Medical%20Device%20Regulatory,%20Reimbursement%20and%20Compliance%20Congress

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Medical Device Regulatory, Reimbursementand
Compliance Congress
Steve Ubl President and CEO AdvaMed
March 28, 2007
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Overview of Remarks

• About AdvaMed
• The Public Policy Environment
• AdvaMeds Priorities for 2007

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About AdvaMed

• Worlds 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.)

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AdvaMeds Daily Focus

• Appropriate Regulation
• Adequate Reimbursement
• Access to Global Markets
• Patient Access to Benefits of Medical Technology

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Defining AdvaMeds Role
FDA
CMS
Design
Clinical
Review
Coverage
Payment
Coding
Idea through FDA 2-6 yrs
Cov Paymt 0-6
Canada
Korea
Mexico
India
Japan
UK
Germany
China
France
Think Tanks
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Policy Environment
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Policy Environment
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Policy Environment, contd

• 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

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Priorities for 2007
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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

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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)

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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

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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 place

Value Price Quality
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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
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Key Legislation, contd

• Diagnostics
• Lab tests account for gt70 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

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Health Reform Principles
Shaping the future instead of being shaped by it.

• 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

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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)

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Build Industry Reputation
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

• Partnership Development
• Enhance partnerships with patient, physician, and
  hospital groups to enhance advocacy efforts

• Value of Technology
• Increase volume and frequency to solidly embed
  core messages
• Broaden channels through partnerships

Integrity of FDA

• Post market reg.
• Value of FDA risk-based approach

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Telling our story
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Medical Device Regulatory, Reimbursementand
Compliance Congress
Steve Ubl President and CEO AdvaMed
March 28, 2007