California Compliance Declaration
Last Modified: 06/01/2023
For purposes of compliance with the requirements of California Health and Safety Code, §§ 119400-119402, Provepharm Inc. (“Provepharm”) has established, as part of its Comprehensive Compliance Program, an annual dollar limit concerning appropriate items covered by California law (“Covered Items”) that are provided to individual California medical and healthcare professionals (“HCPs”) as part of Provepharm’s interactions with these professionals. “Medical or health professional” means any of the following:
- A person licensed by state law to prescribe drugs for human patients.
- A medical student.
- A member of a drug formulary committee.
Provepharm has established an annual dollar limit of $2,000 for promotional materials, or other transfers of value, including items or activities that Provepharm employees may give or otherwise provide to an individual HCP licensed by the State of California in accordance with California Health and Safety Code, §§ 119400-119402. This limit represents an annual spending cap and not an average or target. In most instances, the amount spent per HCP will be substantially less than this annual limit. Provepharm Inc. reserves the right to change this limit at any time.
The annual limit in the aggregate does not include:
- Drug samples intended for free distribution to patients
- Financial support of continuing medical education forums
- Financial support for health education scholarships
- Fair market value compensation for bona fide professional services, and any meals or other expenses related to the provision of such services
2023 Declaration of Compliance
Annually Provepharm set an annual aggregate limit on promotional expenditures provided at $2,000 per California licensed HCP. Based upon our current internal monitoring process, to the best of our knowledge and belief, and based on a good faith understanding of California Health & Safety Code §§ 119400-402, Provepharm declares it is in compliance with all material respects with the requirements described in California Health & Safety Code §§ 119400-402. Provepharm will continually evaluate and update its Compliance Program as necessary and appropriate given the changing environment and needs.
Provepharm makes this declaration available on this website and a copy of this document.
Comprehensive Compliance Program Overview:
The following is an overview of Provepharm’s comprehensive compliance program which is reviewed and updated periodically to meet changing legal and compliance requirements.
Provepharm’s Corporate U.S. Code of Conduct (“Code of Conduct”) reflects our commitment to conducting business with high standards of ethical behavior. The Code of Conduct is applicable to all employees of Provepharm. All directors, officers and employees and agents of the company are expected to act with integrity and to make ethical decisions consistent with the Code of Conduct.
It is Provepharm’s policy to comply with all applicable state and federal laws and regulations, including, but not limited to, those related to Medicare, Medicaid, transparency reporting, and all other State and Federal health care program requirements including CMS and Food and Drug Administration regulation, laws and requirements. In addition to the Code of Conduct, Provepharm has implemented a Compliance Program that is designed to reduce legal and regulatory risks that Provepharm faces and provide a roadmap for appropriate business conduct that complies with all applicable laws and regulations in Provepharm’s United States business.
Employees are responsible for understanding what is expected of them, as outlined in Provepharm’s Code of Conduct and the Compliance Program. Provepharm Employees must always exercise good judgement, and when they are unsure of the proper course of conduct must ask. Knowing the channels for asking questions, raising concerns, and identifying the resources and materials necessary to make the right decisions is a necessary component of every employee’s role at Provepharm.
- Compliance Program Oversight
Provepharm has a Chief Compliance Officer who is responsible for leading, developing, operating, and monitoring the compliance program.
- Written Standards
In addition to the Code of Conduct, Provepharm has developed and implemented compliance policies and procedures to help ensure compliance with applicable laws and to support ethical decision-making. The Compliance Program verbalizes the company’s commitment to compliance (e.g., by including adherence to the compliance program as an element in evaluating management and employees) and addresses specific areas of potential fraud and abuse, such as the reporting of pricing and rebate information to the federal health care programs, and sales and marketing practices.
- Education and Training
All Provepharm employees in the U.S. receive appropriate compliance training (upon hire and updated on at least an annual basis) which includes education on the OIG Guidance, the PhRMA Code, anti-kickback and anti-corruption laws, the federal False Claims Act, and requirements related to product promotion, privacy, conflicts of interest, and other applicable federal, state, and industry rules and guidelines.
- Compliance Reporting
Provepharm’s Compliance Officer and Compliance Department ensure that all Provepharm employees, vendors and contractors are able to report a potential compliance issue, either directly or anonymously, and records, investigates and reports all reported matters as appropriate.
- Auditing and Monitoring
Provepharm’s Compliance Program includes auditing and monitoring to assess the effectiveness of individual policies and the Compliance Program as a whole. Auditing and monitoring results are utilized to continually improve the Compliance Program.
Investigating / Responding to Potential Violations
Provepharm’s Compliance Program requires that potential violations be investigated. If a violation is uncovered, Provepharm shall take appropriate remedial and disciplinary actions, which may include corrective actions and/or disciplinary actions (up to an including possible termination of employment or contract).
Provepharm will assess its compliance program at least annually, for the purpose of declaring compliance with California Health and Safety Code §§ 119400-119402.