IOTA (Increasing Organ Transplant Access) Model

ValuesEdge Strategic Intelligence Brief

---

1. Executive Summary and Strategic Context

What Is This Model and What Problem Does It Solve?

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 a specific, quantifiable failure in the U.S. healthcare system: 13 Americans die every day while waiting for a kidney transplant, despite the fact that kidney transplantation is the superior treatment for most patients with end-stage renal disease (ESRD) across both quality-of-life and cost dimensions. Approximately 90,000 patients sit on the kidney transplant waitlist at any given time, facing wait times of three to five years or longer, while roughly 3,000 additional patients are added to the waitlist each month. Critically, the gap between organ supply and demand is not solely a function of organ scarcity: in 2022, 26.7% of procured kidneys went unused, representing a systemic efficiency failure, not merely a shortage.

IOTA's core theory of change is that misaligned financial incentives, siloed care delivery, accountability gaps, and referral variation are the primary drivers of underperformance in the transplant system—and that payment incentives directed at transplant hospitals can address these drivers. The model tests whether performance-based payments tied to transplant volume, organ offer acceptance, and post-transplant graft survival can increase the total number of kidney transplants, reduce kidney discard, and generate downstream Medicare savings by reducing dialysis utilization.

Strategic Significance for the Value-Based Care Market

IOTA represents CMMI's first mandatory model focused exclusively on the organ transplant system. Its strategic significance for the value-based care market operates on several levels.

First, IOTA creates direct financial accountability for transplant volume in a way that has no prior analog. Transplant hospitals have historically operated in a fee-for-service environment where transplant-adjacent decisions—organ offer acceptance, waitlist management, living donor cultivation—carried no financial consequences tied to system-level performance. IOTA changes that calculus. Beginning in Performance Year 2 (PY2), which started July 1, 2026, underperforming hospitals face a maximum downside risk of $2,000 per Medicare kidney transplant—a modest but structurally meaningful penalty that creates a floor-level accountability mechanism.

Second, IOTA forces cross-institutional collaboration that fee-for-service does not incentivize. Transplant hospitals are explicitly directed to engage Organ Procurement Organizations (OPOs), nephrologists, dialysis facilities, and outpatient providers as partners in achieving model goals. The model's Achievement Domain rewards raw transplant volume increases, which cannot be achieved by a transplant hospital acting in isolation—requiring upstream referral pipelines to function more effectively and organ offer filters to be reviewed and recalibrated.

Third, IOTA's explicit data-sharing infrastructure—including Claim and Claim Line Feeds (CCLFs), Patient Attribution Lists, Transplant Targets, and Preliminary Performance Assessment reports delivered through the 4Innovation (4i) platform—creates a systematic performance feedback loop for transplant hospitals that did not previously exist. This data infrastructure, combined with the IOTA Learning System's peer-learning framework, positions CMS to build a national evidence base on best practices in transplant system optimization.

Fourth, IOTA extends the Medicare Advantage population into its performance-based payment scope. The upside risk payment of up to $15,000 per Medicare kidney transplant applies to both Medicare FFS and Medicare Advantage attributed transplants, making this directly relevant to MA plan strategists who contract with participating transplant hospitals. MA plans with high ESRD populations whose attributed members receive transplants at IOTA-participating hospitals should model the downstream cost implications: a successful transplant eliminates dialysis costs (which average over $90,000 annually per patient in Medicare) and substantially reduces total cost of care.

Political Context and Administrative Alignment

IOTA presents a nuanced political profile under the current Trump administration. The model was finalized under the Biden administration and launched July 1, 2025, shortly after the Trump inauguration. A PY2 Updates Final Rule was issued June 1, 2026, and a PY2 Updates Notice of Proposed Rulemaking was published December 11, 2025—both occurring under the current administration, indicating active stewardship rather than abandonment of the model.

CMMI Director Abe Sutton and CMS Administrator Dr. Mehmet Oz have signaled a general orientation toward models that demonstrate measurable cost reduction and avoid administrative complexity. IOTA has a reasonably strong alignment profile on these dimensions: it targets a disease area (ESRD and transplantation) with enormous Medicare expenditure, its payment methodology is transparent and formulaic, and its mandatory structure across selected Donation Service Areas (DSAs) means it does not require active recruitment or application processes that consume administrative overhead. The model's mandatory nature also increases statistical power for evaluation—the non-participating DSAs serve as a formal comparison group, enabling CMS to generate credible evidence on whether payment incentives drive transplant volume.

The anti-kickback statute safe harbor provisions embedded in IOTA—allowing participating hospitals to address transportation barriers and attributed patients' out-of-pocket drug costs—are consistent with the current administration's interest in reducing non-clinical barriers to care access without restructuring the broader regulatory framework.

The model also operates within the HHS Organ Transplant Affinity Group (OTAG), a cross-agency collaboration between CMS and the Health Resources & Services Administration (HRSA) covering OPO oversight, OPTN contractor management, and payment for transplants. This interagency structure provides political durability because IOTA is nested within a broader accountability effort that spans regulatory, payment, and oversight levers.

Market Transformation Implications

IOTA will produce observable market-level effects in the 103 participating DSAs over its six-year run. Transplant hospitals with historically high discard rates—hospitals that have routinely declined organ offers that other programs might accept—face the most acute strategic challenge. The Efficiency Domain penalizes low organ offer acceptance rate ratios relative to national ranking, meaning that hospitals which have used conservative acceptance filters to protect their outcome metrics are now structurally disadvantaged: their caution in accepting marginal organs (which improves graft survival rankings) now creates risk in the Efficiency Domain.

This creates a genuine domain tension within the scoring architecture. A hospital that aggressively accepts all organ offers maximizes its Efficiency Domain score but may accept lower-quality organs that fail, depressing its Quality Domain (graft survival) score. Institutions that solve this tension through clinical protocol innovation—better donor screening, improved organ assessment, optimized immunosuppression management—will outperform those relying on static operational approaches.

For health systems with both transplant programs and large ESRD populations served through affiliated nephrology practices or dialysis facilities, IOTA creates an integrated value proposition: strengthening the referral pipeline from the system's own ESRD patients into its transplant program simultaneously improves Achievement Domain performance and reduces total cost of care for the health system's attributed Medicare population.

---

2. Model Architecture and Payment Structure

Participation Structure and Eligibility

IOTA participation is mandatory, not voluntary. CMS selected approximately half of all Donation Service Areas (DSAs) nationally. All eligible kidney transplant hospitals within a selected DSA are required to participate—there is no opt-out mechanism for qualifying hospitals in designated DSAs. The non-selected DSAs serve as the evaluation comparison group.

Eligibility criteria for participating kidney transplant hospitals:

• Non-pediatric kidney transplant hospital
• Active kidney transplant program at model start
• Performs an annual average of 15 or more kidney transplants in each of the three baseline years prior to July 1, 2025

(Note: The Welcome Webinar slides reference "11 or more" transplants annually as an eligibility threshold in one slide; the model page and fact sheet consistently state "15 or more" as the operative standard. The 15-transplant threshold from the final rule governs.)

Participation figures:

• PY1 (starting July 1, 2025): 103 kidney transplant hospitals participating
• PY2 (starting July 1, 2026): 95 eligible kidney transplant hospitals participating (eight hospitals became ineligible or were otherwise removed between PY1 and PY2)

The target population for model measurement purposes includes all patients on the participating hospital's waitlist and those who received a transplant from the participant hospital—not limited to Medicare beneficiaries for care coordination purposes. However, performance-based payments are calculated specifically on the basis of Medicare FFS and Medicare Advantage kidney transplants (identified via MS-DRGs 008, 019, 650, 651, and 652).

Patient rights: Medicare beneficiaries receive a notice that their transplant hospital is participating in IOTA. They retain full freedom of choice to seek care from any Medicare provider and are not restricted to their attributed hospital.

Timeline: Performance Years and Baseline Periods

Performance Year	PY Period	Risk Structure	Baseline Years for Transplant Target
PY1	July 1, 2025 – June 30, 2026	Upside only	July 1, 2021–June 30, 2024 (3 years)
PY2	July 1, 2026 – June 30, 2027	Two-sided	July 1, 2022–June 30, 2025 (3 years)
PY3	July 1, 2027 – June 30, 2028	Two-sided	July 1, 2023–June 30, 2026 (3 years)
PY4	July 1, 2028 – June 30, 2029	Two-sided	July 1, 2024–June 30, 2027 (3 years)
PY5	July 1, 2029 – June 30, 2030	Two-sided	July 1, 2025–June 30, 2028 (3 years)
PY6	July 1, 2030 – June 30, 2031	Two-sided	July 1, 2026–June 30, 2029 (3 years)

Baseline periods roll forward annually, meaning each hospital's transplant target is recalculated each PY using three consecutive years of immediately preceding data trended by the national growth rate.

Performance Scoring Architecture

Each participating hospital receives a final performance score out of 100 points across three domains. The score drives the payment calculation on a continuous scale.

Domain	Points Available	Metric	Key Scoring Logic
Achievement	60	Number of kidney transplants vs. participant-specific transplant target	Tiered from 0 pts (< 75% of target) to 60 pts (≥ 125% of target)
Efficiency	20	Organ offer acceptance rate ratio	Higher of achievement scoring (national rank) or improvement scoring (vs. benchmark); 15 pts floor for performing above benchmark
Quality	20	Post-transplant composite graft survival rate	National ranking; 10 pts minimum (< 10th percentile) to 20 pts (≥ 80th percentile)
Total	100

Achievement Domain Detail (60 points):

The transplant target is the sum of the participant's three-year mean of deceased donor and living donor transplants (adults 18+), trended forward by the national growth rate. If the national growth rate is negative, the target equals the unadjusted mean sum—protecting hospitals from being penalized for industry-wide declines.

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% of target	0

Efficiency Domain Detail (20 points):

Scored using whichever method—achievement scoring or improvement scoring—produces the higher point allocation for the participant.

Achievement Scoring (national rank):

National Percentile Rank	Points
≥ 80th percentile	20
≥ 60th and < 80th	15
≥ 40th and < 60th	10
≥ 20th and < 40th	6
< 20th percentile	0

Improvement Scoring: Participants performing at or above the benchmark rate (set at 120% of the participant's third baseline year acceptance rate for each PY) automatically receive 15 points. Those performing at or below their baseline rate receive 0 points. Participants between those bounds receive a proportional score calculated as: 15 × [(Performance Rate − Baseline Rate) ÷ (Benchmark Rate − Baseline Rate)].

Quality Domain Detail (20 points):

The composite graft survival rate = (total functioning grafts) ÷ (total completed transplants). This is a cumulative, expanding denominator measure—all transplants performed since model start are included, not just those from the current PY. Participants are ranked nationally against both IOTA and non-IOTA hospitals.

National Percentile Rank	Points
≥ 80th percentile	20
≥ 60th and < 80th	18
≥ 40th and < 60th	16
≥ 20th and < 40th	14
≥ 10th and < 20th	12
< 10th percentile	10

Note: The Quality Domain has a 10-point floor, meaning no participating hospital can score zero in this domain. This meaningfully limits downside exposure for hospitals with poor graft outcomes.

Payment Methodology

Payment unit: Performance-based payments (both upside and downside) are calculated and applied per Medicare kidney transplant performed during the PY. Payments are additive to standard fee-for-service or Medicare Advantage payments—they do not replace or substitute for existing DRG-based reimbursement.

Payment thresholds and formulas:

Final Performance Score	PY1 Adjustment	PY2–PY6 Adjustment
60–100	Upside risk payment	Upside risk payment
41–59	No payment (neutral zone)	No payment (neutral zone)
0–40	No payment	Downside risk payment

Upside formula (score ≥ 60):

Payment per Medicare kidney transplant = $15,000 × [(Score − 60) ÷ 40]

At a perfect score of 100: $15,000 per transplant At a score of 80: $7,500 per transplant At a score of 60: $0 (threshold, no payment triggered)

Downside formula (score ≤ 40, PY2 onward):

Amount owed to CMS per Medicare kidney transplant = $2,000 × [(40 − Score) ÷ 40]

At a score of 0: $2,000 per transplant At a score of 40: $0 (threshold, no payment owed)

Illustrated examples from source documents:

• Example A (PY1 upside): Score of 78/100 → $6,750 per Medicare kidney transplant to hospital
• Example B (PY2 downside): Score of 37/100 → $150 per Medicare kidney transplant owed to CMS
• Appendix Example A (PY2 upside): Score of 90/100 → $11,250 per Medicare kidney transplant to hospital
• Appendix Example B (PY2 downside): Score of 26/100 → $700 per Medicare kidney transplant owed to CMS

Payment Operations and Reconciliation Timeline

Step	Timing
CMS issues Preliminary Performance Assessment & Payment Calculations	5 to 9 months after close of each PY
Participant review window	30 days to review and request targeted reviews
Targeted review grounds	Data quality/other issues; or misapplication of methodology
CMS issues Final Performance Score and payment determination	At least 30 days after preliminary notification

Extreme and Uncontrollable Circumstances: CMS may reduce downside risk payments for qualifying events (as determined by the Quality Payment Program), calculated as: downside payment × (percentage of PY months affected) × (percentage of attributed patients residing in the affected area). CMS has sole discretion over period determination and affected population percentage.

Compliance and Transparency Requirements

Participating hospitals must:

• Publicly post their criteria for evaluating and selecting patients for the kidney transplant waitlist by end of PY1
• Review transplant organ offer acceptance criteria with each Medicare-beneficiary waitlist patient at least every 6 months while on the waitlist
• Display informational materials about model participation at all office or facility locations where attributed patients receive treatment
• Provide paper notification to each attributed patient of the hospital's model participation
• Include model participation notification clearly on the hospital's public-facing website
• Sign a Data Sharing Agreement via the 4Innovation (4i) platform prior to accessing IOTA reports

Anti-Kickback Statute Safe Harbors: IOTA participants have access to the federal AKS safe harbor for CMS-sponsored model arrangements, enabling them to address transportation barriers and attributed patients' out-of-pocket drug costs without AKS exposure—provided they comply with applicable model and safe harbor requirements.

Future Measure Development

The IOTA NPRM included a Request for Information on two additional measures under development for potential inclusion in later performance years:

1. Patient-Reported Outcome/Experience Measure measuring quality-of-life improvement from dialysis to transplant (no current industry standard exists)
2. Transplant Waitlist Measure addressing referral and listing disparities by race and ethnicity, where current data gaps are significant

CMS has also initiated a Kidney Transplant Health-Related Quality of Life Patient Survey in partnership with RTI International (contact: KidneySurvey@rti.org) to gather patient-reported data from adult kidney transplant hospitals, with results intended to inform a future patient-reported outcome measure for CMS use.

---

Model contact: CMMItransplant@cms.hhs.gov | Model page: cms.gov/priorities/innovation/innovation-models/iota Source documents dated through September 30, 2026. PY2 Updates Final Rule effective June 1, 2026.