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.
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