Compliance

Dave Pacitti

“As we make strides to be more customer-centric, innovative, and growth-oriented, we must remain diligent in conducting ourselves and our business in an ethical and compliant manner. Our Compliance System at Siemens Healthineers demonstrates our commitment to integrity and acting in accordance with applicable laws and policies. With a strong culture of Compliance, we help protect our Company’s reputation, the trust of our customers, and ability to shape the future of healthcare.”

Dave Pacitti, Head of Region Americas, Siemens Healthineers

Our Compliance System

The Business Conduct Guidelines set the ethical and legal framework, within which we intend to act and stay successful. They contain the basic principles and rules for the conduct of all employees and managers within the company as well as in relation to our external partners and the general public.

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 System to instill this awareness in our leadership and our employees.

Our Compliance System is composed of three operating levels: Prevent, Detect, and Respond.

We focus on preventive measures like information, training, and clear regulations which are valid for everybody. Essential business transactions are reviewed thoroughly with regard to Compliance risks, prior to execution. Should there be a potential violation of applicable law, we will investigate the circumstances comprehensively in a fair procedure and then take appropriate disciplinary measures, as deemed necessary.

For more information on the Siemens Healthineers Compliance System please dial 1-302-440-1890.

Channels for Reporting Misconduct

Reliable reporting channels for internal and external stakeholders and the protection of internal whistle-blowers from sanctions help ensure that possible misconduct is reported, thoroughly investigated, and clarified. We provide several reporting channels to internal and external whistle-blowers to inform us about possible compliance violations.

Let Us Know provides a secure channel for reporting non-compliant or otherwise problematic actions 24 hours a day: online, anonymously if desired, and in several languages. We protect the identity of whistleblowers and follow-up on these reports.

In addition, attorney-at-law Dr. Sibylle von Coelln (homepage in German only), from the Duesseldorf-based law firm HEUKING·VON COELLN, has been appointed as our external ombudswoman. Employees and third parties can confidentially and anonymously confide in this impartial professional should they observe improper business practices in the company.

Sunshine Act

Federal Physician Payments Sunshine Act

You may request access to your information by submitting a request using one of the links below.

The law requires medical device manufacturers to collect and report certain information, including but not limited to the following on each recipient:

  • National Provider Identifier (NPI) number – for individuals
  • State License number – for individuals
  • Tax Identification Number (TIN) – for organizations
  • Dollar value of remuneration

Annual Certification

Siemens Medical Solutions USA, Inc.

Annual Certification of Compliance with the Corporate Comprehensive Compliance Program per California Health & Safety Code 119400-119402

I, Andrew Cliver, Head of Compliance, Siemens Healthineers, North America Region ("the Company"), hereby certify that the Company has an established Compliance Program and Policies that comports 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 Code of Ethics on Interactions with Health Care Providers (“The AdvaMed Code”) and NEMA Code of Ethics. The AdvaMed Code and the NEMA Code of Ethics are substantially similar to the PhRMA "Code on Interactions with Health Care Professionals" but designed specifically to 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 13, 2024
/s/ Andrew Cliver, Head of Compliance, Siemens Healthineers, North America Region

Siemens Healthcare USA Compliance Manual

Scope and Purpose

This Compliance Manual governs many aspects of Siemens Healthineers' 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 company products. In addition, Siemens Healthineers and officers/employees of the company 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.

Conclusion

It is the policy of Siemens Healthineers 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 1-302-440-1890.

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