WASHINGTON – Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.), former and current chairmen, respectively, of the Senate Finance Committee, along with Finance Committee members Ben Cardin (D-Md.) and Todd Young (R-Ind.), are calling on the Centers for Medicare & Medicaid Services (CMS) to take additional measures to prevent abuse of pancreata procurement by organ procurement organizations (OPOs).

“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 to CMS Administrator Chiquita Brooks-LaSure.

“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,” the senators continued. “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.”

CMS earlier this year issued a memorandum in an insufficient attempt to clarify the intent of the 2020 rule that has contributed to a dramatic increase in the number of pancreata procured. In a follow up to CMS’s memo, Grassley and his bipartisan colleagues are pushing CMS to take specific actions to close its loopholes and curb further abuse in the pancreata procurement process.  

Read the senators’ full letter HERE.

Background

The senators last year wrote 10 OPOs regarding their pancreata procurement practices. Through their inquiries, they found that the total number of pancreata recovered for research spiked from 169 in 2018 to 1,606 in 2022 – an 850 percent increase in just four years. 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.

In a separate bid to hold OPOs accountable, Grassley last year led Wyden, Cardin and Young in launching an investigation into potential conflicts of interest at eight OPOs nationwide.

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