Societies allocate scarce resources through formal and informal institutions. Informal institutions, usually evolutionary in origin, consist of bundles of norms and conventions about expected behavior in a variety of contexts ranging from families to professions. Formal institutions consist of collections of rules supported by coercive authorities that, in modern societies, are usually law-based. Understanding the relationship between informal and formal institutions is an important project for social scientists. Drawing on this understanding to identify institutional forms that policy designers can consider as alternatives for promoting public values is an important project for policy researchers. This study of the continuous distribution (CD) initiative undertaken by the Organ Procurement and Transplantation Network (OPTN) seeks to make contributions to both these projects.
The OPTN was established by Congress in 1984 as a chartered institution for stakeholder rulemaking to govern the donation and allocation of deceased-donor organs for transplantation. Rather than a federal agency making the rules that govern organ transplantation in the United States, the OPTN, which until recently has been fully administered under a federal contract by the United Network for Organ Sharing (UNOS), a nonprofit organization, does so. The OPTN provides a framework for the participation of stakeholders, primarily transplant professionals and patients, in determining the substantive content of rules. During most of its history, the OPTN has incrementally adjusted rules to take account of changes in technology, growing knowledge through the accumulation of evidence, and concerns about the equity and efficiency of the rules in place. However, in 2018, the Board of Directors of the OPTN committed to a major redesign of organ allocation rules, replacing heavily lexicographic priority across categories of patients and donors with point scores that would largely eliminate stark disparities at categorical boundaries. This book assesses the implementation of this radical change and its implications for students of organizational processes and institutional design.
The organ allocation rules in place in 2018 differed substantially by organ, emphasizing different values, such as avoiding immediate death for patients needing liver transplants and increasing posttransplant survival for patients needing kidney transplants. These organ-specific allocation rules relied heavily on categorization of patients, and for kidneys, categorization of donors, in complex ways. Although a variety of continuous measures were employed to assess such factors as waiting list and posttransplant mortality risks, sensitivities that limit the likelihood that any donated organ would be medically appropriate for a patient, quality of the donated organ, and distance between the hospitals of donors and potential recipients, these measures were largely translated into categories in the allocation systems. For example, all potential recipients listed in transplant centers within a specified distance from the donor hospital were treated equally in terms of distance – consequently, otherwise similar patients listed at centers on opposite sides of this artificial geographic boundary could have very different allocation priorities. The extensive use of categories created many such boundary effects raising obvious concerns about equity but also about efficiency when the boundaries prevent organs from going to patients who would experience larger gains in the reduction of mortality risk or contribute to the likelihood of a sequence of rejected offers with associated delay in subsequent offers that may ultimately result in an organ not being accepted and transplanted.
The CD initiative seeks to mitigate boundary effects by assigning an organ-specific score to each patient commensurate with the scores for all the other patients waiting for transplants of that organ. That is, instead of assigning priority primarily through a hierarchy of categories, it would be based on a single measure. The initiative requires that, for each organ, metrics be assigned to quantify progress toward each of five goals: (1) prioritize sickest candidates to reduce waitlist deaths; (2) improve long-term survival after transplant; (3) increase transplant opportunities for patients who are medically harder to match with donated organs; (4) increase transplant opportunities for candidates with distinct characteristics, such as pediatric or prior living-donor status; and (5) promote the efficient management of organ placement (OPTN 2022a). Organ-specific weights translate the metrics into overall scores for transplant candidates. When an organ becomes available for transplant, CD offers it to candidates in descending order of scores.
Several features of this OPTN initiative make it an attractive object of study for public affairs researchers. First, it is substantively important. The allocation of deceased-donor transplant organs has literally life-and-death consequences. In 2024, there were over 41 thousand transplants in the United States using organs from deceased donors. However, by the end of that year, the waiting list for transplants had grown to approximately 115 thousand and, during the year, almost 5 thousand people left the list because of death, and over 6 thousand were removed because they had become too sick to receive transplants. In the face of such scarcity and its consequences for the longevity and quality of life of patients, allocation rules clearly have important implications for the efficiency and equity of medical care.
Transplantation has fiscal as well as medical importance. The End-Stage Renal Disease (ESRD) Program within Medicare covers both dialysis and transplantation for patients of any age. The ESRD Program accounts for over 5 percent of total Medicare expenditures. Kidney transplantation not only offers greater longevity and quality of life for most renal disease patients but also reduces program costs, because its lifetime costs are lower than those for dialysis (Fu et al. Reference Fu, Sekercioglu, Berta and Coyte2020). More generally, transplantation has fiscal implications through Medicare coverage for seniors and Medicaid coverage for low-income patients.
Second, the unusual transparency of OPTN policy development facilitates the study of organizational processes usually opaque to all but participant-observers. The OPTN develops the substantive content of organ allocation rules through committees of volunteers, primarily transplant professionals but also patients, that are supported by UNOS staff. UNOS publishes summaries of these meetings online, and the meetings themselves are open to the public – rather than having to travel to venues of the committee meetings at locations like O’Hare Airport in Chicago, the move to primarily virtual meetings because of the pandemic allows for remote observation. (During the course of this study, I was able to observe over 100 meetings virtually or in person.) Beyond the committee meetings, well-documented processes, including committee reports to the OPTN Board of Directors and responses to public comments, make process tracing feasible. Although critics have raised concerns about a lack of transparency in terms of information on the performance of its constituent organizations, the OPTN very openly develops allocation rules. The OPTN thus offers a clear window into the nitty-gritty of organizational decision-making usually shaded from external view.
Third, the initiative serves as a “shock” to the OPTN committees that develop the content of allocation rules, requiring a fundamental change in the rubrics they employ in assessing these rules. The initiative has a clear starting point, and the clear goal of making the rubric changes across all transplant organs. Although the initiative includes a strategically determined implementation sequence that makes the experience of the early implementations relevant to later ones, the current allocation systems and their associated transplant communities differ substantially across organs, so that comparisons can nonetheless shed some light on the consequences of these differences and the robustness of this decision-making process.
Fourth, the initiative provides a very rare opportunity to observe explicit negotiation over the translation of values into operational rules. The negotiation most obviously plays out over the weights that committees assign to the general goals set out by the initiative. Committee members may have different views about the relative importance of the goals, and their views may differ from those of the larger transplant community elicited through public comments and application of the Analytical Hierarchy Process (AHP), a formal method for assessing the relative weights on competing goals implied by the hypothetical choices of respondents. Although perhaps less obvious, much value negotiation also plays out in the choice of metrics for measuring progress toward the general goals.
Fifth, the initiative involves negotiation among transplant professionals who, while sharing important norms and general values, nonetheless assess how these values apply to specific decisions from different perspectives. They widely share the norm of deference to evidence. So too is their shared belief in the importance of promoting equity in access to medical care. How these professionals assess equity, however, depends on their interests. For example, because having more transplant organs available at their own transplant centers is beneficial in terms of both their financial interests and the interests of their patients, transplant surgeons might very well have different assessments of the importance of geographic equity in access to transplants. Their assessment of equity may also depend on their experiences. For example, surgeons who specialize in pediatric transplants or tend to have patients with unusual conditions may be particularly sensitive to the implications of rule changes for these populations. Shared norms and values facilitate negotiation, and differing values make it meaningful to the participants.
Sixth, the initiative allows an investigation of the role of evidence about consequences in the application of values. Committees benefit in their deliberations from substantial quantitative evidence derived from the nearly universal longitudinal database of transplant candidates and recipients primarily collected by the OPTN and curated by the Scientific Registry of Transplant Recipients (SRTR) as well as from the extensive tacit knowledge of their members. Assessing how these types of evidence influence value choices furthers our normative understanding of organizational decision processes with implications for organizational design. This assessment offers the potential for generalization about organizational processes beyond the OPTN by identifying the circumstances under which diverse types of evidence influence the development of policy.
Finally, and most directly relevant to public policy, the initiative offers an opportunity to assess the capacity of stakeholder rulemaking, an example of what more generally could be called constructed collaboration, for making fundamental change. My prior research identified the apparent advantage of the OPTN over its most likely alternative, agency regulation, in terms of facilitating continuous incremental change informed by both evidence and explicit weighing of values. Yet interests also play a role, and the question remains as to whether the OPTN can manage conflicting interests sufficiently to accomplish fundamental change. As the robust good governance of complex policy issues requires the capacity for fundamental as well as incremental change, an assessment of the success of the OPTN initiative deepens our understanding of the advantages and disadvantages of stakeholder rulemaking as an institutional form for governing the way complex policy decisions are made.
The following section sets out the questions that this study seeks to answer and the empirical strategies for answering them. The next section views the OPTN as a form of governance. Subsequent sections note the broader questions informed by study of the CD initiative.
Further Assessment of Stakeholder Rulemaking
In 1998, I had a “driveway moment” listening to All Things Considered on public radio. A controversy over the geographic scope of organ allocation rules between the Department of Health and Human Services (DHHS) and UNOS drew public attention and prompted political action by Congress and many state governments. It initially struck me as puzzling that Congress would delegate responsibility for the substantive content of rules with life-and-death implications to a private organization. However, some reflection and a review of the history of organ transplantation solved the puzzle: the OPTN rescues members of Congress from a situation with an unfavorable balance of credit and blame. Almost certainly the alternative to the OPTN would have been conventional rulemaking by a federal agency. Because too few organs are available for all those who would benefit from transplants, members of Congress could expect pleas to intervene with agency “bureaucrats” to raise their constituents’ priority for organs. Yet any intervention that favored one type of patient would likely be perceived as harmful by an even larger number of patients whose priorities would necessarily be reduced. Consequently, blame in the context of agency rulemaking would almost certainly outweigh credit – especially as perceived losses would likely be more politically mobilizing than perceived gains. Thus, delegating rulemaking to transplant professionals offered blame avoidance through a generally, though not always, effective layer of insulation against the conflicting demands of constituents.
Beyond blame avoidance, the creation of the OPTN anticipated the difficulty that an agency would face in securing and maintaining cutting-edge expertise in a rapidly advancing area of medicine. By requiring all transplant centers, organ procurement organizations, and histocompatibility laboratories to be members, the OPTN potentially offered industry-wide participation. Because OPTN rules substantially affect the operations of these organizations, the opportunity to vote on rule changes provides a strong incentive to actually participate. This is especially the case for organ allocation rules that have implications for organizational finances as well as patient well-being.
The first research goal of my investigation of the governance of organ transplantation was to understand the OPTN as an institutional form. Although novel situations, or outliers, of various sorts can be valuable sources of ideas for policy design (Gofen and Weimer Reference Gofen, Weimer, Vigoda-Gadot and Vashdi2020), if the OPTN were just a sui generis way to avoid blame, it would not necessarily be a useful institutional model. Following the strategy of comparing similar processes in different contexts (Read Reference Read, Simmons and Smith2021), I identified several other cases in which rulemaking was effectively delegated to stakeholders (Weimer Reference Weimer2006). These cases involved allocation of things of value, such as agricultural quotas through marketing orders and internet domain names by the Internet Corporation for Assigned Names and Numbers (ICANN), with dominant influence by the most relevant stakeholders. They seemed to offer at least technical efficiency through timely incremental change in contexts in which the stakeholders have relevant expertise or information that is valuable because of changing circumstances in the policy area. I could also gain insight about stakeholder rulemaking from studies of private standard setting, which, although it supplements rather than replaces public rulemaking, similarly engages stakeholders directly in a process of weighing evidence to make consequential decisions (Cheit Reference Cheit1990; Majone Reference Majone1996). The comparisons of private and public standard setting reinforced my initial assessment of stakeholder rulemaking as offering a more flexible response to changing circumstances in complex policy areas than agency rulemaking.
Assessing the characteristics of the rulemaking produced by the OPTN was my next research goal. Of course, the assessment of a particular institution like the OPTN begs the question: compared to what? The counterfactual is rulemaking by a public agency. Rather than make comparisons with a particular agency, I employed a cross-sectional version of the “iron bar” design (Campbell and Stanley Reference Campbell and Stanley1963, p. 37) by comparing the OPTN rulemaking that I observed with the general characteristics of agency rulemaking described by researchers. Assuming these characterizations about agency processes, such as the reliance on advisory committees for tapping cutting-edge expertise, and outcomes, and the predominance of major episodic rather than frequent incremental rule changes, predict the likely performance of an agency charged with making organ allocation rules (the iron bar) and therefore provides a comparative basis for assessing the OPTN.
Understanding how the OPTN changes its allocation rules, as well as how stakeholder rulemaking would likely work in other contexts, required a closer look at the processes it uses to change rules. Specifically, I traced changes in allocation rules for kidneys and livers over the OPTN’s first 20 years with special attention to the roles of values, evidence (drawn both from transplant data and the tacit knowledge of transplant professionals), and interests (Weimer Reference Weimer2010a). My more recent research employed similar process tracing to assess the roles of these factors in subsequent changes to kidney (Weimer and Wilk Reference Weimer and Wilk2019) and liver (Moore and Weimer Reference Moore and Weimer2021) allocation rules. These studies convinced me that the OPTN was very effective, if slowly deliberate, in producing continuous incremental change informed by both values and evidence and therefore would be an appropriate model to consider for improving governance in medicine and other areas in which the effective uses of evolving expertise and evidence can contribute to better policy.
The incremental processes within the OPTN have produced some substantial changes in allocation rules. For example, lung allocation introduced the probability of posttransplant survival as a factor in determining priority, an innovation eventually implemented in kidney allocation following a decade-long development of rules, and liver allocation replaced historical geographic boundaries with pure distance measures, a change subsequently adopted for all organs. Yet the OPTN implemented these substantial changes within the existing organ-specific allocation frameworks. The CD initiative requires non-incremental, indeed radical, change in the structure and content of allocation rules. It also seeks to implement these changes over only a few years, a relatively abbreviated time in view of the much longer periods required for prior substantial changes to rules.
How well can the OPTN implement this non-incremental change? Answering this question sheds further light on stakeholder rulemaking as a potentially desirable form of constructed collaboration. The OPTN has demonstrated the capability of stakeholder rulemaking to adapt incrementally to new evidence as it emerges in a complex policy area. However, incremental responses may not be adequate in some circumstances – more dramatic and rapid changes are sometimes desirable. Observing implementation of the CD initiative informs our understanding of the robustness of stakeholder rulemaking as an institutional alternative for governing in policy areas in which effectively utilizing medical or scientific knowledge requires stakeholder expertise.
Broader Contributions
Beyond an assessment of the capability of stakeholder rulemaking for implementing non-incremental change, the study of the CD initiative contributes to our understanding of several generic processes of broader interest: the management of change in public organizations, the integration of expertise and public participation in policymaking, and the interrelationship of evidence and values in organizational decision-making. Although knowledge about the advantages and disadvantages of stakeholder rulemaking most directly applies to the specific context of US political institutions in which the OPTN is embedded, it informs a fundamental generic problem – how to integrate technical expertise appropriately and effectively into policymaking in rapidly advancing medical and scientific fields – that all countries must address. For example, with respect to the allocation of transplant organs, European countries have employed a variety of institutional forms, such as tapping transplant community advice to inform the National Transplant Agency in France (Agence de la biomédecine), the creation of task forces of government officials and stakeholders on specific issues to inform the UK Organ Donation and Transplantation Directorate within the National Health Service, and, most similar to stakeholder rulemaking, the delegation of the specification of the substantive content of allocation rules to the German Medical Association (Bundesärztekammer). Common to all of these institutional forms are the generic processes integrating expertise and values that I explore in the CD case.
The following sections set out these topics in general and sketch the sorts of comparisons I use to answer the questions they raise (Simmons and Smith Reference Simmons and Smith2021). Chapters 2–8 develop them in the context of relevant literatures.
Managing Change in Public Organizations
A voluminous literature on managing change in public organizations identifies conditions and strategies that contribute to success (Fernandez and Rainey Reference Fernandez and Rainey2006; Kuipers et al. Reference Kuipers, Higgs, Kickert, Tummers, Grandia and Van der Voet2014; Bryson Reference Bryson2018; Stouten et al. Reference Stouten, Rousseau and De Cremer2018). The success of the CD initiative can be assessed on several levels. First, were the initially set out timetables for the start, and subsequently set out for the completion, of the adoption of CD allocation rules met? These timetables provide unusually clear yardsticks for assessing progress. Second, do the new allocation rules provide the anticipated gains in efficiency and equity? As often the case with multidimensional organizational outputs, assessing the substantive impacts of changes is challenging and often necessarily subjective. However, the availability and use of simulation models during the design process and observation of outcomes after implementation provide rare, if imperfect, metrics for assessing the quality of change.
The CD initiative thus provides a substantial case for observing the management of planned organizational change with relatively clear measures of success. It offers an opportunity to assess generalizations in the public management literature about the conditions and strategies that contribute to success. Direct observation, extensive OPTN documentation, and interviews with participants provide the empirical basis for the case. Variation in circumstances across organs in terms of medical complexity and diversity of interests among practitioners offers some potential for assessing the conditionality of strategies.
In contrast to the study of the adoption of policies, which have natural terminal points, the study of their implementation requires researchers to select the durations of periods of observation. Researchers may be confident in defining the relevant time periods for observing implementations of relatively simple policies that clearly succeed or fail to produce their intended outcomes before being institutionalized or abandoned. Researchers studying more complex policies whose implementations require changes in organizational processes, such as rulemaking, discretionary adoption, or substantive adaptation, have the task of determining when the implementation process has sufficiently progressed to offer useful knowledge. In initiating my study of the CD initiative, I expected that I would be able to observe implementation of the initiative to the adoption of actual proposals, or the abandonment of efforts to produce them, at least for lungs, kidneys, and pancreases. CD for lungs was implemented, its evaluation begun, and the first round of modifications to it made on the basis of the evaluation. CD proposals for kidneys and pancreases were on track to be completed by early 2024. However, in September 2023, concerns about the growing rate of the nonuse of allocated kidneys, combined with the fear that CD as it was progressing might increase nonuse as well as the potential for reducing nonuse through modification of the CD initiative goals, led the OPTN Board of Directors to put the kidney and pancreas proposals on hold while the “Expeditious” task force, with broad representation of stakeholders, addressed the nonuse issue. The beginning of this hiatus of indeterminate length provides a natural end point for this study of the implementation of the CD initiative. Although only the CD of lungs had been fully implemented at this breakpoint, observing the substantial progress in implementing CD for kidneys, pancreases, and livers nonetheless provides valuable insight into the management of organizational change as well as the roles of evidence and values in the development of proposals.
Expert and Public Participation in Policymaking
What is the appropriate role of expertise in democracy? Although often cast as a stark choice between democracy and “epistocracy,” or expert rule, the recognition that good democratic governance requires expertise, shifts attention to the institutional arrangements that allow lay people and experts to contribute to practical knowledge jointly (Moore Reference Moore2021). Organ transplantation and its effective governance require specialized medical expertise that applies evolving knowledge from research and practice. The CD initiative provides a window into the effectiveness of the OPTN committee structure in engaging expertise and public comment in policymaking.
Relevant expertise is diverse and widely distributed among transplant professionals. Organ procurement personnel, laboratory scientists, doctors, and transplant surgeons are experts on various aspects of organ transplantation. At the point of the spear (or scalpel) so to speak, surgeons play a significant role in designing allocation rules. They bring specialized explicit knowledge as well as tacit knowledge to the process based not just on the types of organs they transplant but also the types of patients they routinely treat. The organ-specific committees charged with developing CD rules bring the most relevant expertise to bear. However, some relevant expertise resides outside of the organ-specific committees, including in committees organized around themes, such as ethics, patient and minority concerns, and the logistics of recovering and distributing organs. Routinized consultation among committees, facilitated by the UNOS staff, seeks to tap this more widely distributed expertise. During this process, the staff and committee members develop what Harry Collins (Reference Collins2004) labels interactional expertise that allows the participants to communicate across the domains in which they have explicit or tacit knowledge.
The OPTN seeks comments from the broader transplant community through presentations at regional meetings and explicit calls for comments from committees on both their concept papers and formal proposals to the Board of Directors. As is the case with agency regulation, final proposals address public comments either through revisions or discussion of why revisions were not made. Not surprisingly, almost all the public comments come from transplant practitioners and their professional societies. Although patients, and family members of patients, sometimes offer comments, as is the case with advocacy for the approval of new pharmaceuticals directed at the Food and Drug Administration (FDA) (Carpenter Reference Carpenter2004), the organizations that pay close attention and routinely offer comments represent people who suffer from various diseases who would benefit from transplants.
To gather more information from the transplant community to inform the development of CD proposals, the UNOS staff contracted for organ-specific applications of the Analytical Hierarchy Process (AHP). The AHP involves respondents allocating priority weights over pairs of alternatives. Analysis of the responses allows for the extraction of the implicit weights that respondents place on the CD attributes as expressed both in aggregate and for subsets of respondents, such as transplant surgeons and patients. The influence of these weights can be assessed by comparing them to those produced by the parallel AHP completed by committee members, the implicit weights in the categorical rules being replaced, and the weights that the committee ultimately recommends in its proposal.
Public participation in OPTN policymaking suggests the desirability of rethinking the distinction between the public and experts common in the political theory literature. The public participating in the development of organ transplantation policy is the transplant community, broadly defined to include patients and others who have tacit expertise through their involvement in transplantation. Those within the community certainly bring their personal values to the table, but generally in the context of some expertise, or at least familiarity, with organ transplantation and the policies that shape its practice. Indeed, in view of the complexity of the issues that must be addressed in organ transplantation governance, it would be naïve to think that many members of the public could be recruited to participate in the policy process. More generally, in moving from political theory to the actual design of institutions to govern technically complex policy areas, the relevant community of interested parties, the stakeholders, are the most relevant public.
Multigoal Organizational Decisions: The Interrelationship of Values and Evidence
Organizations, like individuals, routinely face trade-offs among desirable goals. A caricature of organizational decision-making separates the specification of goals from the alternatives for achieving them. A more realistic framing of decision-making recognizes the interrelationship of goals and alternatives. Trade-offs among goals that would be difficult for individuals or groups to specify in the abstract become more apparent in assessing the consequences of specific alternatives. The evidence supporting the assessment of consequences is thus interrelated with the values expressed in goals. The ultimate choice of values and the resulting policy choice requires negotiation among organizational members who hold different values and possibly different interpretations of evidence.
The CD initiative provides a rare opportunity to observe the role of evidence in the negotiation among organizational members in the weighting of goals. Although the initiative sets out broad goals, it requires each organ committee to specify metrics for assessing progress toward each of the goals and the distribution of weights across the metrics and their associated goals. Committees draw on a variety of evidence in preforming these tasks: quantitative evidence based on SRTR-curated data and other sources, including simulation models and dashboards that expose trade-offs; scholarly research directly and indirectly relevant to organ transplantation; the tacit knowledge of their members; their own AHP paralleling that of the larger transplant community; and the tacit knowledge embedded in the public comments received on their concept papers and proposals. Meeting summaries and direct observation of committee meetings facilitate process tracing to assess the role of evidence as committees move toward their CD proposals.
The initiative offers multiple cases for assessing the interplay between evidence and values. The implementation of CD for different organs provides a comparison of the roles of evidence and values in shaping final proposals. Within the development of each organ proposal, committees must make several important preliminary decisions. Some of these decisions are common across organs, allowing for comparison of how different committees approached the same task. For example, each organ proposal must develop a metric for the proximity of donors and patients because proximity has relevance to transplant outcomes and the logistical efficiency of allocation. Each organ raises specific issues that must be resolved. For example, the quality of a donated kidney influences priority in the current categorical system and poses a challenge for integration into the CD system. Comparison across the array of preliminary decisions increases the confidence with which we can assess the relationship of evidence and values within the CD initiative and interpret it generically.
As should be clear to readers familiar with the craft of policy analysis, trade-offs among competing goals only become meaningful in the context of specific alternatives. Discovering these trade-offs requires prediction, and therefore evidence. Further, the alternatives considered reflect values, usually implicitly, but sometimes explicitly, so that analysts can rarely cleanly separate goals and alternatives, especially in technically complex policy areas. In other words, evidence shapes values by exposing trade-offs across alternatives, and values shape the pursuit of evidence that leads to alternatives and their assessment. The CD initiative provides a rare window into the process through which values and evidence interact in collective decision-making.
Road Map
Chapter 2 describes the origin of the CD initiative, the object of study. It frames both incrementalism and the challenges to implementing major change in terms of path dependence. Despite incremental reductions in the importance of geography in organ allocation during the last 25 years, DHHS’s eventual conclusion that the OPTN could no longer use the location of hospitals within historically defined local areas as a factor in allocation required more substantial change. In response, the OPTN developed several alternatives. One of these was the replacement of legacy boundaries with pure distance measures, called acuity circles, which the OPTN eventually adopted for all organs. One of the other alternatives was CD, which could potentially eliminate geographic and other boundary effects. The OPTN launched the CD initiative, which would require the radical redesign of the allocation rules for each organ.
Subsequent chapters report on the empirical results previewed in this chapter. Chapter 3 assesses the implementation of the CD initiative in terms of the literatures relevant to organizational change, particularly those that consider planned change in public organizations. It assesses the preparation and execution of the overall initiative and then focuses on the development of the new rules for lung, kidney, pancreas, and liver allocation. The lung implementation was completed and is widely viewed within the transplant community as a success, thus providing a “proof of concept” for the full initiative. The greater complexity of kidney and pancreas allocation eventually prompted the meme “Continuous Distribution Version 1.0” to communicate the value of facilitating future change by primarily transforming the existing categorical allocation priorities into the CD framework. The OPTN was close to finalizing proposals when the Board of Directors decided to delay their completion until it could develop strategies to reduce the nonuse of allocated organs. The greater political complexity of liver allocation, especially in terms of the role of geography in allocation, means that the development of a CD proposal continues but also will not be finalized until the Expeditious task force, described in Chapter 7, provides guidance on how to take account of nonuse. The OPTN will also delay finalizing proposals until SRTR simulation models are modified to predict organ nonuse.
Expertise contributes to substantive, evidence-based, and predictive knowledge underlying rule changes. Chapter 4 considers the varieties of expertise and their roles in the initiative, distinguishing among explicit, tacit, and interactional expertise and the ways they engage in the OPTN committee system. It also introduces the optimization models, developed by MIT researchers using machine learning, that played an increasingly influential role in the development of CD proposals.
The OPTN routinely encourages public participation in its rule development through calls for public comment. However, the complexity and narrow band of the directly affected public result in public participation being mainly by members of the transplant community of practitioners, patients, and their families – so a more descriptive label would be community participation. During the CD initiative, the organ-specific committees also issued updates to solicit community comments prior to the formalization of proposals. Additionally, AHP exercises were used to elicit more, and more focused, comments relevant to the selection of CD weights. Chapter 5 reviews these efforts and discusses how the resulting community input has influenced the development of CD proposals. The AHP exercise for lungs had a direct impact on the selection of CD weights. However, the exercises for kidneys, pancreases, and livers seemed more valuable in terms of expanding community participation and producing informative open-ended comments than directly influencing weights.
The implementation of CD reveals an intricate interplay between evidence and values. Chapter 6 focuses on this interrelationship between evidence and values by process tracing specific decisions about the choice of metrics and their weighting in the development of CD proposals for lungs, kidneys, pancreases, and livers. Rather than treating weights as independent expressions of values, which would be consistent with the use of AHP, the weights became appropriately viewed as components of policy design instead of direct statements of value. Deliberation and analysis focused on valued outcomes, such as avoided deaths and increased access to transplants for disadvantaged patients. Consideration of trade-offs among these outcomes provided the actual revelation of values. This brings into question the usefulness of AHP in addressing multicriteria organizational problems. It also suggests that predictive models made practical by machine learning can, and more likely in the future will, be useful tools in organizational decision-making as well as public policy analysis more generally.
Allocation rules determine which patients are offered organs. However, as discussed in Chapter 7, whether patients receive the organs depends on decisions made by transplant centers. As is the case for most government regulations, outcomes depend not just on rules but also on varied organizational responses to them. With respect to the nonuse of donated organs, new federal rules governing organ procurement organizations incentivize the recovery of more organs of marginal quality while the SRTR report card on transplant centers incentivizes their rejection. Concerns about the consequences of these responses for nonuse of donated organs, both under existing policy and CD, led to a delay in the finalization of CD proposals in anticipation of guidance from a task force created to address the nonuse issue and the modification of SRTR simulation models to allow for the comparison of alternatives in terms of organ nonuse.
Chapter 8 concludes with implications of the study for our understanding of organizational decision-making as well as the advantages and disadvantages of stakeholder rulemaking as a form of constructed collaboration for scientific and medical policymaking. It provides a typology of constructed collaboration to tap stakeholder expertise in terms of the degree to which the stakeholders are involved in policy development and whether their engagement is ongoing or ad hoc. The chapter also considers the role of UNOS as administrator for the OPTN from the perspective of its reputation, which has suffered from its less effective role in improving system logistics to the detriment of its accomplishments in managing the challenges of developing organ allocation rules. Returning to the question of when stakeholder rulemaking would be a viable institution for addressing complex issues, the chapter identifies as prerequisites the feasibility of inducing participation, motivating the engagement of expertise, and making the engagement effective.
