Introduction
Conducting business in a compliant and ethical manner is a core corporate value at BioWound Solutions, guiding how we operate each day. BioWound Solutions has implemented a comprehensive compliance program designed to advance our corporate values, prevent and detect violations of our business standards, and ensure adherence to California Health and Safety Code § 119402 (S.B. 1765).
The BioWound Solutions compliance program is aligned with the Compliance Program Guidance published by the Office of the Inspector General of the U.S. Department of Health and Human Services. As a company whose primary business is the sale of medical devices, BioWound Solutions has adopted policies and procedures tailored to our industry, including compliance with the AdvaMed Code of Ethics on Interactions with Healthcare Professionals. Substantially similar to the PhRMA Code referenced in California Health and Safety Code § 119402, the AdvaMed Code addresses potential risk areas unique to the medical device sector. Accordingly, consistent with OIG guidance, the BioWound Solutions compliance program includes policies and training designed to ensure adherence to the AdvaMed Code.
Compliance Program Components
Code of Business Conduct, Policies, and Procedures
BioWound Solutions has developed and implemented a Code of Business Conduct (“Code”) that establishes the company’s compliance obligations, including adherence to all applicable laws and regulations. In addition, BioWound Solutions has established, and will continue to refine, policies and procedures that reflect our commitment to compliance, address our regulatory obligations, provide clear guidance on conducting activities in a compliant manner, and account for risk areas specific to medical device companies.
Every team member is required to comply with the Code as well as all applicable policies and procedures. In alignment with the requirements of Cal. Health and Safety Code § 119402 (S.B. 1765), BioWound Solutions has established an annual limit of $1,500 for meals and educational items provided to California healthcare professionals. This limit excludes the value of travel expenses for attendance at company medical education and product training meetings, patient education materials, and fair market value compensation for bona fide healthcare services provided by the healthcare professional.
Leadership and Structure
BioWound Solutions has appointed a Chief Compliance Officer (CCO) to design, implement, and oversee the compliance program. The CCO reports directly to the Chief Executive Officer (CEO) and is empowered with the authority to exercise independent judgment. The CCO meets regularly with the CEO to review significant compliance risks, concerns, issues, or violations. The CEO and other members of executive leadership actively support the implementation and effectiveness of the compliance program.
Communication
BioWound Solutions encourages every team member to promptly report any potential compliance violations. Team members seeking guidance on legal or ethical questions, or who have knowledge of potentially illegal or unethical conduct, should consult a supervisor, senior management, company legal counsel, the Human Resources Department, or the Chief Compliance Officer.
Compliance questions and reports of potential violations may also be submitted through the company’s compliance helpline, available via toll-free number or online. These resources are publicized in the Code of Business Conduct and on company communications such as posters. Team members may report anonymously if they choose. All reports are treated confidentially to the extent possible, and retaliation for asking questions or reporting concerns in good faith is strictly prohibited by BioWound Solutions policy.
Education and Training
BioWound Solutions has developed, delivered, and will continue to provide effective compliance training for all team members. Each employee is recertified annually on the Code of Business Conduct. The company regularly reviews and updates training programs, and additional training is delivered on an as-needed basis.
Auditing and Monitoring
BioWound Solutions monitors and periodically audits compliance with established policies and procedures to assess effectiveness and identify areas for improvement.
Investigations and Corrective Action
All reports of alleged violations are promptly and thoroughly investigated by BioWound Solutions. If an investigation indicates corrective action is required, the company will take appropriate measures, which may include employee discipline, termination, legal action, and the implementation of preventive safeguards to avoid recurrence. When appropriate, BioWound Solutions may refer investigations to outside authorities and may engage external investigators to assist with inquiries.
Response and Discipline for Compliance Violations
Each team member is responsible for adhering to all applicable laws, regulations, and BioWound Solutions’ Code of Business Conduct, policies, and procedures. Team members who fail to meet these obligations are subject to disciplinary action, up to and including termination of employment.
Declaration
As of the date of this declaration, and to the best of our knowledge, BioWound Solutions is in compliance with this compliance program and the provisions of California Health and Safety Code § 119402 in all material respects, as of September 24, 2024.