There is virtually no parallel in medicine to the intimate relationship and right decision making necessary to save lives with organ transplants. Caring people must enroll as donors and then often their grieving families are asked to give their life saving consent.

Despite annual lifesaving donation and transplant records being set, in 2025 some donors are removing themselves from registries as sensational stories, often taken out of context, are the new hallmark of media reporting, Congressional hearings and federal regulators on this complex issue. Sadly, this is not just a contemporary tale of conspiracy theories that run amok but the result of decades of federal mismanagement and recent perhaps more nefarious takeover strategies.

The fundamental ethical principle of medicine is do no harm. It is long overdue for the federal government overseers of organ donation and transplant to take that oath.

Despite annual donation and transplant records over 100,000 people remain on transplant waiting lists. How is it decided which patient gets an available organ? Why are there so many patients on the waiting list for organs? Do we truly know how the organ procurement organizations who accept the donated organs and the transplant centers who place them are performing their federally regulated functions?

These are profoundly fair questions that unconscionably the relevant federal agencies, some Congressional committees and once proud mainstream media are answering with half-truths, faulty science and historical ignorance.

Currently, the Organ Procurement and Transplantation Network (OPTN) with the Health Resources and Services Administration (HRSA) is focusing on the issue of Allocation Out of Sequence (equity versus utility). This is nuanced medicine but basically the next person on the list” should” get the organ is the seeming logic. That is so-called equity. Let’s start there. Perhaps it is semantics. Equity sounds so compassionate. Utility perhaps recalls something more mundane.

But follow this: the OPTN creates, implements, and monitors organ allocation policy, i.e. in simple terms how available organs are going to be offered for use in transplant. Currently the (OPTN) by its words “under the direction of the Health Resources and Services Administration (HRSA)” is purporting to ensure fairness, transparency, and optimal use of organs by oversight of Allocation Out of Sequence (AOOS).

The facts show that current government oversight continues its record of failure in this regard. Nearly 10,000 organs were not utilized last year that could have been transplanted. There is nothing fair or optimal for those on the waiting list when usable life-giving organs are discarded.

Because of the mandates is that some 10,000 usable organs are not being used because of this federal strategy. The fact is Health and Human Services (HHS), and the Centers for Medicaid and Medicare Services (CMS). OPTN and HRSA should be working together more cohesively so that this isn’t some “either or” but a blueprint to fairly maximize the use of organs to the most patients’ benefit.

OPTN falsely states: “Despite claims that allocating outside of the OPTN-defined match run can help reduce organ non-use, the evidence does not support this assumption. In fact, as AOOS rates have increased in recent years, organ non-use has also increased. In addition, OPOs with higher rates of AOOS also tend to have higher rates of organ non-use.”

There are many reasons for non-use but the frightening aspect of this assertion from the federal regulator is there is no evidence to support their specious conclusion. The assertion appears to be a rationale for the United States to continue to have the highest nonuse rate of recovered organs in the developed world when it leads in every other donation and transplant category. The question is why?

No study or randomized trial supports the HRSA conclusion and the obvious is ignored. HRSA will say they looked at Accelerated Kidney Placement. They don’t share how flawed the basic premises of the study were. Waiting to accelerate placement after kidneys have been declined by multiple transplant programs locally and regionally of course leads to an intervention that may come too late to effectively increase utilization. They didn't see a difference in organ acceptance or utilization in the program because they waited too long in the process before they began the accelerated placement. They removed the functional DSA and created challenges to share hard-to-place organs, ironically worsening the equity.  For a large subset of organs, the system wasn't designed to allocate efficiency. That's the failure right there. Again, why is that? What is being missed by HRSA and CMS?

The Centers for Medicare and Medicaid Services (CMS) incentivize organ procurement organizations (OPOs) to procure more organs. Donations and transplants have continually grown on an annual basis. However, CMS also rank on OPOs on transplant, which they do not control. (Ed. Note additionally over twenty studies have shown the CMS performance metrics for OPOs are fatally flawed potentially leading to total chaos in 2026: link, link).

As medicine has advanced we are now procuring and placing organs that would have been untenable decades ago. Donors can be older and the organs more challenging than years ago to transplant. The true challenge is to the transplant centers as of course many of these organs are viable and lifesaving if they get to the patient.

On the transplant center side, the incentives by the one-year survival rate. The Scientific Registry of Transplant Recipients (SRTR) clearly notes the wide range of performance among centers. And so, you can argue, why would one center be willing to use an organ 10 miles away from another center who has no interest in using that organ? It's because of a lack of transparency in transplant center performance. It has to do with the reality of performance.

Gather a room of national transplant leaders asked them if the 2021 allocation was a success or failure? The answer will be a resounding no. But surely HRSA with lives at stake will look at the facts? The agency is going so far as the censor taxpayer subsidized independent research that challenges their bureaucratic findings.

What is called for is better alignment, increased transparency, and best practices communication between and among OPOs and transplant centers. And this will promote equity first, and finish with improved utility. That's the way to do it.

Hard-to-place organs, which can and do save lives every day have to go to the centers that are more likely to use them, but that's never been incorporated into the way the organs are allocated. There is only one class that suffers from HRSA’s current allocation approach and that tragically is sick patients.

Can we make the process better? Incorporate transplant center behavior and non-use modeling into a new dynamic allocation model.

Congress and HHS both ignored the groundbreaking 2022 study by the National Academies of Sciences, Engineering and Medicine Realizing the Promise of Equity in the Organ Transplantation System. Its recommendation should have been broadly debated and many implemented. One overriding theme of its expert panel was the need for greater alignment among organ procurement organizations and transplants centers.

The transplant chief at the Health Resources and Services Administration should be its leading advocate. Yet he and others have been promoters of the flawed so-called science that dates back over a decade. That is a worthy subject of a major media investigation.

Our world leading donation and transplant system was created in 1984. Our system has not adapted to over 40 years of medical advancements that have us retrieving far more challenging, yet usable, organs than decades ago.