Arrangements Review. The IRO shall perform an Arrangements Review and prepare an Arrangements Review Report as outlined in Appendix B to this CIA, which is incorporated by reference.
Arrangements Review. The IRO shall perform an Arrangements Review of LMC arrangements and prepare an Arrangements Review Report as outlined in Appendix C to this CIA, which is incorporated by reference. CHSI may engage an IRO to perform the Arrangements Review that is different from the IRO engaged to perform the Inpatient Medical Necessity and Appropriateness Review. Community Health Systems, Inc. Corporate Integrity Agreement
Arrangements Review. The IRO shall perform an Arrangements Review and prepare an Arrangements Review Report as outlined in Appendix B to this IA, which is incorporated by reference.
Arrangements Review. The Arrangements Review shall consist of two components: a systems review and a transactions review. The IRO shall perform all components of each Arrangements Review. If there are no material changes to CVS Health’s systems, processes, policies, and procedures relating to Arrangements, the Arrangements Systems Review shall be performed for the first and fourth Reporting Periods. If CVS Health materially changes the Arrangements systems, processes, Policies and Procedures, the IRO shall perform an Arrangements Systems Review for the Reporting Period in which such changes were made in addition to conducting the systems review for the first and fourth Reporting Periods. The Arrangements Transactions Review shall be performed annually and shall cover each of the five Reporting Periods.
Arrangements Review. The IRO shall perform a review to assess whether Biomet Orthopedics is complying with the Arrangements Procedures and Arrangements Requirements required by Sections III.D.1 and III.D.2 of this CIA. The IRO shall randomly select a sample of 50 Arrangements that were entered into or renewed during the Reporting Period. The IRO shall assess whether Biomet Orthopedics has implemented the Arrangements Procedures and, for each selected Arrangement, the IRO shall assess whether Biomet Orthopedics has complied with the Arrangements Procedures and Arrangements Requirements specifically with respect to that Arrangement. The IRO’s assessment shall include, but is not limited to: (a) verifying that the Arrangement is listed in the Arrangements Database; (b) verifying that the Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented; (c) verifying that the remuneration related to the Arrangement is properly tracked; (d) verifying that the activity logs are properly completed and reviewed; (e) verifying (if applicable) that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored; (f) verifying that the Compliance Officer is reviewing the Arrangements Database, internal review and approval process, and other Arrangements Procedures on a quarterly basis and reporting the results of such review to the Compliance Committee; (g) verifying that effective responses are being implemented when potential violations of the Anti-Kickback Statute are discovered; and (h) verifying that Biomet Orthopedics has met the requirements of Section III.D.2.
Arrangements Review. 1. For the third, fourth, and fifth Reporting Periods, the Monitor shall conduct the Arrangements Review. The Arrangements Review shall consist of two components: a systems review and a transactions review. The Monitor shall perform all components of each Arrangements Review. If there are no material changes to DaVita Dialysis’s systems, processes, policies, and procedures relating to Arrangements after the end of the second Reporting Period, the Arrangements Systems Review shall be performed for the fourth Reporting Period. If DaVita Dialysis materially changes the Arrangements systems, processes, policies, and procedures during the third or fifth Reporting Periods, the Monitor shall perform an Arrangements Systems Review of the material changes for the Reporting Period in which such changes were made in addition to conducting the systems review for the fourth Reporting Period. The Arrangements Transactions Review shall be performed annually for the third, fourth, and fifth Reporting Periods.
Arrangements Review. The IRO shall perform a review to assess whether Vanguard is complying with the Focus Arrangements Procedures and Focus Arrangements Requirements required by Sections III.D.1 and III.D.2 of this CIA (Arrangements Review). The Arrangements Review shall consist of two components – a systems review and a transactions review. The Arrangements Systems Review shall assess Vanguard’s systems, processes, policies, and procedures relating to Arrangements, including Vanguard’s implementation of the Focus Arrangements Procedures (including the Focus Arrangement Tracking System) and Focus Arrangements Requirements. If there are no material changes to Vanguard’s systems, processes, policies, and procedures relating to Arrangements, the Arrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Vanguard materially changes the relevant Arrangements systems, processes, policies and procedures, the IRO shall perform an Arrangements Systems Review for the Reporting Period in which such changes were made in addition to conducting the systems review for the first and fourth Reporting Periods. The Arrangements Transactions Review shall be performed annually and shall cover each of the five Reporting Periods. The IRO shall perform all components of each Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review of all Focus Arrangements that were entered into or renewed during the Reporting Period, provided, however, that if the number of Focus Arrangements exceeds 50, then the number of Focus Arrangements to be reviewed shall be a randomly selected sample to equal 25% of all Focus Arrangements. The IRO shall assess for each selected Focus Arrangement whether Vanguard has complied with the Focus Arrangements Procedures and Focus Arrangements Requirements specifically with respect to that Focus Arrangement. The applicable procedures and reporting requirements for the Arrangements Review are outlined in Appendix B to this CIA which is incorporated by reference.
Arrangements Review. The IRO shall perform a review to assess whether Serono is complying with the Arrangements Procedures and Arrangements Requirements required by Sections XXX.XX and III.D.2 by reviewing the documentation collected, tracked, and maintained with regard to a sample of Educational Sponsorship Arrangements. The IRO shall randomly select for review a sample of 15 of the Educational Sponsorship Arrangements with Serono Symposia International, Inc., that were entered into or renewed during the Reporting Period and a sample of 15 of the 19 Corporate Integrity Agreement Serono Holding, Inc. Case 1:05-cr-10282-RCL Document 7-5 Filed 12/21/05 Page 19 of 27 Educational Sponsorship Arrangements with Serono Symposia International, Inc., that were entered into or renewed during the Reporting Period and a sample of 15 of the Educational Sponsorship Arrangements with other providers of Educational Activities that were entered into or renewed during the Reporting Period. The IRO shall assess whether Serono has implemented the Arrangements Procedures and Requirements. For each selected Educational Sponsorship Arrangement, the IRO shall assess whether Serono has complied with the Arrangements Procedures and Arrangements Requirements specifically with respect to that Educational Sponsorship Arrangement. The IRO's assessment shall include, but is not limited to: (a) verifying that the Educational Sponsorship Arrangement is documented and that records of the arrangement are collected, tracked, and maintained as required by Section III.D.1.a; (b) verifying that the Educational Sponsorship Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented; (c) verifying that the funding or other sponsorship related to the Arrangement is properly documented and that records are maintained; (d) verifying that Serono's involvement in the Educational Activity was properly limited in accordance with Sections Ill.D.l.f-g; (e) verifying that the Compliance Officer is reviewing records relating to Educational Sponsorship Arrangements, the internal review and approval process, and other Arrangements Procedures on a semi-annual basis and reporting the results of such review to the Compliance Committee; (f) verifying that effective responses are being implemented when violations of the Federal anti-kickback statute and/or FDA Sponsorship Requirements ...
Arrangements Review. The IRO shall perform a review to assess whether Boston Scientific and/or Guidant/CRM, as appropriate, is complying with the Arrangements Procedures and Arrangements Requirements required by Section III.D.1 and III.D.2 of this CIA. The IRO shall randomly select a sample of 40 Contractual Arrangements for which payments were made during the applicable Reporting Period. The IRO shall assess whether Boston Scientific and/or Guidant/CRM, as appropriate, has implemented the Arrangements Procedures and, for each selected Arrangement, the IRO shall assess whether Boston Scientific and/or Guidant/CRM, as appropriate, has complied with the Arrangements Procedures and Arrangements Requirements specifically with respect to that Arrangement. The IRO’s assessment shall include, but is not limited to: (a) verifying that the Contractual Arrangement is listed in the Arrangements Database; (b) verifying that the Contractual Arrangement was subject to the internal review and approval process (including both a legal/compliance and business review) and obtained the necessary approvals and that such review and approval is Boston Scientific Corp. Corporate Integrity Agreement appropriately documented; (c) verifying (using a representative sample of Contractual Arrangements) that the remuneration related to the Contractual Arrangement is properly tracked; (d) verifying that the service and activity logs (if applicable) and/or other documented proof of performance is provided to and reviewed by Boston Scientific and/or Guidant/CRM, as appropriate; (e) verifying that the Chief Compliance Officer is reviewing the Arrangements Database, internal review and approval process, and other Arrangements Procedures on a quarterly basis and reporting the results of such review to the Global Compliance Steering Committee; (f) verifying that effective responses are being implemented when violations of the Anti-Kickback Statute are discovered; and (g) verifying that Boston Scientific and/or Guidant/CRM, as appropriate, has met the requirements of Section III.D.2.
Arrangements Review. As set forth more fully in Appendix D, the IRO Arrangements Review shall consist of two components: Systems Review and Transactions Review.
