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2026 Studies
Below are curated studies from 2026.
Statistical Behavior of the Rank-order and Tiering Metric of the 2020 Centers for Medicare and Medicaid Services Organ Procurement Organization Rule
J. Thomas Rosenthal, Department of Urology, UCLA Medical School: University of California Los Angeles David Geffen School of Medicine, Los Angeles, CA. The author declares no funding or conflicts of interest.
Background
The 2020 Centers for Medicare and Medicaid Services (CMS) Organ Procurement Organization (OPO) rule used an estimate of OPO organ donor potential that included contraindications to organ donation, termed cause, age, and location consistent with donation (CALC). CMS asserted that even though CALC was inaccurate, it could still be used to compare OPOs because it highly correlated with CALC-adjusted to exclude the contraindications. Quantitative bias analysis is required to determine whether CALC can, in fact, be reliably used to make certification decisions under the rule.
Methods
A Monte Carlo simulation was carried out with 10 000 simulations using statistical constraints defining the relationship between CALC and CALC-adjusted applied to the published data in the rule.
Results
In every simulation, at least 2 OPOs changed tier assignment, with a median of 10 OPOs changing tiers across the 10 000 simulations. Several validations were carried out to confirm the results. All the tier changes were in OPOs that were closely adjacent to one of the cutoffs that determined tier assignment.
Conclusions
CALC, as applied in the 2020 OPO rule, possesses a level of stochastic instability that exceeds the threshold for accurate regulatory decisions. Its use will result in misclassification of a significant number of OPOs.
Citation
Direct Measurement of Organ Procurement Organization Donor Potential Using Comprehensive Referral Analysis: Feasibility and Implications for Assessing Organ Procurement Organization Performance
J. Thomas Rosenthal, MD,1,2 James R. Rodrigue, PhD,3 Tom Seto, BS,2 Prasad Garimella, MD,2 Alexandra Glazier, JD,3 Jennifer Prinz, MPH,4 Jeffrey Trageser, MSN,5 Sean Van Slyck, MPA,6 Janice F. Whaley, PhD,7 and Tom D. Mone, MSA8
Summary
Background: Previous methods for assessing organ procurement organization (OPO) performance have not been reliable, making it necessary to develop a direct measurement of donation service area donor potential. The purpose of this study was to use a previously validated direct measurement of donor potential using referral data from 6 US OPOs to assess its usability as an alternative to current methods.
Method: Records of all 45 458 potential organ donors referred to 6 US OPOs in 2023, based on Medicare requirements of hospital referral, were reviewed; reasons that cases did not proceed to donation were categorized and quantified. All hospital deaths were reviewed through tissue referrals and chart audits to assess whether potential organ donors had not been referred.
Results: Of the 45 458 referrals, 40 978 cases were ruled out for documented clinical reasons, leaving 4480 medically suitable potential donors. The percentage of medically suitable referrals by OPO varied from 7.5% to 12.4%. Hospitals referred to >99% of the medically suitable potential donors. A review of a large number of referral records was made possible by robust electronic systems in each OPO, which also makes auditing practical.
Conclusion: Determining OPO donor potential directly from a comprehensive analysis of hospital referrals is feasible and can be validated across multiple OPOs. It is more accurate than measures that use administrative data sources and could be a suitable alternative. Efforts should be made by national organizations to further their development.
Citation
Centers for Medicare and Medicaid Services Performance Metrics and the Disproportionate Impact of Decertifying Organ Procurement Organizations on Minority Populations
Rodrigue, James R. PhD1,2,3; Fitzpatrick, Sean MPA1; McKown, Brandon MBA
Summary
CMS OPO Metrics May Deepen Inequities
A new Transplantation study finds that CMS’s OPO performance metrics and tier-based decertification framework disproportionately penalize OPOs serving racially and ethnically diverse communities. Using CMS’s own methodology, the authors show that OPOs serving higher proportions of Black, Hispanic, and other minority populations are significantly more likely to be placed in lower tiers and face decertification.
Because the metrics do not adjust for social determinants of health or long-standing inequities in donor registration and authorization, the study warns that decertification could disrupt donation capacity, erode community trust, and worsen disparities in organ donation and transplantation. The authors conclude that accountability and equity must go hand in hand—and that without contextualized metrics, CMS’s approach risks unintended harm.
Citation