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CMS Mis”calc”ulation Skews OPO Evaluation: Patients, Donor Families, and the Public Deserve Better

The intimate lifesaving act of organ donation requires public trust to encourage the gift of life to patients awaiting transplant. That trust demands accurate evaluation of Organ Procurement Organizations. The Centers for Medicare and Medicaid Services (CMS) has failed for years to best serve patients and donor families through its documented inability to find a reliable method to effectively measure organ procurement organizations (OPOs) performance.

CMS currently relies on a CALC (the Cause, Age and Location Consistent with Donation) adjusted methodology derived from refuted Goldberg/Bridgespan work. To gauge performance, CMS should reliably determine how many potential organ donors exist within each OPO’s donor service area. Without an accurate denominator for this calculation, the agency cannot know whether differences in organ recovery reflect OPO performance or differences among the populations and hospitals the OPOs serve.

CALC still dictates Tier placement and thus a false read despite an irrefutable body of research that demonstrates it is too imprecise and unstable to determine accurately which OPOs should earn federal recertification. CALC Adjusted was created for a 2017 study led by Dr. David Goldberg and co-authored by researchers affiliated with the University of Pennsylvania, the Bridgespan Group and ORGANIZE. Funded by the Laura and John Arnold Foundation.

The Goldberg study used hospital administrative data to identify deaths that appeared consistent with organ donation. The Goldberg/Bridgespan Group/ORGANIZE team conceded that administrative data could not reveal everything found in an individual patient’s medical record, could overestimate donor potential and required numerous assumptions. CMS applied selected cause-and-age criteria to data drawn from death certificates, which contain even less of the relevant clinical information than Goldberg.

Death certificates don’t show whether a patient was ventilated, whether organs were medically suitable for transplantation or whether death occurred under circumstances permitting donation.Subsequent peer-reviewed research has documented the consequences:

• A national evaluation of CALC’s stability found that 20% to 43% of OPOs changed performance tiers depending on the underlying data source and as many as 40% changed tiers from one year to the next—creating a serious risk of flawed recertification. (Jesse D. Schold et. al., “Evaluation of the stability of organ procurement organization performance metrics,” American Journal of Transplantation, October 2025.)

• Another study found that accounting for medical contraindications changed the tiers of 29% of OPOs. (Jesse D. Schold et al., “Significant Discrepancies to Evaluate Organ Procurement Organization Performance Based on Exclusion Criteria,” American Journal of Transplantation, June 2023 – American Transplant Congress abstract.)

• Further research points to a better approach: donor potential directly.

• In an initial proof-of-concept study, the researchers demonstrated that DCD donor potential within an OPO’s donor service area could be measured directly from actual hospital referrals and clinical records. (Tom Mone, Tom Rosenthal et. al., “Direct Measurement of DCD Donor Potential,” Transplantation, April 2025.)

A subsequent study of 45,458 referrals across six OPOs expanded that approach to total donor potential, including both brain-death and DCD donors. It found that OPO electronic records could be used to identify medically suitable potential donors, while reviews of hospital deaths could detect suitable patients whom hospitals had failed to refer.

Combined with separate measures of transplant-center acceptance and utilization, it could help regulators determine where donation opportunities are actually being lost.