contrary to its requirement.

Overview

Facilities covered by this regulation must establish a policy ensuring all eligible staff, regardless of clinical responsibility or patient contact, have received the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine prior to providing any care, treatment, or other services by December 5, 2021. All eligible staff must have completed a primary vaccination series – generally, either two doses of the Pfizer or Moderna vaccines or one dose of the Johnson & Johnson vaccine – by January 4, 2022. The regulation provides for exemptions based on recognized medical conditions or religious beliefs, observances, or practices. Facilities must develop a process or plan for permitting exemptions required by state and federal law.

Covered Facilities

The requirements apply to 21 types of Medicare- and Medicaid-certified providers, ranging from hospitals to hospices and rural health clinics to ambulatory surgery centers and long-term care facilities.  The CMS ETS does not apply directly to physician and dental practices and other providers that are not regulated by CMS, but providers may have to comply with the CMS rule if they practice at covered facilities. In addition, providers may also be subject to other regulations and orders requiring vaccination and COVID-19 safety precautions, including the June 21, 2021 OSHA ETS (Occupational Exposure to COVID-19) applicable to facilities providing healthcare services and healthcare support services (“OSHA Healthcare ETS”), the OSHA Employer ETS, the September 9, 2021 Executive Order 14042 (Ensuring Adequate COVID Safety Protocols for Federal Contractors) (“Federal Contractor Executive Order”), or state mandates.

Covered Staff

The comments to the CMS ETS clarify that the term “staff” is used broadly and is not limited to employees of covered facilities or persons with patient contact.  Instead, the vaccination requirement applies to all staff working at any covered facility, regardless of clinical responsibility or patient contact, who provide any care, treatment or other services for the facility and/or its patients, including 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. The requirement does not apply to individuals who have no direct contact with patients or other staff if they provide such services on an ad hoc or 100 percent remote basis.

Vaccination Deadlines

The CMS ETS requires covered providers to establish a process or policy to ensure covered, non-exempt staff are fully vaccinated over two phases:

Phase 1:  By December 5, 2021, staff at all covered facilities must receive their first dose of a multi-dose vaccine or a single dose of a single dose vaccine, or have received an exemption or have a pending request for an exemption, before they can provide any care, treatment or other services for the facility and/or its patients.

Phase 2:  By January 4, 2022 all staff must complete the primary vaccination series by receiving all doses of a multi-dose vaccine or a single dose of a single dose vaccine, except for staff who have been granted an exemption or whose vaccination must be temporarily delayed. The vaccination requirement only applies to primary series. It does not include booster shots.

In addition, covered facilities must adopt additional policies and procedures containing specified components, including a process for ensuring compliance with nationally recognized infection prevention and control guidelines, additional precautions/contingency plans for staff who are not fully vaccinated, a process for tracking and documenting the vaccination status (including booster doses) of all staff, and a process for staff to request an exemption and to document information provided by such persons.

Covered facilities are required to maintain a record of each staff’s vaccination status and a roster of each staff’s vaccination status.  Examples of acceptable forms of proof of vaccination include:  a CDC COVID-19 vaccination card (or a photo of the card); documentation of vaccination from a healthcare provider or electronic health record; or a state immunization information system record.  Vaccine documentation is considered a medical record and must be kept confidential and stored separately from an employer’s personnel files.

Vaccination Exemptions

Staff may be eligible for exemptions from the vaccination requirement on the basis of certain recognized medical conditions for which vaccines are contraindicated or religious beliefs, observances or practices. With respect to requests for a medical exemption, the CMS ETS contains detailed requirements relating to the documentation and verification of the grounds for the exemption, including ensuring receipt of documentation supporting the request for an exemption signed and dated by a licensed practitioner acting within their scope of practice based on applicable state law. The documentation also must specify which vaccines are clinically contraindicated for the staff member, the recognized clinical reasons for the contraindications, and a recommendation that the staff member be exempted from the vaccination requirement on that basis. Staff who previously had COVID-19 are NOT exempt from the vaccination requirements.

At this time, the CMS ETS does not require testing for unvaccinated staff.  Covered facilities may voluntarily require testing alongside other infection prevention measures to mitigate any risk of COVID-19 transmission.