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CMS Final Rule’s Bias Against Large OPOs Puts Patients At Risk

An evidenced based study published in American Journal of Transplantation proved larger OPOs are “systematically and disproportionally vulnerable to decertification independent of actual performance”.

The controversial Centers for Medicare and Medicaid Services (CMS) performance metric for recertifying Organ Procurement Organizations (OPOs) is riddled with biases that, if unchanged, will leave major population centers such as in California, Texas, Illinois, New York and New England at risk of losing their OPOs to consolidation or closure.

The study was so damaging to CMS’ case for the Final Rule that the Health Resources and Services Administration (HRSA) censored it from a planned presentation at the American Transplant Congress in 2024.

This peer-reviewed finding by researchers with the Scientific Registry of Transplant Recipients (SRTR) was at one time censored by the Health Resources and Services Administration (HRSA). It is now a key piece of evidence in a federal lawsuit that five OPOs filed against the Department of Health and Human Services and CMS in federal district court in Tampa.

“The current CMS methodology systematically identifies larger OPOs as underperforming, independent of quality, suggesting alternative statistical evaluations are needed to assess OPO performance accurately and improve donation processes of care and transplant rates,” the SRTR report stated.

The findings were published in 2025 in American Journal of Transplantation. But in June 2024, SRTR had planned to present its findings and recommended alternatives to the American Transplant Congress (ATC), such as a metric that enabled comparison between facilities even when they have different patient populations. SRTR researchers found that using the observed-to-expected-ratio, a standard metric for measuring healthcare facilities, would offset the volatility of small-volume programs while not disadvantaging large OPOs.

However, at the opening of the ATC, the Health Resources and Services Administration, at the request of CMS, ordered the SRTR researchers not to present this research. In September 2024, AJT published an opinion submitted by researchers in the transplant and donation field condemning the censorship of legitimate and replicable research and “restricting dissemination of highly rated findings and discussion in a scientific forum.”

Lawsuit by 5 OPOs cites high error rates in OPO rankings found in the study in seeking Summary Judgement to overturn the Final Rule.

There are 55 donor service areas covering the entire United States, but they serve communities that vary widely by both size and demographics. Some of the nation’s biggest states and cities depend on the system’s high-volume OPOs to ensure donated organs are available for transplantation. Because recertification is based on ranking all OPOs and grouping them into three tiers that CMS regulations treat differently, any bias or error affecting their scores could result in better-performing OPOs being subjected to unjust enforcement actions like closure or consolidation, while lower-performing OPOs improperly receive four-year certification renewals.

These enforcement actions could leave major areas of the US with their OPOs being closed, or consolidated with distant service areas’ OPOs, in a process CMS has yet to define but that clearly risks disruption and destabilization of organ transplantation in large swaths of the country. The federal government’s laudable goal of improving OPO performance should not require such draconian outcomes, especially when the accuracy and fairness of CMS’ rankings is in serious doubt.

After CMS first proposed its Final Rule in 2019, the federal Scientific Registry of Transplant Recipients (SRTR) raised concerns that the metric failed to measure OPO’s relative performance accurately and put well-performing OPOs at greater risk of decertification due only to their size. However, in response to public comments raising this concern, CMS claimed its statistical formula would not misclassify larger OPOs but instead would protect smaller OPOs.

To further assess the connection between size and ranking, SRTR researchers in 2024 conducted a simulation analysis of CMS rankings of OPOs from 2019-21. They found the methodology was, as predicted, biased against large OPOs. The impact of the bias was substantial. The abstract identified an absurd outcome of CMS’ scheme: the largest OPO could never be ranked by the CMS OPO metric as a Tier One OPO unless all OPOs were ranked Tier One, a near impossibility.

Because CMS’s new Final Rule is certain to produce inaccurate and discriminatory rankings, any attempt by CMS to decertify OPOs based on its metric will result in disadvantaged OPOs appealing CMS’ decisions, ultimately leading to federal litigation and judicial intervention. The study has already been cited in a recent lawsuit filed against the Department of Health and Human Services (DHHS) and CMS by five OPOs, who claim the rule “does not reasonably, accurately, or fairly measure the performance of organ procurement organizations, as Congress directed.”

Given the certainty of failure, Science in Donation & Transplant is renewing its call for CMS to stop ignoring peer-reviewed, scientific evidence that demonstrate conclusively that the Final Rule should be dropped in favor of an assessment methodology that looks at a wider spectrum of OPO data combined with process measurements, such as those recommended by in the National Academies of Sciences, Engineering and Medicine report, Realizing the Promise of Equity in the Organ Transplantation System.