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Making the Best System Better: How We See It

There are few more delicate, precious and lifesaving conversations in the medical field than at the moment of the organ donation decision. Rightly, the approach was long since made to keep this a non-profit community-based process. It has worked. Donation and transplant are a rare medical area where America leads the world. But good is the enemy of the best and the entire integrated industry from Organ Procurement Organizations, to transplant centers, and donor hospitals can (and we would say must) improve.

Let’s establish the first performance-based standards for OPOs that reflect best practices in donor designation, organ recovery, hospital collaboration, and organ transportation. And poorly performing OPOs will be required to submit corrective action plans.

The Secretary of Health and Human Services can deem an organization to have met the standards to be a qualified OPO if it is accredited by a national accrediting organization specified by the Secretary. This ensures that accredited OPOs are held to the highest standards and can maximize organ donations while ensuring equal access to donation opportunities. This model follows the certification process for hospitals.

HHS and CMS Must Benefit Patients Not Special Interests

HHS and CMS must immediately address the larger issue facing the system as tens of thousands of patients wait for organs. The rules meant to evaluate organ procurement organizations and govern transplant performance are misaligned, scientifically unsound and applied unevenly, while patients waiting for kidneys, livers, hearts, and lungs lose time—and sometimes their chance at a transplant.

Start with how we measure performance. In 2020, CMS adopted a rule that depends on metrics shown in peer‑reviewed research to be biased and unreliable. Instead of a rigid, one‑size‑fits‑all formula, the rule should set clear standards based on proven steps: grow donor designation, improve organ recovery, strengthen OPO and transplant hospital teamwork, and ensure fast, safe transportation so organs reach recipients on time. These steps are evidence‑based, teachable, and trackable. They drive improvement rather than punishment and respect real differences among communities and hospitals.

CMS should also allow a second path to compliance: national accreditation by independent experts, similar to how hospitals are reviewed today. This would create accountability without forcing every region into the same mold. CMS successfully uses independent professional survey and accrediting bodies for hospital oversight and accreditation. The same tools could be applied to the organ procurement organizations.

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

Michael J. Goldstein MD, FACS Director of Organ Transplantation, Director, Kidney & Pancreas Transplantation Division of Organ Transplantation, Hackensack University Medical Center   Professor of Surgery Hackensack Meridian School of Medicine.

Proper Alignment and Collaboration Among Opos and Transplant Centers – Discouraged by Bureaucrats – Is Saving Patients

Here in Tampa Bay, we have much to be proud of. In 2024, Tampa General Transplant Institute led the nation in transplant volume, performing 889 lifesaving transplants, including 500 kidney, 279 liver, 51 heart and 42 lung transplants. This success is built on strong collaboration between our transplant center and our regional procurement organization, Lifelink of Florida, a federally certified nonprofit responsible for recovering donated organs.

While the intention of increasing accountability and improving outcomes is commendable, implementing this rule (ed. note CMS governing rule)  has ignored years of peer-reviewed science showing significant statistical flaws in its performance metrics. For example, Science in Donation & Transplant, where I serve on the advisory board, has compiled a robust body of this research on its website.

In 2024, the Health Resources and Services Administration also censored research that critically analyzed the Centers for Medicare & Medicaid Services performance metrics for Organ Procurement Organizations. This action raises serious concerns about transparency and the suppression of scientific discourse.

What’s needed is not a punitive or adversarial approach. Instead, we need one that encourages collaboration, innovation and shared accountability. Pitting Organ Procurement Organizations against transplant centers does not serve the patients or donor families we are all here to support.

Anthony Watkins, M.D., is the surgical director of the Kidney and Pancreas Transplant Center at Tampa General Hospital. He also serves on the advisory board of Science in Donation & Transplant. The views expressed in this piece are solely his and do not necessarily reflect the views of Tampa General Hospital or the Tampa General Transplant Institute.

End Decades of Bureaucratic Mismanagement

I was the surgical director of the UCLA kidney transplant program for 20 years having performed over 2,500 kidney transplants.  I was also the UCLA Hospital Chief Medical Officer, so have experience in how to make systematic improvements in healthcare quality. 

Life-saving organ transplantation is not possible without the 55 Organ Procurement Organizations (OPOs) that do the extraordinarily complex and emotionally challenging work to identify potential donors and secure organs for transplant in the United States.  By every measure this system has been the most effective in the world.

But under special interest group pressure a federal agency, the Centers for Medicare & Medicaid Services (CMS), is steering America’s life-giving system into a ditch.  This is because two thirds of the country’s OPOs are threatened with decertification in 2026 due to an ill-conceived federal rule issued in 2020 by CMS.  This wrecking ball launched at the organ donation infrastructure would create chaos and put patients at risk.

Even worse, the rule calls for decertification of any OPO not in the top 25% of performance using this single flawed measure, which would result in at least half the country’s OPOs being decertified in 2026 with no one to take over.  Imagine if half the country’s hospitals were decertified.

This is a preventable crisis. The lives of 100,000 friends, neighbors, and family members waiting for life-saving organs are at stake.  CMS should recognize that the 2020 rule is fatally flawed and reopen the rule-making process recommends actually more oversight of OPOs by CMS, but more effective oversight by using the same kind of comprehensive accreditation process used for hospitals.

Dr. Rosenthal is the retired Chief Medical Officer, UCLA Medical Center, Associate Vice Chancellor, David Geffen School of Medicine at UCLA, and Director of the Kidney Transplant Program at UCLA. He is an Advisory Board Member of Science in Donation & Transplant and a peer-reviewed published researcher.

Recognize the True Performance of OPO Volunteers

When the dedicated, specially trained OPO staff have the necessary sensitive conversation with their family when the time comes. Lives hang in the balance of that conversation. Donor families and the eventual recipients of their loved one’s selfless act deserve a system governed by the best peer-reviewed science and best medical practices.

The US organ donation and transplantation system, in which I have proudly worked for three decades, is a crown jewel of American medicine. It has saved more than one million lives and broken records in each of the past 14 years. In this country, we usually celebrate great medical achievements, but the Centers for Medicare and Medicaid Services (CMS), a federal regulator of the transplant system since its inception, has shown an inability over decades to accurately assess the performance of Organ Procurement Organizations. This failure is set to trigger chaos, and Federal lawsuits, in the months and years ahead as CMS will shutter or threaten to shutter upwards of half of the 55 OPOs nationwide based on faulty logic.

Anne Murphy, MBA FACHE Consultant and former Chief Administrative Officer, Department of Learning Health Sciences University of Michigan Medical School, and Transplant Center Administrative Director – University of Michigan Hospitals and Health Centers. She is an Advisory Board Member of Science in Donation & Transplant.