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DEVICE CONGRESS - AT-A-GLANCE MARCH 28, 2007 PRECONFERENCE SESSIONS 8:30 am - 11:45 am PRECON I Implementing International Codes of Conduct PRECON II Understanding Private Payers and Maximizing Private Payer Reimbursement Strategies PRECON III After the Inspection: Managing FDA Enforcement Actions GENERAL SESSION 1:00 pm - 5:30 pm 1:00 pm Welcome John Bentivoglio, Esq. and Nancy Singer, Esq. 1:10 pm What We Know and What We Came to Learn Arthur Miller, Esq. 1:35 pm Advocating for Reasonable Regulation Stephen Ubl, AdvaMed 2:15 pm CDRH's Regulatory Agenda for 2007 - 2008 Tim Ulatowski, CDRH 3:15 pm International Harmonization: Reality or Fantasy Larry Kessler, ScD, CDRH and Michael Gropp, Medtronic, Inc. 4:10 pm CMS Priorities for 2007 - 2008: What Device Innovators Should Know about Medicare Reimbursement Carol Kelly, CMS 4:50 pm Fraud and Abuse: Lessons Learned from Government Prosecutions Michael Loucks, US Attorney's Office 5:30 pm Adjournment 5:45 pm Reception - Harvard Faculty Club 7:00 pm PricewaterhouseCoopers Banquet MARCH 29, 2007 MORNING TRACKS 8:30 am - 12:00 pm QUALITY TRACK REIMBURSEMENT TRACK FRAUD AND ABUSE TRACK INTERNATIONAL TRACK 8:30 am Welcome Welcome Welcome Welcome 8:40 am Using Management Controls to Translate Policies and Principles into Practice The Alphabet Soup of Clinical Quality Standards: What's Important? What Isn't Results from the PWC, King & Spalding and Compliance-Alliance Survey Current Regulatory Challenges in Asia 9:20 am Implementing Effective Supplier Management Programs Quality, Performance Measures and practice Guidelines: What Technology Manufacturers Should Know The OIG - Getting Companies to Comply with the Law Regulatory Initiatives in Europe 10:30 am Creating an Effective Internal Audit Program A Dash of FDA, a Pinch of CMS and What Do You Get? AdvaMed's Efforts to Promote Regulatory Compliance Opportunities in South America 11:10 am Building a Cradle-to-Grave Approach with Your Design Documentation and Data Making the Case for the Value of Your Device with Practice-Based Evidence What Healthcare Providers Are Doing to Promote Regulatory Compliance Doing Business in Ireland 11:35 am What GPO's Are Doing to Promote Regulatory Compliance AFTERNOON TRACKS 1:30 pm - 6:00 pm QUALITY TRACK REIMBURSEMENT TRACK FAIR MARKET VALUE (FMV) AND PROMOTION 1:30 pm Welcome Welcome Welcome 1:40 pm Assessing Complaints and Service Reports How to Convince the Medical Director Your Product Is Special Fair Market Value (FMV) Assessments for Health Care Professionals 2:20 pm Implementing an Effective CAPA System Coding Trends: How to Get Your Device Through the Coding Maze 3:30 pm Setting Up a Defensible System to Make Reports of Removals and Corrections Countering the Cuts - Acute Care: Managing Hospital and ASC Payment Policy for Your Products The Regulatory Authority for Off-Label Promotion and Recent Enforcement Actions 3:55 pm Countering the Cuts - Acute Care: Managing Payment Policy and Your Post Acute Care Products Across Systems and Through Competitive Bidding Action Items: Monitoring Off-Label Promotion Do's and Don'ts 4:10 pm Lessons Learned in Integrating Risk management and Process Validation Action Items: Monitoring Off-Label Promotion Do's and Don'ts 4:35 pm Coping with Reimbursement Rules and Challenges: Survey Results on How Device Companies Deploy Their Resources 4:50 pm Putting Together a Global Regulatory/Quality System 5:15 pm Developing a Strategic Reimbursement Plan 5:30 pm Adjournment Adjournment Adjournment Adjournment MARCH 30, 2007 GENERAL SESSION 8:30 am - 11:30 am 8:30 pm Lessons Learned from the Mistakes of Others Susan Alpert, PhD, MD, Medtronic, Inc. John Bentivoglio, Esq. King and Spalding Martin Browning, EduQuest Bob Klepinski, Esq. Fredrickson & Byron Robert O'Holla, Johnson & Johnson Randel Richner, Neocure Jim Sheehan, Esq. U.S. Attorney's Office Nancy Singer, Esq. Compliance-Alliance John Taylor III, Abbott Laboratories 11:30 am What We Learned and What Information Will We Be Able to Put to Use Arthur Miller, Esq. 12:00 pm Adjournment

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