CMS Makes Push to Maximize Donor Organs, Even the Imperfect Ones

 Organs from medically complex donors would get more use as part of a proposed rule for greater federal government oversight of organ procurement organizations (OPOs).

The proposed rule, released Wednesday by the Centers for Medicare & Medicaid Services (CMS), would require OPOs to assess their performance in placing organs from older donors or donors with less-than-optimal health status, and when possible take action to improve their performance to help widen the pool of life-saving matches.

"Every missed opportunity for organ donation is a life lost," CMS Administrator Mehmet Oz, MD, MBA, said in a press release. "CMS will not tolerate unsafe practices or failures that put patients at risk and weaken trust in the system. This proposed rule strengthens accountability, clarifies expectations, and gives us stronger tools to remove underperforming organizations, protect patients, and honor the incredible gift of life."

Many OPOs already have increased retrievals of those less-than-perfect organs, especially kidneys. For example, a less-than-perfect donated kidney might not be good enough to last the lifetime of a young recipient but it could give an older, sicker patient, who might not get another offer, some time off dialysis. Yet for a variety of reasons, many transplant centers don't accept medically complex donated organs even when medical criteria suggest they'd be a good match for a patient.

CMS explained that "medically complex" donors and organs would be defined as donors whose medical history require special considerations for organ placement. This could include organs donated after cardiac death or from individuals with elevated Kidney Donor Profile Index scores, for example.

"These definitions are linked to a proposed new [quality assurance] requirement that would assist OPOs in facilitating appropriate placement and utilization of these organs," according to CMS.

Jeff Trageser, MSN, RN, president of the Association of Organ Procurement Organizations, said Wednesday that he was "cautiously optimistic" on a clearer definition of these donors, and organs would help encourage their use both by OPOs and by hospitals.

"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 that transplant centers have mechanisms in place where they can make use of those," he said.

The proposal is part of HHS' ongoing modernization of the national organ transplant system, the agency said, adding that the modernization includes "new governance, technology, and oversight improvements, to strengthen safety, transparency, and public trust."

More than 100,000 people in the U.S. remain waiting for an organ, mostly kidneys.

Public trust in organ donation has dipped recently, with fewer kidney transplants taking place in 2025 than in 2024, amid reports of people presumed to be deceased -- critically ill, behaviorally unresponsive individuals -- who ended up showing unexpected signs of consciousness just moments before organ retrieval surgery.

Following a slew of OPO controversies, CMS is proposing to codify a clear definition of "unsound medical practices," expand examples of reportable adverse events, and strengthen quality-improvement expectations so serious governance, safety, or organ-handling failures can be identified and addressed quickly.

The term unsound medical practices "is not currently defined but is included as an example of circumstances in which CMS may decertify an OPO based on urgent need. CMS proposes to define 'unsound medical practices' as failures by OPOs that create an imminent threat to patient health and safety or pose a risk to patients or the public," according to the agency.

"These practices would include, but are not limited to, failures in governance; patient or potential donor evaluation and management; and procurement, allocation and transport practices and procedures," the statement continued. "This definition would ensure that instances of actions that constitute unsound medical practices are addressed appropriately and that OPOs continue to provide high-quality care to patients, potential donors, and potential transplant recipients."

Among other provisions, the proposed rule by CMS would:

• Exclude pancreata used for islet cell research for the transplantation rate outcome measure and add recordkeeping requirements to ensure research organs are used in bona fide islet cell research.
• Build on the comprehensive framework established in 2020 by holding underperforming organizations accountable and removing barriers that disincentivize higher-performing OPOs from competing for organ procurement in failing areas.
• Remove an outdated regulatory requirement limiting certification eligibility, paving the way for future certification of new OPOs.

The agency's effort at improving the donation and transplantation system began in December 2020, when CMS published the OPO Conditions for Coverage rule, CMS said in a fact sheet. "In that rule, CMS finalized sweeping reforms that have produced historic results: Between 2021 and 2023, the number of OPOs in the highest performing tier (tier 1) doubled from 15 to 30," the fact sheet continued. "During the same time, the number of OPOs in the lowest performing tier (tier 3), those not meeting performance standards, decreased from 24 to 10. These performance improvements resulted in organ donors increasing by 31% and organ transplants increasing by 25% in just 4 years."

https://www.medpagetoday.com/transplantation/transplantation/119637