Medicare proposes new transplant system rules that might spur use of less-than-perfect organs

WASHINGTON– The government on Wednesday proposed new rules for the national transplant system, aimed at increasing the use of imperfect organs and establishing additional safety standards for donor groups.

The Centers for Medicare and Medicaid Services said the proposal would strengthen its oversight of organ procurement organizations, or OPOs, groups that harvest organs from deceased donors.

In the United States, more than 100,000 people are on the transplant list, the vast majority seeking a kidney, and thousands will die while waiting for a new organ. Wednesday’s decision is part of an ongoing overhaul of the complex transplant system that began during the first Trump administration.

But it comes after donations from the deceased fell last year for the first time in more than a decade, sparking concerns about distrust in the system. Even as organ transplants have increased – just over 49,000 last year compared to 48,150 in 2024 – that year-over-year increase has also slowed.

“Every missed organ donation opportunity is a lost life,” CMS Administrator Dr. Mehmet Oz said in a statement Wednesday.

He said the proposed rule, which is 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.”

In a move toward more potentially usable organs, the proposal recommends maximizing the use of “medically complex organs,” typically those from older or sicker donors. CMS would add new requirements for how OPOs track the recovery and use of these imperfect organs, which the agency said may require “special or additional considerations” to find a suitable recipient.

Many OPOs have already increased the number of samples taken from these imperfect organs, particularly the kidneys. For example, a kidney donated by an imperfect donor might not be good enough to last a young recipient’s life, but it might provide a dialysis holiday to an older, sicker patient, who might not receive another offer. Yet for a variety of reasons, many transplant centers do not accept donations of medically complex organs, even when medical criteria suggest they would be a good fit for a patient.

Jeff Trageser, president of the Association of Organ Procurement Organizations, said Wednesday that he was “cautiously optimistic” that a clearer definition of these donors and organs would help encourage their use by both OPOs and hospitals.

“If we want to maximize the opportunities to get people off the transplant list, we need to make sure that hospitals are supportive of donation, helping us manage these medically complex donors, and that transplant centers have mechanisms to use them,” he said.

CMS officials did not respond when asked whether similar requirements were planned for transplant centers or donor hospitals.

Other steps in the proposed rule include new definitions of what constitutes “unhealthy medical practices” regarding organ handling and patient safety, criteria that CMS uses to regulate and certify organ groups.

These are in addition to other protective measures adopted by OPOs and reviewed by another government agency after rare but frightening reports of patients being prepared for organ harvesting despite signs of life. Those planned clawbacks were halted, but they shook public trust, prompting thousands to remove their names from donor lists last year.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.