The U.S. government has unveiled a set of proposed reforms intended to make significant changes to the national organ transplant framework. Announced by the Centers for Medicare and Medicaid Services (CMS) on Wednesday, the proposals are designed to improve the retrieval and use of organs previously considered less than ideal, known as medically complex organs, and to enhance supervisory protocols for organ procurement organizations (OPOs).
OPOs play a critical role in recovering organs from deceased donors, a vital step in the transplant process. Presently, the demand for such organs far outweighs supply, with over 100,000 individuals on the transplant waiting list in the U.S., most of whom require kidneys. Tragically, numerous individuals on this list succumb while awaiting a transplant. In response, the government has embarked on an extensive overhaul of this intricate system, a process initiated during the Trump administration.
Despite a consistent upward trajectory in organ transplants—with the number reaching just over 49,000 last year compared to 48,150 in the prior year—the number of deceased donor organ donations declined for the first time in over ten years. This downturn has raised concerns about public trust in the transplantation framework.
CMS Administrator Dr. Mehmet Oz emphasized the gravity of missed opportunities for donation, stating, "Every missed opportunity for organ donation is a life lost." He noted that the proposed regulations, expected to be finalized later this year, aim to "strengthen accountability," provide clearer guidelines, and equip authorities with more robust tools to eliminate underperforming organizations, safeguard patients, and honor the generosity of donors.
A central aspect of the proposed changes encourages the expanded use of medically complex organs, typically those donated by older or less healthy donors. Traditionally, these organs have been underutilized due to perceived limitations. CMS plans to implement new mandates requiring OPOs to meticulously monitor the recovery and utilization rates of these organs, recognizing that such organs may necessitate special considerations when matching to recipients.
Currently, many OPOs have increased efforts to recover these types of organs, particularly kidneys. Medically complex kidneys might not be likely to function for the entire lifespan of a young transplant recipient but can provide significant health benefits for older or sicker patients, potentially allowing them to avoid dialysis temporarily. Nevertheless, numerous transplant centers decline medically complex organs, even when clinical guidelines indicate they may constitute a suitable match.
Jeff Trageser, president of the Association of Organ Procurement Organizations, expressed cautious optimism regarding the potential positive impact of clearer definitions for medically complex donors and organs. He highlighted the necessity of hospital participation in promoting organ donation and managing medically complex donors, along with ensuring that transplant centers have mechanisms to appropriately utilize such organs. However, CMS did not respond to questions about whether similar directives would extend to transplant centers or donor hospitals.
Other facets of the proposed rule include promulgating precise definitions of what constitutes "unsound medical practices" concerning organ handling and patient safety, criteria central to CMS's role in regulating and certifying organ procurement groups.
These measures add to existing efforts by OPOs and parallel government agencies aimed at preventing rare but alarming incidents in which organ retrieval preparations occurred on patients exhibiting signs of life. While these retrievals were halted, they generated public discomfort and caused thousands to deregister from donor lists in the previous year.
The initiative reflects a multifaceted approach to increasing organ availability, ensuring patient safety, and restoring public confidence in the organ transplantation system.