Indy Standard

On June 7, 2024, U.S. Senators Todd Young (R-Ind.), Ron Wyden (D-Ore.), Chuck Grassley (R-Iowa), and Ben Cardin (D-Md.) urged the Centers for Medicare & Medicaid Services (CMS) to implement stronger measures against potential misuse of pancreata procurement by organ procurement organizations (OPOs). This appeal follows a significant rise in pancreata recovery rates in recent years.

“It appears that OPOs may be using taxpayer dollars to create demand rather than meet existing research needs, which could represent conflicts of interest or self-dealing,” the senators wrote. “We urge CMS to immediately begin work to clarify by rule that only pancreata recovered for research focused on pancreatic islet cell transplantation and conducted under FDA-approved clinical research be counted toward recertification. These steps will help close the pancreata loophole, and by doing so CMS will protect patients, preserve Medicare integrity, and ensure equitable application of the metrics across OPOs.”

The letter was addressed to CMS Administrator Chiquita Brooks-LaSure following an earlier agency memorandum aimed at clarifying a 2020 rule that has contributed to a sharp increase in pancreata procurement.

An inquiry initiated last year by the senators sought information from ten OPOs regarding their practices in pancreas recovery. Preliminary findings revealed an increase from 169 pancreata recovered for research in 2018 to 1606 in 2022—an 850 percent rise. Notably, the percentage of these organs used for islet cell transplantation-related research decreased from 87.6 percent in 2018 to 47.9 percent in 2022.

The full letter is available here.