Association of organ procurement organization volume with Centers for Medicare and Medicaid Services performance evaluations.

Under 2020 Centers for Medicare and Medicaid Services (CMS) conditions of coverage, Organ Procurement Organizations (OPOs) will be decertified if their 95% upper confidence limit for donation or transplant rate falls below the previous year's median (tier 3) and must recompete if either is below the 75th percentile (tier 2). This study aimed to examine the associations of CMS metrics with OPO volume and evaluate an alternate observed-to-expected tiering system using simulation analysis and CMS's OPO public report. In 2021, CMS tier 3 and 2 OPOs had significantly larger volumes than tier 1 OPOs (median = 2042 vs 2124 vs 1003; P = .028). In a simulation scenario in which OPOs should be CMS tier 2, large OPOs had 95% probability of needing to recompete vs 26% for the smallest OPOs. The observed-to-expected method misclassified OPOs as underperforming ∼5% of simulated cases independent of volume. CMS methodology assigned a worse tier than observed-to-expected to 24%-54% of OPOs across years. Results indicate that the current CMS methodology systematically identifies larger OPOs as underperforming and independent of quality, suggesting alternative statistical evaluations are needed to assess OPO performance accurately and improve donation processes of care and transplant rates.