June 06,2024

Wyden, Grassley, Cardin and Young Call on CMS to Strengthen Protections Against Excessive and Unnecessary Recoveries of Pancreata from Organ Donors

After Alarming Eightfold Increase in Number of Pancreas Recoveries, Bipartisan Senators Seek Tighter Oversight of Procurement

Washington, D.C. – Senate Finance Committee Chair Ron Wyden (D-Ore.), and Senate Finance Committee members Chuck Grassley (R-Iowa), Ben Cardin (D-Md.), and Todd Young (R-Ind.), today called on the Centers for Medicare & Medicaid Services (CMS) to take additional measures to prevent abuse of pancreata procurement by organ procurement organizations (OPOs) after rates of pancreata recovery have dramatically increased 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, sent to CMS Administrator Chiquita Brooks-LaSure, comes after the agency issued a memorandum earlier this year to clarify the intent of a previous rule issued in 2020 that has contributed to a dramatic increase in the number of pancreata procured.

Last year, the senators launched an inquiry seeking information from 10 OPOs about their pancreata procurement practices. While the investigation is ongoing, the senators found that the total number of pancreata recovered for research increased from 169 in 2018 to 1606 in 2022, representing an 850 percent increase. In 2018, 87.6 percent of these pancreata were used for research related to islet cell transplantation, while in 2022 only 47.9 percent of the pancreata were used for the same purpose.

The full letter can be found here.