PUBLIC STATEMENT

Media Contact:
Jenny Daigle | jdaigle@aopo.org

AOPO Statement on Lawsuit Challenging the Centers for Medicare and Medicaid Services (CMS) OPO Final Rule

McLean, VA (August 6, 2025) – A lawsuit was filed on August 1 by seven organ procurement organizations (OPOs) from across the country, challenging the legality of a Centers for Medicare and Medicaid Services (CMS) Final Rule published in 2020 that redefined OPO performance measurement and recertification criteria.

The lawsuit, LifeLink Foundation et al v. Kennedy et al, is driven by concerns that the Final Rule, once implemented in 2026, will generate widespread disruption to the United States’ organ donation and transplantation system and threaten the lives of people waiting for organs.

The Association of Organ Procurement Organizations (AOPO) is not a party to the suit; the OPO plaintiffs acted independently of our representation. Nonetheless, AOPO recognizes this filing as the result of years of frustration by the OPO community, which has tried repeatedly to raise concerns regarding the rule’s well-documented flaws and sought both correction and clarification.

As 2026 draws near, the system risks destabilization if a significant number of OPOs that have shown growth are forced to shut down without plans in place to ensure uninterrupted donation services. The OPO community seeks to protect the patients and families who are counting on a high-functioning, collaborative system to save lives.

Given the ongoing concerns within the donation and transplant community, legal challenges became an inevitable step to ensure these critical issues receive the attention they deserve. We hope this lawsuit will be resolved swiftly, bringing greater focus to the widely acknowledged flaws in the Final Rule and on opportunities to improve it to better serve patients and donors.

Background on the OPO Final Rule

CMS issued its Final Rule establishing new performance metrics for OPOs in November 2020. Based on current data, 47% of all OPOs are slated for automatic decertification or forced competition to continue operating in 2026, despite the system experiencing 14 consecutive years of growth in deceased organ donation. The level of nationwide disruption this would cause is unprecedented in health care regulation. It would jeopardize the lives of patients awaiting transplants and interfere with Americans’ heroic desires to donate.

The Final Rule measures OPOs using just two factors: donation rates and transplant rates. Any OPO falling below the top 75^th percentile but above the median on either metric would be subject to open competition, while any OPO falling below the median on either metric would face automatic decertification. OPOs do not control the transplant rate of organs they recover; this solely depends on decisions made by transplant centers.

The rule mandates OPOs to make more organs available for transplant centers from older and less healthy patients. However, due to misaligned system metrics, these are the organs transplant centers are disincentivized from accepting for transplant. This reality has driven a year-over-year increase in the number of viable, lifesaving organs recovered by OPOs that are going unused.

Since the CMS rule was finalized, extensive peer-reviewed research has highlighted flaws with the metrics used to evaluate OPO performance, including:

• • • • Lack of Adjustment for Population Health – The current metrics fail to account for variability in donor service areas, such as demographics, health disparities, and death rates.
      • Data Lag – Assessments rely on two-year-old data from just one year of donation and transplant activity, making it an inaccurate reflection of current performance.
      • Unrealistic Accountability for Organ Non-Use – OPOs are penalized when transplant centers decline viable organs, even though OPOs have no control over those decisions. In 2024, over 9,000 kidneys recovered by OPOs and offered to transplant centers were declined and ultimately not used.
      • Untenable Ranking System – The rule is structured to evaluate OPOs using relative rankings rather than absolute performance, which means some OPOs will always fall into lower tiers and be at risk.
      • Bias Towards Larger OPOs – The rule disproportionately negatively affects OPOs serving greater population areas because they must ensure a greater volume of donations and transplants than OPOs in smaller communities.
      • Misclassification of Pancreas for Research – CMS incorrectly includes pancreata used for research in performance measurement, distorting OPO rankings.

AOPO’s Advocacy and Call for Immediate Action

AOPO supports efforts to enhance how OPO performance is evaluated. However, it is critical that these improvements are implemented thoughtfully, with careful consideration of their broader impact on the donation and transplantation system to ensure its continued effectiveness.

Despite repeated requests from AOPO, OPOs, transplant surgeons, and members of Congress over the past five years, CMS has not provided any formal guidance on how decertification or competition will be implemented without dismantling the system. The process of forced mergers may divert precious financial and human resources away from our mission of stewarding organ donation, leading to fewer organs available for patients in need of lifesaving transplants. This could be especially onerous if a smaller Tier 1 OPO is expected to absorb a much larger Tier 2 or 3 OPO. The agency has not ensured a continuity of donation services nationwide once the rule is carried out, creating apprehension among patients and the donation and transplant community.

Concerns about the OPO Final Rule have also been raised with Congress and the Office of Management and Budget (OMB), but no solutions have been advanced. With less than a year until the 2026 deadline, AOPO has urged CMS to implement an extended educational and testing period to refine and enhance performance measures, ensuring accuracy and reliability while preventing disruptions to the donors and patients relying on the organ donation system. If this is not possible, AOPO has also requested the Department of Health and Human Services (HHS) rescind and replace the Final Rule with a set of validated metrics and provide a pathway for OPO performance improvement before decertifying OPOs.

AOPO – in collaboration with 53 OPOs – has begun this work by launching an initiative to identify independently validated metrics to accurately measure OPO performance. This collective effort includes transplant patients, donor families, transplant centers, donor hospitals, and oversight bodies, all working together to improve system performance and bolster the mission of OPOs to increase organ donation and save more lives. By identifying updated measures, the project aims to strengthen accountability, trust, and equity within the system and ensure it remains lifesaving and world-leading for years to come.