American Transplant Congress Roiled by Censorship of SRTR Research

BREAKING NEWS: Philadelphia, PA June 2024

The assault on scientific research in organ donation and transplant reached a frightening new low with the censorship by the Health Resources and Services Administration (HRSA) of important peer-reviewed studies just hours before it was scheduled for presentation at the American Transplant Congress (ATC).

 The ATC, held in early June in Philadelphia, is the most significant annual meeting of the transplant community, drawing 1,000 transplant surgeons, organ procurement organization leaders, researchers, lab directors, vendors, and other US organ transplant system leaders. It is often a low-key professional gathering focused on new scientific and medical developments. But this week's meeting was troubling – not because of what happened there, but what didn't.

The taxpayer-funded Scientific Registry of Transplant Recipients (SRTR), under federal contract to provide statistical and analytical support for developing US organ and transplant policy, was scheduled to present two peer-reviewed papers on June 3.

According to the Boston Globe, an SRTR spokesperson said the US Health Resources and Services Administration withdrew approval of the abstracts “citing concerns about HRSA seen as being critical of CMS’ oversight of organ procurement organizations.”

Distinguished national expert and researcher Jesse Schold, PhD, MStat, MEd, Professor of Surgery, Associate Vice Chair of Policy and Outcome, Transplant Surgery, University of Colorado, noted, “What occurred at the American Transplant Congress was a suppression of science by HRSA.  Organ donation and transplantation is a critical function in the health care system and current CMS metrics models are neither robust nor sophisticated.”

The abstracts for those papers were attached to the digital agenda for the meeting, which all participants received and downloaded. SRTR's papers were timely, given the ongoing controversy about CMS' Final Rule:

●      Are the New CMS Performance Tiers Biased Against Larger OPOs? The study simulated 100,000 OPO evaluations using the new rule and applied them to different donation-rate scenarios. It concluded that "the CMS evaluation system as currently defined is biased against larger OPOs, with smaller OPOs having a higher probability of being automatically recertified or being able to compete for renewal of their contracts." As the authors point out, CMS has previously stated, "We do not concur…that our methodology is biased against large OPOs." However, to the contrary, the paper's findings provide strong proof of an uneven playing field depending on the OPO's size. Under each scenario studied, larger OPOs were more likely to be in Tier 2 or Tier 3, and smaller OPOs were more likely to be in Tier 1.

●      Reducing Bias against Larger Organ Procurement Organizations in Performance Evaluations offered a way to address the inequities exposed by the first paper. The authors "propose an alternative tiering system that is not biased against large OPOs and (compared it) with the CMS approach through simulation." The proposed alternative is a commonly used hospital statistical measurement, "observed-to-expected (O-to-E) rate ratios," often applied to "meet regulatory goals and maintain acceptable error rates." After running 30,000 simulations, the study concluded that the O-to-E method removes the bias against larger OPOs "without sacrificing power to detect underperforming OPOs."

No matter what else happened, the SRTR presentation of the two papers would likely draw some attention and prompt conversations among those closely following the CMS OPO metric issue at the American Transplant Congress. The CMS Final Rule looms over the organ donation and transplant field like a thunderhead.

 Multiple reliable sources reported:

• HRSA requested withdrawal of the 2 SRTR, and 4 OPTN/UNOS abstracts that had been previously approved.

• All the abstracts were directly or indirectly related to the new OPO metric (pointing out areas of concerns and/or opportunities for improvement).  HRSA told the OPTN that their abstracts were “not aligned with the contractual objectives for publication and presentation”. 

• HRSA told the SRTR that the presentations conflicted with a prior request “not to produce OPO metrics that conflict or raise questions about CMS’s metrics.” 

• It was also reported that Summome, the contractor who has been helping HRSA with stakeholder engagement for the OPTN Modernization Initiative had an abstract (D293) about their work with that project withdrawn as well. 

• The Summome abstract was not included in the AJT Abstracts publication and has been pulled from the ATC website, but the abstract is referenced in the ATC Author Index in The American Journal of Transplantation (AJT).  The latter includes the fact that HRSA Health Systems Bureau Associate Administrator Suma Nair was apparently one of the authors. 

After it was learned that HRSA had required papers to be stricken from the agenda and that their presentation be canceled, news of the papers spread like wildfire among ATC attendees. They wondered aloud: Did HRSA have the right to "take down" peer-reviewed science? Has anything like this happened at ATC before? Was HRSA trying to suppress evidence that would be seen as adverse to the full implementation of the Final Rule, including the decertification of OPOs? Or was something else going on?

 At the American Society of Transplant Surgeons Town Hall later that day, Dr. Suma Nair, the Associate Administrator for the Health Systems Bureau at HRSA, was hit with questions about the cancellation of the two papers and the simultaneous cancellation of four presentations submitted by UNOS/OPTN that addressed a) Pancreas Utilization b) Rate of Recovery of Pancreas for Research c) Donor Registration Causes of Death vs. Death Certificates and d) Kidney Allocation.

Dr. Nair asserted that her agency always has the right to determine what is and what is not published under its name and contract using federal dollars. She told the Town Hall that HRSA focuses its decisions on what is a productive use of taxpayer dollars to make sure that they are presenting what is sound and defensible policy. She added that the move signaled that HRSA wants researchers to refrain from publicly questioning the Final Rule.

Dr. Nair's defense of censorship triggered audible pushback from the Town Hall crowd of about 300 organ transplant professionals.   A surgeon who spoke with Dr. Nair after the Town Hall asked if she realized that retracting the presentations resulted in a larger audience and serious concerns from the transplant community that would never have happened had they let the research be presented. To which Ms. Nair was said to have agreed and stated, "It could have been handled better."

The six HRSA takedowns fuel suspicions that CMS, HRSA and their parent HHS (Health and Human Services) are putting on blinders when it comes to the mounting peer-reviewed evidence that its Final Rule is fatally flawed and will result in mis-ranking of OPOs at the end of each year – an injustice to OPOs that earned the opportunity to continue providing exemplary service to their communities, and highly disruptive to the delicate local, just-in-time ecosystems that have allowed organ transplantation to grow at a record pace nationwide, year after year.

Ignoring the science is an invitation to chaos, with the certainty of appeals and lawsuits being filed by OPOs wrongly de-certified by a metric whose flaws were identified in peer-reviewed research papers that cannot be wished away or subordinated to political pressure from non-scientists. As President John Adams famously said, "Facts are stubborn things, and whatever may be our wishes, our inclinations, or the dictates of our passions, they cannot alter the state of facts and evidence."

 The obvious questions are: Why is CMS deliberately steering the organ donation and transplantation system into chaos at a time when the US transplants are leading the world? Who and what are putting pressure on CMS to implement the Final Rule regardless of the human consequences? Why oppose an open donation and transplant policy debate based on peer-reviewed data? And, after two years, Why are the Centers for Medicare and Medicaid Services (CMS) and Congress continuing to ignore the National Academies of Sciences, Engineering, and Medicine's roadmap, Realizing the Promise of Equity in the Organ Transplantation System?"

 This highly disturbing episode at the American Transplant Congress took place just three months after the American Journal of Transplantation's publication of another peer-reviewed study that found the CMS Final Rule will shut down the wrong OPOs, this time because CMS failed to include race and ethnicity as an adjustment factor. Donation rates vary by race and ethnicity within every OPO. These disparities, which reflect inequities in the nation's health care system overall, won't be improved by burying our heads in the sand to the differences that exist now, even as OPOs work to close the gaps.

 AJT editors asked another transplant researcher, Jesse Schold, to comment on its study. In his commentary, Schold concluded that the CMS metric was "too fragile," meaning that luck and other factors outside the OPOs' control—not their performance—would determine where they were ranked.

Will HRSA ultimately permit the SRTR to publish the six previously approved papers? Will the accumulating evidence that its untested metric is failing in simulations and will lead to chaos persuade CMS to reconsider its Final Rule design? Will Congress have to step in? Will science and the protections of peer review triumph over the power of politics and billionaire activism? Stay tuned. Science in Donation and Transplant will continue tracking this story and keep our followers posted on any new developments.

###