PUBLIC STATEMENT
Media Contact:
Jenny Daigle | jdaigle@aopo.org
AOPO Statement on HHS Kidney Care National Plan
McLean, VA (October 28, 2026) – The Association of Organ Procurement Organizations (AOPO) shares the U.S. Department of Health and Human Services’ (HHS) commitment to improving kidney care, strengthening patient safety, and expanding access to lifesaving organ transplants. AOPO strongly supports efforts to increase transparency, accountability, and continuous improvement across the organ donation and transplantation system, with the shared goal of saving more lives.
As HHS considers the recommendations outlined in its Kidney Care National Plan—particularly those related to organ procurement organization (OPO) accountability, certification, and increased competition—it is essential that any proposed changes be grounded in accurate data, evidence-based performance measures, transparent processes, procedural due process, and thorough stakeholder engagement.
As the Plan establishes a framework for future federal action, AOPO encourages HHS to engage OPOs and other stakeholders early in the development and implementation of these recommendations. Oversight and accountability should consider all parts of the organ donation and transplantation process – not just OPOs – and must be designed to strengthen the system without disrupting donation services, undermining public trust, or jeopardizing access to transplantation for the over 100,000 patients awaiting life-saving organ transplants.
We are particularly concerned about recommendations in the Plan to accelerate the certification of new OPOs amid the upcoming implementation of CMS’s Revisions to the Conditions for Coverage (CfC) for OPOs Final Rule, which remains under Office of Management and Budget (OMB) review. Layering new certification and competition proposals on top of a recertification cycle set to begin in January 2027—before the revised CfC rule has even been finalized—creates substantial regulatory uncertainty for OPOs, transplant centers, and the patients and families who depend on them. HHS should not advance recommendations that presuppose a regulatory framework that is not yet final.
OPOs are federally designated, nonprofit organizations operating within a complex and highly regulated system. They play a critical role in coordinating organ donation, supporting donor families, and making lifesaving transplants possible.
Increasing OPO competition does not inherently translate to improved performance or better patient outcomes, particularly in a highly coordinated, time-sensitive system where continuity of services is essential. Introducing additional competitors without fully evaluating the operational implications, infrastructure requirements, and potential for disruption risks fragmenting referral pathways, duplicating existing systems, and diverting resources away from the donor and recipient support services that directly save lives—creating unintended consequences for patients and donor families.
Existing OPOs bring decades of experience, established relationships and deep community roots that are critical to supporting organ donation and transplantation. Disrupting these longstanding networks risks undermining trust and the quality of services provided to the communities they serve.
Organ donation is one of the few public health sectors still led by nonprofits and is fundamentally rooted in altruism, generosity, and public trust. Preserving this nonprofit, mission-driven foundation is essential to ensuring the safety, decisions, and dignity of donors, patients, and their families remain the highest priority.
Ahead of the upcoming recertification period, slated to begin January 2027, nearly half of the nation’s OPOs could face decertification or forced competition for their donation service areas (DSAs). Those OPOs currently serve up to 72% of the U.S. population. Such widespread disruption would be unprecedented in health care regulation. The timing of the Plan’s recommendations raises additional concerns, as OPOs approach a consequential recertification cycle without final regulatory guidance or current publicly available performance tiering data.
AOPO strongly urges CMS to make public the current tiering positions for all OPOs, as we cannot move toward a transparent system operating on data that is several years old. This is one of the most immediate and actionable steps HHS and CMS can take, and it should be treated as a threshold matter: no new certification or competition framework should move forward until updated, publicly available tiering data is in hand. Without updated performance data, OPOs, policymakers, and the public lack the information necessary to fully understand the potential scope and impact of upcoming certification decisions that could fundamentally reshape the nation’s organ donation system.
AOPO also supports efforts to strengthen patient safety and ensure the integrity of the organ donation process. We recognize the Plan’s recommendation to establish an Organ Donation Corruption and Safety Task Force to investigate safety and fraud concerns across the system. Patient safety is paramount, and any allegations of misconduct should be thoroughly investigated and addressed through fair, consistent, and transparent processes. Any new oversight mechanisms should include clear standards, appropriate due process, and accountability across all entities responsible for donor and patient care, including OPOs, hospitals, and transplant programs.
AOPO and its member OPOs remain committed to advancing meaningful, evidence-based performance measures, strengthening accountability, and collaborating with federal agencies and other stakeholders to continuously improve the donation and transplant system. We welcome the opportunity to work with HHS as it evaluates and implements the Plan’s recommendations, bringing the operational expertise and perspective of the nation’s OPOs to help shape reforms that protect patients, preserve public trust, and advance our shared mission of saving more lives through organ donation and transplantation.