December 2023 Updates
At every step of the modernization process, HRSA has been committed to robust competition for the first-ever multi-vendor solicitations for OPTN contracts, and we were pleased that Congress supported our vision for fundamental reform through passage of the bipartisan Securing the U.S Organ Procurement and Transplantation Network Act. For more than a year, we have pursued a fundamental sea change in how the OPTN operates in order to improve the performance, transparency, independence, and accountability of this life-saving system for patients – the first time in the nearly 40-year history of this program that any Administration has advocated for this type of fundamental reform to break up the monopoly. Below is an update on the progress made to date and details regarding next steps.
Since June 2023, HRSA has engaged in more than 800 conversations with community members to ensure that implementation of OPTN modernization reforms reflect the input of a broad array of patients, families, providers, and other stakeholders. In addition, we have hosted two separate sessions for potential bidders to broadly communicate our strategy for the modernization solicitations and inform our efforts to make the request for proposals process as easy to navigate, open, and transparent as possible. The first session, held on July 21, was attended by over 300 participants and the second session, held on November 9, was attended by more than 350 participants.
A key element of HRSA’s OPTN Modernization Initiative is the President’s Fiscal Year 2024 Budget proposal to more than double investment in organ procurement and transplantation with a $36 million increase over Fiscal Year 2023 for a total of $67 million. In light of the uncertainty regarding full-year appropriations for Fiscal Year 2024, as well as the upcoming holidays and HRSA’s commitment to providing at least 60 days for potential bidders to respond to solicitations, HRSA plans to issue the solicitations in January 2024.
What will change:
Launching an Independent OPTN Board of Directors
Current practice: For nearly 40 years, the Board of Directors for the Organ Procurement and Transplantation Network (OPTN) has been comprised of the same individuals who serve as the Board of Directors for the private entity that has held the OPTN contract. No formal requirements existed to protect against conflicts of interest resulting from this shared role.
Under HRSA’s OPTN Modernization Initiative:
- HRSA will issue a solicitation in January 2024 for independent non-profit organizations to bid on supporting an independent OPTN Board of Directors in order to ensure mission-driven governance, strong conflict of interest policy, and that the system remains a public good not a private asset. The organization awarded the OPTN Board Support Contract will not be awarded any other OPTN contract.
- HRSA will prohibit OPTN Board members from being officers or employees of any organization with a contract to operate any function of the OPTN.
- HRSA will require the new board support contractor to conduct a full review of the OPTN governance structure and by-laws, including the board nomination process, to further strengthen the independence, accountability, and transparency of the OPTN board as part of the new, modernized multi-vendor OPTN structure.
- The January 2024 independent Board of Directors’ support contract solicitation will be a one-year contract with several option years, as needed, to support standing up and operating the new independent board through the modernization process.
- In addition to the new board support solicitation, over the past year and half, HRSA’s oversight of the Board and the OPTN contractor has included taking action to address key areas of concern, including IT security, patient safety, member conduct and complaints, and removing race-based algorithms, leading to new policies to improve the operations, transparency, and functionality of the nation's organ transplant system.
- Although the Securing the U.S. Organ Procurement and Transplantation Network Act did not address current Board membership, current board members will not remain in place for 5 years, despite reports to the contrary.
- Currently, there are 41 members of the OPTN Board, and the terms of 24 members expire in 2024. HRSA intends for the new Board Support contract to be in place in 2024.
Robust Competition for First Ever Multi-Vendor Solicitations to Support Best-in-Class Vendors for OPTN IT, Operations, Communications, Research and Evaluation
Current practice: Across the nearly 40-year history of the OPTN, all functions of the OPTN have been managed by a single vendor and not competed based on technical expertise in areas like IT or operations. This does not serve patients well and does not allow the system to keep pace with modern technology.
Under HRSA’s OPTN Modernization Initiative:
Phase 1 — Competitive Transition Contracts:
- In January 2024, HRSA will release solicitations open to all non-profit and for-profit organizations for proposals for OPTN work related to information technology management, operations, data analytics/research, and communication.
- These contracts will support the transition from the legacy OPTN system to a modernized system and approach while ensuring uninterrupted access to the organ matching system and related processes in order to support transplantation and prevent unnecessary risk while protecting patients. As such, we refer to them as Competitive Transition Contracts.
- HRSA plans to make multiple awards to multiple vendors for these Competitive Transition Contracts.
- These contracts will have a base term of one year and the flexibility to exercise additional years as needed to support the transition.
- HRSA will issue domain-specific task orders that can be of varying lengths and for different services, maximizing the flexibility to evolve from traditional approaches and legacy systems to modern practices.
- Throughout the transition, HRSA will use data, stakeholder input, proven practices, and pilots to update approaches and advance new innovations.
Phase 2 — Next Gen Contracts:
- In Summer 2024, HRSA will issue solicitations open to all non-profit and for-profit organizations for proposals for the OPTN Next Gen contracts.
- The Next Gen contracts will prioritize human-centered design practices and will focus on developing a truly modern organ matching technology solution that is highly reliable, secure, and user-friendly.
- The Next Gen activities will build on the reforms and innovations implemented through the Competitive Transition Contracts and will include prototyping, testing, scaling, integration, deployment, and adoption support.
- The Next Gen contracts and activities will be continuously informed by the on-going engagement HRSA continues to have with stakeholders and our engagement with leading government technologists. These contracts will have a base-term of one year and the flexibility to exercise additional years as needed.
- HRSA will utilize all applicable federal procurement law, regulation, and policy to ensure accountability from new vendors, as we do with other vendors that currently implement IT or other technical functions through federal contract for other parts of the Agency. HRSA will embed accountability requirements and performance expectations in the contract solicitation process for each OPTN vendor and actively monitor and evaluate contractor performance and finances.
HRSA continues to work with Congress on the President’s Budget request to ensure that resources are available to support all of this critical work.