ACI's 14th National Pharmaceutical Compliance & Enforcement Forum

March 20, 2014

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.