Millennium has implemented a comprehensive compliance program ("Program") based on the fundamental elements outlined in the Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers ("OIG Guidance"). Our Program includes internal controls, policies and procedures that foster compliance with federal and state laws, regulations, the PhRMA Code and other requirements applicable to our business. We periodically review the Program's policies and procedures to ensure that they are clear and consistent with the most recent versions of these standards.
Key elements of our Program are highlighted below. Click each topic to read in full.
Millennium's Core Values Handbook provides guidance to employees regarding the ethical, legal and compliance requirements applicable to their employment. The Handbook describes the internal policies that Millennium has implemented to foster compliance with these requirements and to promote individual accountability. The Core Values Handbook provides a foundation for a wide range of important policies of the Company. The general provisions of the Core Values Handbook are supplemented by more detailed compliance policies and procedures for individual business functions. These policies address risk areas relevant to pharmaceutical manufacturers, including those identified in the OIG Guidance and the updated PhRMA Code.
Millennium has a Compliance Officer (see page 52 of the Core Values Handbook) who coordinates and monitors legal compliance activities across the company. The Compliance Committee, comprised of leaders of key areas throughout the company, meets to discuss best practices, monitor compliance activities and coordinate advice-seeking.
Millennium requires that all new hires complete basic orientation training within 90 days of employment on legal and compliance related topics, processes and policies relevant to their positions, and applicable quality guidelines and regulations.
Millennium also requires employees in the sales, marketing, medical affairs, and medical organizations to complete training on general science and product-specific information and annual health regulatory compliance training. Compliance training sessions focus on, among other issues, the Anti-kickback Statute, False Claims Act, OIG Guidance, updated PhRMA Code, FDA regulatory standards, and ACCME's Standards for Commercial Support.
Training on identified risk areas is conducted at regular meetings of the sales and marketing organizations. This training is tailored specifically to respond to new compliance challenges faced by these organizations. Additional training programs are implemented in response to needs identified through ongoing monitoring and auditing.
Millennium encourages all employees to ask questions, seek guidance on ethical or legal issues, and express any concerns regarding business-related conduct. Millennium provides several channels for these types of communications. Millennium has established an external telephone hotline for reporting compliance concerns where anonymity may be preserved at the caller's request. Employees also may address their questions or concerns to their manager, Human Resources, the Legal Department, or the Compliance Officer. Company policy is designed to protect employees from retaliation for raising concerns in good faith.
Millennium monitors and audits its regulated activities for compliance with applicable laws, regulations, guidelines, and Company policies and procedures. The Quality Assurance group, the Legal Department, the Compliance Officer, and the internal audit functions formulate corrective action plans, working with the Human Resources department as necessary, to address concerns that are identified through monitoring and auditing.
Millennium conducts regular performance reviews of its employees and takes compliance into consideration as an important component of performance. Millennium takes disciplinary action in response to violations of applicable laws, regulations, and Company policies and procedures. Disciplinary action may include oral warnings, suspension, termination and other sanctions, as appropriate. Millennium has a process in place to screen individuals or entities excluded from participation in the federal healthcare programs or debarred by FDA. It is Millennium's policy to not employ such excluded individuals or entities.
Millennium strives to address issues that are identified or that are reported to us. Remediation of such problems may include disciplinary action, training, review or development of policies and procedures, and mechanisms for monitoring and/or auditing.
California Health & Safety Code §§ 119400-119402
Per the requirements of California Health & Safety Code §§ 119400-119402, Millennium has established an annual dollar limit of $1500 for certain spending on individual medical or healthcare professionals licensed in California. Millennium includes in this dollar limit the value of educational items and meals provided to healthcare professionals in connection with business and educational discussions with those individuals. This dollar limit represents a spending maximum and not an average or goal. Millennium reserves the right to change this limit at any time.
July 1, 2015 California Declaration of Compliance
To the best of its knowledge and based on its good faith understanding of the statutory requirements, Millennium declares that it is in compliance with its Program and the requirements of California Health & Safety Code §§ 119400-119402 in all material respects.
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For questions about Millennium's Program or to obtain a copy of this Program, please contact us at 866-469-6566 or firstname.lastname@example.org.