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AIMBE Conference Steve Ubl President and CEO AdvaMed

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World's largest association representing medical technology innovators ... 2008 election has health care center stage. President's FY'08 Budget. Opportunities ... – PowerPoint PPT presentation

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Title: AIMBE Conference Steve Ubl President and CEO AdvaMed


1
AIMBE ConferenceSteve UblPresident and
CEOAdvaMed
February 28, 2007
2
Overview of Remarks
  • About AdvaMed / The Industry
  • The Policy Environment
  • Priorities for 2007
  • Discussion / QA

3
About AdvaMed
  • Worlds largest association representing medical
    technology innovators
  • Now grown to 1,300 member companies and
    subsidiaries (devices, diagnostics, HIS)
  • Members manufacture 90 of sales in domestic
    market, 50 global market
  • More than 70 of member companies have less than
    30 million annual revenue
  • 22 million budget, 70 staff with global
    expertise
  • 45-member Board of Directors (Siemens, Phillips,
    Medtronic, Johnson Johnson, GE, Boston
    Scientific, Roche, BD, etc.)

4

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
Source Lewin Group, 2000, 2004
5
AdvaMeds Daily Focus
  • Appropriate Regulation
  • Adequate Reimbursement
  • Access to Global Markets
  • Patient Access to Benefits of Medical Technology

6
We Have Shared Interests
  • AIMBE
  • An Advocate for Technological Innovations That
    Save, Enhance Lives

AdvaMed
To advocate a legal, regulatory and economic
climate that advances global health care by
assuring patients have access to the benefits of
medical technology.
7
Policy Environment
8
The Public Policy Environment
  • Large deficits
  • Rising health care costs
  • Medicare in the crosshairs
  • Number of the uninsured is large and growing
  • Safety/Ethics issues
  • Public wants health reform
  • 2008 election has health care center stage

9
Presidents FY08 Budget
  • Opportunities
  • 5 increase in FDA funding over 07 will help
    maintain reasonable balance between user fees and
    appropriated funds in the device center
  • 160 billion to advance health information
    technology (HIT)
  • Permanent extension of the RD tax credit
  • Challenges
  • Depth and breadth of Medicare cuts (76 billion
    over 5 yrs) and reductions in Medicare (26
    billion over 5 yrs)
  • Proposed competitive bidding program for
    diagnostics tests
  • Less than 2 of Medicare expenditures, but
    account of gt70 of decision-making

10
Priorities for 2007
11
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

Wall Street Journal February 28, 2007
Monitoring Your Heart via the Internet FDA to
Review One of the First In a Wave of New
Implants That Track Vitals Wirelessly
12
Key Legislation
  • 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

13
Key Regulatory 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

14
Value-based Purchasing
  • 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
15
Under Treatment Opportunity to Provide Value
FAILURE TO RECEIVE RECOMMENDED CARE ()
CONDITIONS
Source McGlynn et al The Quality of Health Care
Delivered to Adults in the United States NEJM
June 26, 2003
16
Regulatory Policy
  • MDUFMA Reauthorization
  • 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

17
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)

18
Regulatory Policy, continued
  • Critical Path Initiative
  • Offers opportunity to streamline development and
    regulatory processes
  • Current FDA focus is on drugs
  • Need to apply comparable analyses to device
    development
  • Stanford Study (due September 2007)
  • Models medical technology development processes,
    including
  • evolution post market entry
  • Will provide a basis for critical path analyses
    for device development

19
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)
  • Progress being made, but challenges remain to
    ensure acceptance of innovation in these
    countries

20
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 Processes
  • Post market reg.
  • Value of FDA risk-based approach

21
InHealth
  • Impact of selected devices diagnostics on six
    major diseases/conditions cardiovascular disease
    and stroke vision hearing musculoskeletal
    disease cancer and diabetes.
  • Impact of medical technology on how premature
    babies fare in neonatal intensive care.
  • Analysis of how defibrillators and stents affect
    patients with cardiovascular disease and stroke

22
How We Can Work Together
  • Collaborate on ideas for Critical Path initiative
    for faster
  • review times
  • Participate in AdvaMeds medical technology
    ambassador
  • program we provide the training and the
    opportunities
  • Leverage collective expertise in reaching out to
    the news
  • media through by-lined feature stories and
    Op-eds
  • Share information through AdvaMed SmartBrief
  • and our internal InBrief e-newsletter

23
AIMBE ConferenceSteve UblPresident and
CEOAdvaMed
February 28, 2007
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