What: On December 11, 2025, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule to update and revise the Increasing Organ Transplant Access (IOTA) Model for Performance Year (PY) 2, set to begin on July 1, 2026. The IOTA Model proposed updates for Medicare Advantage (MA) and Medicare Part D plans, including rules for supplemental benefits, behavioral health access, and marketing and compensation practices for agents and brokers.
Why: CMS proposes to publish IOTA participant waitlist selection criteria and the proposed living donor selection criteria on the IOTA Model website by the end of the second quarter of each subsequent year. CMS also proposes that IOTA participants must provide semi-annual notifications to eligible IOTA waitlist beneficiaries. The proposed rule further clarifies and defines “transplant organ offer acceptance criteria.” Further, CMS proposes the adoption of several provisions for IOTA participants.
Small businesses should review the detailed provisions in section II.B.4.a.(1) of this proposed rule for potential impacts to business models and compliance processes.
For example, small MA and Part D plans should review the proposed rule to determine necessary updates to internal procedures, documentation, and systems for designing benefits, justifying supplemental offerings, and responding to audits, which can be more costly per enrollee for smaller plans. Additionally, small physician, behavioral health, and other provider practices should review the proposed provisions to determine how potential changes in plans structure benefits, networks, and utilization policies may impact patient volume, paperwork, and reimbursements. Small agents, brokers, and marketing firms may also be directly impacted by the proposed provisions, new limits, clarifications on compensation, and marketing activities.
Action: CMS’s proposed rule is published in the Federal Register. Comments are due to CMS on or before February 9, 2026.
FEDERAL REGISTER NOTICE:
Medicare Program: Alternative Payment Model Updates and the Increasing Organ Transplant Access Model
CONTACT: Will Purcell
EMAIL: will.purcell@sba.gov
TOPIC(S): Regulatory Alerts
TAG(S): CMS