Transforming Transplant in the United States

A recent Biden Administration announcement, the Health Resources and Services Administration (HRSA) Organ Procurement and Transplantation Network (OPTN) Modernization Initiative—and bipartisan, bicameral proposed legislation supporting it, the Securing the US OPTN Act—aims to implement crucial reforms to help more patients receive a transplant. It is imperative that nephrologists, transplant professionals, patient advocates, and others collaborate to ensure these efforts fulfill their potential and pursue other opportunities to achieve the ultimate goal: maximizing patient access to kidney transplantation. Too often, that access is treated as a scarce resource, available to only a subset of the many people who could benefit.

By focusing on five key changes, described below, advocates and policymakers have a clear path to achieving that ultimate goal. The initiative and the legislation are foundational steps implementing needed reforms today and enabling significant future advancements.

For most people with kidney failure, transplant is the optimal therapy. It is also the most cost-effective therapy, less than half the cost of dialysis. Although 2022 saw a record number of kidney transplants, an unacceptable 12 people die waiting for a kidney every day. People who die on the waitlist receive a median 16 kidney offers that are declined, often without their knowledge.¹ In total, 26% of kidneys procured from deceased donors go unused, although data show that patients would have benefitted from transplantation with many of those nonused organs.²

Stark and unacceptable disparities also persist in kidney transplantation. As we work toward increasing transplantation, we must ensure equitable access regardless of patients' race/ethnicity, sex/gender, geography, and socioeconomic status. For example, Black patients are less likely to receive a preemptive transplant referral or complete the transplant evaluation. They are less likely to have a living donor and more likely to receive lower-quality kidneys.³ Americans who reside in rural areas are less likely to be waitlisted or transplanted, whereas socioeconomically disadvantaged people face similarly worse odds.^4,5 Women are less likely to be referred for transplant than men.⁶

The initiative and legislation will contribute to changing these grim realities, yet additional safety net efforts supporting underserved populations—including transportation, post-transplant medication access, and financial assistance—are also needed. Transplant reimbursement often does not support best practices in, for example, community education, patient recruitment, living donor support, and post-transplant care—particularly for socioeconomically disadvantaged populations. We must align incentives, financial and otherwise, in a manner that allows all health professionals to make decisions that maximize access for all patients regardless of insurance or income.⁷

Because the kidney transplant community has a rich history of leading and embracing bold advancements, especially during the past decade, the American Society of Nephrology (ASN) is optimistic about the future of transplant policy. Stemming from recognition that the current system is not optimally serving patients, the HRSA initiative and related legislation build on work across the Obama, Trump, and Biden Administrations and on a bipartisan, bicameral basis across many Congresses. Informed by this history and bolstered by the HRSA Modernization Initiative and the Securing the US OPTN Act, we can maximize access to transplant and advance equity by focusing on at least five objectives.

1. Expedite the clear government reforms necessary to maximize access to transplant. Patients deserve a coordinated, system-wide approach that allows all stakeholders to work toward maximizing patients' access to transplant. By requiring OPTN and any OPTN contractor(s) to have separate governing boards, the legislation institutes good governance and increases accountability. Conflicting government incentives must be aligned—such as ending OPTN's use of a 1-year outcome metric for transplant centers, although the Centers for Medicare & Medicaid Services (CMS) eliminated the metric because it impeded patients' access to transplant.⁸ Ensuring patient safety and graft survival is paramount but can be achieved while also making transplant more accessible than current metrics allow. As with all regulatory changes, the effects should continuously be monitored and assessed and updated as new evidence suggests future opportunities for improvement. Policies that conflict with current science must also be reformed—such as ending the use of race, a social construct, in the algorithm that ranks and allocates kidneys, a step we commend OPTN for now undertaking.⁹

2. Establish transparency to improve access to transplant and reduce barriers in the kidney health ecosystem. Lack of transparency at every step in the transplant process makes navigating it difficult, exacerbating inequities and barriers. It is opaque to many patients and their nephrologists which transplant centers might be willing to accept them, and many cannot even ascertain whether they are waitlisted after clearing the many hurdles to be evaluated. A nationwide, centralized clearinghouse is needed to help patients match with a program with the expertise to accept and actually transplant them. HRSA's commitment to increased transparency and data sharing should address these challenges.

   Transplantation generally confers a better, longer life versus dialysis, but many who would benefit are not waitlisted. Nephrologists must embrace greater responsibility in championing transplant as the optimal therapy for most of their patients, supporting them during the early referral and evaluation stages and beyond. CMS and HRSA need to collect and share data about patients who are referred but never make it to the waitlist, so researchers can better understand—and advocates and policymakers can address—their barriers.¹⁰ This transparency is particularly crucial for groups with disproportionate challenges to waitlisting, such as Black, rural, and socioeconomically disadvantaged Americans. Waitlisted patients also deserve transparency about decisions made on their behalf: Most are never notified when surgeons decline kidneys for them, eliminating their voice in these life or death decisions. Would one in four donated kidneys still go unused if potential recipients were aware?

3. Enable the use of more organs. More patients could receive transplants if barriers to using deceased donor organs were removed, and the myriad challenges people must overcome to become living donors were mitigated. For example, regulations, such as the 1-year outcome metric, have pushed transplant centers to become risk averse, aiming for optimal results for a smaller pool of candidates with only the highest-quality donor kidneys instead of maximizing patient access and accepting more offered kidneys. Data show that it is a mistake not to use many of the kidneys that go unutilized.¹¹ It is time for CMS and HRSA to change policy to encourage transplant centers to say “yes” to more offered kidneys, becoming accountable to patients' preferences over short-sighted metrics. Although using 100% of deceased donor kidneys is not a realistic goal, we know we can better serve patients by using more than just 74%.

   Congress should increase appropriations to support living donors and base eligibility for those funds on donor—not recipient—income. No living donor should have to pay to donate their kidney, and the federal program that exists to support this goal, the National Living Donor Assistance Center, needs more support. HRSA, which oversees the program, should ensure that it covers all donation-related costs and allow more donors to qualify. Recently, National Living Donor Assistance Center eligibility increased from 300% to 350% of the poverty level, a trend HRSA should continue.

4. Expand investment in transplant-related research and innovation. Although transplantation has saved thousands of lives, transplant professionals and their patients largely rely on 40-year-old therapies. Establishing a National Institutes of Health National Center for Kidney Health and Transplantation would centralize transplant research in one focused place instead of spread across National Institutes of Health, creating efficiencies and ensuring a balanced portfolio across the research continuum.

   ASN is calling for the Center for Medicare and Medicaid Innovation to launch a transplant model, particularly aimed at meeting patients' long-term needs instead of focusing on short-term outcomes. Living donors also deserve more long-term focus and support. By expanding the Living Donor Collective, a national longitudinal living donor data collection effort, we can narrow the gap between the number of actual and potentially interested living donors and better meet their needs.

5. Embrace modern technology to increase access to transplant. Implementing a modern infrastructure for our transplant system is a foundational step to improving transparency and efficiency and is a focus of HRSA's Modernization Initiative. The legislation will enable competition and new ways of thinking about improving the nation's transplant system—particularly its information technology system. For example, a successful information technology system would make widespread use of application programming interfaces to transfer information across electronic health records, health care systems, and the OPTN registry, instead of relying on fax, phone, and email.

   As with every element of these technologies and other reforms, the voices of patients and transplant and kidney health professionals should lead the way in shaping these initiatives and ensuring they optimally serve patients.

At least ten components within the Department of Health and Human Services (HHS) have a role in kidney health. Today's redundant and often contradictory agency rules impede a synergistic focus on meeting patients' needs. A new Office of Kidney Health and Transplantation, situated in the HHS Secretary's Office, could ensure all components work in coordination toward maximizing access to transplantation. Emphasizing the importance of patients' voices in policymaking, the office would focus on collaborating with patients to ensure their perspectives are central to any changes relating to the 37 million Americans with kidney diseases.

As the world's largest organization of health professionals dedicated to improving care for people living with kidney diseases, ASN's leaders and members stand ready to collaborate with patients, other nephrologists and transplant professionals, and Congress and the Biden Administration—especially HHS, CMS, and HRSA—to transform transplant in the United States, maximizing patients' access to the optimal therapy and ensuring that access is equitable.

Disclosures

M.A. Josephson reports consultancy for Exosome Diagnostics, IMMUCOR, Labcorp, Otsuka, UBC Pharmaceutical Support services for the mycophenolate pregnancy registry, and Vera Therapeutics; ownership interest in Seagen; research funding from Bucksbaum Institute and Gift of Hope; honoraria from ASN Board Review Course and ASN for Highlights; and advisory or leadership role as President of the American Society of Nephrology. R.N. Meyer is Strategic Policy Advisor to the Executive Vice President at the American Society of Nephology, focusing on kidney transplant policy. R.N. Meyer's spouse reports employment with Campside Media.

Funding

None.

Author Contributions

Writing – original draft: Rachel N. Meyer.

Writing – review & editing: Michelle A. Josephson.