March 28, 2007
Medical Device Regulatory, Reimbursementand Compliance Congress
Steve UblPresident and CEOAdvaMed
• About AdvaMed
• The Public Policy Environment
• AdvaMed’s Priorities for 2007
Overview of Remarks
About AdvaMed
• World’s largest medical technology association
• 1,300+ member companies and subsidiaries
• Members produce 90% of sales in domestic market, 50% of sales in global market
• 70%+ of member companies have less than $30 million in annual revenue
• 70 staff with global expertise, bi-partisan backgrounds
• 45 member Board of Directors (BD, Siemens, Philips, Medtronic, Johnson & Johnson, GE, Boston Scientific, Roche, etc.)
AdvaMed’s Daily Focus
Appropriate Regulation
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Adequate Reimbursement
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Access to Global Markets
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Patient Access to Benefits of Medical Technology
Defining AdvaMed’s Role
Design
Clinical Review
Idea through FDA: 2-6 yrs
Coverage
Payment
CodingCov & Paymt:
0-6
JapanCanada
UKKorea
GermanyMexico
ChinaIndiaFrance
Think Tanks
Policy Environment
Policy Environment
Policy Environment, cont’d
The Legislative Front
• More industry oversight
• Critically important legislation pending― Federal budget proposal with deep Medicare cuts― SCHIP― Physician Fee Fix
― Consideration of MDUFMA, PDUFA, drug safety, others will mean major FDA bill
Priorities for 2007
Regulatory Policy
MDUFMA Reauthorization
Issues with MDUFMA I• Unpredictable and unexpectedly high fee increases from year-to-
year
• “Clock-stopping” behavior due to cycle goals
• FDA focused on goals rather than interacting with applicants
Outlook for MDUFMA II• Agreement in principle reached with FDA
• Reduced fees across the board for applications
• Sets forth a user fee structure that instills more predictability in to the year-to-year increases in fees
• Provides important performance goals to significantly reduce application review times while ensuring safety and efficacy
Regulatory Policy, continued
• Post Market Regulation– Inappropriate comparison between drugs and devices
– AdvaMed working to• Assist FDA in streamlining and “connecting the
dots” with adverse event reports
• Establish clearer criteria for communicating risk– Limit use of “recall” to appropriate situations
• Develop flexible approach to Unique Device Identifiers (UDI)
Key Payment Rules
• Inpatient Round II― Severity weighted diagnosis related groups (DRGs)
― Hospital-specific relative values (HSRVs)
― Charge compression adjustment possible
• Competitive Bidding― Potential for cheapest is best approach to technology
― Inappropriately group different technologies together for bidding purposes
― Could deny patients access to best care
Value-based Purchasing
• Legislative initiatives likely – demonstrations ongoing― advocated by key health policy makers / analysts
• If done correctly― Improves quality
― Enhances diffusion of innovative technologies
― Rewards quality and efficiency
• If done incorrectly― “Efficiency” can become code for “cheapest is best”
― Freezes technology in placeValue = Price + Quality
Key Legislation
• Remote Monitoring― Prime example of payment policy not keeping pace with technology
― Offers physicians real-time, remotely accessed patient information
― Provides homebound and rural patients 24/7 link to health care
― Legislation would eliminate disincentives in current Medicare rules that only provide payment for face-to-face meetings between patients and their doctors.
Patient using an ECG/Rhythm strip recorder, a blood pressure cuff and a TeleStation that sends data via modem from the telestation to a server, then on to the care manager. Courtesy: Philips
Key Legislation, cont’d
• Diagnostics― Lab tests account for >70% of treatment decisions, but are less than 2% of Medicare costs
― Horse and buggy payment policy in the age of molecular medicine
― Legislation establishes new payment mechanism for molecular diagnostic tests based on resource use and value
Health Reform Principles
• Expand health coverage to all, so that every American can have access to the best medicine has to offer
• Improve the efficiency and quality of health care– Quality of care highest priority– Control cost the right way: lift the burden of
disease and improve efficiency• Prevention• Quality• Efficiency• Medical innovation
Shaping the future instead of being shaped by it.Shaping the future instead of being shaped by it.
International Top Line
• Nascent health care economies: China, India
• Japan: Foreign reference pricing
• EU: DRGs and procurement policies
– Europeans have followed US model for hospital payment based DRGs (France, Germany, UK, Italy)
Partnership Development
•Enhance partnerships with patient, physician, and hospital groups to enhance advocacy efforts
Industry Reputation
Compliance and Code of Ethics
• Increase outreach and education
• Firmly establish logo license as compliance icon
• Develop other tools / programs to help ensure appropriate HCP relationships
Value of Technology
•Increase volume and frequency to solidly embed core messages
•Broaden channels through partnerships
•Post market reg.
•Value of FDA risk-based approach
Integrity of FDA
Build Industry Reputation
Telling our story
March 28, 2007
Medical Device Regulatory, Reimbursementand Compliance Congress
Steve UblPresident and CEOAdvaMed