Federal organ donation crackdown nears as Florida groups await rankings and Tampa nonprofit appeals court loss

Federal regulators are preparing to shut down the lowest-performing organ procurement organizations as early as next year, and Florida sits at the center of the fight: a Tampa-based nonprofit led the lawsuit that a federal court in Florida rejected this fall, and South Florida's own organ agency was the first in the nation ever decertified in the middle of a contract cycle. The crackdown, detailed by Stateline on Oct. 23, will score all 55 of the nation's procurement groups on donation and transplant rates and strip the bottom tier of its federal contracts.

Organ procurement organizations, known as OPOs, are the regional nonprofits that recover organs from deceased donors and coordinate with families and transplant hospitals. Each holds an exclusive federal territory. Florida is divided among four of them, and the one serving Miami-Dade, Broward and Palm Beach counties changed hands this year after regulators forced out the University of Miami's agency.

What federal regulators are doing

The Centers for Medicare and Medicaid Services will rank the 55 organizations into three tiers based on donation and transplantation rates, Stateline reported. Groups in the top 25% would be renewed automatically for four years. Groups in the second tier would get a chance to improve and compete to keep their territory, and those in the bottom tier would be decertified, with other nonprofits invited to bid for their service areas.

The framework dates to a 2020 rule issued in response to an executive order from President Donald Trump during his first term, and CMS proposed revisions to it earlier this year. The agency has not released which organizations will be renewed or dropped. It said in March that the process would begin late this year. The current four-year contracts expire in January, though CMS has said it will issue extensions as needed so transplants continue, according to Stateline.

CMS told Stateline it "is committed to a process that is transparent, data-driven, and focused on the goal of saving more lives through organ donation," but did not give a date for certification decisions.

The Association of Organ Procurement Organizations, which represents the nonprofits, says nearly 42% of the 55 groups could land in the bottom tier and face automatic decertification. Jeff Trageser, the association's immediate past president, told Stateline that underperformers should be held accountable, but argued the groups should be measured on "what we actually do," such as talking to families and getting organs allocated to the right patients, rather than on transplant rates they do not fully control.

The Florida lawsuit that tested the rule

The most significant legal test so far came in Tampa. In LifeLink Foundation, Inc. v. Kennedy, filed in August 2025 in the U.S. District Court for the Middle District of Florida, seven procurement organizations serving California, Florida, Georgia, Iowa, Puerto Rico, Texas and Washington state challenged the ranking system. The lead plaintiff, the Tampa-based LifeLink Foundation, runs LifeLink of Florida as well as the organ procurement organizations for Georgia and for Puerto Rico and the U.S. Virgin Islands.

The court granted summary judgment to the government in late September, finding the rule lawful and not arbitrary or capricious, according to the court's order and legal analyses of it. The court did agree that some challenges could go straight to federal court instead of first winding through the agency's appeals process. The organizations have appealed, Stateline reported.

Other lawsuits remain. In August, a Hawaii nonprofit sued to block the rule, arguing it would force procurement groups to compete with one another for territory, and some plaintiffs have described the system as a "Hunger Games" approach that could destabilize organ donation, according to Stateline.

South Florida already went through a shutdown

Floridians have seen what decertification looks like. In September 2025, the U.S. Department of Health and Human Services moved to decertify the Life Alliance Organ Recovery Agency, a division of the University of Miami Health System founded in 1978, after an investigation that regulators said "uncovered years of unsafe practices, poor training, chronic underperformance, understaffing, and paperwork errors," the Miami Herald reported. It was the first mid-cycle decertification in the program's history, and Life Alliance did not appeal.

Health and Human Services Secretary Robert F. Kennedy Jr. said at the time that staffing shortages may have caused as many as eight missed organ recoveries each week, roughly one life lost each day, according to the Herald.

On Jan. 8, CMS selected Nevada Donor Network, a Las Vegas nonprofit founded in 1987, to take over the Southern Florida donation service area after a national bidding process. The territory covers more than 7 million people in Miami-Dade, Broward, Palm Beach, Monroe, Collier and St. Lucie counties, plus the Bahamas. Nevada Donor Network is rated Tier 1, meaning it ranks in the top quarter nationally for donation and transplant rates, the Herald reported. The American Society of Transplant Surgeons called the Miami decertification a "powerful decision" that will strengthen the system, according to Stateline.

Florida's organ procurement map

Four organizations cover Florida's donation service areas.

LifeLink of Florida's territory includes Hillsborough, Pinellas, Pasco, Hernando, Polk, Manatee, Sarasota, Charlotte, Lee and Martin counties, among others, according to the foundation's filings. CMS has not published the final rankings that will decide whether LifeLink of Florida, LifeQuest or OurLegacy keep their territories automatically, must compete for them or face decertification.

What it means for Florida patients

More than 109,000 people nationwide were on organ waiting lists as of July, most of them waiting for kidneys, and about a dozen patients die each day on average while waiting, according to federal data cited by Stateline.

Supporters of tougher oversight argue that weak procurement groups cost lives. Greg Segal, founder of the patient advocacy nonprofit Organize, told Stateline that if a group has been "failing and failing and failing, you are not serving patients well." Critics, including leaders of plaintiff organizations, warn that forcing out established groups could fracture the trust they have built with hospitals and families, particularly in communities with a history of distrust of the medical system.

For Florida transplant centers, the immediate question is whether more of the state's territory changes hands. If any Florida organization is ranked in the bottom tier, it would face decertification and the same kind of national bid that brought Nevada Donor Network to South Florida.

What's next

CMS has not set a date to release the certification rankings. The current contracts run through January, with extensions available, and regulators aim to begin shutting down substandard groups early next year. The appeal of the Tampa ruling and the other pending lawsuits could still change the timeline. Floridians who want to register as organ donors can still do so through the state's donor registry or when renewing a driver's license.