Records Reviews. As a component of the FFMP, GSK shall also review various types of records to assess sales personnel interactions with HCPs and HCIs in order to identify potential or actual compliance violations. For each Reporting Period, GSK shall develop and implement a plan for conducting Records Reviews associated with at least three Government Reimbursed Products and a sampling of the personnel supporting those products in regions across the country (as agreed with the OIG for each Reporting Period.) The OIG shall have the discretion to identify the three Government Reimbursed Products to be reviewed for each Reporting Period. The OIG will select the products based on information about GSK’s products provided by GSK, upon request by the OIG no later than 60 days prior to the beginning of the Reporting Period, and other information known to the OIG. If the OIG does not identify the Government Reimbursed Products to be reviewed within the first 30 days of the Reporting Period, GSK shall select the three products to be reviewed. These Records Reviews shall include the monitoring and review of: (1) records and systems relating to sales personnel interactions with HCPs and HCIs (including records from the electronic call reporting system used by sales personnel (which includes call notes), sales communications from managers, sample distribution records, and expense reports); (2) requests for medical information about, or inquiries relating to, Government Reimbursed Products; (3) message recall studies or other similar records (such as Verbatims) purporting to reflect the details of sales personnel interactions with HCPs and HCIs; (4) sales personnel e-mails and other electronic records; and (5) recorded results of the Observations of sales representatives and applicable notes or information from the sales personnel managers.
Records Reviews. As a component of the FFMP, Indivior shall also review various types of records to assess field sales representatives’ interactions with HCPs and HCIs and to identify potential or actual compliance violations.
Records Reviews. As a component of the FFMP, AstraZeneca shall also review various types of records to assess sales representatives’ interactions with HCPs and HCIs and to identify potential or actual compliance violations. For each Reporting Corporate Integrity Agreement AstraZeneca Period, AstraZeneca shall develop and implement a plan for conducting Records Reviews associated with at least three Government Reimbursed Products and a sampling of the representatives promoting those products in every separate region. The OIG shall have the discretion to identify the three Government Reimbursed Products to be reviewed for each Reporting Period. The OIG will select the products based on information about AstraZeneca’s products provided by AstraZeneca, upon request by the OIG no later than 60 days prior to the beginning of the Reporting Period, and other information known to the OIG. If the OIG does not identify the Government Reimbursed Products to be reviewed within the first 30 days of the Reporting Period, AstraZeneca shall select the three products to be reviewed. These Records Reviews shall include the monitoring and review of: 1) records and systems relating to sales representatives’ interactions with HCPs and HCIs relating to promotional speaker program activities, samples, meals, and other events or items (including records from the electronic detailing system for the particular sales representative, sales communications from managers, and expense reports); 2) requests for medical information (including through PIRs and the VSEC); 3) tutorials and preceptorships; 4) message recall studies or other similar records (such as Verbatims) purporting to reflect the details of sales representatives’ interactions with HCPs and HCIs;
Records Reviews. As a component of the FFMP, RMS shall also review various types of records to assess sales representatives’ interactions with HCPs and HCIs and to identify potential or actual compliance violations.
Records Reviews. As a component of the SFMP, Xxxxxxx shall also review various types of records to assess field representatives’ interactions with HCPs and HCIs and to identify potential or actual compliance violations. For each Reporting Period, Xxxxxxx shall develop and implement a plan for conducting Records Reviews associated with at least three Government Reimbursed Products. The Records Reviews shall include a review of records relating to the activities of sales representatives in every separate region who promoted the products under review. These Records Reviews shall include the monitoring and review of: (1) records and systems associated with field sales representatives’ interactions with HCPs and HCIs (including records relating to speaker program activities, samples, travel and entertainment, expense reports, any payments to HCPs or HCIs, and sales communications from managers); (2) message recall studies or other similar records (such as Verbatims) purporting to reflect the details of representatives interactions with HCPs and HCIs; (3) records relating to requests for medical information about or Inquiries relating to, the Government Reimbursed Products under review; (4) call notes, or if Xxxxxxx does not require and/or utilize call notes, the information in Xxxxxxx’s sales force automation tool that captures information about sales representatives’ interactions with HCPs and HCIs and related information; (5) field sales representatives’ e-mails and other electronic records; and (6) recorded results of the Observations of field sales force representatives, coaching guides, if coaching guides are required and/or used, and applicable notes or information from the sales representatives’ managers. For each sales representative reviewed, Monitoring Personnel shall complete a Records Review report that includes:
Records Reviews. As a component of the FFMP, Arthrex shall also review various types of records to assess sales representatives’ interactions with HCPs and HCIs and to identify potential or actual compliance violations.
Records Reviews. As a component of the FFMP, Biotronik shall also review various types of records to assess sales representatives’ interactions with HCPs and HCIs and to identify potential or actual compliance violations.
Records Reviews. As a component of the FFMP, SUN shall also review various types of records to assess Relevant Government Reimbursed Products field sales representatives’ interactions with HCPs and HCIs and to identify potential or actual compliance violations.
Records Reviews. As a component of the FFMP, Endo shall also review various types of records to assess the interactions of sales personnel acting on behalf of Endo (including both employees and contractors) with HCPs and HCIs in order to identify potential or actual compliance violations. For each Reporting Period, Endo shall develop and implement a plan for conducting Records Reviews associated with at least three Government Reimbursed Products and a sampling of the representatives promoting the Government Reimbursed Products in every separate district/region of the United States. The OIG shall have the discretion to identify the Government Reimbursed Products to be reviewed for each Reporting Period. The OIG will select the Government Reimbursed Products based on information about Endo’s Government Reimbursed Products provided by Endo no later than 60 days prior to the beginning of the Reporting Period and other information known to the OIG. If the OIG does not identify the Government Reimbursed Products to be reviewed during a given Reporting Period, Endo shall select the three Government Reimbursed Products to be reviewed. These Records Reviews shall include the monitoring and review of: (1) records and systems relating to sales representatives’ interactions with HCPs and HCIs (including, but not limited to, records from all available electronic detailing system(s), sales communications from managers, sample distribution records, and expense reports);
Records Reviews. The Records Review component of the IMP shall be designed to monitor and assess the appropriateness of interactions between Covered Persons who engage in Pricing and Contracting Functions with competitors and to identify potential improper conduct. For purposes of the Records Reviews, all companies that manufacture and sell generic pharmaceutical products shall be considered “competitors.”
