CMS finalises organ-procurement rules, clarifying competition and appeals for OPOs
A CMS final rule published on 3 November revises the Conditions for Coverage for organ procurement organisations, effective 4 January 2027, at an estimated cost of about $16.5 million in year one.
| Group | Value (value) |
|---|---|
| 2023 | 46634 |
| 2024 | 48150 |
| 2025 | 49065 |
The Centers for Medicare & Medicaid Services has finalised changes to the rules that govern organ procurement organisations, the regional non-profits that recover organs from deceased donors. The final rule was published in the Federal Register on 3 November 2026 under docket number CMS-3409-F, revises the Conditions for Coverage at 42 CFR part 486, and takes effect on 4 January 2027 [s1].
What the rule changes
CMS describes the rule as clarifying procedural questions and giving organ procurement organisations, or OPOs, more operational flexibility rather than rebuilding the system. It revises several definitions, revises the designation requirements for OPOs, clarifies when an OPO's service area is open for competition, and updates the process for appeals [s1]. The agency also adds Quality Assessment and Performance Improvement requirements related to medically complex donors and organs, requires appropriate staff licensure, and expands information-management requirements to include records for organs procured for research [s1].
The agency is explicit about what it is not doing. The rule "does not revise the focus on improving the volume of donors and transplants assessed in the outcome measures or the tier structure used for re-certification and de-certification of OPOs" [s1]. That underlying accountability framework was set by an earlier rule, the December 2020 OPO final rule, which replaced a pass/fail system with a three-tier structure and donor and transplant volume measures [s1].
The numbers CMS attaches
CMS estimates the rule will cost approximately $16.5 million in the first year and $7.9 million annually thereafter, costs it describes as incremental to the broader framework established in 2020 and as "targeted operational and administrative refinements rather than fundamental system restructuring" [s1]. Against that, the agency estimates roughly $598,000 in annual benefits from reduced implementation-inquiry and compliance-interpretation burden, plus a one-time benefit from clarified requirements [s1].
The rule applies to a defined set of organisations. CMS states there are currently 54 OPOs responsible for identifying prospective donors and recovering organs from deceased donors, and that these 54 OPOs serve 55 Donation Service Areas, because one OPO currently serves more than one area [s1]. OPOs must meet the Conditions for Coverage for their organ-procurement costs to be eligible for payment under Medicare and Medicaid [s1].
The scale of the waiting list
CMS frames the rule against a persistent organ shortage. The agency writes that at least 100,000 people are on the waiting list for a lifesaving transplant at any given time, and that every eight minutes another person is added to the list [s1]. Many people on the list, it notes, wait several years for a suitable donor, while others die before an organ becomes available [s1].
Transplant volume has been rising. CMS cites Organ Procurement and Transplantation Network data showing 49,065 organ transplants in 2025, up from 48,150 in 2024 and 46,634 in 2023 [s1]. The agency argues that despite that growth the need for transplantable organs continues to outrun supply, and that OPO performance is "a rate limiting factor on the success of the entire organ transplant system" [s1].
How it got here
The rule has a long regulatory lineage. CMS traces it to a 2019 executive order, "Advancing American Kidney Health," which directed the department to establish more transparent and enforceable metrics for evaluating OPO performance [s1]. The December 2020 final rule followed. After that rule took effect in March 2021, CMS says it received many inquiries from OPOs seeking clarification on operational and administrative elements, rising in volume as the 2022-2026 re-certification cycle neared its end [s1].
CMS published the proposed version of the current rule on 30 January 2026 and took public comment before finalising it [s1]. Among the proposals carried into the final rule: evaluating each Donation Service Area separately for the outcome measures while assessing an OPO as a single entity for process performance, and addressing how an OPO is held accountable on outcome measures when it takes over another OPO's area [s1].
What is settled
What this rule fixes is procedural and dated: a final rule now exists, it is effective 4 January 2027, and it changes definitions, designation, competition triggers, appeals, licensure and quality requirements for the 54 OPOs that serve the country [s1]. A final rule carries the force of regulation once effective.
What it leaves untouched is the measurement system itself. The donor and transplant volume measures and the three-tier re-certification structure established in 2020 remain the yardstick by which OPOs are judged [s1]. CMS has also written a severability clause into the rule, stating that if a court strikes down any part, the remaining provisions should stay in effect [s1].
Sources
- Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Conditions for Coverage — Centers for Medicare & Medicaid Services / Federal Register , November 3, 2026
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