Medicare Proposes New Transplant System Rules

Introduction to the Proposed Rules

The government proposed new rules for the nation’s transplant system Wednesday that aim to increase use of less-than-perfect organs and set additional safety standards for donor groups.

By LAURAN NEERGAARD, Associated Press

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

The Current State of Transplantation

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

Concerns and Challenges

But it comes after donations from the deceased dropped last year for the first time in over a decade, sparking concern about mistrust in the system. While organ transplants have been rising –- just over 49,000 last year compared with 48,150 in 2024 –- that year-over-year increase also slowed.

Goals of the Proposed Rule

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

He said the proposed rule, expected to be finalized later in the year, “strengthens accountability, clarifies expectations and gives us stronger tools to remove underperforming organizations, protect patients and honor the incredible gift of life.”

Increasing Use of Medically Complex Organs

In a step toward more potentially usable 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 those less-than-perfect organs, which the agency said may need “special or additional considerations” in finding an appropriate recipient.

Industry Response

Many OPOs already have increased retrievals of those less-than-perfect 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 it could give an older, sicker patient, who might not get another offer, some time off dialysis. Yet for a variety of reasons, many transplant centers don’t accept medically complex donated organs even when medical criteria suggest they’d be a good match for a patient.

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

Among other steps in the proposed rule are new definitions of what constitute “unsound medical practices” for organ-handling and patient safety, criteria that CMS uses in regulating and certifying organ groups.

Those are in addition to other safeguards being adopted by OPOs and under consideration by another government agency after some 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.

Conclusion

The proposed rules aim to strengthen the transplant system by increasing the use of less-than-perfect organs and enhancing safety standards. This move is crucial in addressing the growing need for organs and restoring public trust in the system.

FAQs

1. What are the main goals of the proposed transplant system rules?
   • The main goals are to increase the use of less-than-perfect organs and set additional safety standards for donor groups.
2. How many people are currently on the U.S. transplant list?
   • More than 100,000 people are on the list, with the majority seeking a kidney.
3. What prompted the proposal for new rules?
   • The proposal was prompted by a drop in donations from deceased donors for the first time in over a decade and concerns about mistrust in the system.
4. What are medically complex organs, and how will their use be maximized?
   • Medically complex organs are typically those from older or sicker donors. Their use will be maximized through new requirements for OPOs to track their retrieval and usage, considering special or additional considerations for finding appropriate recipients.
5. How will the proposed rule affect organ procurement organizations (OPOs) and transplant centers?
   • The rule aims to strengthen accountability and clarify expectations for OPOs, potentially leading to increased use of medically complex organs. The impact on transplant centers may include encouragement to develop mechanisms for utilizing these organs.