Based on an assessment as of June 1, 2019, to our knowledge, Merit Medical Systems, Inc. (“Merit”) is in all material respects in compliance with its Comprehensive Compliance Program (“CCP”) as well as the requirements of California Health and Safety Code §§ 119400‐119402, based on our good faith understanding of the statutory provisions as they may apply to a medical device manufacturer. Consistent with the Department of Health and Human Services Office of the Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers (“HHS‐OIG Guidance”), Merit has tailored its CCP to the nature of its business as a medical device manufacturer, including its expansion into new product areas and therapies.
The Merit Compliance Program includes the following:
- The appointment of a dedicated Compliance Officer
- Oversight by Merit executive leadership through a Compliance Committee
- Documented compliance policies and procedures
- Regular and effective compliance education and training
- Open lines of communication, including a toll-free number for reporting
- Monitoring and auditing activities to continually evaluate and reassess compliance with the Merit Compliance Program
- Procedures for responding to identified problems and implementing corrective action
While California Health and Safety Code §§ 119400‐119402 makes reference to compliance with the Pharmaceutical Research and Manufacturers of America’s Code on Interactions with Healthcare Professionals (“PhRMA Code”), Merit manufactures medical devices rather than pharmaceutical products. Therefore, Merit determined that it was more appropriate for the company instead to adopt policies and procedures consistent with the AdvaMed Code of Ethics on Interactions with Healthcare Professionals (“AdvaMed Code”). Merit has implemented an annual spending limit of $2000 on gifts, promotional materials, or items or activities that Merit may provide to California licensed health care professionals. Our interactions with health care professionals are subject to further restrictions as set forth in our CCP, the AdvaMed Code of Ethics, and other applicable policies.
Consistent with the California statute, this dollar limit does not include (a) product samples of our medical devices intended for free distribution to patients that are provided to hospitals and other medical institutions, (b) financial support for continuing medical education forums, (c) financial support for health educational scholarships, or (d) payments made for legitimate professional services provided by a California medical or health care professional. Consistent with the AdvaMed Code, this dollar limit also does not include plant visits to observe our quality production facilities, training on the safe and effective uses of our medical devices consistent with approved uses, which for many products is required by the U.S. Food and Drug Administration and/or to help health care providers provide better patient care, grants made to support research, fellowship programs and/or charitable initiatives of a California medical or health professional.
Merit is committed to the highest standards of ethical and legal conduct. We have developed a CCP that is reasonably designed to prevent and detect violations, and discipline employees as necessary. Merit has created and maintains an effective line of communication with its employees, including the availability of a compliance helpline (877-874-8416), for its employees to report complaints or ask questions. The CCP is a fluid and ever‐changing program that is designed to meet the evolving regulatory and legislative climate. This program will be assessed on an annual basis. This declaration is made as of June 1, 2019.
To obtain a print version of our CCP or this declaration, please call the Chief Compliance Office at (801) 316-3835 or send an email to: [email protected].