FORT WAYNE, Ind. (WOWO) — Federal regulators are preparing to revoke the government contracts of underperforming organ donation organizations, launching a sweeping overhaul of a system responsible for recovering lifesaving organs and connecting them with patients awaiting transplants.
The Centers for Medicare and Medicaid Services is preparing to evaluate the nation’s 55 organ procurement organizations using new performance criteria based on organ donation and transplantation rates. Organizations will be divided into three tiers, with the lowest-performing groups facing decertification and the loss of their federal contracts.
The changes could begin forcing some organizations out of the system as early as the beginning of next year. The current four-year contracts expire in January, although CMS has said it will issue extensions when necessary to prevent interruptions in organ transplantation.
The proposed changes have drawn support from medical professionals and patient advocates who say the organizations need stronger oversight and greater accountability. But the nonprofits responsible for coordinating donations have challenged portions of the new evaluation system in court, arguing that shutting down organizations could disrupt the complex process of recovering and distributing organs across the country.
The stakes are significant. More than 109,000 people were on organ transplant waiting lists nationwide as of July, according to federal data. Most were waiting for kidneys, and approximately a dozen patients die each day while waiting for an organ.
Organ procurement organizations, commonly known as OPOs, operate across designated geographic areas. They work with hospitals, transplant centers and the families of deceased donors to recover organs and coordinate donations for patients who need transplants.
The organizations have faced increasing scrutiny in recent years following media investigations and academic research highlighting concerns about how organs are allocated. Critics have raised questions about whether some organizations bypass certain transplant centers or patients who are more seriously ill, potentially worsening existing racial and socioeconomic disparities in access to transplantation.
Federal authorities have already shut down at least two organizations over the past two years, citing questionable practices. In one case, the Department of Health and Human Services said workers had ignored signs of consciousness in potential donors.
The latest overhaul has been in development for years. CMS first announced its evaluation framework in 2020 in response to an executive order from President Donald Trump. The agency released proposed revisions to the rules earlier this year, seeking to improve transparency, accountability and patient protections while increasing organ recovery.
Under the revised approach, organizations in the top 25 percent for donation and transplantation rates would automatically receive another four-year certification. Organizations in the middle tier would have an opportunity to improve their performance and reapply for certification. Those ranked in the bottom tier would lose their certification.
If an organization is decertified, other nonprofits would be able to compete for a federal contract to take over its designated service area.
CMS has not yet announced which organizations will retain their contracts and which could be forced out. The agency said in March that the process would begin later this year. In response to questions from Stateline, CMS did not provide a specific date for releasing the certification decisions.
The agency said it remained committed to a process that is transparent, driven by data and focused on saving more lives through organ donation.
The Association of Organ Procurement Organizations, which represents the nonprofits, estimates that nearly 42 percent of the nation’s 55 organizations could land in the lowest tier and face automatic decertification.
The association warns that such widespread changes could create logistical problems in a system where timing, coordination and established relationships among hospitals, donor families and transplant centers are critical.
Jeff Trageser, the association’s immediate past president, said the industry supports accountability for organizations that consistently underperform. But he argued that transplant rates are influenced by factors beyond an individual OPO’s control, including decisions made by transplant centers about whether to accept particular organs.
“Decertification needs to be a part of that. There has to be repercussions if there is just no improvement,” Trageser said.
He argued that regulators should focus on the responsibilities OPOs can directly control, including communicating with donor families, advocating for donation and ensuring organs are allocated effectively to appropriate patients.
The American Society of Transplant Surgeons has also supported stronger oversight, describing changes to the evaluation system as long overdue. The organization praised the federal government’s decision last year to decertify an organ procurement organization in Miami, calling it a significant step toward strengthening the system.
However, transplant surgeons have also expressed concerns about relying on transplant rates to evaluate OPO performance, reflecting a broader debate over how to fairly measure the work of organizations that operate within a complicated medical system.
Dr. Joel Adler, a transplant surgeon and assistant professor of surgery at Dell Medical School at the University of Texas at Austin, said OPO decisions can influence whether transplant centers accept donated organs, but the centers ultimately make their own acceptance decisions as well.
Adler said creating meaningful performance measures for such a complex process is difficult, but necessary to identify problems and improve outcomes.
“At some point, there needed to be quality metrics attached to the whole system, so we can have different ways to measure it and work toward improvement,” Adler said.
The dispute has moved into federal court, with multiple nonprofits challenging the new rules.
In August, an organ procurement organization in Hawaii sued to block the evaluation system, arguing that the rules would force organizations to compete against one another for designated service areas.
Another lawsuit, filed last year by organizations serving California, Florida, Georgia, Iowa, Puerto Rico, Texas and Washington state, challenged the federal government’s approach. A federal district court in Florida recently upheld the rule, and the organizations have appealed that decision.
In their legal challenges, some nonprofits have characterized the proposed system as a competitive “Hunger Games” approach, arguing that forcing organizations out could destabilize the nation’s organ donation network.
One concern involves the relationships OPOs build with communities over many years, particularly communities of color that may already have deep-rooted distrust of the medical system.
Dr. J. Thomas Rosenthal, board secretary of OneLegacy, the nonprofit serving Los Angeles and surrounding counties, said replacing an established organization could damage the trust developed with donor families and local communities. OneLegacy is among the organizations involved in the litigation.
Rosenthal, a former director of renal transplantation at the University of California, Los Angeles, said trust is fundamental to the donation process.
“Trust is the key factor in everything that we do,” Rosenthal said.
But Greg Segal, founder and chief executive of Organize, a patient advocacy nonprofit, disputed the argument that lower-performing organizations necessarily have stronger community relationships worth preserving.
Segal said organizations that consistently deliver poor results should not be allowed to use concerns about disruption as a reason to avoid accountability according to the Indiana Capital Chronicle.
“There’s a lot of fearmongering,” Segal said, questioning whether organizations ranked in the lowest tier had built relationships that were translating into better outcomes for patients.
He argued that stronger performance should demonstrate that an organization is effectively serving both donor families and transplant recipients.
The debate also has implications for Indiana, where researchers are studying disparities in access to transplantation.
Katie Ross-Driscoll, an assistant professor of surgery at Indiana University’s School of Medicine, researches disparities in access to care among liver transplant patients. She also works with the Regenstrief Institute, a health systems research organization, and serves as statistical editor for the journals Liver Transplantation and Hepatology Communications.
Ross-Driscoll said organ procurement organizations play an essential role in connecting potential donors with patients who need transplants. She also said consistent, objective measurements are important for identifying differences in performance and determining where improvements are needed.
The central challenge for federal regulators is to strengthen accountability without interrupting the system that moves donated organs from deceased donors to patients who may have little time to wait.
With more than 109,000 Americans awaiting transplants and roughly a dozen dying each day, the outcome of the federal review could reshape how organ donations are coordinated nationwide. CMS has yet to identify which organizations will be renewed, placed on a path toward recertification or removed from the system.
