Transplant Care Can’t Evolve Without Research-Informed Policy

For clinicians committed to helping patients with end-stage kidney disease (ESKD) receive the care that best meets their needs, care decisions are often constrained by systemic and policy-level factors. While the patient-clinician relationship remains central to care decisions and quality, systemic access to preferred renal replacement treatments — including living and deceased donor kidney transplantation — is heavily influenced by regulatory frameworks. The Centers for Medicare & Medicaid Services (CMS) and the Health Resources and Services Administration (HRSA) establish the structural incentives, payment rules, and performance metrics that govern modern nephrology practice and patients’ pathways to transplant.

A recent Nature article reported that the NIH has begun deprioritizing grant applications aiming to inform policymakers, including CMS and HRSA staff. This shift warrants critical examination. In organ transplant and advanced kidney care, translational health services research that informs policy is critical for determining patients’ treatment options and examining whether they have a fair opportunity to pursue transplantation.

Gaps in Early ESKD Care

Over 120,000 patients transition to ESKD annually in the U.S. For most, the diagnosis is highly disruptive and bewildering, which makes it especially important for patients to receive appropriate care navigation support as well as education about treatment options. While this perspective is emphasized in clinical practice guidelines, observational data demonstrate that more than half (52%) of patients receiving in-center hemodialysis reported they were not educated about home peritoneal dialysis as a treatment option; a similar proportion (52.8%) reported they were not educated about transplantation.

Other research has also observed wide variation in how often dialysis clinics refer patients for transplant evaluation. In Georgia, where our research team first studied this issue, some facilities referred 0% of their patients, while others referred 75%.

These gaps in patient education and transplant referrals may point to some deficits in care coordination and clinical decision-support systems. But from the health policy perspective, they also signal underlying structural challenges of misaligned incentives and care fragmentation in nephrology and dialysis care settings.

Gaps in Post-Referral Transplant Care

When patients are successfully referred for transplant evaluation, they then confront the challenge of completing a series of tests and checkpoints before they can be judged as suitable or unsuitable candidates for transplant. Beyond this, there remains a severe imbalance between demand and supply of kidneys. In 2023, approximately 22,000 kidneys were recovered from living and deceased donors, while nearly 47,000 candidates were added to the national waitlist.

Beyond absolute organ scarcity, transplant care teams and organ procurement organizations struggle with additional challenges. Approximately 28% of deceased donor kidneys recovered for transplantation in 2023 went unused, even though most would have helped patients achieve better health outcomes than remaining on dialysis. An increasing proportion of organ offers are accepted “out of sequence” on behalf of patients with lower waitlist priority than other, higher-priority candidates who were bypassed. Transplant center performance metrics, having long emphasized high performance on post-transplant graft and patient survival, have led many transplant centers to avoid higher-risk patients and organs, with the downstream impact of reducing use of kidney transplantation.

These problems again show that, due to fragmented systems and misaligned incentives, the transplant system as a whole is not yet fulfilling its promise of promoting access for everyone who could benefit.

The Roles of Regulators

The responsibilities of aligning incentives, integrating systems, and otherwise helping clinicians and care organizations keep their promises to ESKD patients fall largely to CMS and HRSA. Among their efforts, CMS — which pays for most dialysis treatment and transplant procedures — has been testing new ways of paying for dialysis and transplant care. One model, the Increasing Organ Transplant Access model, encourages transplant centers to increase the number of transplants they perform by paying bonuses based on that growth. In parallel, HRSA has changed how it measures and holds transplant centers accountable for their performance, including placing greater emphasis on the death rates of patients on transplant center waiting lists.

These policy decisions are hard to get right. The transplant system has many moving parts, competing interests, and complex care decisions. Many policy decisions, even well-intentioned, can have profound unintended consequences (e.g., reduced risk tolerance among transplant centers). One of the most important places CMS and HRSA leaders can, and must, look for help is rigorous, data-driven research on these issues.

The Essential Role of Policy-Oriented Health Services Research

I am part of a team of health services researchers who, like many such teams, play the critical role of evaluating healthcare systems and identifying opportunities to improve them. For our team, that often means analyzing large-scale linked administrative registries such as the U.S. Renal Data System and Scientific Registry of Transplant Recipients to answer some of the most important questions facing the transplant system. Some of our studies recognize challenges that prevent patients with ESKD from receiving appropriate transplant education. Some describe variation in decision processes that may lead more patients to be referred for transplant evaluation in some contexts and fewer referrals in others. Others model organ allocation system reforms, seeking strategies to reduce organ non-use while maintaining fair access to kidneys across regions. Policy leaders regularly use and cite these studies when making decisions that critically determine how well the transplant system functions.

Moreover, all this high-value research answers questions about health and about policy jointly. The NIH’s decision to divide clinical research from policy research overlooks the degree to which the two are intertwined. While transplant care is by no means unique in this regard, it represents a particularly poignant example of how regulatory structures dictate clinical workflows, organ availability, and patient outcomes. Just as transplant policy and clinical care both determine the outcomes of the transplant system, research that informs transplant policy is just as important as research focused more singularly on patient care interactions.

To give every patient a fair chance at a transplant, CMS and HRSA must rely on high-quality evidence — and NIH must continue supporting the research that produces it. Robust evidence is essential to improve policy, and effective policy is required to empower clinicians and strengthen transplant care nationwide.