Note: This insight was originally posted on July 1, 2022. It was updated on October 13, 2023, to include new information.

Chronic kidney disease (CKD) has been recognized as a rising public health concern, with 37 million people (approximately 15% of the adult population) in the US estimated to have some form of kidney function impairment. Patients with CKD often have multiple comorbidities such as diabetes, hypertension, and heart disease, which can both cause and co-exist with kidney disease. Furthermore, approximately 90% of people living with kidney disease do not know that they have it. CKD may progress to kidney failure, otherwise known as end-stage renal disease (ESRD), which requires renal replacement therapy (either via dialysis or kidney transplantation). The cost to treat a patient varies by treatment type; according to the US Renal Data System, Medicare pays $93,000 annually to cover hemodialysis for an ESRD patient versus $37,000 for a patient each year beyond the first year of receiving a kidney transplant.

Barriers to Kidney Transplantation

Kidney transplantation, from both deceased and living donors, is associated with improved survival, reduced expenses, and enhanced quality of life for patients with ESRD. However, despite increasing clinical and economic benefits of kidney transplantation, dialysis remains the most utilized treatment for patients living with ESRD in the US. A survey of transplant center staff identified the following barriers to patients receiving kidney transplants: limited organ availability, low health literacy, lack of understanding of the transplant process, and challenges driven by social determinants of health. Many patients are unaware that transplantation is a treatment option, and patients who do not have access to a living donor are put on the national transplant waiting list to be matched with a kidney from a deceased donor. As of 2022, more than 92,000 patients are waiting for a kidney. The average time spent waiting for a kidney transplantation is 3–5 years, and the 5-year survival rate on maintenance dialysis is 50%.

Policies to Improve Kidney Care and Increase Transplantation Rates

Both the Trump and Biden administrations have introduced policies and initiatives to support access to transplantations. The Advancing American Kidney Health initiative, launched by the Department of Health and Human Services in 2019, was the initial driver of change in the broader kidney care space, creating new policies and payment models to reduce risk of kidney failure and improve access to and quality of treatment options. Specific details of these policies and additional activities are outlined below.

• Innovation Center Models: The Center for Medicare & Medicaid Services’ (CMS) Innovation Center has introduced a series of models to incentivize patient and provider education of treatment options and successful transplantation. For example, the ESRD Treatment Choice Model is a mandatory payment model that includes performance-based payment adjustments for selected ESRD facilities and managing clinicians to incentivize transplantation among Medicare beneficiaries with ESRD. It also aimed to double the number of kidneys available for transplant by 2030.
• Revised Organ Procurement Organization Oversight: Organ Procurement Organizations (OPOs) are nonprofits responsible for the procurement of organs for transplantation. A 2020 rule updated the OPO Conditions for Coverage and established new measures designed to improve OPO transparency, safety, and competition, and to support higher donation rates. CMS conducted OPO performance surveys and reviewed OPO outcome and process measures in 2022; the next survey cycle will begin in 2026.
• Expanded Immunosuppressive Therapy Coverage: Included as part of the Consolidated Appropriations Act, 2021, the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act extends Medicare coverage of immunosuppressive drugs—treatments needed to prevent transplant rejection—to kidney transplant recipients who lose Medicare coverage following a successful transplant and do not have other coverage.
• US OPTN Legislation: In September 2023, President Biden signed the Securing the US Organ Procurement and Transplantation Network Act (H.R. 2544) into law with bipartisan support. The law aims to reform the organ transplant system and waiting process for the hundreds of thousands of individuals that are currently awaiting an organ transplant.

Looking Forward

Broad initiatives to transform the organ transplantation process are underway, with policymakers establishing committees and initiatives to support the broader community of individuals, caregivers, and providers involved with organ donations. For example, the Ad Hoc Multi-Organ Transplantation Committee seeks to establish policies for heart-kidney and lung-kidney allocation to ensure patients in need of multiple organs have access to a lifesaving transplant.

More specifically within kidney care, stakeholders are undertaking new efforts to better identify and provide care to patients with CKD, seeking to slow disease progression and enhance patient awareness of available treatments. Most notably, the recent OPTN modernization initiative is likely to have a significant impact across the kidney care stakeholder community, creating important guardrails on organ waitlist time and financial incentives. To better serve patients with ESRD, policies and models addressing social determinants of health and supporting preemptive transplantation are evolving. Avalere will continue to monitor and assess developments related to patient access and kidney transplantation.

To learn more about the evolving kidney care market and how Avalere can help your business drive access and continuity of care in this dynamic time, connect with us.