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.
People
Related Insights
26 July 2024
Video
Ten Minute Interview: Art Ownership
Brian Lucareli, director of Foley Private Client Services and co-chair of Foley’s Family Offices group, sits down with Lindsey Birch, associate and member of our Intellectual Property practice group, for a 10-minute interview to discuss art ownership.
26 July 2024
Foley In Fashion
Passing the Torch: Technology in the Opening Ceremony Fashion at the Paris Olympics
With the 2024 Olympic Games set in Paris, France, one of the world’s fashion capitals, athletics and aesthetics collide to take center stage at the much-anticipated opening ceremony.
25 July 2024
Foley In Fashion
SHEIN’s $1.9 Million Data Breach: A Cautionary Tale for Online Fashion Brands
The New York Attorney General fined fast-fashion company, Shein Distribution Corporation, $1.9 million for failing to properly handle a data breach in late 2022.