Olympus America

Social Responsibility: Ethics and Corporate Compliance

Ethics and Corporate Compliance

Our Commitment to Integrity
Olympus Corporation of the Americas (OCA) and all of our businesses are subject to the laws, regulations and ethical standards in each industry we serve, some of which are unique to the health care and life sciences areas of our business.

We are committed to complying with the laws, regulations and highest ethical standards, and adhering to our own Codes of Conduct which guide our business processes, decisions and behavior.

GOVERNMENT SETTLEMENT AGREEMENTS UPDATE AS OF MARCH 22, 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://olympusamerica.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
READ DOCUMENT


Code of Ethics

Conducting Business Within a Culture of Compliance
For Olympus Group companies worldwide, compliance with the law does not only mean following the letter of the law. It also means operating within a culture of compliance, and conducting our business in the spirit of corporate social responsibility. Earning and keeping the respect of our employees, business partners and our communities is of paramount importance.

To assist in maintaining the highest ethical standards, and to ensure that our core ethical values are embraced and understood at all levels of the Olympus organization and throughout our global operations, Olympus Corporation of the Americas has established a Code of Ethics (“Code”). Upon employment, each OCA employee is required to certify that he or she has read the Code, understands it and agrees to comply with it. Furthermore, on an annual basis, all OCA employees are required to successfully complete on-line Ethics training and recertify their understanding and agreement to comply with the Code.

The core principles of our Codefocus on:

  • Fostering a culture of compliance
  • Accomplishing innovation with integrity
  • Respecting one another
  • Engaging in corporate social responsibility

Click the following link to view or download a copy of the Olympus Corporation of the Americas’ Code of Ethics.

Compliance Code of Conduct

Governing our Interactions with the Health Care and Life Sciences Industries
The Olympus Health Care Compliance Code of Conduct (“Compliance Code”) governs our interactions with our customers and health care professionals (“HCPs”). It also helps define our commitment as a corporation and as individuals to abide by the laws and industry standards that apply to our day-to-day interactions with our customers and HCPs.

Our Compliance Code is based on three fundamental principles:

  • Medical decisions should be focused on the best interests of patients.
  • Products must be promoted in a manner consistent with the Food and Drug Administration’s (FDA) approved uses (indications) as listed in the product labeling.
  • Training HCPs and others how to utilize our products and services in a safe and effective manner is important to enhance the well-being of the patients they serve.

The Compliance Code for Olympus Corporation of the Americas is summarized in a guide entitled Keeping our Focus: Compliance Summary for Customers and Health Care Professionals (Focus Guide). View or download a copy of Olympus’ Focus Guide.

Advamed
Olympus's commitment to a culture of compliance is fully supported by senior management and Olympus expects all Olympus Representatives to reflect that commitment through their actions and decision-making. 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. In the United States, Olympus plays an active role in the Advanced Medical Technology Association (AdvaMed). 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 AdvaMed Code of Ethics on Interactions with Health Care Professionals (AdvaMed Code). Olympus has certified to the AdvaMed Code.

Integrity Hotline

Ethics Point

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 Hotline").

The Integrity Hotline is maintained by a third-party, Ethics Point. Employees, customers, business partners and other third parties may make reports to the Integrity Hotline 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 Hotline support and translation services.

When using the Integrity Hotline, 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 Hotline 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://olympusamerica.ethicspoint.com

In addition to the Integrity Hotline, OCA welcomes any reporting of concerns about unethical or unlawful conduct directly to management, Human Resources, the OCA Ethics Compliance Officer, 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 Hotline or directly to management in good faith.

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.