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CMS Issues Updated Guidance for Vaccine Mandate

By Sean D. Hurley

On December 28, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued updated guidance and survey procedures to State Survey Agency Directors in 26 states where implementation and enforcement of CMS’s vaccine mandate has not been enjoined by the courts. As previously reported, on December 15, 2021, the U.S. Court of Appeals for the Fifth Circuit limited the scope of a prior injunction that halted CMS’s vaccine mandate nationwide and, instead, restricted the injunction only to the 14 states that are party to that case.  Meanwhile, on December 13, 2021, the U.S. Court of Appeals for the Eighth Circuit entered an order upholding a preliminary injunction entered by the Eastern District of Missouri, which applies to the ten states involved in that lawsuit. Consequently, CMS may proceed in enforcing its mandate in the 26 states that are not party to either lawsuit on this issue: California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont, Virginia, Washington, and Wisconsin. CMS has appealed those decisions to the U.S. Supreme Court, with argument scheduled for January 7, 2022.

Per CMS’s updated guidance, by January 27, 2022 (30 days after issuance of the updated guidance), long-term care facilities subject to the vaccine mandate must be able to establish to surveyors that:

  • Policies and procedures have been developed and implemented for ensuring all facility staff, regardless of clinical responsibility or patient or resident contact are vaccinated for COVID-19, which includes policies relating to tracking of staff vaccinations and documenting medical and religious exemptions; and
  • 100% of staff have received at least one dose of COVID-19 vaccine, or have a pending request for, or have been granted, qualifying exemption, or identified as having a temporary delay as recommended by the CDC. A facility that is above 80% staff vaccination and has a plan to achieve a 100% staff vaccination rate within 60 days would not be subject to additional enforcement action.

With respect to non-medical exemptions, including religious exemptions, CMS’s updated guidance notes that surveyors will not evaluate the details of the request for a religious exemption, nor the rationale for the facility’s acceptance or denial of the request. Rather, surveyors will review to ensure the facility has an effective process for staff to request a religious exemption for a sincerely held religious belief. However, CMS also notes that no accommodation should be provided that is not legally required or if it is requested solely to evade vaccination. For individual staff members that have valid reasons for exemption, the facility can address those individually, and accommodations can be addressed in the facility’s policies and procedures.

By February 28, 2022 (60 days after the issuance of the updated guidance), facilities must be able to demonstrate that:

  • Policies and procedures are developed and implemented for ensuring all facility staff, regardless of clinical responsibility or patient or resident contact, are vaccinated for COVID-19; and
  • 100% of staff have received the necessary doses to complete the vaccine series (i.e., one dose of a single-dose vaccine or all doses of a multiple-dose vaccine series), or have been granted a qualifying exemption, or identified as having a temporary delay as recommended by the CDC. A facility that is above 90% staff vaccination and has a plan to achieve a 100% staff vaccination rate within 30 days are not be subject to additional enforcement action.

Federal, state, Accreditation Organization, and CMS-contracted surveyors will begin surveying for compliance with these requirements as part of initial certification, standard recertification or reaccreditation, and complaint surveys on January 27, 2022. To determine compliance with CMS’s vaccine mandate, surveyors will request the facility’s COVID-19 vaccination policies and procedures, the number of resident and staff COVID-19 cases over the last 4 weeks, and a list of all staff and their vaccination status. The staff list must include the percentage of vaccinated staff, using the vaccine matrix provided by the survey team, and the position or role of each staff member, including staff (facility staff, contracted staff, volunteers, or students) who are or are likely to be in contact with residents or other staff, regardless of frequency. Facility staff vaccination rates under 100% constitute non-compliance under the Interim Final Rule. The level of severity will be cited based on the level of harm, or likelihood of harm for residents.

The U.S. Supreme Court is scheduled to hold a hearing on January 7, 2022, to determine whether CMS should continue to be enjoined from enforcing the Interim Final Rule, whether in the states where an injunction is currently in place or nationwide, or whether the Rule should take effect nationwide.  In the meantime, should you have questions, please contact Michael A. Airdo at 312-506-4480 or [email protected] or Sean Hurley at 312-506-4455 or [email protected].