CMS Final Rule for Organ Donation: Unintended Consequences of the Pancreas Research Loophole

CMS updated the Final Rule for OPO Conditions for Coverage on 11/20/2020 to include new OPO metrics, tiers of classification, and a new definition of a donor that included an individual with: a) [≥]1 organ transplanted; or b) pancreas procured for research or islet cell transplantation. We conducted a retrospective cohort study using data from the OPTN/ UNOS. The number of pancreata procured for research increased four-fold from 2020 to 2022, despite stable numbers of other organs procured for research. Of the 57 OPOs, 8 (14.0%) procured >100 pancreata for research in 2022, accounting for 1,548 (58.2%) pancreata research procurements. Of those 8 OPOs, seven would be at risk for possible (Tier 2; n=3) or definite (Tier 3; n=4) decertification based on CMSs 2022 interim report. Based on these data, two Tier 3 OPOs would be reclassified as Tier 2 and one as Tier 1; three Tier 2 OPOs would be reclassified as Tier 1; and three Tier 3s would be reclassified as borderline Tier 2. The pancreas research carveout may detrimentally impact the system of organ donation by failing to accurately measure OPO performance and flag (and decertify) underpeforming OPOs unless CMS revises its final rule.