On May 8, 2024, CMS released the Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model proposed rule. This rule was accompanied by a fact sheet, a press release, and frequently asked questions. See the model summary here. The rule proposes a new mandatory payment model, IOTA, which would subject eligible kidney transplant hospitals to upside and downside risk based on the number transplants they perform, the efficiency of their matching process, post-transplant success rates, and certain quality measures.
Comments are due by 5:00 EDT on July 16, 2024.
OVERVIEW
The IOTA model would measure participants’ success in kidney transplants across three different domains: quality, achievement, and efficiency. Participants would be scored in these domains and receive payment from or owe payment to CMS based on their scores. Similar to the recently proposed Transforming Episode Accountability Model (TEAM), the IOTA model would ease the transition to value by giving all participants a one-year period with no downside risk. Existing Medicare IPPS payments for kidney transplants furnished to Medicare beneficiaries would not be impacted under the model.
CMS would use random sampling to select donation service areas (DSAs) for participation[1]. Every eligible hospital within a selected DSA would be required to participate in IOTA. Hospitals that performed at least 11 adult kidney transplants annually, regardless of payer type, over the three-year period from January 1, 2021, to December 31, 2023, and that performed at least half of their total kidney transplants on adults, would be eligible for participation. CMS would select roughly 50 percent of eligible kidney transplant hospitals.
While IOTA payments/recoupment would be based only on the volume of transplants where Medicare was the primary or secondary payer, IOTA participant’s scores across the various domains would be based on all eligible patients regardless of payer. Eligible patients would include all patients age 18 or older registered on a waitlist to an IOTA participant or who received a kidney transplant from an IOTA participant during the model performance period.
The model would begin on January 1, 2025, and last for six performance years, until December 31, 2030. CMS would notify hospitals of their participation at least three months prior to the start of the model.
Starting in performance year 2 of the model, participants would be required to submit a health equity plan (HEP) to CMS identifying health disparities within the participant’s attributed patient population and providing next steps to addressing these disparities. Participants would also be required to update this plan each subsequent performance year.
PAYMENT
Participants would be able to score up to 100 points across the three domains. Participants who scored above 60 would receive payments from CMS. Participants who scored between 40 and 59 would not receive a payment or owe a recoupment. Starting in performance year 2, participants who scored below 40 would owe a recoupment to CMS. Both the upside and downside risk payments would be paid/recouped in a lump sum following the performance year. The maximum a participant could earn per Medicare FFS transplant under the model would be $8,000, while the maximum a participant could owe per transplant would be $2,000.
CMS would calculate the upside risk payment using the following formula:
((Final performance score – 60)/40) * $8,000 * Total number of kidney transplants performed by the participant to attributed patients with Medicare as a primary or secondary payer [2]
So, if a hospital scored 80 and performed 30 eligible transplants, their payout would be:
((80 – 60)/40) * $8,000 * 30 = (20/40) * $8,000 * 30 = $120,000.00
CMS would calculate the downside risk payment using the following formula:
((Final performance score – 40)/40) * $-2,000 * Total number of kidney transplants performed by the participant to attributed patients with Medicare as a primary or secondary payer
So, if a hospital scored 30 and performed 30 eligible transplants, they would owe CMS the following:
((30-40)/40) * $-2,000 * 30 = (10/40) * $-2,000 * 30 = $15,000 owed to CMS
To allow for claims runout, CMS would conduct preliminary scoring and payment calculations for a given performance year 3 to 6 months after the end of that performance year. Participants would be notified of their score and payment 5 to 9 months after the end of the performance year and be given 30 days to review the scores before receiving their final performance scores. At the end of this 30-day period, upside payments and demand letters for downside payments would be distributed to participants.
DOMAINS
IOTA would measure participants across three different domains, achievement, efficiency, and quality. The summed scores in these domains would determine whether a participant received a recoupment, owed a repayment, or had no payment adjustment. The total points available across each domain, and the measures used to assess performance in these domains, are below:
Table 1. IOTA Domain Total Available Points and Measures
| Domain | Total Points | Metrics in Domain | Metric Points |
| Achievement | 60 | Number of transplants | 60 |
| Efficiency | 20 | Organ offer acceptance rate ratio | 20 |
| Quality | 20 | Post-transplant composite graft survival rate | 10 |
| CollaboRATE Shared Decision-Making Score | 4 | ||
| Colorectal Cancer Screening | 2 | ||
| Three-Item Care Transition Measure | 4 | ||
| Totals | 100 | 100 |
Achievement
The achievement domain would make up the majority (60 percent) of the total points a participant would be eligible for. This domain would award points to hospitals based on how they performed against a total transplant target set by CMS for each performance year.
To determine each participant’s target, CMS would sum the highest number of deceased donor kidney transplants and living donor kidney transplants performed by the participant on adult patients in a given year during the baseline period. This sum would then be projected forward using the national growth rate to arrive at the final target. If the growth rate were negative, the growth rate would simply be set to zero.
The baseline period for a given performance year would cover three years, beginning four years prior to the performance year. For the 2025 performance year then, the baseline period would cover CY2021 – CY 2023.
The national growth rate would be calculated by taking the percent change in total adult kidney transplants from two years prior to the performance year to one year prior to the performance year. So, for the 2025 performance year, CMS would do the following to calculate the national growth rate:
(Total adult transplants 2023 – Total adult transplants 2022)/ Total adult transplants 2022 = National Growth Rate
If this national growth rate were positive, CMS would do the following to calculate a participants target:
[(D+L) * N ] + (D+L) = Target
D = Highest number of deceased doner transplants in a calendar year from 2021 – 2023
L = Highest number of living doner transplants in a calendar year from 2021 – 2023
N = National growth rate
If the national growth rate were negative, the target would simply be the sum of the highest number of deceased doner transplants performed by the participant in a calendar year from 2021 – 2023 and the highest number of living donor transplants performed by the hospital over the same period. Participants would receive their transplant target by the first day of each performance year.
Participants who performed less than 75 percent of their target would receive a score of zero. Participants scoring at or above 150 percent of their target would receive the full 60 points. The full range of available scores can be seen in Table 2 below:
Table 2. Achievement Domain Scoring[3]
| Performance Relative to Transplant Target | Points |
| 150% of transplant target or higher | 60 |
| 125-150% of transplant target | 45 |
| 100-125% of transplant target | 30 |
| 75-100% of transplant target | 15 |
| 75% of target or below | 0 |
To decrease disparities in transplant rates, participants would be incentivized to perform transplants for “low-income populations” via a health equity performance adjustment. This adjustment would function as a 1.2x multiplier applied to any transplants for these populations.
Low-income populations would include the uninsured, Medicaid beneficiaries, dually eligible beneficiaries, Medicare low-income subsidy (LIS) recipients, and recipients of reimbursements from the Living Organ Donation Reimbursement Program administered by the National Living Donor Assistance Center (NLDAC).
Efficiency
The efficiency domain would be worth up to 20 total points and would evaluate participants based on their organ offer acceptance rate ratio. This ratio would be calculated using the Organ Procurement and Transplantation Network’s (OPTN) offer acceptance rate ratio performance metric.[4]
This metric divides the number of kidney transplant organs accepted by each participant by a risk adjusted measure of expected organ acceptances. The expected organ acceptances would account for factors such as whether the kidney was biopsied, how long the candidate has been on dialysis, and the distance between the donor hospital and the transplant center. The percent chance of acceptance would be calculated for each transplant offer the participant received during a performance year, and these summed percentages would determine the final expected organ acceptances that participants would be measured against. For a list of organ offers that would be excluded from this calculation, see Table 5 on page 128 of the unpublished rule.
Under this measure, participants would receive two scores, an achievement score measuring their current level of performance, and an improvement score measuring how that performance had improved over time. Participants would receive the higher of the two scores as their final score for the efficiency domain.
The achievement score would be determined by performance against all kidney transplant hospitals eligible for IOTA, regardless of whether their DSA was selected for participation.
Table 3. Efficiency Domain Achievement Score[5]
| Performance Relative to National Ranking | Points |
| 80th Percentile ≤ | 20 |
| 60th ≤ and < 80th Percentile | 15 |
| 40th ≤ and < 60th Percentile | 10 |
| 20th ≤ and < 40th Percentile | 6 |
| < 20th Percentile | 0 |
The improvement score would measure performance against the participants’ organ offer acceptance rate in the third baseline year against which their performance year was being measured (e.g. CY 2023 for PY 2025). Participants would receive a benchmark that would take this past acceptance rate and multiply it by 1.2.
The improvement score would only be worth up to 12 points, which a participant be awarded for meeting or exceeding their benchmark target. Participants who failed to reach the same acceptance rate that they achieved in the third baseline year would receive no points, while participants who scored between baseline performance and their benchmark target would be awarded up to 12 points based on how close they were to their benchmark.
Quality
The quality domain would be worth up to 20 points, with ten of these points being based off a participant’s compositive graft survival rate and ten being based off of a quality measure set.
Composite Graft Survival Rate
To reward participants for positive post-transplant outcomes, CMS would award points based on a participant’s unadjusted rolling composite graft survival rate. For performance year one, this metric would simply be the number of successful grafts divided by the number of completed adult transplants. So, if a participant completed 30 transplants to adults, 25 of which were successful, the composite graft survival rate would be .833. For subsequent years, this figure would be updated to account for any failures from past performance years. So, if the same participant completed 20 transplants in PY2, 18 of which were successful, but 2 grafts from PY 1 failed, then their composite graft survival rate would be (18 + 25 – 2) / (30 + 20) = 41/50 = .82.
Grafts would not be counted as successful if graft failure, retransplant, or death were reported following the transplant.
Participants would receive points based on their performance against all hospitals eligible for IOTA, regardless of whether they were selected for the model. The point distribution can be seen in Table 4 below:
Table 4. Composite Graph Survival Rate Point Distribution[6]
| Performance Relative to Target | Points Earned |
| 80th Percentile ≤ | 10 |
| 60th ≤ and < 80th Percentile | 8 |
| 40th ≤ and < 60th Percentile | 5 |
| 20th ≤ and < 40th Percentile | 3 |
| < 20th Percentile | 0 |
Quality Measure Set
IOTA participants would report three quality measures, worth a total of 10 points:
- The CollaboRATE Shared Decision-Making Score, worth up to 4 points, a patient reported measure assessing how much effort the hospital put into involving the patient in their care,
- The Colorectal Cancer Screening (COL) measure, worth up to 2 points, which measures the percentage of patients 50–75 years of age screened for colorectal cancer, and
- The 3-Item Care Transition Measure (CTM-3) measure, worth up to 4 points, a patient reported measure assessing how patients and their families were involved in and educated about their care plans.
For the first two performance years of the model, CMS would award points simply for reporting the measures, before awarding points based off performance in these measures for the last four performance years.
********
This Applied Policy® Summary was prepared by Will Henkes with support from the Applied Policy team of health policy experts. If you have any questions or need more information, please contact him at whenkes@appliedp
[1] A map of DSAs can be found here.
[2] CMS uses two different upside risk payment equations in the proposed rule. On page 10 of the unpublished rule, CMS states that:
“For a final performance score above 60, CMS would apply the formula for the upside risk payment, which we propose would be equal to the IOTA participant’s final performance score minus 60, then divided by 60, then multiplied by $8,000, then multiplied by the number of kidney transplants furnished by the IOTA participant to attributed patients with Medicare as their primary or secondary payer during the PY.” This equation, in which the final performance score minus 60 is divided by 60, is also referenced on page 27.
However, on page 341 of the unpublished rule CMS states that:
“If in PYs 1-6 the IOTA participant’s final performance score is 60 points or above, CMS calculates the IOTA participant’s upside risk payment as follows:
- Subtracts 60 from the IOTA participant’s final performance score from 100.
- (ii) Divides the amount resulting from the calculation in paragraph (b)(1)(i) of this section by 40.
This equation that divides by 40, as opposed to 60, is also used on pages 172 and 292. Given that the agency also states that “the maximum positive payment per Medicare fee-for-service (FFS) transplant under the model (the upside risk payment) would be $8,000” in the model factsheet, AP believes that the model will be dividing by 40, as opposed to 60, and that the equations on pages 10 and 27 were included by mistake. We have reached out to CMS to see if they can correct this discrepancy.
[3] See Table 3 on Page 114 of the unpublished rule
[4] A description of the metric can be found
[5] See Table 6 on page 132 of the unpublished rule
[6] See Table 7 on Page 144 of the unpublished rule