Medicare proposes new organ transplant system rules

The government has unveiled new rules for the nation’s transplant system in an effort to increase the utilization of less-than-perfect organs and establish additional safety standards for donor groups. The Centers for Medicare and Medicaid Services (CMS) announced the proposal, which aims to enhance oversight of organ procurement organizations (OPOs) responsible for retrieving organs from deceased donors.

With over 100,000 individuals on the U.S. transplant list, the majority in need of a kidney, and thousands facing death while awaiting a new organ, the overhaul of the transplant system has been ongoing since the Trump administration. However, concerns arose last year when deceased donations declined for the first time in over a decade, raising doubts about the system’s credibility. Despite an increase in organ transplants from 48,150 in 2024 to just over 49,000 last year, the rate of growth has slowed.

Dr. Mehmet Oz, CMS Administrator, emphasized the urgency of maximizing organ donation opportunities to save lives. The proposed rule, set to be finalized later this year, aims to enhance accountability, clarify expectations, and provide stronger tools for addressing underperforming organizations, safeguarding patients, and honoring the gift of life.

The proposal encourages the use of medically complex organs, typically from older or sicker donors, and introduces new requirements for tracking the retrieval and utilization of these organs by OPOs. These organs may require special considerations in finding suitable recipients, as some transplant centers may be reluctant to accept them even when they could be a good match for certain patients.

Jeff Trageser, President of the Association of Organ Procurement Organizations, expressed optimism that a clearer definition of donors and organs would promote their utilization by OPOs and hospitals. The goal is to ensure that hospitals support donation efforts, manage medically complex donors effectively, and have mechanisms in place to utilize these organs.

The proposed rule also includes new definitions of “unsound medical practices” related to organ handling and patient safety to regulate and certify organ groups. Additional safeguards are being implemented by OPOs and considered by other government agencies following reports of patients being prepared for organ retrieval despite showing signs of life, which led to a decline in public confidence and a decrease in donor list registrations last year.

Overall, the proposed changes aim to streamline the transplant system, increase access to organs, and improve patient outcomes while upholding the highest standards of safety and accountability in organ donation and transplantation.