IOTA Model Frequently Asked Questions

How would the model help increase access to kidney transplants?

The goal of the proposed Increasing Organ Transplant Access (IOTA) Model is to ensure more people with end-stage renal disease get access to transplants by increasing the use of kidneys suitable for transplant that become available in the United States and increasing the number of transplants from living donors. To achieve these goals, the model would provide incentives for transplant hospitals to maximize the use of the current supply of deceased donor kidneys; assist potential donors with education and support through the living donor transplant process; improve care coordination and patient-centeredness in the kidney transplant process; and improve quality of care before, during and after transplantation.

How would transplant hospitals be selected to participate in the model?

Participation would be determined by donation service area (DSA). CMS would select half of the DSAs in the country and all eligible transplant hospitals with an active kidney transplant program would be selected to participate in the model. The other half of transplant hospitals would serve as the comparison group for evaluation purposes.

What is a collaborator? How is this different from a transplant hospital participant?

The required model participants would be the transplant hospitals selected for inclusion in the model. Model collaborators are Medicare providers and suppliers with whom participants may choose to partner in order to achieve the goals of the model.

How would participating hospitals’ performance be measured under the model, and would they be paid?

A participating transplant hospital would receive upside risk payments from CMS, fall in a neutral zone in which the hospital neither receives an upside risk payment nor owes a downside risk payment, or owe downside risk payments to CMS. The payments would be based on a participating transplant hospital’s final performance score after each performance year. The final performance score would be out of 100 possible points and would be calculated on a set of proposed metrics in three domains: achievement, efficiency, and quality. The maximum positive payment per Medicare fee-for-service (FFS) transplant under the model (the upside risk payment) would be $8,000. The maximum negative payment per Medicare FFS transplant under the model (the downside risk payment) would be $2,000.

When would the model start?

The model is a proposed mandatory model that would begin on January 1, 2025. CMS looks forward to public comment about the model start date.

How would individuals know if they are receiving care from a participating transplant hospital?

Attributed individuals would receive a notice of attribution from the participating transplant hospital. Individuals always retain their freedom of choice to seek care from any Medicare provider and are not limited to seeking care from their attributed transplant hospital.

How would the model improve care for people with end-stage renal disease?

CMS expects that people living with end-stage renal disease while on the kidney transplant waitlist could experience greater quality of care from a participating transplant hospital; for example, by having their care teams work to address their health-related social needs, greater access to a kidney transplant sooner, and increased engagement from their care teams post-transplant. Similarly, individuals considering living donation could experience greater engagement from the transplant hospital as they navigate the process of becoming a living donor.

How would the proposed Increasing Organ Transplant Access Model contribute to CMS’ health equity strategy?

CMS is working actively to identify and address disparities and inequities across transplantation, organ donation, and dialysis programs. The model would include requirements for health equity plans to encourage selected transplant hospitals to identify their underserved populations and develop strategies and tools to create a more equitable transplant process. This approach is intended to help transplant hospitals address gaps in care and gain additional insight into their patient populations. The model would also include a health equity performance adjustment that would give participating transplant hospitals more credit for a transplant performed for a person in a pre-defined, low-income population. By adding focus on specific populations that are currently less likely to receive a transplant, the model aims to give people living with end-stage renal disease equitable access to the opportunity for life-saving transplants.

Would the model be an Advanced or MIPS Alternative Payment Model (APM)?

This model is not expected to qualify as an Advanced APM or a MIPS APM.

What are the proposed standard provisions for CMS Innovation Center models included in the Notice of Proposed Rulemaking (NPRM) for the Increasing Organ Transplant Access Model?

Standard provisions for Innovation Center models are included in the NPRM that would be applicable to all Innovation Center models with a performance period that starts on or after January 1, 2025, not just the Increasing Organ Transplant Access Model. Additionally, the proposed standard provisions could be made applicable to models with a performance period that begins before January 1, 2025, if the model amends its governing documentation to adopt them. The proposed revisions are based on standard provisions that have repeatedly been memorialized in models’ governing documentation throughout the years. By adopting these proposed revisions through rulemaking, the Innovation Center is aiming to increase efficiency in the clearance process, as well as transparency for the public around its model policies. The proposed standard provisions address beneficiary protections, cooperation in model evaluation and monitoring, audits and record retention, rights in data and intellectual property, monitoring and compliance, remedial action, model termination by CMS, limitations on review, miscellaneous provisions on bankruptcy and other notifications, and the reconsideration review process.

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