Category: OIG Guidance and Reports
II. Compliance Program Elements G. Enforcing Standards Through Well-Publicized Disciplinary Guidelines
An effective compliance program should include clear and specific disciplinary policies that set out the consequences of violating the law or the pharmaceutical manufacturer’s code...
II. Compliance Program Elements F. Auditing and Monitoring
An effective compliance program should incorporate thorough monitoring of its implementation and an ongoing evaluation process. The compliance officer should document this ongoing monitoring, including...
II. Compliance Program Elements E. Developing Effective Lines of Communication
1. Access to Supervisors and/or the Compliance Officer In order for a compliance program to work, employees must be able to ask questions and report...
II. Compliance Program Elements D. Conducting Effective Training and Education
The proper education and training of officers, directors, employees, contractors, and agents, and periodic retraining of personnel at all levels are critical elements of an...
II. Compliance Program Elements C. Designation of a Compliance Officer and a Compliance Committee
1. Compliance Officer Every pharmaceutical manufacturer should designate a compliance officer to serve as the focal point for compliance activities.12 This responsibility may be the individual’s...
II. Compliance Program Elements B. Written Policies and Procedures (Page 1)
In developing a compliance program, every pharmaceutical manufacturer should develop and distribute written compliance standards, procedures, and practices that guide the company and the conduct...
II. Compliance Program Elements A. The Basic Compliance Elements
The OIG believes that every effective compliance program must begin with a formal commitment by the pharmaceutical manufacturer’s board of directors or other governing body....
Medicaid Rebates For Physician-Administered Drugs
Office of Inspector Generalhttp://oig.hhs.gov The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as amended, is to protect the...