CMS Finalizes Updates to Organ Transplant Access Model for Performance Year 2

The Centers for Medicare and Medicaid Services published a final rule updating the Increasing Organ Transplant Access model for Performance Year 2, signed by President Donald Trump and scheduled to take effect July 1 2026.

The rule affects kidney transplant programs at approximately 200 hospitals that elected to participate in the IOTA Model, which tests whether performance-based payments tied to transplant volume, waitlist management and post-transplant outcomes can increase the number of kidney transplants furnished to Medicare beneficiaries.

Per the Federal Register notice, the model serves traditional Medicare enrollees with kidney failure who are on transplant waitlists or have received a kidney transplant.

The final rule revises certain operational parameters for Performance Year 2 that were established in the model's initial framework. It replaces the prior regulatory text governing performance metrics, upside and downside risk arrangements, and quality measurement with updated requirements while adding a technical correction to align the regulation with the model's intended design.

The revisions become effective July 1 2026, the first day of Performance Year 2.

Downstream, transplant hospitals must adjust their internal tracking and reporting systems to the new Performance Year 2 benchmarks by the July 1 start date. CMS will begin applying the revised payment adjustments and quality scoring formulas to claims and reconciliation processes for all IOTA participants from that date forward.

The rule triggers no new comment period because it is a final rule, but it opens the standard 60-day window for Congressional Review Act consideration before the July 1 effective date. Failure by Congress to pass a joint resolution of disapproval would allow the updated model parameters to remain in force.

This is the first major revision to the IOTA Model since its initial finalization under the Biden administration in 2024. The 86-page notice constitutes the official record for all operational changes that kidney transplant programs must implement beginning in July.