The Centers for Medicare & Medicaid Services on Tuesday finalized a rule revising the conditions organ procurement organizations must meet for their costs to be paid under Medicare and Medicaid. President Donald Trump signed the rule. The regulations take effect on Jan. 4, 2027.
The agency said the rule clarifies procedural questions and gives the organizations more operational flexibility so they can procure, distribute, and transplant more organs. It said the rule does not change the focus on improving the volume of donors and transplants in the outcome measures, or the tier structure used to re-certify and de-certify the organizations.
Organ procurement organizations obtain consent for donation, work with the Organ Procurement and Transplantation Network to match organs with recipients, recover viable organs, and deliver them for transplant. There are 54 organizations, serving 55 donation service areas, because one organization serves more than one area.
At any given time, at least 100,000 people are on the waiting list for a lifesaving transplant, and another person is added every eight minutes, according to figures cited in the rule. In 2025 there were 49,065 organ transplants, compared with 48,150 in 2024 and 46,634 in 2023, the rule says, citing network data. The agency said the need for transplantable organs continues to grow even as donation and transplantation have increased.
The rule revises definitions, revises designation requirements, clarifies when a service area is open for competition, and updates the appeals process. It changes the definition of “organ” so pancreata used for islet cell research and not transplanted are excluded from the transplantation-rate measure. That change applies to outcome-measure reporting after the effective date, beginning with the 2027 assessment period. The agency said it will not apply the new provisions retroactively, and that performance for the 2022 through 2026 re-certification cycle is already complete.
Performance in 2027 will be measured against the median and top 25 percent thresholds set by 2026 performance. For the 2029 public performance report, the agency said it will recalculate those 2026 thresholds using the revised definition so 2027 results are compared with like data. It said existing coding already lets it calculate the rate with and without those pancreata.
The current outcome measures and three-tier system come from a December 2020 rule that followed Executive Order 13879, “Advancing American Kidney Health,” which Trump issued in 2019. That order directed the secretary of health and human services to improve procurement and use of organs from deceased donors and to set clearer performance metrics. The agency published a proposed rule on Jan. 30, 2026, and received 129 timely comments.
The agency said requests to replace the outcome measures, add risk adjustment, or change data sources were outside this rule, and that it stands by the 2020 framework. It said it will keep working with the Health Resources and Services Administration and the Organ Procurement and Transplantation Network and will issue guidance, including updates to the State Operations Manual.
