California Compliance Law Declaration

PROGRAM DESCRIPTION

NOTICE: This information is provided pursuant to the requirements of California Health & Safety Code § 119402 (S.B. 1765), which requires certain pharmaceutical and medical device companies doing business in California to make available their program for compliance with applicable federal and state laws and industry standards governing the healthcare industry and a written declaration of their compliance with such program.

I. INTRODUCTION

Medline has established an Ethics and Compliance Program designed to comply with applicable federal and state laws; guidance issued by the U.S. Department of Health and Human Services, Office of Inspector General (“OIG”); and the principles outlined in the AdvaMed Code of Ethics on Interactions with U.S. Health Care Professionals (“AdvaMed Code”) (collectively “Applicable Healthcare Laws and Guidance”). Medline recognizes that Good Ethics Means Good Business and that with the support of senior management, Medline employees at all levels should play an active role in the company’s compliance activities.

Medline has a strong commitment to establishing and maintaining an effective compliance program that promotes ethical business conduct. To put this commitment into action, the company has established a comprehensive compliance program around the seven elements for an effective compliance program as outlined in the Compliance Program Guidance for Pharmaceutical Manufacturers, published by OIG (the “OIG Guidance”). As described below, these seven elements form the basis of Medline’s program for compliance with Applicable Healthcare Laws and Guidance. Medline’s Ethics and Compliance Program is designed to prevent, detect, and address probable violations of law or company policy.

It is Medline’s policy that all employees must comply with Applicable Healthcare Laws and Guidance as well as with company policies. However, as acknowledged by the OIG Guidance, implementing a comprehensive compliance program cannot guarantee that improper employee conduct will be eliminated in its entirety. If Medline becomes aware of violations of law or company policy, the matter will be investigated and, if appropriate, disciplinary action will be taken and corrective measures will be implemented to prevent future violations.

II. OVERVIEW OF ETHICS AND COMPLIANCE PROGRAM

1. Written Policies and Procedures.
Medline has written policies that guide the conduct of Medline and its employees to help ensure compliance with Applicable Healthcare Laws and Guidance. Medline’s key corporate policies are referenced in the Medline Code of Conduct. The Code of Conduct requires Medline employees to obey all laws, act in an ethical manner, and make business decisions that are consistent with Medline policies.

Medline has also established written policies that address key risk areas for the company, including those that govern activities involving communicating with customers about the appropriate use of Medline products, financial arrangements with customers and potential customers, advancing scientific and educational activities, and supporting research and education. Specific examples of these policies include:

Policy on Travel Expense Reimbursement
Medline reimburses for travel and lodging expenses of attendees at promotional and educational training programs in very limited circumstances that are consistent with Applicable Healthcare Laws and Guidance.

Policy on Business Meals
Medline may occasionally offer a modest meal, consistent with the standards of the AdvaMed Code. Modesty is to be judged by local standards. Medline prohibits offering customer or potential customer meals at venues that feature entertainment or recreation, and prohibits attendance by spouses or guests.

Total Annual Dollar Limit for Meals and Educational or Practice-Related Items
Medline has established an annual limit of $1,500 as the aggregate value of meals, educational or practice-related items, promotional materials, or certain other items or activities that Medline may provide to individual California healthcare professionals pursuant to the requirements of Cal. Health & Safety Code § 119402 (S.B. 1765).

Policy Prohibiting Entertainment
It is the policy of Medline not to provide entertainment (e.g., sporting events, golf outings, concerts, hunting, etc.) to customers or potential customers.

2. Compliance Officer/Compliance Committee.
Medline has appointed a Chief Compliance and Corporate Integrity Officer. who has been empowered with appropriate authority to exercise independent judgment and has free and unencumbered access to senior management to oversee its Ethics and Compliance Program.

Medline has also appointed an Ethics and Compliance Committee. The committee is comprised of the company’s Chief Compliance and Corporate Integrity Officer and members of the company’s management team.

3. Training.
The training and education of Medline officers, directors, and employees of their obligations under Applicable Healthcare Laws and Guidance is a key element of the Ethics and Compliance Program. Medline’s annual Ethics and Compliance training process includes completion of compliance testing and annual certification that compliance training materials have been reviewed and understood for appropriate officers, directors and employees. The training is conducted for appropriate officers, directors and employees upon hire and annually thereafter and covers Applicable Healthcare Laws and Guidance and Medline’s Ethics and Compliance Program. Employees are also trained on the consequences of failure to comply with the requirements of the company’s Ethics and Compliance Program.

4. Communication.
Medline encourages open and candid discussion between management and employees regarding any ethics or compliance concerns. Employees are encouraged to report their concerns to their manager, to the Human Resources Department, to the General Counsel or to the Chief Compliance and Corporate Integrity Officer. In addition, Medline maintains an Ethics and Compliance Helpline through which its employees may report anonymously potential compliance incidents or seek guidance on compliance questions that include, but are not limited to: violations of laws, regulations, or company policy; fraud; unethical behavior; and employment-related issues.

5. Auditing and Monitoring.
Medline self-assesses and periodically audits its compliance with its policies and procedures and Applicable Healthcare Laws and Guidance. The nature of oversight and frequency of compliance monitoring and auditing varies according to a variety of factors, including new regulatory requirements, changes in business practices, and other considerations, in accordance with OIG Guidance.

6. Enforcement and Disciplinary Guidelines.
Medline maintains clear disciplinary policies that set forth the consequences of violating its compliance policies and procedures and will take appropriate disciplinary actions in response to any such violations. Medline will conduct a fair and diligent investigation of matters that are brought to the company’s attention in order to ensure the consistent application of the company’s standards.

7. Responses To Detected Problems and Actions To Correct Issues.
Medline requires a prompt and diligent response to potential violations of the company’s Ethics and Compliance Program, including its standards regulating the marketing and promotion of Medline products. Actions in response to detected problems may include improving policies, procedures, training, communication and monitoring or may require disciplinary action to prevent future violations.

To request a copy of this Comprehensive Compliance Program description and Declaration, please email ComplianceOffice@medline.com with the subject “California Compliance Declaration” or call (866) 833-3450.

California Compliance Law Declaration

Related Links

PROGRAM DESCRIPTION