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

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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

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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.

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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

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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
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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