Referral and Beyond: Restructuring the Kidney Transplant Process to Support Greater Access in the United States

Abstract

Advocates for improved equity in kidney transplant in the US have recently focused efforts on initiatives to increase referral for transplant evaluation. However, because donor kidneys remain scarce, increased referrals are likely to result in an increasing number of patients proceeding through the evaluation process without ultimately receiving a kidney. Unfortunately, the process of referral and evaluation can be highly resource-intensive for patients, families, transplant programs, and payers. Patients and families may incur out-of-pocket expenses and be required to complete testing and treatments that they might not have chosen in the course of routine clinical care. Kidney transplant programs may struggle with insufficient capacity, inefficient workflow, and challenging programmatic finances and payers will need to absorb the increased expenses of upfront pretransplant costs. Increased referral in isolation may risk simply transmitting system stress and resulting disparities to downstream processes in this complex system. We argue that success in efforts to improve access through increased referrals hinges on adaptations to the pretransplant process more broadly. We call for an urgent reevaluation and redesign at multiple levels of the pretransplant system in order to achieve the aim of equitable access to kidney transplantation for all patients with kidney failure.

Introduction

Kidney transplantation is an invaluable treatment option for many people with kidney failure. However, in the United States (US), most patients do not ultimately receive a transplant, and deep disparities in access to this treatment persist for minoritized racial groups and socioeconomically disadvantaged patients. To address disparities in access to transplant, recent years have seen the kidney community in the US focusing efforts on encouraging more frequent and broader referral of patients to transplant programs. Information on referral for transplant will soon be part of routine reporting from dialysis units to Center of Medicare & Medicaid Services.¹ New quality metrics incentivize nephrologists and dialysis facilities to refer patients for transplant evaluation. For example, the percent of prevalent patients waitlisted for transplant is a quality metric under the End-stage Renal Disease Quality Incentive Program.² Some transplant leaders have advocated for an even more aggressive policy of opt-out referral,³ under which all patients with kidney failure would be referred for evaluation unless a patient declined or had a clear contraindication.

If these policy efforts are to succeed, the health care system must prepare itself to translate more transplant referrals into more transplants and/or more equitable access to transplantation. As deceased donor kidneys remain scarce and most patients lack a willing and medicallyappropriate living donor,⁴ increased referrals cannot translate directly into increased transplants. As such, concerted efforts to update and improve the entire pretransplant system are a necessary precondition to achieving the goal of more equitable access to kidney transplantation. The process of referral and evaluation entails challenges for patients and families, transplant providers, and payers. Existing burdens, inefficiencies, and stress points within the transplant system have the potential to obstruct momentum toward increased equity. At the systemic level, the increased costs to transplant providers and payers can detract from efforts aimed at increasing actual organ supply, the only way to resolve the ongoing the organ shortage. In this perspective, we outline the pitfalls of policies focusing exclusively on increased referral and outline a roadmap for additional system adaptations to support patients, local nephrology providers, transplant programs, and payers, such that the ultimate goal of improved transplant access and equity may be achieved.

Kidney transplant evaluation can be taxing for patients and their families and not all will receive a transplant

Patients and caregivers shoulder the cost of the transplant evaluation process in terms of time, physical and emotional energy, and out-of-pocket expenses. While many readily accept these costs in exchange for a life-changing transplant, the balance of these considerations may shift for people with complex comorbidities for whom the evaluation process is more extensive and/or likelihood of receiving transplant lower. It is therefore especially important for referring providers to consider transplantation in the context of the patient’s overall treatment plan and support person-centered decision-making, rather than reflexively refer for transplant.

During transplant evaluation, patients often undergo diagnostic tests and treatments not recommended in the course of usual person-centered care, such blanket screening for cancers or intervention for asymptomatic coronary artery disease.⁵ For example, prostate and breast cancer screening may be relatively benign in isolation, but false positives and detection of early pathological states can cause a cascade of testing and treatment with often equivocal benefit.⁶ Nonetheless, many transplant programs continue to require these screening tests regardless of patient preferences or individual clinical context. While the medical community has shifted away from testing and revascularization for asymptomatic coronary artery disease based on trials demonstrating the unclear value of aggressive intervention,⁷ this practice remains commonplace in the pretransplant process.^8–10 Transplant evaluation pathways should be designed to streamline testing in patients with low risk of complications, follow evidence-based guidelines, and to reduce low-value testing. Patients with multiple comorbidities, such as prior transplant recipients, cancer survivors, and patients with complex cardiovascular conditions, necessarily face more testing and treatments to determine if they would personally benefit from transplant.¹¹ A person-centered approach would candidly present potential trade-offs of pursuing transplant as well as a realistic estimate of likelihood of receiving a kidney such that patients and their families can make individualized decisions about how and whether to engage with the process.

The transplant evaluation can also entail psychosocial burdens for patients and their families. Rigid candidacy requirements may demand adherence to strict treatment plans (e.g., perfect attendance at thrice-weekly 4-hour dialysis sessions), which may not be tailored to individual patient goals or clinical needs.¹² For example, some patients with residual renal function may have lower clearance needs and/or decide that less frequent dialysis aligns with their preference for quality of life. Diligent patients may nonetheless need to shorten dialysis sessions to accommodate childcare or other obligations. Social support requirements can also tax friends and family members and strain relationships.^12,13 Lack of transparency and communication in the evaluation, selection, and waitlisting process can contribute to a sense of loss of control over one’s healthcare and/or distrust of the system.^14,15 Requirements for behavioral change, such as weight loss and smoking cessation, can be difficult or demoralizing and reinforce implicit assumptions about personal worthiness for treatment.¹² Patients tend to over-estimate the likelihood of receiving a transplant,¹⁶ and disappointment at being declined can cause emotional distress,¹² especially for individuals from historically disadvantaged populations.¹⁷ Finally, Medicare offers coverage for most components of testing and treatment, but co-pays and non-medical costs—such as transportation—can be a financial liability. These personal, financial, and social burdens of transplant evaluation are likely to fall more heavily on patients who are already socially and/or economically disadvantaged.¹⁸

Greater referral volumes strain transplant programs which may exacerbate downstream sources of inequities

A default to refer patients for transplant evaluation may reduce inequities in this step of the process, but does not directly address other sources of disparities in the broader process. Otherwise stated, without complementary adaptations throughout the entire pretransplant process, improved equity in referral may not translate into improved equity in receipt of a transplant, the ultimate goal.

Capacity at US kidney transplant programs is limited. The most recent change in the Kidney Allocation System in 2021 (KAS250), wherein the geographic unit of allocation was expanded such that more transplant programs and OPOs became “local” to each other, substantially increased the volumes of kidney offers at many programs, but these volume increases did not translate into higher rates of transplant.¹⁹ The net effect was more work for clinicians, but little additional value for patients or revenue for the transplant program. The lack of transplant growth after the policy implementation suggests that capacity is a key limiting factor for programs. Current referral volumes and waitlist sizes are already a challenge in at least some programs, which likely contributes to the observation that 30% of prevalent waitlisted patients have an “inactive” status, in which they are ineligible to receive kidney offers.²⁰ Substantial increases in the number of referrals without changing existing infrastructure and capacity risks reducing efficiency and equity of the pretransplant process at individual institutions. Transplant programs must allocate their internal resources to pretransplant evaluation, living donor evaluation, waitlist management, responding to deceased donor offers,²¹ and posttransplant care. In the short term, an increased number of referrals could force programs to divert resources from the other activities to pretransplant evaluation and waitlist management. Strain on transplant program staff may also mean less support for individual patients, requiring them to be increasingly responsible for coordinating their own pretransplant care. Further, strained transplant programs may feel increasingly pressured to select against patients who require more institutional support for navigating the healthcare system in the pre- and posttransplant period. These challenges disproportionately impact those with limited health literacy and personal and social resources, a group of patients who are already less likely to receive transplants even after they complete the evaluation and are determined to be candidates.²⁰

Finally, increasing referrals cannot address mal-aligned incentives conferred by existing transplant center performance metrics. Performance metrics reflecting waitlist and/or post-transplant survival encourage transplant programs to decline “high-risk” candidates, even if these patients would personally derive benefit from transplant. Risk-adjustment of these performance metrics is unlikely to fully account for the manifold and complex social factors (e.g. social environment or social support), associated with adverse posttransplant outcomes. Without changing these incentives, the forces causing disproportionate selection against people at social disadvantage may be simply shifted downstream in the evaluation process.

Shifting referral patterns may increase costs for national payers

As the payer for majority of kidney failure treatments in the US, Medicare absorbs much of the costs of transplant-related expenses as well as posttransplant cost savings from those patients who no longer require maintenance dialysis.²² While transplantation is typically considered to be cost-saving on aggregate, the upfront cost of pretransplant evaluation and the transplant procedure take time to recoup, and this time to “breaking even” lengthens for medically complex recipients and donors.²³ Policies and practices that disproportionately increase costs for pretransplant care without substantially increasing the number of organs may fail to meet cost-effectiveness thresholds, let alone achieve goals to reduce overall Medicare spending. Funds disbursed through the Organ Acquisition Cost Center (OACC), a main source of revenue for transplant programs to cover pretransplant costs, amounted to $1.3 billion in 2017, or 3.7% of total Medicare End-Stage Renal Disease Program expenditures.²⁴ Because the OACC reimbursed transplant programs at cost,²⁵ little incentive, other than capacity constraints, exists for transplant programs to limit pretransplant spending. Absent concurrent measures to boost organ supply, increased investment in the pretransplant evaluation may not be recovered by a proportionate increase in transplantation.

Improving transplant access and equity will require changes to multiple parts of the transplant system

Before enacting additional policies targeted specifically at increasing transplant referrals, multiple changes to the broader transplant evaluation and selection process should be in place. Effective system change requires improvements in how primary nephrology teams and transplant specialists engage patients in the evaluation process, how programs conduct the evaluation and manage the waitlist, and how these processes are regulated and reimbursed (Box 1).

Box 1. Adaptations needed to enhance equitable access to kidney transplantation.

Person-centered care

• Develop better educational resources and support for shared decision-making between patients, local kidney care providers, and transplant team about referral, evaluation, and waitlist management

• Offer realistic and individualized assessments of whether and when a patient is likely to receive a transplant updated throughout the referral and evaluation process.

• Develop patient-facing electronic health communication tools to list outstanding evaluation items and communicate waitlist status in real-time. Establish portals of multi-directional communication between transplant team and local kidney care providers. Patients and providers should be able to see if patients are waitlisted and active through a simple interaction with a phone- and a web-based application

• Refine transplant evaluation protocols and guidelines to eliminate low-value testing in low-risk candidates

• Reduce logistical barriers to transplant evaluation (e.g., outreach programs, telehealth; streamlined transplant evaluation day, electronic health record integration)

Transplant center practice and policy

• Publish explicit, transparent, evidence-based, and pragmatic candidacy criteria

• Develop more strategic and efficient timing of pretransplant diagnostic tests and procedures guided by prediction of the next appropriate organ offer

• Advance research and development of operational strategies for more efficient waitlist management, potentially using cluster randomization and sequential randomization designs

• Disseminate best practice guidelines through professional societies and regulatory agencies

Regulation and Policies

• Establish quality metrics to capture the entire pretransplant process

• Remove penalties linked to existing metrics that are heavily influenced by socioeconomic factors that cannot be accounted for by existing risk adjustment models, e.g. post-transplant graft loss due to nonadherence

• Offer sufficient funding for transplant centers to support capacity expansion and practice innovation, through Medicare and federal and state pilot programs

First, the decision about how and whether to engage in the kidney transplant evaluation process should be tailored to individual patient needs and preferences. Local providers are well-positioned to support shared decision-making about transplant referral that is grounded in a patient’s broader care goals. These discussions need to be informed by an understanding of what the evaluation would entail and how likely a patient is to receive transplant. Such an approach requires tighter collaboration and bi-directional communication between transplant programs and referring providers. In the United Kingdom’s hub-and-spoke model, providers familiar with transplant requirements are located in “spokes” closer to the patients and begin the conversation and evaluation to decide if a patient moves to the transplant hub for full evaluation.²⁶ The Veterans Administration Health Care System also offers a model in which transplant evaluation is initiated with local providers before referral to a transplant center.²⁷ Transplant evaluation pathways can be designed to streamline testing in low-risk candidates,²⁸ minimize travel requirements,²⁹ and help patients navigate the process. Candidacy requirements should be founded on a strong evidence base to justify any potential risks of testing and treatment for patients and families. Long-standing practices, such as screening for asymptomatic coronary heart disease and malignancy in low-risk candidates, ought to evolve with newer evidence and medical practice.⁸ Research is needed to develop educational tools^30,31 and strategies of supporting shared decision-making⁵ to support patients in navigating the pretransplant process in a way that aligns with their overall care goals.

To improve equity and efficiency in the evaluation process, transplant programs should publish candidacy criteria—including absolute contraindications—such that patients and local providers can make informed decisions regarding referral. Researchers, professional societies, and regulatory agencies should collaborate to create, test, and disseminate standardized and efficient workflows for managing waitlist candidates,²⁸ living donor work-up,^32,33 and deceased donor offers. Psychosocial criteria—such as requiring adequate social support²⁷ and adherence to dialysis regimens—risk reinforcing disparities grounded in social determinants of health. At a minimum, programs should transparently report how these criteria will be assessed. Ideally, rather than serving as a gatekeeper, identification of psychosocial challenges should prompt efforts to provide additional support to help these patients succeed.¹³ Psychosocial barriers to transplant are likely to shape health care more broadly and are more effectively addressed upstream of the transplant evaluation process. Collaborative networks between transplant centers and referring providers, incentivized by programs such as the Kidney Care Choices model,³⁴ may be an important opportunity to address these complex factors across multiple care settings.

Policy-makers and regulatory agencies have a role in promoting equity in access to transplant. Systematic collection of information on steps of the transplant process occurring before patients are added to the waitlist—including referral and evaluation—is necessary to monitor and improve fairness in the pretransplant phase of care as a whole.³⁵ Better understanding barriers to progression through each step in the pretransplant process may identify opportunities to intervene and improve access to transplant. What constitutes completion of referral and evaluation steps needs to be explicitly defined by regulating agencies to ensure meaningful inferences based on these metrics. Governmental agencies can help transplant programs to accommodate increased volumes of referred patients by adding funding to support greater capacity and pilot awards to develop innovative care models.

Ambitious efforts aimed at increasing referral for transplant evaluation are underway. However, treatments for kidney failure, including transplantation, are embedded in some of the most complex US healthcare systems. Complementary transformation of the broader pretransplant process is needed to achieve the aims of more equitable access to kidney transplantation for all patients with kidney failure.