§ 512.160 Remedial action. ( a ) *Grounds for remedial action.* CMS may take one or more remedial actions described in paragraph (b) of this section if CMS determines that the model participant or a downstream participant: ( 1 ) Has failed to comply with any of the terms of the Innovation Center Model, including this subpart.
( 2 ) Has failed to comply with any applicable Medicare program requirement, rule, or regulation.
( 3 ) Has taken any action that threatens the health or safety of a beneficiary or other patient.
( 4 ) Has submitted false data or made false representations, warranties, or certifications in connection with any aspect of the Innovation Center model.
( 5 ) Has undergone a change in control that presents a program integrity risk.
( 6 ) Is subject to any sanctions of an accrediting organization or a Federal, State, or local government agency.
( 7 ) Is subject to investigation or action by HHS (including the HHS Office of Inspector General and CMS) or the Department of Justice due to an allegation of fraud or significant misconduct, including being subject to the filing of a complaint or filing of a criminal charge, being subject to an indictment, being named as a defendant in a False Claims Act qui tam matter in which the Federal government has intervened, or similar action.
( 8 ) Has failed to demonstrate improved performance following any remedial action imposed under this section.
( 9 ) For the ETC Model only, has misused or disclosed the 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 model participant and, if appropriate, require the model participant to notify its downstream participants of the violation.
( 2 ) Require the model participant to provide additional information to CMS or its designees.
( 3 ) Subject the model participant to additional monitoring, auditing, or both.
( 4 ) Prohibit the model participant from distributing model-specific payments, as applicable.
( 5 ) Require the model participant to terminate, immediately or by a deadline specified by CMS, its agreement with a downstream participant with respect to the Innovation Center model.
( 6 ) In the ETC Model only: ( i ) Terminate the ETC Participant from the ETC Model.
( ii ) Suspend or terminate the ability of the ETC Participant, pursuant to § 512.397(c), to reduce or waive the coinsurance for kidney disease patient education services.
( 7 ) Require the model participant to submit a corrective action plan in a form and manner and by a deadline specified by CMS.
( 8 ) Discontinue the provision of data sharing and reports to the model participant.
( 9 ) Recoup model-specific payments.
( 10 ) Reduce or eliminate a model-specific payment otherwise owed to the model participant.
( 11 ) Such other action as may be permitted under the terms of this part.
[85 FR 61362, Sept. 29, 2020, as amended at 86 FR 62020, Nov. 8, 2021]