A Commentary by Matthew Cooper, MD, Renowned Transplant Surgeon

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A Commentary by Matthew Cooper, MD, Renowned Transplant Surgeon

I became a transplant surgeon, like the great majority of my colleagues, to make a difference. The vast landscape of healthcare in America reveals few areas more contingent on the nurturing of right relationships than those in organ donation and transplant. As a new year unfolds, we have much work to do for those on transplant waiting lists and the selfless donor families to protect our world-leading donation and transplant system from misguided forces.

“Government overreach and agency ineptitude is extending beyond the organ donation system overseen by CMS and into the transplant process overseen by HRSA. HRSA has dismantled the non-profit structure of allocating organs through the ‘OPTN Modernization Act.’”

The very existence of life-saving transplants is based on altruistic donors, and equally willing donor families being approached by trained non-profit employees to offer the gift of life to others at the time of family grief. This intimate exchange is made even more vital by the extremely small percentage of potential donors who pass on in a manner medically suitable for donation.

Tragically, in recent years, neglectful federal governance and sensational headline seekers have diverted attention from the true track record of the world’s foremost system toward what seems to be a special interest agenda to undo the system first established under President Reagan in 1984. Tellingly, the adoption of the deeply flawed regulation (rule) governing donation and transplant in late 2020 by the Centers for Medicare and Medicaid Services (CMS) ignored the great body of research data then and growing ever since (see https://sidandt.org/the-science/peer-reviewed-science) enumerating its flaws and biases. This has contributed to inaccurate headlines and ill-informed Congressional hearings which have impacted the public trust in the system.  Of note, for the first time in decades, 2024 saw a decrease in the number of US citizens listed on national and state Donate Life registries potentially reflecting the public’s distrust in the stewardship of their Gift of Life.

Research exposing bias has unconscionably been censored. The taxpayer-funded Scientific Registry of Transplant Recipients (SRTR), under federal contract to provide statistical and analytical support for developing organ and transplant policy, was scheduled to present two peer-reviewed papers on June 3 at the American Transplant Congress (ATC) in Philadelphia. The Health Services and Resources Administration (HRSA) overstepped their bounds by engaging with CMS to censor the presentations, Further, HRSA declared limits on the SRTR from researching and opining on the biases inherent in the metrics evaluating OPO performance.

Government overreach and agency ineptitude is extending beyond the organ donation system overseen by CMS and into the transplant process overseen by HRSA. HRSA has dismantled the non-profit structure of allocating organs through the “OPTN Modernization Act.” It is not modernization, it is bureaucratization. Now millions of taxpayer dollars are flooding into multiple for-profit corporations to do what the non-profit UNOS, and its all-volunteer advisory board, was doing for a fraction of the cost. Those who have spent a lifetime in volunteer service and the general public has begun to see the ‘problem’ with the OPTN was not with the contractor but with the federal government, appropriations that remain unchanged for decades and unable to meet the needs of necessary ‘modernization’, and HRSA leadership unwilling to be a true partner in the service of patients.

Our system is by every measure the envy of the world in donation and transplant. Records are set every year. Yet this is scant solace for those awaiting lifesaving transplants. The way to honor patients and donor families in 2025 is to move past falsehoods and politics.

Organ donation and transplant is governed by CMS and HHS in a manner unlike any other major health care area. In 2020 CMS adopted a governing rule whose metrics have been shown by peer-reviewed research to be biased and faulty.

The flawed performance metric CMS adopted for the nation’s 55 regional, community based non-profit Organ Procurement Organizations (OPOs) demands decertification (i.e. closures) in 2026 of somewhere from 25% up to 65% of the OPOs. This is an unconscionable Hunger Games that quite frankly is likely to be indefensible in Federal court given the published research. It is not overstating that we are headed for organ procurement chaos in 2026. No well-meaning or well-informed person wants to ignore underperforming segments of the healthcare industry, but those judgements must be based on legitimate science-based data and best practices.

CMS divides the OPOs into 3 tiers. Tier 3’s would be decertified in 2026 based on two-year-old data. Given that within the CMS model many OPOs change tiers every year even if one assumed (wrongly) the metrics were accurate it would be quite possible in 2026 that CMS would be urging an OPO to take over the territory of another OPO that was decertified that it was currently outperforming.

All told this is a recipe for the Federal courts to be deciding donation and transplant policy.

A 2022 study by the National Academies of Sciences Engineering and Medicine (NASEM), mandated and funded by Congress, is an essential roadmap for true policy discussions going forward on improving the system. Surprisingly, there was no follow-up from Congress nor from CMS nor HRSA.  Some in Congress wrongly settled in on the “there are not enough organs” mantra. We need more organization to improve utilization of existing donations. It is not finger pointing but cooperation, alignment of the various aspects in the system that will reduce our 25% rate of non-use of donated kidneys.

Our government regulators, both CMS and HRSA, have not been very good partners for donation and transplant as the mounting research shows. At the same time, Congress, while ignoring serious subjects such as the NASEM report, settled for unrepresentative testimony that would spur sensational headlines, instead of true policy progress. Who suffers? Donor families making the ultimate altruistic gift and potential recipients awaiting the gift of life.

What is needed in 2025 is a true system wide calibration, and collaboration, to improve the alignment between and among patients, donor families, OPOs, transplant centers and yes, the federal government. The NASEM study, a great body of recent published research, and the dedication and experience of countless OPTN volunteers who remain invested in true ‘modernization’ provide the foundation on which true progress can be made.

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Matthew Cooper is the Chief of Transplantation, Director of the Solid Organ Transplant Service Line and a Professor of Surgery at the Medical College of Wisconsin. Dr. Cooper is an UNOS/OPTN Past President and an Advisory Board member of Science in Donation & Transplant.