Association of Organ Procurement Organization Volume with CMS Performance Evaluations.

Abstract

Under 2020 Centers for Medicare & 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 examines associations of CMS metrics with OPO volume and evaluates 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=2,042 vs. 2,124 vs. 1,003, p=0.028). 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, independent of quality, suggesting alternative statistical evaluations are needed to assess OPO performance accurately and improve donation processes of care and transplant rates.