PUBLIC STATEMENT
Media Contact:
Jenny Daigle | jdaigle@aopo.org
AOPO Statement on CMS Guidance Reinforcing Safeguards
McLean, VA (March 13, 2026) – This week, the U.S. Centers for Medicare & Medicaid Services (CMS) announced new guidance concerning the roles of hospitals and organ procurement organizations (OPOs) in order to reinforce safeguards and clarify the unique responsibilities of each stakeholder in the donation process.
The Association of Organ Procurement Organizations (AOPO) supports policies that strengthen patient protections and public trust in the organ donation system. The safeguards highlighted in CMS’s announcement reflect longstanding medical and ethical standards that already guide OPOs and hospitals nationwide.
Patient care and safety always come first. OPOs do not play roles in clinical decisions about medical treatment, end-of-life care, or the declaration of death. These are made by a patient’s treating physicians and are completely separate from the organ donation process. Maintaining clear boundaries between teams responsible for providing care and those responsible for donation is critical to patient safety, clinical integrity, and public confidence in the system.
Organ donation is only ever considered once all lifesaving efforts have been exhausted by a patient’s hospital team. At that point, conversations will be held with the patient’s family to ensure they are given the time, information, and support they need to make informed decisions. While donations must occur within specific medical timeframes for organs to remain viable for transplant, highly skilled OPO professionals are trained to approach these discussions with compassion and respect during moments of profound loss. This process is also guided by whether their loved one was a registered organ donor, reflecting one’s legally documented decision to give the gift of life – akin to a will or advance directive – and the OPO’s responsibility to honor that decision as defined by the Uniform Anatomical Gift Act.
Overall, CMS’s guidance reinforces existing principles that are already foundational to our nation’s organ donation system. However, the system must also continue evolving as new technologies and clinical innovations become available. AOPO and its members are working diligently to support the development of uniform, transparent guidelines for complex donation practices, including donation after circulatory death and normothermic regional perfusion. Standardizing best practices nationwide will allow us to better fulfill donors’ final decisions, support their families, uphold public trust, and ensure patient safety while enabling more lifesaving transplants.
CMS’s announcement also outlined upcoming milestones clarifying how the agency will enforce its current performance metrics to determine OPO recertification later this year. AOPO appreciates these additional details, plans to respond to the proposed updates to the OPO Final Rule, and continues to work with partners to strengthen how performance in the organ donation system is measured.
To support that effort, AOPO – in collaboration with 53 OPOs and Econometrica, Inc. – launched an initiative last year to develop validated performance metrics that are scientifically sound, independently evaluated, aligned with CMS’s own measurement framework, and designed to more accurately measure OPO processes and outcomes. The project aims to strengthen transparency, accountability, and trust while ensuring oversight reflects how the organ donation system actually functions.
Based on current data, OPOs serving 71.5% of the U.S. population are projected to face automatic decertification or be required to compete for their donation service areas by the end of 2026 under the existing framework. AOPO is concerned that putting nearly half of our nation’s OPOs at risk under the current rule could create unnecessary, widespread disruption and destabilize the donation system, potentially impacting the lives of more than 100,000 patients awaiting transplants.
AOPO strongly supports oversight and continuous improvement to enhance OPO performance. Accountability and system stability are not mutually exclusive; both are essential to maximizing organ donation and transplantation. Through its validated metrics initiative, AOPO and its partners are working to provide practical, evidence-based solutions to strengthen accountability while preserving the continuity of donation operations and ensuring that as many lives as possible can be saved through transplantation.
Each person who becomes an organ, eye, and tissue donor can save up to eight lives and heal more than 75. We encourage everyone to learn more and consider signing up as a donor. You can register today by visiting RegisterMe.org/AOPO50K.