The Health Resources and Services Administration (HRSA) is taking historic steps as part of its Organ Procurement and Transplantation Network (OPTN) Modernization Initiative, leveraging new legal authority proposed in the President’s Fiscal Year 2024 Budget and signed into law as part of the Securing the U.S. Organ Procurement and Transplantation Network Act in September.
For the first time in four-decades supporting the national organ transplantation system, HRSA is issuing requests for proposals (RFPs) to support multiple different contract awards. This action will increase competition ensuring patients and their families benefit from best-in-class vendors.
HRSA is also taking steps to modernize the critical organ matching technology while increasing transparency and accountability by issuing new data reporting requirements to better address pre-waitlist and organ procurement practices. This important work on “pre-waitlist” practices will help address inequities in the transplant waitlist process by reducing racial and ethnic variation both in patient referrals and in organ procurement.
“For the more than 100,000 patients on the organ waitlist and their families, the time for reform is now,” said HRSA Administrator Carole Johnson. “The steps we at HRSA are taking today demonstrate our commitment to a more fair, well-managed, and high functioning organ transplant system in this country. Patients in need of organ transplant, their families and people who have committed to being organ donors deserve no less.”
Throughout the Biden-Harris Administration, HRSA strengthened the OPTN to better meet the urgent needs of the individuals on the organ transplant waitlist. In March 2023, HRSA launched its visionary OPTN Modernization Initiative to strengthen accountability and the performance of the nation’s organ transplant system by focusing on improving the OPTN’s governance, technology, and operations.
Across the nearly 40-year history of the OPTN, all functions of the OPTN were managed by a single vendor, rather than awarding multiple contracts based on technical expertise in areas like IT or operations. In 2023, new legislation reformed the decades-old statute, enabling HRSA to fundamentally transform the system and make multiple different contract awards to access best-in-class vendors. The legislation also gives HRSA the authority to implement its goal of creating an OPTN Board of Directors independent from other OPTN contractors to strengthen accountability and oversight. In addition, the new law eliminated the arbitrary appropriation cap to fund this work.
As part of HRSA’s OPTN Modernization Initiative, HRSA conducted extensive market research, reviewed responses to a HRSA request for information seeking public input on reforms, hosted two industry days with over 300 participants each, and engaged in more than 800 conversations with patients and community members. For the first time in the history of the program, today HRSA is issuing a solicitation to support an independent OPTN Board of Directors and releasing multi-vendor solicitations for the OPTN informed by this market research and centered on improving outcomes for patients.
HRSA actions include:
- Releasing a contract solicitation to break up the OPTN monopoly and create an independent OPTN Board of Directors, including supporting a special election to seat a new Board of Directors within six months of contract award. For nearly 40 years, the vendor that received the only OPTN contract and the OPTN itself had the same exact Board of Directors. To improve OPTN fairness, provide independent governance, and ensure strong conflict of interest requirements for the Board, HRSA is separating the Board of Directors, implementing robust new requirements to ensure the independence of the new Board, and issuing a solicitation for a non-profit entity with expertise in governance and process improvement to support the independent OPTN Board. This will include:
- Establishing a transitional nominating committee and seeking public input to develop a slate of candidates for a Board of Directors special election.
- Conducting a special election to establish a new, independent OPTN Board of Directors.
- Reviewing and providing recommendations for modernizing OPTN by-laws and conflict of interest policy and supporting Board implementation.
- Reviewing Board composition and structure, making recommendations and supporting implementation of approved reforms to improve functionality and system outcomes.
- Supporting the new Board of Directors in executing its oversight and management responsibilities.
- Issuing a multi-vendor contract solicitation to support broad competition and best-in-class vendors for critical OPTN functions. This will include:
- Reviewing and mapping legacy OPTN operations approaches and identifying actionable reforms to improve patient outcomes, system functionality, and system accountability through open competition and heightened HRSA oversight.
- Developing and implementing processes and metrics for monitoring and measuring patient safety, OPTN member performance, and compliance across all OPTN membership types and phases of the organ donation, procurement, waitlist, matching, transportation, and transplantation processes with a focus on improving patient, donor, and donor family experience.
- Supporting HRSA Modernization Initiative contractors in the development phase of new modular IT functionalities and the transition to a modernized OPTN IT system that leverages industry-leading standards.
- Updating and improving IT infrastructure now as a new modernized OPTN IT platform is built and deployed.
- Providing strategic and administrative services – including improving transparency and increasing public input – to support key OPTN operations functions.
- Analyzing and implementing approved recommendations to improve transplant program waitlist processes and acceptance criteria.
- Launching the discovery and development phase of the transition to a modernized OPTN IT matching system that leverages industry-leading IT standards and practices. The discovery process will help build the foundation for the comprehensive organ matching IT system redesign in the Next Gen contract solicitation, which will be released this summer.
- Taking action to address “pre-waitlist” inequities in the organ waitlist process and reduce variations in referrals to transplant and in organ procurement practices. HRSA is directing the current OPTN vendor to standardize and update data reporting on referral to transplant center, time-to-patient assessment, time-to-organ procurement, and other data to allow for greater accountability in organ procurement and transplant practices across geography and populations and facilitate improved system performance.
The scope and scale of HRSA’s awards under these new solicitations is contingent on final Fiscal Year 2024 appropriations. HRSA’s Fiscal Year 2024 Budget proposes a $36 million increase over Fiscal Year 2023 to support these modernization efforts.
View the full contract solicitations at https://sam.gov.