Preconference
Day One
Day Two
Day Three
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Device Congress Agenda: Day III
Friday, March 31, 2006
Annenberg Hall
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8:00 a.m. |
Introduction to Day III
Nancy Singer, Esq.
President, Compliance-Alliance
Former Special Counsel, AdvaMed
Founder, AdvaMed Medical Technology Learning Institute
Arlington, VA
(Co chair)
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8:15 a.m. |
How Access to Medical Technology Improves Quality of Life - from the Patient's Perspective
Paul E. Berger
Publisher, Stroke Survivor.com
Merrifield, VA
Handout Material (Acrobat)
George M. Burditt, Esq.
Of Counsel, Drug and Device Law Group
Bell Boyd and Lloyd
Chicago, IL
Handout Material (Acrobat)
Handout Material (Microsoft Word)
Stephanie Mensh
Former Vice President
Payment and Policy, AdvaMed
Falls Church, VA
(Moderator)
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8:45 a.m. |
Hypothetical Problem
Ace Medical Products received approval for a left-brain stimulation device that uses an implantable stimulator with one lead that goes into a specific area in the left side of the brain. The device is indicated for the treatment of stroke patients. Although Ace submitted a PMA supplement for a lead that would also go to a different area of the right side of the brain for treating motion disorders, the FDA informed Ace that the company lacked the data necessary for the approval of the second claim.
Ace promotes the left brain lead, however, it also promotes the right brain lead. It does this during an educational training conference. sponsored by Ace in which Ace's customers and their families are invited to an all expenses paid trip at the Four Seasons Hotel in Las Vegas.
CMS agrees to reimburse this product for the left brain lead, but certain sales representatives are encouraging providers to use this product with the right brain lead and use the reimbursement code for the left brain lead. This product fails 6 times when used for left brain and 15 times when used the leads go the right brain. Ace has decided to conduct a limited recall of this product.
Discussion will explore these questions:
- How did Ace get CMS to reimburse for the left brain stimulation device with the lead going to the left brain?
- What options are there for the FDA to take against Ace for off-label promotion for the lead going to the right brain?
- What action can government agencies take against Ace for its inappropriate promotion and coding advicefor the product?
- How will the company conduct the limited recall with a product replacement?
- What will CMS do to get back the money that it paid for the procedures using the product?
Various speakers from Thursday's 3 tracks, and others, will discuss these questions, including:
Willie R. Bryant, Jr.
NNC Group, Former Senior Recall Officer
Food and Drug Administration
Middletown, MD
William T. Fitzgerald
Vice President, Global Compliance
Alcon Laboratories, Inc.
Ft. Worth, TX
Robert J. Klepinski, Esq.
Of Counsel, Fredrikson & Byron
Former Senior Regulatory Counsel, Medtronic
Minneapolis, MN
Michael Loucks, Esq.
First Assistant US Attorney
US Attorney's Office
Boston, MA
Michael J. Ruggiero, Esq.
Of Counsel, King & Spalding, LLP
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Stephen Terman, Esq.
Partner, Olsson Frank and Weeda
Washington, DC
Mark Vare, RPh, RAC
Director Marketing & Business Development
Stericycle Pharmaceutical Services
Indianapolis, IN
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11:30 a.m. |
What We Learned and What We Will Do with This Knowledge
Arthur Miller, Esq.
Bruce Bromley Professor of Law
Harvard Law School
Cambridge, MA
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Noon |
Symposium Adjournment
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