IRO Transactions Review. As described more fully below in Sections IV.A-C, the Transactions Review shall include: (1) a review of Aegerion’s call plans and Aegerion’s call plan review process; (2) a review of records relating to a sample of the Payments that are reported by Aegerion to CMS as referenced in Section III.O of the CIA; and (3) a review of up to three additional items identified by the OIG in accordance with Section III.E.2 of the CIA (hereafter “Additional Items”.) The IRO shall report on all aspects of its reviews in the Transactions Review Reports.
Appears in 1 contract
Samples: Corporate Integrity Agreement (Novelion Therapeutics Inc.)
IRO Transactions Review. As described more fully below in Sections IV.A-C, the Transactions Review shall include: (1) a review of Aegerion’s call plans and Aegerion’s call plan review process; (2) a review of records relating to a sample of the Payments that are reported by Aegerion Daiichi pursuant to CMS as referenced in Section III.O III.M of the CIA; and (32) a review of up to three additional items identified by the OIG in accordance with Section III.E.2 III.E. of the CIA (hereafter “Additional Items”.) The IRO shall report on all aspects of its reviews in the Transactions Review Reports.
Appears in 1 contract
Samples: Corporate Integrity Agreement
IRO Transactions Review. As described more fully below in Sections IV.A-CD, the Transactions Review shall include: (1) a review of Aegerion’s call plans and Aegerion’s call plan review processEvaluation Product activities; (2) a review of Consulting Activities; (3) a review of records relating to a sample of the Payments that are reported by Aegerion ACell to CMS as referenced in Section III.O III.N of the CIA; and (34) a review of up to three additional items identified by the OIG in accordance with Section III.E.2 of the CIA (hereafter “Additional Items”.) ). The IRO shall report on all aspects of its reviews in the Transactions Review Reports.
Appears in 1 contract
Samples: Integrity Agreement
IRO Transactions Review. As described more fully below in Sections IV.A-C, the Transactions Review shall include: (1) a review of Aegerion’s call plans and Aegerion’s call plan review process; (2) a review of records relating to a sample of the Payments that are reported by Aegerion Xxxxxxx pursuant to CMS as referenced in Section III.O III.M of the CIA; and (32) a review of up to three additional items identified by the OIG in accordance with Section III.E.2 III.E. of the CIA (hereafter “Additional Items”.) The IRO shall report on all aspects of its reviews in the Transactions Review Reports.
Appears in 1 contract
Samples: Corporate Integrity Agreement