The In-House Counsel Forum on Government Regulation of Medical Device Pricing & Reimbursement

• Analyzing Medicare coverage rules for non-approved devices
  
• Strategies for dealing with national and local Medicare coverage issues
  
• Investigational cardiac device litigation update
  
  
  
  • Yale-New Haven v. Leavitt (2nd Circuit)
    
  • United States ex rel. Sikkenga v. Regence Blue Cross Blue Shield of Utah (10th Circuit)
  
  
• Steering clear of potential liability under the beneficiary inducement prohibition if the device is given away
  
• Preventing claims under the False Claims Act and other fraud and abuse statutes for off-label marketing and providing inappropriate reimbursement advice to customers
  
• Ensuring that your compliance program complies with off-label rules and prevents the giving of reimbursement advice

• Janice A. Anderson, Partner, Foley & Lardner LLP (Chicago, IL)
  
• Thomas S. Crane, Partner, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (Boston, MA)

• Potential anti-kickback and False Claims Act violations that stem from reimbursement policy
  
  
  
  • Criminal and civil liability risk areas where reimbursement policy is perceived as pricing manipulation of off-label promotion


• Educating sales force on coverage issues
  
• Incorporating reimbursement options into DTC campaigns
  
• Current DOJ and OIG enforcement priorities and targets
  
• Avoiding enforcement triggers: what to do if your client is engaging in one of these red flag practices
  
• Government investigation tactics
  
• Intervening in device qui tam suits: key factors the government will consider in determining whether to join the suit

Speakers:

• Judy Waltz, Partner, Foley & Lardner LLP (San Francisco, CA)
  
• Kenneth J. Yood, Partner, Paul, Hastings, Janofsky & Walker LLP (Los Angeles, CA)