On December 11, 2025, CMS issued a proposed rule to update and revise the Increasing Organ Transplant Access (IOTA) Model for Performance Year (PY) 2 (the Proposed Rule). The IOTA Model is a 6-year mandatory alternative payment model tested by the CMS Innovation Center that began on July 1, 2025, and will end on June 30, 2031. The IOTA Model tests whether performance-based incentives paid to participating kidney transplant hospitals can increase access to kidney transplants for kidney transplant waitlist patients, while enhancing quality of care and reducing Medicare expenditures.
The IOTA Model allows kidney transplant hospitals to be eligible to be selected as an IOTA Participant if it meets the following criteria:
- Annually performs 11 or more kidney transplants for patients aged 18 years or older, regardless of payer, each of the baseline years; and
- Annually performs more than 50% of its kidney transplants on patients 18 years of age or older each of the baseline years.
The Proposed Rule modifies the eligible kidney transplant hospital criteria to comply with statutory requirements to exclude VA medical facilities and military medical treatment facilities from the IOTA Model for PYs 2 through 6. Additionally, the Proposed Rule raises the low volume threshold from a minimum of 11 to a minimum of 15 kidney transplants performed annually during each of the baseline years.
The Proposed Rule also updates the composite graft survival rate metric with 3 modifications:
- Adding a risk-adjustment methodology that includes several transplant recipient and donor characteristics;
- Excluding multi-organ transplants from the composite graft survival rate exclusion and inclusion criteria; and
- Updating the allocation of points awarded for performance on the composite graft survival rate.
Additionally, the Proposed Rule modifies the Extreme and Uncontrollable Circumstances payment policy and makes changes to the downside risk payment. Under the Proposed Rule, IOTA participants must remit the downside risk payment to CMS in a single payment within 60 days after the date on which the demand letter is issued. If the payment is late, the remaining amount owed will be considered a delinquent debt.
The Proposed Rule also updates the IOTA Model’s transparency requirements, public reporting requirements, beneficiary protections, monitoring activities, and adds noncompliance with the Organ Procurement and Transplantation Network as a reason for CMS to terminate an IOTA participant from the IOTA Model. Lastly, the Proposed Rule removes all health equity plan provisions and related definitions from the IOTA Model to allow IOTA participants to focus their resources on care redesign activities that would improve their model performance and the quality of care and experience for the patient.
The full text of the Proposed Rule can be found here. Comments are due by February 9, 2026.
