Procurement of Pancreatic Islet Cells from Deceased Donors: Updated Data and Gaps in Reporting

In 2020, CMS updated the Final Rule for organ procurement organizations (OPO) in 2020 to include new metrics of OPO performance with a carveout whereby pancreata procured for research count as a "donor" to reward OPOs procuring pancreata for islet cell research or transplantation. Yet data suggested OPOs took advantage of this loophole, leading to updated guidance in 2024 to require OPOs classify whether procured research pancreata were "accepted for islet cell research." Based on updated data using the new CMS codes, the increase in research pancreas procurement was nearly half previously reported, but far greater than prior to 2020. Importantly, the number of pancreata OPOs reported were accepted for islet cell research were an order of magnitude greater than what was used by the Integrated Islet Cell Distribution Program (IIDP) and the Network for Pancreatic Organ Donors with Diabetes (nPOD), the two largest sources of islet cell/pancreata for qualified researchers in the US. Inappropriate procurement of organs, and mislabeling them as being used for "islet cell research" raises questions of fraud, waste, and abuse that requires further investigation and transprancy.