Federal Court Upholds CMS OPO Performance Rule: What Organ Procurement Professionals Should Know

Another federal court has upheld the CMS rule that could determine which organ procurement organizations keep their service areas. But what does the rule actually do?

On October 29, 2026, the U.S. District Court for the District of Columbia upheld the Centers for Medicare & Medicaid Services (CMS) 2020 performance rule for organ procurement organizations (OPOs).

The case was brought by New England Donor Services, We Are Sharing Hope SC, and Donor Network of Arizona. The organizations challenged CMS's authority to impose the new certification and competition framework.

Judge Sparkle L. Sooknanan ruled in favor of CMS, finding that the agency acted within its legal authority and reasonably explained its decisions.

The ruling follows a similar September 29 decision in Florida involving LifeLink Foundation and other OPOs.

So what does this mean for OPOs, and why does it matter?

What the CMS OPO Rule Actually Does

Every OPO has an exclusive geographic region called a donation service area (DSA). To keep that territory, the organization must maintain CMS certification.

The 2020 rule changes how CMS measures OPO performance, replacing older outcome measures with two primary metrics:

1. Donation rate: The number of actual organ donors compared with the estimated number of potential donors in the service area.
2. Transplantation rate: The number of organs actually transplanted compared with that same donor potential, adjusted for age.

An important difference is how CMS determines donor potential. Instead of relying on OPO-reported eligible deaths, CMS uses federal mortality data to estimate potential donors.

The goal is to create more objective, comparable performance measurements across OPOs.

The Three Performance Tiers

Under the rule, CMS uses performance thresholds to place OPOs into three tiers at the end of the certification cycle.

Tier	Performance	What happens
Tier 1	Meets the top 25% threshold on both measures	Recertified for four years if other requirements are met
Tier 2	Meets the median threshold on both, but not Tier 1	Must compete to retain its service area
Tier 3	Falls below the median threshold on either measure	Faces decertification and loss of its service area

CMS uses statistical confidence intervals when making these determinations, rather than simply ranking raw percentages.

This is a significant change. An OPO could lose the exclusive right to serve its region based on its performance under the new system.

Why Are OPOs Challenging the Rule?

The controversy isn't necessarily about whether OPOs should be accountable. It's about how that accountability is measured.

An OPO can identify a donor, obtain authorization, manage the donor, and offer organs for transplantation. But the ultimate decision to accept an organ rests with the transplant center.

Geographic differences, donor characteristics, hospital practices, and transplant-center acceptance decisions can all influence final outcomes.

OPOs have argued that the measures may penalize organizations for factors they cannot fully control.

CMS maintains that the new framework creates stronger accountability and encourages organizations to increase both donation and transplantation.

The D.C. court concluded that CMS had the legal authority to adopt its approach, even though reasonable people could disagree with the policy.

What Happens Next?

The court ruling does not mean an OPO was immediately decertified.

It means the legal challenge did not overturn the performance framework governing the 2026 certification cycle. Individual certification decisions, competition, and applicable appeals are separate processes.

Further legal challenges or appeals may still affect how the rule proceeds.

For OPO leadership, the stakes are substantial. For organ procurement coordinators, the implications are more practical: donor identification, documentation, donor management, organ evaluation, and placement all contribute to the outcomes their organizations are measured against.

Having worked in organ procurement, I understand how much effort can go into a single donor case—and how many decisions involve people and organizations outside the OPO.

Accountability matters. So does recognizing the complexity of the donation and transplantation process.

Ultimately, the question is whether these measures will lead to more successful transplants and better outcomes for patients waiting for organs.

That's the result everyone in this field wants to see.

Sources

• U.S. District Court for the District of Columbia — New England Donor Services v. HHS, October 29, 2026 (Justia)
• CMS — 2020 OPO Performance Rule Fact Sheet
• 42 CFR § 486.316 — Recertification and Competition Processes
• LifeLink Foundation v. Kennedy — Florida Court Decision, September 29, 2026 (Justia)

Written by Brooke Wallace, BSN, RN, CCRN — ICU nurse, former organ procurement coordinator, and founder of CPTCexam.com.

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CPTCexam.com is an independent educational resource and is not affiliated with or endorsed by CMS, HHS, ABTC, AOPO, or any organ procurement organization.