Federal regulations · Through 2026-08-25 · Newer source version available

42 CFR 512.428: Quality domain.

(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:
Table 1 to Paragraph (d)—IOTA Model Composite Graft Survival Rate Scoring
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

Where this section sits in the code

Title 42—Public Health
CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H—HEALTH CARE INFRASTRUCTURE AND MODEL PROGRAMS
PART 512—STANDARD PROVISIONS FOR MANDATORY INNOVATION CENTER MODELS AND SPECIFIC PROVISIONS FOR CERTAIN MODELS
Subpart D—Increasing Organ Transplant Access (IOTA) Model

(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.

(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:

Table 1 to Paragraph (d)—IOTA Model Composite Graft Survival Rate Scoring

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

Collected 2026-08-27T02:26:11Z. Source file · JSON

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