Alert
CMS Finalizes New Mandatory Program to Improve Kidney Transplant Access
The article was updated January 7, 2025.
The Centers for Medicare & Medicaid Services (CMS) has finalized the Increasing Organ Transplant Access (IOTA) Model, a value-based care model aimed at transforming organ transplantation in the United States.
Set to begin July 1, 2025, this six-year mandatory program focuses on increasing the availability and efficiency of kidney transplants through performance-based payment incentives.
Key points of the finalized IOTA Model include:
- Mandatory Participation. 103 transplant hospitals located in selected donation service areas (DSAs) are required to participate.
- Financial Incentives. Participating hospitals will receive financial incentives to increase the number of kidney transplants performed. Performance will be evaluated based on metrics related to achievement, efficiency, and quality.
- Revisions in the Final Rule Based on Stakeholder Feedback. In response to public comments, CMS has made significant revisions to the model, including increasing the maximum upside risk payment per transplant and adjusting various performance metrics. CMS has delayed implementation by six months to allow selected hospitals additional time to prepare.
Help prepare your hospital to meet the IOTA Model’s requirements with insights into eligibility requirements, performance score parameters, and payment methodology.
IOTA Model Overview
The IOTA Model is a mandatory payment model that begins July 1, 2025, and ends June 30, 2031, encompassing six individual performance years. The model holds selected participants accountable through upside and downside performance-based payments and includes requirements to address health equity and transparency.
The IOTA Model provides incentives to participants to promote the following goals:
- Maximize the use of deceased donor kidneys
- Improve quality of care before, during and after kidney transplantation
- Create greater equity in access to a kidney transplant by addressing social determinants of health and other barriers to care
- Identify more living donors and assist potential donors through the donation process
- Improve care coordination and patient-centeredness in the kidney transplant process.
Hospital Eligibility
CMS has selected roughly half of the donation service areas (DSAs) in the country.
Non-participating hospitals will serve as the comparison group to evaluate the effectiveness of the model.
Eligibility for participation includes non-pediatric transplant hospitals with an active kidney transplant program that performed at least 11 or more kidney transplants during each of the prior three years—2022 to 2024—in addition to having at least 50% of the hospital’s annual transplants being furnished to non-pediatric patients.
Performance Score
Although the model payments are specifically for Medicare beneficiaries, it is important to note that the model performance score is based on all patients and payors. The maximum performance score is 100 points and is calculated on the following metrics in three distinct domains.
- Achievement. Based on the total number of kidney transplants relative to a participant-specific target, for a total of 60 points. The target is determined as the participant’s average number of transplants in three baseline years, multiplied by a national growth rate which may be positive or negative.
- Efficiency. Based on the organ offer acceptance rate ratio, for a total of 20 points. Points will be awarded for the higher score of either percentile performance—such as comparison to peers or nationally—or improvement over the participant’s third baseline year rate, such as self-improvement.
- Quality. Based on the Post-Transplant Composite Graft Survival Rate measure, for a total of 20 points. Points will be earned based on percentile performance, like comparison to peers, nationally.
Payment
Based on a final performance score at the end of each year, selected participants will fall into one of three categories:
Upside Risk Payment from CMS
A lump sum payment made by CMS after the end of each performance year (PY) if a participant has a final performance score of 60 or greater. The maximum positive payment per kidney transplant performed will be $15,000.
Neutral Zone
With a final performance score of 41 to 59, participants will not receive either an upside risk payment or owe a downside risk payment to CMS.
Downside Risk Payment to CMS
For a final performance score of 40 or below, the participant will owe CMS a lump sum payment after the PY. The maximum negative payment per transplant will be $2,000.
To accommodate participants who are new to value-based payment models, CMS has finalized that upside risk payments begin in PY1, while downside risk payments begin in PY2. This means that for PY1, participants with a score above 60 will receive upside payments, while participants below 60 will neither receive nor owe payments.
The model’s payment methodology doesn’t incorporate risk adjustment in the first performance year, although future rulemaking may change this approach. This model doesn’t qualify as an Advanced APM or a MIPS APM under the Quality Payment Program.
Increased Transparency Requirements
Per CMS, IOTA participants must publicly report on their website their criteria for evaluating and selecting patients for addition to their kidney transplant waitlist by the end of the first performance year, June 30, 2026.
Additionally, IOTA participants must review transplant organ offer acceptance criteria with waitlist patients who are Medicare beneficiaries at least once every six months.
Health Equity Strategy
Each IOTA Model participant may voluntarily submit a health equity plan to CMS.
Per CMS, IOTA participants will have access to anti-kickback statute safe harbors to enable them to address barriers related to social determinants of health, such as transportation and attributed patients’ out-of-pocket drug costs.
For more information, the final rule can be found in the Federal Register, and a fact sheet is available on the CMS website.
We’re Here to Help
To learn more about the IOTA Model and how your organization can prepare and thrive under this CMS initiative, contact your Moss Adams professional.