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| Increasing Organ Transplant Access Model Scope and Participation | 512.412 – 512.414 | |||||||
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42 U.S.C. 1302, 1315a, and 1395hh.
85 FR 61362, Sept. 29, 2020, unless otherwise noted.
89 FR 96445, Dec. 4, 2024, unless otherwise noted.
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Subscribe to: 42 CFR Part 512 Subpart D - Increasing Organ Transplant Access Model Scope and Participation
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(a) Participant eligibility. A kidney transplant hospital is eligible to be selected as an IOTA participant, in accordance with the methodology described in paragraph (c) of this section, if the kidney transplant hospital meets all of the following criteria:
(1) The kidney transplant hospital annually performed 15 or more kidney transplants for patients aged 18 years or older, regardless of payer, each of the baseline years.
(2) The kidney transplant hospital annually performed more than 50 percent of its kidney transplants on patients 18 years of age or older each of the baseline years.
(3) The kidney transplant hospital is not an MTF or VA medical facility as defined at § 512.402.
(b) IOTA participant selection. CMS uses the following process to select IOTA participants for inclusion in the model.
(1) DSA stratification criteria. CMS uses the following criteria to stratify DSAs using the list of DSAs as of January 1, 2024:
(i) Census division of the DSA.
(ii) Total number of adult kidney transplants performed per year across eligible kidney transplant hospitals in the DSA during PY 1's baseline years.
(2) DSA stratification process. Prior to sampling DSAs, CMS uses the following steps to group DSAs into mutually exclusive groups.
(i) CMS assigns each DSA to one of the nine Census Divisions. CMS assigns each DSA to the Census Division where the majority of the DSA's population resides. CMS determines each DSA's population, and the share of a DSA's population in the applicable Census Division(s) using data from the 2020 Census.
(A) CMS assigns the Puerto Rico DSA to the South Atlantic Census Divisions.
(B) CMS combines the Middle Atlantic and New England Census Divisions and all DSAs therewithin creating eight groups of Census Divisions.
(ii) CMS identifies all kidney transplant hospitals located in each DSA within each Census Division group.
(iii) For each DSA within its assigned Census Division group, CMS identifies the eligible kidney transplant hospitals using the criteria specified in paragraph (a) of this section.
(iv) Using data from each of the baseline years for PY 1, CMS determines the average number of adult kidney transplants performed annually by eligible transplant hospitals located in each DSA as follows:
(A) Sums the number of adult kidney transplants performed across eligible kidney transplant hospitals in a DSA during each of the baseline years for PY 1; and
(B) Divides each DSA's sum resulting from the calculation in paragraph (b)(2)(iv)(A) of this section by three to determine the average number of adult kidney transplants furnished during the baseline years for PY 1.
(v) CMS separates DSAs in each Census Division group into two mutually exclusive groups of the same size, based on the average number of adult kidney transplants performed annually across the baseline years for PY 1, except where there are an odd number of DSAs within a Census Division group:
(A) DSAs with a higher number of adult kidney transplants per year across the baseline years for PY 1.
(B) DSAs with a lower number of adult kidney transplants per year across the baseline years for PY 1.
(vi) Where there are an odd number of DSAs within a Census Division group CMS uses the methodology set forth in paragraph (b)(3) of this section.
(3) Random sampling of DSAs.
(i) For each DSA group within a Census Division group containing an odd number of DSAs, CMS randomly selects one DSA and determines its participation in the IOTA Model with a 50 percent probability.
(ii) CMS randomly samples, without replacement, 50 percent of the remaining DSAs in each group within each Census Division group created in paragraph (b)(2)(v) of this section.
(c) Selection of IOTA participants in selected DSAs. All eligible kidney transplant hospitals in the selected DSAs are required to participate in the IOTA Model.
(d) Notification of participation. CMS notifies IOTA participants of their selection to participate in the IOTA Model in a form and manner chosen by CMS at least 3 months prior to the start of the model performance period.
[89 FR 96445, Dec. 4, 2024, as amended at 91 FR 32870, June 1, 2026]
(a) General.
(1) CMS attributes kidney transplant waitlist patients and kidney transplant patients to IOTA participants based on the attribution criteria as described in paragraphs (b)(1) and (b)(2) of this section, for all of the following purposes:
(i) Sharing Medicare claims data for attributed beneficiaries with IOTA participants.
(ii) Assessing each IOTA participant's performance across the achievement domain, efficiency domain, and quality domain.
(iii) Determining performance-based payments paid to or by IOTA participants.
(2) Once a kidney transplant waitlist patient or kidney transplant patient is attributed to an IOTA participant, that respective patient may not opt out of attribution to an IOTA participant and remains attributed to the IOTA participant for the duration of the model performance period, unless the attributed patient meets the de-attribution criteria under paragraph (b)(3) of this section during annual attribution reconciliation as described in paragraph (b)(3) of this section.
(b) Patient attribution and de-attribution criteria —
(1) IOTA waitlist patient attribution.
(i) At the time CMS conducts attribution, as described in paragraph (c) of this section, if a kidney transplant waitlist patient meets the definition of an IOTA waitlist patient, as defined at § 512.402, CMS attributes the kidney transplant waitlist patient as an IOTA waitlist patient to an IOTA participant.
(ii) [Reserved]
(2) IOTA transplant patient attribution.
(i) At the time CMS conducts attribution, as described in paragraph (c) of this section, CMS attributes a kidney transplant patient as an IOTA transplant patient if the kidney transplant patient meets all of the following:
(A) The definition of an IOTA transplant patient, as defined at § 512.402.
(B) Is 18 years of age or older at the time of the patient's kidney transplant.
(C) Is alive.
(ii) [Reserved]
(3) De-attribution from an IOTA participant. During annual attribution reconciliation, CMS uses the fourth quarter attribution list for each IOTA participant and de-attributes any attributed patients who, as of the last day of the PY being reconciled, meet any of the following de-attribution criteria:
(i) An IOTA waitlist patient that was removed from and remains unregistered on an IOTA participant's kidney transplant waitlist.
(ii) An IOTA waitlist patient that has died at any point during the PY.
(iii) An IOTA transplant patient that has died at any point during the PY.
(iv) An IOTA transplant patient who experiences transplant failure at any point during the model performance period and has not rejoined an IOTA participant's kidney transplant waitlist or received another transplant from an IOTA participant before the last day of the respective PY.
(c) Attribution methodology. CMS employs the following methodology to attribute kidney waitlist patients and kidney transplant patients to an IOTA participant after identifying all kidney waitlist patients and kidney transplant patients that meet the attribution criteria as specified in paragraphs (b)(1) and (b)(2) of this section:
(1)
(i) Initial attribution. Prior to the model start date, CMS conducts initial attribution, as defined at § 512.402.
(ii) Initial attribution list.
(A) CMS provides the initial attribution list to the IOTA participant no later than 15 days prior to the start of PY 1 and in a form and manner as determined by CMS.
(B) The initial attribution list includes a list of IOTA waitlist patients identified through initial attribution, effective on the model start date.
(2)
(i) Quarterly attribution. CMS conducts attribution, as defined at § 512.402, on a quarterly basis after the model start date, and updates the quarterly attribution list, as defined at § 512.402, for each IOTA participant, except in the event of termination in accordance with § 512.466.
(ii) Quarterly attribution list. CMS provides the quarterly attribution list, as defined at § 512.402, to the IOTA participant no later than 15 days prior to the start of each quarter and in a form and manner determined by CMS. The quarterly attribution list includes, at minimum, all of the following:
(A) A list of all newly attributed patients, whose attribution to the IOTA participant becomes effective on the first day of the relevant upcoming quarter.
(B) A list of all attributed patients who continue to be attributed to the IOTA participant from the previous quarter.
(C) The dates in which attribution began, changed, or ended, where applicable for attributed patients.
(D) The attributed patient's data sharing preferences under § 512.440(b).
(3)
(i) Annual attribution reconciliation. After the fourth quarter of each PY, CMS conducts annual attribution reconciliation as defined at § 512.402.
(ii) Annual attribution reconciliation list. CMS provides the annual reconciliation list to the IOTA participant before the second quarter of the following PY. Using the fourth quarter quarterly attribution list for each IOTA participant, the annual attribution reconciliation list identifies, at a minimum, all of the following, where applicable:
(A) A list of all attributed patients who remain attributed to the IOTA participant because they satisfied the attribution criteria under §§ 512.414(b)(1) and (2) for the respective PY.
(B) The dates in which attribution began, changed, or ended, where applicable.
(C) A list of all attributed patients who are de-attributed because they failed to satisfy the attribution criteria under § 512.414(b)(1) and (2).
(D) A list of all attributed patients who are de-attributed because they satisfy a de-attribution criterion under § 512.414(b)(3).
(E) The dates on which each attributed patient satisfied a de-attribution criterion as specified under § 512.414(b)(3).
(F) A list of the de-attribution criterion each attributed patient satisfied under § 512.414(b)(3).
[89 FR 96445, Dec. 4, 2024, as amended at 91 FR 32870, June 1, 2026]