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Compliance Program
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1. |
Compliance Officer and Compliance Committee
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Talecris' Compliance Officer is a member of senior management who oversees all compliance activities. The Compliance Officer is responsible for developing and implementing policies, procedures, and practices designed to ensure compliance with federal health care programs. The Compliance Officer makes periodic reports regarding compliance activities directly to the Chief Executive of Talecris Biotherapeutics, Inc.
The Compliance Officer chairs the Compliance Committee, which is comprised of senior managers from various departments, such as Sales, Marketing, Contracting, Human Resources, and Internal Audit. The Compliance Committee supports the Compliance Officer in all activities of the Compliance Program.
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2. |
Written Standards of Conduct
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Talecris has established written standards of conduct, including the Code of Ethics and Business Conduct (PDF) posted on this Web site, that are designed to ensure compliance with the requirements associated with federal healthcare programs. The Code of Conduct is reviewed annually and updated as necessary. Relevant employees are required to certify on an annual basis that they have read and understand Talecris' written standards. Talecris uses audit tools to assess and monitor compliance with its written standards, to identify areas of potential concern, and to correct and prevent the recurrence of problems identified.
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3. |
Confidential Disclosure Program
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Talecris maintains a confidential disclosure program, which includes a toll-free telephone line, that allows employees to report to the Compliance Officer suspected violations of federal or state health care program requirements or of the company's policies and procedures. Reports may be made anonymously. Talecris will thoroughly investigate all reports it receives and no employee will be subjected to retaliation or any other adverse action for making a report in good faith.
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4. |
Compliance Training
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Relevant employees receive annual training that covers healthcare compliance policies and procedures and the pertinent legal requirements. Employees who have direct responsibility for establishing or reporting prices for Government reimbursed products or who set policy for or supervise marketing and sales of those products receive additional annual training covering the reporting of accurate pricing information; the obligation to ensure that prices are accurately reported; and examples of proper and improper drug price reporting and marketing and sales practices. Employees must certify completion of all training.
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5. |
Ineligible Persons
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Prior to hiring any individual for a position involving marketing, selling, contracting for or reporting prices for Talecris products, Talecris ascertains that the job candidate is not an Ineligible Person — i.e., an individual who is excluded, suspended, debarred or otherwise ineligible to participate in Government reimbursement programs or who has been convicted of a criminal offense related to federal health care programs. If an individual becomes an Ineligible Person while employed with Talecris, the company will, at a minimum, remove the employee from work involving Government reimbursement programs.
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| II. |
Government Price Reporting
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6. |
Promotion and Government Reimbursement
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Talecris employees must comply with all applicable laws and federal health care program requirements in marketing and promoting drug and biologic products. Talecris expressly prohibits any promotion of product based on the "spread" — or the difference between what a customer pays for a product and the amount the customer receives in government reimbursement.
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7. |
Reporting Product Prices to the Government
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It is Talecris' policy to comply with all applicable laws and regulations pertaining to product pricing and the reporting of those prices to Government agencies. Everything that may affect the net pricing of Talecris products, including discounts, rebates, and all other price concessions, is taken into account in reporting prices to the Government in accordance with the laws and regulations of Medicare, Medicaid and other Government reimbursement programs.
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| III. |
Interactions with Healthcare Professionals
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8. |
Incentives to Prescribe or Use Talecris Products
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No Talecris employee may offer any remuneration — that is, anything of value — to induce or encourage prescriptions or purchases of Talecris products. Certain discounts and other price concessions may be provided in conformance with the PhRMA Code and the Discount Safe Harbor to the Anti-Kickback Statute.
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9. |
Customer Assistance Programs/Product Support Services
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Talecris may support programs that foster increased understanding of scientific of clinical issues in order to improve patient care. No program may be supported in exchange for an agreement to prescribe or order Talecris products or be given in place of a discount on product price.
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10. |
Educational Grants
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Talecris provides grants to fund educational activities that foster increased understanding of scientific, clinical, or health care issues that contribute to the improvement of patient care. Grants may not be provided to encourage recipients to prescribe, purchase, order, or recommend Talecris products or provided in place of a product discount
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11. |
Sponsorship of Medical Educational Programs
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Talecris provides financial support for educational programs in accordance with the U.S. Food and Drug Administration ("FDA") and industry guidelines. Talecris employees may not, directly or indirectly, control or influence the content of a program if that program contains references to unapproved uses. Talecris employees may control and influence the content of a program only if its contents do not involve unapproved uses of Talecris products.
Talecris may support continuing medical education (CME) or other third-party educational conferences or professional meetings that contribute to the improvement of patient care by providing educational grant funds to the conference sponsor or by contracting with a third-party to plan and execute the event. Talecris does not provide financial support for travel or lodging for non-faculty members at third-party educational events and does not compensate attendees for time spent at the event. Talecris may provide financial support to the event sponsor to defray the costs of registration, modest meals, or receptions for all attendees.
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12. |
Research and Clinical Study Support
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Talecris only supports research and clinical studies that promote legitimate research goals and are conducted pursuant to a written agreement. Support for such studies cannot be provided with the intent to induce or encourage the entity receiving the support to prescribe, purchase or order Talecris products.
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13. |
Advertising and Promotion of Talecris Products
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No Talecris employee may promote any company product for uses that are not addressed in the approved product labeling or package insert or otherwise approved.
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14. |
Gifts and Meals Provided to Healthcare Professionals
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As required by the PhRMA Code, all gifts or promotional items must primarily benefit patients or be primarily associated with a health care professional's work. Talecris may provide occasional modest meals to healthcare professionals in connection with informational presentations and discussions that occur in a venue and manner that is conducive to educational and scientific communication.
Talecris currently has a $1,000 annual dollar limit on gifts, promotional materials and business meals that it may provide to an individual healthcare professional practicing in the State of California.
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15. |
Consultants
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Talecris may engage healthcare professionals as consultants or advisors to furnish important and needed information to Talecris, provided that it selects such consultants based on their relevant qualifications, experience, and expertise and pays them fair market value for their legitimate services, pursuant to written contracts.
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| IV. |
Other Policies
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16. |
Samples
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Talecris employees must comply with the Prescription Drug Marketing Act ("PDMA"), including documentation requirements, when distributing drug samples to physicians for free distribution to patients.
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17. |
Reports of Adverse Experiences Involving Talecris Products
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Any Talecris employee who learns of an adverse experience involving a patient receiving a Talecris product must report that information to Global Drug Safety as promptly as possible, regardless of whether the adverse event appears to have been caused by, or related to, the administration of the Talecris product.
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18. |
Discipline
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Violations of Talecris' healthcare compliance policies and procedures subject employees to disciplinary action. Employees who fail to comply with these policies, or who negligently or willfully fail to detect and report violations of these policies, will be subject to a variety of sanctions, up to and including termination.
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