Compliance and ethics

The Code of Conduct serves as a foundation for our existing policies and rules. We use the Code of Conduct to help ensure that integrity and ethics in all business relationships are maintained while simultaneously striving for high customer satisfaction and to encourage ethical discussions and improve how we address ethical dilemmas. Acting with integrity is about more than our image and reputation or avoiding legal issues. It’s about sustaining a place where we are all proud to work.

Download Code of Conduct - English (PDF)

The Code is also available to you in each of the languages listed below (PDF).

Boston Scientific provides several resources that employees and others can use to ask a question, obtain guidance or report a Code of Conduct concern. Boston Scientific strongly encourages use of these resources. One of the resources for reporting concerns is our Advice Line.

The Advice Line allows anyone to ask a question, raise a concern or file a report relating to integrity at Boston Scientific. The Advice Line is managed by a third-party vendor. If you have an ethics or compliance question or an inquiry regarding a company policy, you can ask anonymously and confidentially.

The Advice Line can also be accessed via a toll-free telephone number that anyone can call, 24 hours a day, seven days a week. The Advice Line handles calls in multiple languages. The toll-free number is 888-968-8425.

The Advice Line allows anonymous reporting, except where local law restricts it. For additional information about calling the Advice Line, see Code of Conduct, page 49.

Note: The Advice Line is not designed for reporting product complaints. If you are not a Boston Scientific employee and need to report a product complaint, please call Customer Service at 888-272-1001. Boston Scientific employees, please follow corporate complaint reporting guidelines. Please visit our Advice Line Portal.

It is our employees’ responsibility to immediately raise any integrity concern or suspected violation of the Code, company policy or procedure. See Code of Conduct, page 8.

Boston Scientific does not tolerate any form of retaliation against an individual arising from a good-faith report of a potential violation of our Code of Conduct, a related policy or of an integrity concern. Retaliation is also prohibited against anyone who assists with, or cooperates in, an investigation of such a report.

The fundamental elements of our compliance program are described below. Note that our compliance program is constantly evolving to meet the changing needs and demands of the compliance environment and of Boston Scientific.

The company’s Global Compliance Program is led by our Vice President and Chief Compliance Officer, who makes periodic reports to the Boston Scientific Board of Directors. The program also includes Compliance Committees, which have been established by division and in various regional and country-level sales offices. The Compliance Committees include participation by senior leadership to provide strategic direction and oversight relating to the management of compliance risks for the company.

Our Code of Conduct is a cornerstone of our compliance program and provides guidance on business conduct and practices to all Boston Scientific team members. While the implementation of a compliance program cannot guarantee that all improper employee conduct will be eliminated, it is the expectation of Boston Scientific that each of our team members will comply with our Code of Conduct and the policies that have been established in support of that code.

Boston Scientific is committed to fostering effective lines of communication between management and employees. Employee training and education programs increase awareness of the legal and ethical implications of abiding by our Code of Conduct and related policies and making sound and ethical business decisions. We monitor the nature of inquiries that our compliance program receives and make appropriate adjustments, as needed, to our training and communications.

The Boston Scientific compliance program includes ongoing efforts to monitor, assess and audit compliance with our Code of Conduct and related policies. Our compliance program has a dedicated group that conducts both cause and risk-based audits and also works with our internal financial audit function to monitor compliance, identify potential problem areas, and support preventative measures and corrective actions.

Boston Scientific aims to respond promptly and impartially to questions, concerns and reports of potential violations of our compliance program. We have implemented policies and processes for the prompt and proper investigation of such reports. With regard to complaints received concerning accounting, internal accounting controls or auditing matters, Boston Scientific has established a process to escalate matters to the Audit Committee of the Board of Directors, as appropriate.

The Boston Scientific compliance program includes clear policies that set out the consequences of violating the law, our Code of Conduct and related policies. Although each situation is considered on a case-by-case basis, Boston Scientific consistently undertakes appropriate corrective action to address inappropriate conduct and to deter future violations.

Many changes in laws and ethical codes that govern interactions between industry and physicians and other health care providers have occurred since Boston Scientific was founded.

Boston Scientific was an early supporter of the AdvaMed Code of Ethics and remains a strong supporter of this important industry code. We respect the obligation of physicians and other health care providers to make independent decisions that are in the best interest of patient care. Selection of medical devices should be based solely on their effectiveness, quality and value.

The United States Physician Payment Sunshine Act (also referred to as the Open Payments Program), a provision of the Patient Protection and Affordable Care Act, is a U.S. federal law that requires pharmaceutical, biologic and medical device manufacturers to track and report payments and transfers of value provided to U.S. physicians and teaching hospitals. If a company such as Boston Scientific makes a "payment or transfer of value" to a U.S. physician or teaching hospital (for example, a meal, travel, lodging, etc.), the company must provide information about the interaction to the U.S. government. The U.S. Sunshine Act applies to interactions with U.S. physicians regardless of the country where those interactions occur.

Payments and transfers of value that Boston Scientific must capture and report include expenses such as travel, lodging and meals, consulting payments, royalty payments and licensing fees, research and clinical-trial related expenditures, educational items such as textbooks and journal reprints, training and education expenses, educational and research grants, and charitable donations, among others.

Companies are required to submit an annual report regarding interactions with U.S. physicians and teaching hospitals to the U.S. federal government. The government subsequently makes this information available to the public annually through a searchable website.

Boston Scientific is committed to acting with integrity in all of our interactions with physicians and other health care providers. We value and look forward to continuing our essential collaboration with health care providers, which allows us to deliver innovative, less-invasive medical devices and procedures for the benefit of patients.

Some states have imposed restrictions on how medical device companies can interact with health care providers who are licensed to practice by these states. These state regulations remain in effect alongside the U.S. Physician Payment Sunshine Act. Boston Scientific complies with state requirements, some of which are detailed further in this section.

California requires device and pharmaceutical manufacturers to post information relating to their compliance program and provide an annual declaration as to compliance with its elements. Access our California Comprehensive Compliance Program and related declaration.

Massachusetts, Vermont and Connecticut require pharmaceutical, biologic and medical device manufacturers to submit an annual report detailing financial interactions with certain physicians and other health care providers licensed by those states. Similar to other pharmaceutical, biologic and medical device manufacturers who do business in those jurisdictions, Boston Scientific may be required by law to report many types of direct and indirect payments and other transfers of value to physicians and other health care providers licensed by those jurisdictions. This generally includes the name of the contracting party, the purpose of the payment, the amount and nature of any payments made, and possibly other information about the payment.

Massachusetts and Vermont also require pharmaceutical, biologic and medical device manufacturers to comply with separate marketing codes of conduct, which regulate how employees of these companies can interact with health care providers licensed by these states. Access more information about the Massachusetts requirements and about the Vermont requirements.

If you are a health care provider and have a question about the company’s disclosure of information in compliance with the U.S. Physician Payment Sunshine Act, other state reporting requirements, or about a payment that was reported to the government by Boston Scientific and attributed to you, you can send an email to BSCHCPSupport@bsci.com and someone will respond to your question as soon as possible.

We understand that most of our U.S. customers are “Covered Entities” under the Health Insurance Portability and Accountability Act (“HIPAA”) privacy and security regulations. As HIPAA Covered Entities, our customers are legally obligated to maintain the privacy of all patient information that they create or receive.

While Boston Scientific is not a HIPAA Covered Entity (except for the endoscopy pathology lab and certain portions of our group health plan), we recognize the impact that HIPAA privacy and security regulations have on our customers. Boston Scientific remains committed to interacting with our customers and their patients as responsible professionals who are dedicated to maintaining the privacy of information that we receive on the job, consistent with applicable law and regulations.

To perform our jobs, Boston Scientific employees may create, develop or receive information about patients' experiences with our medical devices in a variety of situations, including:

• Providing information or technical support for our products
• Interacting with other members of the health care provider team regarding a particular patient’s diagnosis and treatment
• Receiving questions and suggestions about our products and services from patients, nurses, physicians and other health care providers
• Enrolling patients in clinical trials we sponsor and in our remote monitoring system for certain cardiac rhythm management patients
• Collecting information as required by the FDA and other governmental authorities relating to the quality, safety and efficacy of our devices
• Collecting, analyzing and re-analyzing our data in a continuous effort to improve the design, quality and function of our devices
• Assisting patients and Covered Entities with receiving pre-authorization from insurance companies for some procedures
  

We have provided training materials on HIPAA to our sales and marketing teams and expect our employees to respect each customer's explicit and implicit instructions regarding incidental exposure to protected health information while visiting that customer's site.

If you have any questions or concerns, please contact us at GlobalPrivacy@bsci.com.

Boston Scientific seeks to act ethically in our business practices, comply with local tax and business laws and regulations, and be transparent in our reporting. We extend these practices to our operations as well as to our customers, suppliers and communities in which we operate.

Commitment to Comply with and follow all Country Tax Laws

Boston Scientific seeks to comply with all local country laws including country tax laws, to promote transparency and conduct tax reporting as required under applicable rules and regulations; Boston Scientific includes disclosure regarding tax matters in its annual report on Form 10-K filed with the US Security and Exchange Commission.

Tax Structure and Strategies Oversight by Board

The business and affairs of Boston Scientific are managed by or under the direction of its Board of Directors.  The Board of Directors of Boston Scientific, including through one or more of its committees, reviews Boston Scientific’s tax structure and strategies on a regular basis.

Policy Statement on Anti-Corruption

Boston Scientific is committed to acting ethically in dealing with customers, employees, shareholders, partners, suppliers, competitors, and the community and with respect for applicable laws. One way that we make this happen is through the implementation of our Global Compliance Program, and our Code of Conduct, both of which are discussed in more detail in the Compliance and Ethics portion of our internet site. The primary purpose of our compliance program is to detect and prevent violations of laws, regulations, and company policies, taking into account and tailoring the program to our unique environment.

Due Diligence of New Channel Business Partners – Corruption and Bribery

As part of Boston Scientific’s commitment to acting ethically in all matters and with respect for all applicable laws, due diligence is conducted of new channel business partners, during which time Boston Scientific looks to partner with other entities that demonstrate a similar commitment to acting ethically in these matters.

Communication of Anti-Corruption Policy to Employees

The Corporate Citizenship section of Boston Scientific’s company website clearly communicates the company’s commitment to acting ethically in all dealings.  This website reflects the information communicated to our employees through formal training and knowledge-based testing, as well as via direct email.

Training on Anti-Corruption

Employees are required annually to complete a training course on ethics and compliance, including a section on anti-corruption.

Corruption Risk Assessments for Company Operations

As part of our standard audit process, operational risks are assessed, including those at risk of corruption.

Procedures to Address Corruption

Our Code of Conduct is about acting with integrity by treating people honestly and with respect, both inside and outside of Boston Scientific.  This Code lays out clear guidelines for dealing with corruption, as well as various means to ask a question or confidentially raise a concern should a related issue arise.

Compliance with Anti-Corruption Requirements

Boston Scientific maintains policies and procedures reasonably designed to comply with compliance and anti-corruption rules and regulations.  Violations of such policies may lead, and has led, to discipline up to and including termination.

In August 2012, the Securities and Exchange Commission (SEC) adopted final rules implementing disclosure requirements related to "conflict minerals," as directed by Section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010.

The term "conflict minerals" is defined to include tin, tantalum, tungsten and gold (the derivatives of cassiterite, columbite-tantalite, and wolframite) regardless of their country of origin; the U.S. Secretary of State may designate additional minerals in the future.

The final rules are intended in part to bring greater supply chain transparency to the use of such minerals originating from the Democratic Republic of Congo and adjoining countries (covered region) in an effort to help end the violent conflict in the covered region. These rules require companies that file certain reports with the SEC to disclose whether the products they manufacture or contract to manufacture contain "conflict minerals" originating from that region that are "necessary to the functionality or production" of those products.

Boston Scientific is supportive of efforts to enable supply chain transparency and responsible sourcing. We are committed to complying with the new conflict minerals reporting and disclosure requirements. Furthermore, we fully expect our suppliers to undertake reasonable efforts to provide us with pertinent information in a timely manner, and to otherwise support our efforts in complying with these requirements.

To ask questions or to report a concern about Boston Scientific’s Conflict Minerals Policy or Program, please use Boston Scientific’s Advice Line.