PUBLIC STATEMENT

Media Contact:
Jenny Daigle | jdaigle@aopo.org

AOPO Outlines Key Recommendations to Strengthen Accountability
and Safeguard the Future of Organ Donation

McLean, VA (April 10, 2026) – On March 30, the Association of Organ Procurement Organizations (AOPO) submitted a comment letter in response to the Centers for Medicare & Medicaid Services’ (CMS) proposed revisions to the 2020 OPO Conditions for Coverage Rule. AOPO is urging CMS to correct oversight inconsistencies, clarify how the rule will be implemented at the same time OPO recertifications are underway, and ensure the necessary frameworks and safeguards are in place to prevent imminent and potentially catastrophic disruptions to our nation’s only organ donation and transplant system.

According to the most recent public data from CMS, OPOs serving nearly 72% of the U.S. population will face automatic decertification or be required to compete for their donation service areas. Putting nearly half of our nation’s OPOs at risk under the current rule could create irreparable, widespread disruption and destabilize the donation system, jeopardizing the lives of more than 100,000 patients currently awaiting lifesaving transplants.

AOPO’s comment seeks clarification on how CMS’s proposed revisions to the rule will impact existing system policies and clinical processes including:

• • • Patient safety policies
    • Referral and allocation of potential donors and donated organs
    • The handling of medically complex donors
    • How OPO rulemaking will intersect with accountability for other system stakeholders
    • Reporting requirements for research organs
    • The scope of OPO responsibility and authority before, during, and after the donation process

AOPO also recommended strategies to strengthen accountability, align stakeholder incentives, more accurately measure OPO performance, and mitigate the growing risk of system disruption.

The importance of these clarifications cannot be overstated as the current four-year OPO certification cycle is nearing completion. OPOs require clear standards and federal guidance to ensure accountability as they perform their daily work of saving lives, supporting donor families, and providing public education about organ donation.

AOPO strongly supports actions to strengthen the U.S. donation and transplant system, maximize the number of lives it saves and hold each of its stakeholders accountable. At the same time, the pace and approach to achieving these improvements must reflect the realities of clinical practice, donor potential, available technology, health system capacity, and the perspectives of donor families and the broader public as we work collaboratively with all stakeholders to advance donation and transplantation.

The framework CMS is using to evaluate OPO performance is based on two outcome measures: donation and transplant rates within a designated Donation Service Area (DSA). However, not only does organ acceptance fall outside an OPO’s control, this two-measure approach fails to account for variability between DSAs, such as population size and demographics, health disparities, and local donor hospital and transplant center practices. Both outcome measures also rely on the same underlying denominator derived from estimated donor potential within a DSA, which is factually unsound and insufficiently risk-adjusted for medically complex donors.

Additionally, the rate of organs that are recovered by OPOs but go unused has increased dramatically in recent years as CMS and HRSA are pushing OPOs to recover more organs, including from medically complex donors. In fact,11,342 organs were recovered by OPOs last year and not accepted by transplant centers, according to current OPTN data. Simultaneously, transplant center metrics disincentivize them from accepting these same organs. This systemic misalignment further demonstrates the importance of refining performance metrics and aligning regulatory incentives across the system to ensure every donation opportunity is maximized.

A Path Forward to Ensure System Stability

In addition to outlining the OPO community’s urgent concerns, AOPO recommends CMS consider further opportunities to accurately measure OPO performance, ensure accountability, and strengthen the system’s long-term ability to save lives as rulemaking is finalized. These include:

• • • The adoption of validated performance metrics that are scientifically-sound, independently validated, risk adjusted and aligned with CMS’s measurement framework. Separate from the current two-measure performance assessment framework, AOPO – in partnership with 53 OPOs and Econometrica, Inc. – is actively developing validated metrics that align stakeholder incentives, account for medically complex donors and reflect operational realities of the donation and transplantation system.
    • Implementing a “hold-harmless” period that allows for continued accountability and performance improvement during the sequenced transition to more robust and validated performance measures beginning in Fall 2026.
    • Administering a structured, phased approach that prioritizes the continuity of donation operations and patient access that remains threatened by abrupt mass decertification.

Accountability and system stability are not mutually exclusive; both are essential to maximizing organ donation and transplantation. By working with OPOs and hospitals to mitigate the risk of system disruptions and safeguard donor and patient access to organ donation and transplantation, CMS can ensure the system evolves safely and saves more lives. Above all else, AOPO urges CMS to prioritize operational continuity, ensuring efforts to strengthen oversight never come at the expense of America’s transplant patients, whose survival depends on this system’s stability.

AOPO greatly appreciates CMS’s engagement, especially the personal attention of CMS Administrator Dr. Mehmet Oz, and reiterates our unwavering commitment to improving our nation’s organ donation and transplantation system. AOPO stands ready to continue to work collaboratively with CMS to improve performance, strengthen accountability, and protect the continuity of donation operations so that more patients receive lifesaving transplants.

Each person who becomes an organ, eye, and tissue donor can save up to eight lives and heal more than 75. AOPO encourages everyone to learn more and consider signing up as a donor. You can register today by visiting RegisterMe.org/AOPO50K.