HealthTronics, Inc., together with its wholly-owned subsidiaries (collectively, “HealthTronics”) is committed to the highest quality of patient care and conducting its business activities in full compliance with all applicable laws and in accordance with the highest standards of honesty, integrity, ethics and professionalism.
Our Compliance Program takes into consideration the nature of our business, and is one of the key components of our commitment to the highest standards of corporate conduct.
The purpose of our Corporate Compliance Program is to prevent and detect violations of law or company policy. Our Corporate Compliance Program is dynamic; we regularly review and enhance our Corporate Compliance Program to meet our evolving compliance needs.
To the best of our knowledge, we are in compliance with our Compliance Program as described, meaning that we have established the elements outlined.
Overview of Our Corporate Compliance Program
1. Leadership and Structure
Our Chief Compliance Officer is charged with the responsibility for developing, operating, and monitoring the Corporate Compliance Program. This individual has the ability to effectuate change within the organization as necessary and to exercise independent judgment. Our Compliance Officer reports directly to the President of HealthTronics and is empowered to report compliance matters directly to our Board of Directors.
2. Written Standards
We continue to review, update and implement standardized written policies, including our Code of Conduct. Our Code of Conduct is our statement of ethical and compliance principles that guide our daily operations. The Code of Conduct establishes that we expect management and employees of the company to act in accordance with law and applicable company policy. The Code of Conduct articulates our fundamental principles, values, and framework for action within our organization. In addition to our Code of Conduct, we have policies and procedures that address various legal and regulatory requirements that apply to our company. We also have adopted a Compliance Plan Relating to Physician-Owned Entities and the AdvaMed Code of Ethics on Interactions with U.S. Health Care Professionals.
3. Education and Training
A critical element of our Compliance Program is the education and training of our employees on their legal and ethical obligations under applicable federal health care program requirements. Accordingly, we conduct regular education and training sessions with our employees.
4. Internal Lines of Communication
HealthTronics is committed to fostering dialogue between management and employees. Our goal is that all employees, when seeking answers to questions or reporting potential instances of fraud and abuse, should know who to turn to for a meaningful response and should be able to do so without fear of retaliation or retribution. To that end, employees are encouraged to seek advice from their supervisors, Compliance Officer, or our Legal Department
.. Employees may also report such matters anonymously by calling the ethics hotline. The substance of every report will be taken seriously and promptly investigated, and where necessary, HealthTronics will put corrective measures in place.
5. Auditing and Monitoring
Our Compliance Program includes efforts to monitor, audit, and evaluate compliance with the company’s compliance policies and procedures. The nature of our reviews as well as the extent and frequency of our compliance monitoring and auditing varies according to a variety of factors, including new regulatory requirements, changes in business practices, and other considerations.
6. Responding to Potential Violations
Our Compliance Program includes disciplinary policies that set out the consequences of violating the law or company policy. Although each situation is considered on a case-by-case basis, we will consistently undertake appropriate disciplinary action to address inappropriate conduct and deter future violations.
7. Corrective Action Procedures
A Compliance Program increases the likelihood of preventing, or at least identifying unlawful and unethical behavior. However, even an effective Corporate Compliance Program may not prevent all violations. As such, our Corporate Compliance program requires the company to respond promptly to potential violations of law or company policy, take appropriate disciplinary action, assess whether the violation is in part due to gaps in our policies, practices, or internal controls, and take action to prevent future violations.
California Compliance Declaration
Our Compliance Program is consistent with the “Compliance Program Guidance for Pharmaceutical Manufacturers,” published by the Office of Inspector General, U.S. Department of Health and Human Services (the “HHS-OIG Guidance”).
Based on our good faith understanding of the statutory requirements, our Corporate Compliance Program is compliant with the requirements of California Health & Safety Code §§ 119400-119402. While the California law makes reference to compliance with the PhRMA Code on Interactions with Healthcare Professionals, our business involves medical devices rather than pharmaceutical products, and we have adopted the AdvaMed Code of Ethics on Interactions with Health Care Professionals which is comparable to the PhRMA Code.
In accordance with California Health and Safety Code §§ 119400-119402, we have established an annual dollar limit of $2,500 on food, gifts, and promotional materials that we may provide to individual medical or health care professionals in California, as defined in the statute.
For a copy of our Compliance Program documents or a print version of this declaration, please dial toll-free 844-835-4876. Provide your name, mailing address and request that a copy of the Compliance Program documents or a print version be sent.