AOPO Priorities for OPTN Modernization

Key Actions for the Future of Organ Donation & Transplantation

As the Health Resources and Services Administration (HRSA) moves into the next phase of implementing the Organ Procurement and Transplantation Network (OPTN) modernization, AOPO has identified several critical actions and policies HRSA and the OPTN should pursue. These steps, if taken in collaboration with key stakeholders, aim to create a system that better meets the needs of everyone involved in organ donation and transplantation, with donors, their families, and patients at the forefront.

Ensuring Legal Protections for OPTN Leadership

A top priority for AOPO is ensuring that members of the OPTN Board of Directors and the committees under their purview have standard legal protections. These safeguards are essential to maintain their ability to oversee and guide the work of current and future contractors in partnership with HRSA. The authority of the OPTN Board must remain intact, enabling them to effectively prioritize and lead modernization efforts.

Addressing Organ Non-Utilization

A growing concern in the donation community is the issue of organ non-utilization. AOPO believes HRSA should tackle this problem by:

1. Enhancing the efficiency of OPTN’s IT systems used by Organ Procurement Organizations (OPOs) to place organs.
2. Supporting technological innovations that can help transplant centers make faster decisions.
3. Requiring transplant programs to use systems like offer filters that improve organ allocation.
4. Implementing a dynamic allocation system that is more responsive and efficient.

Maximizing the use of donor organs is crucial, and instances of non-utilization should trigger quality improvement initiatives to ensure every donated organ is given the chance to save a life.

Optimizing Policy-Making Processes

AOPO advocates for HRSA to optimize the policy-making process to ensure balanced and equitable representation from all key stakeholders, including OPOs, transplant centers, recipients, donors, and donor families. To improve this process, HRSA should:

1. Add more public comment cycles to reduce the time from policy proposal to approval.
2. Complete the standard policy approvals within one year whenever possible.
3. Accelerate the approval pathway for urgent policy needs, with the option to sunset these policies if necessary.
4. Create a process for testing changes without violating existing policies.

Inclusive and thoughtful decision-making must guide modernization efforts. It’s vital the system is designed to protect science, fairness, and patient interests, rather than any profit motives or partisan influences. The system should collaborate with various oversight agencies to ensure its goals are in alignment with broader organ donation and transplantation processes.

Collaboration for Fair and Effective Leadership

The leadership and policymaking function of the OPTN must be supported by a nonprofit entity to ensure that improvements are based on fairness, equity, and sound medical and financial principles. Collaboration should include not only the OPTN but also other key agencies like the Scientific Registry of Transplant Recipients (SRTR), the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH).

Transparent communication and ongoing reporting will help all stakeholders stay informed about expected changes and timelines, ensuring the donation and transplantation ecosystem operates with efficiency and trust.

Fostering Transparency and Public Trust

HRSA, CMS, and the OPTN must continue to foster a transparent ecosystem which engenders public trust. Performance metrics for OPOs, transplant programs, and hospitals should be uniform, transparent, and consistently enforced. AOPO urges HRSA to work with CMS, OPOs, and stakeholders to develop common tools for data collection, validated metrics for assessing performance, and a process for improvement before any OPO is decertified.

Increased hospital accountability is also critical to improving donation outcomes. This could include implementing electronic referrals, recognizing non-donor events as significant, and launching quality initiatives to boost organ donation rates.

Ensuring Contractor Accountability and Transparency

HRSA must ensure all contractors supporting the OPTN are meeting the needs of the donation and transplantation community. This includes transparent performance expectations and clear alignment of each contractor’s responsibilities. It is essential the OPTN and its Board of Directors have a defined level of autonomy, protecting them from undue influence while ensuring they can carry out their mission in alignment with congressional intent.

Creating an Inclusive and Excellence-Driven OPTN

Finally, AOPO emphasizes the importance of equal representation in the leadership of the OPTN Board of Directors and its committees. This leadership should include voices from OPOs, patients, donor families, transplant surgeons, and hospitals. Government and regulatory bodies like SRTR, HRSA, and CMS should also play an active role in providing feedback and guidance to ensure the system remains robust and inclusive.

By pursuing these key actions, AOPO believes the OPTN modernization can deliver a more efficient, transparent, and equitable organ donation and transplantation system. Together, we can maximize the precious gift of donated organs, providing life-saving transplants to those in need.

Thank you,
Steve Miller, MBA, CAE
AOPO CEO