Preventing Organ Donation Disruption: SID&T Policy Brief
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Preventing Organ Donation Disruption: SID&T Policy Brief
22 Peer-Reviewed Studies Demonstrate the CMS OPO Metric Is Biased and Unreliable
Table of Contents
Section I — Executive Summary
Section II — SID&T Mission and Role
Section III — The Denominator is Wrong
Section IV — What the Research Shows
Section V — Risks if the Metric is Not Corrected
Section VI — Policy Recommendations
Section VII — Conclusion
Section VIII — Summary of Published Research
Section I: Executive Summary
The Centers for Medicare & Medicaid Services (CMS) intends to begin decertifying Organ Procurement Organizations (OPOs) in Spring 2026 using a performance metric adopted in 2020 as part of their Final Rule.
Since the Final Rule was implemented, 22 peer-reviewed studies, published in leading medical journals, have evaluated the CMS OPO performance metric.
These studies reach a consistent conclusion:
The CMS metric is statistically unstable.
It misranks OPOs 20–50% of the time.
It is biased against large OPOs.
It fails to account for social determinants of health.
It relies on an inaccurate denominator.
It risks decertifying the wrong OPOs.
Absent correction, the current framework could trigger:
Decertification of well-performing OPO
Litigation challenging the Final Rule
Service disruption in areas with decertified OPOs
Reduced donation capacity
Risk to transplant candidates
Section II: SID&T Mission and Role
Science in Donation and Transplant (SID&T) is a non-profit organization devoted to advancing and safeguarding the world-leading United States organ donation and transplantation system and all its participants.
We serve as a national watchdog, raising awareness about bureaucratic overreach and calling on agencies and Congress to use quality science to make healthcare policy.
Our Advisory Board is comprised of national experts and leaders in organ donation and transplantation. SID&T provides access to peer-reviewed research, independent experts, and supporting documentation relevant to organ donation policy.
Section III: The Denominator is Wrong
The CMS metric uses a flawed denominator used to estimate donor potential. CMS currently relies on CDC mortality data and the CALC methodology to estimate donor potential.
Research demonstrates this denominator:
Relies on a single cause-of-death diagnosis
Uses high-level mortality estimates rather than clinical referral data
Assumes uniform donor potential across hospitals and service areas
Fails to account for demographic and socioeconomic variation
CMS acknowledged in 2020 that hospital referral data is the most accurate denominator but declined to use it, citing concerns about feasibility.
For healthcare performance measurement, the accepted gold standard is Observed-to-Expected (O:E). In organ donation, O:E is measured as: Actual Donors ÷ Hospital-Referred Donor Potential
New research demonstrates that:
Hospital referral data is electronically available
It is verifiable and replicable
It can be validated using EMR and donor records
It is financially and technically feasible to implement
The gold standard denominator is now available for CMS to use for OPO evaluation.
Section IV: What the Research Shows
Across 22 peer-reviewed studies, the evidence demonstrates six consistent findings:
1. The CMS Metric Misranks OPOs
20–43% tier changes when alternate denominators are used
36–41% of OPOs change tiers year-to-year
11–29% shift tiers depending on data source
This level of volatility indicates instability and unreliability.
2. The Metric Is Biased Against Large OPOs
Simulation studies show:
The smallest OPO was incorrectly placed in Tier 1 72% of the time
The largest OPOs can rarely reach Tier 1, even when performance is equal
Large OPOs have a 95% probability of needing to recompete under certain scenarios
Small OPOs have as little as a 26% probability
The methodology produces systematic volume bias unrelated to quality .For healthcare performance measurement, the accepted gold standard is Observed-to-Expected (O:E). In organ donation, O:E is measured as: Actual Donors ÷ Hospital-Referred Donor Potential
3. The Metric Fails to Adjust for Social Determinants of Health
The CMS metric does not adjust for:
Race
Area Deprivation Index
Community-level social capital
Research shows:
16–41% of OPOs change tiers when ADI is incorporated
8 OPOs shifted tiers when race adjustment was applied
OPOs serving racially and ethnically diverse communities are disproportionately penalized
The metric measures demographics rather than performance.
4. One-Year Measurement Is Statistically Fragile
33–41% of OPOs change tiers from one year to the next
24 of 58 OPOs lie within 5% of a tier edge
Tier 1 and Tier 2 OPOs can be separated by as little as 0.01%
Such narrow margins indicate a fragile and unstable framework.
5. CDC Mortality Data Is an Inadequate Proxy
The CALC denominator:
Relies on death certificate data widely acknowledged to contain inaccuracies
Cannot exclude non-ventilated deaths
Is constrained by statutory limitations under the Public Health Service Act
Researchers consistently conclude that reliance on CDC Integrity mortality data reduces validity.
6. Hospital Referral Data Is Available and Feasible
New research demonstrates:
95%+ of referrals can be accurately categorized using EMR Respect and donor records
Referral data allows objective clinical assessment of donor potential
The data is verifiable and technically feasible to implement
CMS previously rejected referral data as infeasible. Evidence now shows it is viable.
Section V: Risks if the Metric is Not Corrected
If CMS proceeds with decertifications under the current metric:
High-performing OPOs will be decertified
Minority communities may experience disproportionate disruption
Litigation risk increases
Service transitions will destabilize donation processes
Transplant candidates may experience reduced access
Given the structural volatility in the tiering system, decertification decisions reflect statistical noise rather than true underperformance.
Section VI: Policy Recommendations
To prevent unnecessary disruption, policymakers should:
Require CMS to use hospital verified imminent death referrals and death referrals
Use OPTN policy defined Exclusion Criteria to rule in or out referred possible donors to remove concerns about OPO self-reporting.
Adopt CMS hospital practice of independent accrediting bodies to assess OPO performance.
Replace tier rankings with standard deviation-based evaluation.
Replace confidence interval with Observed to Expected.
Incorporate appropriate social determinants of health.
Evaluate performance using multi-year data rather than a single year.
Pause decertifications until methodological corrections are implemented.
Section VII: Conclusion
Twenty-two peer-reviewed studies published in leading journals consistently conclude that the current CMS OPO metric is unstable, biased, and statistically unreliable.
The research demonstrates the inaccuracy and non-reliability of the CMS metric being used to rank and decertify up to ⅔ of the nonprofit OPOs that run the best organ donation system in the world.
The research does not suggest abandoning accountability. It suggests improving measurement.
We encourage policymakers to review these studies and findings and ask that CMS be required to use OtoE as their performance evaluation with Hospital Referral Data serving as the denominators. CMS leadership and Congress must act prior to OPO decertifications starting in Spring 20206 to
Before Spring 2026 decertifications begin, CMS and Congress have an opportunity to align policy with evidence, to prevent lawsuits, chaos and deaths on the list, and to preserve the stability of the U.S. organ donation system.
Section VIII: Summary of Published Research
1. Centers for Medicare and Medicaid Services Performance Metrics and the Disproportionate Impact of Decertifying Organ Procurement Organizations on Minority Populations, Rodrigue, James R. PhD, et.al.;
https://www.amjtransplant.org/article/S1600-6135(25)00281-3/abstract
This 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, decertification could disrupt donation capacity, erode community trust, and worsen disparities in organ donation and transplantation.
2. Evaluation of the Stability of Organ Procurement Organization Performance Metrics; Lopez, Rocio et al., American Journal of Transplantation (May 21, 2025);
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 CALC Adjusted performance from Agency for Healthcare Research and Quality’s State Inpatient Databases (SID).
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, was found to result in a 20-43% change in tiers when the more detailed SID data was used.
“The present study confirms that CALC and CALC-adjusted rates are highly correlated, but … results in changes in tier assignments for 11-29% of OPOs.”
3. Direct Measurement of DCD Donor Potential, Tom Mone MS, Tom Rosenthal MD, and Tom Seto BS; OneLegacy, Azusa, CA; Transplantation April, 2025);
CMS has acknowledged that hospital to OPO referral is the gold standard oto assess donor potential, but concludes that it is too expensive and time concuming.
This study demonstrates that hospital referral and clinical data are available, can be validated, and can enable objective determination of donor potential based on multiple MD diagnoses and clinical testing results, with 95+% of referrals accurately categorized into Potential and Non-Potential.
Necessary systems include hospital OPO referral of all deaths and imminent deaths, OPO and hospital validation of referrals, Electronic Medical and Donor Records, and OPTN Exclusionary criteria.
Expanding OPTN criteria to specifically address DCD acceptance practices will result in even greater accuracy.
4. 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, et.al.;
https://www.amjtransplant.org/article/S1600-6135(24)00737-8/pdf
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.
Results indicate that the current CMS methodology systematically misidentifies 24-54% of OPOs across years 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.
5. Are the New CMS Performance Tiers Biased against Larger OPOs?, G. Lyden, et.al. American Journal of Transplantation (AJT), Volume 24, Issue 6, Supplement 1; Oral Abstracts Pg. S531, Abstract 1168,
https://www.amjtransplant.org/issue/S1600-6135(24)X0006-4
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.
This study uses simulation to assess biases against larger OPOs in the CMS OPO 2020 metric.
Smaller OPOs in Scenario 2 were much more likely to be placed in Tier 1, resulting in a 95% probability that the largest OPOs would have to compete compared to only a 26% probability for the smallest OPOs.
Large OPOs have an equal chance of being in Tier 1 only when all OPOs have an underlying rate equal to the previous year’s 75th percentile, but not in other scenarios where all OPOs perform the same.
Results indicate that the current CMS methodology systematically misidentifies 24-54% of OPOs across years 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.
6. Reducing Bias against Larger Organ Procurement Organizations in Performance Evaluations, G. Lyden, et.al., American Journal of Transplantation (AJT), Volume 24, Issue 6, Supplement 1. Poster Abstracts Pg. S1114, Abstract D294,
https://www.amjtransplant.org/issue/S1600-6135(24)X0006-4.
Under the CMS OPO 2020 metric smaller OPOs have a higher probability of being automatically recertified. This study proposes an alternative tiering system that is not biased. The CMS method incorrectly placed the smallest OPO in Tier 1 72% of the time and virtually never placed the largest OPO in Tier 1.
The O-to-E method has a uniform error rate across OPO volumes when all OPOs perform the same, thus removing the bias against larger OPOs, without sacrificing power to detect underperforming OPOs.
7. Prediction of Cause, Age, and Location-Consistent Deaths: A Useful Tool to Identify Areas for Improvement for Organ Procurement Organizations, J. Miller, et.al.; American Journal of Transplantation (AJT), Volume 24, Issue 6, Supplement 1. Oral Abstracts Pg. S532, Abstract 1170,
https://www.amjtransplant.org/issue/S1600-6135(24)X0006-4
Data used for CMS’ 2023 OPO evaluations are deaths from 2021. The data lag limits OPOs’ ability to track impacts of changes to their practice in near-real time.
This study presents a method to predict OPOs’ current CALC deaths using Scientific Registry of Transplant Recipients (SRTR) data.
The predicted CALC deaths can be used as a denominator for donation rate or transplant rate in years for which actual CALC deaths are not yet available from CDC or reported by CMS.
8. Adjusting for race in metrics of organ procurement organization performance, Jonathan M. Miller, et.al.;
https://www.amjtransplant.org/article/S1600-6135(24)00122-9/fulltext
CMS chose not to adjust for most demographic variables other than age (for the transplant rate), arguing that there is no biological reason that these variables would affect the organ donation/utilization decision.
However, organ donation is a process based on altruism and trust, not a simple biological phenomenon.
When adjusting for race, 8 of the 58 OPOs moved 1 tier: 5 in one direction and 3 the other direction.
Among the OPOs that moved to a lesser tier ranking in our study, 2 of the 3 currently underperform the national rates among White potential donors.
Failing to adjust for race puts OPOs that are currently performing well among minorities relative to national rates at risk, and elevates poorer performing OPOs.
9. Are the Centers for Medicare & Medicaid Services metrics evaluating organ procurement organization performance too fragile?, Jesse D. Schold, et.al American Journal of Transplantation,
https://doi.org/10.1016/j.ajt.2024.03.025
In statistical terms, Miller et al and Lopez et.al. research on CMS OPO metrics studies suggest that the CMS models are fragile.
OPO performance). This fragility, in the context of highly consequential ramifications, may be concerning without clear evidence validating poor OPO performance beyond current models.
The policy could lead to a revolving door (or a shrinking pool) of OPOs with additional performance cycles—and the attendant challenges of disruption to the donation/transplant process.
10. Population Characteristics and Organ Procurement Organization Performance Metrics, Rocio Lopez, MS, MP , et.al
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2809988
The CMS OPO rule evaluates performance based on an unadjusted donation rate and an age-adjusted transplant rates.
The study evaluates whether adjusting for age and/or area deprivation index yields the same tier assignments as the CALC tier used by CMS.
Age and ADI adjustment resulted in 19.0% to 31.0% reclassification of tier ratings for the OPOs, with 46.6% of OPOs changing tier ranking at least once during the 3-year period. Between 6.9% and 12.1% moved into tier 1 and up to 8.6% (5 of 58) moved into tier 3.
11. OPO Measured Donation Rate is Highly Volatile Year to Year and Not a Stable Quality Indicator, J. Schold, R. Lopez,
https://www.amjtransplant.org/article/S1600-6135(23)00475-6/fulltext
With new CMS regulations, Organ Procurement Organizations (OPO) are to be evaluated yearly and certified/decertified every 4 years based on a single year’s data. The purpose of this study was to assess the volatility of annual evaluations.
OPOs’ donor potential and donor rate are not stable year to year and 24/58 OPOs lie within 5% of a tier edge with many OPOs having shifts in donor potential >5%.
The consequence of yearly measurement may result in well-functioning OPOs inadvertently being decertified
12. Significant Discrepancies to Evaluate Organ Procurement Organization Performance Based on Exclusion Criteria, J. D. Schold, et.al
https://www.amjtransplant.org/article/S1600-6135(23)00475-6/fulltext
The study evaluates whether incorporating data with exclusions (CALC or CALC-adjusted) produce the same tier assignments, which determines OPO certification or decertification.
11/21 OPOs (52%) have greater than 5% difference in actual versus predicted donors. As a result, 29% (6/21) of OPOs change tiers using donor potential measured by CALC compared to that measured by CALC-adjusted.
Conclusions: Contraindicating exclusion factors are not equal across OPO service areas. Current tier assignments using CALC may be unreliable compared to those calculated by CALC-adjusted, using a large sample of OPOs across the country.
13. Impact of Area Deprivation Index on Organ Procurement Organization Performance Metrics, J. Schold, et.al.,
https://www.amjtransplant.org/article/S1600-6135(23)00474-4/fulltext
The evaluates if applying an Area Deprivation Index (ADI) adjustment yields the same tier assignments as the metrics used by CMS.
Compared to unadjusted donation rate and age-adjusted transplantation rate, additional ADI-adjustment resulted in 16% to 41% of OPOs changing tiers (figure) each year. Between 1-2 OPOs moved out of tier 1 and 3-7 moved into tier 1 each year.
14. Concordance by Data Source for Defining Donor Potential Using Cause, Age, and Location Consistent with Donation Used for New CMS OPO Regulations; J. Schold, et.al.
https://www.amjtransplant.org/article/S1600-6135(23)00474-4/fulltext
The study assesses whether CALC is a sufficiently reliable and objective determination of donor potential on which to make OPO decertification decisions.
Approximately 20% of OPOs changed tiers with State Independent Databases (SID) as compared to final rule (figure). Similar results are seen with transplant and overall tiers.
Tier assignments significantly change OPOs are reclassified for performance based on the different data sources. Given the structure of the tiering system and the significant ramifications, CMS should revisit their decision to use CALC for certification decisions.
15. Stability of New CMS Metrics for Organ Procurement Organizations: Comparison of 2 Consecutive Years, A. Israni, et.al.;
https://www.amjtransplant.org/article/S1600-6135(23)00475-6/fulltext
For the donation rate metric, between 2019 and 2020, 67% of the OPOs stayed consistent in their tiers and 33% changed tiers. For the overall tiers, 59% stayed consistent and 41% changed tiers.
Illustrating a limitation of using the prior year to set the performance targets.
16. Adjusting for Race in Metrics of Organ Procurement Organization Performance, J. Miller, et.al.;
https://www.amjtransplant.org/article/S1600-6135(23)00475-6/fulltext,
The CMS OPO donation rate metric is unadjusted, and the transplant rate metric is adjusted for age only. This study examines the impact of additionally adjusting these metrics for race.
Nationally, donation rates and transplant rates were higher among White potential donors than non-White potential donors.
When adjusting for race, 8 OPOs changed tiers (5 improved their tier, 3 lowered their tier).
Failing to adjust for race risks extreme penalties for OPOs that have high proportions of non-White potential donors
17. OPO performance improvement and increasing organ transplantation: Metrics are necessary but not sufficient; Kevin O’Connor, et.al.
https://www.amjtransplant.org/article/S1600-6135(22)08620-8/fulltext
The CALC methodology as the data set used to calculate the denominator for the new OPO metrics reliance on death certificates widely acknowledged to be fraught with errors and its inability to exclude non-ventilated deaths reduces the value of this data set for accurately assessing performance.
OPO performance improvement strategies use multiple measurements to identify opportunities to target and trial operational interventions.
18. The Centers for Medicare and Medicaid Services’ proposed metrics for recertification of organ procurement organizations: Evaluation by the Scientific Registry of Transplant Recipients, Jon J. Snyder, et.al.
https://www.amjtransplant.org/article/S1600-6135(22)22564-7/fulltext
On December 23, 2019, the US Centers for Medicare and Medicaid Services proposed 2 new standards that organ procurement organizations (OPOs) must meet for recertification.
This research examines how OPOs would fare under the proposed performance standards in 2016-2017 and concludes that the proposed new standards may result in over half of OPOs facing decertification, and risk adjustment suggests that underlying characteristics of deaths vary regionally such that decertification decisions may be affected.
Therefore, the overall 75th quantile will be too low for small OPOs and too high for large OPOs.
19. Assessment of National Organ Donation Rates and Organ Procurement Organization Metrics, Luke J. DeRoos, MS, et.al;
https://jamanetwork.com/journals/jamasurgery/fullarticle/2773525?resultClick=1
Objective is to evaluate OPO performance metrics using combined mortality and donation data and quantify the associations of population demographics with donation metrics.
We demonstrate significant variability in OPO performance rankings, depending on which donation metric is used.
The performance of OPOs should be evaluated using a range of donation metrics.
20. Examination of Racial and Ethnic Differences in Deceased Organ Donation Ratio Over Time in the US, Amber B. Kernodle, MD, MPH, et.al.
https://jamanetwork.com/journals/jamasurgery/fullarticle/2776217
Historically, deceased organ donation was lower among Black compared with White populations, motivating efforts to reduce racial disparities.
The study objective is to examine changes in deceased organ donation over time.
The findings of this cohort study suggest that differences in deceased organ donation between White and some racial minority populations have attenuated over time.
Despite improvements, substantial differences remain, suggesting that novel approaches are needed to understand and address relatively lower rates of deceased organ donation among all racial minorities.
21. Does Social Capital Explain Community-Level Differences in Organ Donor Designation?, Keren Ladin, et.al.; The Milbank Quarterly, Vol. 93, No. 3, 2015 (pp. 609-641)
Groups with higher levels of social capital, racial homogeneity, income, workforce participation, owner-occupied housing, native-born residents, and white residents had higher rates of organ donor designation.
These factors explained more than half the geographic variance in organ donor designation.
A better understanding of social capital may enhance efforts to increase organ donation.
Future interventions should tailor strategies to specific communities.
22. National Death Index Users Guide, CDC; National Center for Health Statistics. National Death Index User’s Guide. Hyattsville, MD. 2013;
https://www.cdc.gov/nchs/data/ndi/ndi_users_guide.pdf (accessed 7/31/2024)
The CMS OPO regulation metric relies on CDC Mortality data to certify and decertify OPOs in contravention of the Public Health Service Act limitations on its use to reporting and statistical purposes in medical and health research.
The Public Health Service Act (42 U.S.C. 242m) provides in Section 308(d) that the data collected by the National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC), may be used only for the purpose of health statistical reporting and analysis.
Furthermore, the applicant has assured NCHS that the identifying information will be used only for statistical purposes in medical and health research.