CMS finalizes organ procurement rule as 35 of 55 donation areas head for competition

The Centers for Medicare & Medicaid Services has finalized new rules for organ procurement organizations, the groups that secure consent for donation, recover organs from deceased donors and coordinate their delivery to transplant programs. CMS announced the final rule on October 30. The document is scheduled to appear in the Federal Register on November 3 and takes effect 60 days after publication, which would be January 2, 2027.

There are 54 such organizations, and they serve 55 donation service areas: each covers at least one area, and one covers more than one. They must meet CMS's conditions for coverage for their organ procurement costs to be eligible for Medicare and Medicaid payment. At least 100,000 people are on the waiting list for a transplant at any given time, and another person is added every 8 minutes, the rule says.

What the rule changes

The main changes, as CMS's fact sheet describes them:

• It defines unsound medical practices as failures that create an imminent threat to patient health and safety or pose a risk to patients or the public, such as failures in governance, in evaluating and managing potential donors, or in procuring, allocating and transporting organs. CMS may decertify an organization immediately in cases of urgent need.
• Each organization's quality program must have policies to identify, report, analyze and prevent adverse events during the donation process.
• A donor whose pancreas is recovered only for islet cell research still counts toward the donation rate, but the pancreas no longer counts toward the transplantation rate unless it is transplanted. Organizations must also record what happens to organs sent for research.
• An organization's medical director must hold a license in at least one state or territory within its service areas.
• When an area changes hands, the outgoing organization must cooperate with its successor, and the successor must give CMS a transition plan and progress reports.
• The rule spells out when CMS may end an organization's agreement, adds a discretionary review by the CMS administrator to the appeals process, and makes clear that a middle-tier rating alone is not a reason to decertify.

Apart from the islet cell change, the rule keeps the outcome measures and the three-tier system that CMS set in December 2020, which rank each area on its donation rate and its transplantation rate. Organizations whose areas reach the top tier can be recertified for another four years. Those in the middle tier can be recertified but must compete to keep their areas. Organizations whose only areas fall in the bottom tier are decertified and cannot compete for other open areas.

A turnover is already coming

The rule arrives as the 2022 to 2026 review cycle ends. Performance for that cycle is already complete, the rule notes, and CMS says it will move to decertify bottom-tier organizations as the 2020 rule provides. Its impact analysis says updated tier assignments show 35 areas expected to open for competition. Using preliminary 2026 data, CMS estimates that about 14 of them may be classified in the bottom tier, after any appeals.

Not everyone welcomed that prospect. Several commenters told CMS it would decertify and replace an unreasonable number of organizations, potentially disrupting donation and transplantation. They argued that stability is critical to keeping relationships with donor families and hospitals, and to making sure organs are not lost when operations are disrupted. CMS received 129 timely pieces of correspondence on the proposed rule, which it published in January 2026.

Americans waiting for lifesaving transplants cannot afford poor performance by OPOs, and CMS is committed to holding these organizations accountable.

Since the 2020 rule, organ donations have risen 36% nationwide and transplants 30%, CMS said in its announcement.

What CMS dropped, and what it costs

CMS did not adopt its proposal to require licenses for staff who perform clinical work. Commenters warned that the requirement could create significant operational and compliance problems and hurt the workforce and donation activity. CMS replied that roles within the organizations can be mixed and blurred, so the requirement could create staffing difficulties, and said it may return to the idea in future rulemaking. It finalized only the medical director requirement.

The rule estimates the cost at about $16.5 million in the first year and $7.9 million a year after that, most of it borne by the organizations, against about $598,000 a year in benefits from fewer questions about how to comply.