Department of Health and Human Services, Centers for Medicare & Medicaid Services: 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
Summary
A GAO report, B-335355, dated June 15, 2023, to the leaders of the Senate Committee on Finance, the House Committee on Energy and Commerce and the House Committee on Ways and Means on a major rule of the Centers for Medicare & Medicaid Services (CMS) on the Omnibus COVID-19 Health Care Staff Vaccination Requirements and long-term care facility vaccine education and testing requirements (RINs 0938-AU75, 0938-AU57, 0938-AU33). GAO states that it received the rule on May 25, 2023, that it was published at 88 Fed. Reg. 36485 on June 5, 2023 and that it takes effect August 4, 2023. According to CMS, the rule removes expired LTC testing language, finalizes vaccine education and offering requirements and withdraws the November 5, 2021 staff vaccination interim final rule. The enclosure records CMS's estimate of $690 million in benefits per year from 2023 to 2025.
Summary drafted by a model from the document's text below and checked by script against that text before publication. It is a navigation aid, not a reading of what the document proves. Where AI is used
Full text
Department of Health and Human Services, Centers for Medicare & Medicaid Services: 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 B-335355 Jun 15, 2023 Jump To: Skip to Highlights Highlights html PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN" "http://www.w3.org/TR/REC-html40/loose.dtd" GAO reviewed the Department of Health and Human Services, Centers for Medicare & Medicaid Services' (CMS) new rule entitled "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." GAO found that the final rule (1) removes expired language addressing staff and patient COVID-19 testing requirements for LTC Facilities; (2) also finalizes requirements for these facilities to provide education about COVID-19 vaccines and to offer COVID-19 vaccines to residents, clients, and staff; and (3) withdraws the regulations in the IFC "Omnibus COVID-19 Health Care Staff Vaccination. Enclosed is our assessment of CMS's compliance with the procedural steps required by section 801(a)(1)(B)(i) through (iv) of title 5 with respect to the rule. If you have any questions about this report or wish to contact GAO officials responsible for the evaluation work relating to the subject matter of the rule, please contact Shari Brewster, Assistant General Counsel, at (202) 512-6398. View Decision B-335355 June 15, 2023 T he Honorable Ron Wyden Chairman The Honorable Mike Crapo Ranking Member Committee on Finance United States Senate The Honorable Cathy McMorris Rodgers Chair The Honorable Frank Pallone, Jr. Ranking Member Committee on Energy and Commerce House of Representatives The Honorable Jason Smith Chairman The Honorable Richard Neal Ranking Member Committee on Ways and Means House of Representatives Subject: Department of Health and Human Services, Centers for Medicare & Medicaid Services: 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 Pursuant to section 801(a)(2)(A) of title 5, United States Code, this is our report on a major rule promulgated by the Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS) entitled “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” (RINs: 0938-AU75, 0938-AU57, 0938-AU33). We received the rule on May 25, 2023. It was published in the Federal Register as a final rule on June 5, 2023. 88 Fed. Reg. 36485. The effective date is August 4, 2023. According to CMS, the final rule removes expired language addressing staff and patient COVID‑19 testing requirements for LTC Facilities issued in the interim final rule with comment (IFC) “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 . 85 Fed. Reg. 54820. The final 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 final rule withdraws the regulations in the IFC “Omnibus COVID-19 Health Care Staff Vaccination,” published in the November 5, 2021 Federal Register , 86 Fed. Reg. 61555, 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 (ICFs-IID) Residents, Clients, and Staff” IFC, published in the May 13, 2021 Federal Register . 86 Fed. Reg. 26306. Enclosed is our assessment of CMS’s compliance with the procedural steps required by section 801(a)(1)(B)(i) through (iv) of title 5 with respect to the rule. If you have any questions about this report or wish to contact GAO officials responsible for the evaluation work relating to the subject matter of the rule, please contact Shari Brewster, Assistant General Counsel, at (202) 512-6398. Shirley A. Jones Managing Associate General Counsel Enclosure cc: Calvin E. Dukes II Regulations Coordinator Centers for Medicare & Medicaid Services Department of Health and Human Services ENCLOSURE REPORT UNDER 5 U.S.C. § 801(a)(2)(A) ON A MAJOR RULE ISSUED BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES, CENTERS FOR MEDICARE & MEDICAID SERVICES ENTITLED “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” (RINS: 0938-AU75, 0938-AU57, 0938-AU33) (i) Cost-benefit analysis The Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) estimated the final rule would create $690 million in benefits per year at both the seven and three percent discount rates from 2023–2025. CMS stated the benefits come from reduction of costs. (ii) Agency actions relevant to the Regulatory Flexibility Act (RFA), 5 U.S.C. §§ 603–605, 607, and 609 CMS stated that HHS determined the final rule would not have a significant adverse economic impact on a substantial number of small entities. CMS also stated that HHS determined the final rule would not have a significant impact on the operations of a substantial number of rural hospitals. (iii) Agency actions relevant to sections 202–205 of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. §§ 1532–1535 CMS determined that the final rule contains no state, local, or tribal governmental mandates, nor any mandates on private sector entities. (iv) Other relevant information or requirements under acts and executive orders Administrative Procedure Act, 5 U.S.C. §§ 551 et seq. CMS stated it did not issue a proposed rule. CMS noted the three interim final rules would have expired after three years if not finalized due to statutory limitations. Paperwork Reduction Act (PRA), 44 U.S.C. §§ 3501–3520 CMS stated the final rule contains no new information collection requirements and sunsets those implemented in the prior interim final rules. Statutory authorization for the rule CMS promulgated the final rule pursuant to sections 263a, 273, 1302, 1320a-7, 1320b-8, 1395, 1395i, 1395hh, 1395rr, 1395eee, 1396r, and 1396u-4 of title 42, United States Code. Executive Order No. 12866 (Regulatory Planning and Review) CMS stated the Office of Management and Budget determined the final rule was economically significant. Executive Order No. 13132 (Federalism) CMS determined the final rule was not subject to the requirements of the Order. Full Report Full Report (4 pages) GAO Contacts Shirley A. Jones Managing Associate General Counsel Office of the General Counsel jonessa@gao.gov Media Inquiries Sarah Kaczmarek Managing Director Office of Public Affairs media@gao.gov Public Inquiries Contact Us
File and source
- File
- 25-SN12b.html
- Size
- 91,539 bytes
- SHA-256
- c3e62a1d31f4eabc126b0c4c0b4aea4ec731c1139339345c11b6878c01db6114
- Our copy
- 25-SN12b.html
- Original
- www.gao.gov