(a) General.
(1) CMS establishes the performances measures described in §§ 512.424, 512.426, and 512.428 to assess IOTA participants in the achievement domain, efficiency domain and quality domain.
(2) CMS assigns each set of metrics within a domain a point value with the total possible points awarded to an IOTA participant across the three domains equaling 100, as described in §§ 512.424, 512.426, and 512.428.
(b) Data sources.
(1) CMS uses Medicare claims data and Medicare administrative data about beneficiaries, providers, suppliers, and data from the OPTN, to calculate performance for the IOTA participant based on the methodologies under §§ 512.424, 512.426, and 512.428.
(2) CMS may also use model-specific data reported by an IOTA participant to CMS under the IOTA Model to calculate IOTA participant performance in the domains.
(a) General.
(1) After each PY, CMS calculates the number of kidney transplants that each IOTA participant performed for the respective PY, in accordance with the provisions in paragraph (d) of this section.
(2) CMS compares the number of kidney transplants that an IOTA participant performed during the PY to the IOTA participant's transplant target to determine the IOTA participant's score for the achievement domain.
(b) Transplant target methodology. CMS determines the IOTA participant's transplant target for each PY as follows:
(1) Analysis of baseline years. CMS analyzes the baseline years for the relevant PY and identifies:
(i) The mean number of deceased donor kidney transplants furnished by the IOTA participant to patients 18 years of age or older across the baseline years, as defined at § 512.402; and
(ii) The mean number of living donor kidney transplants furnished by the IOTA participant to patients 18 years of age or older across the baseline years, as defined at § 512.402.
(2) Mean of kidney transplants. CMS sums the numbers in paragraphs (b)(1)(i) and (ii) of this section.
(3) National growth rate calculation. CMS calculates the national growth rate, as defined at § 512.402, using the baseline years for the relevant PY as follows:
(i) Subtracts the total number of kidney transplants furnished to patients 18 years of age or older during the second baseline year from the total number of kidney transplants furnished to patients 18 years of age or older during the third baseline year.
(ii) Divides the amount resulting from the calculation in paragraph (b)(3)(i) of this section by the total number of kidney transplants furnished to patients 18 years of age or older during the third baseline year. The resulting amount is the national growth rate for the relevant PY.
(4) Calculation of transplant target. If the national growth rate calculated in paragraph (b)(3) of this section is—
(i) Positive, CMS multiples that national growth rate by the sum calculated in paragraph (b)(2) of this section. The resulting amount is an IOTA participant's transplant target for the relevant PY; or
(ii) Negative, CMS does not multiply the national growth rate by the sum calculated in paragraph (b)(2) of this section. The IOTA participant's transplant target for the relevant PY is the sum calculated in paragraph (b)(2) of this section.
(c) Notification of transplant target. CMS notifies the IOTA participant of the transplant target by the first day of the start of each PY in a form and manner determined by CMS.
(d) Calculation of kidney transplants performed during the PY.
(1)
(i) After each PY, CMS counts the number of kidney transplants performed by the IOTA participant on patients who were 18 years of age or older at the time of transplant, during the PY.
(ii) CMS identifies kidney transplants performed by the IOTA participant using OPTN data, regardless of payer, and Medicare claims data.
(2) CMS counts each kidney transplant described in paragraph (d)(1) of this section as one transplant.
(e) [Reserved]
(f) Achievement domain scoring. For each PY, CMS awards the IOTA participant zero to 60 points for its performance in the achievement domain.
(1) CMS compares the total number of kidney transplants identified under paragraph (d)(2) of this section to the IOTA participant's transplant target, as described in paragraph (b) of this section.
(2) CMS uses the following scoring methodology to determine an IOTA participant's score on the achievement domain.
(a) General. For each PY, CMS assesses each IOTA participant on the metric described in paragraph (b) of this section to determine the IOTA participant's score for the efficiency domain.
(b) Metric included in the efficiency domain. For each PY, CMS assesses the IOTA participant on the following metric:
(1) Organ-offer acceptance rate ratio. For each PY, CMS calculates the organ-offer acceptance rate ratio by dividing the number of kidneys the IOTA participant accepted by the risk-adjusted number of expected organ-offer acceptances using SRTR's methodology as described in equation 1 to paragraph (b)(1) introductory text of this section.
Equation 1 to Paragraph (b)(1) Introductory Text—Organ Offer Acceptance Rate Ratio
(i) CMS uses both of the following:
(A) SRTR data to calculate the organ-offer acceptance rate ratio.
(B) SRTR's adult kidney model strata risk-adjustment methodology and most available set of coefficients to calculate the number of expected organ-offer acceptances.
(ii) CMS includes all of the following kidney offers when calculating the organ-offer acceptance rate ratio for the IOTA participant:
(A) Offers that are ultimately accepted and transplanted.
(B) Offers to candidates on a single organ waitlist (except for kidney/pancreas candidates that are also listed for kidney alone).
(iii) CMS excludes the following kidney offers when calculating the organ-offer acceptance rate:
(A) Offers with multiple match runs from the same donor combined and duplicate offers.
(B) Offers with no match run acceptances.
(C) Offers that occurred after the last acceptance in a match run.
(D) Offers with a missing or bypassed response.
(E) Offers to multi-organ candidates (except for kidney/pancreas candidates that are also listed for kidney alone).
(c) Efficiency domain scoring. For each PY, CMS awards the IOTA participant 0 to 20 points for its performance in the efficiency domain.
(1) General. CMS determines the IOTA participant's score for the efficiency domain for each PY by taking the IOTA participant's score for the organ offer acceptance rate ratio, as described under paragraph (c)(2) of this section. This number is the IOTA participant's score for the efficiency domain for the PY.
(2) Scoring for organ offer acceptance rate ratio. CMS calculates the IOTA participant's achievement score, as described in paragraph (c)(2)(i) of this section, and improvement score, as described under paragraph (c)(2)(ii) of this section, for the organ offer acceptance rate ratio, compares the IOTA participant's achievement score and improvement score and awards to the IOTA participant the points that correspond to the higher score.
(i) Achievement scoring. CMS calculates the IOTA participant's achievement score based on the IOTA participant's performance on organ offer acceptance rate ratio relative to national ranking, including all eligible kidney transplant hospitals, using the scoring methodology described in table 1 to paragraph (c)(1)(i) of this section.
Table 1 to Paragraph (c)(1)(i)—IOTA Model Organ Offer Acceptance Rate Ratio Achievement Scoring
(ii) Improvement scoring. CMS compares the IOTA participant's organ offer acceptance rate ratio during the PY, calculated as described under paragraph (c)(1)(i) of this section, to the IOTA participant's improvement benchmark rate, calculated as described under paragraph (c)(1)(ii)(A) of this section.
(A) Improvement benchmark rate. CMS calculates an improvement benchmark rate for the IOTA participant. To determine an IOTA participant's improvement benchmark rate for a given PY, CMS multiplies an IOTA participant's organ offer acceptance rate ratio during the third baseline year by 120 percent.
(B) Improvement score calculation. For each PY, CMS uses the following methodology to determine each IOTA participant's improvement score on the organ offer acceptance rate ratio:
(1) If the IOTA participant's organ-offer acceptance rate ratio is greater than or equal to the improvement benchmark rate, CMS awards the IOTA participant 15 points in the efficiency domain.
(2) If the IOTA participant's organ offer acceptance rate ratio is equal to or less than the IOTA participant's organ-offer acceptance rate ratio in the third baseline year for that respective PY, CMS awards the IOTA participant 0 points in the efficiency domain.
(3) If the IOTA participant's organ offer acceptance rate ratio is greater than the IOTA participant's organ-offer acceptance rate ratio in the third baseline year for that respective PY but less than the improvement benchmark rate, CMS uses the following equation:
(a) General. For each PY, CMS assesses each IOTA participant on the metric described under paragraph (b)(1) of this section to determine the IOTA participant's quality domain score, as described under paragraphs (c) through (e) of this section, for the quality domain.
(b) Metrics included in the quality domain. For each PY, CMS assesses each IOTA participant using the following quality metrics:
(1) Post-transplant graft survival. For each PY, CMS calculates an IOTA participant's composite graft survival rate by dividing the cumulative number of all functioning kidney grafts for the IOTA participant's IOTA transplant patients by the cumulative number of all kidney transplants performed by the IOTA participant during the first PY and all subsequent PYs on patients 18 years or older at the time of the transplant, as described in equation 1 to paragraph (b)(1) introductory text of this section.
Equation 1 to Paragraph (b)(1) Introductory Text—Composite Graft Survival Rate
(i) For the first PY, CMS calculates the IOTA participant's composite graft survival rate based solely on the number of functioning grafts furnished to IOTA transplant patients during that PY and the number of completed kidney transplants during that PY, as described in paragraph (b)(1) of this section.
(ii) For all subsequent PYs, CMS calculates the IOTA participant's cumulative composite graft survival rate using the same calculation methodology described in paragraph (b)(1) of this section and in accordance with paragraph (b)(2) of this section.
(iii) CMS excludes the following from the numerator when calculating the composite graft survival rate:
(A) Graft failure, based on OPTN adult kidney transplant recipient follow-up forms for all completed kidney transplants to determine failed grafts as defined by SRTR.
(B) Re-transplant.
(C) Death.
(D) Patients who are under the age of 18 years of age at the time of the kidney transplant.
(E) Multi-organ transplants (except for kidney/pancreas transplants).
(iv)
(A) When calculating the composite graft survival rate, CMS only includes single-organ kidney transplants, as defined at § 512.402, and kidney/pancreas transplants for patients who are 18 years of age and older at the time of the kidney transplant in the number of kidney transplants performed by the IOTA participant during each PY in the denominator.
(B) CMS identifies kidney transplants performed by the IOTA participant using OPTN data, regardless of payer, and Medicare claims data.
(2) Risk-adjustment transplant recipient and donor characteristics. In accordance with paragraphs (b)(1) through (3) of this section, CMS risk-adjusts the composite graft survival rate using SRTR's adult kidney graft survival first-year outcomes variables in accordance with paragraphs (3)(i) through (iii) of this section.
(3) Risk-adjustment methodology —
(i) Calculation of Observed Composite Graft Survival Rate. In accordance with paragraph (b)(1) of this section, CMS calculates the observed composite graft survival rate by dividing the number of functioning grafts plus two by the total number of completed kidney transplants plus two, as described in equation 2 to paragraph (b)(3)(i) of this section.
Equation 2 to Paragraph (b)(3)(i): Observed Composite Graft Survival Rate Calculation.
(ii) Risk score calculation methodology. CMS calculates a risk score for each IOTA participant as follows:
(A) Expected graft failure rate Calculation.
(1) CMS calculates the expected graft failure rate using SRTR's methodology as described in equation 3 to paragraph (b)(3)(ii)(A)(1).
Equation 3 to Paragraph (b)(3)(ii)(A)(1): Expected Graft Failure Rate Calculation.
(2) CMS uses both of the following:
(i) SRTR adult kidney graft survival first-year post-transplant risk-adjustment models for both deceased donor and living donor kidney transplants.
(ii) SRTR's most available set of coefficients.
(B) National graft failure rate calculation.
(1) CMS calculates the national graft failure rate by dividing the number of graft failures in a given PY by the number of completed kidney transplants in a given PY, as described in equation 4 to paragraph (b)(3)(ii)(B)(1) of this section.
Equation 4 to Paragraph (b)(3)(ii)(B)(1): National Graft Failure Rate Calculation.
(2) When calculating the national graft failure rate, CMS excludes all of the following:
(i) Patients who are under the age of 18 years of age at the time of the kidney transplant.
(ii) Pediatric kidney transplant hospitals as defined at § 512.402.
(iii) Multi-organ transplants (except for kidney/pancreas transplants).
(3) In accordance with the provisions in paragraph (b)(3)(ii)(B)(2) of this section, CMS includes kidney transplant patients who have experienced any of the following in the numerator when calculating the national graft failure rate:
(i) Graft failure, based on OPTN adult kidney transplant recipient follow-up forms for all completed kidney transplants to determine failed grafts as defined by SRTR.
(ii) Re-transplant.
(iii) Death.
(4) When calculating the national graft failure rate, CMS only includes single-organ kidney transplants, as defined at § 512.402, and kidney/pancreas transplants for patients who are 18 years of age and older at the time of the kidney transplant in the number of kidney transplants performed during the given PY in the denominator.
(C) Risk Score Calculation. CMS calculates the risk score for each IOTA participant by dividing the amount resulting from the calculation in paragraph (b)(3)(ii)(A) by the amount resulting from the calculation in paragraph (b)(3)(ii)(B) as described in equation 5 to paragraph (b)(3)(ii)(C) of this section.
Equation 5 to Paragraph (b)(3)(ii)(C): Risk Score Calculation.
(iii) Risk-Adjusted Composite Graft Survival Rate Calculation. CMS calculates the risk-adjusted composite graft survival rate for each IOTA participant by multiplying the amount resulting from the calculation in paragraph (b)(3)(i) of this section by the amount resulting from the calculation in paragraph (b)(3)(ii) of this section, as described in equation 6 to paragraph (b)(3)(iii) of this section.
Equation 6 to Paragraph (b)(3)(iii): Risk-Adjusted Composite Graft Survival Rate Calculation
(c) Quality domain scoring. For each PY, CMS awards the IOTA participant zero to 20 points for the IOTA participant's performance in the quality domain, in accordance with the following:
(1) For composite graft survival rate, as described under paragraph (d) of this section, the IOTA participant may receive up to 20 points.
(2) [Reserved]
(d) Composite graft survival rate scoring. CMS awards points to the IOTA participant based on the IOTA participant's performance on the composite graft survival rate, as described in paragraph (b)(1) of this section, ranked nationally, inclusive of all eligible kidney transplant hospitals. CMS awards points to the IOTA participant for composite graft survival rate as described in table 1 to paragraph (d) of this section:
| Performance relative to national ranking |
Lower bound condition | Upper bound condition | Points earned |
|---|---|---|---|
| 87.5th percentile | Equals 87.5th percentile | Greater than 87.5th percentile | 20 |
| 75th percentile | Equals 75th percentile | Less than 87.5th percentile | 18 |
| 62.5th percentile | Equals 62.5th percentile | Less than 75th percentile | 15 |
| 50th percentile | Equals 50th percentile | Less than 62.5th percentile | 13 |
| 37.5th percentile | Equals 37.5th percentile | Less than 50th percentile | 10 |
| 25th percentile | Equals 25th percentile | Less than 37.5th percentile | 8 |
| 12.5th percentile | Equals 12.5th percentile | Less than 25th percentile | 5 |
| 12.5th percentile | N/A | Less than 12.5th percentile | 0 |
[89 FR 96445, Dec. 4, 2024, as amended at 91 FR 32870, June 1, 2026]