Coloplast's Comprehensive Compliance Program

Coloplast is committed to conducting its business in an ethical manner and in compliance with applicable laws and regulations, industry ethics codes to which Coloplast subscribes, including the AdvaMed Code of Ethics on Interactions with Health Care Professionals (“AdvaMed Code”), Coloplast’s BEST Code of Conduct, Coloplast’s Policy on Interactions with U.S. Healthcare Professionals, and Coloplast’s compliance policies and procedures, including its training, investigations, audit and monitoring policies (collectively, the “Compliance Standards”). Further, Coloplast recognizes that a comprehensive compliance program may help reduce risk and build trust with customers.  Coloplast is therefore committed to operating an effective compliance program as described in the Compliance Program Guidance of the Office of Inspector General of the U.S. Department of Health and Human Services. This document contains an overview of Coloplast’s Comprehensive Compliance Program. 

Elements of the Compliance Program

I. Written Policies and Procedures

Coloplast develops, distributes, and implements written policies and procedures to provide guidance to Coloplast employees and, where appropriate, contractors, concerning compliance issues. These policies articulate Coloplast’s commitment to compliance and address areas of potential compliance concerns, such as sales and marketing practices and interactions with health care professionals.  Without limiting the foregoing, Coloplast will not provide gifts or incentives to health care professionals where doing so violates applicable Compliance Standards, and will limit all permitted business meals to $1,500 annually per health care professional in California. This spending limit does not apply to business meals provided to California HCPs in connection with the provision of consulting services under an approved consulting agreement. Coloplast reviews and updates its policies and procedures as needed to comply with changes in the Compliance Standards.

II. Compliance Office and Executive Compliance Committee

Coloplast has designated a Corporate Compliance Officer, North America Compliance Officer, and Compliance Committee, who is responsible for overseeing the development, operation and monitoring of the compliance program.  The Corporate Compliance Officer has authority to report compliance issues directly to Executive Management. Coloplast shall ensure the Board of Directors is informed of compliance matters as appropriate.

III. Training Programs

Coloplast recognizes that training is a critical element of a successful compliance program and develops and implements regular, effective compliance education and training programs for its employees.  In addition, Coloplast also provides compliance training to agents, such as independent sales staff, as needed to address compliance issues raised by their work for Coloplast.  Coloplast will regularly review and update its training programs, identify areas of concern on an as-needed basis, and assess employees and agents to ensure they are familiar with the subject matter covered in the training.

IV. Effective Lines of Communication

Coloplast maintains effective lines of communication between the Compliance Officer and Coloplast’s employees to communicate Coloplast’s compliance policies and to receive reports of potential compliance concerns.  Coloplast ensures its employees understand they are expected to report good faith belief of non-compliance with the Compliance Standards. Coloplast has implemented a hotline to permit anonymous reporting of compliance concerns in the United States. Coloplast will provide as much anonymity as possible under the circumstances to individuals who report potential compliance violations, consistent with Coloplast’s responsibilities to investigate concerns and take necessary corrective action.  Coloplast will not retaliate against individuals who make compliance reports in good faith.

V. Auditing and monitoring

Coloplast understands that the success of its compliance program depends in part on ongoing monitoring and auditing of adherence to the Compliance Standards.  Coloplast conducts periodic audits as deemed necessary and appropriate to ensure its employees and contractors comply with the Compliance Standards.  

VI. Policies regarding Excluded Persons and Disciplinary Action

Coloplast takes appropriate steps to ensure it does not employ or retain individuals or entities that are excluded from participation in federal health care programs, including the Medicare and Medicaid program.  Further, consistent with its policies, including its human resources policies, and applicable law, Coloplast will take appropriate disciplinary action against employees and contractors who have violated the Compliance Standards.

VII. Policies for addressing noncompliance

Coloplast has developed and implemented policies to investigate and address detected compliance issues.  These policies will ensure the prompt and proper response to violations of the Compliance Standards.  The response may include corrective action, termination of employment, preventive measures, and, where appropriate, reports of violations to the relevant authorities.