ANTI-KICKBACK STATUTE POLICIES AND PROCEDURES
Bayer HealthCare LLC ("Bayer") shall not offer or pay to any person "remuneration" or anything of value intended to induce, influence, encourage or reward that person's order, referral, use, prescription or recommendation of a Bayer product. Where reasonably possible and practical, Bayer will attempt to structure arrangements with potential sources of sales or referrals in a manner that complies with an applicable regulatory "safe harbors."
Bayer policy prohibits employees from offering anything of value – (for example, fee-for-service agreements, data purchases, educational grants, clinical research support, charitable contributions, business meals or educational items) – to a healthcare professional or other person (1) to encourage such person to prescribe, purchase, order, refer, use or recommend Bayer products, or (2) as a price term or in lieu of price discounts. Accordingly, Bayer has established the following policies and procedures consistent with the Anti-Kickback Statute, as well as its regulatory safe harbors, governmental guidance documents, and voluntary industry standards, such as the PhRMA Code on Interactions with Healthcare Professionals and the AdvaMed Code of Ethics on Interactions with Healthcare Professionals.
- Fee-For-Service Agreements. Fee-for-service agreements with healthcare professionals include arrangements for speaking events, consulting, advisory board participation, compliance and persistency programs, patient education programs, medical writers and other activities where individuals (or the companies that employ them) are compensated by Bayer for services rendered. Bayer may enter into fee-for-service agreements with healthcare professionals for bona fide services that are necessary for a commercially reasonable Bayer business purpose, and for which the compensation represents fair market value based on the nature of, and commensurate with, the services provided. Bayer may not enter into agreements with any healthcare professional for services that are not necessary for a Bayer business purpose, not commercially reasonable, or for which the amount of compensation provided by Bayer is based on, or related to, the past, present or future volume or value of business generated directly or indirectly for Bayer by that healthcare professional. Bayer shall choose service providers (e.g., speakers, advisors and/or consultants) based upon relevant qualifications, experience and expertise, as well as the value their services would provide to Bayer. The number of service providers chosen must be consistent with Bayer's business needs.
- Contracting with Members of Formulary or Clinical Practice Committees. Bayer requires any healthcare professional who is a member of a committee that sets formularies or develops clinical practice guidelines and also has a fee-for-service agreement with Bayer to disclose to the committee the existence and nature of his or her relationship with Bayer during the period of the contract and two years beyond contract termination.
- Promotional Speaker Events. Bayer may sponsor or furnish product education and training to healthcare professionals to facilitate the safe and effective use of Bayer products and to provide clinically relevant information on disease state issues. Topics must address only FDA-approved uses of Bayer products and be of a scientific or medical nature. Prior to the event taking place, the speakers must participate in a Bayer speaker training program, and all materials to be used by the speakers must be approved in advance by Bayer. The speaker and the materials must clearly identify that Bayer is sponsoring the presentation, the fact that the speaker is presenting on behalf of Bayer, and that the speaker is presenting information that is consistent with FDA regulations. A Bayer representative must attend each program. Speakers may receive compensation at fair market value for each speaking event, subject to an overall aggregate cap for such speaking engagements across Bayer divisions.
- Medical Practice Training. Bayer does not engage in preceptorship arrangements as traditionally defined within the pharmaceutical or medical industries. Bayer may contract with a healthcare professional to provide medical practice training for Bayer employees, consistent with Bayer’s policies on fee-for-service arrangements and medical practice training.
- Purchasing Data from Customers. Bayer may acquire clinical or sales data that is necessary for a commercially reasonable Bayer business purpose, such as data necessary to support the marketing of Bayer products or to demonstrate safety and efficacy. Any data purchase must be at fair market value for data actually needed and used by Bayer.
- Customer Program Support. Customer programs, such as disease awareness programs and managed care organizations reminding patients to refill their Bayer prescriptions, are undertaken with healthcare organizations in order to foster increased understanding of scientific or clinical issues in order to improve patient care. No program may be established or operated in exchange for an agreement to prescribe or order Bayer products or be given in place of a discount on product price. Payment for customer programs must represent fair market value. Customer programs may not substitute for, or subsidize, activities that are part of a customer's normal costs of providing healthcare services or of running its business. In addition, customer programs may not be used to support a patient "switch" program (e.g., a program intended to convert patients from a competitor product to a Bayer product).
- Product Displays. Bayer may make payments for costs associated with displays of Bayer products at health care facilities or commercial exhibition booths at conventions only if an equal opportunity for participation is afforded to other pharmaceutical and/or biotech companies. Payment for displays or exhibits made to potential sources of sales or referrals must represent fair market value. For product displays where payment is made to hospitals or other customer facilities, Bayer may not solicit or receive display space in return for payments for research or educational grants or any charitable contribution.
- Charitable Contributions (Other Than Free Bayer Products). Bayer’s decision to make charitable contributions shall be made independently of Bayer's sales and marketing functions. Bayer may make charitable contributions only if the contribution is intended solely for charitable purposes, and Bayer receives nothing of value in return other than an acknowledgement of Bayer’s sponsorship by the charitable organization. The recipient must be a qualified 501(c)(3) or otherwise IRS tax-exempt charitable organization. Bayer does not provide charitable contributions to Bayer customers or physician private practice groups, or to charitable organizations that are legally associated with or controlled by a Bayer customer or an individual physician private practice group.
- Patient Assistance Programs ("PAPs"). Bayer may provide free Bayer products through its PAPs. PAP assistance is available only for patients that: (1) reside in the U.S., (2) are financially disadvantaged, (3) do not have coverage for the requested Bayer product, and (4) have a valid prescription from an healthcare professional for the product.
- Medical Education Grants. Bayer funding for activities associated with educational conferences, Continuing Education ("CE") or Continuing Medical Education (“CME”) programs or professional meetings is limited to programs sponsored by an accredited medical organization and which will contribute to the improvement of patient care. Bayer’s sales and marketing personnel shall not be involved in decisions regarding educational grant support. Educational grants may only be made to foster increased understanding of scientific, clinical, or health care issues that contribute to the improvement of patient care. Grants to support federal government speakers may only be provided to bona-fide third-party organizations established for the purpose of accepting and disseminating grant funds on behalf of federal entities. Medical education grants may not be provided to individuals or private physician practice groups. Bayer shall not influence the disbursement of the funds, or the selection by the organization of content, faculty, educational methods, materials and venues. Grant funds cannot be used to offset expenses not directly related to the educational program nor can they be used for expenses of attendees.
- Clinical Research and Clinical Study Support. All research and clinical studies supported by Bayer must promote legitimate research goals. Bayer’s sales and marketing personnel shall not be involved in the approval of any such research or study supported by Bayer. Funding decisions are based on a review of the statement of the research objectives, the research protocol, and a written budget. All research support requires the recipient to submit progress reports and, where applicable, a final report. Bayer will only sponsor or authorize clinical research that is related to developing clinical information concerning Bayer products that is reasonably necessary to achieve a commercially reasonable business purpose (such as to demonstrate the safety or efficacy of a Bayer product). Payments for clinical or research studies must represent fair market value. Bayer may not pay a clinical investigator compensation that is based on, or related to, the past, present or future volume or value of business generated for Bayer by that clinical investigator.
- Investigator-Initiated Studies or Clinical Trials. All investigator-initiated studies or trials supported by Bayer must promote legitimate research goals. Grants are provided based on a review of the research protocol and objectives, qualifications of the investigator and staff, and the written budget. Bayer does not provide investigator-initiated grants to induce or reward an investigator for prescribing or purchasing Bayer products or to familiarize an investigator with a Bayer product. Payment must represent fair market value. Investigator-initiated grants are made only to an entity, such as a hospital or research facility, and not directly to the investigator or to a private physician practice.
- Discounts and Rebates. Bayer must disclose the terms of all discounts, rebates and other price concessions provided to customers fully and accurately on invoices, written agreements and other documents which notify the recipient of its potential obligation to report the arrangement to government payors, such as Medicare and Medicaid. Bayer may not do anything to interfere with its customers reporting pricing information to the government. "Side deals," or price concessions, whether oral or written, offered outside of written contracts, are not allowed.
- Administrative Fees. Administrative fee payments made to Group Purchasing Organizations ("GPOs") and Pharmacy Benefits Managers ("PBMs") must represent fair market value compensation for bona fide administrative services that are necessary for a commercially reasonable Bayer business purpose and that are defined in an administrative services agreement. Administrative fees should not be related to whether a particular product is on formulary.