CMS Policy and Regulatory Changes to the Omnibus COVID-19 Health Care Staff Vaccination Requirements

Posted in COVID-19, Senior Living

Mary Madison, RN, RAC-CT, CDP
Clinical Consultant – Briggs Healthcare

Late afternoon on Wednesday, May 31, 2023, CMS filed Final Rule 2023-11449 to be published in the Federal Register on Monday, June 5, 2023.   The official title is Medicare and Medicaid Programs; Policy and Regulatory Changes to the Omnibus COVID-19 Health Care Staff Vaccination Requirements; Additional Policy and Regulatory Changes to the Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICFs-IID) to Provide COVID-19 Vaccine Education and Offer Vaccinations to Residents, Clients, and Staff; Policy and Regulatory Changes to the Long Term Care Facility COVID-19 Testing Requirements.

This final rule removes expired language addressing staff and patient COVID-19 testing requirements for LTC Facilities issued in the interim final rule with comment “Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” published in the September 2, 2020 Federal Register. The rule also finalizes requirements for these facilities to provide education about COVID-19 vaccines and to offer COVID-19 vaccines to residents, clients, and staff. In addition, the rule withdraws the regulations in the interim final rule with comment (IFC) “Omnibus COVID-19 Health Care Staff Vaccination” published in the November 5, 2021 Federal Register, and finalizes certain provisions of the “COVID-19 Vaccine Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities This document is scheduled to be published in the Federal Register on 06/05/2023 and available online at federalregister.gov/d/2023-11449, and on govinfo.gov (ICFs-IID) Residents, Clients, and Staff” IFC, published in the May 13, 2021 Federal Register.

The regulations in this final rule are effective on Friday, August 4, 2023.  The final rule is 82 pages in length.

This final rule withdraws the regulatory provisions set forth on November 5, 2021, in the Omnibus COVID-19 Health Care Staff Vaccination IFC and deletes expired provisions set forth on May 13, 2021, in the LTC facility testing IFC. Also, this final rule finalizes the “educate and offer” provisions set forth on May 13, 2021, in the COVID-19 Vaccine Requirements for LTC Facilities and ICFs-IID Residents, Clients, and Staff IFC. This final rule has been published within the 3-year time limit imposed by section 902 of the MMA.  Federal rules generally become effective 60 days after publication; however, the COVID-19 PHE expired on May 11, 2023. Our decision to terminate the omnibus facility staff vaccination requirements in this final rule reflect our determination that the emergency circumstances which occasioned these vaccination provisions no longer exist. Since facilities are no longer operating under PHE circumstances, and considering the lower policy priority of enforcement within the remaining time, we will not be enforcing the staff vaccination provisions between now and August 4, 2023.

In this final rule, we are withdrawing the health care staff COVID-19 vaccination provisions issued in the staff vaccination IFC and deleting the expired COVID-19 testing provisions of the LTC testing IFC. We are also finalizing the COVID-19 “educate and offer” provisions established in the educate and offer IFC. In this section we provide a summary of the public comments received and responses to them, and the policies we are finalizing. In section III.A. of this final rule, we discuss the comments and responses pertaining to the COVID-19 health care staff vaccination requirements. In section III.B. of this final rule, we discuss the comments and responses regarding the requirements for LTC facilities and ICFs-IID to educate residents, clients, and staff about COVID-19 vaccines and to offer COVID-19 vaccines when available. Lastly, in section III.C. of this final rule, we discuss the comments and responses concerning the COVID-19 testing requirements for LTC facilities.

On page 28 of this Final Rule, CMS reports that they received approximately 10,102 timely public comments. Of these, roughly 2/3 were virtually identical letters from individuals from around the country urging CMS to retract the rule. Of the remaining 3,175 unique comments, the majority were from individuals, while over 500 of those unique comments were from industry groups or individual commenters who were commenting as representatives of organizations, companies, and other entities. About 2,000 of these unique comments opposed the regulation, while the remainder of the commenters supported the regulation, some offering suggestions as to how CMS could improve the requirements. A summary of the major themes addressed by commenters and our responses follow.

I encourage all LTC and ICF-IID providers to review this FR carefully with their team.  I will be reviewing it as well.  There’s a lot of material in this document.  As of this writing, there is no Press Release from CMS but there will be additional details to come.