ACI's 14th National Pharmaceutical Compliance & Enforcement Forum

20 March 2014 Philadelphia, PA Past Event

Location

The Union League
140 South Broad Street
Philadelphia, PA

Agenda

March 19-20, 2014
Partner Judith Waltz is moderating a panel discussion titled “CIA Focus Group – Identifying Compliance Issues; Best Methods to Respond to an Investigation; Discussing Negotiation Tactics to Create Feasible Conditions,” at the American Conference Institute’s 14th National Pharmaceutical Compliance & Enforcement Forum on 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.

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ACI's 14th National Pharmaceutical Compliance & Enforcement Forum

Location

The Union League
140 South Broad Street
Philadelphia, PA

Agenda

March 19-20, 2014