Velocity Orthopedics, Inc. (“Velocity” or the “Company”) is committed to compliance with the applicable laws and regulations that govern medical device marketing and selling activities in the United States. Velocity Orthopedics’ Compliance Program is also consistent with applicable portions of both the voluntary guidelines set forth in the “OIG Compliance Program Guidance for Pharmaceutical Manufacturers” published by the Office of the Inspector General, U.S. Department of Health and Human Services (“OIG Guidance”) and the provisions of the AdvaMed Code of Ethics.
The goal of Velocity Orthopedics’ Compliance Program is to maintain a culture that promotes the prevention, detection and resolution of potential violations of law or Company policy.
Our organization is guided by the belief that we can have a significant and sustainable impact on global healthcare by maintaining an unwavering commitment to transparent business practices. To this end, we conduct business in an open and honest manner and reject business practices that unnecessarily increase the cost of healthcare, compromise patient safety, or stifle innovation.
CORPORATE COMPLIANCE OVERVIEW
Velocity Orthopedics has adopted a Comprehensive Compliance Program (“Compliance Program”) summarized below. It is Velocity’s expectation that all Team Members, officers, directors, agents, representatives, consultants and distributors shall comply with Company policies and procedures as well as all of the laws, rules and regulations of the U.S. and other countries, and the states, counties, cities and other jurisdictions, applicable to the Company’s sale or marketing of its products. We have implemented written polices and procedures tailored to our operations and regulatory environment to provide guidance to govern the business conduct of Velocity Orthopedics’ employees, agents and contractors.
Velocity Orthopedics is committed to upholding the highest standards of business conduct and ethics. In all of its activities, Velocity Orthopedics seeks to promote the core principles of good citizenship, regulatory compliance and business integrity. The goal of Velocity Orthopedics’ Compliance Program is to:
- Exemplify Velocity Orthopedics’ commitment to good corporate citizenship.
- Develop a process that encourages employees to report potential problems.
- Monitor adherence to applicable statutes, regulations, and program requirements.
- Investigate acts of alleged misconduct and initiate corrective action where appropriate.
- Emphasize the dedication of the Company and the Company’s employees to honesty, integrity, and ethics.
Velocity Orthopedics reviews and enhances its Compliance Program on a periodic basis in order to meet changing needs and demands.
COMPREHENSIVE COMPLIANCE PROGRAM SUMMARY
The OIG advises that an effective compliance program is comprised of seven elements which Velocity has used as a basis for its Compliance Program. Fundamental elements of our compliance program are summarized below.
- Written Policies and Procedures: Velocity Orthopedics has adopted the AdvaMed Code of Ethics on Interactions with Healthcare Professionals as the Company’s primary statement of policies for assuring compliance with applicable laws, regulations and standards governing the marketing and promotion of Velocity Orthopedics’ products.
- Compliance Leadership and Oversight: Velocity Orthopedics has appointed Fred Edwards as Chief Compliance Officer (TEL 909.987.4343, email [email protected]). The Compliance Officer is the focal point of compliance activities, reports to the President, and is empowered to exercise independent judgment and is responsible for developing, monitoring and otherwise administrating the Compliance Program.
- Education and Training: The Company routinely trains and educates appropriate Team Members on their legal and ethical obligations and Velocity Orthopedics’ policies and procedures concerning marketing and promotional activities relevant to Velocity Orthopedics’ products. We review and modify the training programs as needed and enhance the training to incorporate additional areas of training necessitated by the changing business environment.
- Internal Communication: We seek to foster open discourse within and between management and employees and Velocity Orthopedics encourages Team Members to talk to the President, managers, the Compliance Officer, or any other appropriate personnel about suspected illegal or unethical conduct or violations of Velocity Orthopedics’ policies. Employees are encouraged to ask questions about compliance issues and urged to make reports of potentially problematic situations and conduct to their managers or directly to the Corporate Compliance Officer. Company policy prohibits retaliation by any employee against another employee for good faith reports of potential or suspected violations of law, regulations, or company policies. All reports will be referred to the Compliance Officer for review.
- Auditing and Monitoring: The Compliance Officer, working with Management, is responsible for auditing and monitoring compliance with Company policies and procedures. The Compliance Officer works with management to evaluate and document audit results and implement any training or corrective action deemed necessary resulting from audits and routine monitoring activities.
- Enforcement and Disciplinary Action: The Compliance Program’s goal is to prevent violations. All reported potential violations shall be forwarded to the Compliance Officer. The Compliance Officer or an appointed delegate will, when possible, confirm receipt of the report to the individual making the report unless such report was made anonymously. The Compliance Officer or delegate also will investigate reports of suspected violations brought to the Company’s attention and, with input from appropriate Company personnel, will take appropriate disciplinary action to address inappropriate conduct and deter future violations by Team Members or third parties.
- Corrective Action Procedures: As needed and on an ongoing basis, the Compliance Officer will assess the need to revise policies, procedures, training, communication or other elements of Velocity Orthopedics’ Compliance Program to improve its content, to prevent future violations from occurring, or to address gaps, if any.
REPORTING OF VIOLATIONS; NO RETALIATION
Any Team Member who suspects a violation of the Company policy, financial fraud, accounting irregularities, or auditing issues should promptly contact the Compliance Officer or the Personnel Department. Any Team Member wishing to make an anonymous report regarding suspected illegal behavior or financial fraud of any type may do so by providing anonymous notification. For other workplace issues, Team Members should contact their manager or the Personnel Department. The Company will investigate and treat confidentially (to the extent possible) all reported potential violations. All Team Members are expected to cooperate in any internal or external investigations of possible violations of Company policy. The Company will not permit retaliation of any kind by, or on behalf of, the Company or its Team Members against good faith reports or complaints of potential violations involving financial irregularities, violations of Company policy or other illegal or unethical behavior.
DECLARATION OF COMPLIANCE WITH CALIFORNIA LAW
California Health & Safety Code §119402 requires certain medical device manufacturers to develop a Comprehensive Compliance Program for interactions with healthcare professionals. Consistent with the OIG’s Compliance Program Guidance for Pharmaceutical Manufacturers, Velocity Orthopedics has tailored its Compliance Program to the nature of our business as a medical device company. While §119402 references the PhRMA Code on Interactions with Healthcare Professionals (“PhRMA Code”), Velocity Orthopedics has adopted policies and procedures for compliance which are substantially similar to the PhRMA Code given Velocity Orthopedics is a medical device company. To the best of our knowledge, as of the date of this declaration, Velocity Orthopedics is in compliance with California Health & Safety Code §119402 and the Company’s Compliance Program. Anyone may obtain a copy of this document by calling 909-987-4343.
Adopted August 1, 2012
Last revised: August 1, 2012