Transplant teams often reject organs offered to their patients for a variety of reasons, including the assessment that the qualities of the organs are too low. Rejections add to cold ischemic time, which makes low-quality organs even less desirable and thus increases the risk of nonuse. Recent changes by the Centers for Medicare & Medicaid Services (CMS) in the way it assesses organ procurement organizations (OPOs) and the more credible threat these changes pose to their local monopolies have incentivized the recovery of more low-quality organs. A change in the organizational report card for transplant centers has incentivized lower-volume transplant centers to reject more low-quality organs despite risk adjustment. The OPTN has developed several policies, such as offer filters, that attempt to reduce the number of organ offers transplant centers receive that they are unlikely to accept. The increasing rates of organ nonuse and the recognition that continuous distribution (CD) could help address it or make it worse led to the Expeditious Task Force and the postponement of the finalization of CD proposals for kidneys and pancreases.

The United Network for Organ Sharing (UNOS) began as the network administrative organization (NAO) overseeing the voluntary sharing of organs among transplant centers. It subsequently became the administrator of the Organ Procurement and Transplantation Network (OPTN), which Congress created to allocate deceased-donor organs when it nationalized them in 1984. The OPTN continuously makes incremental changes to organ allocation rules, raising concerns that the path dependence of allocation rules would hinder more radical change. Under pressure from the federal government, the OPTN gradually reduced the role of geographic boundaries in its allocation rules. However, it also introduced other categories so that allocation rules became increasingly complex. It initially considered continuous distribution (CD), a radical change, as an alternative for eliminating historical geographic boundaries. The OPTN subsequently committed to implementing CD for all solid organs because it offered improvements in efficiency, equity, and transparency, and because its relative simplicity would allow more expeditious incremental changes to allocation rules.

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 draws on a variety of expertise in designing organ allocation rules. Expertise arises from both explicit and tacit knowledge. Explicit knowledge includes generally accepted theories and empirical regularities that are accessible without first-hand experience of practice in some domain of knowledge. Tacit knowledge arises from experience, such as professional practice. In addition to this contributory tacit knowledge, it may also arise through interaction among participants in some domain of knowledge. Through its committee system, the OPTN taps the contributory knowledge of practitioners and patients and creates interactional tacit knowledge, especially among committee staff. Explicit knowledge arises from analysis of near universal longitudinal data on transplant candidates and other data collected within the transplantation system. These data support predictions of policy outcomes through simulation models and optimization tools utilizing machine learning.

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.

The development of continuous distribution (CD) proposals for lungs, kidneys, pancreases, and livers display the interrelationship of values and evidence. CD involves identifying attributes that assess progress toward five goals: (1) prioritize sickest candidates first to reduce waitlist deaths; (2) improve long-term survival after transplant; (3) increase transplant opportunities for patients who are medically harder to match; (4) increase transplant opportunities for candidates with distinct characteristics, such as pediatric and prior living donor status; (5) promote efficient management of organ placement through consideration of geographic proximity between donor hospitals and patient transplant centers. Weights are then assigned to the attributes and goals to obtain a composite priority score. Both values and evidence influenced the choice of attributes and their functional forms. Rather than primarily statements of values, weights became design features in machine learning optimization exercises that allowed for the identification of alternatives that predicted the most favorable combinations of efficiency and equity outcomes.

The OPTN routinely secures public comment on its proposals. The public generally consists of organ transplantation practitioners, individual patients, and organizations representing patients with transplant-relevant diseases. Thus, it might be better labeled “community participation.” Community participation occurs within the organ-specific committees that lead on the development of allocation rules as well as through interaction with committees with crosscutting portfolios, such as those considering patient and minority interests, and regional meetings. Committees issue white papers, progress reports, and proposals for community comment. Particularly with respect to proposals, committees respond to community comments in their submission of final proposals to the Board of Directors. For the CD initiative, the OPTN also sought community input from analytical hierarchy process (AHP) exercises at both the committee and community level. Information from the AHP had some influence in the development of the CD proposal for lungs. More generally, its value was in providing a focus for eliciting more participation and obtaining more focused qualitative comments.