The government has put forth 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 organizations. The Centers for Medicare and Medicaid Services (CMS) announced the proposal, which focuses on enhancing oversight of organ procurement organizations (OPOs) responsible for retrieving organs from deceased donors.
With over 100,000 individuals on the U.S. transplant waiting list, the majority of whom are in need of a kidney, the urgency to improve the transplant system is evident. The proposed changes are part of an ongoing overhaul initiated during the previous administration and seek to address the decline in donations observed last year, the first decrease in over a decade. While the number of organ transplants has been on the rise, concerns about trust in the system have surfaced.
CMS Administrator Dr. Mehmet Oz emphasized the importance of every missed opportunity for organ donation, highlighting the proposed rule’s role in strengthening accountability, setting clear expectations, and providing tools to remove underperforming organizations. The rule, expected to be finalized later this year, aims to enhance the tracking and utilization of medically complex organs, often from older or sicker donors, by OPOs.
The proposal encourages the maximization of less-than-perfect organs, particularly kidneys, which may not meet the criteria for young recipients but could benefit older or sicker patients. Despite the potential benefits, many transplant centers are hesitant to accept these organs. Jeff Trageser, president of the Association of Organ Procurement Organizations, expressed optimism that a clearer definition of these donors and organs would promote their use.
In addition to promoting the use of medically complex organs, the proposed rule introduces new definitions for “unsound medical practices” related to organ handling and patient safety. These criteria will aid CMS in regulating and certifying organ groups. The rule also addresses concerns about patient safety, following reports of patients showing signs of life being prepared for organ retrieval, prompting public confidence issues.
As the government continues to refine the transplant system, it is crucial for hospitals to support donation efforts and for transplant centers to be equipped to utilize medically complex donors effectively. The proposed changes signify a step towards enhancing the transplant system’s efficiency and ensuring that more lives can be saved through organ donation.

