Federal regulators are cracking down on nonprofits responsible for coordinating organ donations, aiming to begin shutting down substandard groups by early next year. The move targets the nation’s 55 organ procurement organizations, which recover organs from deceased donors and work with families and transplant centers to coordinate donations, though some have faced scrutiny over issues like skipping transplant centers or sicker patients.
More than 109,000 people are on waiting lists nationwide for organ procurement, according to federal data as of July. The majority of patients await kidneys, with about a dozen patients dying daily while waiting for an organ.
New Evaluation Criteria
CMS will score the nation’s 55 organ procurement organizations based on their donation and transplantation rates, ranking them into three tiers. Top-tier organizations – those calculated in the top 25% of organizations for donation and transplantation rates – would be automatically renewed for another four years. Those in the second tier will have the opportunity to improve and reapply for certification, while those in the bottom tier will be decertified entirely.
CMS hasn’t yet released which organizations’ contracts will be renewed or dropped, but said the process would begin sometime late this year. The current four-year contracts expire in January, but CMS has said it will issue extensions as needed to ensure organ transplants continue.
The Association of Organ Procurement Organizations, which represents the nonprofits, says nearly 42% of the 55 organizations could be ranked in the bottom tier, meaning they would face automatic decertification. Jeff Trageser, the association’s immediate past president, noted that many groups argue outcomes like transplant rates aren’t within their control and shouldn’t be considered in evaluations.
Some medical and policy experts, such as Dr. Joel Adler, a transplant surgeon and assistant professor of surgery at Dell Medical School, support the changes, saying quality metrics are necessary for the complex process of organ donation. However, nonprofits have brought several lawsuits against CMS, arguing the new evaluation method would force them to compete with each other for service areas and destabilize the nation’s organ donation system.
A federal district court in Florida recently upheld the rule in a case brought by organizations serving several states, which had argued the new evaluation method was a competitive approach. The organizations appealed the ruling, and another lawsuit was filed in August by a nonprofit in Hawaii, arguing the rule would force organ procurement organizations to compete for service areas.
Dr. J. Thomas Rosenthal, board secretary of OneLegacy, an organ procurement nonprofit, said trust is key in building relationships with local communities, particularly in communities of color that may have historic distrust in the medical system. However, Greg Segal, founder and CEO of patient advocacy nonprofit Organize, questioned the success of community relationships among lower-ranking organizations, saying “if you’ve been failing and failing and failing, you are not serving patients well.”
Katie Ross-Driscoll, assistant professor of surgery at Indiana University’s school of medicine, noted that organ procurement organizations serve a vital role in the system and community, making the promise of transplantation possible for patients. She added that objective measures enabling comparability across organizations help understand how to improve.
The Centers for Medicare and Medicaid Services said it “is committed to a process that is transparent, data-driven, and focused on the goal of saving more lives through organ donation.” The agency’s decision on which organizations will be decertified is expected to be released late this year, with the current contracts set to expire in January.
Implementation and Next Steps
The American Society of Transplant Surgeons said it supports “long-overdue” changes to how the nonprofits are evaluated and called the feds’ decertification last year of a Miami group a “powerful decision” that will strengthen the system. However, the society has also raised concerns about using transplant rates to grade the nonprofits. They believe that this approach may not be the best way to evaluate the organizations.
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