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Enhanced HRSA and CMS Collaboration, HRSA Stakeholder Engagement, and Industry Day

On March 22, 2023, the Health Resources and Services Administration (HRSA) announced a Modernization Initiative to strengthen accountability and transparency in the Organ Procurement and Transplantation Network (OPTN). This initiative is focused on five key areas: technology, data transparency, governance, operations, and quality improvement and innovation.

The OPTN Modernization Initiative is centered on putting patients first, prioritizing information flow to clinicians, promoting innovation through continuous competition, and enhancing transparency and accountability.

HRSA continues to work in close partnership with the United States Digital Service on human centered design and technology approaches to modernize the OPTN.

HRSA and CMS Collaboration

On September 15, 2023, CMS published an announcement about a coordinated effort with HRSA to improve organ donation, procurement, and transplantation through an Organ Transplantation Affinity Group (OTAG). The announcement describes efforts committed to by both agencies to drive improvements in donations, clinical outcomes, system improvement, quality measurement and transparency, and regulatory oversight.  

Anticipated efforts of the collaborative working group include:

  • Enhancing collaboration on federal policy development and implementation and communication to improve transparency and advance progress on national goals
  • Harmonizing data across the organ transplantation system to improve system performance and to develop a core set of national organ transplantation system performance metrics
  • Further strengthening accountability to patients, families, and the public by:
    • Advancing equitable access to transplantation by collecting data and establishing criteria for standardization and transparency of waitlist practices
    • Ensuring a transparent process for intake of stakeholder complaints and ensuring that concerns and recommendations are addressed in a timely manner
    • Promoting patient safety and engagement

External Engagement

HRSA is committed to continuing open dialogue with all OPTN stakeholders to ensure that patient, family, and clinician voices are engaged in the OPTN modernization efforts. In June 2023, HRSA, through its engagement with a program management support contractor, kicked off stakeholder interviews to better understand the pain points and perspectives of individuals and organizations that directly interact with the OPTN. This dialogue is a key part of the Human Centered Design (HCD), patient safety, and equity focused approach to the OPTN Modernization Initiative. HRSA will also engage with stakeholders in the form of focus groups to gather valuable feedback on the Modernization Initiative in the future.

A web-based contact form is now available on the OPTN Modernization website to provide another avenue to solicit feedback from patients, families, clinicians, and other interested parties.

Industry Day

HRSA is conducting market research to inform the development of the Fall 2023 contract solicitation and hosted an Industry Day for interested parties and vendors on July 21, 2023. Information shared during Industry Day is available on SAM.gov.

Stakeholder input and feedback from industry will inform the multi-vendor competitive solicitation that will be issued this Fall to manage the OPTN Modernization transition. Throughout this transition, continuity of services and patient safety will remain paramount.

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