CMS Increasing Organ Transplant Access (IOTA) Model finalized: What to know

The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), has finalized a mandatory six-year model called the Increasing Organ Transplant Access (IOTA) Model.  

This model, finalized by the Biden-Harris administration, is designed to address critical challenges in the nation’s kidney transplant system and significantly improve access to kidney transplants. 

IOTA Model background 

CMS has implemented various initiatives to improve care for patients living with kidney disease and address access to kidney transplantation. The IOTA Model builds on these efforts, enhancing organ availability and providing better education for patients, their families and caregivers.  

The model aligns with previous CMS initiatives like the ESRD Treatment Choices (ETC) Model, launched in 2021, which emphasizes the use of home dialysis and increased access to kidney transplantation to improve the quality of life for patients with end-stage renal disease. Additionally, the Kidney Care Choices (KCC) Model, launched in 2022, aims to delay the need for dialysis by improving care coordination and quality for people with chronic kidney disease. 

3 Goals of the IOTA Model 

1. Increase kidney transplants 

An average of 13 Americans die each day while awaiting a kidney transplant, and nearly 30% of donor kidneys are discarded annually, according to the National Kidney Foundation’s “Kidney Disease: Fact Sheet”. This model aims to save lives by ensuring more kidneys are successfully transplanted. 

2. Reduce disparities 

The model tackles inequities in transplantation by engaging hospitals in efforts to better address social determinants of health, such as food insecurity and transportation barriers, for underserved populations. 

3. Enhance patient experience 

By emphasizing patient-centered care, the model improves the overall transplant process for individuals with chronic kidney disease (CKD) and ESRD. 

How the new CMS model works 

Participation 

The program is mandatory for 103 kidney transplant hospitals across half of the nation’s donation service areas (DSAs). The selection process used ensures geographic diversity and represents hospitals with varying experiences in value-based care. 

Performance-based payments 

Hospitals will be financially incentivized to increase transplant numbers and reduce inefficiencies in organ acceptance. 

• Performance is evaluated on metrics including the number of adult kidney transplants (achievement), acceptance rates of offered organs (efficiency) and post-transplant outcomes (quality). 

• Payments or penalties will be applied based on scoring, with maximum incentive payments increasing from $8,000 to $15,000 per Medicare kidney transplant to encourage higher performance. 
  
  

Why CMS finds the IOTA Model essential 

CMS found that kidney transplantation accounts for 24% of yearly annual Medicare spending, with 130,000 individuals diagnosed with CKD. While transplants significantly improve quality of life, there’s a glaring gap between organ supply and demand. Currently: 

• approximately 90,000 people are on the kidney transplant waiting list; 

• wait times average three to five years or longer; and 

• only 28,000 kidneys are procured annually despite high demand. 

This model aims to better align transplant hospital incentives, improve the quality of care for patients on the waitlist and reduce disparities associated with organ transplants. 

IOTA Model revisions based on feedback 

After receiving and reviewing 160 comments on the proposed rule earlier this year, CMS incorporated several significant revisions: 

• delayed the model start date to July 1, 2025, allowing hospitals more time to prepare; 

• adjusted transplant targets to better reflect historical data; 

• simplified the process by removing certain administrative requirements, such as reviewing declined organ offers; and  

• allowed health equity payment adjustments to remain voluntary. 

Additional CMS initiatives and coordination 

The IOTA Model is part of broader efforts under the HHS Organ Transplant Affinity Group, which focuses on: 

• reducing variability in pre-transplant practices; 

• improving accountability in organ transplant system performance; 

• increasing organ availability; and 

• enhancing patient, family and caregiver education. 

This final rule builds on ongoing initiatives like the Burden Reduction Rule and the ESRD Treatment Choices Model, aligning incentives across the transplant process. 

CMS implementation information and resources 

CMS believes this model highlights its commitment to modernizing healthcare systems and improving equity, efficiency and accessibility for all patients relying on kidney transplants for life-saving care. For them, this new model represents a significant step in creating a better, fairer organ transplantation system for Americans. 

You can find the final rule for the IOTA Model in the Federal Register. For a quick overview, check out CMS’ fact sheet.