Rising Momentum on Kidney Transplant Reforms

In 2025, the US transplant landscape entered a new phase marked by stronger federal oversight, clearer accountability, and a focus on expanding  access through the advancement of policy initiatives and payment models. The Centers for Medicare and Medicaid Services’ (CMS’s) Health Resources and Services Administration continued to advance the Organ Procurement and Transplant Network Modernization Initiative as an effort to prioritize patient safety, strengthen allocation oversight, modernize current data and technology infrastructures, and promote greater transparency across the transplant continuum. Meanwhile, CMS proposed updates in January 2026 to organ procurement organization requirements to strengthening certification standards and performance measurement to improve organ utilization.

The implementation of the Increasing Organ Transplant Access (IOTA) Model, a six-year mandatory model also began on July 1, 2025, for selected transplant hospitals with incentives. This reflects the administration’s continued emphasis and investment in optimizing access to kidney transplants.

Meanwhile, innovation in the organ supply pipeline also continued to advance, underscored by Food and Drug Administration clearance of an investigational xenokidney clinical trial using a gene edited source pig, signaling a potential future pathway to expand transplantable kidney availability for patients with end-stage renal disease (ESRD). Together, these developments reflect a coordinated push to modernize transplant infrastructure while beginning to prepare for cutting-edge technologies that will transform the US transplant system.

Recalibrating Kidney Care Models and Payment Policy

Historically, CMS Innovation Center models have produced mixed results on cost savings, and current leadership has publicly announced that shifting toward “models that show the greatest promise for generating savings and improving quality.” In kidney care, this shift sunsetted the ESRD Treatment Choices model after falling short on cost-saving and clinical outcome goals, while refining and extending voluntary Kidney Care Choices models that remain central to the value-based kidney care paradigm. The second performance year (PY2023) evaluation of the Kidney Care Choices model found that, despite strong improvements in ESRD quality-of-care outcomes, the model was associated with a $304 million increase in net Medicare spending in 2023. At the same time, CMS is signaling continued focus on models that reward ongoing care coordination and measurable improvements in patient outcomes across chronic conditions, as reflected in the new Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model, which aligns payments with better chronic disease control, including kidney, rather than one‑off services.

Against this backdrop, CMS is evolving core payment policies within the ESRD Prospective Payment System (PPS) bundled payment system. Since January 1, 2025, oral only phosphate binders are now included in the ESRD PPS bundled payment. This shifts these therapies into the dialysis bundle and medical benefit context rather than standalone pharmacy coverage, a change that is intended to streamline care and incentivize efficient management by having the dialysis facility manage these commonly utilized medications directly.

Advancing Value-Based Kidney Care Through Partnerships and Data-Driven Innovation

As value-based kidney care (VBC) evolves, many commercial and Medicare Advantage plans are increasingly partnering with VBC-backed entities to strengthen care coordination, an especially important trend as ESRD enrollment in Medicare Advantage has rapidly grown to match traditional fee-for-service levels. These organizations are focused on improving outcomes through better management of CKD progression, reducing hospitalizations, and expanding home dialysis.

Newer policy reforms such as the ACCESS Model reinforce this direction, emphasizing longitudinal, technology-enabled support for patients with CKD.  Underpinning these efforts is a growing reliance on data and AI-driven analytics to identify high-risk patients earlier, predict disease progression and hospitalization, support modality choice and care transitions, and support more informed, equitable transplant-related decision-making.

At the same time, innovation is also extending upstream into R&D, with new pre-clinical research using “predictive” insights from donated human organs to generate more predictive evidence for new kidney therapies.

Innovation in New Therapies for Patients with CKD

The kidney treatment landscape is rapidly evolving toward disease-modifying therapies. In more common conditions such as diabetes-related CKD, GLP1 receptor agonists continually contribute to growing evidence demonstrating improved clinical kidney function.  As these therapies gain traction, they are reshaping the broader cardio-renal-metabolic landscape by linking glycemic control, cardiovascular risk reduction, and kidney protection into more integrated treatment paradigms.

In parallel, innovation in rare kidney diseases is accelerating, with a growing pipeline of late-stage therapies targeting underlying disease mechanisms. These approaches have demonstrated meaningful reductions in proteinuria and early signals of delaying progression to kidney failure. Together, these advances point to an emerging wave of treatments across both common and rare conditions, expanding access for patients with historically limited therapeutic options.

Looking Ahead

The kidney care landscape in 2026 is poised for continued innovation alongside tighter policy oversight and greater accountability. Advances in disease-modifying therapies, ranging from GLP-1s to emerging treatments for rare kidney diseases, are reshaping care paradigms by integrating kidney management within cardiovascular and metabolic pathways. At the same time, federal efforts to modernize the transplant ecosystem, including Organ Procurement and Transplantation Network reforms, organ procurement organization oversight, the Increasing Organ Transplant Access model, and early progress in xenokidney research, signal sustained focus on expanding transplant access and infrastructure.

Parallel shifts in payment and delivery, from the original Advancing American Kidney Health models to longer-term pathways like ACCESS, are driving a stronger focus on cost-efficient, upstream, and data-enabled coordinated care. Providers and dialysis organizations are leveraging telehealth, predictive analytics, and integrated care strategies to manage risk, streamline transitions, establish greater optionality for home dialysis, and improve access to kidney transplants. Together, these developments aim to shape a kidney care ecosystem that is more integrated, streamlined, and oriented toward better outcomes and cost savings across the full spectrum of kidney disease.

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Avalere Health is monitoring these developments and will continue to leverage its expertise across policy, market access, data analytics, and quality disciplines to assess how kidney care policy and markets evolve in the coming months. To learn more about the evolving kidney care space and how Avalere Health can help your business drive access and continuity of care in this dynamic time, connect with us.