GNYHA recently submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the fiscal year (FY) 2025 Increasing Organ Transplant Access (IOTA) Model proposed rule. The IOTA Model is a proposed six-year mandatory payment demonstration to incentivize growth in the national rate of kidney transplantation. The model would apply to transplant centers located in roughly half of donation service areas nationwide and begin January 1, 2025. Participants could earn additional payment or be subject to a penalty based on the number of transplants they perform relative to a target, the ratio of organ offers they accept, and a set of quality metrics.
GNYHA asserted that implementation of the IOTA model would be inappropriate given recent regulatory changes to the organ procurement and transplantation ecosystem, including to the kidney allocation system, the Organ Procurement Organization (OPO) conditions for coverage, and the Organ Procurement and Transplantation Network modernization initiative. GNYHA recommended that CMS wait until the impact of these reforms is better understood before implementing IOTA.
If CMS does proceed with IOTA, GNYHA urged that participation be voluntary. GNYHA opposes mandatory payment demonstrations and believes that a mandatory model risks exacerbating existing resource disparities. GNYHA also urged that, rather than mandate participation, CMS should incentivize it by designing a model that provides sufficient value to transplant hospitals.
Additionally, GNYHA expressed several concerns with the model’s methodology. The proposed methodology does not provide a meaningful opportunity for transplant centers to succeed due to unrealistic performance targets, a lack of risk adjustment when measuring transplant volume, and a failure to recognize centers that are already high performers. GNYHA recommended that CMS use a risk-adjusted measure of transplantation—the Transplant Rate Ratio—and suggested methodological changes that would reward hospitals that historically furnish high numbers of transplants relative to expectations.
CMS also proposed transparency, public reporting, and health equity plan requirements for participating hospitals. GNYHA opposed these requirements due to the administrative burden and overlap with existing requirements.