CMS Finalizes Organ Procurement Rule as 35 Donation Service Areas Are Expected to Open for Competition

The Centers for Medicare & Medicaid Services (CMS) has finalized a rule that tightens federal oversight of the organizations that recover donated organs, giving the agency a clearer path to shut down poor performers. The agency announced the final rule on Oct. 30.

The rule covers the nation’s 54 organ procurement organizations, or OPOs, which serve 55 donation service areas, according to the final rule text filed with the Federal Register. It is scheduled for publication Nov. 3 and takes effect 60 days after publication.

More than 49,000 transplants were performed in the U.S. in 2025, but more than 100,000 Americans are waiting for one, CMS said.

What do organ procurement organizations do?

OPOs link donor hospitals and transplant programs. They seek authorization for donation, recover organs and coordinate their delivery for transplant, according to CMS. Each serves an assigned donation service area.

Since a 2020 rule, CMS has graded each OPO on two outcome measures, a donation rate and a transplantation rate, and sorted their service areas into three tiers. Tier 1 OPOs can be recertified for four years. Tier 2 OPOs can also be recertified but must compete to keep their areas. OPOs whose only areas fall in tier 3 are decertified, CMS said in its fact sheet.

What does the final rule change?

CMS said the rule does not change the outcome measures or the tier system. Instead, it fills in procedural gaps. Key provisions, according to the agency, include:

• Immediate decertification for “unsound medical practices.” The rule defines these as failures that create an imminent threat to patient health and safety, including in governance, donor management, and procurement, allocation and transport.
• Adverse events. Every OPO must have policies to identify, report, analyze and prevent adverse events during the donation process.
• Research organs. OPOs must keep records on what happens to organs recovered for research, including pancreata used for islet cell research.
• Islet cell research no longer counts as a transplant. A donor whose pancreas goes only to islet cell research still counts toward the donation rate, but that pancreas no longer counts toward the transplantation rate unless a transplant takes place.
• Medical director licensure. An OPO’s medical director must be licensed in at least one state or territory in its service area. CMS did not finalize a broader proposed licensure requirement for clinical staff, the rule text shows.
• Appeals. The CMS administrator may review hearing officers’ decisions.

How will competition for donation areas work?

The rule lets high-performing OPOs compete for more than one donation service area. It also clarifies that tier 2 status alone is not grounds for decertification, CMS said.

When an area changes hands, the outgoing OPO must cooperate with the incoming one, and the new OPO must submit a transition plan to CMS with periodic progress reports.

Using its 2026 performance data, CMS estimates that 14 tier 3 areas and 21 tier 2 areas, 35 in all, will open for competition during the recertification cycle. The agency said that figure is not an estimate that 35 OPOs will be decertified or that every open area will move to a different organization. It expects the number of OPOs serving more than one area to grow from 10 to 14.

Why is CMS acting now?

CMS proposed the changes in January 2026 and received 129 comments, according to the rule. The agency says it intends to move forward with decertifying tier 3 OPOs as laid out in the 2020 rule, and that performance for the 2022 through 2026 cycle is already complete.

Since the 2020 rule, organ donations have risen 36% nationwide and transplants 30%, CMS said. “Americans waiting for lifesaving transplants cannot afford poor performance by OPOs, and CMS is committed to holding these organizations accountable,” CMS Administrator Dr. Mehmet Oz said in the announcement.

Not every commenter agreed with the approach. Several said the proposal put too much weight on OPO performance without accounting for donor hospitals and transplant centers, and called for shared accountability and more transparency about transplant centers’ organ acceptance practices, according to CMS’s summary of comments in the rule. CMS disagreed, saying low performers should be replaced by organizations that have shown better results.

The rule advances a goal of HHS’s Kidney Care National Plan and comes alongside Medicare’s final 2027 dialysis payment rule.

What does this mean for patients and donor families?

The rule governs how CMS certifies and oversees OPOs. Matching donated organs with patients is handled through the Organ Procurement and Transplantation Network (OPTN), which maintains the national registry for matching, according to the rule, and CMS did not announce any action patients on a waiting list need to take. If an area changes OPOs, a different organization would handle donation locally, and CMS says transition plans are meant to prevent gaps in service.

People who want to become donors can register through their state registry or at organdonor.gov, the federal government’s donation site.

Key Takeaways

• CMS finalized a rule on Oct. 30 tightening oversight of the 54 U.S. organ procurement organizations; it takes effect 60 days after its Nov. 3 publication.
• CMS can immediately decertify an OPO for “unsound medical practices” that threaten patient safety.
• Pancreata used only for islet cell research no longer count as transplants in OPO scores.
• CMS estimates 35 donation service areas will open for competition this recertification cycle.
• CMS did not announce any action that patients on a transplant waiting list need to take.

Frequently Asked Questions

Featured image: The Louisiana Organ Procurement Agency (LOPA) headquarters in St. Tammany Parish, La., in 2018. LOPA is Louisiana’s organ procurement organization. Illustrative photo. (Photo by U.S. Department of Agriculture, public domain, via Wikimedia Commons)