Organ Donation System Faces Overhaul to Avert Looming Crisis

MCLEAN, VA – May 05, 2026 – In a move aimed at preventing a potential nationwide crisis in the U.S. organ transplant system, the Association of Organ Procurement Organizations (AOPO) has formally submitted a new slate of performance metrics for federal review. The proposal seeks to redefine how the nation's 58 organ procurement organizations (OPOs) are judged, challenging a controversial federal rule that could see nearly half of them decertified by the end of 2026.

This initiative, announced today, places a spotlight on the high-stakes regulatory battle over the future of organ donation. With more than 100,000 patients currently on the national transplant waiting list, the outcome could have life-or-death consequences. The new measures were submitted for endorsement to the Partnership for Quality Measurement, a consensus-based body contracted by the Centers for Medicare & Medicaid Services (CMS) to vet healthcare metrics, marking a critical step in a campaign to reform the system from within.

A System on the Brink

The urgent push for reform stems from the CMS OPO Final Rule, which was finalized in 2020 and is scheduled for full enforcement in late 2026. Designed to increase organ donation, the rule implemented a competitive, tiered ranking system based on two key metrics: a donation rate and an organ transplantation rate.

Under this framework, OPOs are evaluated annually. Those performing in the top 25th percentile are recertified. Those scoring above the median but below the top tier must compete to retain their exclusive service areas. Critically, any OPO falling below the median on either of the two metrics faces automatic decertification.

According to AOPO, the consequences of this rule are dire. Projections indicate that nearly half of all U.S. OPOs—organizations that serve up to 72% of the nation's population—are at risk of decertification or forced competition. Such a widespread disruption would be unprecedented in American healthcare regulation, potentially destabilizing the intricate network that facilitates the gift of life from donors to recipients.

Measuring What Matters, or Missing the Mark?

Critics of the CMS Final Rule argue that its fundamental flaw lies in what it measures. The current system relies exclusively on outcome metrics that, according to a growing body of research, are statistically flawed and fail to account for the operational realities of organ procurement.

One of the most significant points of contention is the "transplant rate." This metric holds OPOs accountable for the number of organs that are ultimately transplanted. However, OPOs do not have the final say in this process. While they are responsible for identifying potential donors, securing authorization, and recovering organs, the crucial decision to accept or decline a specific organ is made by transplant surgeons and their respective centers. This creates a disconnect between an OPO's performance and the metric used to judge it.

"We cannot improve this lifesaving system if we do not measure it accurately," said Dr. Jean O'Connor, Health Practice Area Director for Econometrica, the nationally recognized research firm that partnered with AOPO to develop the new measures. "Oversight must be grounded in precise measures that reflect the role each stakeholder plays in the overall system."

Further complicating the issue is the data source. The CMS rule calculates its rates using a denominator derived from death certificate data to estimate the pool of potential donors. However, studies have shown that death certificates can have a high error rate in reporting the cause of death, leading to an inaccurate baseline for evaluating an OPO's effectiveness.

A New Blueprint for Performance

In response to these challenges, AOPO's project, developed in partnership with 53 OPOs and Econometrica, proposes a shift in focus from outcomes to process. The four new metrics submitted for review are designed to measure the foundational stages of the donation process, for which OPOs are directly responsible. These include:

• Referral Rate: The rate at which hospitals refer potential donors to the OPO.
• Approach Rate: The rate at which OPOs approach the families of referred potential donors to discuss donation.
• Authorization Rate: The rate at which families provide authorization for donation after being approached.
• Donation Rate: A redefined rate focusing on the number of actual donors relative to the pool of potential donors.

These measures were developed using CMS's own 'Blueprint Measure Lifecycle' framework and are grounded in the Donabedian Model, a widely accepted method for evaluating healthcare quality. By focusing on the direct work of OPOs, the new metrics aim to create a system where accountability is aligned with operational control.

This submission represents the first phase of a broader effort. AOPO has announced that additional measures focusing on donor management, organ yield, and utilization are expected to be submitted later this year, creating a more comprehensive picture of performance.

"Countless donors, patients and their families are depending on regulators and the donation community working together to protect this delicately complex system," said Jeff Trageser, President of AOPO. "Today's submission supports the growing need for refined performance measures and the alignment of regulatory goals across the system to ensure every donation opportunity is maximized and more lives can be saved."

By seeking endorsement from the Partnership for Quality Measurement, AOPO hopes to provide CMS with a scientifically validated, viable alternative to the current rule. The goal is to foster genuine improvement and collaboration across the organ donation community, ensuring the system's stability and protecting the continuity of care for the thousands of Americans waiting for a second chance at life.