Less-than-perfect organs for transplant list recipients is Medicare’s latest proposal

New regulations for the United States’ organ transplant system have been proposed, aiming to boost the utilisation of "less-than-perfect" organs and introduce enhanced safety standards for donor organizations.

The Centers for Medicare and Medicaid Services (CMS) announced on Wednesday that the proposed rules would significantly strengthen its oversight of Organ Procurement Organizations (OPOs), the entities responsible for retrieving organs from deceased donors.

With over 100,000 individuals currently on the US transplant waiting list – the vast majority seeking a kidney – thousands tragically die each year awaiting a new organ. This move forms part of an ongoing overhaul of the intricate transplant system, which commenced during a previous administration.

The announcement follows a concerning trend: deceased organ donations saw a decline last year for the first time in over a decade, raising fears of eroding public trust in the system. While the total number of organ transplants did rise to just over 49,000 last year, compared with 48,150 the year prior, the rate of this year-over-year increase has notably slowed.

Dr Mehmet Oz, CMS Administrator, stated: "Every missed opportunity for organ donation is a life lost." He added that the proposed rule, expected to be finalized 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."

A key aspect of the proposal is to maximise the use of "medically complex organs," typically sourced from older or sicker donors. CMS intends to impose new requirements on OPOs for tracking the retrieval and usage of these organs, which the agency notes may require "special or additional considerations" to find a suitable recipient.

Many OPOs have already increased their retrieval of such organs, particularly kidneys. For instance, a less-than-perfect kidney might not be suitable for a young recipient but could offer an older, sicker patient – who might not receive another offer – valuable time off dialysis.

However, many transplant centres currently decline these medically complex organs, even when medical criteria suggest they would be a good match.

Jeff Trageser, President of the Association of Organ Procurement Organizations, expressed "cautious optimism" on Wednesday, believing a clearer definition of these 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 similar requirements for transplant centres or donor hospitals.

The proposed rule also includes new definitions for "unsound medical practices" concerning organ handling and patient safety – criteria CMS uses for regulating and certifying organ groups. These measures complement other safeguards being adopted by OPOs and considered by another government agency, following rare but alarming reports of patients showing signs of life before planned organ retrieval. Although these retrievals were halted, the incidents severely impacted public confidence, prompting thousands to remove their names from donor lists last year.