Department of Health and Human Services, Centers for Medicare & Medicaid Services: Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model
Highlights
GAO reviewed the Department of Health and Human Services, Centers for Medicare & Medicaid Services' (CMS) new rule entitled "Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model." GAO found that the final rule updates and revises the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2026.
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 Will Shakely, Acting Assistant General Counsel, at (202) 512-3363.
B-337919
December 9, 2025
The Honorable Mike Crapo
Chairman
The Honorable Ron Wyden
Ranking Member
Committee on Finance
United States Senate
The Honorable Brett Guthrie
Chairman
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 Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model
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 (collectively, CMS) titled “Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model” (RIN: 0938-AV52). We received the rule on November 24, 2025. It was published in the Federal Register on November 24, 2025. 90 Fed. Reg. 53068. The stated effective date of the rule is January 1, 2026.
According to CMS, this rule updates and revises the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2026. CMS stated that the rule includes updates to the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. CMS also stated that the rule updates the requirements for the ESRD Quality Incentive Program and terminates and modifies requirements for the ESRD Treatment Choices Model.
The Congressional Review Act (CRA) requires a 60-day delay in the effective date of a major rule from the date of publication in the Federal Register or receipt of the rule by Congress, whichever is later. 5 U.S.C. § 801(a)(3)(A). The rule was published in the Federal Register on November 24, 2025. 90 Fed. Reg. 53068. The House of Representatives received the rule on November 21, 2025. 171 Cong. Rec. H4900 (daily ed. Nov. 25, 2025). The Senate received the rule on December 2, 2025. 171 Cong. Rec. S8506 (daily ed. Dec. 4, 2025). The rule has a stated effective date of January 1, 2026. Therefore, the stated effective date is less than 60 days from the date of receipt by Congress.[1]
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 Will Shakely, Acting Assistant General Counsel, at (202) 512-3363.
Shirley A. Jones
Managing Associate General Counsel
Enclosure
cc: Calvin E. Dukes II
Regulations Coordinator
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
TITLED
“MEDICARE PROGRAM; END-STAGE RENAL DISEASE PROSPECTIVE PAYMENT SYSTEM, PAYMENT FOR RENAL DIALYSIS SERVICES FURNISHED TO INDIVIDUALS WITH ACUTE KIDNEY
INJURY, END-STAGE RENAL DISEASE QUALITY INCENTIVE PROGRAM, AND END-STAGE RENAL DISEASE TREATMENT CHOICES MODEL”
(RIN: 0938-AV52)
(i) Cost-benefit analysis
The Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) (collectively, CMS) prepared an analysis of the costs and benefits for this rule. 90 Fed. Reg. 53068, 53136 (Nov. 24, 2025). CMS stated that the rule will result in both increased transfers and burden reductions across several programs. Id. at 53068. CMS estimates the annualized monetized transfers from the federal government to End-Stage Renal Disease (ESRD) providers for the ESRD Prospective Payment System and acute kidney injury provisions for calendar year 2026, to be approximately $140 million, along with an additional $40 million in increased beneficiary coinsurance payments to providers. Id. CMS also estimates the annualized monetized transfers from the federal government to ESRD providers for the ESRD Quality Incentive Program (QIP) for payment year 2027, to be $21.6 million and an annualized burden-reduction cost savings of $15.5 million. For payment year 2028, CMS estimates that ESRD QIP will generate $20.6 million in annualized monetized transfers and $0.7 million in burden-reduction costs. Id. Finally, CMS estimates the annual monetized transfers from the federal government to ESRD providers for the ESRD Treatment Choices Model to be $1 million for payment years 2026–2027. Id.
(ii) Agency actions relevant to the Regulatory Flexibility Act (RFA), 5 U.S.C. §§ 603–605, 607, and 609
CMS stated that the HHS Secretary has determined that this rule will have a significant economic impact, reflecting a positive revenue increase, on a substantial number of small entities, and CMS stated that the rule's RFA section and the Regulatory Impact Analysis constituted the Final Regulatory Flexibility Analysis. 90 Fed. Reg. at 53136–37.
(iii) Agency actions relevant to sections 202–205 of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. §§ 1532–1535
CMS stated that this rule does not mandate any requirements for state, local, or tribal governments, or for the private sector. Id. at 53137.
(iv) Other relevant information or requirements under acts and executive orders
Administrative Procedure Act, 5 U.S.C. §§ 551 et seq.
On July 2, 2025, CMS issued a proposed rule. 90 Fed. Reg. 29342. CMS stated that it received comments from various interested parties. See id. at 53072. CMS responded to comments in the rule. See id.
Paperwork Reduction Act (PRA), 44 U.S.C. §§ 3501–3520
CMS determined that this rule contains information collection requirements under the Act. 90 Fed. Reg. at 53121.
Statutory authorization for the rule
CMS promulgated this rule under sections 1302, 1395d, 1395f, and 1395g of title 42, United States Code.
Executive Order No. 12866 (Regulatory Planning and Review)
CMS stated that based on its analysis, the Office of Information and Regulatory Affairs has determined that this rulemaking is significant pursuant to section 3(f)(1) of the Order, as amended. See 90 Fed. Reg. at 53124.
Executive Order No. 13132 (Federalism)
CMS determined that this rule will not have substantial direct effects on the rights, roles, and responsibilities of state, local, or tribal governments. 90 Fed. Reg. at 53137–38.
[1] CMS stated in the rule that there was good cause to waive the 60-day delay in effective date in accordance with 5 U.S.C. § 808(2). 90 Fed. Reg. at 53138. According to CMS, the government funding lapse that started on October 1, 2025, caused an administrative delay, making it impossible to comply with CRA's 60-day delayed effective date requirement while still meeting the statutory implementation deadline for the Medicare payment updates. Id. The 60‑day delay in effective date does not apply if the agency finds for good cause that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, and the agency incorporates the finding and a brief statement of its reasons in the rule. 5 U.S.C. § 808(2). Here, however, CMS's good cause finding relates to waiving the delay in effective date, not to waiving the notice and public procedure requirements, and CMS published a notice of proposed rulemaking and request for comment. 90 Fed. Reg. 29342. Accordingly, this exception does not apply to this rule.