The U.S. Healthcare Compliance Plan (the “Compliance Plan”) for MAQUET Cardiovascular, LLC, Maquet Cardiovascular U.S. Sales, LLC d/b/a Maquet Medical Systems USA, and Maquet, Inc. (collectively “MAQUET”), as adopted, and as supplemented by this California Addendum, complies with the California Health and Safety Code, Division 104, Part 15, Chapter 8, Sections 119400-19402 (“California Law”), which requires pharmaceutical and medical device companies doing business in California to publically make available their compliance program regulating the marketing and promotion of their products.
The U.S. Department of Health and Human Services’ 2003
“OIG Compliance Guidance for Pharmaceutical Manufacturers” (“OIG Guidance”), referenced in the California Law, notes that a pharmaceutical manufacturer should tailor compliance measures to fit the unique environment of the company. Consistent with the OIG guidance, MAQUET has tailored its Compliance Plan to the nature of our medical device business. The established medical device industry code is the Advanced Medical Technology Association “Code of Ethics on Interactions with Health Care Professionals” (the “AdvaMed Code”). MAQUET has implemented the July 1, 2009 version of the AdvaMed Code. The AdvaMed Code is substantially equivalent to the PhRMA Code, but reflects the unique interactions between medical device companies and health care professionals.
As required by California Law, MAQUET has established an annual aggregate limit of $3,500 for certain expenditures to licensed healthcare professionals (persons) in California. This annual aggregate limit does not include (1) device samples given to health care professionals for free distribution to patients; (2) financial support for continuing medical education forums; (3) financial support for health educational scholarships; and (4) the fair market value paid to a health care professional for legitimate professional services, including consulting.
As of June 30, 2012, MAQUET declares that to our knowledge, we are, in all material aspects, in compliance with the Compliance Plan as well as California Health and Safety Code § 119402 et seq. Since compliance is best achieved through ongoing efforts, MAQUET continues to develop, review and periodically enhance its many ongoing compliance programs. A copy of the Compliance Plan and/or MAQUET’s written declaration can be obtained by calling the numbers 1-201-995-8985 or 1-800-777-4222 x28985 (toll-free) or by emailing USCompliance@maquet.com.