The Broader Sharing of Deceased Donor Kidneys Is an Ethical and Legal Imperative

Organ allocation policy cannot improve access to health care or compensate for regional differences in disease prevalence. Its primary purpose is to ration a scare resource. The laws governing organ transplantation in the United States require that allocation policy conforms to the two ethical principles of utility and equity. Furthermore, without utility, equity cannot exist and thus, the primacy of avoiding organ wastage. Each organ-specific allocation algorithm must balance the demand for optimal use of the organ with its fair distribution in a consistent and socially unbiased manner. The debate surrounding revisions to allocation policies reflects the evolving clinical and political landscape of solid organ transplantation. The underlying tension is caused by the challenge of achieving equipoise when geography imposes inherent barriers to developing equitable policy.

Prior to the year 2000, the distribution of donated organs was “local” and primarily on the basis of state boundaries. These local areas are referred to as donor service areas (DSAs). This made it possible for an organ to be allocated to a patient inside an area who was less medically urgent than a patient just outside the area.¹ Because organ availability varied among DSAs and as the need for organs outstripped the supply, there was a recognition that changes were needed in the allocation system. To address this, the Department of Health and Human Services (DHHS) issued the Final Rule in March of 2000. The Final Rule replaced local organ allocation systems with a national distribution protocol and operationalized the National Organ Transplantation Act of 1984. This act directed the Organ Procurement and Transplantation Network (OPTN) to develop national allocation policies. Specifically, the amended Final Rule in section 121.8 a(8) states that allocation “[s]hall not be based on the candidate’s place of residence or place of listing, except to the extent required by paragraphs (a) (1)–(5) of this section.”² Although this section is often selectively referenced to support either a pro or con argument about the wider sharing of organs, it is important to quote this provision in its entirety because the caveats place boundaries on how broadly organs are required to be shared. Paragraphs (a) (1)–(5) provide the constraints in which an allocation system must operate: sound medical judgement, best use of organs, preserve transplant program decision making, be organ specific, avoid organ wastage and futile transplants, and promote system efficiency. Therefore, restrictions on how broadly organs are distributed are appropriate and acceptable as long as the allocation rules can be justified under the criteria of paragraphs (a) (1)–(5). The crux of the current change in allocation is that using DSAs as the primary unit of allocation does not meet this standard.

The allocation of organs on the basis of DSA conflicts with the Final Rule, which requires prioritization of available organs among potential recipients by medical priority regardless of geographic location.² This conflict came to the attention of the judicial system in 2017 when Miriam Holman, a patient awaiting a lung transplant in New York, brought forth a lawsuit against the DHHS. She argued that DSA-based lung allocation was illegal because it assigned priority on the basis of a candidate’s place of listing for transplantation and not medical need.³ At the time, the allocation system was reliant on the arbitrarily drawn boundaries of the 58 DSAs and 11 OPTN regions. Neither DSAs nor regions were constructed with a consistent size or population and were never intended to be used for organ distribution. As such, policies that use DSAs for organ distribution violate the Final Rule because they result in allocation that prioritizes a candidate’s location over medical need and cannot be justified by the criteria put forth in paragraphs (a) (1)–(5).

The recent directive to change allocation policy is to ensure that organs are allocated in a manner that is legal, maximizes lives saved, is equitable, and minimizes the effect of geography.⁴ It has previously been established that the leading cause of disparity in access to kidney transplantation was the listing DSA of the recipient.⁵ However, the tipping point for change occurred when Ms. Holman sued the DHHS. In response, the OPTN formed the ad hoc Geography Committee to develop a new framework for organ allocation. The committee reviewed three distinct approaches; concentric circles on the basis of distance from the donor hospital, mathematically optimized regions, and continuous distribution.⁶ The committee decided that a model on the basis of continuous distribution⁷ was most appropriate because it combines the medical needs of the recipient with system efficiency and can easily be adapted to the clinical requirements of individual organs. Therefore, this approach meets a rigorous interpretation of the Final Rule.

The new change to the kidney allocation system (KAS) distributes kidneys first within a 250-nautical miles (nm) circle that is centered on the donor hospital, and it assigns up to two points on the basis of proximity of the recipient’s transplant center to the donor. Each allocation point is equivalent to 1 year of waiting time, and the proximity points are scaled down linearly as the distance from the donor hospital to the recipient’s transplant center increases out to 250 nm. This approach improves system efficiency by prioritizing a recipient who is closer to the donor and therefore, reducing travel distances. If the kidney is not allocated within the 250-nm circle, it is then offered out to a wider circle with up to four proximity points awarded with the same goal of minimizing travel. Although this approach is not a true continuous distribution model, it does represent a necessary incremental step. Foremost, it allows the existing KAS rules⁸ to remain intact as they can be applied in the 250-nm circle. This is important because it allowed the OPTN to meet the time constraints imposed by the courts for elimination of DSAs as the unit of allocation without throwing the entire system into chaos. It also allows organ procurement organizations and transplant centers that have previously not worked together to develop protocols and procedures for accepting and placing organs.

Predicting the effect of any change in allocation policy is difficult because the most important and least certain variable is how it changes behavior. However, certain changes will occur. The very concept of broader sharing means that organs will be distributed over a greater distance. This will require new working relationships to be formed between organ procurement organizations and transplant centers that previously had little interaction. Similarly, there will now be competition between transplant centers that previously did not exist and in certain regions of the country between a greater number of centers. Because the allocation score for kidney transplantation is heavily dependent on waiting time, it is more important than ever for kidney transplant programs to develop thoughtful and efficient list management practices. In the short term, there will be a “bolus” effect, where areas with longer waiting times experience an increase in the supply of kidneys at the expense of areas with shorter waiting times. However, the use of proximity points will attenuate the effect. Similar bolus phenomena were observed in patients with high calculated panel reactive antibodies and those with long dialysis time after the KAS was implemented.⁹ As with these two examples, after the system re-equilibrates, the new steady state will be predictable, and the number of transplants performed will loosely correlate with the number of patients on a center’s list.

Other potential but harder to anticipate effects are as follows. How will organs flow between urban and rural centers that are in close proximity? How will patients approach multiple listing opportunities? How will the increased distance and time of shipping kidneys effect organ acceptance practices, and what will be the effect of this shipping on organ acquisition costs? Finally, what changes will occur in living kidney donation? Currently, areas with shorter waiting time have lower rates of living donation.¹⁰ As waiting times equilibrate upward, will there be an increase in living donation? Although there are no clear answers to these questions, the OPTN has an existing mechanism for the monitoring of policies after implementation. The organ-specific OPTN committees receive regular data reports on new policies to monitor outcomes and assess for unintended consequences and unanticipated patterns. This approach has already been used to modify policy after implementation of the KAS in 2014 and the simultaneous liver-kidney allocation policy in 2017. This same approach will be used to assess and modify broader geographic sharing. In any allocation system, there is always a tradeoff between utility and equity, and the magnitude cannot be fully assessed beforehand. This will be true with the wider geographic distribution of kidneys. Therefore, it is necessary to observe the performance of the policy in real life to understand how it changes the behavior of individual practitioners and centers. With this information, it can be appropriately calibrated to achieve its intended goals.

It must be pointed out that a KAS on the basis of 250-nm circles is a steppingstone to a model that uses continuous distribution. The current legal environment brought about by patient-driven lawsuits to gain access to deceased donor organs and transplant center lawsuits to block the wider geographic sharing of them places the transplant community’s long enjoyed privilege of self-governance through policy making at risk. If the community fails to implement organ allocation policies that conform to the Final Rule and that place the needs of patients above the interests of transplant centers, legislators may step in and impose their “ideas.” These legislative “rules” by which organs are allocated are likely to be less informed and exceedingly difficult to change because they will be law. Therefore, the Rubicon has been crossed, and the only viable path is forward. Attempting to turn back will certainly lead to the transplant community losing its ability to self-govern. The path forward, although holding many uncertainties, offers the possibility of developing a patient-centered allocation system, and this is in the best interest of everyone.

Disclosures

None.

Funding

None.