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.
(a) For each Reporting Period, Indivior shall develop and implement a plan for conducting Records Reviews associated with at least two Government Reimbursed Products. The Records Reviews shall include a review of records relating to the activities of sales representatives using either a risk-based targeting approach or a random sampling approach.
(b) The Records Reviews shall include the monitoring and review of:
(i) 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);
(ii) message recall studies or other similar records (such as Verbatims) purporting to reflect the details of representatives’ interactions with HCPs and HCIs;
(iii) records relating to requests for medical information about or inquiries relating to, the Government Reimbursed Products under review;
(iv) field sales representative call notes;
(v) field sales representatives’ e-mails and other electronic records; and
(vi) recorded results of the Observations of field sales force representatives, coaching guides, and district manager notes.
Records Reviews. As a component of the FFMP, Merit shall also review various types of records to assess sales representatives’ interactions with HCPs and HCIs and to identify potential or actual compliance violations.
a. For each Reporting Period, Merit shall develop and implement a plan for conducting Records Reviews associated with at least five Government Reimbursed Products. The Records Reviews shall include a review of records relating to the activities of sales representatives in every separate district and/or region (as applicable) who promoted the products under review.
b. The Records Reviews shall include the monitoring and review of:
(i) records and systems associated with sales representatives’ interactions with HCPs and HCIs (including records relating to Co-Marketing activities, consulting and other fee-for-service arrangements, speaker program activities, travel and entertainment, expense reports, any payments to HCPs or HCIs, and sales communications from managers);
(ii) records relating to requests for medical information about or inquiries relating to, the Government Reimbursed Products under review;
(iii) sales representative call notes;
(iv) sales representatives’ e-mails and other electronic records; and
(v) recorded results of the Observations of sales force representatives, coaching guides, and manager notes.
Records Reviews. As a component of the FFMP, Allergan 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 Period, Allergan 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 Allergan’s products provided by Allergan, 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, Allergan shall select the three products to be reviewed. For the first Reporting Period, the Records Reviews shall include the monitoring and review of: 1) records in BEACON relating to sales representatives’ interactions with HCPs and HCIs relating to promotional speaker program activities, meals and expenses, and advisory boards; 2) requests for medical information; 3) sales representatives’ call notes; 4) sales representatives’ e-mails; and 5) recorded results of the Observations of sales representatives. For the second and subsequent Reporting Periods, the Records Reviews shall include the monitoring and review of: 1) records in BEACON relating to sales representatives’ interactions with HCPs and HCIs; 2) requests for medical information; 3) message recall studies or any other similar records in Allergan’s possession purporting to reflect the details of sales representatives’ interactions with HCPs and HCIs; 4) sales representative call notes; 5) sales representatives’ e-mails and any electronic records; and 6) recorded results of the Observations of sales representatives and other notes or information from the sales representatives’ managers relating to interactions between the sales representatives and HCPs and HCIs pertaining to the Government Reimbursed Product at issue.
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.
a. For each Reporting Period, Arthrex shall develop and implement a plan for conducting Records Reviews associated with at least five Government Reimbursed Product Lines.1 The Records Reviews shall include a review of records relating to the activities of sales representatives in every separate district and/or region (as applicable) who promoted the products under review.
b. The Records Reviews shall include the monitoring and review of:
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.”
a. For each Reporting Period, Sandoz shall develop and implement a plan for conducting Records Reviews associated with at least five Covered Persons who are engaged in establishing or changing the actual prices at which Government Reimbursed Products are sold or offered for sale or who communicate or negotiate with customers or potential customers about actual prices, bids, or offers for Government Reimbursed Products (Reviewed Covered Persons). Monitoring Personnel shall conduct the Records Review described below. The Reviewed Covered Persons shall be selected using either a risk-based targeting approach or a random sampling approach;
b. For each Reviewed Covered Person, the Records Reviews shall include an interview of the Reviewed Covered Person and a review of:
(i) all Sandoz records relating to interactions or communications between the Reviewed Covered Person and any competitor, including but not limited to all e-mails and other electronic records of the Reviewed Covered Person;
(ii) all training records of the Reviewed Covered Person; and
(iii) all performance review records and any disciplinary records for the Reviewed Covered Person.
c. Based on the review of the records listed above and the interview, Monitoring Personnel shall prepare a report which includes:
(i) the identity of the Reviewed Covered Person;
(ii) the identity of the Monitoring Personnel;
(iii) an overall assessment of the Reviewed Covered Person’s compliance with Sandoz Policies and Procedures; and
(iv) the identification of any potential improper conduct by the Reviewed Covered Person.
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.
a. For each Reporting Period, RMS shall develop and implement a plan for conducting Records Reviews associated with at least 2 Government Reimbursed Products. The
Records Reviews. As a component of the FFMP, EGS 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 Period, EGS shall develop and implement a plan for conducting Records Reviews, which shall include a sampling of the representatives. These Records Reviews shall include the monitoring and review of: 1) records and systems relating to sales representatives’ interactions with HCPs and HCIs (including sales representative corporate charge card expense records, and aggregate spend records concerning sales representatives’ interactions with HCPs); 2) sales representatives’ emails and other electronic records; 3) recorded results of the Observations of sales representatives and applicable notes or information from the sales representatives’ managers; and 4) any other data that reflects or relates to sales representatives’ interactions with HCPs and HCIs.
Records Reviews. As a component of the FFMP, Essilor shall also review various types of records to assess sales representatives’ interactions with ECPs and ECIs and to identify potential or actual compliance violations.
a. For each Reporting Period, Essilor shall develop and implement a plan for conducting Records Reviews associated with at least five (5)
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);
