ACI's 14th National Pharmaceutical Compliance & Enforcement Forum

Topics to be discussed include:

• Lessons to be learned from recent CIA agreements: Separating out individual considerations and identifying across-the-board negotiation points
  • How much of your global and domestic business will be covered by the CIA?
  • What kind of monitoring controls and systems need to be implemented?
  • What kind of restraints on HCP relationships can you enter into?
• What trends about OIG priorities can be extrapolated from recent CIAs?
• Determining the ramifications of multi-violators
• Distinguishing between boiler-plate and investigation specific provisions
  • What provisions are subject to modification based on company specific factors?
  • Insights into what provisions have been successfully tailored by other companies
• Creating a cooperative relationship with your appointed monitors and communicating effectively with the OIG during the pendency of the CIA
• Proactively fortifying your compliance system based on the requirements of other pharmaceutical and medical device CIAs before negotiating with the government
• Living under a CIA
  • Understanding the effects
  • Getting the Board of Directors involved
  • Discussing the likelihood of “probation” becoming a new standard
• Preparing for potential tax consequences to settlements – distinguishing between repayments and penalties
  • Evaluating what constitutes a “reportable event”
  • Setting up internal review organizations and data collection as to implementation of programs
• Preparing for allegations of a breach
  • Identifying who can enforce CIA conditions
  • Comparing jurisdictional views on whether a breach of a CIA can give rise to an action under the False Claims Act
  • Updating investigators on what systems have been implemented and providing data on efficacy
  • Retaining independent review organizations

For more information, visit the event website.