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Clinical Forum, Track I: Comparative Effectiveness

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Title: Clinical Forum, Track I: Comparative Effectiveness


1
Clinical Forum, Track I Comparative
Effectiveness
  • FAHP 2009 Annual Conference
  • September 22, 2009

2
Session Topics and Speakers
  • Comparative Effectiveness Initiatives
  • Craig A. Hunter, MPP, PGDPSenior Manager,
    Science Policy, United BioSource Corporation
  • Evidence Based Medicine as a Bridge to
    Comparative Effectiveness for Oncology Care
  • Dr. Mickey GoldsmithChief Medical Officer, New
    Century Infusion Solutions
  • Building a Case for the Prevention of Diabetes
    through Behavioral Weight Loss Interventions in a
    Managed Care Organization
  • Gareth R. Dutton, Ph.D.Assistant Professor,
    Florida State University, College of Medicine

3
Federal Initiatives in Support of Comparative
Effectiveness Research
  • Craig A. Hunter, MPP, PGDP
  • Senior Manager, Science Policy
  • United BioSource Corporation
  • FAHP 2009 Annual Conference
  • September 22, 2009

4
Overview
  • Placing CER in the US evidentiary historical
    context
  • Recent government initiatives and support for CER
    prior to September 2009
  • CERs importance in current US healthcare reform
    attempts

5
Is CER New?
  • Baseball is too much of a sport to be called a
    business, and too much of a business to be called
    a sport. 
  • Philip Wrigley, Owner of the Chicago Cubs,
    1932-1977
  • Comparative Effectiveness Research (CER) has been
    practiced too long to be considered new, and is
    too new to be understood as part of standard
    practice.

6
Evidence Eras in the US
  • 1970s Health Technology Assessment (HTA)
  • 1980s Effectiveness Research
  • 1990s Outcomes Research
  • 2000s Evidence-Based Medicine
  • Today Comparative Effectiveness Research
  • The Future? Risk-sharing/Payment for Outcomes?

7
Early Federal Evidence Eras in the US
  • 1970s Health Technology Assessment (HTA)
  • Congress Office of Technology Assessment
  • National Center for Health Care Technology
  • 1980s Effectiveness Research
  • IOMs Council for Health Care Technology
  • Agency for Health Care Policy Research
  • Veterans Health Administration

8
Where Does CER Fit In Current Practice?
Drummond et al., IJTAHC, June, 2008
9
Recent Government Support for CER
10
The President, OMB, and HHS
  • Better information about the costs and benefits
    of different treatment optionscould eventually
    lower health care spending
  • Peter Orszag, CBO, Testimony from Congressional
    Hearing on 6/12/07
  • "I think there's a general recognition that the
    system we have in America is fundamentally
    broken. We spend more than any country on Earth.
    Our health results look like we're a developing
    nation."
  • Secretary Kathleen Sebelius, HHS, CNNs State of
    the Union, 8/16/09
  • Quality is important but cost is the driver.

11
American Recovery and Reinvestment Act of 2009
  • 1.1 billion for CER through 9/30/2010
  • AHRQ 300 million
  • NIH 400 million (appropriated to AHRQ and
    transferred)
  • Office of the Secretary 400 million
  • 20 billion to CMS for Health IT Beginning in
    2011 to Provide Incentives for EMR Adoption
  • 2 billion in discretionary funds
  • 18 billion in Medicare/Medicaid Incentives

12
Institute of Medicine Committee on Comparative
Effectiveness Research Prioritization
  • Formed by ARRA to recommend national priorities
    for comparative effectiveness research
  • IOM operationalized this charge by identifying
    three objectives
  • 1) Establish a working definition of CER
  • 2) Using broad stakeholder input, develop a
    priority list of research topics for ARRA
    funding
  • 3) Identify necessary requirements to support a
    robust national CER enterprise
  • Final Recommendations published June 30, 2009
    took a broad view of potential research
    priorities (technology, systems of care,
    dissemination of information, etc.)
  • 100 research priority topics, divided into
    quartiles of importance
  • 10 recommended priorities for a robust CER
    enterprise

Committee on Comparative Effectiveness Research
Prioritization, Institute of Medicine. Initial
National Priorities for Comparative Effectiveness
Research. June 2009.
13
Agency for Healthcare Research and Quality
  • Primary Agency for CER in the US
  • Current Programs
  • Effective Health Care Program (MMA 1013)
  • Evidence-based Practice Centers (EPCs)
  • DEcIDE Research Network
  • Eisenberg Center
  • Centers for Education and Research on
    Therapeutics (CERTs)
  • Technology Assessment Program (TAP)
  • 700 million from ARRA for CER

14
Agency for Healthcare Research and Quality
  • 700 million of 1.1 billion from ARRA for CER
  • 400 passed through to National Institutes of
    Health
  • 148 million for Evidence Generation, to include
  • 100 million for Clinical and Health Outcomes
    Initiative in Comparative Effectiveness (CHOICE)
  • 48 million for patient registries
  • 29.5 million to support innovative translation
    and dissemination
  • 20 million to support CER training and
    development
  • 9.5 million for CER infrastructure
  • 10 million to Citizens Forum for stakeholder
    involvement
  • 1 million in other grants
  • 50 million toward existing evidence synthesis
    contracts
  • 24 million for additional (unspecified) evidence
    generation
  • 5 million for translation and dissemination
  • 3 million for three full-time ARRA-specific
    positions

15
Agency for Healthcare Research and Quality
  • New Evidence Generation will get most of AHRQs
    funds (172 million)
  • Stakeholder outreach and dissemination efforts
    second (44.5 million)
  • Clinical and Health Outcomes Initiative in
    Comparative Effectiveness (CHOICE)
  • a new, coordinated, national effort to
    establish a series of prospective pragmatic
    clinical comparative effectiveness studies that
    measure the benefits treatments produce in
    routine clinical practice and will include novel
    study designs focusing on real-world and
    under-represented populations (children, elderly,
    racial and ethnic minorities, and other
    understudied populations).

16
Congress, Pre-September 2009
  • Baucus/White House/PhRMA Deal of June 20, 2009
  • Cost-based negotiation
  • PhRMA members to pay 80 billion over 10 years to
    help offset Medicare drug costs
  • Legislation
  • S. 1110 Medicare Payment Advisory Commission
    (MedPAC) Reform Act of 2009
  • making the Commission an executive branch
    agency, and providing the Commission new
    resources and authority to implement Medicare
    payment policy.

17
Congress, Pre-September 2009 (contd)
  • S. 1213 Patient-Centered Outcomes Research Act
    of 2009 (Sen. Baucus)
  • H.R. 2502 Comparative Effectiveness Research Act
    of 2009 (Rep. Schrader)
  • provide for the conduct of comparative
    effectiveness research and to establish a
    Patient-Centered Outcomes Research Trust Fund

18
CERs Importance in Current US Healthcare Reform
Attempts
19
Americas Healthy Future Act of 2009
  • Chairmans Mark released September 16, 2009
  • Descriptive summary of what will be included in
    the bill once introduced
  • Lays out justifications and analysis for proposed
    changes
  • Schedule to be taken up by Senate Finance
    Committee today (September 22, 2009)
  • This is the point at which official legislative
    language will be introduced and released
  • Debate and amendments will begin immediately
  • Scope of Mark includes large range of healthcare
    reform issues

20
Americas Healthy Future Act of
2009Comparative Effectiveness
  • Two concepts previously introduced by Senator
    Baucus (Chair, Senate Finance Committee) included
    in Mark
  • Patient-Centered Outcomes Research Institute
  • Patient-Centered Outcomes Research Trust Fund
  • Patient-Centered Outcomes Research Institute
  • The purpose of the private, non-profit
    Institute would be to assist patients,
    clinicians, purchasers, and policy makers in
    making informed health decisions by advancing the
    quality and relevance of clinical evidence
    through research and evidence synthesis.ß
  • Can conduct range of Comparative Effectiveness
    Research (meta-analysis, RCTs, novel approaches)
    within guidance from methods and prioritization
    advisory panels
  • ß Chairmans Mark, Americas Healthy Future Act
    of 2009

21
Americas Healthy Future Act of
2009Comparative Effectiveness (contd)
  • Patient-Centered Outcomes Research Trust Fund
  • Establishes new trust to pay for the Institute
  • Funding comes from multiple sources including
  • 1.26 billion from General Treasury (total for
    FY2010-2019)
  • 10 million from ARRA funds appropriated to the
    Secretary (2009/10)
  • Fees on Medicare, insured, and self-insured
    (FY2013-2019)
  • Medicare
  • 1 per average number of Part A and B enrollees
    for FY2013 and 2 per average number of Part A
    and B enrollees for FY2014-19 (updated by the
    rate of medical inflation)
  • Insured and self-insuredµ
  • 1 in FY2013 and 2 in FY2014-19 on each health
    insurance policy in the United States multiplied
    by the number of lives covered under that policy
    (updated by the rate of medical inflation)
  • µApplicable self-insured health plans in the
    United States would be defined as plans providing
    accident or health coverage provided other than
    through an insurance policy and maintained by a
    plan sponsor for the benefit of members,
    employees or former employees, etc.., Chairmans
    Mark, Americas Healthy Future Act of 2009

22
Americas Healthy Future Act of 2009Medicare
Commission
  • Similar to S. 1110 Medicare Payment Advisory
    Commission (MedPAC) Reform Act of 2009, but with
    fewer teeth
  • Scope of new commission limited to making
    proposals to Congress
  • 15 person commission appointed by the President
    and confirmed by the Senate
  • Creates new commission directed to develop and
    submit proposals to Congress aimed at extending
    the solvency of Medicare, slowing Medicare
    cost-growth, and improving the quality of care
    delivered to Medicare beneficiaries.ß
  • ß Chairmans Mark, Americas Healthy Future
    Act of 2009

23
Summary
24
Summary
  • Aspects of, or related to, Comparative
    Effectiveness Research (CER) have been part of US
    healthcare policy for decades.
  • As a methodological research priority, CER has
    only recently taken a position of prominence in
    the national healthcare reform debate
  • CER is part of the current healthcare reform
    package being debated in Congress, though what
    part(s) will remain in any legislation passed
    remains to be seen.

25
Special Thanks
  • Bryan R. Luce, PhD, MBASenior Vice President,
    Science Policy, UBC
  • Rebecca Singer Cohen, MPPScience Policy Analyst,
    UBC
  • Emily Sargent, BA Production Assistant, UBC

26
Thank You
Craig A. Hunter, MPP, PGDP Senior Manager,
Science Policy, UBC craig.hunter_at_unitedbiosource.
com
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