Common use of Review of Consulting Activities Clause in Contracts

Review of Consulting Activities. For purposes of this Appendix B, the term “Consulting Activities” shall include all consulting and other fee for service arrangements entered with HCPs (including but not limited to speaker programs, speaker training programs, training and education services, product development activities, presentations, consultant task force meetings, advisory boards, ad hoc advisory activities, research and research-related activities, authorship and authorship-related activities, and any other financial engagement or arrangement with an HCP or HCI) and all events and expenses relating to such engagements or arrangements. a. For the first Reporting Period, the IRO shall select and review a sample of 10 Consulting Activities entered into with HCPs and all related expenses. For the second and subsequent Reporting Periods, the IRO shall review a sample of 10 Consulting Activities which shall include a review of specified numbers of each type of Consulting Activities as determined by OIG. Prior to the determination of the number of each type of Consulting Activity to be reviewed during the second and subsequent Reporting Periods, Merit shall provide to OIG the information specified below in the next paragraph within 60 days prior to the end of the applicable preceding Reporting Period. b. The IRO shall select its sample of Consulting Activities for review in consultation with OIG after the provision of information about the Consulting Activities to the OIG. Merit shall provide the following information to the OIG: (1) a description of each type of Consulting Activity undertaken during the Reporting Period and a description of the services to be provided under each Consulting Activity; (2) the number of each type of Consulting Activity undertaken during the Reporting Period; and (3) the overall budgeted amount to be spent in connection with each type of Consulting Activity during the Reporting Period. c. For each Consulting Activity reviewed, the IRO shall determine whether: i. a written agreement was in place for each Consulting Activity that describes the scope of work to be performed, the fees and related expenses to be paid for the Consulting Activity, and the compliance obligations for the Consultant; ii. the compensation to be paid for the Consulting Activity was determined in accordance with a centrally managed, pre-set rate structure established by Merit; iii. the rate structure was established based on an independent FMV analysis; iv. the Consulting Activity was identified in the annual Consultant budgeting plan developed by Merit; v. a needs assessment that identifies the business need for the Consulting Activity and provides details about the Consulting Activity was completed prior to the initiation of the Consulting Activity; vi. the Consulting Activity was reviewed and approved in accordance with Merit Policies and Procedures; vii. Merit collected and retained a record of the specific activity performed by the HCP and, if applicable, a copy of the work product generated by the HCP in connection with the Consulting Activity; and viii. the activity undertaken by the Consultant and/or the work product generated by the HCP was used by Merit in a manner consistent with the needs assessment that was completed prior to the initiation of the Consulting Activity.

Review of Consulting Activities. For purposes of this Appendix BB , the term “Consulting Activities” shall include all consulting and other fee for service arrangements entered with HCPs (including but not limited to speaker programs, speaker training programs, training and education services, product development activities, presentations, consultant task force meetings, advisory boards, ad hoc advisory activities, research and research-related activities, authorship and authorship-related activities, and any other financial engagement or arrangement with an HCP or HCI) and all events and expenses relating to such engagements or arrangements. a. For the first Reporting Period, the IRO shall select and review a sample of 10 3 Consulting Activities entered into with HCPs and all related expenses. For the second and subsequent Reporting Periods, the IRO shall review a sample total of 10 at least 3 Consulting Activities which shall include a review of specified numbers of each type of Consulting Activities as determined by the OIG. Prior to the determination of the number of each type of Consulting Activity to be reviewed during the second and subsequent Reporting Periods, Merit RMS shall provide to the OIG the information specified below in the next paragraph within 60 days prior to the end of the applicable preceding Reporting Period. b. The IRO shall select its sample of Consulting Activities for review in consultation with OIG after the provision of information about the Consulting Activities to the OIG. Merit RMS shall provide the following information to the OIG: (1) a description of each type of Consulting Activity undertaken during the Reporting Period and a description of the services to be provided under each Consulting Activity; (2) the number of each type of RMS Consulting Activity undertaken during the Reporting Period; and (3) the overall budgeted amount to be spent in connection with each type of Consulting Activity during the Reporting Period. c. For each Consulting Activity reviewed, reviewed the IRO shall determine whether: i. a written agreement was in place for each Consulting Activity that describes the scope of work to be performed, the fees and related expenses to be paid for the Consulting Activity, and the compliance obligations for the Consultant; ii. the compensation to be paid for the Consulting Activity was determined in accordance with a centrally managed, pre-set rate structure established by MeritRMS; iii. the rate structure was established based on an independent FMV analysis; iv. the Consulting Activity was identified in the annual Consultant budgeting plan developed by MeritRMS; v. a needs assessment that identifies the business need for the Consulting Activity and provides details about the Consulting Activity was completed prior to the initiation of the Consulting Activity; vi. the Consulting Activity was reviewed and approved in accordance with Merit RMS Policies and Procedures; vii. Merit RMS collected and retained a record of the specific activity performed by the HCP and, if applicable, a copy of the work product generated by the HCP in connection with the Consulting Activity; and viii. the activity undertaken by the Consultant and/or the work product generated by the HCP was used by Merit RMS in a manner consistent with the needs assessment that was completed prior to the initiation of the Consulting Activity.

Review of Consulting Activities. For purposes of this Appendix BB , the term “Consulting Activities” shall include all consulting and other fee for service arrangements entered with HCPs (including but not limited to speaker programs, speaker training programs, training and education services, product development activities, presentations, consultant task force meetings, advisory boards, ad hoc advisory activities, research and research-related activities, authorship and authorship-related activities, and any other financial engagement or arrangement with an HCP or HCI) and all events and expenses relating to such engagements or arrangements. a. For the first Reporting Period, the IRO shall select and review a sample of 10 3 Consulting Activities entered into with HCPs and all related expenses. For the second and subsequent Reporting Periods, the IRO shall review a sample total of 10 at least 3 Consulting Activities which shall include a review of specified numbers of each type of Consulting Activities as determined by the OIG. Prior to the determination of the number of each type of Consulting Activity to be reviewed during the second and subsequent Reporting Periods, Merit RMS shall provide to the OIG the information specified below in the next paragraph within 60 days prior to the end of the applicable preceding Reporting Period. b. The IRO shall select its sample of Consulting Activities for review in consultation with OIG after the provision of information about the Consulting Activities to the OIG. Merit RMS shall provide the following information to the OIG: (1) a description of each type of Consulting Activity undertaken during the Reporting Period and a description of the services to be provided under each Consulting Activity; (2) the number of each type of RMS Consulting Activity undertaken during the Reporting Period; and (3) the overall budgeted amount to be spent in connection with each type of Consulting Activity during the Reporting Period.Period.‌ c. For each Consulting Activity reviewed, reviewed the IRO shall determine whether:whether:‌ i. a written agreement was in place for each Consulting Activity that describes the scope of work to be performed, the fees and related expenses to be paid for the Consulting Activity, and the compliance obligations for the Consultant; ii. the compensation to be paid for the Consulting Activity was determined in accordance with a centrally managed, pre-set rate structure established by MeritRMS; iii. the rate structure was established based on an independent FMV analysis; iv. the Consulting Activity was identified in the annual Consultant budgeting plan developed by Merit;RMS;‌ v. a needs assessment that identifies the business need for the Consulting Activity and provides details about the Consulting Consulting‌ Activity was completed prior to the initiation of the Consulting Activity; vi. the Consulting Activity was reviewed and approved in accordance with Merit RMS Policies and Procedures; vii. Merit RMS collected and retained a record of the specific activity performed by the HCP and, if applicable, a copy of the work product generated by the HCP in connection with the Consulting Activity; and viii. the activity undertaken by the Consultant and/or the work product generated by the HCP was used by Merit RMS in a manner consistent with the needs assessment that was completed prior to the initiation of the Consulting Activity.

Review of Consulting Activities. For purposes of this Appendix BB , the term “Consulting Activities” shall include all consulting and other fee for service arrangements entered with HCPs (including but not limited to speaker programs, speaker training programs, training and education services, product development activities, presentations, consultant task force meetings, advisory boards, ad hoc advisory activities, research and research-related activities, authorship and authorship-related activities, and any other financial engagement or arrangement with an HCP or HCI) and all events and expenses relating to such engagements or arrangements. a. For the first Reporting Period, the IRO shall select and review a sample of 10 Consulting Activities entered into with HCPs and all related expenses. For the second and subsequent Reporting Periods, the IRO shall review a sample of 10 Consulting Activities which shall include a review of specified numbers of each type of Consulting Activities as determined by the OIG. Prior to the determination of the number of each type of Consulting Activity to be reviewed during the second and subsequent Reporting Periods, Merit Life Spine shall provide to the OIG the information specified below in the next paragraph within 60 days prior to the end of the applicable preceding Reporting Period. b. The IRO shall select its sample of Consulting Activities for review in consultation with OIG after the provision of information about the Consulting Activities to the OIG. Merit Life Spine shall provide the following information to the OIG: (1) a description of each type of Consulting Activity undertaken during the Reporting Period and a description of the services to be provided under each Consulting Activity; (2) the number of each type of Life Spine Consulting Activity undertaken during the Reporting Period; and (3) the overall budgeted amount to be spent in connection with each type of Consulting Activity during the Reporting Period. c. For each Consulting Activity reviewed, reviewed the IRO shall determine whether: i. a written agreement was in place for each Consulting Activity that describes the scope of work to be performed, the fees and related expenses to be paid for the Consulting Activity, and the compliance obligations for the Consultant; ii. the compensation to be paid for the Consulting Activity was determined in accordance with a centrally managed, pre-set rate structure established by MeritLife Spine; iii. the rate structure was established based on an independent FMV analysis; iv. the Consulting Activity was identified in the annual Consultant budgeting plan developed by MeritLife Spine; v. a needs assessment that identifies the business need for the Consulting Activity and provides details about the Consulting Activity was completed prior to the initiation of the Consulting Activity; vi. the Consulting Activity was reviewed and approved in accordance with Merit Life Spine Policies and Procedures; vii. Merit Life Spine collected and retained a record of the specific activity performed by the HCP and, if applicable, a copy of the work product generated by the HCP in connection with the Consulting Activity; and viii. the activity undertaken by the Consultant and/or the work product generated by the HCP was used by Merit Life Spine in a manner consistent with the needs assessment that was completed prior to the initiation of the Consulting Activity.