Increasing Organ Transplant Access (IOTA) Model

The CMS Innovation Center will be hosting a welcome webinar to present an overview of the model on December 18, 2024, from 2 to 3 p.m. ET. Register to attend: https://cms.zoomgov.com/webinar/register/WN_hvGDyZTxQ5eNhX1OBolevA

The Increasing Organ Transplant Access Model aims to increase access to life-saving transplants for patients living with end-stage renal disease and reduce Medicare expenditures. This model focuses on providing incentives to transplant hospitals to increase transplantation. Additionally, the model is designed to support greater care coordination, improved patient-centeredness in the process of being waitlisted for and receiving a kidney transplant, and greater access to kidney transplants. Through the model payments and policies, CMS aims to increase the care delivery capabilities and efficiency of kidney transplant hospitals selected for participation, with the goal of improving quality of care while reducing unnecessary spending.

On average, 13 Americans die each day while waiting for a life-saving kidney transplant. There are approximately 90,000 people on the kidney transplant waiting list, facing a wait time of 3 to 5 years or longer for an offer. The final rule for the model builds on other federal initiatives dating back to 2018 to improve care for people with kidney disease, including the Burden Reduction Rule, the updated Organ Procurement Organization  Conditions for Coverage, and the Kidney Care Choices (KCC) and ESRD Treatment Choices (ETC) models. These efforts align with the Increasing Organ Transplant Access Model to incentivize collaboration across the transplant process and increase patient access to transplants.

The Increasing Organ Transplant Access Model is a 6-year, mandatory model that begins on July 1, 2025. Visit the Federal Register to access the final rule for the model

Highlights

  • Kidney transplantation is the best treatment for most patients with chronic kidney disease and end-stage renal disease, but there are more people in need of a kidney than there are organs available. Many people die while waiting for a kidney transplant.
  • Around 90,000 people were on the waitlist for a kidney transplant in the U.S. in 2023, but only about 28,000 kidney transplants were performed during that same time period, according to the Organ Procurement and Transplantation Network.
  • The Increasing Organ Transplant Access Model aims to increase the number of people who receive kidney transplants while improving their quality of care and the patient-centeredness of the kidney transplant process. 
  • The goal of the model is to drive meaningful growth in the kidney transplant rate by maximizing the use of deceased donor kidneys and facilitating more transplants from living donors.

Background

Chronic kidney disease (CKD) affects nearly 15% of adults and is a leading cause of death in the United States. Approximately 130,000 Americans are diagnosed with (ESRD) each year, the most advanced form of CKD. Kidney transplantation is the best treatment for many people with kidney failure; however, there are far fewer donor kidneys available than people who need them, and approximately 5,000 people die each year while waiting for a kidney transplant.

The model builds on previous efforts by the Centers for Medicare & Medicaid Services (CMS) to improve care for patients living with kidney disease by addressing access to kidney transplantation, which is an important aspect of the care continuum for patients living with ESRD. The ETC Model, launched in 2021, focuses on improving quality of life with greater use of home dialysis and increased access to kidney transplantation. The KCC Model, launched in 2022, builds on the structure established by the Comprehensive ESRD Care (CEC) Model and aims to delay the need for dialysis for people with chronic kidney disease by improving the coordination and quality of care. 

How the CMS Innovation Center is Supporting Care for Chronic Kidney Disease (PDF)
(PDF)

The Increasing Organ Transplant Access Model is part of a wider effort by the Department of Health and Human Services’ Organ Transplant Affinity Group (OTAG), a collaborative effort by the Centers for Medicare & Medicaid Services (CMS) and the Health Resources & Services Administration (HRSA), to increase equitable access to organ transplants, improve accountability for the U.S. organ transplantation system, and increase the availability and use of donated organs.

Model Overview

Increasing Organ Transplant Access Model (PDF)

The Increasing Organ Transplant Access Model — also referred to as the IOTA Model — is a mandatory model that aims to increase the number of kidney transplants, increase access to a kidney transplant, and improve the efficiency and capabilities of participating transplant hospitals.

The model provides incentives for transplant hospitals to promote the following goals:

  • Maximize the use of deceased donor kidneys.
  • Improve quality of care before, during and after kidney transplantation.
  • Create greater access to a kidney transplant by addressing social determinants of health and other barriers to care.
  • Identify more living donors and assist potential living donors through the donation process.
  • Improve care coordination and patient-centeredness in the kidney transplant process.

In performance year 1, participating transplant hospitals will only have the potential for a positive payment adjustment (upside risk); beginning in performance year 2, they will have the potential for either upside or downside risk. This means that, based on their final performance score, participating transplant hospitals will:

  • Receive upside risk payments from CMS. 
  • Fall in a neutral zone in which the hospital neither receives an upside risk payment nor owes a downside risk payment.
  • Beginning in performance year 2, owe downside risk payments to CMS.

The final performance score is out of 100 points and is calculated on a set of proposed metrics in three domains:

  • Achievement: based on the number of kidney transplants for a total of 60 points.
  • Efficiency: based on the organ offer acceptance rate ratio for a total of 20 points.
  •  Quality: based on post-transplant composite graft survival rate measure for a total of 20 points. 

Addressing Health Disparities

Access to organ transplantation can vary by such factors as race, ethnicity, disability, and socio-economic status. Transplants, particularly living donor transplants, are much more common for people with private insurance. The Increasing Organ Transplant Access Model provides flexibilities to transplant hospitals selected for the model to help them support their underserved populations, address gaps in care, and develop strategies and tools to create a more accessible transplant process. This may include addressing barriers related to social drivers of health, such as lack of transportation. 

Model Participation

Under the Increasing Organ Transplant Access Model, CMS is selecting half of the donation service areas (DSAs) and all eligible kidney transplant hospitals there, for a total of 103 kidney transplant hospitals, to participate in the mandatory model. The other half of transplant hospitals will serve as the comparison group for evaluation purposes. Eligible hospitals are non-pediatric transplant hospitals with an active kidney transplant program that perform an annual average of 11 or more kidney transplants in the three baseline years before the start of the model in 2025. The model includes data-sharing requirements and incentives for participating transplant hospitals to improve the patient experience. 

Individuals receive a notice if their transplant hospital is participating in the model. In addition, individuals retain their freedom of choice to seek care from any Medicare provider and are not limited to their attributed transplant hospital.

Events

Additional Information

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