As a former surgeon and U.S. representative who led the passage of the Securing the Organ Procurement and Transplantation Network Act, I am committed to ensuring the future of our nation’s organ donation and transplantation system — which I now fear is in jeopardy.

The U.S. system is the best in the world, saving more lives than any other country, but it remains highly delicate. Every donation and transplant performed involves hundreds of professionals working to test, recover, match, transport, and transplant each organ. 

At its core, the system is built upon a “three-legged stool” made up of donor hospitals, transplant centers and organ procurement organizations. Each of these stakeholders are deeply interdependent. If one leg of that stool is destabilized, the entire structure — and the more than 100,000 patients relying on it — will unequivocally suffer.

That’s not to say this is a perfect system that shouldn’t ever be changed. This system has improved steadily over time as new research, technologies, and best practices become available, are tested and carefully implemented. This deliberate, evidence-based evolution has made organ donation a vital pillar of our nation’s healthcare infrastructure and it remains one of the few sectors still led by nonprofit organizations. Organ procurement organizations — the nonprofits responsible for coordinating donations and supporting donor families — are an irreplaceable component of this system that continue to drive its evolution.

Later this year, the Centers for Medicare and Medicaid Services is set to shut down or force competition upon dozens of organ procurement organizations, thereby destabilizing the donation infrastructure serving as much as 72 percent of our nation. This is the consequence of a final rule enacted in 2020, which redefined how organ procurement organizations’ performance is measured.

Although strong performance and stringent accountability are necessary to save more lives, oversight must reflect the system’s realities to ensure regulatory improvements don’t occur at the expense of patient lives.

The final rule evaluates organ procurement organizations using two measures: donation rates and transplant rates. This framework effectively measures the success of the system as a whole instead of an organ procurement organization’s role in the donation process. It doesn’t recognize that these organizations have no control over transplant rates.

Organ procurement organizations can offer matched organs to transplant centers, but only the transplant center can decide whether it will accept them. In fact, although federal regulations insist that organ procurement organizations must recover more organs, they disincentivize transplant centers from accepting organs from medically complex donors. This has led to thousands of viable organs going unused each year.

Since the final rule was introduced, extensive research has revealed the metrics used to evaluate organ procurement organizations have numerous flaws. They do not account for differences in public health disparities between states. They rely on two-year-old data and measure these organizations using relative rankings — so that by definition, a fixed share of them will fall below the national median each cycle, regardless of performance improvements.

This approach is unprecedented in federal healthcare quality programs, where providers are typically evaluated against objective benchmarks rather than against one another. Consequently, even high-performing organ procurement organizations may face decertification or competition simply because they fall below the median in a given cycle. This creates instability and undermines the very progress the policy is intended to promote.

The organ procurement organization final rule, if left unchanged, will result in fewer donors and more Americans dying while waiting for transplants. We cannot improve the system without accurately measuring it. This is too important to get wrong.

CMS must consider implementing a phased transition period that protects the system’s continuity while evaluating more comprehensive ways to measure organ procurement organizations’ performance. That way, the organizations and hospitals can continue saving lives.

Over the past year, organ procurement organizations have been supporting the development of independently validated metrics that provide a full picture of their performance. The project is led by Econometrica, Inc, a healthcare analytics firm. The new metrics are being built using CMS’s own framework to be scientifically sound. Implementing them will ensure system continuity and accountability while empowering organ procurement organizations to save more lives.

As discussions about reform continue, it is critical lawmakers have a clear understanding of how this intricate system operates. I urge every legislator to connect with their local organ procurement organization, observe the work they do, and learn about the complexities they navigate to make donation possible every day. CMS and Administrator Dr. Mehmet Oz were kind enough to meet with myself and other stakeholders to foster solutions. Constructive engagement like this is essential to ensuring that policy changes strengthen this life-saving system.

Federal lawmakers should proceed with caution. We have the world’s best donation and transplant system. Although there is always room for improvement, we must ensure changes don’t undo the progress that has allowed organ procurement organizations and hospitals to save over a million lives.

Dr. Larry Bucshon is a surgeon and former U.S. representative who championed the bipartisan Securing the Organ Procurement and Transplantation Network Act. Today he is a senior policy advisor at Holland & Knight, where he advocates on behalf of the Association of Organ Procurement Organizations.

This article originally appeared in The Hill (source link).