When a Transplant Center Says No: What the Court Ruling on CMS's OPO Rule Means for Coordinators

Here's a question every organ procurement coordinator has felt in their gut: your team finds the donor, the family says yes, you manage the donor all night, the organs are offered, and transplant centers turn them down. Should that count against your OPO?

A federal judge just answered part of that question. The answer matters for every OPO in the country, and for the people who work in them.

What happened

On September 29, 2026, Judge Kathryn Kimball Mizelle of the U.S. District Court for the Middle District of Florida ruled in LifeLink Foundation, Inc. v. Kennedy. The court upheld the 2020 rule the Centers for Medicare & Medicaid Services (CMS) uses to measure OPO performance. Judgment was entered the next day.

The groups that sued were LifeLink Foundation, OneLegacy, Iowa Donor Network, LifeCenter Northwest and LifeGift Organ Donation Center. The court said together they represent seven OPOs.

The rule measures every OPO on two numbers:

  • Donation rate: donors in the service area compared with the "donor potential," which CMS figures from federal death-certificate data (inpatient deaths, age 75 and under, with a cause of death consistent with donation).
  • Organ transplantation rate: organs actually transplanted from those donors, compared with the same donor potential and adjusted for age.

Those two numbers place each OPO in a tier. Tier 1 OPOs (top 25 percent on both) are recertified. Tier 2 OPOs (above the median but not top 25 percent) must compete to keep their service area. Tier 3 OPOs (below the median on either number) get an initial decertification notice. OPOs also have to meet CMS's process requirements.

The court found the rule follows the law and isn't "arbitrary and capricious." It upheld the use of federal death data, the 12-month measurement window, comparing OPOs against each other, and CMS's choice not to add more geographic or demographic risk adjustment. It also found CMS reasonably answered the major public comments.

There was one twist. The court said OPOs expecting Tier 2 or Tier 3 could bring the case, and noted that a Tier 2 OPO that loses its service area has no administrative appeal. Iowa Donor Network, which expects to be Tier 1, was dismissed for lack of standing because it couldn't show the rule harmed it.

The question at the center: declined organs

The OPOs argued that the transplantation rate doesn't measure them. In the court's words, they said whether an organ is accepted and transplanted is up to the transplant surgeon.

The court disagreed. It said OPOs can still influence transplant hospital practice and can place organs outside their own service area, including at centers that successfully transplant "less than perfect" organs. Other people's decisions affect the number, the court said, but that doesn't make it an invalid measure.

There's a detail coordinators should know. Under the rule, a donor with zero organs transplanted doesn't count as a "donor." The OPOs called that unfair, because they can't control a center's decline or a late finding that rules organs out. CMS said it wants OPOs to keep pursuing marginal donors and work to place their organs. The court sided with CMS.

Both sides, fairly

CMS's view: OPOs should be judged on results, not self-reported numbers. CMS also says the rule is working. It reports that from 2021 to 2023 the number of Tier 1 OPOs doubled from 15 to 30, Tier 3 dropped from 24 to 10, and that over four years donors rose 31 percent and transplants 25 percent.

The OPOs' view: service areas aren't alike. Distance to transplant centers, how many centers are nearby, how aggressive those centers are, and who lives in the area all shape the numbers. In 2025 the national OPO association, AOPO, warned that nearly half of OPOs could face decertification or competition and called for validated metrics before anyone is decertified.

Both ideas can be true at once. OPOs do influence utilization. They also don't control all of it.

What's happened since

  • Congress weighed in just before the ruling. On September 22, Senators Maria Cantwell and Steve Daines led 17 lawmakers from Washington, Montana and Alaska in a letter urging CMS to recertify LifeCenter Northwest. They pointed to a service area of about 808,000 square miles with five transplant centers, all in Washington state, and asked CMS not to decertify automatically based on single-year outcome numbers.
  • CMS put the ruling to work. On October 2, CMS filed it as new authority in HonorBridge's separate lawsuit, according to Crowell & Moring.
  • More cases are pending. Hall Render (October 7) called this the first ruling on the merits and noted that other lawsuits are still open. One of them was filed in August by Legacy of Life Hawaii, according to Crowell & Moring.
  • No appeal filed yet. As of October 9, no notice of appeal appeared on the public docket. The OPOs generally have 60 days from judgment to appeal to the Eleventh Circuit.
  • Final tiers are still coming. At the August hearing, the government said final rankings "presumably" must come out before January 31, 2027, when current OPO agreements expire. CMS also has a proposed rule, released in January 2026, that would change how recertification and competition work. CMS said it expected to finalize it in late 2026.

What this means at the bedside

Think about the path every donor takes: identification, authorization, donor management, allocation, acceptance, transplant. Under this rule, the whole chain counts, not just the parts your OPO controls.

So the everyday work matters more than ever. Timely referrals, a well-prepared authorization conversation, solid donor management, complete information in the offer, and persistence in placing organs beyond the usual centers all move the numbers. Hall Render's advice to OPOs fits coordinators too: the ruling doesn't change your referral rules, recovery practices or transplant center duties tomorrow. What it changes is how much rides on all of it.

Whether you agree with the rule or not, knowing how your OPO is measured makes you a better coordinator. It's also exactly the kind of system-level knowledge the CPTC exam expects.

Sources

Back to blog