The In-House Counsel Forum on Government Regulation of Medical Device Pricing & Reimbursement
June 20, 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.
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)
- Yale-New Haven v. Leavitt (2nd 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
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)
People
Related Insights
June 4, 2026
Foley Career Perspectives
Foley AANHPI Heritage Month Program: A Conversation With Professor Kenji Yoshino
In celebration of Asian American, Native Hawaiian, and Pacific Islander (AANHPI) Heritage Month, Foley & Lardner hosted a firmwide virtual program on May 28 featuring Professor Kenji Yoshino. He is the Chief Justice Earl Warren Professor of Constitutional Law at NYU School of Law and the Director of the Meltzer Center for Diversity, Inclusion, and Belonging.
June 5, 2026
Events
Advanced Estate Planning with S Corporations: Tax Structuring, Trust Design & Succession Strategies for Closely Held Business Owners
June 2, 2026
Manufacturing Industry Advisor
Foley Automotive Update
Foley is here to help you through all aspects of rethinking your long-term business strategies, investments, partnerships, and technology. Contact the authors, your Foley relationship partner, or our Automotive Team to discuss and learn more.