Comprehensive Compliance Policy
OPTI Medical’s Compliance Program is dynamic, involving not only multiple policies, procedures and programmatic activities, but also the commitment of senior management and the support of all employees, contractors and agents to make the program effective. We regularly review and enhance our Compliance Program to meet our evolving compliance needs.
- OPTI Medical follows our parent company’s Purpose and Principles statements of ethical and compliance principles that guide our daily operations. The statements establish that we expect management, employees, independent dealers, distributors and agents of the company to act in accordance with law and applicable company policy. The Purpose and Principles articulate our fundamental principles, values and framework for action in our organization.
- The AdvaMed Code of Ethics has identified several potential risk areas for manufacturers, and called on companies to develop compliance policies in these risk areas. As relevant to device manufacturers, these risk areas include (1) data integrity pertaining to government reimbursement practices and (2) kickbacks and other illegal remuneration. OPTI Medical’s Policies and Procedures for Interactions with Healthcare Professionals speaks to these issues. A specific annual dollar limit has been imposed on promotional materials, items or activities provided by any OPTI Medical employee to covered recipients.
Leadership and Structure—
OPTI Medical has designated Theron Gober, Regulatory Affairs Director, as its Compliance Officer. Mr. Gober serves as the focal point for compliance activities. OPTI Medical is committed to ensuring that Mr. Gober, as Compliance Officer, has the ability to effectuate change within the organization as necessary and to exercise independent judgment. Mr. Gober is charged with the responsibility for developing, operating and monitoring the Compliance Program.
Education and Training—
A critical element of our Compliance Program is the education and training of relevant personnel on their legal and ethical obligations under applicable federal health care program requirements. OPTI Medical is committed to effectively communicating our standards and procedures to all affected personnel. Moreover, OPTI Medical will regularly review and update its training programs, as well as identify additional areas of training on an “as-needed” basis.
Internal Lines of Communication—OPTI Medical 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 compliance violations, should know whom to turn to for a meaningful response and should be able to do so without fear of retribution. To that end, we have adopted open-door policies, as well as confidentiality and non-retaliation policies. In order to further encourage open lines of communication regarding potential violations, we have established a toll- free compliance line to allow individuals who want to report anonymously to do so.
Auditing and Monitoring—
OPTI Medical’s Compliance Program includes efforts to monitor, audit, and evaluate compliance with the company’s compliance policies and procedures, including efforts to monitor the activities of sales force personnel. We note that in accordance with the OPTI Medical 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. We will utilize ongoing assessment of compliance programs to identify new and emerging risk areas and address these risks.
Responding to Past and Potential Violations—
OPTI Medical’s Compliance Program includes clear disciplinary and other policies that set out the consequences for violation of 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.
Corrective Action Procedures—
A compliance program increases the likelihood of preventing, or at least identifying unlawful and unethical behavior. However, OPTI Medical recognizes that even an effective compliance program may not prevent all violations. As such, our 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.
A copy of our Comprehensive Compliance Policy may be obtained by calling 1-800-490-6784.