The Senate Committee on Finance wants answers on how exactly organ procurement organizations are counting their pancreata when reporting performance metrics to the Centers for Medicare & Medicaid Services (CMS).
Four bipartisan committee members led by Chair Ron Wyden, D-Oregon, announced this morning the delivery of letters to 10 organ procurement organizations (OPOs) requesting information on organs they recovered, placed for transplant and conducted research on from 2018 to 2022.
The senators’ concern centers on a potential loophole in CMS’ final rule that gives OPOs “the ability to falsely inflate their performance” when reporting the collection of a pancreas to the agency, they wrote.
Specifically, the loophole allows organizations to count pancreata obtained for research purposes under those procured for transplants, which the committee members said could explain how OPOs doubled the total number of pancreata reported for research in 2021.
“We are concerned some OPOs may be reporting pancreas procurements that are not, in fact, meeting the standard of bona fide research consistent with regulation and statute,” the senators wrote in the letters (PDF). “Based on communications we have received, we are concerned that many of these pancreata may not have been recovered for legitimate research purposes. This trend raises serious questions about OPO practice regarding procurement of pancreata for transplant in light of the CMS performance metrics.”
The senators’ letter described internal emails between OPO employees advising others on how to “game” CMS’ updated metrics.
“Savvy (or cynical?) OPOs ought to start a pancreas for research program immediately,” wrote one in an email, as cited in the senators’ letter to the organizations.
The lawmakers said they’ve also heard from whistleblowers within the OPOs warning that some OPOs are flagrantly gaming the OPO Final Rule, including by instructing staff and partner hospitals to create frivolous explanations for recovering pancreata, classifying such pancreata as "research and education."
Data provided to The Washington Post by an anonymous government contractor suggest that annual transplant pancreata collected nationwide held steady at 500 or so from 2013 to 2020 but jumped to more than 1,000 in 2021 and then over 2,500 in 2022.
Alongside information on how many pancreata were procured and how they were used in total, the senators requested information from the 10 OPOs on how they reported those numbers to CMS, documentation on the research the provided pancreata were used for and whether there were any financial transactions with those using the organs for research.
The senators’ letter was sent to: One Legacy, Donor Alliance, LifeQuest Organ Recovery Services, Indiana Donor Network, Kentucky Organ Donor Affiliates, Mid-America Transplant, New Jersey Organ and Tissue Sharing Network, LifeBanc, Lifeline of Ohio and Texas Organ Sharing Alliance.
Kathleen Giery, a director of one of those organizations, LifeQuest Organ Recovery Services, in Florida, told the Post in an email that “It is bewildering that anyone could claim that following the exact direction of the … Code of Federal Regulations could be construed as ‘exploiting a loophole’ or ‘gaming the system’.”
The other three senators who signed on to the letters were committee members Chuck Grassley, R-Iowa; Ben Cardin, D-Maryland; and Todd Young, R-Indiana.
The Senate Committee on Finance’s latest scrutiny comes nearly a year after it flagged the jump in reported organs to the Department of Health and Human Services. The committee also issued a report and convened hearings last summer that focused on “failures” in the organ transplant system that led to deaths. Later in the year, senators raised concerns on potential conflicts of interest (PDF) at the National Academy for Science, Engineering and Medicine in the wake of reports issued by the group that aligned closely with industry lobbyists.