IRO Transactions Review. As described more fully below in Sections IV.A-C, the Transactions Review shall include: (1) a review of Lundbeck’ arrangements with selected Independent Charity PAPs; and (2) a review of up to three additional items identified by 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.
IRO Transactions Review. The Transactions Review shall include a review of: (1) a sample of consultant or other fee-for-service arrangements entered into with HCPs (including all events and expenses related to such engagements or arrangements), (2) a sample of Co-Marketing Activity agreements, (3) a sample of medical education grants and charitable contributions, and (4) a sample of Payments. The IRO shall report on all aspects of its reviews in the Transactions Review Report.
IRO Transactions Review. As described more fully below in Sections IV.A-C, the Transactions Review shall include: (1) a review of Jazz’s arrangements with selected Independent Charity PAPs; and (2) a review of up to three additional items identified by 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. Jazz Pharmaceuticals plc CIA Appendix B
IRO Transactions Review. The Transactions Review shall include a review of : (1) a sample of Co-Marketing Activities, (2) a sample of Discount Arrangements, and (3) a sample of Grants and Contributions involving ECPs and ECIs. The IRO shall report on all aspects of its reviews in the Transactions Review Report.
IRO Transactions Review. The Transactions Review shall consist of a review and assessment of whether TAF has complied with the PAP Measures outlined in Section III.F of the IA. For the first Reporting Period, the IRO shall review six of the active disease funds operated by TAF during calendar year 2020. (Active disease funds are those which provided financial assistance to patients during the applicable Reporting Period.) Four of the six funds reviewed shall be funds with a single donor. Those single-donor funds shall be randomly selected by the IRO from among the ten TAF single-donor funds that provided assistance to the largest number of patients in 2020. The remaining two funds reviewed for calendar year 2020 shall be randomly selected by the IRO from the active disease funds with multiple donors. For the second and third Reporting Periods, the IRO shall review six, or ten percent, of the active disease funds operated by TAF, whichever is a larger number. OIG shall have the discretion to select the types of funds to be reviewed by the IRO, and the number of each fund type reviewed (up to a total of six or 10% of the active disease funds), and shall do so based on information provided by TAF and other information known to OIG. No later than November 1 of each calendar year beginning in 2020, TAF shall submit to OIG information about the number of active disease funds operated by TAF, which of those funds are single-donor funds, and other information requested by OIG. For purposes of the Transactions Review, the term “Reviewed Materials” shall include, for each disease fund reviewed, the records specifically referenced in Section III.F of the IA and other documents sufficient to allow the IRO to review and assess whether TAF complied with each element of the PAP Measures outlined in Section III.F. In addition, the IRO may interview TAF personnel regarding TAF’s policies and practices relating to Patient Assistance Related Functions.
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.
IRO Transactions Review. As described more fully below in Sections IV.A-C, the Transactions Review shall include: (1) a review of Amgen’s arrangements with selected Independent Charity PAPs; and (2) a review of up to three additional items identified by OIG (hereafter “Additional Items”). The IRO shall report on all aspects of its reviews in the Transactions Review Reports.
IRO Transactions Review. As described more fully below in Sections IV.A-D, the Transactions Review shall include: (1) a review of a sample of Inquiries reflected in the Inquiries Databases; (2) a review of call plans and the call plan review process described at Section III.B.3.h of the CIA; (3) a review of records relating to a sample of the Payments that are reported by Shire pursuant to Section III.M of the CIA; (4) a review of Shire’s promotional materials review and approval process; and (5) as described in IV.E below, a review of up to three additional items identified by OIG in accordance with Section III.E.1.b of the CIA (hereafter “Additional Items”.) The IRO shall report on all aspects of its reviews in the Transactions Review Reports.
A. Review of Inquiries and Inquiries Databases 1) Description of Inquiries Databases As set forth in Section III.B.3.f of the CIA, Shire shall establish databases (Inquiries Databases) to track information relating to all requests for information received by medical affairs personnel about Government Reimbursed Products (Inquiries). Shire shall record in the Inquiries Databases the following information for each Inquiry received: (a) date of Inquiry; (b) form of Inquiry (e.g., fax, phone, medical information request form); (c) name of requesting HCP or HCI;
IRO Transactions Review. As described more fully below in Sections IV.A-E, the Transactions Review shall include: (1) a review of a sample of Inquiries reflected in the Inquiries Database; (2) a review of Endo’s call Plans and Endo’s call plan review process; (3) a review of Sampling Events as defined below in Section IV.C; (4) a review of records relating to a sample of the Payments that are reported by Endo pursuant to Section III.M of the CIA; and (5) a review of up to three additional items identified by the OIG in accordance with Section III.E.1.b of the CIA (hereafter “Additional Items”.) The IRO shall report on all aspects of its reviews in the Transactions Review Reports.
IRO Transactions Review. The Transactions Review shall consist of a review and assessment of whether, during the applicable Reporting Period, PANF complied with the PAP Measures outlined in Section III.F of the IA. For the first Reporting Period, the IRO shall review seven of the active disease funds operated by PANF during calendar year 2020. (Active disease funds are those which provided financial assistance to patients during the applicable Reporting Period.) Five of the seven funds reviewed shall be funds with a single donor. Three of those single-donor funds shall be randomly selected by the IRO from the 15 PANF single-donor funds that provided assistance to the largest number of patients in 2020 and the remaining single-donor funds to be reviewed shall be randomly selected by the IRO from all other PANF single-donor funds. The remaining two funds reviewed for calendar year 2020 shall be randomly selected by the IRO from the active disease funds with multiple donors. For the second and third Reporting Periods, the IRO shall review seven, or ten percent, of the active disease funds operated by PANF, whichever is a larger number. OIG shall have the discretion to select the types of funds to be reviewed by the IRO, and the number of each fund type reviewed (up to a total of seven or 10% of the active disease funds), and shall do so based on information provided by PANF and other information known to OIG. No later than November 1 of each calendar year beginning in 2020, PANF shall submit to OIG information about the number of active disease funds operated by PANF, which of those funds are single-donor funds, and other information requested by OIG. For purposes of the Transactions Review, the term “Reviewed Materials” shall include, for each disease fund reviewed, the records specifically referenced in Section III.F of the IA and other documents sufficient to allow the IRO to review and assess whether PANF complied with each element of the PAP Measures outlined in Section III.F. In addition, the IRO may interview PANF personnel regarding PANF’s policies and practices relating to Patient Assistance Related Functions during the applicable Reporting Period.
