Cut through the noise, find the signal: Intelligence for serious healthcare leaders
Analysis updated November 9, 2026
The Increasing Organ Transplant Access (IOTA) Model is a six-year mandatory CMMI model that began July 1, 2025 and runs through June 30, 2031. It targets one of the most acute supply-demand imbalances in American healthcare: approximately 90,000 patients are on the kidney transplant waiting list, roughly 3,000 are added each month, and 13 Americans die every day while waiting for a life-saving organ. In 2024, approximately 27,000 kidney transplants were performed nationally — yet despite this persistent shortfall, 26.7% of procured kidneys went unused in 2022. IOTA is explicitly designed to attack both sides of that equation simultaneously: increasing total transplant volume while reducing organ waste.
The model operates on a straightforward diagnostic: existing fee-for-service payment structures create no financial incentive for transplant hospitals to maximize organ acceptance rates, aggressively work living donor pipelines, or invest in the post-transplant care coordination that sustains graft survival. Standard MS-DRG payments for kidney transplants (MS-DRGs 008, 019, 650, 651, and 652) are paid regardless of whether a hospital's transplant volume grows, whether it accepts marginal deceased donor organs, or whether its one-year graft survival rates are above or below the national median. IOTA overlays performance-based payment adjustments — both positive and negative — on top of those FFS payments, introducing accountability that the existing payment system lacks.
IOTA represents a structurally distinct category of CMMI model: procedure-volume-based mandatory accountability, not attribution-based population health management. Most value-based care models in the CMMI portfolio — ACO REACH, MSSP, KCC, ETC — operate by holding providers accountable for the total cost of care or utilization rates for a defined population. IOTA instead holds a specific institutional actor (the transplant hospital) accountable for increasing a specific high-value procedure volume relative to a participant-specific historical benchmark.
This design reflects a sophisticated recognition that kidney transplantation is cost-reducing for Medicare relative to maintaining patients on dialysis. A patient who receives a successful kidney transplant exits the dialysis cost trajectory — a trajectory that is both clinically inferior and fiscally burdensome for the Medicare program. The model's theory of change is therefore that every incremental transplant is simultaneously a quality improvement and a Medicare savings event, making volume incentives and cost-reduction goals fully aligned rather than in tension.
For health system CFOs and CMOs, IOTA creates a new financial variable that did not previously exist: per-transplant payment adjustments of up to +$15,000 (upside) or up to -$2,000 (downside) layered on top of base DRG payments. For a high-volume center performing 300 Medicare kidney transplants per year with a top-quartile performance score of 90/100, the upside payment would be $11,250 per transplant — representing over $3.375 million in annual incremental revenue. For a low-performing center scoring 26/100, the downside exposure would be $700 per Medicare FFS transplant, which at 300 transplants equates to $210,000 in annual penalty payments. The asymmetry between upside ($15,000 maximum) and downside ($2,000 maximum) is deliberate: CMS has calibrated the model to be heavily incentive-positive while introducing enough downside pressure in PY2 onward to change behavior at underperforming centers.
IOTA also sits at the intersection of three overlapping federal policy streams. First, it builds directly on the Kidney Care Choices (KCC) Model (launched 2022) and the ESRD Treatment Choices (ETC) Model (launched 2021), which addressed upstream kidney disease management and home dialysis access, respectively. IOTA completes that care continuum by addressing the transplant access bottleneck. Second, it is part of the HHS Organ Transplant Affinity Group (OTAG), a cross-agency collaboration between CMS and the Health Resources & Services Administration (HRSA) that also encompasses updated Organ Procurement Organization (OPO) Conditions for Coverage and HRSA oversight of the Organ Procurement and Transplantation Network (OPTN). Third, IOTA explicitly aligns with the Burden Reduction Rule and federal initiatives dating to 2018 aimed at improving the organ procurement system.
IOTA was finalized under the Biden administration but launched under the Trump administration, which took office January 20, 2025. The model's final rule was published in 2024, and a PY 2 Updates Final Rule was issued June 1, 2026, under the Trump administration's CMS leadership — indicating active model stewardship by the current administration rather than termination or suspension. Under CMS Administrator Dr. Mehmet Oz and CMMI Director Abe Sutton, the model proceeded to its mandatory launch on July 1, 2025 and has been updated through its PY 2 final rule, which reduced the participant count from 103 to 95 eligible kidney transplant hospitals as of July 1, 2026.
The model's emphasis on maximizing organ utilization and reducing unnecessary waste aligns with broad bipartisan interest in organ transplant system reform. The mandatory structure — covering approximately half of all donation service areas — also gives IOTA a large enough footprint to generate statistically meaningful evaluation data, suggesting CMS and CMMI view this as a genuine test rather than a demonstration project vulnerable to early termination.
IOTA will structurally alter competitive dynamics among transplant centers within participating DSAs. Because the achievement domain carries 60 of 100 possible points and is based on transplant volume relative to a participant-specific historical target, centers that have been historically conservative in organ acceptance — maintaining artificially low benchmarks — will face a different incentive structure than historically high-volume centers whose targets are correspondingly elevated. High-volume centers (the Financial Fact Sheet example of Participant B performing 330 transplants but falling below target) can find themselves in downside risk territory precisely because their historical excellence set a high baseline.
For transplant hospital executives, the model creates immediate pressure on three operational levers: organ offer filter review (to reduce organ discard and improve the efficiency domain score), living donor program expansion (to grow transplant volume in the achievement domain), and post-transplant care coordination investment (to defend quality domain scores based on composite graft survival rates). The model explicitly authorizes use of Anti-Kickback Statute safe harbors for CMS-sponsored model arrangements, enabling participating hospitals to address patient transportation barriers and attributed patients' out-of-pocket drug costs — operational flexibilities that can tangibly improve access and care coordination without AKS exposure.
Additionally, the model's transparency requirements — including mandatory public posting of waitlist selection criteria by end of PY 1 and semi-annual reviews of organ offer acceptance criteria with Medicare beneficiary waitlist patients — will create unprecedented public visibility into how transplant hospitals operate their waitlist programs, a development with significant reputational and regulatory implications.
IOTA is a mandatory model — participation is not voluntary for eligible hospitals within selected donation service areas. CMS selected approximately half of all U.S. donation service areas (DSAs) and required participation from all eligible transplant hospitals within those DSAs.
Eligibility criteria for kidney transplant hospitals:
(Note: The Welcome Webinar slides reference "11 or more kidney transplants annually" as the original eligibility threshold cited during the rulemaking presentation. The final rule and CMS model page specify the operative threshold of 15 or more transplants per year across three baseline years.)
Participant counts:
| Performance Year | Participant Count | Start Date |
|---|---|---|
| PY 1 | 103 hospitals | July 1, 2025 |
| PY 2 | 95 hospitals | July 1, 2026 |
| PY 3–6 | TBD (per final rule updates) | July 1, 2027–2030 |
The non-participating half of DSAs serve as the comparison group for model evaluation purposes. Medicare beneficiaries whose transplant hospital participates in IOTA receive written notice of that participation and retain full freedom of choice to seek care from any Medicare provider — they are not locked to their attributed hospital.
The model uses the 4Innovation (4i) platform for participant onboarding, legal agreement execution (including Data Sharing Agreements), and ongoing report delivery. CMS shares the following data with participants:
| Report Type | Description | Frequency |
|---|---|---|
| CCLFs/Exclusion Files | Claim and Claim Line Feeds for attributed beneficiaries | Monthly |
| Patient Attribution Lists | Beneficiary-identifiable attributed patient data | Quarterly (15 days prior to PY start) |
| Transplant Target | Participant-specific transplant target for achievement domain | Annually (by first day of PY) |
| Preliminary Performance Assessment & Payment Calculations | Preliminary scores and payment amounts | Annually (following PY conclusion) |
| Final Performance Score | Final scores and upside/downside payment determination | Annually (≥30 days after preliminary) |
Performance is assessed across three domains totaling 100 points, applied uniformly across all six performance years:
| Domain | Points | Metric | Weight Rationale |
|---|---|---|---|
| Achievement | 60 | Number of kidney transplants vs. participant-specific historical target | Primary goal: volume increase |
| Efficiency | 20 | Organ offer acceptance rate ratio | Reduces organ discard |
| Quality | 20 | Post-transplant composite graft survival rate | Prevents volume-at-expense-of-outcomes gaming |
Achievement Domain (60 Points)
The transplant target is participant-specific and calculated annually using the following methodology:
Sample calculation (PY 1, positive growth rate): A hospital with a mean of 125 deceased donor and 60 living donor transplants across baseline years has a sum of 185. With a sample national growth rate of 6.7%, its transplant target = 1.067 × 185 = 197 transplants.
Baseline years roll forward each PY, creating targets that keep pace with national transplant growth trends. The baseline year windows for each PY are:
| Performance Year | Baseline Years Used |
|---|---|
| PY 1 (Jul 2025–Jun 2026) | Jul 2021–Jun 2022 / Jul 2022–Jun 2023 / Jul 2023–Jun 2024 |
| PY 2 (Jul 2026–Jun 2027) | Jul 2022–Jun 2023 / Jul 2023–Jun 2024 / Jul 2024–Jun 2025 |
| PY 3 (Jul 2027–Jun 2028) | Jul 2023–Jun 2024 / Jul 2024–Jun 2025 / Jul 2025–Jun 2026 |
| PY 4 (Jul 2028–Jun 2029) | Jul 2024–Jun 2025 / Jul 2025–Jun 2026 / Jul 2026–Jun 2027 |
| PY 5 (Jul 2029–Jun 2030) | Jul 2025–Jun 2026 / Jul 2026–Jun 2027 / Jul 2027–Jun 2028 |
| PY 6 (Jul 2030–Jun 2031) | Jul 2026–Jun 2027 / Jul 2027–Jun 2028 / Jul 2028–Jun 2029 |
Achievement domain scoring table:
| Performance vs. Target | Points Earned |
|---|---|
| ≥125% of target | 60 |
| ≥120% and <125% | 55 |
| ≥115% and <120% | 50 |
| ≥105% and <115% | 40 |
| ≥95% and <105% | 30 |
| ≥85% and <95% | 20 |
| ≥75% and <85% | 10 |
| <75% | 0 |
Efficiency Domain (20 Points)
The organ offer acceptance rate ratio = observed organ offer acceptances ÷ expected organ offer acceptances. Performance is ranked nationally across all non-pediatric kidney transplant hospitals. Critically, scoring uses a dual-pathway approach — each participant receives points under whichever method yields the higher allocation:
Achievement Scoring:
| National Percentile Rank | Points |
|---|---|
| ≥80th percentile | 20 |
| ≥60th and <80th | 15 |
| ≥40th and <60th | 10 |
| ≥20th and <40th | 6 |
| <20th percentile | 0 |
Improvement Scoring:
Quality Domain (20 Points)
Composite Graft Survival Rate = Total number of functioning grafts ÷ Total number of completed kidney transplants (cumulative across all model years). This is a cumulative and compounding measure — grafts from prior years that fail in later years reduce the score. IOTA participants are ranked nationally against both IOTA and non-IOTA participants.
| National Percentile Rank | Points Earned |
|---|---|
| ≥80th percentile | 20 |
| ≥60th and <80th | 18 |
| ≥40th and <60th | 16 |
| ≥20th and <40th | 14 |
| ≥10th and <20th | 12 |
| <10th percentile | 10 |
Critically, the quality domain has a floor of 10 points (not zero), ensuring that even very low performers cannot be fully zeroed out on this dimension — a design choice that reduces the model's ability to generate extreme downside scores.
IOTA performance-based payments are per-Medicare-kidney-transplant lump-sum adjustments paid on top of base FFS or Medicare Advantage payments. A "Medicare kidney transplant" is defined as a kidney transplant furnished to an attributed patient whose primary or secondary insurance is Medicare FFS, identified via Medicare FFS claims with MS-DRGs 008, 019, 650, 651, and 652.
Risk structure by performance year:
| Performance Year | Risk Structure |
|---|---|
| PY 1 (Jul 2025–Jun 2026) | Upside only (no downside) |
| PY 2–6 (Jul 2026–Jun 2031) | Two-sided (upside and downside) |
Payment thresholds and formulas:
| Score Range | PY 1 Treatment | PY 2–6 Treatment |
|---|---|---|
| 60–100 | Upside risk payment | Upside risk payment |
| 41–59 | Neutral zone (no payment) | Neutral zone (no payment) |
| 0–40 | Neutral zone (no payment) | Downside risk payment owed to CMS |
Upside payment formula (score ≥ 60):
Payment to IOTA participant per Medicare kidney transplant = $15,000 × [(Score − 60) ÷ 40]
Downside payment formula (score ≤ 40, PY 2–6 only):
Amount owed to CMS per Medicare kidney transplant = $2,000 × [(40 − Score) ÷ 40]
Worked financial examples from source documents:
| Scenario | Score | Formula Result | Payment Per Medicare Transplant | Direction |
|---|---|---|---|---|
| PY 1 Participant A (high performer) | 78/100 | $15,000 × (18/40) | $6,750 | CMS pays hospital |
| PY 2 Participant B (low performer) | 37/100 | $2,000 × (3/40) | $150 | Hospital pays CMS |
| Webinar Appendix: Center A | 90/100 | $15,000 × (30/40) | $11,250 | CMS pays hospital |
| Webinar Appendix: Center B | 26/100 | $2,000 × (14/40) | $700 | Hospital pays CMS |
Payment operations timeline:
Extreme and Uncontrollable Circumstances provision: CMS may reduce applicable downside risk payments by multiplying the downside amount by the percentage of total PY months affected by the circumstance AND the percentage of attributed patients residing in the affected area. CMS retains sole discretion to determine both the affected period and the affected patient percentage.
IOTA imposes two category-specific transparency obligations beyond standard CMMI model provisions:
The model also incorporates standard Innovation Center provisions finalized in the 2024 IOTA final rule, applicable to all CMMI mandatory models with performance periods starting on or after January 1, 2025. These cover beneficiary protections, audit and record retention, model termination rights, and the reconsideration review process — establishing a consistent governance framework across mandatory models.
Participating hospitals have access to Anti-Kickback Statute safe harbors for CMS-sponsored model arrangements, specifically enabling interventions around patient transportation barriers and attributed patients' out-of-pocket drug costs — flexibility that did not previously exist under standard FFS rules and that creates meaningful operational latitude for centers seeking to improve access and adherence for lower-income transplant candidates.