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2025 Studies
Below are curated studies from 2025.
Evaluation of the Stability of Organ Procurement Organization Performance Metrics
Lopez, Rocio et al., American Journal of Transplantation (May 21, 2025)
Summary
This article reports on a 4-year evaluation of the CMS OPO regulation’s CALC performance metrics using 2018-2021 data from Centers for Disease Control (CDC) mortality data) and Agency for Healthcare Research and Quality’s State Inpatient Databases (SID).
The authors analyzed yearly performance variability, compared data sources, and examined the impact of CALC versus CALC-adjusted, which excludes donors with potential contraindications. There was significant year-to-year variability in CDC CALC tiers with 36%-41% of OPOs changing tiers year-over-year, making reliance on 1 year problematic.
CMS's reliance on CDC Mortality data that is based on a single cause of death as reported in death certificates, as compared to SID, was found to result in a 20-43% change in tiers when the more detailed SID data was used.
Addressing CMS’s response to public comments about the then proposed rule, the authors note that, “The present study confirms that CALC and CALC-adjusted rates are highly correlated, but despite these correlations, using different metrics results in changes in tier assignments for 11-29% of OPOs.“
These differences identify opportunities for potential changes to create more stable and consistent OPO performance measures and concludes that, “Although we cannot determine which data source is more accurate, the significant observed discrepancies raise concerns about accurately defining eligible deceased donors. It is challenging to confidently de-certify OPOs based on one of the two without knowing which data source is more accurate. The inherent limitations and potential biases in administrative data highlight the need to validate these sources through gold standard chart audits to ensure accurate identification of potential donors.”
Citation
Direct Measurement of DCD Donor Potential
Tom Mone MS, Tom Rosenthal MD, and Tom Seto BS; OneLegacy, Azusa, CA; Transplantation (Accepted for Publication, July 2024)
Summary
Existing methods of comparing organ procurement organization (OPO) performance utilize administrative data as an indirect measurement of donation after circulatory death (DCD).
The purpose of this study was to categorize and quantify reasons that potential DCD donors do not progress to donation to facilitate the direct measurement of OPO donor potential.
OPO donor potential calculated from referral and hospital death record reviews is substantially lower than donor potential determined by administrative data.
Direct measurement of OPO donor potential will be more accurate than any administrative measure, because many factors that rule out donors are not captured in hospital coded data or death certificates.
Citation
The Economic Value of Volunteers Directing and Managing the US Organ Donation and Transplantation System
Macey L. Levan, JD, PhD, NYU Grossman School of Medicine, NYU Langone Health, New York; Tessa L. Flower, BS, CCLS, Department of Population Health, NYU Grossman School of Medicine, New York; Allan B. Massie, PhD, Department of Population Health Science and Policy, Mt. Sinai Icahn School of Medicine, New York; Dianne LaPointe Rudow, ANP-BC, DNP, FAAN, Mt. Sinai Icahn School of Medicine, New York; Carolyn N. Sidoti, BS, NYU Grossman School of Medicine, NYU Langone Health, New York; Richard N. Formica Jr, MD, Department of Medicine, Yale University, New Haven, CT.; and Lloyd E. Ratner, MD, MPH, Department of Surgery, Vagelos College of Physicians & Surgeons, Columbia University, New York;
Summary
The organ donation and transplantation system in the United States is governed by a unique public-private partnership, largely driven by volunteer donation and transplant professionals and patients in Board and Committee roles.
From June 2023 to June 2024, 502 meetings occurred, with a mean of 23.94 participants; assuming each meeting lasted at least 1 h, this conservatively represents 12,019 volunteer hours, with an estimated value of $1,333,508.10, with another $4,633,493.90 of value when pre-and post-meeting work is included.
This level of volunteer effort is unique in the US healthcare system, and the expertise provided is invaluable.
While the federal government implements the “Modernization Act” restructuring it is essential to appreciate the economic and experiential value of this volunteer network that has a broad diversity of expertise, experience, geography, sex, ethnicity, creed, and race.
Citation
Transplantation,. 2025 Jan 27. doi: 10.1097/TP.0000000000005293.
Association of Organ Procurement Organization Volume With Centers for Medicare and Medicaid Services Performance Evaluations
Rocio Lopez Colorado Center for Transplantation Care (CCTCARE), Research and Education, Division of Transplant Surgery, Department of Surgery, University of Colorado Anschutz Medical Campus, Aurora, Colorado;, Sumit Mohan Division of Nephrology, Department of Medicine, Vagelos College of Physicians and Surgeons, Department of Epidemiology, Mailman School of Public Health, Renal Epidemiology Group Columbia University, New York, James R. Rodrigue Transplant Institute, Beth Israel Deaconess Medical Center, Boston, Massachusetts, Department of Surgery, Department of Psychiatry Harvard Medical School, Boston, Massachusetts, New England Donor Services Inc, Waltham, Massachusetts, Susana Arrigain, Ryan Lavanchy, Bruce Kaplan, and Elizabeth A. Pomfret Colorado Center for Transplantation Care (CCTCARE), Research and Education, Division of Transplant Surgery, Department of Surgery, Anschutz Medical Campus, Aurora, Colorado, Jesse D. Schold Department of Epidemiology, Colorado Center for Transplantation Care (CCTCARE), Research and Education, Division of Transplant Surgery, Department of Surgery, Anschutz Medical Campus, Aurora, Colorado.
Summary
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 64 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.
Citation
Lopez, Rocio et al. American Journal of Transplantation, Volume 0, Issue 0; https://www.amjtransplant.org/article/S1600-6135(24)00737-8/pdf