Promotional and Product Related Functions Systems Review. The Promotional and Product Related Functions Systems Review shall be a review of systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of Indivior relating to Promotional Functions, Product Related Functions, and other systems as described below. Where practical, Indivior personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by Indivior in accordance with the preceding sentence. Specifically, the IRO shall review systems, processes, policies, and procedures of Indivior associated with the following (hereafter “Reviewed Policies and Procedures”): 1. Indivior’s systems, policies, processes and procedures applicable to the manner in which sales representatives and personnel from Medical Affairs handle requests or inquiries relating to information about the uses of Government Reimbursed Products (including non-FDA-approved (i.e., off-label) uses of Government Reimbursed Products) and the dissemination of materials relating to the uses of these products. This review shall include: (a) the manner in which Indivior sales representatives handle requests for information about off-label uses of Government Reimbursed Products, (b) the manner in which Medical Affairs personnel, including those at Indivior’s headquarters, handle and respond to requests for information about off-label uses of Government Reimbursed Products; (c) the form and content of information and materials related to Government Reimbursed Products disseminated to HCPs, HCIs, payors, and formulary decision-makers by Indivior; (d) the systems, processes, policies, and procedures to track requests to Medical Affairs for information about off-label uses of products and responses to those requests; (e) the manner in which Indivior collects and supports information reported in any systems used to track and respond to requests to Medical Affairs for Government Reimbursed Product information; (f) the processes and procedures by which Medical Affairs or other appropriate individuals within Indivior identify situations in which it appears that off-label or other improper promotion may have occurred; and (g) Indivior’s processes and procedures for investigating, documenting, resolving, and taking appropriate disciplinary action for potential situations involving improper promotion; 2. Indivior’s systems, policies, processes, and procedures applicable to the manner and circumstances under which Indivior’s medical personnel (including those from Medical Affairs) participate in meetings or events with HCPs or HCIs (either alone or with sales representatives) regarding Government Reimbursed Products, and the role of the medical personnel at such meetings or events; 3. Indivior’s systems (including any centralized systems), processes, policies, and procedures relating to speaker programs, speaker training programs, and all events and expenses relating to such engagements or arrangements; 4. Indivior’s systems, processes, policies, and procedures relating to the engagement of non-speaker related consultants or other fee-for-service arrangements (including, but not limited to, presentations, advisory boards, preceptorships, mentorships, and ad hoc advisory activities, and any other financial engagement) that Indivior entered with HCPs or HCIs and all events and expenses associated with such activities; 5. Indivior’s systems, policies, processes, and procedures applicable to Indivior’s internal review of promotional materials related to Government Reimbursed Products that are disseminated to HCPs, HCIs, and payors or individuals or entities acting on behalf of HCPs, HCIs or payors (e.g.¸ PBMs); 6. Indivior’s systems, policies, processes, and procedures applicable to Indivior’s internal review of non-promotional materials related to Government Reimbursed Products (e.g.¸ disease state awareness materials, information on social media platforms, etc.) disseminated to HCPs, HCIs, payors, patients, or other individuals or entities; 7. Indivior’s systems, policies, processes, and procedures applicable to patient outreach efforts and materials used in connection with such efforts, including direct-to-consumer advertising, patient education, and the dissemination of materials/information through social media; 8. Indivior’s systems, policies, processes, and procedures applicable to the development and review of Indivior processes relating to incentive compensation for Covered Persons who are sales representatives and their direct managers, with regard to whether the systems, policies, processes, and procedures are designed to ensure that financial incentives do not inappropriately motivate such individuals to engage in or tolerate the improper promotion, sales, and marketing of Government Reimbursed Products. To the extent that Indivior establishes different methods of compensation for different Government Reimbursed Products, the IRO shall review each type of compensation arrangement separately; 9. Indivior’s systems, policies, processes, and procedures applicable to the development and review of Indivior’s call plans for Government Reimbursed Products. This shall include a review of the bases upon which HCPs and HCIs belonging to specified medical specialties are included in, or excluded from, the call plans based on expected utilization of Government Reimbursed Products for FDA-approved uses or non- FDA-approved uses; 10. Indivior’s systems, policies, processes, and procedures applicable to the development and review of Sample Distribution Plans (as defined in Section III.B.1.h of the CIA). This shall include a review of the bases upon, and circumstances under, which HCPs and HCIs belonging to specified medical specialties or types of clinical practice may receive samples from Indivior (including, separately, from Indivior sales representatives and other Indivior personnel or components). It shall also include a review of whether samples of Government Reimbursed Products are distributed by Indivior through sales representatives or are distributed from a central location and the rationale for the manner of distribution; 11. Indivior’s systems, processes, policies, and procedures applicable to the submission of information about any Government Reimbursed Product to any Compendia (as defined in Section III.B.1.o of the CIA) such as Drugdex or other published source of information used in connection with the determination of coverage by a Federal health care program for the product; 12. Indivior’s systems, processes, policies, and procedures of Indivior’s funding, directly or indirectly, of Third-Party Educational Activities (as defined in Section II.C.6 of the CIA) and all events and expenses relating to such activities; 13. Indivior’s systems, processes, policies, and procedures applicable to Research (as defined in Section III.B.1.p), including the decision to provide financial or other support for Research; the manner in which Research support is provided; the publication of information about the Research, including the publication of information about the Research results and trial outcomes; and uses made of publications relating to such Research; 14. Indivior’s systems, processes, policies, and procedures relating to authorship-related practices (as defined in Section III.B.1.q of the CIA), including, but not limited to, the disclosure of all financial relationships between the author and Indivior, the identification of all authors or contributors (including professional writers, if any) associated with a given publication, and the scope and breadth of research results made available to each author or contributor; 15. Indivior’s systems, processes, policies, and procedures applicable to the provision of any reimbursement and/or coding support, advice, or assistance (including relating to prior authorization issues) to any HCPs, HCIs, or payers and the internal review and approval of any materials used in connection with such activities; 16. Indivior’s systems, processes, policies, and procedures relating to its risk assessment and mitigation process outlined in Section III.D of the CIA. This review shall assess whether the risk assessment and mitigation process identifies and addresses relevant and appropriate risks for Indivior’s compliance with Federal health care program and FDA requirements, including risks relating to Government Reimbursed Products and other applicable risks.
Appears in 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement
Promotional and Product Related Functions Systems Review. The Promotional and Product Related Functions Systems Review shall be a review of systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of Indivior USWM relating to Promotional Functions, Functions and Product Related Functions, and other systems as described below. Where practical, Indivior USWM personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by Indivior USWM in accordance with the preceding sentence. Specifically, the IRO shall review systems, processes, policies, and procedures of Indivior USWM associated with the following (hereafter “Reviewed Policies and Procedures”):
1. IndiviorUSWM’s systems, policies, processes and procedures applicable to the manner in which sales representatives and personnel from Medical Affairs Information handle requests or inquiries relating to information about the uses of Government Reimbursed Products (including non-FDA-approved (i.e., off-label) uses of Government Reimbursed Products) and the dissemination of materials relating to the uses of these products. This review shall include: (a) the manner in which Indivior USWM sales representatives handle requests for information about off-label uses of Government Reimbursed Products, (b) the manner in which Medical Affairs Information personnel, including those at IndiviorUSWM’s headquarters, handle and respond to requests for information about off-off- label uses of Government Reimbursed Products; (c) the form and content of information and materials related to Government Reimbursed Products disseminated to HCPs, HCIs, payors, and formulary decision-makers by IndiviorUSWM; (d) the systems, processes, policies, and procedures of USWM to track requests to Medical Affairs Information for information about off-label uses of products and responses to those requests; (e) the manner in which Indivior collects USWM collect and supports information reported in any systems used to track and respond to requests to Medical Affairs Information for Government Reimbursed Product information; (f) the processes and procedures by which Medical Affairs Information or other appropriate individuals within Indivior USWM identify situations in which it appears that off-off- label or other improper promotion may have occurred; and (g) Indivior’s the processes and procedures of USWM for investigating, documenting, resolving, and taking appropriate disciplinary action for potential situations involving improper promotion;promotion;
2. IndiviorUSWM’s systems, policies, processes, and procedures applicable to the manner and circumstances under which IndiviorUSWM’s medical personnel (including those from Medical Affairs) participate in meetings or events with HCPs or HCIs (either alone or with sales representatives) regarding Government Reimbursed Products, Products and the role of the medical personnel at such meetings or events;events;
3. Indivior’s systems (including any centralized systems), processes, policies, and procedures relating to speaker programs, speaker training programs, and all events and expenses relating to such engagements or arrangements;
4. Indivior’s systems, processes, policies, and procedures relating to the engagement of non-speaker related consultants or other fee-for-service arrangements (including, but not limited to, presentations, advisory boards, preceptorships, mentorships, and ad hoc advisory activities, and any other financial engagement) that Indivior entered with HCPs or HCIs and all events and expenses associated with such activities;
5. IndiviorUSWM’s systems, policies, processes, and procedures applicable to IndiviorUSWM’s internal review of promotional materials related to Government Reimbursed Products that are disseminated to HCPs, HCIs, HCIs and payors or and individuals or entities (e.g.¸ PBMs) acting on behalf of HCPs, HCIs or payors (e.g.¸ PBMs);payors;
64. Indivior’s systems, policies, processes, and procedures applicable to Indivior’s internal review of non-promotional materials related to Government Reimbursed Products (e.g.¸ disease state awareness materials, information on social media platforms, etc.) disseminated to HCPs, HCIs, payors, patients, or other individuals or entities;
7. Indivior’s systems, policies, processes, and procedures applicable to patient outreach efforts and materials used in connection with such efforts, including direct-to-consumer advertising, patient education, and the dissemination of materials/information through social media;
8. IndiviorUSWM’s systems, policies, processes, and procedures applicable to the development and review of Indivior USWM processes relating to incentive compensation for Covered Persons who are prescriber-facing sales representatives and their direct managers, with regard to whether the systems, policies, processes, and procedures are designed to ensure that financial incentives do not inappropriately motivate such individuals to engage in or tolerate the improper promotion, sales, and marketing of Government Reimbursed Products. To the extent that Indivior USWM establishes different methods of compensation for different Government Reimbursed Products, the IRO shall review each type of compensation arrangement separately;separately;
95. IndiviorUSWM’s systems, policies, processes, and procedures applicable to the development and review of IndiviorUSWM’s call plans for Government Reimbursed Products. This shall include a review of the bases upon which HCPs and HCIs belonging to specified medical specialties are included in, or excluded from, the call plans based on expected utilization of Government Reimbursed Products for FDA-approved uses or non- FDA-approved uses;uses;
106. IndiviorUSWM’s systems, policies, processes, and procedures applicable to the development and review of Sample Distribution Plans (as defined in Section III.B.1.h III.B.8 of the CIA). This shall include a review of the bases upon, and circumstances under, which HCPs and HCIs belonging to specified medical specialties or types of clinical practice may receive samples from Indivior USWM (including, separately, from Indivior USWM sales representatives and other Indivior USWM personnel or components). It shall also include a review of whether samples of Government Reimbursed Products are distributed by Indivior USWM through sales representatives or are distributed from a central location and the rationale for the manner of distribution;distribution;
117. IndiviorUSWM’s systems (including any centralized electronic systems), processes, policies, and procedures of USWM’s speaker programs, speaker training programs, and all events and expenses relating to such engagements or arrangements;
8. USWM’s systems, processes, policies, and procedures of USWM relating to engagement of non-speaker related consultants or other fee-for-service arrangements (including, but not limited to, presentations, advisory boards, preceptorships, mentorships, and ad hoc advisory activities, and any other financial engagement) that the USWM entered with HCPs or HCIs and all events and expenses associated with such activities;
9. USWM’s systems, processes, policies, and procedures of USWM’s funding, directly or indirectly, of Third Party Educational Activities (as defined in Section II.C.8 of the CIA) and all events and expenses relating to such activities;
10. USWM’s systems, processes, policies, and procedures applicable to the submission of information about any Government Reimbursed Product to any Compendia CMS- recognized Compendium (as defined in Section III.B.1.o of the CIAUSWM’s Policies and Procedures) such as Drugdex or other published source of information used in connection with the determination of coverage by a Federal health care program for the product;product (hereafter “Compendia”);
1211. Indivior’s systems, processes, policies, and procedures of Indivior’s funding, directly or indirectly, of Third-Party Educational Activities (as defined in Section II.C.6 of the CIA) and all events and expenses relating to such activities;
13. IndiviorUSWM’s systems, processes, policies, and procedures applicable to Research (as defined in Section III.B.1.pIII.B.16), including the decision to provide financial or other support for Research; the manner in which Research support is provided; the publication of information about the Research, including the publication of information information about the Research results and trial outcomes; and uses made of publications relating to such Research;; and
1412. IndiviorUSWM’s systems, processes, policies, and procedures relating to authorship-related practices (as defined in Section III.B.1.q III.B.17 of the CIA), including, but not limited to, the disclosure of all financial relationships between the author and IndiviorUSWM, the identification of all authors or contributors (including professional writers, if any) associated with a given publication, and the scope and breadth of research results made available to each author or contributor;
15. Indivior’s systems, processes, policies, and procedures applicable to the provision of any reimbursement and/or coding support, advice, or assistance (including relating to prior authorization issues) to any HCPs, HCIs, or payers and the internal review and approval of any materials used in connection with such activities;
16. Indivior’s systems, processes, policies, and procedures relating to its risk assessment and mitigation process outlined in Section III.D of the CIA. This review shall assess whether the risk assessment and mitigation process identifies and addresses relevant and appropriate risks for Indivior’s compliance with Federal health care program and FDA requirements, including risks relating to Government Reimbursed Products and other applicable risks.contributor.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Promotional and Product Related Functions Systems Review. The Promotional and Product Related Functions Systems Review shall be a review of systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of Indivior Insys relating to Promotional Functions, Functions and Product Related Functions, and other systems as described below. Where practical, Indivior Insys personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by Indivior Insys in accordance with the preceding sentence. Specifically, the IRO shall review systems, processes, policies, and procedures of Indivior Insys associated with the following (hereafter “Reviewed Policies and Procedures”):
1. IndiviorInsys’s systems, policies, processes and procedures applicable to the manner in which sales representatives and personnel from Medical Affairs handle requests or inquiries relating to information about the uses of Government Reimbursed Products (including non-FDA-approved (i.e., off-label) uses of Government Reimbursed Products) and the dissemination of materials relating to the uses of these products. This review shall include: (a) the manner in which Indivior Insys sales representatives handle requests for information about off-label uses of Government Reimbursed Products, (b) the manner in which Medical Affairs personnel, including those at IndiviorInsys’s headquarters, handle and respond to requests for information about off-label uses of Government Reimbursed Products; (c) the form and content of information and materials related to Government Reimbursed Products disseminated to HCPs, HCIs, payorspayers, and formulary decision-decision- makers by IndiviorInsys; (d) the systems, processes, policies, and procedures of Insys to track requests to Medical Affairs for information about off-label uses of products and responses to those requests; (e) the manner in which Indivior collects Insys collect and supports information reported in any systems used to track and respond to requests to Medical Affairs for Government Reimbursed Product information; (f) the processes and procedures by which Medical Affairs or other appropriate individuals within Indivior Insys identify situations in which it appears that off-label or other improper promotion may have occurred; and (g) Indivior’s the processes and procedures of Insys for investigating, documenting, resolving, and taking appropriate disciplinary action for potential situations involving improper promotion;promotion;
2. IndiviorInsys’s systems, policies, processes, and procedures applicable to the manner and circumstances under which IndiviorInsys’s medical personnel (including those from Medical AffairsAffairs (e.g., medical science liaisons or other medical or scientific personnel) participate in meetings or events with HCPs or HCIs (either alone or with sales representatives) regarding Government Reimbursed Products, Products and the role of the medical Medical Affairs personnel at such meetings or events;events;
3. IndiviorInsys’s systems, policies, processes, and procedures applicable to Insys’s internal review of promotional materials related to Government Reimbursed Products disseminated to HCPs, HCIs and payers and individuals or entities (e.g.¸ PBMs) acting on behalf of HCPs, HCIs or payers;
4. Insys’s systems, policies, processes, and procedures applicable to the development and review of Insys processes relating to incentive compensation for Covered Persons who are prescriber-facing sales representatives and their direct managers, with regard to whether the systems, policies, processes, and procedures are designed to ensure that financial incentives do not inappropriately motivate such individuals to engage in the improper promotion, sales, and marketing of Government Reimbursed Products. To the extent that Insys establishes different methods of compensation for different Government Reimbursed Products, the IRO shall review each type of compensation arrangement separately;
5. Insys’s systems, policies, processes, and procedures applicable to the development and review of Insys’s call plans for Government Reimbursed Products. This shall include a review of the bases upon which HCPs and HCIs belonging to specified medical specialties are included in, or excluded from, the call plans based on all relevant factors including expected utilization of Government Reimbursed Products for FDA-approved uses or non-FDA-approved uses;
6. Insys’s systems, policies, processes, and procedures applicable to the development and review of Sample Distribution Plans (as defined in Section III.X.x of the CIA). This shall include a review of the bases upon, and circumstances under, which HCPs and HCIs belonging to specified medical specialties or types of clinical practice may receive samples from Insys (including, separately, from Insys sales representatives and other Insys personnel or components). It shall also include a review of whether samples of Government Reimbursed Products are distributed by Insys through sales representatives or are distributed from a central location and the rationale for the manner of distribution;
7. Insys’s systems (including any centralized electronic systems), processes, policies, and procedures relating to Insys’s speaker programs, speaker training programs, and all events and expenses relating to such engagements or arrangements;arrangements;
48. IndiviorInsys’s systems, processes, policies, and procedures relating to the engagement of non-speaker related consultants or other fee-for-service arrangements (including, but not limited to, presentations, advisory boards, preceptorships, mentorships, and ad hoc advisory activities, and any other financial engagement) that Indivior Insys entered with HCPs or HCIs and all events and expenses associated with such activities;activities;
59. IndiviorInsys’s systems, processes, policies, processes, and procedures applicable to Indivior’s internal review of promotional materials related to Government Reimbursed Products that are disseminated to HCPs, HCIs, and payors or individuals or entities acting on behalf of HCPs, HCIs or payors (e.g.¸ PBMs);
6. Indivior’s systems, policies, processes, and procedures applicable to Indivior’s internal review of non-promotional materials related to Government Reimbursed Products (e.g.¸ disease state awareness materials, information on social media platforms, etc.) disseminated to HCPs, HCIs, payors, patients, or other individuals or entities;
7. Indivior’s systems, policies, processes, and procedures applicable to patient outreach efforts and materials used in connection with such efforts, including direct-to-consumer advertising, patient education, and the dissemination of materials/information through social media;
8. Indivior’s systems, policies, processes, and procedures applicable relating to the development and review funding, directly or indirectly, of Indivior processes relating to incentive compensation for Covered Persons who are sales representatives and their direct managers, with regard to whether the systems, policies, processes, and procedures are designed to ensure that financial incentives do not inappropriately motivate such individuals to engage in or tolerate the improper promotion, sales, and marketing of Government Reimbursed Products. To the extent that Indivior establishes different methods of compensation for different Government Reimbursed Products, the IRO shall review each type of compensation arrangement separately;
9. Indivior’s systems, policies, processes, and procedures applicable to the development and review of Indivior’s call plans for Government Reimbursed Products. This shall include a review of the bases upon which HCPs and HCIs belonging to specified medical specialties are included in, or excluded from, the call plans based on expected utilization of Government Reimbursed Products for FDA-approved uses or non- FDA-approved uses;
10. Indivior’s systems, policies, processes, and procedures applicable to the development and review of Sample Distribution Plans Third Party Educational Activities (as defined in Section III.B.1.h II.E.7 of the CIA)) and all events and expenses relating to such activities;
10. This shall include a review of the bases upon, and circumstances under, which HCPs and HCIs belonging to specified medical specialties or types of clinical practice may receive samples from Indivior (including, separately, from Indivior sales representatives and other Indivior personnel or components). It shall also include a review of whether samples of Government Reimbursed Products are distributed by Indivior through sales representatives or are distributed from a central location and the rationale for the manner of distribution;
11. IndiviorInsys’s systems, processes, policies, and procedures applicable to the submission of information about any Government Reimbursed Product to any Compendia (as defined in Section III.B.1.o III.B.u of the CIA) such as Drugdex or other published published source of information used in connection with the determination of coverage by a Federal health care program for the product;
1211. Indivior’s systems, processes, policies, and procedures of Indivior’s funding, directly or indirectly, of Third-Party Educational Activities (as defined in Section II.C.6 of the CIA) and all events and expenses relating to such activities;
13. IndiviorInsys’s systems, processes, policies, and procedures applicable to Research (as defined in Section III.B.1.pIII.B.v of the CIA), including the decision to provide financial or other support for Research; the manner in which Research support is provided; the publication of information about the Research, including the publication of information about the Research results and trial outcomes; and uses made of publications relating to such Research;Research;
1412. IndiviorInsys’s systems, processes, policies, and procedures relating to authorship-related practices (as defined in Section III.B.1.q III.B.w of the CIA), including, but not limited to, the disclosure of all financial relationships between the author and IndiviorXxxxx, the identification of all authors or contributors (including professional writers, if any) associated with a given publication, and the scope and breadth of research results made available to each author or contributor;contributor;
1513. IndiviorInsys’s systems, processes, policies, and procedures applicable relating to the provision of any reimbursement and/or coding support, advice, advice or assistance (including relating to prior authorization issues) to any HCPs, HCIs, HCIs or payers and the internal review and approval of any materials used in connection with such activities;; and
1614. IndiviorInsys’s systems, processes, policies, and procedures relating to its risk assessment and mitigation process outlined in Section III.D of the CIAinternal review process. This review shall assess whether the risk assessment and mitigation internal review process identifies and addresses relevant and appropriate risks for Indivior’s compliance with Federal health care program and FDA requirements, including risks relating relevant to Government Reimbursed Products and other applicable risks.the Covered Functions
Appears in 1 contract
Samples: Corporate Integrity Agreement
Promotional and Product Related Functions Systems Review. The Promotional and Product Related Functions Systems Review shall be a review of systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of Indivior Avanir relating to Promotional Functions, Functions and Product Related Functions, and other systems as described below. Where practical, Indivior Avanir personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by Indivior Xxxxxx in accordance with the preceding sentence. Specifically, the IRO shall review systems, processes, policies, and procedures of Indivior Avanir associated with the following (hereafter “Reviewed Policies and Procedures”):
1. IndiviorAvanir’s systems, policies, processes and procedures applicable to the manner in which sales representatives and personnel from Medical Affairs Information handle requests or inquiries relating to information about the uses of Government Reimbursed Products (including non-FDA-approved (i.e., off-label) uses of Government Reimbursed Products) and the dissemination of materials relating to the uses of these productsGovernment Reimbursed Products. This review shall include: (a) the manner in which Indivior Avanir sales representatives handle requests for information about off-label uses of Government Reimbursed Products, (b) the manner in which Medical Affairs Information personnel, including those at IndiviorAvanir’s headquarters, handle and respond to requests for information about off-label uses of Government Reimbursed Products; (c) the form and content of information and materials related to Government Reimbursed Products disseminated to HCPs, HCIs, payorspayers, and formulary decision-makers by IndiviorAvanir; (d) the systems, processes, policies, and procedures of Avanir to track requests to Medical Affairs Information for information about off-label uses of products Government Reimbursed Products and responses to those requests; (e) the manner in which Indivior collects Avanir collect and supports information reported in any systems used to track and respond to requests to Medical Affairs Information for Government Reimbursed Product information; (f) the processes and procedures by which Medical Affairs Information or other appropriate individuals within Indivior Avanir identify situations in which it appears that off-label or other improper promotion may have occurred; and (g) Indivior’s the processes and procedures of Avanir for investigating, documenting, resolving, and taking appropriate disciplinary action for potential situations involving improper promotion;promotion;
2. IndiviorAvanir’s systems, policies, processes, and procedures applicable to the manner and circumstances under which IndiviorXxxxxx’s medical personnel (including those from Medical AffairsAffairs (e.g., medical science liaisons or other medical or scientific personnel) participate in meetings or events with HCPs or HCIs (either alone or with sales representatives) regarding Government Reimbursed Products, Products and the role of the medical personnel from Medical Affairs at such meetings or events;
3. Indivior’s systems (including any centralized systems), processes, policies, and procedures relating to speaker programs, speaker training programs, and all events and expenses relating to such engagements or arrangements;
4. Indivior’s systems, processes, policies, and procedures relating to the engagement of non-speaker related consultants or other fee-for-service arrangements (including, but not limited to, presentations, advisory boards, preceptorships, mentorships, and ad hoc advisory activities, and any other financial engagement) that Indivior entered with HCPs or HCIs and all events and expenses associated with such activities;
5. Indivior’s systems, policies, processes, and procedures applicable to Indivior’s internal review of promotional materials related to Government Reimbursed Products that are disseminated to HCPs, HCIs, and payors or individuals or entities acting on behalf of HCPs, HCIs or payors (e.g.¸ PBMs);
6. Indivior’s systems, policies, processes, and procedures applicable to Indivior’s internal review of non-promotional materials related to Government Reimbursed Products (e.g.¸ disease state awareness materials, information on social media platforms, etc.) disseminated to HCPs, HCIs, payors, patients, or other individuals or entities;
7. Indivior’s systems, policies, processes, and procedures applicable to patient outreach efforts and materials used in connection with such efforts, including direct-to-consumer advertising, patient education, and the dissemination of materials/information through social media;
8. Indivior’s systems, policies, processes, and procedures applicable to the development and review of Indivior processes relating to incentive compensation for Covered Persons who are sales representatives and their direct managers, with regard to whether the systems, policies, processes, and procedures are designed to ensure that financial incentives do not inappropriately motivate such individuals to engage in or tolerate the improper promotion, sales, and marketing of Government Reimbursed Products. To the extent that Indivior establishes different methods of compensation for different Government Reimbursed Products, the IRO shall review each type of compensation arrangement separately;
9. Indivior’s systems, policies, processes, and procedures applicable to the development and review of Indivior’s call plans for Government Reimbursed Products. This shall include a review of the bases upon which HCPs and HCIs belonging to specified medical specialties are included in, or excluded from, the call plans based on expected utilization of Government Reimbursed Products for FDA-approved uses or non- FDA-approved uses;
10. Indivior’s systems, policies, processes, and procedures applicable to the development and review of Sample Distribution Plans (as defined in Section III.B.1.h of the CIA). This shall include a review of the bases upon, and circumstances under, which HCPs and HCIs belonging to specified medical specialties or types of clinical practice may receive samples from Indivior (including, separately, from Indivior sales representatives and other Indivior personnel or components). It shall also include a review of whether samples of Government Reimbursed Products are distributed by Indivior through sales representatives or are distributed from a central location and the rationale for the manner of distribution;
11. Indivior’s systems, processes, policies, and procedures applicable to the submission of information about any Government Reimbursed Product to any Compendia (as defined in Section III.B.1.o of the CIA) such as Drugdex or other published source of information used in connection with the determination of coverage by a Federal health care program for the product;
12. Indivior’s systems, processes, policies, and procedures of Indivior’s funding, directly or indirectly, of Third-Party Educational Activities (as defined in Section II.C.6 of the CIA) and all events and expenses relating to such activities;
13. Indivior’s systems, processes, policies, and procedures applicable to Research (as defined in Section III.B.1.p), including the decision to provide financial or other support for Research; the manner in which Research support is provided; the publication of information about the Research, including the publication of information about the Research results and trial outcomes; and uses made of publications relating to such Research;
14. Indivior’s systems, processes, policies, and procedures relating to authorship-related practices (as defined in Section III.B.1.q of the CIA), including, but not limited to, the disclosure of all financial relationships between the author and Indivior, the identification of all authors or contributors (including professional writers, if any) associated with a given publication, and the scope and breadth of research results made available to each author or contributor;
15. Indivior’s systems, processes, policies, and procedures applicable to the provision of any reimbursement and/or coding support, advice, or assistance (including relating to prior authorization issues) to any HCPs, HCIs, or payers and the internal review and approval of any materials used in connection with such activities;
16. Indivior’s systems, processes, policies, and procedures relating to its risk assessment and mitigation process outlined in Section III.D of the CIA. This review shall assess whether the risk assessment and mitigation process identifies and addresses relevant and appropriate risks for Indivior’s compliance with Federal health care program and FDA requirements, including risks relating to Government Reimbursed Products and other applicable risks.events;
Appears in 1 contract
Samples: Corporate Integrity Agreement
Promotional and Product Related Functions Systems Review. The Promotional and Product Related Functions Systems Review shall be a review of systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of Indivior SUN relating to Promotional Functions, Functions and Product Related Functions, and other systems as described below. Where practical, Indivior SUN personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by Indivior SUN in accordance with the preceding sentence. Specifically, the IRO shall review systems, processes, policies, and procedures of Indivior SUN associated with the following (hereafter “Reviewed Policies and Procedures”):
1. IndiviorSUN’s systems, policies, processes and procedures applicable to the manner in which sales representatives and personnel from Medical Affairs handle requests or inquiries relating to information about the uses of Relevant Government Reimbursed Products (including non-FDA-approved (i.e., off-label) uses of Relevant Government Reimbursed Products) and the dissemination of materials relating to the uses of these products. This review shall include: (a) the manner in which Indivior SUN sales representatives handle requests for information about off-label uses of Relevant Government Reimbursed Products, (b) the manner in which Medical Affairs personnel, including those at IndiviorSUN’s headquarters, handle and respond to requests for information about off-label uses of Relevant Government Reimbursed Products; (c) the form and content of information and materials related to Relevant Government Reimbursed Products disseminated to HCPs, HCIs, payorspayers, and formulary decision-makers by Indivior; (d) the systems, processes, policies, and procedures to track requests to Medical Affairs for information about off-label uses of products and responses to those requests; (e) the manner in which Indivior collects and supports information reported in any systems used to track and respond to requests to Medical Affairs for Government Reimbursed Product information; (f) the processes and procedures by which Medical Affairs or other appropriate individuals within Indivior identify situations in which it appears that off-label or other improper promotion may have occurred; and (g) Indivior’s processes and procedures for investigating, documenting, resolving, and taking appropriate disciplinary action for potential situations involving improper promotionSUN;
2. Indivior’s systems, policies, processes, and procedures applicable to the manner and circumstances under which Indivior’s medical personnel (including those from Medical Affairs) participate in meetings or events with HCPs or HCIs (either alone or with sales representatives) regarding Government Reimbursed Products, and the role of the medical personnel at such meetings or events;
3. Indivior’s systems (including any centralized systems), processes, policies, and procedures relating to speaker programs, speaker training programs, and all events and expenses relating to such engagements or arrangements;
4. Indivior’s systems, processes, policies, and procedures relating to the engagement of non-speaker related consultants or other fee-for-service arrangements (including, but not limited to, presentations, advisory boards, preceptorships, mentorships, and ad hoc advisory activities, and any other financial engagement) that Indivior entered with HCPs or HCIs and all events and expenses associated with such activities;
5. Indivior’s systems, policies, processes, and procedures applicable to Indivior’s internal review of promotional materials related to Government Reimbursed Products that are disseminated to HCPs, HCIs, and payors or individuals or entities acting on behalf of HCPs, HCIs or payors (e.g.¸ PBMs);
6. Indivior’s systems, policies, processes, and procedures applicable to Indivior’s internal review of non-promotional materials related to Government Reimbursed Products (e.g.¸ disease state awareness materials, information on social media platforms, etc.) disseminated to HCPs, HCIs, payors, patients, or other individuals or entities;
7. Indivior’s systems, policies, processes, and procedures applicable to patient outreach efforts and materials used in connection with such efforts, including direct-to-consumer advertising, patient education, and the dissemination of materials/information through social media;
8. Indivior’s systems, policies, processes, and procedures applicable to the development and review of Indivior processes relating to incentive compensation for Covered Persons who are sales representatives and their direct managers, with regard to whether the systems, policies, processes, and procedures are designed to ensure that financial incentives do not inappropriately motivate such individuals to engage in or tolerate the improper promotion, sales, and marketing of Government Reimbursed Products. To the extent that Indivior establishes different methods of compensation for different Government Reimbursed Products, the IRO shall review each type of compensation arrangement separately;
9. Indivior’s systems, policies, processes, and procedures applicable to the development and review of Indivior’s call plans for Government Reimbursed Products. This shall include a review of the bases upon which HCPs and HCIs belonging to specified medical specialties are included in, or excluded from, the call plans based on expected utilization of Government Reimbursed Products for FDA-approved uses or non- FDA-approved uses;
10. Indivior’s systems, policies, processes, and procedures applicable to the development and review of Sample Distribution Plans (as defined in Section III.B.1.h of the CIA). This shall include a review of the bases upon, and circumstances under, which HCPs and HCIs belonging to specified medical specialties or types of clinical practice may receive samples from Indivior (including, separately, from Indivior sales representatives and other Indivior personnel or components). It shall also include a review of whether samples of Government Reimbursed Products are distributed by Indivior through sales representatives or are distributed from a central location and the rationale for the manner of distribution;
11. Indivior’s systems, processes, policies, and procedures applicable to the submission of information about any Government Reimbursed Product to any Compendia (as defined in Section III.B.1.o of the CIA) such as Drugdex or other published source of information used in connection with the determination of coverage by a Federal health care program for the product;
12. Indivior’s systems, processes, policies, and procedures of Indivior’s funding, directly or indirectly, of Third-Party Educational Activities (as defined in Section II.C.6 of the CIA) and all events and expenses relating to such activities;
13. Indivior’s systems, processes, policies, and procedures applicable to Research (as defined in Section III.B.1.p), including the decision to provide financial or other support for Research; the manner in which Research support is provided; the publication of information about the Research, including the publication of information about the Research results and trial outcomes; and uses made of publications relating to such Research;
14. Indivior’s systems, processes, policies, and procedures relating to authorship-related practices (as defined in Section III.B.1.q of the CIA), including, but not limited to, the disclosure of all financial relationships between the author and Indivior, the identification of all authors or contributors (including professional writers, if any) associated with a given publication, and the scope and breadth of research results made available to each author or contributor;
15. Indivior’s systems, processes, policies, and procedures applicable to the provision of any reimbursement and/or coding support, advice, or assistance (including relating to prior authorization issues) to any HCPs, HCIs, or payers and the internal review and approval of any materials used in connection with such activities;
16. Indivior’s systems, processes, policies, and procedures relating to its risk assessment and mitigation process outlined in Section III.D of the CIA. This review shall assess whether the risk assessment and mitigation process identifies and addresses relevant and appropriate risks for Indivior’s compliance with Federal health care program and FDA requirements, including risks relating to Government Reimbursed Products and other applicable risks.
Appears in 1 contract
Samples: Corporate Integrity Agreement
