A Year in Review: Advancing OPTN Modernization and Strengthening the National Transplant System
January 2026 Update
From January through December 2025, the Health Resources and Services Administration (HRSA) advanced a historic transformation of the U.S. organ donation, procurement, and transplantation system through decisive actions under the Organ Procurement and Transplantation Network (OPTN) Modernization Initiative. Over the past year, HRSA took decisive steps to strengthen governance, improve transparency, modernize data and technology, and elevate patient safety and oversight across the OPTN.
These actions reflect a focused effort to modernize how the OPTN operates—improving effectiveness, increasing accountability, strengthening federal oversight, and putting patient safety at the center of the system. Together, these actions represent the most comprehensive modernization of the OPTN since its inception and set a strong foundation for continued progress in 2026.
Strengthening governance and federal oversight
Throughout 2025, HRSA focused on strengthening OPTN governance and reinforcing clear lines of accountability. A major milestone was the establishment of an independent, elected OPTN Board of Directors separate from the OPTN contractor structure. This change clarified decision-making authority, reduced potential conflicts of interest, and strengthened the role of the Board in representing the needs of patients, families, and providers. The successful completion of national and regional elections, along with the selection of Board officers, marked an important step toward a more representative and accountable governance structure.
HRSA also took steps to improve transparency and trust across the OPTN community. This included initiating development of a secure collaboration platform to support OPTN governance activities and volunteer communications, as well as establishing a new process that allows anyone in the OPTN community to anonymously report allegations of misconduct directly to HRSA for independent review.
In parallel, HRSA transitioned to a new multi-vendor model for OPTN operations while maintaining continuity of critical services. HRSA also implemented recommendations stemming from multiple OPTN Discovery Task Orders that examined patient safety, communications, policymaking, and financial management, helping to address long-standing weaknesses and strengthen accountability across the system.
Improving financial transparency and accountability
In 2025, HRSA made major progress in improving financial transparency by transitioning OPTN registration fee collection from the contractor to direct federal management as required by new legislation. The legislative change brought fee collection and oversight under HRSA, increased visibility into OPTN fee collection and utilization, and aligned OPTN financial operations with federal standards.
HRSA approved the Fiscal Year 2026 OPTN patient registration fee and implemented a secure electronic billing process for fees for the September, October, November, and December 2025 billing cycles. These changes modernized how fees are collected, enabled fees to support multiple OPTN operations contracts, and improved consistency across the system. Additionally, by removing contractor-level opacity in financial reporting, HRSA strengthened fiscal oversight and reinforced confidence in how OPTN funds are managed.
Modernizing data, technology, and infrastructure
HRSA also made substantial progress modernizing OPTN data systems and technology infrastructure. HRSA initiated development of a unified OPTN data system to bring OPTN data into a single, secure, government-managed environment. This marked a clear shift away from the prior model, in which OPTN and Scientific Registry of Transplant Recipients (SRTR) data were maintained in separate systems, and is designed to improve data reliability, consistency, public access, and federal oversight.
To further improve transparency, HRSA enhanced allocation-related data tools, including new allocation out of OPTN sequence (AOOS) dashboards, standardized data definitions, and new compliance and monitoring tools. These improvements provide clearer, more timely insight into system performance and emerging risks.
HRSA also received approval from the Office of Management and Budget for the new Ventilated Patient Form, which standardizes reporting for critically ill patients referred to OPOs for the purpose of potential organ donation. This enables consistent data collection nationwide about all patients coming into contact with the organ donation and procurement system, and begins laying the groundwork for future automated data flows that will increase insights into differences between OPO providers, identify opportunities to increase safety and reduce unnecessary variation in quality of care for potential organ donors, reduce administrative burden, and improve data quality.
Collectively, these efforts are improving interoperability across OPTN systems and expanding HRSA’s ability to identify patient safety trends and operational risks earlier.
Advancing patient safety and clinical oversight
HRSA intensified its patient safety and compliance oversight across the organ donation, procurement, and transplantation system by taking decisive enforcement and corrective actions to address unsafe practices and systemic risks. This included issuing corrective action plans to address identified unsafe organ procurement practices and decertifying OPOs that failed to meet regulatory and performance requirements. Operational accountability was further embedded through the directive to create a Patient Safety Officer (PDF - 286 KB) role within each OPO, ensuring patient safety considerations are integrated into day-to-day operations.
In parallel, HRSA expanded surveillance activities focused on organ donor screening and the prevention of disease transmission, strengthening monitoring of emerging and known infectious risks. These efforts were reinforced through close collaboration with the Centers for Disease Control and Prevention (CDC) to update and strengthen policies on transmissible diseases (including rabies, Chagas disease, West Nile virus, and HHV-8), improving donor screening protocols, reporting requirements, and communication across the transplant continuum.
HRSA also conducted a comprehensive review of Allocation Out of OPTN Sequence (AOOS) practices, identifying the need for greater consistency, transparency, and compliance safeguards. As a result of this review, HRSA directed the OPTN to pause related Continuous Distribution policy development until corrective remediation could be completed. To support this work, HRSA established an AOOS Workgroup and a formal compliance framework to improve transparency, fairness, and accountability in organ allocation decisions.
Most recently, the AOOS Workgroup delivered three draft proposals to HRSA and the OPTN Board of Directors. These draft proposals, which were produced by the three AOOS Workgroup sub-groups, address:
- Creating an administrative definition of an “offer”
- An expedited protocol for the allocation of hard-to-place kidneys
- Proposed approaches to improve member compliance with OPTN policy
As of January 2026, these documents are being reviewed by the HRSA Division of Transplantation, the HRSA Office of General Counsel, and the OPTN Board of Directors. Products of the AOOS Workgroup will be published for public comment in accordance with the OPTN policy development process.
To further strengthen allocation oversight, HRSA developed new internal Allocation Compliance Reports for all 55 OPOs, providing a standardized mechanism to assess performance, identify outliers, and promote consistent application of allocation policies nationwide. In addition, HRSA launched efforts to develop comprehensive safety and quality standards for OPTN member organizations, beginning with OPOs and with plans to expand these standards to transplant centers and histocompatibility laboratories. Collectively, these actions represent a sustained effort to elevate patient safety, strengthen regulatory enforcement, and ensure equitable and compliant organ allocation across the transplant system.
Driving policy innovation and public engagement
HRSA also accelerated policy development and strengthened engagement with patients, families, and stakeholders. In 2025, HRSA led one of the fastest OPTN policy sprints in the program’s history to establish national standards for donation after circulatory death (DCD) family education, ensuring families receive clear, consistent information during critical decision-making moments.
HRSA expanded outreach, education, and reimbursement programs for living donors, reducing barriers to donation and strengthening support for individuals who choose to donate an organ.
To improve access to information and responsiveness, HRSA launched a centralized OPTN 411 call line that provides an easy entry point for questions, guidance, and support. The call line offers services in English and Spanish and supports additional languages through interpretation services, improving accessibility for patients, families, and professionals across the country.
Since becoming operational, OPTN 411 has responded to more than 200 calls, serving as a key resource for membership inquiries, waitlist information, finding a transplant center, and patient-focused information related to organ donation, procurement, and transplantation.
HRSA also strengthened communication with the community by launching an OPTN-specific email distribution channel, enabling more timely and consistent dissemination of policy updates, guidance, and operational information. This email distribution channel consists of more than 85,000 clinicians, transplant organizations, OPOs, labs, federal partners, patients, families, and the public. To stay up-to-date on the latest from the OPTN, subscribe here.
Finally, HRSA successfully transitioned the OPTN website to a new site hosted on a secure, government-managed server, improving reliability, cybersecurity, and federal oversight. Additional usability enhancements are planned for 2026 to further improve navigation, accessibility, and user experience for the public and transplant stakeholders alike.
Continuity of operations: contract extension to support patient safety and system stability
In December, HRSA awarded a contract with UNOS to continue supporting key components of OPTN Operations, including the national matching system, while advancing broader modernization efforts under the congressionally mandated multi-vendor model. Several functions historically performed by UNOS, most notably patient safety, reporting and tracking of potential donor-derived transmission events, and committee support, are no longer in the UNOS scope of work and will be competitively awarded to new vendors in early 2026. This shift is a core requirement of the Securing the U.S. OPTN Act, which called for stronger accountability, improved oversight, and increased independence across the transplant system following well documented safety concerns.
To ensure continuity during this transition, HRSA has reinforced and expanded federal management of all critical patient safety functions. In addition, OPTN Members and the general public should continue to report any allegations of misconduct – see the Contact the OPTN call out box above for points of contact.
These changes mark a significant evolution in OPTN operations. While service delivery models are shifting, patient safety is being strengthened—not reduced. Through direct federal oversight, clearer accountability, improved transparency, and stable operational management, HRSA is building a more reliable, equitable, and responsive transplant system as new vendors come online in 2026 and beyond.
Looking ahead: what’s next for OPTN modernization
While the progress made over the past year represents a major step forward, OPTN modernization is an ongoing effort, not a finished project. Many of the changes launched in 2025 laid essential groundwork, establishing stronger governance, clearer oversight, and more modern systems, but fully realizing their impact will require sustained focus and continued action. In the coming year, HRSA will continue to transition to cloud-based, modern OPTN technologies; expand and refine public-facing dashboards; improve oversight of safety reporting and allocation practices; engage patients, registered organ donors, donor families, clinicians and OPTN members in modernization efforts; build new tools to support real-time operations and data transparency; and ensure that all OPTN contracts reflect modern performance expectations.
As HRSA looks ahead, the next phase of modernization will further strengthen patient safety, complete key system transitions, deepen accountability, and ensure the OPTN operates with the reliability, transparency, and effectiveness that patients, organ donors, and the public expect.