California Compliance Declaration
Annual Compliance Declaration (July 1, 2020)
California Health and Safety Code § 119400-119402
Declaration of Compliance
Medicem, Inc. (“Medicem”) is committed to complying with all applicable laws, regulations and industry standards and guidelines. Medicem has, as a result, developed a Comprehensive Compliance Program that is in accordance with the California Health and Safety Code §119402. We declare that our Compliance Program is in accordance with the Compliance Program Guidance published by the Office of the Inspector General of the U.S. Department of Health and Human Services.
Medicem’s US Compliance Program includes a Code of Conduct and policies and procedures that all Medicem employees, officers and directors are required to follow. As Medicem is in the business of selling and marketing medical devices, our compliance program reflects the adoption of the policies and procedures that are appropriate to a medical device company and in compliance with the AdvaMed Code of Ethics on Interactions with Healthcare Professionals (the “AdvaMed Code”). The AdvaMed Code is the guiding document for the Medical Device industry. This document is substantially similar to the PhRMA Code as referenced in the California Health and Safety Code § 11940. Therefore, Medicem has built its program and developed its policies and procedures in accordance with the AdvaMed Code.
The Medicem Compliance Program is designed to prevent, detect and remediate violations of law or company policies. The Company has appointed a Compliance Officer and it will regularly review and update its Compliance Program to ensure it stays consistent with any new laws or guidance documents. Our Program is designed to promote an ethical culture that will guide Medicem’s interactions with healthcare professionals, healthcare organizations and all business contacts as stated in our company policies and the AdvaMed Code.
Medicem has also established an annual limit of $2500 for meals and educational items as the maximum aggregate value that may be provided to California licensed healthcare professionals This limit excludes the value of travel provided for attendance at an educational or training meeting, product samples, educational materials for patients, evaluation units, items used to provide charity care, and fair market value payments for legitimate consulting services.
Medicem declares in good faith that it is in compliance with this compliance program and the provisions of the California Health and Safety Code § 119402 in all material respects as of the date above. For copies of the Medicem Comprehensive Compliance Program please contact 1 (888) 257-9676 or via email at firstname.lastname@example.org.