Bringing Integrity to Organ Donation and Transplant Oversight
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Bringing Integrity to Organ Donation and Transplant Oversight
by Anthony Watkins, MD Michael Goldstein MD, Matthew Cooper MD
The Department of Health and Human Services Secretary Kennedy and Centers for Medicare and Medicaid Services Administrator Oz with their dramatic decertification of the Miami organ procurement organization demonstrate that the previous disjointed approach to federal oversight of the system of past years will no longer be acceptable.
“SID&T continues to recommend changes to the Final Rule to establish performance-based standards for OPOs that reflect best practices in donor designation, organ recovery, hospital collaboration, and organ transportation.”
Lives literally are at stake.
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.
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. 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.
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.
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.
SID&T continues to recommend changes to the Final Rule to establish performance-based standards for OPOs that reflect best practices in donor designation, organ recovery, hospital collaboration, and organ transportation. CMS’ current Final Rule takes a one-size fits all approach that ignores the principles of evidence-based, peer reviewed science and will unleash chaos into the system, leading to endless appeals and the prospect of Federal court intervention.
We also urge CMS to allow national accreditation as an alternative method of compliance with the Final Rule. CMS successfully uses independent professional survey and accrediting bodies for hospital oversight and accreditation. The same tools could be applied to the Donor Hospital-OPO- Transplant Center partnerships in each donation service area.
Dr. Oz served for many years as a heart surgeon who performed many transplants. Based on that experience, he said, “I want to applaud the OPO’s that are doing a great job because most are. They're spectacularly effective at that tense moment of dealing with the doctor, the nurses, the family, the estranged sibling, all the things that happen at the moment of death that is sacred. We want those OPOs to be celebrated.”
Unfortunately, the current CMS Final Rule offers no meaningful support to help OPOs improve or adopt best practices. We urge CMS to follow the science. (see https://sidandt.org/the-science/peer-reviewed-science) enumerating its flaws and biases. We strongly encourage the new leadership to take a fresh look at, and consider adopting, the landmark 2022 National Academies of Sciences, Engineering, and Medicine (NASEM) report recommendations on modernizing the organ donation system.
HHS has a chance to rebuild trust among all the system’s stakeholders by embracing a new approach to CMS’ regulatory responsibilities. Better alignment between transplant centers and OPOs will save more lives. Now it’s time for their oversight agency join them in the trenches. We encourage the new leaders at HHS to reach out to the transplant community to ensure its regulatory approach reflects the best of what we all have to offer.
