Organ transplantation offers patients greater longevity and quality of life. The allocation of scarce deceased-donor organs involves high stakes for patients, transplant centers, and Medicare. The US Congress delegated authority for the development of allocation rules to the Organ Procurement and Transplantation Network (OPTN), which engages stakeholders in the process. In 2018, the OPTN committed to replacing categorical allocation rules with continuous distribution, a new framework that sought to eliminate inefficiencies and inequities at categorical boundaries. The transparency of the OPTN provides an opportunity to observe this attempt to implement a consequential planned organizational change. The process reveals the extent to which the stakeholder rulemaking of the OPTN, an example of constructed collaboration, can implement radical as well as incremental change. More generally, it offers insight into the roles of expertise and values in high-stakes and complex organizational decision-making.

The OPTN Board of Directors adopted strategies to build support and administrative capacity for implementing continuous distribution (CD). It also sequenced implementation of CD by organ to ensure adequate staff support for committees, learn from early implementations, and gain “small wins.” Implementation of CD began with lungs, because of the relative simplicity of the lung categorical allocation rules and the success of the lung committee in making substantial rule changes in the past. The lung proposal was completed, and its subsequent revisions indicated CD flexibility. CD implementation began for the more complex kidney and pancreas allocation prior to the finalization of lung CD. The kidney and pancreas CD proposals were near completion when the CD initiative was put on hold because of concern about the nonuse of donated organs. CD development was also under way for the more politically challenging liver allocation when CD was put on hold. The lung CD success serves as a proof of concept for CD. The kidney, pancreas, and liver efforts show the challenges encountered in making substantial planned organizational change.