The federal government unveiled new proposed rules Wednesday aimed at overhauling the nation’s organ transplant system, with a focus on increasing the utilization of less-than-perfect organs and establishing stricter safety standards for organ procurement organizations.

The Centers for Medicare and Medicaid Services (CMS) announced the proposal as part of ongoing efforts to address critical shortages in the U.S. transplant system. More than 100,000 Americans currently await organ transplants, with the majority in need of kidneys, and thousands die annually while waiting.

“Every missed opportunity for organ donation is a life lost,” said CMS Administrator Dr. Mehmet Oz in a statement. The proposed rules, expected to be finalized later this year, aim to “strengthen accountability, clarify expectations and give us stronger tools to remove underperforming organizations, protect patients and honor the incredible gift of life.”

The announcement comes at a concerning time for the U.S. organ donation system. Last year marked the first decline in deceased donor donations in over a decade, raising alarms about public trust in the system. While the total number of transplants slightly increased from 48,150 in 2022 to just over 49,000 in 2023, the growth rate has slowed considerably.

A key component of the new proposal focuses on maximizing the use of “medically complex organs,” typically retrieved from older or sicker donors. CMS plans to implement new requirements for how organ procurement organizations (OPOs) track and utilize these less-than-perfect organs, which often require special considerations when matching with appropriate recipients.

Many OPOs have already increased their retrieval of such organs, particularly kidneys. For example, while a kidney from an older donor might not be suitable for a young recipient needing decades of function, it could significantly benefit an older patient by providing relief from dialysis for their remaining years. However, transplant centers often decline medically complex organs even when they could benefit certain patients.

Jeff Trageser, president of the Association of Organ Procurement Organizations, expressed cautious optimism about the proposed changes. “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.

The new rules also establish clearer definitions of “unsound medical practices” for organ handling and patient safety – critical criteria that CMS uses when regulating and certifying organ procurement groups.

These safeguards come amid a crisis of public confidence in the organ donation system. Recent incidents where organ retrieval was nearly performed on patients showing signs of life – although ultimately halted – have shaken public trust. These alarming cases prompted thousands of individuals to remove themselves from donor registries last year, further exacerbating the shortage of available organs.

The proposed regulations represent the continuation of a transplant system overhaul that began during the first Trump administration. However, CMS officials did not respond to inquiries about whether similar requirements were being planned for transplant centers or donor hospitals, leaving questions about the comprehensive nature of the reforms.

The organ donation and transplantation system in the United States involves a complex network of procurement organizations, transplant centers, hospitals, and regulatory agencies. Streamlining this system while maintaining rigorous safety standards and maximizing organ utilization presents significant challenges.

Addressing the current inefficiencies could potentially save thousands of lives annually while providing better care for patients suffering from end-stage organ failure. As the proposal moves through the regulatory process, stakeholders across the transplant community will be watching closely to see if these changes can successfully increase organ availability while rebuilding public confidence in the system.