The United States' organ transplant system could undergo significant changes under new proposals from Medicare, designed to increase the use of "less-than-perfect" organs and enhance safety standards across donor organisations.
Strengthening Oversight and Accountability
The Centers for Medicare and Medicaid Services (CMS) announced on Wednesday that it is proposing regulations to substantially strengthen its oversight of Organ Procurement Organizations (OPOs). These entities are responsible for retrieving organs from deceased donors across the country.
With more than 100,000 individuals currently on the national transplant waiting list – the vast majority awaiting kidney transplants – thousands tragically die each year while hoping for a new organ. This regulatory move forms part of an ongoing, comprehensive overhaul of the intricate transplant system that commenced during a previous administration.
Addressing Declining Donation Rates
The announcement follows concerning trends in organ donation. Last year marked the first time in over a decade that deceased organ donations saw a decline, raising serious concerns about eroding public trust in the transplant system.
While the total number of organ transplants did increase to just over 49,000 last year, compared with 48,150 the previous year, the rate of this year-over-year growth has notably slowed. This slowdown has intensified pressure on authorities to find innovative solutions to address the critical organ shortage.
Maximising 'Medically Complex' Organs
A central aspect of the proposal focuses on maximising the utilisation of what CMS terms "medically complex organs." These organs typically come from older or sicker donors and may require special considerations to find suitable recipients.
CMS intends to impose new requirements on OPOs for tracking both the retrieval and usage of these medically complex organs. The agency notes that these organs may need "special or additional considerations" to be successfully matched with appropriate patients.
Many OPOs have already increased their retrieval of such organs, particularly kidneys. For example, a less-than-perfect kidney might not be suitable for a young, otherwise healthy recipient but could offer an older, sicker patient – who might not receive another offer – valuable time off dialysis.
Current Challenges with Organ Acceptance
Despite the potential benefits, many transplant centres currently decline these medically complex organs, even when medical criteria suggest they would be a good match for certain patients. This reluctance contributes to missed opportunities to save lives.
Dr Mehmet Oz, CMS Administrator, emphasised the urgency of addressing this issue, stating: "Every missed opportunity for organ donation is a life lost." He added that the proposed rule, expected to be finalised later this year, "strengthens accountability, clarifies expectations and gives us stronger tools to remove underperforming organizations, protect patients and honor the incredible gift of life."
Industry Response and Future Implementation
Jeff Trageser, President of the Association of Organ Procurement Organizations, expressed "cautious optimism" about the proposals on Wednesday. He believes that clearer definitions of medically complex donors and organs would encourage their use by both OPOs and hospitals.
He commented: "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."
CMS officials did not respond to inquiries about whether similar requirements would be imposed on transplant centres or donor hospitals as part of these regulatory changes.
Enhanced Safety Standards and Public Confidence
The proposed rule also includes new definitions for "unsound medical practices" concerning organ handling and patient safety. These criteria are used by CMS for regulating and certifying organ groups.
These measures complement other safeguards being adopted by OPOs and considered by another government agency. They follow rare but alarming reports of patients showing signs of life before planned organ retrieval. Although these retrievals were halted immediately, the incidents severely impacted public confidence, prompting thousands to remove their names from donor lists last year.
The comprehensive approach aims to rebuild trust while simultaneously addressing the critical shortage of transplant organs through more efficient utilisation of available resources.
