Regulators crack down on organ donation groups

Federal regulators are cracking down on the nonprofits responsible for coordinating organ donations, aiming to begin shutting down substandard groups by early next year, according to the Tribune News Service.

New criteria will score the organisations on donation and transplantation rates and will decertify the bottom tier, meaning their contracts with the federal government will be revoked. Many professional medical groups welcome more stringent evaluations. But the nonprofits strongly oppose aspects of the criteria and have filed lawsuits, warning of potential disruptions in some states or regions.

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. Each day on average, about a dozen patients die waiting for an organ.

State- and region-based nonprofits known as organ procurement organizations recover organs from deceased donors and work with families and transplant centers to coordinate donations. The procurement organisations have faced heavy scrutiny in recent years, with media reports and research papers highlighting issues such as skipping over some transplant centers and sicker patients, which worsens racial and socioeconomic disparities in organ transplants. The feds have shut down at least two groups in the past two years, citing questionable practices and saying that there were cases in which workers ignored signs of consciousness in donors.

Changes have been in the works for years. The Centers for Medicare and Medicaid Services first announced the new evaluation framework in 2020, in response to an executive order from President Donald Trump. Earlier this year, CMS released proposed revisions to that rule.

Aiming for better accountability, transparency and oversight of the groups, as well as increasing patient protections and organ recovery, CMS will score the nation’s 55 organ procurement organisations based on their donation and transplantation rates. It will rank them into three tiers: Top tier organisations — those calculated in the top 25% of organisations for donation and transplantation rates — would be automatically renewed for another four years. Those that fall in the second tier will have the opportunity to improve and reapply for certification, while those ranking in the bottom tier would be decertified entirely. Other nonprofits will then make bids to the federal government to take over their service areas, according to CMS.

The new evaluation method has stirred debate. Some medical and policy experts say better oversight of the nonprofits is long overdue, while organ procurement organisations say they will face logistical hurdles in coordinating lifesaving organs if some are shut down. CMS hasn’t yet released which organization’s contracts will be renewed or dropped, but said in March that 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.

CMS did not provide a specific date in response to Stateline’s request for information about when it would release certification decisions. The agency said it “is committed to a process that is transparent, data-driven, and focused on the goal of saving more lives through organ donation.” But 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. The association says this may disrupt logistics around organ donation coordination.

Jeff Trageser, the association’s immediate past president, said the organisation agrees that underperforming nonprofits should be held accountable. But he noted that many of the groups argue that outcomes such as transplant rates aren’t within their control and shouldn’t be considered in evaluations. “Decertification needs to be a part of that. There has to be repercussions if there is just no improvement,” Trageser said. “Let’s measure the OPOs on what we actually do, and that is talking to families, advocating for donation, working to get organs allocated effectively to the right patients.”

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. But it had also raised concerns about using transplant rates to grade the nonprofits.