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

20 June 2007 Chicago, IL Past Event

Location

Swissotel
323 E. Wacker Dr.
Chicago, IL 60601

Agenda

June 20 - 21, 2007
Partner Janice Anderson and Partner Judith Waltz will be presenting at the American Conference Institute's (ACI) "The In-House Counsel Forum on Government Regulation of Medical Device Pricing & Reimbursement: Overcoming Coverage, Coding, and Payment Challenges to Increase Clients' Market Share," June 20 - 21, 2007 in Chicago, IL.
 
Topic: Grappling with the Reimbursement Implications Associated with Off-Label Uses of Medical Devices
Date: Thursday, June 21, 2007
Time: 11:45 a.m. - 12:45 p.m.
  • 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
Speakers:
  • Janice A. Anderson, Partner, Foley & Lardner LLP (Chicago, IL)
  • Thomas S. Crane, Partner, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (Boston, MA)

 
Topic: Reimbursement-Related Compliance Issues and the Government Investigations and Enforcement Actions that Follow
Date: Thursday, June 21, 2007
Time: 2:00 p.m. - 3:00 p.m.
  • 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)

Related Services

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

Location

Swissotel
323 E. Wacker Dr.
Chicago, IL 60601

Agenda

June 20 - 21, 2007