(a) Right to audit. The Federal Government, including CMS, HHS, and the Comptroller General, or their designees, has the right to audit, inspect, investigate, and evaluate any documents and other evidence regarding implementation of the IOTA Model.

(b) Access to records. The IOTA participant and its IOTA collaborators must maintain and give the Federal Government, including, but not limited to, CMS, HHS, and the Comptroller General, or their designees, access to all such documents (including books, contracts, and records) and other evidence sufficient to enable the audit, evaluation, inspection, or investigation of the implementation of the IOTA Model, including without limitation, documents, and other evidence regarding all of the following:

(1) Compliance by the IOTA participant and its IOTA collaborators with the terms of the IOTA Model.

(2) The accuracy of model-specific payments made under the IOTA Model.

(3) The IOTA participant's downside risk payments owed to CMS under the IOTA Model.

(4) Quality measure information and the quality of services performed under the terms of the IOTA Model.

(5) Utilization of items and services furnished under the IOTA Model.

(6) The ability of the IOTA participant to bear the risk of potential losses and to repay any losses to CMS, as applicable.

(7) Contemporaneous documentation of cost sharing support furnished under Part B and Part D immunosuppressive drug cost sharing support that includes the following:

(i) The identity of the eligible attributed patient to whom Part B and Part D immunosuppressive drug cost sharing support was provided.

(ii) The date or dates on which Part B and Part D immunosuppressive drug cost sharing support was provided.

(iii) The amount or amounts of the cost sharing support provided to the attributed patient.

(8) Contemporaneous documentation of items and services furnished as attributed patient engagement incentives in accordance with § 512.458 that includes all of the following, at minimum:

(i) The date the attributed patient engagement incentive is provided.

(ii) The identity of the attributed patient to whom the item or service was provided.

(9) Patient safety.

(10) Any other program integrity issues.

(c) Record retention. (1) The IOTA participant and its IOTA collaborators must maintain the documents and other evidence described in paragraph (b) of this section and other evidence for a period of 6 years from the last payment determination for the IOTA participant under the IOTA Model or from the date of completion of any audit, evaluation, inspection, or investigation, whichever is later, unless—

(i) CMS determines there is a special need to retain a particular record or group of records for a longer period and notifies the IOTA participant at least 30 days before the normal disposition date; or

(ii) There has been a termination, dispute, or allegation of fraud or similar fault against the IOTA participant or its IOTA collaborators, in which case the records must be maintained for an additional 6 years from the date of any resulting final resolution of the termination, dispute, or allegation of fraud or similar fault.

(2)(i) If CMS notifies the IOTA participant of the special need to retain a record or group of records in accordance with paragraph (c)(1)(i) of this section, the IOTA participant must maintain the records for such period of time as determined by CMS.

(ii) If CMS notifies the IOTA participant of a special need to retain records in accordance with paragraph (c)(1)(ii) of this section, the IOTA participant must notify its IOTA collaborators of this need to retain records for the additional period specified by CMS.