Medicare proposes new rules to expand deceased organ use and oversight

The U.S. government proposed new rules for the nation’s organ transplant system aimed at increasing the use of organs from deceased donors that may be medically more complex, while also tightening oversight and safety requirements for organizations that retrieve and manage those organs.

In a statement Wednesday, Centers for Medicare and Medicaid Services Administrator Dr. Mehmet Oz said the proposal would “strengthens accountability, clarifies expectations and gives us stronger tools to remove underperforming organizations, protect patients and honor the incredible gift of life.” CMS said the proposal, expected to be finalized later in the year, would strengthen its oversight of organ procurement organizations, known as OPOs, which retrieve organs from deceased donors.

CMS said more than 100,000 people are on the U.S. transplant list, with the vast majority seeking a kidney. The agency said thousands will continue to die waiting for an organ as it continues an overhaul of the complex transplant system that began during the first Trump administration, even as donation from deceased donors dropped last year for the first time in over a decade.

Oz said, “Every missed opportunity for organ donation is a life lost,” framing the rule as part of efforts to reduce delays and increase access to transplants.

A central part of the proposal is a push toward maximizing the use of “medically complex organs,” which CMS said typically come from older or sicker donors. CMS would add new requirements for how OPOs track the retrieval and use of those less-than-perfect organs, which the agency said may require “special or additional considerations” in finding a suitable recipient.

CMS said some OPOs and transplant stakeholders have already increased retrievals of medically complex organs, especially kidneys. The agency described a scenario in which a less-than-perfect donated kidney might not last for a young recipient but could provide an older, sicker patient with time off dialysis.

Still, CMS said many transplant centers do not accept medically complex organs even when medical criteria suggest a good match would exist. Jeff Trageser, president of the Association of Organ Procurement Organizations, said Wednesday that he was “cautiously optimistic” that clearer definitions would encourage increased use by both 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,” Trageser said.

CMS officials did not respond when asked whether the agency planned to impose similar new requirements on transplant centers or donor hospitals.

Among other steps in the draft rule, CMS would add new definitions of what constitute “unsound medical practices” for organ-handling and patient safety, which CMS said it uses in regulating and certifying organ groups. The proposal also comes alongside other safeguards that OPOs have been adopting and additional steps under consideration by another government agency after reports raised rare concerns about patients being prepared for organ retrieval despite signs of life—reports that were followed by changes that stopped the planned retrievals and shook public confidence, leading thousands to remove their names from donor lists last year.