Purpose

The Baxano Compliance Program is designed to comply with applicable US and international laws and industry standards relating to the ethical marketing and promotion of Baxano products.

Introduction and Scope

Baxano is an active member of the Advanced Medical Technology Association (AdvaMed), and has voluntarily adopted AdvaMed’s Code of Ethics on Interactions with Health Care Professionals, which is intended to help the medical technology industry facilitate ethical interactions with the healthcare community.

Baxano is committed to following the seven elements of an effective compliance program as set forth in the voluntary “Compliance Program Guidance for Pharmaceutical Manufacturers” published by the Office of Inspector General, U.S. Department of Health and Human Service. These seven elements are described in the Procedure section. The Baxano program also requires compliance with the California Health and Safety Code § 119400-119402 and the voluntary Pharmaceutical Research and Manufacturers of America’s Code on Interactions with Healthcare Professionals.

This procedure requires Baxano management, employees, independent dealers, distributors and agents of the Company to act in accordance with law and applicable company policy.

References

• AdvaMed Code of Ethics on Interactions with Health Care Professionals
• 42 USC § 1320a-7b Criminal penalties for acts involving Federal health care programs (a.k.a. “anti-kickback” statute)
• 42 CFR § 1001.101   Basis for liability; Program Integrity - Medicare and State Health Care Programs
• California Health and Safety Code § 119400-119402; Drug Marketing Practices
• OIG Compliance Program Guidance for Pharmaceutical Manufacturers - Federal Register, Vol. 68, No. 86; May 5, 2003
• Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals

Ethics and Compliance Responability Statement

Baxano is a dynamic organization and committed to operating with integrity between employees, business partners, and our physician and patient customers throughout the world. We intend to fully comply with the laws, regulations and industry standards relating to the marketing and promotion of our products, wherever we do business. To achieve this, Baxano supports open and honest communication about our standards of ethical practice and has established a program for compliance with our responsibilities. Every employee and contractor is expected to adhere to this policy as a condition of employment.

Responsibilities

The Compliance Committee is comprised of senior management (including the CEO) and assists in the implementation of the Compliance Program. They designate a Compliance Officer (CO) and ensure that the CO has the ability to effect change within the organization as necessary and to exercise independent judgment.

The Compliance Officer (CO) is responsible for developing, operating and monitoring the Compliance Program.

Baxano management, employees, contractors, independent dealers, distributors and agents of the company are responsible to act in accordance with law and applicable company policy.

Employees are expected to know and follow the laws of each relevant market in which Baxano does business. Managers are expected to ensure such compliance.

It is the responsibility of every employee to promptly bring suspected violations of the Ethics and Compliance Program to the attention of the Company.

Managers must address employees’ concerns about appropriate conduct promptly and with care and respect.

Employees at all levels are prohibited from retaliating against or threatening anyone for reporting or supplying information about a policy or conduct concern.

Procedures

Leadership

The Compliance Committee is comprised of members of senior management (including the CEO) and assists in the implementation of the Compliance Program. They designate a Compliance Officer (CO) and ensure that the CO has the ability to effect change within the organization as necessary and to exercise independent judgment. 

The Compliance Officer (CO) is responsible for developing, operating and monitoring the Compliance Program. 

Written Standards

The Baxano Ethics and Compliance Responsibility Statement and this Operating Procedure are the foundation of the Baxano program. It includes the basic requirement of compliance with all applicable laws and regulations. The compliance program places restrictions and internal controls to address more specific areas of compliance risk within our business.

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Policies

Baxano-Conducted Training and Education

Baxano may provide healthcare professionals with training and education on our products and disease states. This may include “hands on” training sessions, cadaver workshops, lectures and presentations.

• Programs and events must be conducted in a setting that is conducive to the effective transmission of information (resort locations, for example, are not acceptable).
• Baxano may provide attendees with modest meals and refreshments
• When necessary, Baxano may pay for reasonable travel and modest lodging costs of Health Care Professionals attending out-of-town programs.
• It is not appropriate for Baxano to pay any expenses for guests of the attending Health Care Professionals.

Third-Party Educational Conferences

Baxano may provide grants to bona fide independent, educational, scientific, and policymaking conferences when the conference sponsor is responsible for selection of program content, faculty educational methods, and materials.

• Baxano can provide funding to the conference sponsor (not individual Health Care Professionals) to support the provision of meals and refreshments for all of the healthcare professional attendees.
• Baxano may make grants to conference sponsors for reasonable honoraria, travel, lodging, and modest meals for healthcare Professionals who are bona fide conference faculty members.
• Baxano may purchase advertisements and lease booth space for Company displays at conferences.

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Records

• Training records will be maintained according to company procedure.
• Records relating to reports of potential violations and subsequent investigation, corrective and preventive action will be maintained in the Regulatory Affairs files for 3 years.
• Records of disciplinary action will be maintained in the specific employee file in Human Resources for the duration of the individuals’ employment.