The OPTN/UNOS Policy Development Cycle: Challenges and Opportunities

The policies governing organ procurement and transplantation in the USA are developed and implemented by the Organ Procurement and Transplantation Network (OPTN) which was established by the National Organ and Transplant Act in 1984. The OPTN, operated by the United Network for Organ Sharing (UNOS), develops and revises policies through an iterative, evidence-based, consensus-driven process involving input from OPTN/UNOS committees and regions, the donation and transplant community, and the general public. Nonetheless, circumstances have arisen where the OPTN/UNOS Board of Directors has acted prior to public comment in response to urgent situations, including development of new technology, adoption of new statutes and regulations, and in response to legal challenges. These events have led to updates to the OPTN bylaws and processes to provide a more transparent framework for future actions and improve the efficiency of the OPTN policy development process. Nonetheless, opportunities for improvement remain, particularly with regard to alignment of OPTN policies with those developed by the Centers for Medicare and Medicaid Services.