(a) Grounds for remedial action. CMS may impose one or more remedial actions described in paragraph (b) of this section if CMS determines that:

(1) The IOTA participant has failed to furnish 11 or more kidney transplants for patients aged 18 years or older, regardless of payer, during a PY or any baseline years.

(2) The IOTA participant or its IOTA collaborator has failed to comply with any of the terms of the IOTA Model, including this subpart.

(3) The IOTA participant has failed to comply with transparency requirements described at § 512.442.

(4) The IOTA participant or its IOTA collaborator has failed to comply with any applicable Medicare program requirement, rule, or regulation.

(5) The IOTA participant or its IOTA collaborator has taken any action that threatens the health or safety of an attributed patient.

(6) The IOTA participant or its IOTA collaborator has submitted false data or made false representations, warranties, or certifications in connection with any aspect of the IOTA Model.

(7) The IOTA participant or its IOTA collaborator has undergone a change in control that presents a program integrity risk.

(8) The IOTA participant or its IOTA collaborator is subject to any sanctions of an accrediting organization or a Federal, State, or local government agency.

(9) The IOTA participant or its IOTA collaborator is subject to investigation or action by HHS (including the HHS Office of Inspector General or CMS) or the Department of Justice due to an allegation of fraud or significant misconduct, including any of the following:

(i) Being subject to the filing of a complaint or filing of a criminal charge.

(ii) Being subject to an indictment.

(iii) Being named as a defendant in a False Claims Act qui tam matter in which the Federal Government has intervened, or similar action.

(10) The IOTA participant or its IOTA collaborator has failed to demonstrate improved performance following any remedial action imposed under this section.

(11) The IOTA participant has misused or disclosed beneficiary-identifiable data in a manner that violates any applicable statutory or regulatory requirements or that is otherwise non-compliant with the provisions of the applicable data sharing agreement.

(b) Remedial actions. If CMS determines that one or more grounds for remedial action described in paragraph (a) of this section has taken place, CMS may take one or more of the following remedial actions:

(1) Notify the IOTA participant and, if appropriate, require the IOTA participant to notify its IOTA collaborators of the violation.

(2) Require the IOTA participant to provide additional information to CMS or its designees.

(3) Subject the IOTA participant to additional monitoring, auditing, or both.

(4) Prohibit the IOTA participant from distributing model-specific payments, as applicable.

(5) Require the IOTA participant to terminate, immediately or by a deadline specified by CMS, its sharing arrangement with an IOTA collaborator with respect to the IOTA Model.

(6) Terminate the IOTA participant from the IOTA Model.

(7) Suspend or terminate the ability of the IOTA participant to provide Part B and Part D immunosuppressive drug cost sharing support in accordance with § 512.456 or attributed patient engagement incentives in accordance with § 512.458.

(8) Require the IOTA participant to submit a corrective action plan in a form and manner and by a deadline specified by CMS.

(9) Discontinue the provision of data sharing and reports to the IOTA participant.

(10) Recoup model-specific payments.

(11) Reduce or eliminate a model-specific payment otherwise owed to the IOTA participant.

(12) [Reserved]

(13) Any other action as may be permitted under the terms of this part.