Dr. Hippen on the Finalization of the Improving Organ Transplant Access (IOTA) Rule

The Improving Organ Transplant Access (IOTA) rule was finalized by the Center for Medicare and Medicaid Services (CMS) on November 26, 2024. The rule is a mandatory two-sided risk model for kidney transplant centers designed to increase transplant volume and improve organ utilization while maintaining a track record of high patient and graft survival. Readers may recall that when the draft rule was published in May 2024, I found it to be a mixed bag: on the positive side of the ledger, CMS staked out some creative and thoughtful positions when developing transplant center focused outcomes metrics, refreshingly prioritizing increasing total transplant volume and reducing kidney non-utilization by improving organ offer acceptance behaviors over short term graft survival outcomes. But the modest upside and negligible downside financial incentives for transplant centers led me to conclude that an IOTA of intervention was not the pound of cure the transplant ecosystem really needed to improve access to kidney transplantation.

After processing 160 public comments on the draft rule, the diligent and hard-working folks at CMS deserve our gratitude for listening and responding to public stakeholders. The final IOTA rule isn’t perfect but, for anyone interested in aligning incentives in a manner to expand access to kidney transplantation for all patients in need, the final IOTA rule is a great start.

So, how does the finalized version of IOTA shake out? The model will now start on July 1, 2025 instead of January 1, giving enrolled transplant programs some breathing room to discuss and negotiate preparations with their health system leadership. (Note to medical and surgical directors: Get on your hospital C-suite’s calendar in January to secure the resources you’ll need.)

Speaking of financial bonuses and penalties, CMS did directionally respond to suggestions the that the total dollar amounts allocated to upside bonus payments to IOTA participants seemed low. In the final rule, CMS increased the total mean expenditures for financial bonuses from mean of $36M to $117M over the course of the six-year model, with a concomitant projected increase in the total number of transplants from a mean of 2,625 to 3,683. (The downside financial penalties for IOTA participants are still negligible.) These are still modest financial and performance targets, but modest expectations are reasonable when implementing a novel pilot intervention. Some of us were hoping CMS would include a waiver to the Medicare Advantage rules ( Section 1851(i)(2) ) so the IOTA financial bonuses and penalties might also be applied to Medicare Advantage beneficiaries who now make up ~50% of the Medicare eligible ESKD population, but CMS declined to do so, noting the effects of waiving this requirement “...would be unprecedented and the effects are unknown.” CMS did commit to “…engage with the payer community….to discuss opportunities and approaches for alignment,” which is good news, especially if recent Medicare Advantage enrollment positive growth trends persist.

Advocates for the “transparency” provisions in the draft rule will be disappointed to learn that the requirement for IOTA participants to notify waitlisted patients about organ offers declined on the patients’ behalf on a monthly basis was not finalized. However, the final rule retained requirements that IOTA participants publish their waitlisting criteria on a publicly available website, as well as a requirement that IOTA participants disclose their organ acceptance criteria to waitlisted patients and re-review those disclosures every six months. CMS also confirmed that the new rule will publish performance data of IOTA participants on a public website. The health equity modifiers (which would provide positive Achievement Domain scoring modifiers for transplant performance among “low income” candidates) and the proposed requirement for IOTA participants to submit a Health Equity Plan to CMS for review was instead made voluntary in the final rule.

All told, the final IOTA rule represents a successful policy compromise between CMS and stakeholders: Achievement of performance targets is more feasible for IOTA participants, the outcomes metrics are straightforward, easy to explain, properly weighted and aligned, and combined with new and tangible gains for patients. In their commentary on the final rule, CMS was clear and specific that there will be additional opportunities to propose and implement ideas for improvement to the IOTA model, especially as the Kidney Care Choices model is up for reconsideration in 2027. The finalization of the IOTA model represents one more positive step forward in a longer path to a fully integrated, end-to-end payment model which includes patients with late-stage chronic kidney disease, end-stage kidney disease, and functioning kidney transplants. The next step is to develop and deepen collaborative and care coordination relationships between patient advocacy groups, nephrologists, dialysis providers, kidney value-based care organizations, transplant centers, health systems, organ procurement organizations, and public/private payors, so that more patients have access to kidney transplantation as well as the longitudinal care delivery resources needed to live longer and live better across the years-and-decades long continuum of kidney disease.

Publication date: December 2024