Compliance and Ethics at Olympus

BECAUSE WHAT WE DO MATTERS.

For Olympus Group companies worldwide, our purpose is to make people’s lives healthier, safer, and more fulfilling, and that responsibility is always in the front of our minds. While we always strive to deliver strong business results, how we achieve those results is equally as important.

Good business results are not sustainable without a commitment to do the right thing the right way.

Being true to our customers, our environment, and our company, and respecting each other are fundamental expectations of every Olympus employee and business partner. 

At Olympus, we have a Corporate Philosophy, which consists of Our Purpose, Core Values and associated Behaviors. Olympus Corporation of the Americas’ Code of Business Conduct aligns with the Olympus Global Code of Conduct and serves as our guide to responsible business conduct. 

Olympus's commitment to a culture of compliance is fully supported by senior management. Olympus fosters this culture of compliance by developing clear and consistent policies, conducting regular compliance trainings, encouraging open communication, responding timely to concerns and identified risks and administering corrective action when necessary. 
 

The Olympus Compliance Program has been developed based upon published guidance from the U.S. Federal Government, and its foundational elements are also consistent with the Advanced Medical Technology Association (AdvaMed) Code of Ethics on Interactions with Health Care Professionals. In the United States, Olympus plays an active role in AdvaMed and has certified to the AdvaMed Code.

OPEN PAYMENTS REPORTING

Open Payments is a U.S. national disclosure program created by the Affordable Care Act that increases public awareness of financial relationships between the health care industry (like medical device manufacturers and pharmaceutical companies) and physicians or teaching hospitals. Olympus is required to report payments or transfers of value they make to physicians or teaching hospitals. The Centers for Medicare & Medicaid Services (CMS) collects this data annually and makes it publicly available and searchable online.

Visit https://openpaymentsdata.cms.gov to use the CMS Open Payments Data search tool to search for information regarding payments made by Olympus to doctors or teaching hospitals. You can download all Open Payments data in detail, or search based on the Physician or Teaching Hospital receiving the payment, or the Company making the payment. Additional information on Open Payments is available on the Centers for Medicare and Medicaid Services website at https://www.cms.gov/OpenPayments.

Any questions/inquiries regarding the Olympus Open Payments report can be directed to AggSpend@olympus.com

REPORTABLE PAYMENTS AND TRANSFERS OF VALUE

Olympus collaborates and interacts with health care providers in order to advance new, safe and effective medical technologies that lead to improvements in patient care, helping people around the world lead safer, healthier and more fulfilling lives.

Olympus values its relationship with health care providers and is committed to the transparency afforded by the Open Payments Reporting. Olympus’ Open Payments report includes the following types of transfers of value it makes to Physicians and Teaching Hospitals:

• Compensation paid to health care professionals for services performed for the Company
• Educational items (e.g., medical text books, scientific journal articles)
• Food, beverage, travel, and lodging relating to consulting services, product training, and other business related activities
• Education on the use of our products and related treatments
• Research on new products to help advance patient care
• Charitable contributions
• Royalties or license payments
• Grants to support independent healthcare education
• Space rental or facility fees associated with product training, clinical studies, or booth/exhibit space

CALIFORNIA COMPLIANCE LAW

Olympus is committed to conducting business ethically and in compliance with all applicable laws, regulations, guidelines, and policies.

Statement regarding compliance with California Health & Safety Code § 119402

Olympus has established and is operating in accordance with a Comprehensive Compliance Program (“CCP”). Because Olympus is a medical device manufacturer and not a pharmaceutical manufacturer, certain guidance set forth in the PhRMA Code on Interactions with Health Care Professionals and the Office of Inspector General (OIG) Compliance Guidance for Pharmaceutical Manufacturers does not apply to Olympus and its operations. Consistent with this, Olympus is making good faith efforts to conform its CCP to applicable requirements of Sections 119400-119402 of the California Health & Safety Code and will generally follow the Code of Ethics adopted by the Advanced Medical Technology Association (AdvaMed).

To obtain a print version of this document, please contact Olympus’ Integrity Hotline at 1-844-277-1698 or email compliance@olympus.com.

GOVERNMENT SETTLEMENT AGREEMENTS AS OF MARCH, 2019

Dear Olympus Employees & Families, Customers, Partners and Community Stakeholders,

On February 29, 2016, Olympus Corporation of the Americas (OCA) entered into two, three-year Deferred Prosecution Agreements (DPAs) to resolve two criminal complaints for federal Anti-kickback statute violations and Foreign Corrupt Practices Act violations. Pursuant to the Agreements, Olympus agreed to engage an outside monitor. Larry A. Mackey, a partner with Barnes & Thornburg LLP, was selected as the Monitor. Mr. Mackey and his team have worked collaboratively with OCA for the three years.

The DPAs have concluded successfully and the criminal Complaints against OCA have been dismissed.

Over the past three years, the Monitor team has been engaged in a number of ways in reviewing and enhancing OCA’s compliance program, including: monitoring business activities, assessing the effectiveness of OCA’s compliance program, evaluating controls toward compliance risk reduction, and making constructive recommendations for improvement. The Monitor has observed that Olympus has invested significant resources to build a robust program that ensures adherence with all applicable laws and regulations. These have included the development of appropriate internal policies aligned with industry best practices, robust training requirements for Olympus employees, and the continual monitoring of company activities.

Mr. Mackey’s final reports to the government were extremely positive, noting that not only had OCA met and even exceeded its obligations under the DPAs, but that it also demonstrated across the organization, from senior executive leadership through its sales force, a culture of integrity and compliance. He stated that, as a result, the problematic conduct that led to the DPAs is very unlikely to recur, that the company has proven that its systems, policies and procedures are sustainable and that there is no further need for oversight. Mr. Mackey commended OCA for committing to and implementing compliance “best practices” in the United States and Latin America.

In 2016, OCA also entered into a civil settlement pursuant to which it paid $306 million and entered into a Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) at the United States Department of Health and Human Services. Under this agreement, OCA agreed to undertake certain obligations to promote compliance with Federal health care program and FDA requirements. OCA also agreed to notify health care providers about the settlement and inform them that they can report any questionable practices by OCA representatives using the information set out further below. The five-year CIA is scheduled to conclude on February 28, 2021.

Questions Regarding the Corporate Integrity Agreement Referenced Above

Please call OCA at 1-866-861-8386 or send your inquiries via email to Compliance@olympus.com if you have questions about the settlements.

To Report Inappropriate Product Promotion or Questionable Conduct

Please call the Olympus Integrity Line at:

U.S., Canada & Puerto Rico: 1-844-277-1698
Canadian French: 1-855-350-9393
Brazil: 0800-892-0649
Mexico: 001-855-232-1301

Alternatively, visit http://olympus.ethicspoint.com to report any instances in which you believe that an OCA sales representative inappropriately promoted a product or engaged in other questionable conduct.

The mission of Olympus is to make people’s lives healthier, safer, and more fulfilling. We remain committed to achieving this mission, both as individuals and as a company, with uncompromised integrity.

Anti-Kickback Statute - OCA Corporate Integrity Agreement

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INTEGRITY LINE

Olympus strives for ethical and compliant behavior. Every Olympus Representative (including Company personnel and agents) has a duty to report any actual or suspected violations of any laws, regulations, government health care program requirements, internal policies and procedures, or inappropriate actions. To ensure that allegations of improper or illegal conduct, activities or practices are heard and addressed, OCA maintains an anonymous, confidential reporting system (the "Integrity Line").

The Integrity Line is maintained by a third-party, Ethics Point. Employees, customers, business partners and other third parties may make reports to the Integrity Line 24 hours a day, 7 days a week, every day of the year, by telephone or by using the internet. Ethics Point provides issue reporters with multi-lingual  support and translation services.

When using the Integrity Line, issue reporters may elect to remain anonymous. In all cases, reports are treated with the utmost discretion. To maintain anonymity, issue reporters are assigned a unique code, called a “report key” within the Ethics Point system after reports are submitted, which is intended for the reporter’s eyes only.

The Integrity Line is accessed in the following manner:

Telephone:
U.S., Canada & Puerto Rico: 1-844-277-1698
Canada-French: 1-855-350-9393
Costa Rica: 0800-011-1248
Mexico: 001-855-232-1301
Brazil: 0800-892-0649

Encrypted website: http://olympus.ethicspoint.com

In addition to the Integrity Line, OCA welcomes any reporting of concerns about unethical or unlawful conduct directly to management, Human Resources, the OCA Legal Department and/or the OCA Compliance Department. The OCA Compliance Department can be reached directly via phone at 484-896-4472 or via email at compliance@olympus.com. Company policy prohibits retaliation against any individual for reporting concerns to the Integrity Line or directly to management in good faith.