Corporate Compliance
For a written copy of the Compliance Program description or this declaration, call 844-811-7367 or visit vcel.ethicspoint.com
Compliance Program
Compliance starts with, and is the responsibility and continuing obligation of, each Vericel employee. We rely upon and expect that Vericel employees will conduct themselves in compliance with Vericel policies, and applicable laws, rules and regulations. In an effort to ensure that our employees remain abreast of and informed about these policies, and the laws, rules and regulations that govern our business, Vericel developed its Compliance Program. The Compliance Program provides training and education and is designed to monitor, detect, correct, and as necessary take disciplinary action, in respect of activities or practices that do not comply with the law or Vericel policies and expectations.
Vericel Code of Business Conduct, Policies and Procedures
The Vericel Code of Business Conduct and Ethics is based on the Company’s core values, good business practices and applicable law. Vericel employees are expected to comply with the Vericel Code of Business Conduct and Ethics, the AdvaMed Code of Ethics on Interactions with Healthcare Professionals (“AdvaMed Code”) as updated and made effective as of January 2009, and any and all compliance policies and procedures applicable to their function at, and activities performed on behalf of, Vericel. Vericel’s Code of Business Conduct and Ethics can be found here.
Compliance Officer and Compliance Committee
Vericel has appointed a Compliance Officer and has established a Compliance Committee to assist in the implementation of the Compliance Program. The Compliance Committee is chaired by the Compliance Officer and is comprised of leaders from key functions within Vericel.
Compliance Training and Education
Vericel is committed to developing and providing its employees with effective compliance training. This training covers not only relevant company policies and procedures governing the conduct of Vericel employees, but also applicable state and federal laws, rules and regulations.
Employee Communications
Under the Code of Business Conduct and Ethics, Vericel encourages and promotes the prevention, detection, reporting and correction of unlawful or improper conduct. Vericel is committed to fostering dialogue between management and employees through multiple channels. Employees must report any concerns to their managers, or to an officer, the Compliance Officer, the Chief Executive Officer or the Chairman of the Audit Committee of Vericel’s Board of Directors. In addition, employees are free to report concerns anonymously 24 hours a day, 7 days per week through the Vericel Compliance Hotline by calling 844-811-7367. The Compliance Department and other departments as appropriate will evaluate all reports and as appropriate investigate the reports. Although each situation is considered on a case-by-case basis, Vericel imposes discipline to address inappropriate conduct and to deter potential future violations of law or company policies. No retaliation will be taken against any employee for a good faith report of what they honestly believe to be an actual or suspected violation.
Auditing and Monitoring
To measure the effectiveness of Vericel’s training and education program and confirm that Vericel employees are acting in a compliant manner. Vericel will periodically perform monitoring and auditing activities to evaluate compliance with company policies and applicable laws. The nature, frequency and extent of these reviews may vary according to factors such as internal risk assessments, regulatory requirements and developments, and changes in Vericel’s business practices.
CALIFORNIA COMPREHENSIVE COMPLIANCE PROGRAM AND DECLARATION PURSUANT TO CAL. HEALTH & SAFETY CODE §§ 119400-119402
Introduction
Vericel Corporation (“Vericel”) is committed to conducting business with uncompromising integrity and the highest levels of business ethics. Vericel has established a comprehensive compliance program in accordance with the Compliance Program Guidance published by the U.S. Department of Health and Human Services’ Office of Inspector General (“HHS OIG Guidance”). To the best of our knowledge and belief and based on our good faith understanding of the law, our compliance program meets the requirements of Cal. Health & Safety Code §§ 119400-119402. Consistent with the HHS OIG Guidance, we have tailored our compliance program to the size, organizational structure, resources, and nature of our medical device and biologics business. Although the statute references compliance with the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals (the “PhRMA Code”), Vericel’s compliance program has been developed in accordance with the AdvaMed Code of Ethics on Interactions with Healthcare Professionals (“AdvaMed Code”), which is substantially similar to the PhRMA Code, while taking into account the uniqueness of interactions between medical device manufacturers and healthcare professionals. The purpose of our compliance program is to prevent and detect violations of law or company policy. As the HHS OIG Guidance recognizes, however, the implementation of such a program cannot guarantee the elimination of improper conduct. It is Vericel’s expectation that all employees will comply with our compliance program as well as with all applicable laws, regulations, and policies. We continuously review, assess, and improve our compliance program to meet changing needs and circumstances.
Compliance Program Overview
- Written Policies and Procedures. Vericel has adopted a series of policies and procedures in furtherance of its commitment to the highest standards of business ethics, including a U.S. Healthcare Compliance Code that incorporates the AdvaMed Code and helps to ensure that Vericel complies with all relevant healthcare compliance laws, regulations, and codes.
- Leadership and Oversight. Vericel’s compliance program is overseen by the Chief Compliance Officer with input from executive management through the Compliance Committee and is operated and monitored by experienced compliance professionals.
- Training and Education. Vericel provides comprehensive training (online and live) on its Standards of Business Conduct as well as training to relevant audiences on healthcare compliance, anti-corruption, privacy, and related subjects.
- Communication Lines. Vericel has an open-door policy that allows employees to report their concerns to any level of management. Employees are encouraged to communicate their compliance concerns to their direct managers and are also invited to share their concerns with other resources, including but not limited to, Human Resources, Legal, or Compliance, or via the Compliance Hotline which allows for anonymous reporting of compliance concerns. Vericel adheres to a zero tolerance non-retaliation policy.
- Auditing and Monitoring. On a routine basis, Vericel conducts internal audits, risk assessments, and targeted monitoring activities to identify potential issues, control gaps, and identify opportunities for improvements to policies, procedures, and processes.
- Disciplinary Action. Vericel has implemented processes for addressing compliance violations, and employees are aware that failures to comply with Vericel policies, procedures, and ethical standards can lead to disciplinary action up to and including termination.
- Investigation and Corrective Action. All reported compliance concerns are investigated objectively, fairly, and promptly. Where appropriate, corrective action plans are implemented to remediate or improve existing policies, procedures, and processes. Such corrective actions may include disciplinary action in situations involving employee misconduct.
