Proposed Changes to the US Transplant System Aim to Increase Organ Donation
The US government has proposed new rules for the nation’s transplant system, aiming to increase the use of less-than-perfect organs and set additional safety standards for donor groups. The Centers for Medicare and Medicaid Services (CMS) announced the proposal, which would strengthen its oversight of organ procurement organizations (OPOs), groups that retrieve organs from deceased donors.
According to CMS Administrator Dr. Mehmet Oz, “Every missed opportunity for organ donation is a life lost.” The proposed rule, expected to be finalized later this year, “strengthens accountability, clarifies expectations and gives us stronger tools to remove underperforming organizations, protect patients and honor the incredible gift of life.” The move is part of an ongoing overhaul of the complex transplant system, which began during the first Trump administration.
Increasing the Use of Medically Complex Organs
The proposal urges maximizing the use of “medically complex organs,” typically those from older or sicker donors. CMS would add new requirements for how OPOs track the retrieval and usage of these less-than-perfect organs, which may need “special or additional considerations” in finding an appropriate recipient. Many OPOs have already increased retrievals of these organs, especially kidneys. For example, a less-than-perfect donated kidney might not be good enough to last the lifetime of a young recipient but could give an older, sicker patient some time off dialysis.
Jeff Trageser, president of the Association of Organ Procurement Organizations, expressed cautious optimism about the proposal, stating that a clearer definition of medically complex donors and organs could help encourage their use by OPOs and hospitals. “If we’re going to look at maximizing opportunities to get people off the transplant list, we’ve got to be sure hospitals are supporting donation, helping us to manage those medically complex donors, and transplant centers have mechanisms in place where they can make use of those,” he said.
Additional Safety Measures and Oversight
The proposed rule includes new definitions of what constitute “unsound medical practices” for organ-handling and patient safety, criteria that CMS uses in regulating and certifying organ groups. These measures are in addition to other safeguards being adopted by OPOs and under consideration by another government agency, following rare but scary reports of patients prepared for organ retrieval despite showing signs of life. Those planned retrievals were stopped, but they shook public confidence, prompting thousands of people to remove their names from donor lists last year.
More than 100,000 people are on the US transplant list, with the vast majority seeking a kidney. While organ transplants have been rising, with just over 49,000 last year compared to 48,150 in 2024, the year-over-year increase slowed. Donations from deceased donors also dropped last year for the first time in over a decade, sparking concern about mistrust in the system. The proposed changes aim to address these issues and increase the number of available organs for those in need.
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