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.
Appears in 1 contract
Samples: Corporate Integrity Agreement (Merit Medical Systems Inc)
Records Reviews. As a component of the FFMP, Merit Life Spine 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 Life Spine shall develop and implement a plan for conducting Records Reviews associated with at least five 2 Government Reimbursed ProductsProduct Lines1. 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-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 Product Lines 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. .
Appears in 1 contract
Samples: Corporate Integrity Agreement
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. .
Appears in 1 contract
Samples: Corporate Integrity Agreement
Records Reviews. As a component of the FFMP, Merit 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. .
a. For each Reporting Period, Merit Biotronik shall develop and implement a plan for conducting Records Reviews associated with at least five 5 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; andand
(v) recorded results of the Observations of sales force representatives, coaching guides, and manager notes. notes.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Records Reviews. As a component of the FFMP, Merit 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, Merit RMS shall develop and implement a plan for conducting Records Reviews associated with at least five 2 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) 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) v. recorded results of the Observations of sales force representatives, coaching guides, and manager notes. .
Appears in 1 contract
Samples: Corporate Integrity Agreement (Ra Medical Systems, Inc.)
