A Culture of Compliance
Spectranetics has established a culture of compliance by leveraging the seven widely recognized and fundamental elements of an effective compliance program, consistent with the OIG’s voluntary Compliance Program Guidance for Pharmaceutical Manufacturers dated May 2003. At Spectranetics we are committed to conducting our affairs in compliance with all applicable legal and regulatory standards that govern our industry with unquestionable integrity. Spectranetics’ Compliance Department is dedicated to the development, implementation and monitoring of an effective compliance program throughout the Company. Our program is led by the Vice President and Chief Compliance Officer, who reports directly to the President and CEO with a “dotted line” reporting responsibility to the Company’s Board of Directors.
In order to fully integrate into the day-to-day business operations, the Compliance Department actively participates in the creation of and training to Company policies and procedures. At the foundation of all policies and procedures is the Spectranetics Code of Conduct and Ethics. The Code of Conduct and Ethics embodies the characteristics we value as a company and that each Teammate is accountable to uphold. In addition, the Compliance Department is closely aligned with our Sales and Marketing Teammates to support ethical interactions with health care professionals who are customers and consultants in accordance with the AdvaMed Code of Ethics on Interactions with Healthcare Professionals. Spectranetics has adopted the AdvaMed Code and supports adherence to all state and federal laws that govern our interactions with health care professionals, including disclosure of financial transactions pursuant to applicable federal and state reporting requirements.
Health Care Compliance
There have been many recent changes in laws and ethical codes that govern interactions between industry and health care professionals. Additional regulations are forthcoming that will further affect how industry and health care professionals work together.
We respect the right and obligation of health care professionals to make independent decisions that are in the best interest of patient care. We agree that the selection of medical devices should be based solely on their effectiveness, quality, and value.
At Spectranetics we strive to support the best possible care for patients, independent of consulting arrangements, research or education support. We believe that patient care comes before all else.
Support for research and medical education is provided to educational organizations and physicians under carefully evaluated circumstances according to established Company policies and procedures. Before any support for a Continuing Medical Education event or a research grant may be awarded, the proposed event/research is reviewed by the appropriate internal committees to ensure that all prospective awards adhere to Spectranetics standards.
Patient Privacy and HIPPA
We understand that most of our U.S. customers are “Covered Entities” under the Health Insurance Accountability Act (“HIPPA”) privacy and security regulations. As HIPPA Covered Entities, our customers maintain the privacy of all patient information that they create or receive. Spectranetics 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 laws and regulations. We provide training materials on HIPPA to our sales and marketing teams and expect our Teammates to respect each customer’s explicit and implicit instructions regarding incidental exposure to Protected Health Information while visiting that customer’s site.
We encourage that any concerns regarding a known or suspected violation of Company policies and procedures, the Code of Conduct and Ethics, and/or applicable laws and regulations be reported by our Teammates, our customers, and/or our distributors. You may report your concerns directly to the Vice President and Chief Compliance Officer by email at email@example.com.
Alternatively, if you wish to remain anonymous you are encouraged to contact Spectranetics toll-free Compliance Hotline at (877) 792-6460. The Hotline is managed by a third party to ensure anonymity.
Spectranetics Code of Conduct and Ethics
The Spectranetics Code of Conduct and Ethics is the seminal document advancing our commitment—as a company and as individuals—to execute every aspect of our business with the highest level of integrity at all times. The primary tenets of this Code are:
- Positive Working Environment: We work hard to make Spectranetics a great place to work and strive to treat people with respect, courtesy, fairness and dignity.
- Culture of Compliance: We are committed to integrating compliant practices into all aspects of our business.
- Interactions with Health Care Professionals: We conduct business with industry professionals supporting adherence with the AdvaMed Code of Ethics on Interactions with Health Care Professionals.
- Participation in Federal Healthcare Programs: Spectranetics strives to fulfill all of its obligations in support of compliance with federally funded healthcare programs including Medicare, Medicaid, TRICARE and others.
- Avoidance of Ineligible Persons: Spectranetics does not hire or retain people to work in our operations who are ineligible to participate in U.S. government health care programs or other U.S. government procurement and non-procurement programs.
- Business with Foreign Governments: Spectranetics strives to adhere to international business standards with both domestic and foreign regulations at the forefront of our business.
- Commitment to Fair Competition: We are committed to fair competition in the marketplace both within and outside of the United States.
- Uncompromised Product Quality: By performing our jobs with integrity, each of us helps to ensure that every single medical device that we develop, manufacture, test and deliver meet governmental regulatory standards, our own stringent quality requirements and ultimately, user and patient needs.
For more information, please see the full Code of Business Conduct and Ethics posted to our website.