HRSA Continues Its Heavy Hand of Censorship
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HRSA Continues Its Heavy Hand of Censorship
The frustrating history of the Centers for Medicare and Medicaid Services’ (CMS) failure to establish reliable performance metrics for Organ Procurement Organizations persists today, as SID&T has learned about a federal agency threatening a health research firm that was contracted to work with OPOs to develop an unbiased and accurate alternative to CMS’ latest flawed rule.
SID&T is told that the Association of Organ Procurement Organizations (AOPO)’s former contractor, Arbor Research, withdrew from the work it had begun after the Health Resources and Services Administration (HRSA) let firm executives know they would be barred from further federal work if they continued work on developing a statistically sound performance metric. This followed HRSA’s censorship of research abstracts due to be presented at the American Transplant Congress in June 2024.
The Center for Medicare and Medicaid Services and HRSA have repeatedly resorted to heavy-handed tactics to preserve the flawed Rule from scrutiny and suppress momentum within the donation and transplantation community to establish an accurate measure of quality.
In June 2024, at the annual meeting of the American Transplant Congress, an official with the Health Resources and Services Administration (HRSA) demanded that the authors of six peer-reviewed studies take down the abstracts and remove the presentation of the studies from the conference agenda. The studies all pointed out areas of concern and provided recommendations to improve CMS’s Rule.
SID&T has been reliably told that Arbor Research is not the first company with relevant expertise to turn down the opportunity to analyze the OPO performance metric owing to worries about losing access to federal contract opportunities. Arbor Research consults with the pharmaceutical industry, private foundations, and the federal government on policy and program development. Losing access to federal contracts would have hindered Arbor’s business viability.
The AOPO project in question was meant to enable the association to demonstrate that it was possible to design a statistical tool to measure the relative performance of the nation’s 55 OPOs that could rank them accurately without bias and provide valuable insights to enable all OPOs to improve their performances.
Since 2020, CMS’s current Rule has been the subject of more than 20 peer-reviewed published research studies. These studies found that the metric grossly misranks OPO performance and has been judged by leading donation and transplantation biostatisticians to be “too fragile” to be a reliable judge.
Among the metric’s “failings” are:
It is biased against the largest OPOs
It is biased against OPOs serving racially and ethnically diverse communities
It is biased against OPOs serving socioeconomically challenged communities
The death certificate data it is based on lacks crucial mandatory details for estimating donor potential, such as percentage of cancer deaths
It assesses only 1 year of performance despite the known issue that performance varies year-over-year in every OPO
It disregards evidence of variations in organ donor registration by each community
Aside from the built-in biases, the Rule was overtly designed to decertify up to 74% of all OPOs despite the certainty of untold disruption, prolonged appeals, and litigation. These are damaging to the reputation of the organ donation and transplantation community and undermining the faith with which potential donors and donors’ families have entrusted the transplant system.
Meanwhile, the current corps of 55 OPOs contributed to 14 consecutive record-breaking years for organ donation and transplantation. Any known factual record of system-wide performance concerns does not warrant CMS’ aggressive stance against OPOs. It appears to be inspired primarily by political pressure from a Wall Street-affiliated “patient advocacy” group with undisclosed motivations.
