State of California
Comprehensive Compliance Program
June 15, 2018
Adopted in accordance with California law, this Comprehensive Compliance Program (“CCP”) reflects the commitment of AesDex, LLC (“AesDex” or “Company”) to act in accordance with the highest standards of corporate conduct and ethics. AesDex believes that adherence to applicable laws, regulations, and industry standards is critical to the Company’s operations and success.
As of the date above, AesDex declares that, to the best of its knowledge and based on a good faith understanding of the requirements of the statute, it is in compliance with this CCP and with California Health & Safety Code §119402 in all material respects.
The Company has developed this CCP in accordance with the 2003 OIG Compliance Program Guidance for Pharmaceutical Manufacturers (the “OIG Guidance”), the California Health and Safety Code §§119400 et. seq., the Anti-Kickback Statute, the Physician Payments Sunshine Act, and other applicable state, federal, and international laws. Consistent with the OIG Guidance, AesDex has adopted a CCP that is designed to fit the size and structure of the company.
This CCP is designed to meet requirements relevant to a medical device manufacturer. The medical device industry has established the AdvaMed Code of Ethics on Interactions with Healthcare Professionals (the “AdvaMed Code”), which is substantially equivalent to the PhRMA Code referenced in California Health & Safety Code §119402, but which reflects the unique interactions between medical device companies and healthcare professionals. Accordingly, our CCP includes policies for compliance with the current AdvaMed Code of Ethics on Interactions with Health Care Professionals.
The Compliance Program is designed to prevent and detect violations of applicable law, compliance standards, and Company policies. It is our expectation that every AesDex employee meets ethical standards, and that interactions between AesDex employees and healthcare professionals and others are conducted with appropriate transparency and in compliance with applicable laws, regulations and government guidance.
As part of this CCP, and consistent with California Health & Safety Code §119402, AesDex has established an annual per-practitioner spending limit of $1500 for gifts, promotional materials, items, and activities directed toward “individual medical and healthcare professionals” in the State of California.
The elements of AesDex’s CCP are described below.
Written Policies, Procedures and Training
This CCP includes the Code of Business Conduct and Ethics and the Employee Handbook.
AesDex periodically trains its employees on the provisions of this CCP, particularly employees who interact with healthcare professionals. The Company maintains records of this training.
Communication Regarding Compliance Matters
AesDex has adopted confidentiality and non-retaliation policies, as set forth in the Code of Business Conduct and Ethics and the Employee Handbook, to encourage employees to report any potential violations of this CCP. AesDex provides an anonymous, confidential reporting system that includes a toll-free, 24-7 telephone service to allow employees and others to ask questions and/or report possible violations of this CCP, without fear of retaliation, anonymously if desired.
Employees are encouraged to ask questions of and/or report concerns to their immediate supervisor or to any member of management. There will be no retaliation against anyone who has reported a concern or a suspected violation in good faith.
Corrective or Preventive Action
The Company will assess whether any violation of the CCP is a result of gaps in policies, practices, training, internal controls, or individual acts, and will take action to prevent future violations. If improper conduct is detected, AesDex will address it with corrective action that includes, as appropriate, disciplinary action against individuals.
Monitoring and Periodic Review
AesDex makes ongoing efforts to monitor, audit and assess compliance with this CCP. The CCP is regularly reviewed to ensure that it still meets applicable legal and ethical requirements.
A hardcopy of this CCP can be obtained by printing this webpage from your browser, or by calling our toll-free number at (888) 544-7194.