MedPointe Healthcare Inc.
Comprehensive Healthcare Compliance Program
Policy
MedPointe Healthcare Inc. is committed to conducting its business in an ethical and lawful manner. We will engage only in sales and marketing practices that comply with all applicable laws and regulations. The Company will also comply with all laws and regulations that ensure the integrity of data used in calculating and reporting government pricing and discounts.
To assure that our policy objective is achieved, we have established a Comprehensive Healthcare Compliance Program. We have also designated a Compliance Committee and a Corporate Compliance Officer who will be responsible to oversee and monitor the Healthcare Compliance Program to effectively ensure compliance with our legal and regulatory obligations. The elements of our Healthcare Compliance Program are set forth below.
Employees are required to comply with the Healthcare Compliance Program as it affects their responsibilities. Employees who suspect that any corporate activity is not in compliance with law or our Healthcare Compliance Program policies are urged to report their concern through the 24 hour business conduct hotline or through their supervisory chain of command. If a satisfactory resolution is not achieved through the 24 hour hotline or supervisory chain of command, employees are urged to contact the Corporate Compliance Officer. Anonymity (if desired) will be respected to the maximum extent permitted by law, and there will be absolutely no retaliation permitted for reporting such activities or concerns.
Comprehensive Healthcare Compliance Program
Written Standards of Conduct
The Company has adopted written standards of conduct that verbalize the company’s commitment to compliance with law and has determined that its pharmaceutical marketing and promotional activity will comply with the principles incorporated in the PhRMA Code on Interactions with Healthcare Professionals dated July 1, 2002. For compliance with California law, Section 119402(d)(1) of the California Health and Safety Code, we have adopted a specific annual limit of [$1000.00] on gifts, promotional materials, and other promotional items or activities (such as modest meals during informational presentations) provided to individual medical or health care professionals. We have adopted additional policies and procedures concerning the integrity of data collection and reporting to ensure that our government pricing and rebating obligations are properly fulfilled.
Designation of Corporate Compliance Officer and Compliance Committee
We have designated a Corporate Compliance Officer and Compliance Committee with responsibility for overseeing and monitoring the Healthcare Compliance Program including its training, auditing and monitoring components. The members of the Compliance Committee and the Compliance Officer will also address employee concerns and will be responsible for enforcement of the Healthcare Corporate Compliance Program within the company. The Compliance Committee and Compliance Officer report directly to the Board of Directors on these matters.
Training and Education
Employees are trained on the rules and regulations affecting their responsibilities as well as the principles of the PhRMA Code on Interactions with Health Care Professionals, dated July 1, 2002, and any updates or revisions, and, as applicable, the Compliance Program Guidance for Pharmaceutical Manufacturers developed by the United States Department of Health and Human Services Office of Inspector General (OIG).
Effective Lines of Communication
Employees should feel comfortable expressing any concerns they may have with our corporate activities. Anyone who suspects that a corporate activity is not in compliance with law or any of our written policies and procedures is encouraged to raise the matter through their supervisory chain of command or through the 24 hour business conduct hotline. If a satisfactory resolution is not achieved through the supervisory chain of command or the business contact hotline, the employee is urged to contact the Corporate Compliance Officer. Anonymity (if desired) will be respected to the maximum extent permitted by law, and there will be absolutely no retaliation permitted for reporting such activities or concerns.
Auditing and Monitoring
The Corporate Compliance Officer and the Compliance Committee will be responsible to oversee and monitor periodic audits of our sales and marketing activities, our data collection and monitoring activities and any other activities that affect compliance with laws and regulations covered by this Healthcare Compliance Program and will assure that appropriate corrective action is undertaken as may be required.
Disciplinary Action
All employees and contractors are required to comply with our policies and procedures. We will enforce appropriate disciplinary action against anyone who does not. Disciplinary actions, ranging from warnings up to and including termination, are determined on a case-by-case basis and applied consistently in light of the nature and severity of the violation.
Investigation and Corrective Action
The Corporate Compliance Officer and the Compliance Committee will promptly investigate actual or suspected noncompliance or misconduct and institute corrective action and preventative measures whenever appropriate.
Annual Declaration of Compliance
In accordance with Section 119402 of the California Health and Safety Code, the Company will post an Annual Declaration of Compliance on its website at the conclusion of each fiscal year of the Company.
Meda Pharmaceuticals