Unconditional compliance with external and internal requirements and regulations guides all our actions as a company and is fundamental to the way we conduct business. We set up our Compliance Program to instill this awareness in our leadership and our employees.
Siemens Medical Solutions USA, Inc.
Annual Certification of Compliance with the Corporate Comprehensive Compliance Program per California Health & Safety Code 119400-119402
I, Mark Petrille, Vice President, Head of Compliance, Siemens Healthineers, North America Region ("the Company"), hereby certify that the Company has an established Compliance Program and Policies that accords with the seven key compliance program elements as set forth in the "Compliance Program Guidance for Pharmaceutical Manufacturers" published in April 2003 by HHS-OIG and includes policies designed to incorporate guidance contained in the AdvaMed and NEMA "Code of Ethics on Interactions with Health Care Providers." The AdvaMed and NEMA codes are substantially similar to the PhRMA "Code on Interactions with Health Care Professionals", but are designed to specifically address compliance issues pertinent to medical device manufacturers.
To the best of our knowledge and belief and based on our good faith understanding of the applicable statutory requirements, the Company is operating under a Compliance Program and the requirements of California Health & Safety Code 119400-119402. For a copy or copies of our Compliance Program, and this written declaration of compliance, please call 1-302-440-1890.
Dated: February 28, 2019
/s/ Mark A. Petrille, Vice President, Head of Compliance, Siemens Healthineers, North America Region and Global Ultrasound Business Area
Siemens Healthcare USA Compliance Manual
Scope and Purpose
Attached is the Siemens Healthineers USA Compliance Manual. This Compliance Manual governs many aspects of Siemens' relationships with customers, including customer education and training; sponsoring customers' attendance at professional conferences and CME programs; contracting for site visits; grants to doctors and hospitals; consulting agreements; speaking sponsorships; entertainment; limits on gifts and charitable contributions.
Our relations with our customers are legally governed by, and the guidance addressed in our Compliance Manual principally emanates from, the Federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)). (There are also related state laws, many of which apply regardless of whether federal healthcare programs are involved, and guidelines such as the AdvaMed Code on Interactions with Healthcare Professionals and NEMA Code of Ethics). The Federal Anti-Kickback Statute establishes severe civil and criminal penalties for anyone who knowingly and willfully offers or pays (or solicits or receives) any "remuneration" in cash or in kind, directly or indirectly, to induce someone (e.g. a physician or a hospital) to purchase, lease, order, arrange for or recommend purchasing, leasing, or ordering any item for which payment may be made under any federal or state healthcare program. Under current judicial and administrative decisions, a violation may be found even if only one purpose of the “remuneration” is to induce the purchase of products; it does not matter if there are other legitimate purposes for the payment. In addition, there does not have to be an agreement to purchase in exchange for the remuneration, and there is no requirement that the remuneration result in an increase in state or federal healthcare expenditures.
Please note that if it is found that Siemens Healthineers violated the anti-kickback statute, hospitals and all other customers and potential customers could be barred from seeking Medicare or other government reimbursement for their purchases of Siemens products. In addition, Siemens and officers/employees of Siemens Healthineers could face stiff fines and exclusion/debarment from all federal and state healthcare programs, as well as potential jail sentences for violations of this statute.
It is the policy of Siemens to comply fully with all federal requirements in every aspect of its business involving Siemens Healthineers products that are reimbursed by the government. All employees and contractors conducting business in the United States are expected to comply fully with all federal and state healthcare program requirements as well as with the Siemens Healthineers USA Compliance Manual. Violations of this policy can lead to disciplinary action, possibly including termination of employment.
Copies of this Compliance Manual and the Certification may be obtained by calling 1-855-303-9798 or emailing us.