(a) General. Subject to the limitations on review in paragraph (c) of this section, an IOTA participant may submit a targeted review request for one or more calculations made, and issued by, CMS within the preliminary performance assessment and payment calculations, if either of the following occur:

1. (1) The IOTA participant believes an error occurred in calculations due to data quality or other issues.
2. (2) The IOTA participant believes an error occurred in calculations due to misapplication of methodology.

(b) Requirements. The request must satisfy the following criteria:

1. (1) Be submitted within 30 days, or another time period as specified by CMS, of receiving its preliminary performance assessment and payment calculations from CMS.
2. (2) Include supporting information in a form and manner as specified by CMS.

(c) Limitations on review.

1. (1) CMS does not provide IOTA participants the ability to dispute the policy or methodology, as the targeted review process would be limited to the dispute of calculations. CMS would not consider targeted review requests regarding, without limitation, the following:

   1. (i) The selection of the kidney transplant hospital to be an IOTA participant.
   2. (ii) The attribution of IOTA waitlist patients and the attribution of IOTA transplant patients to the IOTA participant, or to any other kidney transplant hospital selected for participation in the IOTA Model, or to any kidney transplant hospital not selected for participation in the IOTA Model.
   3. (iii) The methodology used for determining the achievement domain, efficiency domain, and quality domain.
   4. (iv) The methodology used for calculating and assigning points for each metric within the achievement domain, efficiency domain, and quality domain.
   5. (v) The methodology used for calculating the payment amount per Medicare kidney transplant paid to an IOTA participant.
2. (2) CMS may review a targeted review request that includes one or more of the limitations in paragraph (c)(1) of this section, provided that all remaining considerations of the request meet all other criteria for consideration by CMS in this section.

(d) Targeted review process. The IOTA participant must submit a request for targeted review in accordance with paragraphs (a) through (c) of this section. The process for a targeted review is as follows:

1. (1) Initial and final assessments. Upon receipt of a targeted review request from an IOTA participant CMS conducts an initial and final assessment as follows:

   1. (i) Initial assessment.

      1. (A) CMS determines if the targeted review request meets the targeted review requirements in paragraph (b) of this section and contains sufficient information to substantiate the request.

      2. (B) If the request is not compliant with paragraphs (a) through (c) of this section or requires additional information:

         (1) CMS follows up with the IOTA participant to request additional information in a form and manner as specified by CMS.

         (2) The IOTA participant must respond within 30 days of CMS's request for additional information in a form and manner as specified by CMS.

         (3) An IOTA participant's non-responsiveness to the request for additional information from CMS may result in the closure of the targeted review request.

   2. (ii) Final assessment.

      1. (A) Upon completion of an initial assessment, as described in paragraph (d)(1)(i) of this section, CMS determines whether it erred in calculation, as disputed by the IOTA participant.

      2. (B) If a calculation error is found as a result of an IOTA participant's targeted review request—

         (1) CMS—

         (i) Notifies the IOTA participant within 30 days of any findings in a form and manner as specified by CMS; and

         (ii) Resolves and corrects any resulting error or discrepancy in the amount of the upside risk payment or downside risk payment in a time and manner as determined by CMS.

         (2) CMS' correction of any error or discrepancy may delay the effective date of an IOTA participant's upside risk payments or downside risk payments.

2. (2) Targeted review decisions. Targeted review decisions made by CMS are final, unless submitted for administrative review as described in § 512.190.