2025-22543Proposed RuleSignificantWallet

Medicare Tweaks Payment Rules to Boost Organ Transplants

Published Date: 12/11/2025

Proposed Rule

Summary

Medicare is updating its payment plans to help more people get organ transplants through the Increasing Organ Transplant Access (IOTA) Model starting in Performance Year 2. These changes affect hospitals and doctors who work with Medicare patients needing transplants, aiming to improve care and save lives. Comments on the proposed rule are open until February 9, 2026, so stakeholders can share their thoughts before it’s finalized.

Analyzed Economic Effects

9 provisions identified: 6 benefits, 3 costs, 0 mixed.

New payment scoring and downside rules

CMS restates that final performance scores determine payments: scores above 60 can trigger an upside payment calculated as ((score − 60)/40) × $15,000 × number of Medicare transplants; scores below 40 (beginning PY2) can trigger a downside payment. CMS proposes that downside payments must be remitted in a single payment within 60 days after the demand letter, and unpaid amounts will be treated as delinquent debt.

Change how graft survival is scored

CMS proposes updates to the composite graft survival rate metric used in the quality domain, including adding a risk-adjustment methodology (using recipient and donor characteristics such as age, diabetes status, sex, and kidney function), excluding multi-organ transplants from the metric, and updating how points are allocated for performance.

Emergency (EUC) payment flexibilities

CMS proposes to update the Extreme and Uncontrollable Circumstance (EUC) provisions to give CMS sole discretionary authority to apply flexibilities during declared emergency periods, extend payment and reporting accommodations, and adjust upside or downside payments for impacted IOTA participants.

More patient transparency and notices

CMS proposes multiple transparency and beneficiary-notification changes: (1) publish participant waitlist and living donor selection criteria on the IOTA website (living donor criteria by end of PY2); (2) beginning in PY3, provide semi‑annual notifications to 'eligible IOTA waitlist beneficiaries' who are Medicare beneficiaries about the number and reasons for organ declinations, with an opt-out right; (3) review individual acceptance criteria with Medicare waitlist patients at least every 6 months; and (4) notify Medicare waitlist patients when their status changes, including providing reasons and how to become active again, with a 10-day requirement when ineligibility affects organ offers.

Termination grounds include HHS and OPTN findings

CMS proposes to add HHS and the Organ Procurement and Transplantation Network (OPTN) as sources of information that could trigger termination of an IOTA participant. CMS may terminate a participant if HHS or OPTN determines the participant violated OPTN policies, OPTN Management and Membership policies, or HHS regulations at 42 CFR 121 following review.

Raise small-hospital eligibility cutoff

CMS proposes to raise the IOTA Model low-volume eligibility threshold from 11 to 15 adult kidney transplants performed annually in each baseline year. This change would remove a small number of very-low-volume transplant hospitals from mandatory model participation.

Exclude VA and military hospitals

CMS proposes to exclude Department of Veterans Affairs (VA) medical facilities and military medical treatment facilities (MTFs) from eligibility for the IOTA Model for PYs 2 through 6. CMS proposes definitions for 'VA medical facility' and 'military medical treatment facility' and would not select these federal facilities as IOTA participants.

Remove voluntary health equity plans

CMS proposes to remove the voluntary Health Equity Plan (HEP) submission requirement and related definitions from the IOTA Model, so participants would no longer submit HEPs under the model.

Estimated federal savings of $21 million

CMS estimates that the proposed changes to the IOTA Model would increase net Federal savings by $21 million. This is CMS's stated estimate of the budgetary impact of the proposed updates.

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Key Dates

Published Date
Comments Due
Effective Date
12/11/2025
2/9/2026
7/1/2026

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
Centers for Medicare & Medicaid Services
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