IRO Systems Review. The IRO Systems Review shall be a review of systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of Taro relating to Pricing and Contracting Functions and other systems as described below. Where practical, Taro 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 Taro in accordance with the preceding sentence. Specifically, the IRO shall review systems, processes, policies, and procedures of Taro associated with the following (hereafter “Reviewed Policies and Procedures”): 1. Taro’s systems (including any electronic systems), processes, policies, and procedures relating to Pricing and Contracting Functions. This review shall include an assessment of the following: a. Xxxx’s organizational structure as it relates to Pricing and Contracting Functions, including: i. The identification of those individuals, departments, or groups within Taro responsible for conducting market (and other) research relevant to setting prices and establishing pricing strategies and policies for Government Reimbursed Products, including the individuals, departments, or groups authorized to approve pricing terms and pricing strategies; and ii. The identification of those individuals, departments, or groups within Taro responsible for bidding, negotiating, and contracting with customers or potential customers of Government Reimbursed Products, including the individuals, departments, or groups authorized to approve bids submitted to potential customers and contracts (including contract terms and changes in contract terms, including pricing terms) entered with customers; b. the systems, processes, policies, and procedures that Taro uses or follows in connection with setting prices (including but not limited to suggested wholesale price (SWP), wholesale acquisition cost (WAC), and average wholesale price (AWP)) and establishing pricing strategies, including i) the information and factors to be considered in connection with setting prices and establishing pricing strategies; and ii) the types and sources of information (both internal and external) used to make decisions about prices and pricing strategies; and c. the systems, processes, policies, and procedures that Taro uses or follows in connection with the offering or selling of Government Reimbursed Products to any potential customer or current customer, including offering, bidding, negotiating, and contracting for the sale of Government Reimbursed Products and the manner and circumstances under which such activities occur. 2. systems, processes, policies and procedures relating to Xxxx’s review of records relating to interactions between Covered Persons who engage in Pricing and Contracting Functions and competitors, including: a. record-keeping systems relating to records reflecting interactions or communications between Reviewed Covered Persons (as defined in Section III.K of the CIA) and competitors; b. Taro’s reviews of records relating to interactions and communications between Reviewed Covered Persons and competitors; and c. records relating to performance review records and any disciplinary records for Reviewed Covered Persons. 3. Taro’s systems, policies, processes, and procedures applicable to the development and review of Taro processes relating to incentive compensation for Covered Persons engaged in Pricing and Contracting Functions 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 improper sales, marketing, pricing, or contracting activities or other improper conduct relating to Government Reimbursed Products. To the extent that Xxxx establishes different methods of compensation for different Government Reimbursed Products or different compensation arrangements based on the type of Pricing and Contracting Function in which the Covered Person engages, the IRO shall review each type of compensation arrangement separately; and 4. Taro’s systems, processes, policies, and procedures relating to its risk assessment and internal review process outlined in Section III.D of the CIA. This review shall assess whether the risk assessment and internal review process identifies and addresses relevant and appropriate risks associated with Government Reimbursed Products, including risks associated with the sales, pricing, and contracting activities relating to such products.
Appears in 1 contract
Samples: Corporate Integrity Agreement
IRO Systems Review. The IRO Systems Review shall be a review of systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of Taro Sandoz relating to Pricing and Contracting Functions and other systems as described below. Where practical, Taro Xxxxxx 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 Taro Xxxxxx in accordance with the preceding sentence. sentence. Specifically, the IRO shall review systems, processes, policies, and procedures of Taro Sandoz associated with the following (hereafter “Reviewed Policies and Procedures”):
1. TaroSandoz’s systems (including any electronic systems), processes, policies, and procedures relating to Pricing and Contracting Functions. This review shall include an assessment of the following:
a. Xxxx’s x. Xxxxxx’x organizational structure as it relates to Pricing and Contracting Functions, including:including:
i. The identification of those individuals, departments, or groups within Taro Sandoz responsible for conducting market (and other) research relevant to setting prices and establishing pricing strategies and policies for Government Reimbursed Products, including the individuals, departments, or groups authorized to approve pricing terms and pricing strategies; and
ii. The identification of those individuals, departments, or groups within Taro Sandoz responsible for bidding, negotiating, and contracting with customers or potential customers of Government Reimbursed Products, including the individuals, departments, or groups authorized to approve bids submitted to potential customers and contracts (including contract terms and changes in contract terms, including pricing terms) entered with customers;
b. the systems, processes, policies, and procedures that Taro Sandoz uses or follows in connection with setting prices (including but not limited to suggested wholesale price (SWP), wholesale acquisition cost (WAC), and average wholesale price (AWP)) and establishing pricing strategies, including i) the information and factors to be considered in connection with setting prices and establishing pricing strategies; and ii) the types and sources of information (both internal and external) used to make decisions about prices and pricing strategies; andand
c. the systems, processes, policies, and procedures that Taro Sandoz uses or follows in connection with the offering or selling of Government Reimbursed Products to any potential customer or current customer, including offering, bidding, negotiating, and contracting for the sale of Government Reimbursed Products and the manner and circumstances under which such activities occur.occur.
2. systems, processes, policies and procedures relating to Xxxx’s Xxxxxx’x review of records relating to interactions between Covered Persons who engage in Pricing and Contracting Functions and competitors, competitors including:
a. record-keeping systems relating to records reflecting interactions or communications between Reviewed Covered Persons (as defined in Section III.K of the CIA) and competitors;competitors;
b. Taro’s x. Xxxxxx’x reviews of records relating to interactions and communications between Reviewed Covered Persons and competitors; andand
c. records relating to performance review records and any disciplinary records for Reviewed Covered Persons.
3. Taro’s systems, policies, processes, and procedures applicable to the development and review of Taro processes relating to incentive compensation for Covered Persons engaged in Pricing and Contracting Functions 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 improper sales, marketing, pricing, or contracting activities or other improper conduct relating to Government Reimbursed Products. To the extent that Xxxx establishes different methods of compensation for different Government Reimbursed Products or different compensation arrangements based on the type of Pricing and Contracting Function in which the Covered Person engages, the IRO shall review each type of compensation arrangement separately; and
4. Taro’s systems, processes, policies, and procedures relating to its risk assessment and internal review process outlined in Section III.D of the CIA. This review shall assess whether the risk assessment and internal review process identifies and addresses relevant and appropriate risks associated with Government Reimbursed Products, including risks associated with the sales, pricing, and contracting activities relating to such products.Persons.
Appears in 1 contract
Samples: Corporate Integrity Agreement
IRO Systems Review. The IRO Systems Review shall be a review of Arthrex’s systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of Taro relating to Pricing and Contracting Functions and other systems as described belowCovered Functions. Where practical, Taro 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 Taro in accordance with the preceding sentence. SpecificallyMore specifically, the IRO shall review Arthrex’s systems, processes, policies, and procedures of Taro associated with the following (hereafter “Reviewed Policies and Procedures”):
1. Taro’s systems (including any electronic systems), processes, policies, and procedures relating to Pricing and Contracting Functions. This review shall include an assessment of the following:
a. Xxxx’s organizational structure as it relates to Pricing and Contracting Functions, including:
i. The identification of those individuals, departments, or groups within Taro responsible for conducting market (and other) research relevant to setting prices and establishing pricing strategies and policies for Government Reimbursed Products, including the individuals, departments, or groups authorized to approve pricing terms and pricing strategies; and
ii. The identification of those individuals, departments, or groups within Taro responsible for bidding, negotiating, and contracting with customers or potential customers of Government Reimbursed Products, including the individuals, departments, or groups authorized to approve bids submitted to potential customers and contracts (including contract terms and changes in contract terms, including pricing terms) entered with customers;
b. the systems, processes, policies, and procedures that Taro uses or follows in connection with setting prices (including but not limited to suggested wholesale price (SWP), wholesale acquisition cost (WAC), and average wholesale price (AWP)) and establishing pricing strategies, including i) the information and factors to be considered in connection with setting prices and establishing pricing strategies; and ii) the types and sources of information (both internal and external) used to make decisions about prices and pricing strategies; and
c. the systems, processes, policies, and procedures that Taro uses or follows in connection with the offering or selling of Government Reimbursed Products to any potential customer or current customer, including offering, bidding, negotiating, and contracting for the sale of Government Reimbursed Products and the manner and circumstances under which such activities occur.
2. systems, processes, policies and procedures relating to Xxxx’s review of records relating to interactions between Covered Persons who engage in Pricing and Contracting Functions and competitors, including:
a. record-keeping systems relating to records reflecting interactions or communications between Reviewed Covered Persons (as defined in Section III.K of the CIA) and competitors;
b. Taro’s reviews of records relating to interactions and communications between Reviewed Covered Persons and competitors; and
c. records relating to performance review records and any disciplinary records for Reviewed Covered Persons.
3. TaroArthrex’s systems, policies, processes, and procedures relating to conducting Covered Functions in compliance with (a) applicable Federal health care program requirements, including but not limited to the development Federal Anti-Kickback Statute, and review of Taro processes relating to incentive compensation for Covered Persons engaged in Pricing the False Claims Act; and Contracting Functions with regard to whether the (b) all applicable FDA requirements;
2. Arthrex’s systems, policies, processes, and procedures are designed to ensure that financial incentives do not inappropriately motivate such individuals to engage in improper sales, marketing, pricing, or contracting activities or other improper conduct relating to Government Reimbursed Products. To the extent materials and information that Xxxx establishes different methods of compensation for different may be distributed by Arthrex sales representatives (including any contract sales force) about Government Reimbursed Products or different compensation arrangements based on the type of Pricing and Contracting Function the manner in which the Covered Person engagesArthrex sales representatives respond to requests for information about uses of Government Reimbursed Products that are not FDA approved, the IRO shall review each type of compensation arrangement separately; andcleared, or exempt (“non-FDA approved uses”);
43. TaroArthrex’s systems, policies, processes, policies, and procedures relating to its risk assessment the materials and information that may be distributed and the mechanisms through, and manner in which, Arthrex receives and responds to requests for information from an HCP or another individual or entity about non-FDA approved uses of Government Reimbursed Products; the form and content of information disseminated by Arthrex in response to such requests; and the internal review process outlined for the information disseminated;
4. Arthrex’s systems, policies, processes, and procedures relating to the manner and circumstances under which Arthrex medical personnel interact with or participate in Section III.D meetings or events with HCPs, HCIs, or payors (either alone or with Arthrex sales representatives) and the role of Arthrex medical personnel at such meetings or events, as well as how they handle responses to requests for information about non- FDA approved uses of Government Reimbursed Products;
5. Arthrex’s systems, policies, processes, and procedures relating to the materials and information that may be distributed or made available by Arthrex through social media and/or direct-to-consumer advertising;
6. Arthrex’s systems, policies, processes, and procedures relating to the development, implementation, and review of all polices for the distribution of Government Reimbursed Products for evaluation purposes (Evaluation Product). This shall include a review of the CIA. This review shall assess whether the risk assessment and internal review process identifies and addresses relevant and appropriate risks associated with Government Reimbursed Products, including risks associated with the sales, pricingbases upon, and contracting activities circumstances under, which HCPs and HCIs belonging to specified medical specialties or types of clinical practice may receive Evaluation Product from Arthrex (including, separately, from sales representatives, or through other channels);
7. Arthrex’s systems, policies, processes, and procedures relating to consultant or other fee-for-service arrangements entered into with HCPs or HCIs (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 activities, and any other financial engagement or arrangement with an HCP or HCI) and all events and expenses relating to such products.engagements or arrangements;
8. Arthrex’s systems, policies, processes, and procedures relating to agreements or arrangements with HCPs or HCIs for the purchase or licensing of intellectual property or for the payment of royalties for intellectual property contributions to the development of a product, technology, process, or method;
9. Arthrex’s systems, policies, processes, and procedures relating to programs by HCPs to educate sales representatives, including but not limited to presentations by HCPs at sales meetings, preceptorships, tutorials, and experience-based learning activities;
10. Arthrex’s systems, policies, processes, and procedures relating to the review and approval of, and payment for, travel and related expenses for HCPs including those in connection with an HCP’s participation in educational, research, training, or other Arthrex-sponsored programs or activities;
11. Arthrex’s systems, policies, processes, and procedures relating to the sponsorship or funding of grants (including educational grants) or charitable contributions involving HCPs or HCIs;
12. Arthrex’s systems, policies, processes, and procedures relating to funding of, or participation in, any Sponsorships or Third-Party Educational Activity as defined in Section II.C.4 and II.C.5 of the CIA;
13. Arthrex’s systems, policies, processes, and procedures relating to the review of promotional, reimbursement-related, and disease state materials and information intended to be disseminated outside Arthrex by appropriate qualified personnel (such as regulatory, medical, and/or legal personnel) in a manner designed to ensure that legal, regulatory, and medical concerns are properly addressed during Arthrex’s review and approval process and are elevated when appropriate;
14. Arthrex’s systems, policies, processes, and procedures relating to compensation (including through salaries, bonuses, or other means) for Covered Persons who are sales representatives and their managers; and
15. Arthrex’s systems, policies, processes, and procedures relating to disciplinary policies and procedures for violations of Arthrex’s Policies and Procedures, including policies relating to Federal health care program and FDA requirements.
Appears in 1 contract
Samples: Corporate Integrity Agreement
IRO Systems Review. A. Description of Reviewed Policies and Procedures The IRO Systems Review shall be a review of Novartis’ systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of Taro relating to Pricing and Contracting certain Promotional Functions and other systems as described belowProduct Related Functions. Where practical, Taro Novartis 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 Taro in accordance with Novartis pursuant to the preceding sentence. sentence. Specifically, the IRO shall review Novartis’ systems, processes, policies, and procedures of Taro associated with the following (hereafter “Reviewed Policies and Procedures”):
1. Taro’s systems (including any electronic systems), processes, policies, and procedures relating to Pricing and Contracting Functions. This review shall include an assessment of the following:
a. Xxxx’s organizational structure as it relates to Pricing and Contracting Functions, including:
i. The identification of those individuals, departments, or groups within Taro responsible for conducting market (and other) research relevant to setting prices and establishing pricing strategies and policies for Government Reimbursed Products, including the individuals, departments, or groups authorized to approve pricing terms and pricing strategies; and
ii. The identification of those individuals, departments, or groups within Taro responsible for bidding, negotiating, and contracting with customers or potential customers of Government Reimbursed Products, including the individuals, departments, or groups authorized to approve bids submitted to potential customers and contracts (including contract terms and changes in contract terms, including pricing terms) entered with customers;
b. the systems, processes, policies, and procedures that Taro uses or follows in connection with setting prices (including but not limited to suggested wholesale price (SWP), wholesale acquisition cost (WAC), and average wholesale price (AWP)) and establishing pricing strategies, including i) the information and factors to be considered in connection with setting prices and establishing pricing strategies; and ii) the types and sources of information (both internal and external) used to make decisions about prices and pricing strategies; and
c. the systems, processes, policies, and procedures that Taro uses or follows in connection with the offering or selling of Government Reimbursed Products to any potential customer or current customer, including offering, bidding, negotiating, and contracting for the sale of Government Reimbursed Products and the manner and circumstances under which such activities occur.
2. systems, processes, policies and procedures relating to Xxxx’s review of records relating to interactions between Covered Persons who engage in Pricing and Contracting Functions and competitors, including:
a. record-keeping systems relating to records reflecting interactions or communications between Reviewed Covered Persons (as defined in Section III.K of the CIA) and competitors;
b. Taro’s reviews of records relating to interactions and communications between Reviewed Covered Persons and competitors; and
c. records relating to performance review records and any disciplinary records for Reviewed Covered Persons.
3. Taro’s Novartis’ systems, policies, processes, and procedures applicable to the development manner in which Novartis sales representatives handle and submit requests or inquiries to Medical Information & Communications (“MIC”) relating to information about the uses of Novartis Government Reimbursed Products (including non-FDA-approved (i.e., off-label) uses) and the dissemination of materials relating to off-label uses of Novartis Government Reimbursed Products. This review shall include:
a) the manner in which Novartis sales representatives handle and submit or generate requests for information about off-label uses of Taro Government Reimbursed Products to MIC;
b) the manner in which MIC personnel handle and respond to requests for information about off-label uses of Government Reimbursed Products (including tracking the requests and using the materials provided in response to the request);
c) the form and content of information and materials related to Government Reimbursed Products that are disseminated to physicians, pharmacists, or other health care professionals (collectively “HCPs”) or health care institutions (HCIs) by Novartis;
d) Novartis’ systems, processes, and procedures (including the Inquiries Database) used to track requests for information about off-label uses of Novartis Government Reimbursed Products and responses to those requests;
e) the manner in which Novartis collects and supports information reported in any systems used to track and respond to requests for product information, including the Inquiries Database;
f) the processes and procedures by which MIC and Novartis’ Compliance Department or their designees monitor and identify situations in which it appears that improper off-label promotion may have occurred; and
g) Novartis’ processes and procedures for investigating, documenting, resolving, and taking appropriate disciplinary action for potential situations involving improper promotion;
2) Novartis’ systems, processes, policies and procedures applicable to the manner and circumstances under which personnel from Medical Affairs (e.g., medical science liaisons or other medical or scientific personnel) interact with or participate in meetings or events with HCPs or HCIs (either alone or with sales representatives) and the role of the Medical Affairs personnel at such meetings or events, including the manner in which the Medical Affairs personnel handle responses to unsolicited requests about off-label indications of Government Reimbursed Products. This review shall include any internal monitoring plan designed to monitor the activities of Medical Affairs personnel;
3) Novartis’ systems, policies, processes, and procedures relating to Novartis’ internal review and approval of information and materials related to Government Reimbursed Products that are disseminated to HCPs or HCIs by Novartis;
4) Novartis’ systems, processes, polices, and procedures relating to incentive compensation (including through salaries, bonuses, or contests) for Relevant Covered Persons engaged in Pricing and Contracting Functions who are sales representatives, 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, marketing, pricing, or contracting activities or other improper conduct relating to and marketing of Novartis’ Government Reimbursed Products. This shall include a review of the bases upon which compensation is determined and the extent to which compensation is based on product performance. To the extent that Xxxx Novartis establishes different methods of compensation for different Government Reimbursed Products or different compensation arrangements based on the type of Pricing and Contracting Function in which the Covered Person engagesProducts, the IRO shall review each type of compensation arrangement separately; and;
4. Taro’s 5) Novartis’ systems, processes, policies, and procedures relating to its risk assessment the development, implementation, and internal review process outlined of Call Plans (as defined in Section III.D III.B.3.i of the CIA.) 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, among other factors, expected utilization of Government Reimbursed Products for FDA-approved uses or non-FDA-approved uses;
6) Novartis’ systems, processes, policies, and procedures relating to the development, implementation, and review of Sample Distribution Plans (as defined in Section III.B.3.j of the CIA). This shall include a review shall assess whether of the risk assessment bases upon, and internal review process identifies circumstances under, which HCPs and addresses relevant HCIs belonging to specified medical specialties or types of clinical practice may receive samples from Novartis (including, separately, from Novartis sales representatives and appropriate risks associated other Novartis personnel, components, or vendors);
7) Novartis’ systems (including any centralized electronic system), processes, policies, and procedures relating to speaker programs, speaker training programs, and all events and expenses relating to such engagements or arrangements;
8) Novartis’ systems, processes, policies, and procedures relating to non-speaker related consultant or other fee-for-service arrangements entered into with HCPs or HCIs (including, but not limited to, presentations, consultant task force meetings, advisory boards, preceptorships, mentorships (if any), and ad hoc advisory activities, and any other financial engagement or arrangement with an HCP or HCI) and all events and expenses relating to such engagements or arrangements;
9) Novartis’ systems, processes, policies and procedures relating to the submission of information about any Government Reimbursed ProductsReimbursed Products to any compendia 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 such products (“Compendia”). This includes any initial submission of information to any Compendia and the submission of any additional, including risks updated, supplemental, or changed information, (e.g., any changes based on Novartis’ discovery of erroneous or scientifically unsound information or data associated with the salesinformation in the Compendia.) The review shall also assess Novartis’ processes relating to its annual review of all arrangement, pricingprocessing fees, or other payments or financial support (if any) provided by the company to any Compendia;
10) Novartis’ systems, processes, policies, and contracting activities procedures relating to such products.investigator-initiated studies (ISSs) including the decision to provide financial or other support for those studies; the manner in which support is provided for those studies; and support for publication of the information about those studies, including publication of information about the trial outcomes and results and the uses made of publications relating to those studies; and
11) Novartis’ systems, processes, policies and procedures relating to authorship or any articles or other publications about Novartis products or about therapeutic areas or disease states that may be treated with Novartis products, including, but not limited to, the disclosure of any and all relationships between the author and Novartis, the identification of all authors or contributors (including professional writer, if any) associated with a given publication, and the scope and breadth of research results made available to each author or contributor.
Appears in 1 contract
Samples: Corporate Integrity Agreement
IRO Systems Review. The IRO Covered Functions and RAMP Systems Review shall be a review of Shire’s systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of Taro relating to Pricing and Contracting certain Covered Functions and other systems as described belowits RAMP. Where practical, Taro Shire 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 Taro in accordance with Shire pursuant to the preceding sentence. sentence. Specifically, the IRO shall review Shire’s systems, processes, policies, and procedures of Taro associated with the following (hereafter “Reviewed Policies and Procedures”):
1. Taro’s systems (including any electronic systems), processes, policies, and procedures relating to Pricing and Contracting Functions. This review shall include an assessment of the following:
a. Xxxx’s organizational structure as it relates to Pricing and Contracting Functions, including:
i. The identification of those individuals, departments, or groups within Taro responsible for conducting market (and other) research relevant to setting prices and establishing pricing strategies and policies for Government Reimbursed Products, including the individuals, departments, or groups authorized to approve pricing terms and pricing strategies; and
ii. The identification of those individuals, departments, or groups within Taro responsible for bidding, negotiating, and contracting with customers or potential customers of Government Reimbursed Products, including the individuals, departments, or groups authorized to approve bids submitted to potential customers and contracts (including contract terms and changes in contract terms, including pricing terms) entered with customers;
b. the systems, processes, policies, and procedures that Taro uses or follows in connection with setting prices (including but not limited to suggested wholesale price (SWP), wholesale acquisition cost (WAC), and average wholesale price (AWP)) and establishing pricing strategies, including i) the information and factors to be considered in connection with setting prices and establishing pricing strategies; and ii) the types and sources of information (both internal and external) used to make decisions about prices and pricing strategies; and
c. the systems, processes, policies, and procedures that Taro uses or follows in connection with the offering or selling of Government Reimbursed Products to any potential customer or current customer, including offering, bidding, negotiating, and contracting for the sale of Government Reimbursed Products and the manner and circumstances under which such activities occur.
2. systems, processes, policies and procedures relating to Xxxx’s review of records relating to interactions between Covered Persons who engage in Pricing and Contracting Functions and competitors, including:
a. record-keeping systems relating to records reflecting interactions or communications between Reviewed Covered Persons (as defined in Section III.K of the CIA) and competitors;
b. Taro’s reviews of records relating to interactions and communications between Reviewed Covered Persons and competitors; and
c. records relating to performance review records and any disciplinary records for Reviewed Covered Persons.
3. TaroShire’s systems, policies, processes, and procedures applicable to the development manner in which sales representatives handle requests or inquiries relating to information about the uses of Government Reimbursed Products (including non-FDA-approved (i.e., off-label) uses) and the dissemination of materials relating to off-label uses of Government Reimbursed Products. This review includes:
a) the manner in which sales representatives handle requests for information about off-label uses of Taro Government Reimbursed Products (i.e., by referring all requests to medical affairs), including any electronic system(s) that Shire uses to collect, process, and/or store such information;
b) the manner in which medical affairs personnel handle and respond to requests for information about off-label uses of Government Reimbursed Products (including tracking the requests and using the materials provided in response to the request);
c) the form and content of information and materials related to Government Reimbursed Products disseminated to physicians, pharmacists, or other health care professionals (collectively “HCPs”) or health care institutions (“HCIs”) by Shire;
d) Shire’s systems, processes, and procedures (including the Inquiries Databases) used to track requests for information about off-label uses of Government Reimbursed Products and responses to those requests;
e) the manner in which Shire collects and supports information reported in any systems used to track and respond to requests for Government Reimbursed Product information, including the Inquiries Databases;
f) the processes and procedures by which medical affairs personnel and Shire’s Compliance Department or their designees monitor and identify situations in which it appears that improper promotion may have occurred; and
g) Shire's processes and procedures for investigating, documenting, resolving, and taking appropriate disciplinary action for potential situations involving improper promotion;
2) Shire’s systems, processes, policies and procedures applicable to the manner and circumstances under which Medical Science Liaisons (MSLs) interact with or participate in meetings or events with HCPs or HCIs (either alone or with sales representatives) and the role of the MSLs at such meetings or events, including the manner in which they handle responses to unsolicited requests about off-label indications of Government Reimbursed Products;
3) Shire’s systems, policies, processes, and procedures relating to Shire’s internal review and approval of information and materials that are disseminated to HCPs or HCIs and relate to Government Reimbursed Products;
4) Shire's systems, processes, polices, and procedures relating to incentive compensation for Relevant Covered Persons engaged in Pricing and Contracting Functions who are sales representatives, 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, marketing, pricing, or contracting activities or other improper conduct relating to and marketing of Government Reimbursed Products. This shall include a review of the bases upon which compensation is determined and the extent to which compensation is based on product performance. To the extent that Xxxx Shire establishes different methods of systems, processes, policies, or procedures relating to compensation for different Government Reimbursed Products or different compensation arrangements based on the type of Pricing and Contracting Function in which the Covered Person engagesProducts, the IRO shall review each type of compensation arrangement separately; and;
4. Taro5) Shire’s systems, processes, policies, and procedures relating to its risk assessment the development and internal review process outlined of call plans (as described in Section III.D III.B.3.h of the CIA). 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, among other factors, expected utilization of Government Reimbursed Products for FDA-approved uses or non-FDA-approved uses;
6) Shire’s systems, processes, policies, and procedures relating to sample distribution (as described in Section III.B.3.i 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 Shire (including, separately, from sales representatives and other personnel or components). It shall also include a review of whether samples of Government Reimbursed Products are distributed through sales representatives or are distributed from a central location and the rationale for the manner of distribution;
7) Shire’s systems (including any centralized electronic system), processes, policies, and procedures relating to speaker programs, speaker training programs, and all events and expenses relating to such engagements or arrangements;
8) Shire’s systems, processes, policies, and procedures relating to non-speaker related consultant or other fee-for-service arrangements entered into with HCPs or HCIs (including, but not limited to, presentations, consultant meetings, advisory boards, and ad hoc advisory activities, and any other financial engagement or arrangement with an HCP or HCI) and all events and expenses relating to such engagements or arrangements;
9) Shire’s systems, processes, policies and procedures relating to the submission of information about any Government Reimbursed Product to any compendia 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 Government Reimbursed Product (“Compendia”). This includes any initial submission of information to any Compendia and the submission of any additional, updated, supplemental, or changed information, (e.g., any changes based on Shire’s discovery of erroneous or scientifically unsound information or data associated with the information in the Compendia.) The review shall also assess whether Shire’s processes relating to its annual review of all arrangements with, and processing fees or other payments or financial support (if any) provided by the company to any Compendia;
10) Shire’s systems, processes, policies and procedures relating to RAMP, including but not limited to, a review of: (a) the sources and types of information used in connection with the risk assessment (e.g., the individual personnel, departments or functional areas, and/or any data and systems involved); and (b) the timing for development of the risk assessment and internal risk mitigation plans;
11) An assessment of whether, in developing the risk assessment or risk mitigation plans: (a) additional or different sources of information should be utilized; (b) additional or different types of data or information should be utilized; and (c) additional or different timing cycles should be utilized;
12) A review process identifies of the experience, background, and addresses training of personnel responsible for the development of the risk assessment and risk mitigation plans; and an assessment of the completeness and appropriateness of the relevant training, policies, procedures, standard operating procedures, and appropriate risks guidance each such individual receives;
13) An assessment of whether risk monitoring, review, and, as appropriate, audit activities related to RAMP: (a) adequately monitor all relevant identified risks; (b) identify any actual problems that have occurred in connection with the identified potential sales, marketing or promotional risk; and/or (c) prevent reoccurrence of any problems associated with an identified risk;
14) An assessment of whether risk monitoring, review, and, as appropriate, audit activities related to Shire’s RAMP should be: (a) enhanced, revised, or refined; (b) changed to include additional or different mitigation/monitoring options to be considered based upon specific identified risks; and/or (c) tracked and reviewed more frequently than prescribed by current policies to ensure that the mitigation/monitoring options address all relevant risks for the specific Government Reimbursed ProductsReimbursed Products reviewed; and
15) A review of the systems, including risks associated with the salespolicies, pricingprocedures, and contracting processes by which Shire tracks and manages RAMP activities relating to such products.and an assessment of whether the systems, policies, procedures and processes ensure that risk mitigations plans are appropriately implemented (including by identifying individuals responsible for the follow-up action items).
Appears in 1 contract
Samples: Corporate Integrity Agreement
IRO Systems Review. A. Description of Reviewed Policies and Procedures The IRO Systems Review shall be a review of Par’s systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of Taro relating to Pricing and Contracting Functions and other systems as described belowcertain of the Covered Functions. Where practical, Taro Par 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 Taro Par in accordance with the preceding sentence. sentence. Specifically, the IRO shall review Par’s systems, processes, policies, and procedures of Taro associated with the following (hereafter “Reviewed Policies and Procedures”):). If Par does not conduct an activity described below during that Reporting Period, the IRO does not need to conduct a Systems Review of that activity.
1. Taro) Par’s systems systems, processes, policies, and procedures applicable to the manner in which Par sales representatives and field personnel (including sales personnel and marketing personnel) and personnel from the Medical Affairs department 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 Par sales personnel and other field personnel handle requests for information about off-label uses of Government Reimbursed Products (i.e., by referring all such requests to Medical Affairs personnel at Par);
b) the manner in which Medical Affairs personnel, including those at Par’s headquarters, handle and respond to requests for information about off-label uses of Government Reimbursed Products (including tracking the requests and using pre-approved materials for purposes of responding to the request);
c) the form and content of information and materials related to Government Reimbursed Products disseminated to HCPs (as defined in section II.C.9 of the CIA), and health care institutions (HCIs), Payers, and formulary decision-makers by Par;
d) Par's systems, processes, policies, and procedures (including the Inquiries Database) to track requests to Medical Affairs for information about off-label uses of products and responses to those requests;
e) the manner in which Par collects and supports information reported in any electronic systems used to track and respond to requests to Medical Affairs for Government Reimbursed Product information, including its Inquiries Database;
f) the processes and procedures by which Medical Affairs, the Compliance Officer, or other appropriate individuals within Par identify situations in which it appears that off-label or other improper promotion may have occurred; and
g) Par's processes and procedures for investigating, documenting, resolving, and taking appropriate disciplinary action for potential situations involving improper promotion;
2) Par’s systems), processes, policies, and procedures applicable to the manner and circumstances under which its Medical Affairs personnel 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 Affairs personnel at such meetings or events;
3) Par’s systems, processes, policies, and procedures relating to Pricing and Contracting Functions. This Par's internal review shall include an assessment of the following:
a. Xxxx’s organizational structure as it relates promotional materials related to Pricing and Contracting Functions, including:
i. The identification of those individuals, departments, or groups within Taro responsible for conducting market (and other) research relevant to setting prices and establishing pricing strategies and policies for Government Reimbursed Products, including the individuals, departments, or groups authorized to approve pricing terms and pricing strategies; and
ii. The identification of those individuals, departments, or groups within Taro responsible for bidding, negotiating, and contracting with customers or potential customers of Government Reimbursed Products, including the individuals, departments, or groups authorized to approve bids submitted to potential customers and contracts (including contract terms and changes in contract terms, including pricing terms) entered with customers;
b. the systems, processes, policies, and procedures that Taro uses or follows in connection with setting prices (including but not limited to suggested wholesale price (SWP), wholesale acquisition cost (WAC), and average wholesale price (AWP)) and establishing pricing strategies, including i) the information and factors to be considered in connection with setting prices and establishing pricing strategies; and ii) the types and sources of information (both internal and external) used to make decisions about prices and pricing strategies; and
c. the systems, processes, policies, and procedures that Taro uses or follows in connection with the offering or selling of Government Reimbursed Products disseminated to any potential customer HCPs, HCIs and Payers and individuals or current customerentities (e.g.¸ PBMs) acting on behalf of HCPs, including offering, bidding, negotiating, and contracting for the sale of Government Reimbursed Products and the manner and circumstances under which such activities occur.HCIs or government payers;
2. systems, processes, policies and procedures relating to Xxxx’s review of records relating to interactions between Covered Persons who engage in Pricing and Contracting Functions and competitors, including:
a. record-keeping systems relating to records reflecting interactions or communications between Reviewed Covered Persons (as defined in Section III.K of the CIA4) and competitors;
b. Taro’s reviews of records relating to interactions and communications between Reviewed Covered Persons and competitors; and
c. records relating to performance review records and any disciplinary records for Reviewed Covered Persons.
3. Taro’s Par's systems, policies, processes, processes and procedures applicable to the development and review of Taro processes relating to incentive compensation for Covered Persons engaged in Pricing who are prescriber-facing sales personnel and Contracting Functions 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, marketing, pricing, or contracting activities or other improper conduct relating to and marketing of Relevant Government Reimbursed Products. This shall include a review of the bases upon which compensation is determined and the extent to which compensation is based on product performance. Par’s systems, policies, and procedures shall be consistent with the Employee and Executive Incentive Compensation Restriction Program required under section III.H of the CIA. To the extent that Xxxx Par establishes different methods of compensation for different Relevant Government Reimbursed Products or different compensation arrangements based on the type of Pricing and Contracting Function in which the Covered Person engagesProducts, the IRO shall review each type of compensation arrangement separately; and;
4. Taro5) Par’s systems, policies, processes and procedures relating to the Executive Financial Recoupment Program described in Section III.H of the CIA and in Appendix D;
6) Par’s systems, processes, policies, and procedures relating to its risk assessment the development and internal review process outlined of Call Plans (as defined in Section III.D III.B.2.h of the CIA) for Relevant 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 Relevant Government Reimbursed Products for FDA-approved uses or non-FDA-approved uses;
7) Par’s systems, processes, policies, and procedures relating to Sample Distribution Policies and Procedures (as defined in Section III.B.2.i of the CIA). This shall assess 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 Par (including, separately, from Par sales representatives and other Par personnel or components). It shall also include a review of whether samples of Government Reimbursed Products are distributed by Par through sales representatives or are distributed from a central location and the risk assessment rationale for the manner of distribution;
8) Par’s systems (including any centralized electronic systems), processes, policies, and internal review process identifies procedures relating to speaker programs, speaker training programs, and addresses relevant all events and appropriate risks expenses relating to such engagements or arrangements;
9) Par’s systems, processes, policies, and procedures relating to engagement of non-speaker related consultants or other fee-for-service arrangements entered into with HCPs or HCIs and all events and expenses associated with such activities;
10) Par’s systems, processes, policies, and procedures relating to Par’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;
11) Par’s systems, processes, policies, and procedures relating to the submission of information about any Government Reimbursed ProductsReimbursed Product to any compendia 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 (hereafter Compendia). This includes any initial submission of information to any Compendia and the submission of any additional, including risks updated, supplemental, or changed information, (e.g., any changes based on Par's discovery of erroneous or scientifically unsound information or data associated with the salesinformation in the Compendia). Par represents that it does not make any submissions to the Compendia. The review shall also assess Par's processes relating to Par’s annual review of information in the Compendia about Par’s Government Reimbursed Products when Par makes any submission of information during the Reporting Period to any Compendia and Par’s review of all arrangements, pricingprocessing fees, or other payments or financial support (if any) related to Government Reimbursed Products provided to any Compendia; and
12) the form and content of information and materials disseminated by Par to Payers and Payer subcontractors, e.g., PBMs, and contracting activities Par’s systems, policies, processes, and procedures relating to such products.Par's internal review and approval of information and materials related to Government Reimbursed Products disseminated to Payers and Payer subcontractors by Par.
B. IRO Systems Review Report The IRO shall prepare a report based upon each Systems Review. For each of the Reviewed Policies and Procedures identified in Section II.A above, the report shall include the following items:
1) a description of the documentation (including policies) reviewed and any personnel interviewed;
2) a detailed description of Par’s systems, policies, processes, and procedures relating to the items identified in Sections II.A.1-12 above, including a general description of Par’s control and accountability systems (e.g., documentation and approval requirements, and tracking mechanisms) and written policies regarding the Reviewed Policies and Procedures;
Appears in 1 contract
Samples: Corporate Integrity Agreement
IRO Systems Review. A. Description of Reviewed Policies and Procedures The IRO Systems Review shall be a review of BIPI’s systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of Taro relating to Pricing and Contracting Functions and other systems as described belowcertain aspects of the Covered Functions. Where practical, Taro BIPI 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 Taro in accordance with BIPI pursuant to the preceding sentence. sentence. Specifically, the IRO shall review BIPI’s systems, processes, policies, and procedures of Taro associated with the following (hereafter “Reviewed Policies and Procedures”):
1. Taro’s systems (including any electronic systems), processes, policies, and procedures relating to Pricing and Contracting Functions. This review shall include an assessment of the following:
a. Xxxx’s organizational structure as it relates to Pricing and Contracting Functions, including:
i. The identification of those individuals, departments, or groups within Taro responsible for conducting market (and other) research relevant to setting prices and establishing pricing strategies and policies for Government Reimbursed Products, including the individuals, departments, or groups authorized to approve pricing terms and pricing strategies; and
ii. The identification of those individuals, departments, or groups within Taro responsible for bidding, negotiating, and contracting with customers or potential customers of Government Reimbursed Products, including the individuals, departments, or groups authorized to approve bids submitted to potential customers and contracts (including contract terms and changes in contract terms, including pricing terms) entered with customers;
b. the systems, processes, policies, and procedures that Taro uses or follows in connection with setting prices (including but not limited to suggested wholesale price (SWP), wholesale acquisition cost (WAC), and average wholesale price (AWP)) and establishing pricing strategies, including i) the information and factors to be considered in connection with setting prices and establishing pricing strategies; and ii) the types and sources of information (both internal and external) used to make decisions about prices and pricing strategies; and
c. the systems, processes, policies, and procedures that Taro uses or follows in connection with the offering or selling of Government Reimbursed Products to any potential customer or current customer, including offering, bidding, negotiating, and contracting for the sale of Government Reimbursed Products and the manner and circumstances under which such activities occur.
2. systems, processes, policies and procedures relating to Xxxx’s review of records relating to interactions between Covered Persons who engage in Pricing and Contracting Functions and competitors, including:
a. record-keeping systems relating to records reflecting interactions or communications between Reviewed Covered Persons (as defined in Section III.K of the CIA) and competitors;
b. Taro’s reviews of records relating to interactions and communications between Reviewed Covered Persons and competitors; and
c. records relating to performance review records and any disciplinary records for Reviewed Covered Persons.
3. TaroBIPI’s systems, policies, processes, and procedures applicable to the development manner in which BIPI sales representatives and/or MTI personnel and MTI agents handle requests or inquiries relating to information about the uses of Government Reimbursed Products (including non-FDA-approved (i.e., off- label) uses) and the dissemination of materials relating to off-label uses of products. This review includes:
a) the manner in which BIPI sales representatives handle requests for information about off-label uses of Taro Government Reimbursed Products (e.g., by referring all such requests to MTI);
b) the manner in which MTI personnel and MTI agents handle and respond to requests for information about off-label uses of Government Reimbursed Products (including tracking the requests and using pre-approved materials for purposes of responding to the request);
c) the form and content of information and materials related to Government Reimbursed Products disseminated to physicians, pharmacists, or other health care professionals (collectively “HCPs”) or health care institutions (“HCIs”) by BIPI;
d) BIPI's systems, processes, and procedures (including the Inquiries Database) to track requests for information about off-label uses of products submitted to MTI and its agents and responses to those requests;
e) the manner in which BIPI collects and supports information reported in any systems used to track and respond to requests for product information, including its Inquiries Database;
f) the processes and procedures by which MTI and its agents, the CECO, or other appropriate individuals or their designees within BIPI identify situations in which it appears that off- label or other improper promotion may have occurred; and
g) XXXX's processes and procedures for investigating, documenting, resolving, and taking appropriate disciplinary action for potential situations involving improper promotion;
2) BIPI’s policies and procedures applicable to the manner and circumstances under which its medical personnel (including personnel from Field Based Medicine) 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) BIPI’s systems, policies, processes, and procedures relating to BIPI's internal review and approval of information and materials related to Government Reimbursed Products disseminated to HCPs or HCIs by BIPI;
4) BIPI's systems, polices, processes and procedures relating to incentive compensation for Relevant Covered Persons engaged in Pricing and Contracting Functions who are sales representatives, 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, marketing, pricing, or contracting activities or other improper conduct relating to and marketing of Government Reimbursed Products. This shall include a review of the bases upon which compensation is determined and the extent to which compensation is based on product performance. To the extent that Xxxx BIPI establishes different methods of compensation for different Government Reimbursed Products or different compensation arrangements based on the type of Pricing and Contracting Function in which the Covered Person engagesProducts, the IRO shall review each type of compensation arrangement separately; and;
4. Taro5) BIPI’s systems, processes, policies, and procedures relating to its risk assessment the development and internal review process outlined of call plans (as defined in Section III.D of the CIA. This review shall assess whether the risk assessment and internal review process identifies and addresses relevant and appropriate risks associated with Government Reimbursed Products, including risks associated with the sales, pricing, and contracting activities relating to such products.III.B.3.
Appears in 1 contract
Samples: Corporate Integrity Agreement
IRO Systems Review. The IRO Systems Review shall be a review of Essilor’s systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of Taro relating to Pricing and Contracting Functions and other systems as described belowCovered Functions. Where practical, Taro 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 Taro in accordance with the preceding sentence. SpecificallyMore specifically, the IRO shall review Essilor’s systems, processes, policies, and procedures of Taro associated with the following (hereafter “Reviewed Policies and Procedures”):
1. Taro’s systems (including any electronic systems), processes, policies, and procedures relating to Pricing and Contracting Functions. This review shall include an assessment of the following:
a. Xxxx’s organizational structure as it relates to Pricing and Contracting Functions, including:
i. The identification of those individuals, departments, or groups within Taro responsible for conducting market (and other) research relevant to setting prices and establishing pricing strategies and policies for Government Reimbursed Products, including the individuals, departments, or groups authorized to approve pricing terms and pricing strategies; and
ii. The identification of those individuals, departments, or groups within Taro responsible for bidding, negotiating, and contracting with customers or potential customers of Government Reimbursed Products, including the individuals, departments, or groups authorized to approve bids submitted to potential customers and contracts (including contract terms and changes in contract terms, including pricing terms) entered with customers;
b. the systems, processes, policies, and procedures that Taro uses or follows in connection with setting prices (including but not limited to suggested wholesale price (SWP), wholesale acquisition cost (WAC), and average wholesale price (AWP)) and establishing pricing strategies, including i) the information and factors to be considered in connection with setting prices and establishing pricing strategies; and ii) the types and sources of information (both internal and external) used to make decisions about prices and pricing strategies; and
c. the systems, processes, policies, and procedures that Taro uses or follows in connection with the offering or selling of Government Reimbursed Products to any potential customer or current customer, including offering, bidding, negotiating, and contracting for the sale of Government Reimbursed Products and the manner and circumstances under which such activities occur.
2. systems, processes, policies and procedures relating to Xxxx’s review of records relating to interactions between Covered Persons who engage in Pricing and Contracting Functions and competitors, including:
a. record-keeping systems relating to records reflecting interactions or communications between Reviewed Covered Persons (as defined in Section III.K of the CIA) and competitors;
b. Taro’s reviews of records relating to interactions and communications between Reviewed Covered Persons and competitors; and
c. records relating to performance review records and any disciplinary records for Reviewed Covered Persons.
3. TaroEssilor’s systems, policies, processes, and procedures for conducting Covered Functions in compliance with all applicable to the development Federal health care program requirements and review of Taro processes relating to incentive compensation for Covered Persons engaged in Pricing and Contracting Functions with regard to whether the all applicable FDA requirements;
2. Essilor’s systems, policies, processes, and procedures are designed to ensure for ensuring that financial incentives do not inappropriately motivate such individuals to engage all Discount Arrangements as defined in improper sales, marketing, pricing, or contracting activities or other improper conduct relating to Government Reimbursed ProductsSection III.K of the CIA comply with the Federal Anti-Kickback Statute;
3. To the extent that Xxxx establishes different methods of compensation for different Government Reimbursed Products or different compensation arrangements based on the type of Pricing and Contracting Function in which the Covered Person engages, the IRO shall review each type of compensation arrangement separately; and
4. TaroEssilor’s systems, policies, processes, policies, and procedures relating to its risk assessment the materials and information that may be distributed by Essilor sales representatives (including any contract sales force) about Government Reimbursed Products and the manner in which Essilor sales representatives respond to requests for information about uses of Government Reimbursed Products that are not FDA approved, cleared, or exempt (“non-FDA approved uses”);
4. Essilor’s systems, policies, processes, and procedures relating to the materials and information that may be distributed and the mechanisms through, and manner in which, Essilor receives and responds to requests for information from an ECP or another individual or entity about non-FDA approved uses of Government Reimbursed Products; the form and content of information disseminated by Essilor in response to such requests; and the internal review process outlined for the information disseminated;
5. Essilor’s systems, policies, processes, and procedures relating to the manner and circumstances under which Essilor medical personnel interact with or participate in meetings or events with ECPs, ECIs, or payors (either alone or with Essilor sales representatives) and the role of Essilor medical personnel at such meetings or events, as well as how they handle responses to requests for information about non-FDA approved uses of Government Reimbursed Products;
6. Essilor’s systems, policies, processes, and procedures relating to the materials and information that may be distributed or made available by Essilor through social media and/or direct-to-consumer advertising;
7. Essilor’s systems, policies, processes, and procedures relating to the development, implementation, and review of all polices for the distribution of Government Reimbursed Products for evaluation purposes (Evaluation Product). This shall include a review of the bases upon, and circumstances under, which ECPs and ECIs belonging to specified medical specialties or types of clinical practice may receive Evaluation Product from Essilor (including, separately, from sales representatives, or through other channels);
8. Essilor’s systems, policies, processes, and procedures relating to agreements or arrangements with ECPs or ECIs for the purchase or licensing of intellectual property (including, but not limited to, patents, patent applications, and payment of royalties);
9. Essilor’s systems, policies, processes, and procedures relating to programs by ECPs to educate sales representatives, including but not limited to presentations by ECPs at sales meetings, preceptorships, tutorials, and experience-based learning activities;
10. Essilor’s systems, policies, processes, and procedures relating to the review and approval of, and payment for, travel and related expenses for ECPs including those in connection with an ECP’s participation in educational, research, training, or other Essilor- sponsored programs or activities;
11. Essilor’s systems, policies, processes, and procedures relating to the sponsorship or funding of Grants (including educational grants) or Contributions as defined in Section III.D III.M of the CIACIA involving ECPs or ECIs;
12. This Essilor’s systems, policies, processes, and procedures relating to funding of, or participation in, any Sponsorships, Third Party Educational Activity, or Co-Marketing Activity as defined in Section II.C.4, II.C.5, and II.C.6 of the CIA;
13. Essilor’s systems, policies, processes, and procedures relating to the review shall assess whether the risk assessment of promotional, reimbursement-related, and internal disease state materials and information intended to be disseminated outside Essilor by appropriate qualified personnel (such as regulatory, medical, and/or legal personnel) in a manner designed to ensure that legal, regulatory, and medical concerns are properly addressed during Essilor’s review and approval process identifies and addresses relevant are elevated when appropriate;
14. Essilor’s systems, policies, processes, and appropriate risks associated with Government Reimbursed Productsprocedures relating to compensation (including through salaries, bonuses, or other means) for Covered Persons who are sales representatives and their managers; and
15. Essilor’s systems, policies, processes, and procedures relating to disciplinary policies and procedures for violations of Essilor’s Policies and Procedures, including risks associated with the sales, pricing, and contracting activities policies relating to such products.Federal health care program and FDA requirements.
Appears in 1 contract
Samples: Corporate Integrity Agreement
