(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 both of the following criteria:
(1) The kidney transplant hospital annually performed 11 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.
(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.