1. Evidence-Based Medicine: Making Today’s Goals Tomorrow’s Reality Carolyn M. Clancy, MD Director Agency for Healthcare Research and Quality Washington, DC Health Policy Seminar Washington, DC – April 21, 2009

2. Current Challenges Concerns about health spending – about $2.3 trillion per year in the U.S. and growing Concerns about health spending – about $2.3 trillion per year in the U.S. and growing Large variations in clinical care Large variations in clinical care A lot of uncertainty about best practices involving treatments and technologies A lot of uncertainty about best practices involving treatments and technologies Pervasive problems with the quality of care that people receive Pervasive problems with the quality of care that people receive Translating scientific advances into actual clinical practice Translating scientific advances into actual clinical practice Translating scientific advances into usable information for clinicians and patients Translating scientific advances into usable information for clinicians and patients

3. According to Yogi Berra “If you don't know where you are going, you might wind up someplace else.” “If you don't know where you are going, you might wind up someplace else.”

4. Comparative Effectiveness and the American Recovery Reinvestment Act of 2009 (ARRA) Comparative Effectiveness and the American Recovery Reinvestment Act of 2009 (ARRA) AHRQ’s Role in Comparative Effectiveness AHRQ’s Role in Comparative Effectiveness How Can We Further Enhance Our Efforts? How Can We Further Enhance Our Efforts? Q&A Q&A Evidence-Based Medicine

5. AHRQ Priorities Effective Health Care Program Medical Expenditure Panel Surveys Ambulatory Patient Safety Patient Safety Patient Safety  Health IT  Patient Safety Organizations  New Patient Safety Grants  Comparative Effectiveness Reviews  Comparative Effectiveness Research  Clear Findings for Multiple Audiences  Quality & Cost-Effectiveness, e.g. Prevention and Pharmaceutical Outcomes  U.S. Preventive Services Task Force  MRSA/HAIs  Visit-Level Information on Medical Expenditures  Annual Quality & Disparities Reports  Safety & Quality Measures, Drug Management and Patient-Centered Care  Patient Safety Improvement Corps Other Research & Dissemination Activities

6. AHRQ FY 2009 Funding $372 million $372 million – $37 million more than FY 2008 – $46 million more than the president’s request FY 2009 appropriation includes: FY 2009 appropriation includes: – $50 million for comparative effectiveness research, $20 million more than FY 2008 – $49 million for patient safety activities – $45 million for health IT

7. Comparative Effectiveness and the Recovery Act The American Recovery and Reinvestment Act of 2009 includes $1.1 billion for comparative effectiveness research: The American Recovery and Reinvestment Act of 2009 includes $1.1 billion for comparative effectiveness research: – AHRQ: $300 million – NIH: $400 million (appropriated to AHRQ and transferred to NIH) – Office of the Secretary: $400 million (allocated at the Secretary’s discretion) Funding for health IT, prevention and other areas could have implications for the Agency

8. Recovery Act Timeline: AHRQ 2009 March 19: Establishment of Federal Coordinating Council for Comparative Effectiveness Research February 17: The American Recovery and Reinvestment Act of 2009 is signed into law JanuaryAprilJuly June 30: Due date for IOM submission of a list of national priority conditions* May 1: Due date for Agency wide and program- specific Recovery Act plans October November 1: AHRQ FY ‘10 operations plan due July 30: AHRQ to submit FY ’09 Operations Plan 2010 December 31, 2010: All Recovery Act funding to be obligated * Stakeholder input required

9. Federal Coordinating Council Established by the Office of the Secretary to offer guidance and coordination to achieve maximum use of the funding Established by the Office of the Secretary to offer guidance and coordination to achieve maximum use of the funding – Members include representatives from agencies involved in comparative effectiveness research – The Council will consider the needs of populations served by federal programs and opportunities to build and expand on current investments and priorities – The Council will not recommend clinical guidelines for payment, coverage or treatment

10. Other Aspects of the Recovery Act Includes significant funding for health IT, prevention and other activities Includes significant funding for health IT, prevention and other activities HHS-wide Recovery Act Implementation Team to address all aspects of implementing bill HHS-wide Recovery Act Implementation Team to address all aspects of implementing bill Specific subgroups for comparative effectiveness research, health IT and prevention; AHRQ and NIH co-lead comparative effectiveness workgroup Specific subgroups for comparative effectiveness research, health IT and prevention; AHRQ and NIH co-lead comparative effectiveness workgroup Detailed reporting requirements as outlined by the Office of Management and Budget and Health & Human Services Detailed reporting requirements as outlined by the Office of Management and Budget and Health & Human Services

11. Effective Health Care Program A. Evidence synthesis (EPC program) – Systematically reviewing, synthesizing, comparing existing evidence on treatment effectiveness – Identifying relevant knowledge gaps B. Evidence generation (DEcIDE, CERTs) – Development of new scientific knowledge to address knowledge gaps. – Accelerate practical studies C. Evidence communication/translation (Eisenberg Center) – Translate evidence into improvements – Communication of scientific information in plain language to policymakers, patients, and providers

12. The Future Public-private funding and participation likely a necessity Public-private funding and participation likely a necessity More effort to get better conditional reimbursement study designs/protocols More effort to get better conditional reimbursement study designs/protocols Patients should be engaged as partners at the local and national levels Patients should be engaged as partners at the local and national levels Need to tackle important issues Need to tackle important issues – Ethical – When to know when the evidence is sufficient – Transparency – Setting priorities

13. Evidence of Progress Wal-Mart Wal-Mart – Plans to sell electronic medical records to doctors Geisinger Health Systems Geisinger Health Systems – Building the capability to push specific types of information to select patient populations Marriott Marriott – Launched a preventive health campaign to help address multiple languages and diverse backgrounds of employees

14. Progress (Cont.)

15. How Can We Further Enhance Our Efforts? Key T1 activity to test what care works what care works Clinical efficacy research Key T2 activities to test who benefits from who benefits from promising care Outcomes research Comparative effectiveness Research Health services research Key T3 activities to test how to deliver high-quality how to deliver high-quality care reliably and in care reliably and in all settings all settings Measurement and accountability of health care quality and cost care quality and cost Implementation of Interventions and health care system redesign care system redesign Scaling and spread of effective interventions Research in above domains T1T2T3 Basic biomedical science Clinical efficacy knowledge Clinical effectiveness knowledge Improved health care quality and value and population health Source: JAMA, May 21, 2008: D. Dougherty and P.H. Conway, pp. 2319-2321. The “3T’s Roadmap to Transform U.S. Health Care: The ‘How’ of High-Quality Care.” The “3T’s” Road Map to Transforming U.S. Health Care

16. Future Challenges Downstream effects of policy applications Downstream effects of policy applications Making sure that comparative effectiveness is “descriptive, not prescriptive” Making sure that comparative effectiveness is “descriptive, not prescriptive” Creating a level playing field among all stakeholders Creating a level playing field among all stakeholders Ensuring that information is presented to clinicians and consumers so they can actually use it Ensuring that information is presented to clinicians and consumers so they can actually use it

17. Funding Opportunities Opportunities for the field to become involved will be made available as soon as possible: Opportunities for the field to become involved will be made available as soon as possible: – To sign up for updates, visit http://effectivehealthcare.ahrq.gov http://effectivehealthcare.ahrq.gov – To review AHRQ’s standing program and training award announcements http://www.ahrq.gov/fund/grantix.htm http://www.ahrq.gov/fund/grantix.htm

18. 2009 AHRQ Annual Conference “Research to Reform: Achieving Health System Change” September 13-16, 2009 Bethesda North Marriott Convention Center Bethesda, MD Sessions on topics including the following: - Increased Funding for Comparative Effectiveness - AHRQ’s Rapidly Expanding Health IT Portfolio - Implementation of Research Findings into Changes in Practice and Policy MARK YOUR CALENDARS!

19. Comparative Effectiveness and the American Recovery Reinvestment Act of 2009 (ARRA) Comparative Effectiveness and the American Recovery Reinvestment Act of 2009 (ARRA) AHRQ’s Role in Comparative Effectiveness AHRQ’s Role in Comparative Effectiveness Comparative Effectiveness Research and IT: The Future? Comparative Effectiveness Research and IT: The Future? Q&A Q&A Health Policy Research in the 21 st Century