The Medical Device Regulatory and Compliance Congress Features Reimbursement Track
  • Benchmarking Your Firm's Practices in Risk Management, Quality Systems, Fraud and Abuse, and Reimbursement
  • Classes Held in Harvard University's Annenberg Hall and Harvard Faculty Club
  • Congress Hotels: The Inn at Harvard and Harvard Square Hotel, Cambridge, MA
  • March 29 - 31, 2006
Phone: 800-684-4549

CAMBRIDGE, MA USA -- PHARMA UPDATE NEWS SERVICE(TM) -- JANUARY 17, 2006: The First Annual Medical Device Regulatory and Compliance Congress (Device Congress),, held on the campus of Harvard University March 29 - 31, 2006, will feature a special Reimbursement Track. The Device Congress is sponsored by AdvaMed, Compliance-Alliance, Harvard Health Policy Review, Health Affairs, Medical Education Collaborative and a variety of leading publications.

Arthur Miller, Esq.
Bruce Bromley Professor of Law
Harvard Law School
Cambridge, MA

"It is my pleasure to welcome attendees of the Medical Device Congress to the campus of Harvard University. I hope that you will take advantage of this unique experience to study key Medical Device Regulatory and Compliance issues."

Medical Devices: Reimbursement Track
March 30, 2006
Morning Session
Moderators: Susan Morris, VP, Reimbursement Policy and Compliance, Kinetic Concepts, Inc.
Ron Geigle, Partner: Polidais, LLC
8:30 a.m. Timing Is Everything: Best Practices in Timing Coverage, Coding, and Payment
How do the timing of coverage, coding, and payment events, annual updates, and application due dates affect your strategy and planning? Where's the best place to start?

  • Stephanie Mensh, Former Vice President, Payment and Policy, AdvaMed
  • Michael J. Ruggiero, Esq., King & Spalding, LLP
9:00 a.m. Doing Double-Duty": Collecting Data for FDA and CMS in the Same Study
How do the demands from FDA and CMS for clinical trial data compare? How can companies collect data for both agencies in the same clinical trials?

  • Barbara Calvert, Director, Medical Products Reimbursement, Abbott Diagnostics
  • Gregory de Lissovoy, Ph.D., VP and Sr Research Scientist, The MEDTAP Institute, United BioSource
  • Donald P. Conway, MD, MBA, Executive Director, ABT Associates
  • Robin Strongin, Partner, Polidais LLC (Moderator)
10:00 a.m. Break
10:30 a.m. "E" Is for Evidence: Innovative Strategies for Meeting Medicare Coverage Demands
What are Medicare's new models for "coverage with evidence development" and how are they working? How can device manufacturers benefit from registries, post-market monitoring, and other approaches?

  • M. Weston Chapman, Chairman and CEO, Medical Metrx Solutions
  • Ron Milhorn, Former Senior Policy Analyst with Coverage and Analysis Group, Centers for Medicare and Medicaid Services, Managing Partner, Ron Milhorn, LLC
Noon Lunch

Afternoon Session
Moderator: Rob in Strongin, Partner: Polidais
1:30 p.m. Medicare's IT Paradigm: How Real, How Soon?
How real is CMS Director Dr. Mark McClellan's vision of "pay for performance," and an IT feedback loop on the post-marketing performance of technology? What systems currently exist and how do they function? How can device manufacturers participate and benefit?

  • Sharon Canner, Vice President, Government Affairs, eHealth Initiative
  • Rosemarie Sweeney, Vice President, Socioeconomic Affairs and Policy Analysis, American Academy of Family Physicians
2:30 p.m. Case Study: Roundtable Discussion on Challenges of Trials, Evidence, and IT
How can device manufacturers successfully manage the intricately intertwined issues of planning clinical trials, coverage with evidence development, and advances in health information technology? How can these efforts result in reasonable payment under Medicare?

  • Donald W. Moran, Founder and President, The Moran Company
  • Randel Richner, Vice President, Government Affairs and Reimbursement and Outcomes Planning, Boston Scientific
  • Ron Geigle, Partner, Polidais LLC
3:30 p.m. Break
4:00 p.m. Integrated Operations
How are the industry trends driving us toward transformational change? How can integrated operations assist with improving customer service, quality, compliance and risk management?

  • Bonnie Handke, RN, Senior Reimbursement Manager, Medtronic, Inc.
  • Donald W. Moran, Founder and President, The Moran Company
  • Susan Morris, Vice President, Reimbursement Policy and Compliance, Kinetic Concepts, Inc.
  • Parashar Patel, Vice President for Reimbursement and Outcome Planning, Boston Scientific
  • Greg White, Director of Health Policy, Johnson and Johnson
  • Stephanie Mensh, Former Vice President, Payment and Policy, AdvaMed
5:30 p.m. Adjournment and Networking Reception

For sponsorship and exhibit information contact Joni Lipson, Exhibit Manager, 215-599-6626 phone, 215-545-8107 fax, or at


Register online at, call 800-684-4549, email:

Device Congress Office
7790 Barberry Ave.
Yucca Valley CA USA 92284