The Current Evidence-Based Medicine Landscape

Report Prepared for:National Pharmaceutical Council

Prepared by:Bryan R. Luce, PhD, MBA

Rebecca Singer Cohen, MPPCraig Hunter, MPP, PGDP

Lael Cragin, MPHJeanene Johnson, BA

April 2008

THE CURRENT EVIDENCE-BASED

MEDICINE LANDSCAPE

7101 Wisconsin AvenueSuite 600Bethesda, MD 20814

Phone: 1-301-654-9729Fax: 1-301-654-9864

www.UnitedBioSource.com

The Current Evidence - Based Medicine Landscape National Pharmaceutical Council 1

TABLE OF CONTENTS

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

I. GOVERNMENT INITIATIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Agency for Healthcare Research and Quality (AHRQ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

AHRQ Organizational Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5National Advisory Council for Healthcare Research and Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6U.S. Preventive Services Task Force (USPSTF) Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Evidence-Based Practice Center (EPC) Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12Effective Health Care (EHC) Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15Comparative Effectiveness Reviews (CERs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18Centers for Education & Research on Therapeutics (CERT) Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

CMS’s Coverage with Evidence Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24Coverage with Appropriateness Determination (CAD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24Coverage with Study Participation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25Data Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

HHS Value-Driven Health Care Initiative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27Chronic Conditions Data Warehouse (CCW) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27The Department of Defense PharmacoEconomic Center (PEC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28Veterans Affairs Technology Assessment Program (VATAP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28National Institutes of Health- Clinical and Translational Science Awards (CTSA) . . . . . . . . . . . . . . . . . . . . . . .28National Institutes of Health- Antihypertensive and Lipid Lowering Treatment to

Prevent Heart Attack Trial (ALLHAT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29National Institutes of Health- Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) . . . . . . . . .30Centers for Disease Control and Prevention- Evaluation of Genomic Application

in Practice and Prevention (EGAPP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30Oregon Health & Science University Drug Effectiveness Review Project (DERP) . . . . . . . . . . . . . . . . . . . . . . . .31Medicaid Evidence-Based Decisions Project (MED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33Washington State Health Technology Assessment Program (SHTAP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

II. PROPOSALS FOR COMPARATIVE EFFECTIVENESS CENTERS . . . . . . . . . . . . . . . . . . . . . . . . . .34Gail Wilensky’s Proposed Center for Comparative Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34Blue Cross and Blue Shield Association Proposed Payer-Funded Center for Comparative Effectiveness . . . . .34Enhanced Health Care Value for All Act of 2007 (H.R. 2184) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35S.3, Medicare Prescription Drug Price Negotiation Act of 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37H.R. 3162: The Children’s Health and Medicare Protection Act of 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38Baucus/Conrad Senate bill: Introduced and Withdrawn March 4, 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40Congressional Budget Office report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40

III. PRIVATE INITIATIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41America’s Health Insurance Plans (AHIP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41Center for Medical Technology Policy (CMTP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41Institute for Clinical and Economic Review (ICER) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43

National Pharmaceutical Council The Current Evidence - Based Medicine Landscape2

IV. INDEPENDENT EVIDENCE-BASED MEDICINE INITIATIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . .44Institute of Medicine (IOM) Roundtable on Evidence-Based Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44The James Lind Alliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46The Cochrane Collaboration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46ECRI Institute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47Hayes, Inc. – The Health Technology Assessment Company . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48AcademyHealth Support of Comparative Effectiveness Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48Academy of Managed Care Pharmacy’s Format for Formulary Submissions . . . . . . . . . . . . . . . . . . . . . . . . . . . .48

V. CONSUMER-FOCUSED INITIATIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49Consumer Reports Best Buy Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49American Association of Retired Persons (AARP) ResearchRx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51Alliance for Better Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51National Working Group on Evidence-Based Healthcare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51US Cochrane Collaboration’s Consumers United for Evidence-based Healthcare (CUE) . . . . . . . . . . . . . . . . .52

VI. MEASURING VALUE IN HEALTH CARE: Standardizing Metrics . . . . . . . . . . . . . . . . . . . . . .54National Committee for Quality Assurance (NCQA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54The Health Plan Employer Data and Information Set (HEDIS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55Pharmacy Quality Alliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55

VII. INTERNATIONAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57U.K.’s National Institute for Health and Clinical Excellence (NICE) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57Canadian Agency for Drugs and Technologies in Health (CADTH) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58The International Network of Agencies for Health Technology Assessment (INAHTA) . . . . . . . . . . . . . . . . . . .58Health Technology Assessment International (HTAi) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59The OECD Health Care Quality Indicators Project . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59

VIII. EVIDENCE-BASED MEDICINE CONGRESSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60October 2006 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60November 2006 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61January 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62February 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62March 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63April 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64May 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65June 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69July 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71August 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72September 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73October 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74December 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76


January 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76February 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77March 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .78April 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79May 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80June 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82July 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85September 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86October 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87November 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88March 2009 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88On-going . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89

APPENDIX A: AHRQ STAFF BIOS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90

APPENDIX B: National Advisory Council for Healthcare Research and Quality Bios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98

APPENDIX C: U.S. Preventive Services Task Force Bios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .105

APPENDIX D: Evidence–Based Practice Center Bios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109

APPENDIX E: Effective Health Care Program’s Stakeholder Group Bios . . . . . . . . . . . . . .126

APPENDIX F: Center for Medical Technology Policy Staff Bios . . . . . . . . . . . . . . . . . . . . . . . .135

TABLES AND FIGURESTable 1. National Advisory Council for Healthcare Research and Quality as of April 2008 . . . . . . . . . . . . . . . .7-9Table 2. USPSTF Members as of May 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10Table 3. EPC Evidence-Based Reports in Progress as of April 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14Table 4. Technology Assessments in Progress as of April 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15Table 5. EHC Program’s Stakeholder Group (Fall 2007 – Summer 2009) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16Table 6. DERP Drug Reviews . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32Table 6. Comparative Effectiveness Reviews (CERPS) by Priority Condition . . . . . . . . . . . . . . . . . . . . . . . . . . .19Table 7. EHC Programs DEcIDE Research Projects as of May 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22Table 7. Center for Medical Technology Policy Staff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40Table 8. AHRQ’s CERT Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23Table 8. Consumers Reports Best Buy Drug Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49Table 9. Members of Consumers Reports Best Buy Drugs Advisory Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50Table 10. Consumers United for Evidence-based Healthcare: 2007 Member Organizations . . . . . . . . . . . . . . .53Table 11. Members of Pharmacy Quality Alliance Steering Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56Figure 1. AHRQ Official Organizational Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Figure 2. AHRQ Organizational Structure and Programs Related to EBM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Figure 3. Evidence-based Practice Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13Figure 4. Organizational Substructure of AHRQ’s EHC Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18


INTRODUCTION

This reference guide was developed to identify and document all relevant organizations, activities, proposalsand key individuals associated with the evidence movement in the U.S. This includes anything of note under therubric of evidence-based medicine (EBM), comparative effectiveness, health (or medical) technology assessment(HTA), outcomes research, effectiveness research, etc. This identification process was accomplished via literaturereview, Web exploration, word of mouth and, generally, via existing professional contacts.


I. GOVERNMENT INITIATIVES

AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ)

The Agency for Healthcare Research and Quality (AHRQ) was established in 1989 as the Agency forHealthcare Policy and Research. Reauthorizing legislation, passed in November 1999, establishes AHRQ as thelead Federal agency charged with supporting research designed to improve the quality, safety, efficiency, andeffectiveness of health care for all Americans, reduce its cost, and broaden access to essential services. To achievethese goals, the Agency conducts and supports a broad base of scientific research and promotion ofimprovements in clinical and health systems practices, including the prevention of diseases and other healthconditions. AHRQ sponsors and conducts research that develops and presents evidence-based information onhealth care outcomes, quality, patient safety, cost, use and access. Included in AHRQ’s mandate is support ofsynthesis and dissemination of available scientific evidence, including dissemination research and analyticmethods or systems for rating the strength of scientific evidence.

AHRQ Organizational StructureFigure 1 shows the official organizational structure of AHRQ. Figure 2 shows the AHRQ organizational

structure and programs related to EBM.

FIGURE 1. AHRQ Official Organizational Structure

Office of the Director

Carolyn M. Clancy, MDDirector

Kathie Kendrick, RN, MS, C.S.Deputy Director

Office of Extramural Research, Education and Priority Populations

Francais D. Chesley, Jr., MDDirector

Directs the scientific review process for grantsand contracts, manages Agency research training programs, evaluates the scientific

contribution of proposed and ongoing researchand demonstrations; and supports and conductshealth services research on priority populations

Center for Financing, Access, and Cost Trends

Steven B. Cohen, PhDDirector

Conducts, supports, and manages studies of the cost and financing of health care,

the access to health care services and related trends. CFACT also develops

data sets to support policy and behavioral research and analyses

Office of Communicationsand Knowledge Transfer

Allan J. Lazar, MBADirector

Designs, develops, implements, and manages programs for disseminating

the results of Agency activites with the goal of changing audience behavior

Office of Performance Accountability,Resources and Technology

Jeffrey TovenDirector

Directs and coordinates Agency-wide program planning and evaluations

activites and administrative operations.

Center for Delivery, Organization, and Markets

Irene Fraser, PhDDirector

Provides a locus of leadership and expertise foradvances in health care delivery, organization,

and markets through research

Center for Quality Improvement and Patient Safety

William B. Munier, MDDirector

Works to improve the quality and safety of ourhealth care system through research and

implementation of evidence

Center for Primary Care, Prevention, and Clinical Partnerships

David Meyers, MDDirector

Expands the knowledge base for clinical providers and patients and assures the

translation of new knowledge and systemsimprovment into primary care practice

Center for Outcomes and Evidence

Jean R. Slutsky, PA, MSP.HDirector

Conducts and supports research and assessment of health care, technologies,

processes, and systems


FIGURE 2. AHRQ Organizational Structure and Programs Related to EBM

Biographies of key AHRQ individuals involved in EBM are provided in Appendix A. The following sectionsdescribe in further detail the EBM programs supported by AHRQ, including their organizational sub-structureand key individuals.

National Advisory Council for Healthcare Research and QualityThe National Advisory Council for Healthcare Research and Quality provides advice and recommendations

to the Director of AHRQ and to the Secretary, Department of Health and Human Services (HHS), on prioritiesfor a national health services research agenda.

The 21-member panel is comprised of private-sector experts who contribute a varied perspective on thehealth care system and the most important questions that AHRQ’s research should address in order to promoteimprovements in the quality, outcomes, and cost-effectiveness of clinical practice. The private-sector membersare appointed by the Secretary, HHS, to serve 3-year terms and represent health care plans, providers, purchasers,consumers, and researchers.

National Advisory Council for Healthcare Research & Quality

Evidence-based Practice Centers (EPC) Program*

Director: Kenneth Fink, MD, MGA, MPH

U.S. Preventive Services Task Force ProgramProject Coordinator: Therese Miller, DrPH (AHRQ)

Reviews by: Oregon Evidence-Based Practice Center

Centers for Education & Research onTherapeutics (CERTs) Program*

Coordination Center: Duke University Medical CenterDirector: Robert M. Califf, MD

AHRQ Program Officer: Lynn A. Bosco, MD, MPH

U.S. Preventive Services Task Force (USPSTF)Chair: Bruce N. Calonge, MD, MPH

Vice Chair: Diana B. Petitti, MD, MPH

Effective Health Care (EHC) Program*

Scientific Resource Center located at Oregon EPC

Center for Outcomes and Evidence (COE)Director: Jean R. Slutsky, PA, MSPH

Center for Primary Care, Prevention, & Clinical Partnerships

Director: Helen Burstin, MD, MPHDeputy Director: David C. Lanier, MD

Agency for Healthcare Research and Quality (AHRQ) U.S. Department of Health and Human Services

Office of the DirectorDirector: Carolyn M. Clancy, MD

Deputy Director: Kathie Kendrick, MS, CS, RN

* Organizational sub-structure of these EBM programs are provided in subsequent sections of report.


Also serving in an ex-officio capacity are principal representatives of seven Federal agencies that address healthcare system issues:

1. National Institutes of Health (NIH); the Department of Defense (Health Affairs) (DoD)

2. Centers for Disease Control and Prevention (CDC)

3. Department of Veterans Affairs (VA)

4. Office of Personnel Management (OPM)

5. Food and Drug Administration (FDA)

6. Centers for Medicare & Medicaid Services (CMS)

7. Assistant Secretary for Health

Current Members(See Appendix B for National Advisory Council biographies.)

T A BLE 1. National Advisory Council for Healthcare Research and Quality as of April 200Jane F. Barlow, MD, MPH, MBA (2009)Vice President Medical Strategy & Clinical QualityMedco Health Solutions, Inc.100 Parsons Pond Drive, MailstopF2-16Franklin Lakes, NJ 07417Phone: (201) 269-3539E-mail: [email protected]

Dale W. Bratzler, DO, MPH (2008)QIOSC Medical DirectorOklahoma Foundation for MedicalQuality, Inc.14000 Quail Springs Parkway, Suite400Oklahoma City, OK 73134Phone: (405) 840-2891 X209Fax: (405) 840-1343E-mail: [email protected]

Timothy J. Brei, MD (2009)Clinical Assistant Professor ofPediatricsThe James Whitcomb Riley Hospitalfor Children702 Barnhill Drive, Room 1601Indianapolis, IN 46202-5200Phone: (317) 274-4846Fax: (317) 278-0126E-mail: [email protected]

Patricia Flatley Brennan, PhD, RN,FAAN, FACMI (2008)Moehlman Professor of Nursing andIndustrial EngineeringUniversity of Wisconsin-Madison600 Highland Avenue H6/241Madison, WI 53792Phone: (608) 263-5251Fax: (608) 263-5251E-mail: [email protected]

Andrew J. Fishmann, MD, FCCP,FACP (2009)Director, Intensive Care Unit Good Samaritan HospitalCalifornia Lung Associates1245 Wilshire Boulevard, Suite 407Los Angeles, CA 90017Phone: (213) 977-4979Fax: (213) 977-0544E-mail: [email protected]

Robert S. Galvin, MD (2010)Director, Global Health CareGeneral Electric 376 Hillside RoadFairfield, CT 06824Phone: (203) [email protected]

TABLE 1. National Advisory Council for Healthcare Research and Quality as of April 2008


M. Carolina Hinestrosa, M.A., MPH (2009)Executive Vice President, Programsand PlanningNational Breast Cancer Coalition1101 17th Street NW Suite 1300Washington, DC 20036Phone: (202) 973-0575Fax: (202) 265-6854E-mail:[email protected]

Ada Sue Hinshaw, PhD, RN (2008)2006 Nurse ScholarNational Academy of Sciences500 Fifth Street NWWashington, DC 20001Phone: (202) 334-2000E-mail: [email protected]

Carlos Roberto Jaen, MD, PhD, FAAFP (2008)Co-Director, Center for Research inFamily Medicine and Primary CareThe Dr. John M Smith, Jr. Professor& ChairmanDepartment of Family & CommunityMedicine University of Texas Health ScienceCenter7703 Floyd Curl DriveSan Antonio, TX 78229-3900Phone: (210) 567-4553Fax: (210) 567-4579E-mail: [email protected]

Brent C. James, MD (2008)Vice President for Medical ResearchExecutive Director, Institute forHealth Care Delivery ResearchIntermountain Health Care36 South State Street, 16th FloorSalt Lake City, UT 84111-1486Phone: (801) 442-3730Fax: (801) 442-3486E-mail: [email protected]

Wishwa N. Kapoor, MD, MPH (2010)School of MedicineUniversity of Pittsburgh200 Lothrop Street, Suite 933W-MUHPittsburgh, PA 15213Phone: (412) 692-4821E-mail: [email protected]

Munr Kazmir, MD (2008)Founder, Direct Meds, Inc.345 Grand AvenueLeonia, NJ 07605Phone: (201) 585-9234Fax: 9202) 585-7950E-mail: [email protected]


Kathleen Lohr, PhD (2010)Distinguished Fellow, Health Services ResearchRTI InternationalPO Box 121943040 Cornwallis RoadResearch Triangle Park, NC 27709-2194Phone: (919) 541-6512E-mail: [email protected]

Thomas P. Miller, JD (2009)American Enterprise Institute1150 Seventeenth Street, NWWashington, DC 20036Phone: (202) 862-5886Fax: (202) 828-7177E-mail: [email protected]

Neil R. Powe, MD, MPH, MBA(2009)Director, Welch Center forPrevention, Epidemiology & Clinical ResearchProfessor of Medicine, Epidemiology and Health Policy &ManagementThe Johns Hopkins University School of Medicine and BloombergSchool of Public Health2024 E. Monument Street, Suite 2-600Baltimore, MD 21287-2223Phone: (410) 955-6953Fax: (410) 955-0476E-mail: [email protected]


U.S. Preventive Services Task Force (USPSTF) ProgramThe U.S. Preventive Services Task Force (USPSTF), first convened by the U.S. Public Health Service in 1984,

and since 1998 sponsored by the AHRQ, is the leading independent panel of private-sector experts in preventionand primary care. The USPSTF conducts rigorous, impartial assessments of the scientific evidence for theeffectiveness of a broad range of clinical preventive services, including screening, counseling, and preventivemedications. Its recommendations are considered the “gold standard” for clinical preventive services.

The USPSTF is supported by the Oregon Evidence-Based Practice Center, is a collaboration between theOregon Health & Science University Department of Medicine, the Portland Veterans Affairs Medical Center, andthe Kaiser Permanente Center for Health Research. Under contract to AHRQ, the Oregon EPC conductssystematic reviews of the evidence on specific topics in clinical prevention that serve as the scientific basis forUSPSTF recommendations. The USPSTF, in turn, reviews the evidence, estimates the magnitude of benefits andharms for each preventive service, reaches consensus about the net benefit for each preventive service, and issuesa recommendation.

The USPSTF comprises primary care clinicians (e.g., internists, pediatricians, family physicians,gynecologists/obstetricians, and nurses). Individual members’ interests include: decision modeling andevaluation; effectiveness in clinical preventive medicine; clinical epidemiology; the prevention of high-riskbehaviors in adolescents; geriatrics; and the prevention of disability in the elderly.

AHRQ’s Center for Primary Care, Prevention, and Clinical Partnerships, which is directed by Helen BurstinMD, MPH, oversees the USPSTF Program. Therese Miller, DrPH, serves as the USPSTF project coordinator.Their biographies are available in Appendix A.

William Smith, PharmD, MPH,PhD, FASHP (2010)Executive Associate DeanSchool of PharmacyVirginia Commonwealth UniversitySmith BuildingSuite 155Richmond, VA 23298-0581Phone: (804) 828-3009E-mail: [email protected]

Myrl Weinberg, CAE (2010)President, National Health Council1730 M. Street, NWSuite 500Washington, DC 20036Phone: (202) 785-3910E-mail: [email protected]

Anthony C. Wisniewski, JD (2009)Executive Director, Health PolicyU.S. Chamber of Commerce1615 H Street, NWWashington, DC 20006Phone: (202) 463-5500E-mail: [email protected]

Michael K. Raymond, MD (2010)Chief Medical OfficerRush North Shore Medical Center9600 Goss Point RoadSkokie, IL 60076Phone: (847) 933-6007E-mail: [email protected]

James J. Rohack, MD, FACC, FACP (2008)Senior Staff CardiologistMedical Director, Scott & WhiteHealth PlanScott & White Clinic2401 South 31st StreetTemple, TX 76508Phone: (254) 724-4258Fax: (254) 724-0720E-mail: [email protected]

David L. Shern, PhD (2010)President and CEONational Mental Health Association2600 North Beauregard Street, 6th FloorAlexandria, VA 22311Phone: (703) 838-7500E-mail: [email protected]



Current Members(See Appendix C for USPSTF biographies.)

TABLE 2. USPSTF Members as of May 2007

Lucy N. Marion, PhD, RNDean and Professor, School ofNursing Medical College of GeorgiaAugusta, GA

Bernadette Melnyk, PhD, RN,CPNP./NPPDean and Distinguished FoundationProfessor in NursingCollege of Nursing & HealthcareInnovationArizona State University Phoenix, AZ

Virginia A. Moyer, MD, MPHProfessor, Department of PediatricsDirector of the Fellowship Programin Academic General PediatricsBaylor College of Medicine,Houston, TXAssociate Director of AmbulatoryServicesTexas Children’s Hospital Houston,TX

TABLE 2. USPSTF Members as of May 2007Bruce N. Calonge, MD, MPH (Chair)Chief Medical Officer and State EpidemiologistColorado Department of PublicHealth and Environment, Denver, CO

Diana B. Petitti, MD, MPH (ViceChair)Adjunct ProfessorUniversity of Southern CaliforniaLos Angeles, CA

Allen J. Dietrich, MDProfessor, Community and FamilyMedicineDartmouth Medical School

Thomas G. DeWitt, MDCarl Weihl Professor of Pediatrics Director of the Division of Generaland Community PediatricsDepartment of Pediatrics, Children’s Hospital Medical CenterCincinnati, OH

Kimberly D. Gregory, MD, MPHDirector, Maternal-Fetal Medicineand Women’s Health ServicesResearch Cedars-Sinai Medical Center Los Angeles, CA

David Grossman, MDMedical Director, Preventive Careand Senior Investigator, Center forHealth Studies, Group HealthCooperativeProfessor of Health Services andAdjunct Professor of PediatricsUniversity of Washington Seattle,WA

George Isham, MD, MSMedical Director and Chief HealthOfficerHealthPartners Minneapolis, MN

Michael L. LeFevre, MD, MSPHProfessor, Department of Family andCommunity MedicineUniversity of Missouri School ofMedicineColumbia, MO

Rosanne Leipzig, MD, PhDProfessor, Geriatrics and AdultDevelopment, Medicine, Health PolicyMount Sinai School of Medicine

Judith K. Ockene, PhD, MEdProfessor of MedicineUniversity of Massachusetts MedicalSchoolWorcester, MA

George F. Sawaya, MDAssociate ProfessorDepartment of Obstetrics,Gynecology, and ReproductiveSciencesDepartment of Epidemiology andBiostatisticsUniversity of CaliforniaSan Francisco. CA

J. Sanford (Sandy) Schwartz, MDLeon Hess Professor of Medicine,Health Management, andEconomicsUniversity of Pennsylvania School ofMedicine and Wharton SchoolPhiladelphia, PA

Timothy Wilt, MD, MPHProfessor, Department of Medicine,Minneapolis VA Medical CenterUniversity of MinnesotaMinneapolis, MN


These topics are being reviewed by the U.S. Preventive Services Task Force:

• Additional Risk Factors for Intermediate CHD Risk

• Aspirin Use for the Primary Prevention of CHD

• Aspirin Use to Prevent Preeclampsia

• Asymptomatic Bacteriuria

• Breastfeeding

• Breast Cancer Screening

• Cervical Cancer Screening

• Colorectal Cancer Screening

• Counseling to Prevent Sexually Transmitted Infections

• Depression in Adults

• Depression in Children and Adolescents

• Diabetes Mellitus

• Falls in Older Adults

• Folic Acid Supplementation

• Gestational Diabetes

• Hearing Impairment, Older Adults

• Hearing, Newborn

• Lipid Disorders in Adults (Cholesterol Abnormalities, Dyslipidemia)

• Osteoporosis Screening

• Osteoporosis Preventive Medicine

• Ovarian Cancer

• Prostate Cancer Screening

• Skin Cancer Counseling

• Skin Cancer Screening

• Visual Impairment in Older Adults

• Vitamin Supplements to Prevent Cancer and CHD


Evidence-Based Practice Center (EPC) ProgramUnder the Evidence-based Practice Center (EPC) Program of AHRQ, launched in 1997 to synthesize existing

scientific literature about important health care topics and promote evidence-based practice and decision-making, 5-year contracts are awarded to institutions in the United States and Canada to serve as EPCs. The EPCsdevelop evidence reports and technology assessments on topics relevant to clinical, social science/behavioral,economic, and other health care organization and delivery issues — specifically those that are common,expensive, and/or significant for the Medicare and Medicaid populations. These reports are used for informingand developing coverage decisions, quality measures, educational materials and tools, guidelines, and researchagendas. Topics are nominated by non-federal partners such as professional societies, health plans, insurers,employers, and patient groups. The EPCs also conduct research on methodology of systematic reviews.

AHRQ’s Center for Outcomes and Evidence (COE), directed by Jean Slutsky, PA, MSPH, oversees the EPCProgram. Beth Collins Sharp, PhD, RN, serves as Director of the EPC Program. See Appendix A for theirbiographies.

The following figure lists the 14 EPCs that comprise AHRQ’s Evidence-Based Practice Center Program as wellas the director(s) of each EPC. See Appendix D for biographies for each of the EPC directors and co-directors,if applicable.


FIGURE 3. Evidence-based Practice Centers

* Three EPCs (Duke University, ECRI, and Tufts University) focus on technology assessments for CMS.

† The Oregon EPC focuses on evidence reports for the U.S. Preventive Services Task Force (USPSTF).

‡ Three EPCs (Duke University, Johns Hopkins University, and RTI International—University of North Carolina at Chapel Hill) also serve as DEcIDE Research Centers aspart of the Effective Health Care Program, discussed in a subsequent section.

Blue Cross and Blue Shield Association, Technology Evaluation CenterDirector: Naomi Aronson, PhD

Duke University * ‡Director: David B. Matchar, MD

Head: Douglas McCrory, MD

RTI International —University of North Carolina at Chapel Hill††

Co-Director: Kathleen N. Lohr, PhD (RTI)Co-Director: Timothy S. Carey, MD, MPH (UNC)

Oregon Evidence-Based Practice Center †(collaboration between OHSU School of Medicine,

the Portland Veterans Affairs Medical Center, and theKaiser Permanente Center for Health Research)

Director: Mark Helfand, MD, MS, MPH

University of ConnecticutCo-Director: C. Michael White, PharmDCo-Director: Craig Coleman, PharmD

Southern California Evidence-Based Practice Center-RAND

Director: Paul Shekelle, MD, PhD

Vanderbilt UniversityDirector: Katherine E. Hartmann, MD, PhD

Assoc. Director for Methods: Sandra Micucci, MSC

Tufts University — New England Medical Center *Director: Joseph Lau, MD

University of Minnesota, Minneapolis, MNDirector: Robert L. Kane, MD

McMaster UniversityDirector: Parminder Raina, PhD

ECRI *Director: Karen Schoelles, MD, SM

Principal Investigator: Vivian H. Coates, MBA

University of Alberta, CanadaDirector: Terry P. Klassen, MD, MSc

Associate Director: Brian H. Rowe, MD, MSc Associate Director: Donna Dryden, PhDCo-Director: Lisa Hartling, BScPT, MSc

Johns Hopkins University ‡Director: Eric B. Bass, MD, MPH

Co-Director: Neil R. Powe, MD, MPH, MBACo-Director: Karen A. Robinson, MSc

University of Ottawa, Ottawa, CanadaDirector: David Moher, PhD

Coordinator: Chantelle Garritty

AHRQ’s Evidence-based Practice Center (EPC) Program

Director: Kenneth Fink, MD, MGA, MPH


EPC Evidence-Based ReportsThe EPCs develop evidence reports and technology assessments based on rigorous, comprehensive syntheses

and analyses of the scientific literature on topics relevant to clinical, social science/behavioral, economic, andother health care organization and delivery issues. EPC reports and assessments emphasize explicit and detaileddocumentation of methods, rationale, and assumptions. These scientific syntheses may include meta-analysesand cost analyses. All EPCs collaborate with other medical and research organizations so that a broad range ofexperts is included in the development process.

The resulting evidence reports and technology assessments are used by federal and state agencies, privatesector professional societies, health delivery systems, providers, payers, and others committed to evidence-basedhealth care. In addition, the EPCs undertake methods research, update prior evidence reports, and providetechnical assistance to professional organizations, employers, providers, policymakers, etc. to facilitate translationof the reports into quality improvement tools, evidence-based curricula, and reimbursement policies.

The following two tables list the evidence-based reports and technology assessments in progress.

Disease Area Evidence-Based Report

Cancer and Blood Disorders HER2 Testing to Manage Patients with Breast or Other Solid Tumors(mid 2008)

Financing Regulation of Healthcare, Costs (mid 2008)

Heart and Vascular Diseases Erectile Dysfunction, Diagnosis and Treatment (mid 2008)

Information Technology Barriers and Drivers of Health IT Use for the Elderly, Chronically Ill, and Underserved (late 2008)

Metabolic, Nutritional, and Nutrition (mid 2008)Endocrine Conditions

Obstetric and Gynecologic Conditions Adverse Maternal & Child Health Outcomes Associated with Maternal Weight Gain (mid 2008)

Assisted Reproductive Technology, Effectiveness and Efficiency (mid 2008)

Bariatric Surgery in Women of Reproductive Age (mid 2008)

Elective Induction of Labor (mid 2008)

Oral and Gastrointestinal Disorders Management of Chronic Hepatitis B (late 2008)

Pediatric Adverse Maternal & Child Health Outcomes Associated with Maternal Weight Gain (mid 2008)

Effectiveness of Weight Reduction Programs in Children (mid 2008)

TABLE 3. EPC Evidence-Based Reports in Progress as of April 2008


Effective Health Care (EHC) ProgramThe Effective Health Care (EHC) Program is a new program authorized under Section 1013 of the Medicare

Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. The essential goals of the Section1013 mandate are to develop evidence on the comparative effectiveness of different treatments and appropriateclinical approaches to difficult health problems. To achieve these goals, AHRQ has begun to support projects(via the EHC program) that review, synthesize and translate published and unpublished scientific evidence, aswell as identify important issues for which existing scientific evidence is insufficient to inform decisions abouthealth care.

Supporting the EHC Program as a whole is the Scientific Resource Center. Located at the Oregon EPC (acollaboration of Oregon Health & Science University—Department of Medical Informatics and ClinicalEpidemiology, the Portland Veterans Affairs Medical Center, and the Kaiser Permanente Center for HealthResearch) and directed by Mark Helfand, MD, the Scientific Resource Center has specific responsibilities to:

• Communicate with stakeholders.

• Assist with the development of key questions and research topics.

• Coordinate peer review and public input for comparative effectiveness reviews.

• Support the methodological work of effectiveness reviews and research projects.

The EHC Program’s primary principle is that all stakeholders should have the best available evidence onwhich to make decisions about health care items and services. They should be active participants and partnersin these efforts. Therefore, a Stakeholder Group was established to support the program in collaboration withthe Scientific Resource Center. The volunteer group represents several broad constituencies of stakeholders,including clinicians, researchers, third-party payers, consumers of federal and state beneficiary programs, andhealth care industry professionals. The Stakeholder Group’s role is to:

• Provide input on research information gaps for practice and policy and the key research questionsaddressing these gaps.

Technology Assessment

• Discharge Planning: Effectiveness of Discharge Planning in Patients with Heart Failure

• Focused Reviews on Selected Gene Tests for Cancer and Noncancer Conditions

• Health and Behavior Assessment/Intervention for the Management of Physical Health Problems — Cancer Pain

• Horizon Scan: Clinical Trials Enrollment and Third Party Payment

• Horizon Scan: Lipoprotein Subfractions for Identifying Patients at Increased Risks for Cardiovascular Diseases

• Peripheral Artery Stenting

• Pulmonary Artery Catheterization

• Quality, Regulation and Clinical Utility of Laboratory-developed Tests

• Spinal Fusion for the Treatment of Low Back Pain Secondary to Lumbar Degenerative Disc Disease

• Targeted Therapies for Cancer

• Use of Bayesian Techniques in Randomized Clinical Trials: A CMS Case Study

TABLE 4. Technology Assessments in Progress as of April 2008


• Review public input and participate in topic and key question development and refinement in collaborationwith the Scientific Resource Center.

• Provide input on implementation issues for EHC Program reports.

• Provide input on issues of methodology for synthesis, research, and translation of effectiveness evidence.

The following table presents the current members of the Stakeholder Group.* These members serve a two-yearterm, Fall 2007 to Summer 2009.

Peter Juhn, MD, MPHVice President, Evidence and Regulatory Policy,Johnson & Johnson

Dick Justman, MDNational Medical Director of United Healthcare

TABLE 5. EHC Program’s Stakeholder Group (Fall 2007 – Summer 2009)

Darrell R. Abernethy, MD, PhDChief Science Officer at the United StatesPharmacopeia

Wade M. Aubry, MDAssociate Director of the Center for MedicalTechnology Policy and Senior Medical Advisor to theCalifornia Technology Assessment Forum

Jennifer L. Bright, MPAExecutive Director, Society for Healthcare Epidemiologyof America (SHEA) and Founder, National WorkingGroup on Evidence-Based Healthcare

W. Gary Erwin, PharmDSenior Vice President, Professional Services, Omnicare,Inc., and President, Omnicare Senior Health Outcomes

Patricia M. Hart, MD, FACPPrivate Practice, Brooklyn, New York

Maria Carolina Hinestrosa, MA, MPHExecutive Vice President for Programs and Planning atthe National Breast Cancer Coalition, and Co-founderof Nueva Vida

Sharon Levine, MDAssociate Executive Director, The Permanente MedicalGroup, Inc.

David B. Lorber, MDVice President of Medical Affairs for Caremark

Alan B. Rosenberg, MDVice President of Medical Policy, TechnologyAssessment and Credentialing Programs for WellPoint, Inc.

Eric M. Wall, MD, MPHSenior Medical Director of Qualis Health

Anthony C. Wisniewski, EsqExecutive Director for Health Care at the U.S. Chamberof Commerce

Doris H. Lotz, MD, MPHMedicaid Medical Director for the State of NewHampshire

George Lundberg, MDEditor in Chief of MedGenMed, Editor in Chief of Medscape Core, and Editor in Chief of eMedicine

Newell McElwee, PharmD, MSPHVice-President of Evidence-Based Strategies at Pfizer

G. Gregory Raab, MA, PhDPresident, Raab & Associates, Inc.

* See Appendix E for EHC’s Stakeholder Group biographies.


The Secretary of HHS has established a list of 10 priority conditions relevant to the Medicare population tobe addressed by the EHC program. These priority conditions were selected by a steering committee comprisedof representatives from AHRQ, the Centers for Medicare & Medicaid Services, the Food and DrugAdministration, and the HHS Office of the Secretary. The priority conditions identified for study are:

• Arthritis and nontraumatic joint disorders (Muscle, bone, and joint conditions)

• Cancer (Cancer)

• Chronic obstructive pulmonary disease and asthma (Breathing conditions)

• Dementia including Alzheimer’s disease (Brain and nerve conditions)

• Depression and other mood disorders (Mental health)

• Diabetes mellitus (Diabetes)

• Ischemic heart disease (Heart and blood vessel conditions)

• Peptic ulcer disease and dyspepsia (Digestive system conditions)

• Pneumonia (Breathing conditions)

• Stroke and hypertension (Heart and blood vessel conditions)

Future reviews will address issues related to Medicaid and the State Children’s Health Insurance Program, inaddition to Medicare.

The organizational sub-structure of AHRQ’s EHC program is presented in the following figure.


FIGURE 4. Organizational Substructure of AHRQ’s EHC Program

Comparative Effectiveness Reviews (CERs) AHRQ created Evidence-based Practice Centers (EPCs) in 1997 to synthesize existing scientific literature

about important health care topics and promote evidence-based practice and decision-making. The expertise ofthe EPCs is now also used for Comparative Effectiveness Reviews (CERs) on medications, devices, and otherrelevant interventions. These reviews use a research methodology that systematically and critically appraisesexisting research to synthesize knowledge on a particular topic. An important aspect of the ComparativeEffectiveness Reviews is the identification of research gaps, as well as recommendations for studies andapproaches to fill those gaps.

The following table presents studies in progress or completed as of May 2007.

* Refer to Section 2.4 for a list of AHRQ’s EPCs.

† Three DEcIDE Research Centers (Duke University, Johns Hopkins University, and RTI International) also serves as EPCs.

DEcIDE=Developing Evidence to Inform Decisions about Effectiveness

DEcIDE Research NetworkScientific Resource CenterLocation: Oregon EPC

Director: Mark Helfand, MD

Stakeholders Group

Vanderbilt University Medical Center, Nashville, TN

PI: Marie R. Griffin, MD

Acumen, LLC, Burlingame, CAPI: Thomas E. MaCurdy, PhD

Brigham and Women’s Hospital, Boston, MAPI: Sebastian Schneeweiss, MD

Duke University, Durham, NC †

PI: David B. Matchar, MD

Outcome Sciences, Cambridge, MA PI: Richard E. Gliklich, MD

University of Maryland – BaltimorePI: Bruce C. Stuart, PhD

University of North Carolina at Chapel HillPI: Suzanne L. West, PhD

Johns Hopkins University, Baltimore, MD †PI: Albert W. Wu, MD

RTI International, Research Triangle Park, NC †

PI: Kathleen Lohr, PhD

University of Illinois-ChicagoPI: Glen T. Schumock, PharMD

Harvard Pilgrim Health Care, Harvard Medical School, Boston, MA

PI: Richard Platt, MD

University of Pennsylvania School of Medicine,Philadelphia, PA

PI: Sean Hennessy, PharmD, PhD

University of Colorado at Denver and HealthSciences Center, Aurora, CO

PI: John F. Steiner, MD

EPCs*Comparative Effectiveness

Reviews (CER)

AHRQ’s Effective Health Care Program

John M. Eisenberg ClinicalDecisions & Communications

Science CenterDirector: David Hickam, MD


TABLE 6. Comparative Effectiveness Reviews (CERs) by Priority Condition

Priority Condition Comparative Effectiveness Review Status

Cancer Comparative Effectiveness and Safety of Radiotherapy Treatments In progressfor Head and Neck Cancer

Comparative Effectiveness of Chemotherapy Agents in the Prevention In progressof Primary Breast Cancer in Women

Comparative Effectiveness of Therapies for Clinically Localized CompletedProstate Cancer

Core Needle Breast Biopsy and Surgical Excision Biopsy for Diagnosing In progressBreast Lesions

Comparative Effectiveness of Epoetin and Darbepoetin for Managing CompletedAnemia in Patients Undergoing Cancer Treatment

Effectiveness of Noninvasive Diagnostic Tests for Breast Abnormalities Completed

Technical Brief: Particle Beam Radiation Therapies for Cancer In progress

Diabetes Comparative Effectiveness and Safety of Oral Diabetes Medications Completedfor Adults With Type 2 Diabetes

Comparative Effectiveness, Safety, and Indications of Insulin Analogues In progressin Premixed Formulations for Adults with Type 2 Diabetes

Digestive system Comparative Effectiveness of Management Strategies for Completedconditions Gastroesophageal Reflux Disease

Heart and blood Comparative Effectiveness of Combinations of Lipid-Modifying Agents In progress vessel conditions

Comparative Effectiveness of Medical Therapies for Stable Ischemic In progressHeart Disease

Comparative Effectiveness of Management Strategies for CompletedRenal Artery Stenosis

Comparative Effectiveness of Percutaneous Coronary Interventions Completed and Coronary Artery Bypass Grafting for Coronary Artery Disease

Effectiveness and Off-label Use of Recombinant Factor VIIa In progress

Comparative Effectiveness of Angiotensin-Converting Enzyme Completed Inhibitors (ACEIs) and Angiotensin II Receptor Antagonists (ARBs) for Treating Essential Hypertension

Effectiveness of Radiofrequency Catheter Ablation (RFA) for Atrial Fibrillation In progress

Mental health Comparative Effectiveness of Second-Generation Antidepressants Completedin the Pharmacologic Treatment of Adult Depression

Efficacy and Comparative Effectiveness of Off-Label Use of Atypical CompletedAntipsychotics

Muscle, bone, Comparative Effectiveness of Drug Therapy for Rheumatoid Arthritis and Completedjoint conditions Psoriatic Arthritis in Adults

Comparative Effectiveness of Treatments To Prevent Fractures in Men and CompletedWomen With Low Bone Density or Osteoporosis

Comparative Effectiveness and Safety of Analgesics for Osteoarthritis Completed

Research DRAFT: Methods Reference Guide for Effectiveness and Comparative In progressmethodology Effectiveness Reviews

TABLE 6. Comparative Effectiveness Reviews (CERs) by Priority Condition as of May 2007


Developing Evidence to Inform Decisions about Effectiveness: DEcIDE Research Centers A new network of 13 Developing Evidence to Inform Decisions about Effectiveness research centers (referred

to as DEcIDE) will carry out accelerated studies, including research aimed at filling knowledge gaps abouttreatment effectiveness. Operating under strict procedures to guarantee privacy and security, DEcIDE centerswill use de-identified data available through insurers, health plans and other partner organizations to answerquestions about the use, benefits and risks of medications and other therapies. Collectively, the DEcIDE centerswill have access to de-identified medical data for millions of patients, including Medicare’s 42 millionbeneficiaries. Initial research focuses on the outcomes of prescription drug use and other interventions for whichrandomized controlled trials would not be feasible or timely, or would raise ethical concerns that are difficult toaddress. Other DEcIDE network projects may focus on electronic registries, methods for analyzing healthdatabases, and prospective observational or interventional studies. The following table lists the DEcIDE projectsin progress or completed as of May 2007.


Priority Condition DEcIDE Research Projects Status

Brain and nerve Methods for Studying Dementia Treatment and Outcomes in In progressconditions Observational Databases

Breathing Community Pharmacy/Call Center Assessment of Medication In progressconditions Effectiveness & Safety

Comparative Effectiveness of Anticholinergic Medications in Patients with In progressChronic Obstructive Pulmonary Disease (COPD)

Comparative Effects of Classes of Antidepressants on the Risk of In progressAspiration Pneumonia in the Aged

Outcomes of COPD Management In progress

Cancer Testing Cancer Quality Measures for End of Life Care In progress

Advancing Research Methodology for Measuring and Monitoring In progressPatient-Centered Communications in Cancer Care

Diabetes Comparative Effectiveness and Safety of New Therapies for Glucose In progressControl in Diabetes Mellitus

Digestive system Comparative Safety of NSAIDs with Gastroprotective Therapy In progressconditions

Heart and blood Comparable Effectiveness of B-Adrenergic Antagonists on the Risk of vessel conditions Rehospitalization in Adults with Diagnosed Heart Failure In progress

Medical Management of Congestive Heart Failure and the Effectiveness In progressof Isosorbide Dinitrate and Hydralazine

Treatment of In-Stent Restenosis In progress

Research on Optimal Second-Line Therapy for Hypertension In progress

A Multicenter, Observational Cohort Study to Assess the Cardiovascular In progressRisks of Medications Prescribed for Attention Deficit Hyperactivity Disorder

A Qualitative Study to Understand Barriers to Conducting Cluster In progressRandomized Trials

TABLE 7. EHC Program’s DEcIDE Research Projects as of May 2007



Heart and blood Development of a Software Tool for Obtaining Doubly Robust Estimate In progressvessel conditions of Treatment Effects

Development of Statistical Estimators to Address Questions of In progressComparative Effectiveness in Elderly Heart Failure Patients

Mental health Comparative Effects of Classes of Antidepressants on the Risk of Aspiration Pneumonia in the Aged In progress

Comparative Safety of Conventional and Atypical Antipsychotic Medications: Risk of Death in British Columbia Seniors Completed

A Multicenter, Observational Cohort Study to Assess the Cardiovascular In progressRisks of Medications Prescribed for Attention Deficit Hyperactivity Disorder


Muscle, bone, Comparative Safety of NSAIDs with Gastroprotective Therapy In progressand joint disorders

Assessment of Factors Modulating Treatment Outcomes of In progressRheumatoid Arthritis

Adaptation of Data Mining Algorithms Assessing the Comparative In progressEffectiveness and Safety of NSAIDs

Research Emerging Methods in Comparative Effectiveness and Safety - Completedmethodology Medical Care Supplement

Registries for Evaluating Patient Outcomes: CompletedA User’s Guide

Survey of Medicare Part D Plans’ Medication Therapy CompletedManagement Programs


Adaptation of Data Mining Algorithms Assessing the Comparative In progressEffectiveness and Safety of NSAIDs

Assessing the Validity of Administrative Data Using Clinical In progressMedical Records

Community Pharmacy/Call Center Assessment of Medication In progressEffectiveness & Safety

Data Development for Patient Safety – A Pilot Study using Medicare In progressPart B Drug Data

Developing a Distributed Research Network to Conduct Population-based In progressStudies and Safety Surveillance

Development and Validation of Instrumental Variable Methods for In progressEffectiveness Research

Development of a Software Tool for Obtaining Doubly Robust Estimate In progressof Treatment Effects

Development of Statistical Estimators to Address Questions of In progressComparative Effectiveness in Elderly Heart Failure Patients

Distributed Network for Ambulatory Research in Therapeutics In progress




John M. Eisenberg Clinical Decisions and Communications Science CenterThe John M. Eisenberg Clinical Decisions and Communications Science Center (Eisenberg Communications

Center), named after the former director of AHRQ, was established on October 1, 2005, and is directed by DavidH. Hickam, MD. As scientific evidence about effectiveness is synthesized by the EHC program and generated bythe DEcIDE network, the Eisenberg Communications Center will, in turn, translate the scientific knowledge intotargeted products for all stakeholders — including patients, providers, and policymakers. Stakeholders can usethis knowledge to maximize benefits from their health care, minimize harm, and optimize the use of health careresources. The Eisenberg Communications Center will take a systematic approach to translate knowledge abouteffective health care into understandable, actionable language for all decision-makers. An important function ofthe Center is to present the often complex scientific information in a format that stakeholders and the public caneasily understand. It also will conduct its own program of research into effective communication of researchfindings in order to improve usability and rapid incorporation of findings into medical practice.

The core staff of the Eisenberg Communications Center is located at Oregon Health & Science University inPortland, Oregon. Other organizations that participate in the work of the Eisenberg Center include AmericanInstitutes for Research (AIR), Decision Research, Inc., Oregon State University College of Pharmacy, RhodeIsland Hospital, Rochester University, and the University of Oregon.

Centers for Education & Research on Therapeutics (CERT) ProgramThe Centers for Education and Research on Therapeutics (CERTs) program, established in 1999, is a national

initiative to conduct research and provide education that advances the optimal use of therapeutics (i.e., drugs,medical devices, and biological products). The program consists of seven research centers and is administeredas a cooperative agreement by AHRQ, in consultation with the U.S. Food and Drug Administration (FDA). Eachcenter focuses on therapies used in a particular patient population or therapeutic area. These seven centers, aCoordinating Center, a Steering Committee, and numerous partnerships with public and private organizationsmake up the CERTs program. The following table presents the seven centers, their emphasis, and principalinvestigators.


Research Medicare Prescription Drug Data Development: Methods for In progressmethodology Improving Patient Safety and Pharmacovigilance Using Observational Data

Needs Assessment to Establish an Infrastructure for Monitoring the In progressUtilization and Outcomes of Gene-Based Applications in the United States Health Care System

Research and Surveillance Methods for Improving Medication Safety In progressUsing Administrative Claims Databases

Testing Cancer Quality Measures for End of Life Care In progress




The CERTs receive funds from both public and private sources, with AHRQ providing core financial support.The research conducted by the CERTs program has three major aims:

1. To increase awareness of both the uses and risks of new drugs and drug combinations, biological products,and devices, as well as of mechanisms to improve their safe and effective use.

2. To provide clinical information to patients and consumers; health care providers; pharmacists, pharmacy(HMOs) and health care delivery systems; insurers; and government agencies.

3. To improve quality while reducing cost of care by increasing the appropriate use of drugs, biologicalproducts, and devices and by preventing their adverse effects and the consequences of these effects (such asunnecessary hospitalizations).

CERT Centers Emphasis Principal Investigators

Duke University Medical * Therapies for disorders of the heart and Eric Peterson, MD, MSCenter blood vessels

HMO Research Network Drug use; safety and effectiveness studies in Richard Platt, MD, MSchealth maintenance organization populations

University of Alabama Therapies for musculoskeletal disorders Kenneth G. Saag, MD, at Birmingham MSc

University of Arizona Reduction of drug interactions that result in Raymond L. Woosley, MD, Health Sciences Center harm to women PhD

University of North Carolina Therapies for children Alan D. Stiles, MDat Chapel Hill

University of Pennsylvania Therapies for infection; antibiotic drug resistance Brian L. Strom, MD, MPHSchool of Medicine

Vanderbilt University Prescription drug use in a Medicaid population Wayne A. Ray, PhDMedical Center

Rutgers, The State University Safe and effective use of treatments for Stephen Crystal, PhDof New Jersey mental health problems

University of Iowa Safety and effectiveness of medication use Elizabeth A. Chrischilles,among the elderly MS, PhD

Baylor College of Medicine Consumers and strategies to help patients Maria E. Suarez-Almazor,take prescription medications appropriately MD, PhD

Weill Cornell Medical Center Medical devices Alvin I. Mushlin, MD, ScM

University of Chicago Clinical and economic issues in hospital settings David Meltzer, MD, PhD

Brigham and Women’s Hospital Health information technology David Bates, MD, MSc

Cincinnati’s Children’s Pediatric therapeutics Carole Lannon, MD, MPHHospital Medical Center

University of Illinois at Chicago Tools for optimizing prescribing Bruce L. Lambert, PhD

TABLE 8. AHRQ’s CERT Centers

* The Duke University Medical Center also serves as the Coordinating Center, which is directed by Robert M. Califf, MD


The CERTs concept grew out of recognition that, while pharmaceuticals and other medical products improvethe lives of many patients, underuse, overuse, adverse events, and medical errors may cause serious impairmentto patient health. The following gaps in knowledge remain:

• Limited comparative information exists on the risks, benefits, and interactions of both new and older agents.

• Health professionals need guidance on the appropriate, cost-effective use of therapeutics that will, in turn,lead to improved outcomes, error reduction, and prevention of adverse events.

The CERTs Coordinating Center is located at Duke University Medical Center. Directed by Robert M. Califf,MD, the Coordinating Center helps support the work of the research centers by enhancing cross-center synergyand disseminating findings from the research conducted by the centers.

A Steering Committee, organized by the Coordinating Center, serves in an advisory capacity to the CERTsprogram. Steering Committee members include representatives from each center, the Federal Government(AHRQ, FDA, and currently the Centers for Medicare & Medicaid Services), the private sector, and consumergroups. In addition, work groups of representatives from all centers address broad issues related to the CERTseffort, such as public-private partnerships.

AHRQ’s Center for Outcomes and Evidence oversees the CERTs program and provides technical assistanceand research support. Lynn A. Bosco, MD, MPH, serves as the Program Officer. See Appendix A for herbiography.

CMS’S COVERAGE WITH EVIDENCE DEVELOPMENT

On July 12, 2006, CMS released new guidance entitled “National Coverage Determinations with DataCollection as a Condition of Coverage: Coverage with Evidence Development”. The guidance describes thenational coverage determinations (NCDs) that include, as a condition of payment, the development andcapture of additional patient data to supplement standard claims data. According to CMS, “The purpose ofCED is to generate data on the utilization and impact of the item or service evaluated in the NCD, so thatMedicare can a) document the appropriateness of use of that item or service in Medicare beneficiaries undercurrent coverage; b) consider future changes in coverage for the item or service; c) generate clinical informationthat will improve the evidence base on which providers base their recommendations to Medicare beneficiariesregarding the item or service.”

CMS performs evaluations to determine whether they can obtain conclusive answers to assessment questionsspecific to the process of the evidence evaluation and whether the investigational item or service will result inimproved patient outcomes. This assessment takes the following three factors into account: 1) the quality of theindividual studies; 2) the relevance of findings from individual studies to the Medicare population; and 3)overarching conclusions that can be drawn from the body of the evidence about the direction and magnitude ofthe risks and benefits of the item or service under investigation. As such, CMS applies coverage with evidencedevelopment in two ways: coverage with appropriateness determination (CAD) and coverage with studyparticipation (CSP).

Coverage with Appropriateness Determination (CAD)In the application of CAD, CMS may determine that the evidence for an item or service being evaluated is

adequate to deem it reasonable and necessary, but that additional clinical data is needed that is not routinelyavailable on claims forms to ensure that the item or service is being provided to appropriate patients in themanner described in the NCD. The extra data supplements the information that is routinely gathered byproviders through claims. For the most part, providers will submit extra data to databases or registries


specifically designed for collecting data specified in the NCD in question. CAD will only be invoked when thereis sufficient evidence to determine that the item or service is to be covered. However, when an NCD requiresCAD, only items or services for patients included in the data collection are covered. CMS outlines the followingconcerns that may lead to a coverage decision that requires CAD as a condition of coverage:

1. If the newly covered item or service should be restricted to patients with specific conditions and criteria.

2. If the newly covered item or service should be restricted for use by providers with specific training or credentials.

3. If there is concern among clinical thought leaders that there are substantial opportunities for misuse ofthe item or service.

4. If the coverage determination significantly changes how providers manage patients utilizing this newlycovered item or service.

Coverage with Study Participation (CSP)CSP will allow coverage of certain items or services for which the evidence is not adequate to support coverage

and where additional data gathered in the context of clinical care would further clarify the impact of these itemson the health of patients. CSP allows CMS to determine that an item or service is only reasonable and necessarywhen it is provided within a research setting where there are added safety, patient protections, monitoring, andclinical expertise. The CED/CSP concept considers the item to be reasonable and necessary only while evidenceis being developed. Under section 1142 of the MMA, which describes the authority of the ARHQ, research maybe conducted on the outcomes, effectiveness, and appropriateness of health care services and procedures toidentify the manner in which diseases, disorders, and other health conditions can be prevented, diagnosed,treated, and managed clinically. In addition, evaluations of the comparative effects, health and functionalcapacity; alternative services and procedures utilized in preventing, diagnosing, treating, and clinically managingdiseases, disorders, and other health conditions may be conducted. If the evidence is inadequate to determinethat the item or service is reasonable and necessary, coverage may be extended to patients enrolled in a clinicalresearch study. The following list includes some of the evidentiary findings that might result in CMS issuing anNCD for items and services that do not otherwise have sufficient evidence for coverage:

1. Available evidence may be a product of otherwise methodologically rigorous evaluations but may not haveevaluated outcomes that are relevant to Medicare beneficiaries.

2. The available clinical research may have failed to address adequately the risks and benefits to Medicarebeneficiaries for off-label or other unanticipated uses of a drug, biologic, service, or device.

3. Available clinical research studies may not have included specific patient subgroups or patients with disease characteristics that are highly prevalent in the Medicare population.

4. New applications may exist for diagnostic services and devices that are already on the market, but there is little or no published research that supports a determination of reasonable and necessary for Medicarecoverage at the time of the request for an NCD.

5. Sufficient evidence about the health benefits of a given item or service to support a reasonable andnecessary determination is available only for a subgroup of Medicare patients with specific clinical criteriaand/or for providers with certain experience or other qualifications. Other patient subgroups or providersrequire additional evidence to determine if the item or service is reasonable and necessary.


CSP research may include a broader range of studies than RCTs to include observational studies. In rareinstances, CMS may determine that existing evidence is very preliminary and not reasonable and necessary forMedicare coverage; however, if the following criteria are met, CSP might be appropriate in these instances:

1. The evidence includes assurances of basic safety;

2. The item or service has a high potential to provide significant benefit to Medicare beneficiaries; and

3. There are significant barriers to conducting clinical trials.

This research, however, must be rigorously designed and meet the standards to be developed in areconsideration of the current Clinical Trial Policy established under a 2000 NCD. If the research results arepublished in a peer-reviewed journal, the evidence will be used in an NCD reconsideration to determine if achange in Medicare coverage is appropriate.

Data SourcesCMS may require that data be sent to a centralized database (formal registry). Data collected under CAD will

commonly be submitted to an approved registry and then sent to CMS to ensure that the item or service wasprovided in accordance with the NCD, which is payment data. Data submission to a registry may also benecessary within clinical studies required under CSP. CMS will use the information to meet specific CAD and/orCSP determinations for Medicare beneficiaries, but the data will also be available to researchers to evaluatepatient safety and health benefits, comparative effectiveness, utilization and diffusion of the item or service, andvariations in outcomes among providers or patients. The data may also be used to evaluate the long-termoutcomes, patient management issues, mortality, and post-coverage utilization of services, or to conduct otherobservational studies. The length of data collection will be determined by the requirements of the NCD, andCMS will use discretion in determining the research that will be funded.

If CMS determines that the evidence for a service or item is inadequate to establish coverage (under section1862(a) (1) (A)), Medicare may still reimburse for that item or service for beneficiaries enrolled in a researchstudy that provides data and information to be used to evaluate that item or service, as well as reimburse for theroutine costs incurred by beneficiaries in the study. However, to qualify for reimbursement, the study must bedesigned to produce evidence that could be used in a future NCD. In addition, CMS will only provide paymentfor clinical research that meets the standards to be outlined in the revision of the Clinical Trial Policy. The lengthof data collection will be outlined in the study protocol, and CMS will pay for the clinical costs of patient care forbeneficiaries for which data collection is required.

The following principles govern the application of CED:

1. NCDs requiring CED will occur within the NCD processes, which is transparent and open to public comment.

2. CED will not be used when other forms of coverage are justified by the available evidence.

3. CED will in general expand access to technologies and treatments for Medicare beneficiaries.

4. CMS expects to use CED infrequently.

5. CED will lead to the production of evidence complementary to existing medical evidence.

6. CED will not duplicate or replace the FDA’s authority in assuring the safety, efficacy, and security of drugs,biological products, and devices.

7. CED will not assume the NIH’s role in fostering, managing, or prioritizing clinical trials.

8. Any application of CED will be consistent with federal laws, regulations, and patient protections.


HHS VALUE-DRIVEN HEALTH CARE INITIATIVE

On August 22, 2006, President Bush signed Executive Order 13410, committing the federal government to the“four cornerstones” of value-driven care:

1. Health information technology,

2. Public reporting of provider quality information,

3. Public reporting of cost information, and

4. Incentives for value comparison.

In summary, it is a broad based initiative to collect and publicly report information about the cost and qualityof health care. As noted previously, the premise is that if consumers and other purchasers of health care cancompare cost and quality of health care services, they will choose the best quality for the lowest price. The resultwill be a system that will respond with better quality for less money. The goal is to get more transparency intothe system at all levels, including consumers, employer/purchasers, health plans, providers and policymakers.

Less than a year after launching his Value-Driven Health Care Initiative, HHS Secretary Leavitt announcedthat more than 100 million Americans are now served by health plans that are committed to providingconsumers with transparent quality and cost information. The federal government; half of the states; about 775employers, including almost half of the top 200 U.S. corporations; and numerous unions, communities, doctorsand hospitals have joined the movement.

Most plans that are committed to the value-based approach, including all federal agencies that contract withhealth plans, will embody the principles of value-driven care in their next contracting cycle. And most enrolleesin these plans are expected to have access to Web-based “report cards” on quality or cost within the next 12months.

Website: www.hhs.gov/valuedriven

CHRONIC CONDITIONS DATA WAREHOUSE (CCW)

Section 723 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 requires theSecretary of the Department of Health and Human Services (DHHS) to make Medicare data readily available toresearchers who are studying chronic illness in the Medicare population. To support this effort, the Office ofResearch, Development, and Information (ORDI) of the Centers for Medicare & Medicaid Services (CMS)contracted with the Iowa Foundation for Medical Care (IFMC) to establish the Chronic Condition DataWarehouse (CCW).

The CCW is based on the 5 percent national Medicare sample and includes claims, enrollment and assessmentdata. The data cover numerous common chronic conditions such as various types of cancer, cardiovasculardisease, and mental illness. The CCW data are considered RIFs, which contain person-specific data on Medicareproviders, beneficiaries, and recipients including individual identifiers that would permit the identity of abeneficiary or physician to be deduced. The data are, therefore, subject to the Privacy Act, and CMS mustcarefully approve data requests to ensure that confidential information is used in accordance with this regulation.

Website: http://www.resdac.umn.edu/CCW/data_available.asp


THE DEPARTMENT OF DEFENSE PHARMACOECONOMIC CENTER (PEC)

The Department of Defense (DoD) PharmacoEconomic Center (PEC) is a customer oriented Center ofExcellence implementing recognized state of the art pharmacoeconomic analysis for the purpose of improvingreadiness by increasing value, quality, and access to medical care and pharmacotherapy within the availableresources of the Military Health System (MHS). In this capacity, PEC monitors drug usage and cost trends andperforms pharmacoeconomic analyses to support DoD formulary management, national pharmaceuticalcontracts, and clinical practice guidelines, and also provides extensive administrative and technical support forthe DoD Pharmacy & Therapeutics Committee, which manages the DoD Basic Core Formulary (BCF) and theMail Order Pharmacy Formulary. The Pharmacy Operations Center (POC), a component of PEC, supportsusers of the Pharmacy Data Transaction Service, a centralized prescription data repository that provides a single,comprehensive patient drug profile for DoD beneficiaries across the Military Health System. PEC also helps inthe development and management of information systems that support the provision of drug therapy andevaluation of the pharmacy benefit. The Center also seeks to educate health care providers and other pharmacybenefit stakeholders about cost-effective drug therapy through the publication of a monthly newsletter andworks with the Defense Supply Center Philadelphia & the VA Pharmacy Benefits Management Strategic HealthGroup and National Acquisition Center to establish national pharmaceutical contracts. Finally, the center workswith the VA/DoD Clinical Practice Guideline Workgroup to formulate the drug therapy components of clinicalpractice guidelines.

Website: http://www.pec.ha.osd.mil/

VETERANS AFFAIRS TECHNOLOGY ASSESSMENT PROGRAM (VATAP)

The Veterans Affairs Technology Assessment Program (VATAP) is a national program within the Office ofPatient Care Services dedicated to advancing evidence-based decision making in the VA. VATAP helps senior VApolicymakers to determine the effectiveness of health technologies through systematic reviews of the medicalliterature. The impartial, peer-reviewed evaluations encompass devices, drugs, procedures, and organizationaland supportive systems used in health care. VATAP’s products include bibliographies, INAHTA briefs,comprehensive reports, brief overviews, short reports, and e-newsletters, all of which are available to VeteransHealth Administration senior managers. VATAP is a member of both HTAi and INAHTA.

Website: http://www.va.gov/VATAP/index.htm

NATIONAL INSTITUTES OF HEALTH – CLINICAL AND TRANSLATIONAL SCIENCE AWARDS (CTSA)

The Clinical and Translational Science Awards provide funding to academic institutions pursuing research in clinical and translational science, which strives to translate innovative advances in medical research intoapplicable knowledge and practices that will benefit and improve human health nationwide. The awards are a response in part to the progress of the NIH Roadmap for Medical Research, as well as extensivecommunity input.


Grants are awarded to academic institutions with Centers, Departments, or Institutes (C/D/I) that conductstudies addressing at least one of nine topic areas:

• Development of Novel Clinical and Translational Methodologies

• Pilot and Collaborative Translational and Clinical Studies

• Biomedical Informatics

• Design, Biostatistics, and Clinical Research Ethics

• Regulatory Knowledge and Support

• Participant and Clinical Interactions Resources

• Community Engagement

• Translational Technologies and Resources

• Research, Education, Training and Career Development

In October of 2006, the first 12 Academic Health Centers (AHCs) received funding. The next round of awardswill be announced in September of 2007. The program is anticipated to be fully implemented by 2012 with 60institutions pursuing research in the discipline of clinical and translational science. The CTSA now acts as anational consortium of institutions pursuing this research.

Website: http://www.ncrr.nih.gov/clinical_research_resources/clinical_and_translational_science_awards/

NATIONAL INSTITUTES OF HEALTH – ANTIHYPERTENSIVE AND LIPID LOWERING TREATMENT TO PREVENT HEART ATTACK TRIAL (ALLHAT)

In 1994, the National Heart, Lung, and Blood Institute (part of the National Institutes of Health) began amajor clinical study to analyze the available treatments for high blood pressure (or hypertension) and highcholesterol, both of which are major risk factors for heart disease. The Antihypertensive and Lipid-LoweringTreatment to Prevent Heart Attack Trial (ALLHAT) lasted for 8 years, and examined two primary researchprongs: 1) comparing the effects of a diuretic (or a “water” pill) with three newly available and more costlyprescription drugs to lower blood pressure, and 2) comparing the effects of a typical diet alone1 with a typicaldiet aided by a cholesterol-lowering statin drug.

This seminal study provided one of the first large-scale (over 40,000 participants) comparative effectivenessstudies conducted and remains a standard reference for treating high blood pressure and high cholesterol.

Website: http://www.nhlbi.nih.gov/health/allhat/facts.htm

1 A cholesterol lowering drug was added to this “usual care” group when their doctor believed that it was necessary for their health.


NATIONAL INSTITUTES OF HEALTH – CLINICAL ANTIPSYCHOTIC TRIALS OF INTERVENTION EFFECTIVENESS (CATIE)

The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) is another study examining thecomparative effectiveness of antipsychotic medication intended to treat schizophrenia. The study is funded bythe NIH’s National Institute of Mental Health at $42.6 million.

In 2005, the first iteration of this study involved 1400 people and examined the comparative effectiveness andside effects of five new and older drugs that were prescribed to treat people with schizophrenia at the time. Thefirst year’s findings were published in the September 22 issue of JAMA that year.

In December 2006, CATIE published new findings incorporating economic implications of older versusnewer antipsychotic medication juxtaposed with the comparative effectiveness of treatments (American Journalof Psychiatry). Its primary conclusion was that the older generation of drugs (developed in the 1950s) was lessexpensive and no less effective than newer medications.

This study underscores the clinical policy relevance of comparative effectiveness research efforts and inparticular of reconsidering available therapies and medications.

Website: http://www.nimh.nih.gov/press/catie-cost-effectiveness.cfm

CENTERS FOR DISEASE CONTROL AND PREVENTION–EVALUATION OF GENOMIC APPLICATION IN PRACTICE AND PREVENTION (EGAPP)

The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) began in the fall of 2004 as amodel project of the Office of Genomics and Disease Prevention at the Centers for Disease Control andPrevention (CDC). The project’s goal is to coordinate the process for evaluating genetic tests and other genomicapplications and facilitate the transfer of this knowledge from research to clinical and public health application.

The EGAPP Working Group is the principal actor in this initiative and is comprised of 13 experts withmultidisciplinary backgrounds such as clinical practice, public health, genomics, epidemiology, evidence-basedreview, policy, economics, and health technology assessment. The group focuses on developing understandableconnections from scientific evidence to conclusions and recommendations of research.

Of the four topics currently under review, evidence reviews for three are being conducted by Evidence-basedPractice Centers associated with the Agency for Healthcare Research and Quality. The fourth is undergoing amore technical review by a private contractor.

Website: http://www.cdc.gov/genomics/gtesting/egapp.htm


OREGON HEALTH & SCIENCE UNIVERSITY’S DRUG EFFECTIVENESS REVIEW PROJECT (DERP)

The Drug Effectiveness Review Project (DERP) is a collaboration of organizations that have joined togetherto obtain the “best available evidence” on effectiveness and safety comparisons between drugs in the same class,and to apply the information to public policy and decision-making in local settings. DERP is part of the Centerfor Evidence-Based Policy located within the Oregon Health & Sciences University (OHSU) and funded mainlyby a consortium of state Medicaid agencies. The Policy Center contracts with AHRQ’s EPCs around the countryto develop evidence-based drug class reviews for its clients. The DERP product is a series of comprehensive,updated and formal systematic reviews conducted by Evidence-Based Practice Centers (EPC) with oversight andcoordination from the Oregon EPC. Each participating organization (e.g., each member State Medicaid agency)contributes an equal amount to the financing of DERP, and guides its operation through a self-governing processin which each organization is equally represented. The drug classes to be studied are determined through thisself-governance process. The structure of the DERP is summarized graphically:

DERP commenced its reviews in November 2003, with ten member organizations, and has since expanded toinclude fourteen participants: thirteen states (Arkansas, Idaho, Kansas, Michigan, Minnesota, Missouri,Montana, New York, North Carolina, Oregon, Washington, Wisconsin, and Wyoming) and the Canadian Agencyfor Drugs and Technologies in Health). Participating organizations have used DERP reports not only forMedicaid coverage decisions, including setting preferred drug lists (PDLs), but also to inform drug coveragepolicy for state employees or other public programs. Notably, Consumers Union (CU) and AARP, although notDERP members, have begun adapting DERP reviews for consumers. Consumers Union (CU), publisher ofConsumer Reports magazine, has adopted the DERP reports as one critical component of a free publicinformation project, started in December 2004, on the comparative effectiveness, safety, and cost of prescriptiondrugs. Drawing on other sources and adding information on drug costs, the Best Buy Drugs Web site(www.bestbuydrugs.org) chooses Best Buy drugs in each category it evaluates. Similarly, the AmericanAssociation for Retired Persons (AARP) has introduced its Web site, www.aarp.org/health/comparedrugs/, whichpublishes the DERP reports for members to consult.

The Oregon Evidence-Based Practice Center (Oregon EPC) conducts the reviews and assigns, coordinates andoversees reviews conducted by other EPCs, updates reviews on a 6-month schedule, and ensures the productionof its reports. The Oregon EPC provides support to the participating organizations in developing key questionsfor the reviews, interpreting the reports, and by being available to answer specific questions.

PRIVATE NON-PROFITS AND STATES

CENTER FOR EVIDENCE-BASED POLICY

COORDINATING EVIDENCE PRACTICE CENTER

OHSU EPC UNC EPC RAND EPC


ACE inhibitors Fixed-dose Combination Products: Hyperlipidemia

ADHD Drugs Hepatitis C Drugs

Angiotensin 2 Receptor Antagonists Hormone Replacement Therapy

Antidepressants, 2nd Generation Hypoglycemics, Oral

Antiemetics, Newer Inhaled Corticosteroids

Antiepileptic Drugs Insomnia Drugs, Newer

Antihistamines, 2nd Generation Multiple Sclerosis Drugs

Antiplatelets Neuropathic Pain Drugs

Atypical Antipsychotics Opioids

Alzheimer’s Drugs Overactive Bladder Drugs

Beta Blockers Proton Pump Inhibitors

Calcium Channel Blockers Skeletal Muscle Relaxants

Constipation Drugs Statins

Controller Medications for Asthma Targeted Immune Modulators

COX-2/ NSAIDs Thiazolidinediones

Diabetes Drugs Topical Calcineurin Inhibitors

Fixed-dose Combination Products: Diabetes Triptans

Website: http://www.ohsu.edu/drugeffectiveness

TABLE 6. DERP Drug Reviews

DERP Drug Reviews

The Center for Evidence-based Policy, not to be confused with the Oregon EPC, supports the collaborationby executing the agreements and contracts required to operate the collaboration, and by staffing the governanceprocess that directs DERP projects. In addition, the Center for Evidence-based Policy supports communicationbetween the participating organizations and the EPCs, provides technical assistance to participatingorganizations on the understanding and use of systematic reviews, ensures that timelines are met, and managescommunication among the participating organizations, and between pharmaceutical companies and DERP. TheCenter for Evidence-based Policy does not participate in the evaluation of the evidence. In addition, the Centerfor Evidence-based Policy has other projects that are distinct from DERP and do not involve the EPCs.

According to Neumann (2006), the DERP has drawn criticism from a number of sources, especially thepharmaceutical industry and some patient advocacy groups. The criticism centers mostly on allegations that theDERP is merely a cost containment exercise that restricts access to important therapies; the project, some suggest,gives Medicaid programs and other organizations political cover to justify not paying for expensive new drugs.Detractors also claim that DERP reviewers favor evidence from RCTs to the exclusion of observational studiesand other sources of data. In addition, there is some criticism that DERP reviews do not promote the true “value”of drugs in any meaningful sense because they do not consider cost-effectiveness formally. Furthermore, somecontend that the review process lacks transparency and should allow more opportunity for input and feedback.Finally, drug industry officials have argued that the opportunity for public input during the P&T committeeprocess is limited.

The following table lists the DERP drug reviews in progress as of April 2008.


MEDICAID EVIDENCE-BASED DECISIONS PROJECT (MED)

The Medicaid Evidence-Based Decisions Project (MED) is a collaboration of state Medicaid programs forthe purpose of making high quality evidence available to states to support benefit design and coverage decisionsmade by state programs. MED is a part of the OHSU Center for Evidence-Based Policy and is affiliated withDERP. This project includes commissioning and access to systematic reviews, technology assessments, a web-based clearinghouse, and support from research staff at the Center in designing evaluations and applyingthe evidence.

Website: http://www.ohsu.edu/med/

WASHINGTON STATE HEALTH TECHNOLOGY ASSESSMENT PROGRAM (SHTAP)

In March 2006, Washington State’s Governor Gregoire signed legislation creating the State Health TechnologyAssessment Program (SHTAP). SHTAP is an effort by the state to employ evidence-based medicine principlesinto its purchasing of health care. The program will determine which health technologies to evaluate, contractwith an evidence-based practice center or similar entity to conduct the technology assessment, establish, staff andmanage a health technology clinical committee that will then take that technology assessment and make acoverage recommendation to the state agencies; the efficacy of medical devices, procedures, diagnostic tests, andservices will be evaluated.

Website: http://www.hca.wa.gov/shtap/


II. PROPOSALS FOR COMPARATIVE – EFFECTIVENESS CENTERS

GAIL WILENSKY’S PROPOSED CENTER FOR COMPARATIVE EFFECTIVENESS

Gail Wilensky’s paper in Health Affairs has spurred much discussion surrounding the concept of a center forcomparative effectiveness. Her paper assesses the various options regarding the structure, placement, financing,and functions of an agency devoted to comparative (clinical) effectiveness assessment. Pros and cons of the majoroptions are presented, along with a judgment about which strategies would be most likely to be acceptable to themost important stakeholders. A brief discussion of how other countries have handled decisions about theplacement and financing of comparative effectiveness centers is also included.

In summary, the proposed multi-billion dollar center would provide an independent assessment of thecomparative effectiveness of alternative therapies and procedures for use by various payers and providesupporting information so that both patients and providers can improve their decision making. Such anassessment would involve systematic reviews of existing research as well as the conduct of prospective trials toaddress key questions for which comparative effectiveness evidence was lacking.

The center’s multibillion-dollar size would reflect the need to sponsor new research and produce new data oncomparative clinical effectiveness for the many new and existing technologies that have come on the market overthe past several decades.

Results of each assessment would be made available to the public.

Wilensky GR. Developing a Center for Comparative Effectiveness Information. Health Affairs. 25 (2006):w572–w585.

BLUE CROSS AND BLUE SHIELD ASSOCIATION’S PROPOSED PAYER – FUNDED CENTER FOR COMPARATIVE EFFECTIVENESS

On May 7, 2007, the Blue Cross and Blue Shield Association (BCBSA) proposed that Congress enactlegislation to establish a new, independent institute - funded by all health care payers - to provide consumers andproviders with much needed information on which medical treatments work best. This proposal is an importantcomponent of a multi-pronged strategy BCBSA will be announcing in the coming months to improve health carevalue and quality for consumers.

Under BCBSA’s proposal, the institute would support research comparing the effectiveness of new andexisting medical procedures, drugs, devices, and biologics. The institute would support a broad range ofresearch, including much-needed clinical trials, and be governed by a board representing stakeholders in thegovernment and private sector.

BCBSA proposes funding the institute by assessing all private (insured and self-funded) and public health carecoverage such as Medicare, Medicaid, and other government programs. BCBSA, as a leading provider of healthcare coverage to more than 98 million people, is prepared to contribute substantial financial support to theinitiative.

BCBSA recommends that the new comparative information be quickly and efficiently disseminated toproviders, patients, and others, and that the research results be incorporated into clinical practice guidelinesthrough close collaboration with medical societies.


Another important element of the proposal calls for physicians who rely on practice guidelines establishedthrough the institute’s research to be given safe harbor for non-economic and punitive damages when faced withclaims of medical malpractice.

A summary of the proposal and more information can be found online at:http://www.bcbs.com/issues/transparency/

To complement this paper, and to increase the relevancy of their position on the issue, the BCBSA released anupdate of its commitment to comparative effectiveness research with a five point health care reform plan,released in January 2008. The plan, entitled, “The Pathway to Covering America: Ensuring Quality, Value andAccess,” states in its first point, “Encourage Research on What Works,” that quality and value must be improvedby “comparing the relative effectiveness of new and existing medical procedures, drugs, devices, and biologics.”

Most notably, the Blue Cross Blue Shield Association endorsed an “Institute” in this plan that very closelyresembles the “Institute” outline in the Senate draft bill by Senator Baucus and Senator Conrad discussed below.The BCBSA advocates for a broad range and scope of research, entity independence, and stable funding sourceswith contributions from stakeholders.

Additionally, the paper recommends that the government take steps to establish incentives for integration andadoption of new research into clinical practice, as well as acceptance of evidence-based standards to informmedical malpractice.

BCBSA’s “Pathway to Covering America” health care reform proposal can be found online at:http://www.bcbs.com/issues/uninsured/pathway-to-covering-america/

ENHANCED HEALTH CARE VALUE FOR ALL ACT OF 2007 (H.R. 2184)

Introduced May 7, 2007, by Rep. Allen (D-ME); co-sponsored by Rep. Emerson (D-MO)

• Amends Section 1013 of the MMA of 2003 “…to expand comparative effectiveness research and to increase funding for such research to improve the value of health care.”

• Scope to include all “Federal health care programs,” including:� Programs under title XVIII, XIX, or XXI of SSA

� Federal employees health benefits program

� Dept. of Veteran Affairs

� TRICARE

� Indian Health Service (IHS)

• Funding� Comes from a newly established Trust Fund

� Money comes from fees on each policy written for a cover life (i.e., proportional payments per covered lives) as an equal percentage of total moneys gathered that year

� $100M in FY 2008

� $200M in FY 2009

� $900M in each FY 2010-2012

� Medicare contribution capped at $200M in any given year, regardless of lives covered


• Forms two independent bodies� Comparative Effectiveness Advisory Board

� Primary purpose is to advise Secretary of HHS and Congress on scientific and research issues,with any funding recommendations

� Comprised of

� head of AHRQ (currently Carolyn Clancy)

� 14 other stakeholder representatives including: “…clinicians, patients, researchers, third-party payers,consumers of Federal and State beneficiary programs, and health care industry professions“

� Charged with

� Providing input on research priorities

� Recommending how to organize research, taking into consideration a “…full range of appropriatemethodologies, including randomized control trials, practical clinical trials, observation studies,and synthesis of existing research.”

� Recommending how findings should be described, presented and disseminated

� Creating recommendations within 2 years “…regarding the establishment of one or more federally-funded research and development centers.”

� Define priority areas of research (e.g., chronic care, high cost areas, greatest need, etc.)

� Establish a clinical peer-review advisory board for each priority area to advise on appropriate methods and conduct studies

� Drafts 2012 status report with Secretary HHS that includes

� ROI evaluation of program

� Evaluation of any backlog of unfunded research

� Assessment of

– How the program is working

– The governance structure of the program

– Ability of the program to include public comment and patient perspectives in priority setting

– Ability of program to disseminate findings and conclusions

� Permanent council

� Purpose is to assist the relevant offices and agencies in coordinating the conduct or support ofhealth services research and work to set national strategic goals and plans; more “big picture” than advisory council

� Comprised of 20 members, including:

� Director of AHRQ, who in-turn selects other members

� One senior official from each of the following

– VA

– Dept of Defense Military Health Care

– CDC

– NCHS

– NIH

– CMS

– Federal Employees Health Benefits Program


� 4 senior leaders from major national philanthropic foundations that fund and use health services research

� 8 stakeholder members “…in health services research, including private purchasers, health plans,hospitals and other health facilities, and health consumer groups.”

� Members serve lifetime appointments

� Secretary of HHS designates chair and co-chair once all members selected

� Duties of the council are to examine:

� major infrastructural challenges facing the field of health services research

� the field’s research priorities over the next 5 years

� the current portfolio of health services research being funded

� ways to stimulate innovation in the field

� goals for transformation by 2020

� Tasked with creating a strategic plan within 2 years that addresses each of the topics of examination on the national level

S.3, MEDICARE PRESCRIPTION DRUG PRICE NEGOTIATION ACT OF 2007

Introduced January 4, 2007, by Baucus.Section 4: Prioritizing Studies of Comparative Clinical Effectiveness of Covered Part D Drugs

I. Priority: The Secretary of HHS, “…shall develop a comprehensive prioritized list of comparative clinicaleffectiveness studies that are most critical to building the evidence needed to advance value-based purchasingof covered part D drugs….”

II. Prioritized list will:

a. specify items and services to be evaluated;

b. include the methodology to use in each identified study “…taking into account the full range ofmythologies available, from systematic reviews to clinical trials;” and

c. be delivered in draft form to the Congress within 1 year of enactment with final version delivered followinga 60-day public comment period.

III.Development of prioritized list will take into consideration:

a. work already completed by AHRQ, including areas in which AHRQ has deemed evidence as insufficient;

b. priority medical conditions developed for section 1013;

c. “areas where patients and doctors are most lacking the information needed to make the best decisionregarding covered Part D drugs, such as the areas where there is a large gap in knowledge of drug therapiesand areas that involve the most widely prescribed covered part D drugs;” and

i. “…areas where patients and doctors…” part of this section leaves an open door to consider anything

ii. latter half of this part encourages CE applied to most prescribed part D drugs, but does not mandate it


d. advice from a new advisory committee

i. made-up of a “…diverse range of public and private clinical experts, stakeholders, and interests from the following groups” with no majority membership from any one group:

1. medical and health industries

2. patients and representatives of patients

3. researchers

4. government

ii. all advice given by committee to be made public

iii.committee will accept oral or written comments prior to any advisement

IV. Rule of Construction

a. gives Secretary of HHS ability to prioritize and conduct comparative clinical effectiveness research asdeemed appropriate by the secretary

b. meant as a catch-all clause, but could be used to circumvent procedure laid out within the bill (e.g.,undertake non-prioritized research)

H.R. 3162: THE CHILDREN’S HEALTH AND MEDICARE PROTECTION ACT OF 2007

The debate around comparative effectiveness research in the House last summer was folded in to the largerhealth care debate on children’s health insurance that intensified with the impending expiration of the SCHIPauthorization in September of 2007. This bill, nicknamed the “CHAMP” bill (for the Children’s Health andMedicare Protection Act) incorporated language closely derived from H.R. 2184 (see above) and established aCenter for Comparative Effectiveness under AHRQ to “conduct, support, and synthesize research with respect tothe outcomes, effectiveness, and appropriateness of health care services and procedures.”

Funding for this center would begin with $300 million from 2008 to 2010 and $375 million per year thereafter,originating with the Medicare trust funds, and transfer over time to insurance companies. This contributionwould be calculated as a per capita amount multiplied by the average number of lives per policy.

The Center would be overseen by two governing bodies. The first, entitled a Comparative EffectivenessResearch Commission, would be comprised of major stakeholders in government and the private sector andmonitor the quality of research conducted at the Center. Manufacturing stakeholders are not explicitly listed inthe bill as potential appointees, but are similarly not excluded from playing this kind of role. The second, aCouncil for Health Services Research, would be comprised of a larger proportion of research- focusedgovernment stakeholders with the intention of advising the Secretary on health services research priorities andagenda setting.

Due in part to the political jostling around the reauthorization of SCHIP, the CHAMP bill was not passed intolaw. However, the CHAMP bill represents the current position and perspective of the House of Representativeson comparative effectiveness, and further debate will likely use this language as a starting point. As we anticipatedin the previous report in August 2007, this remains the primary vehicle in the House for the establishment of acomparative effectiveness research entity.


Introduced July 24, 2007, by Congressman John Dingell.H.R. 3162, Title IX, Section 904: Comparative Effectiveness Research

Amends Part A of title XVIII of the Social Security Act

I. Center for Comparative Research Established

i. conduct, support, and synthesize research relevant to the comparative clinical effectiveness of the fullspectrum of health care treatments including systematic reviews and RCT and observational clinicalresearch

II. Oversight by Comparative Effectiveness Research Commission

a) Duties

i. Oversee and evaluate the activities carried out by the Center and ensure highly credible and relevantresearch projects

ii. Establish national research priorities, ensure appropriate use of funds from the CERTF, engage in andoversee comparative effectiveness research activities across government agencies

b) Structure

i. Director of AHRQ (currently Dr. Carolyn Clancy)

ii. Chief Medical Officer of CMS

iii.Up to 15 other stakeholders including “clinicians, patients, researchers, third-party payers, consumers ofFederal and State beneficiary programs,” and

iv. At least one member of the Commission must represent clinical researchers “who conduct research onbehalf of pharmaceutical or device manufacturers.“

III.Coordinating Council for Health Services Research

a) Duties

i. Coordinate health services research across all federal departments and agencies

ii. Advise the Congress and President on national health services research agenda, infrastructure needs,expenditures.

b) Comprised of 20 members including

i. Director of AHRQ

ii. VA

iii.DoD Military Health Care System

iv. CDC

v. National Center for Health Statistics

vi. NIH

vii. CMS

viii. FEHB Program

ix. 4 senior leaders from major national, philanthropic foundations that fund and use health services research

x. Remaining members are stakeholders including “private purchasers, health plans, hospitals and other health facilities, and health consumer groups.“


IV. Establishment of Comparative Effectiveness Research Trust Fund

a) Funding for FY2008- FY2011 will be $90-110 million per year from Medicare trust funds, specifically thetrust fund established for Medicare Part D

b) Beginning in 2011, a tax is established on all health insurance plans, including self insured plans, accordingto a “fair share per capita” amount, a government established fee multiplied by the number of covered lives.This total contribution amount is set at $375,000,000 in 2011.

BAUCUS/CONRAD SENATE BILL: INTRODUCED AND WITHDRAWN MARCH 4, 2008

In early March of 2008, Senator Baucus and Senator Conrad introduced, and several hours later withdrew, theSenate’s response to the House comparative effectiveness legislation. Although the provisions closely resembledthose in the House bill, there were a few major differences that represented both the Senate’s commitment andthoughtfulness.

As in the CHAMP bill, the Baucus/Conrad bill establishes a new entity for Comparative EffectivenessResearch, entitled a “Healthcare Comparative Effectiveness Research Institute,” with a Medicare Trust Fund-connected funding stream and governance that involves wide stakeholder representation.

However, the Senate bill departs from the House bill in several major ways. First, the bill specifies a stakeholderrole for industry on the Board of Governors, identifying pharmaceutical, device, and technology manufacturers.This Board of Governors, which oversees the research priority setting for the Institute, would be appointed bythe Comptroller General of the Government Accountability Office (GAO). The bill connects the Center withAHRQ only so far as a contracting relationship for literature reviews.

The bill establishes a funding stream from annual appropriations and the Medicare Trust Fund, beginningwith $400 million over the first 5 years and increasing to $200 million by the fifth year.

The bill was withdrawn due to jurisdictional issues. At this time, the bill has not yet been reintroduced, and itis unclear whether these jurisdictional issues will be resolved successfully, or whether other Senators willcollaborate to consider related legislation this spring.

CONGRESSIONAL BUDGET OFFICE REPORT

In December 2007, the Congressional Budget Office released a major report entitled, “Research on theComparative Effectiveness of Medical Treatments: Issues and Options for an Expanded Federal Role.” This reportwas prepared in response to requests from the Senate Budget and Finance Committee and presented the case thatcomparative effectiveness research can improve health care quality and simultaneously help to reduce spendingon health care.

The report reflected the most comprehensive review to date of current activity in comparative effectiveness,federal investment in generating and reviewing evidence, options for comparing the effectiveness of treatments,and available opportunities for the federal government to support these options. Although no newgroundbreaking information was presented, the fact that this report was prepared and disseminated widely isillustrative of the increasing traction of comparative effectiveness proposals and the intent of Congress to passlegislation.

Notably, Dr. Peter Orszag, director of the CBO, has been very public in giving speeches about the importanceand necessity of investing in CER, citing CBO forecasts that over an extended period CER will generate a positivereturn on investments.


III.PRIVATE INITIATIVES

AMERICA’S HEALTH INSURANCE PLANS (AHIP)

AHIP is the national association representing nearly 1,300 member companies providing health insurancecoverage to more than 200 million Americans. The organization’s principal purpose is to represent the interestsof its members on legislative and regulatory issues at the federal and state levels, and with the media, consumersand employers. AHIP is involved in advocacy around issues such as creating standards for portable personalhealth records, rewarding quality performance in health care, regulatory reform to improve access and efficiency,and initiatives to make evidence-based medicine the standard for health care.

The AHIP Foundation is the non-profit, educational, scientific and research arm of AHIP. The Foundationseeks to create, support, and enhance programs in health insurance plans which will improve quality,effectiveness, and value in health care through research, education, information sharing, and other activitieswhich strengthen and reward exemplary practices by individuals and organizations. As such, the Foundationoffers leadership training programs for health insurance plan executives, medical directors and middle-managers. Through its programs, AHIP works to ensure that the best health care practices are understood anddisseminated to a wide audience.

For 2008, AcademyHealth has identified “Broad based and Adequate funding for Comparative EffectivenessResearch” as one of its top public policy priorities.

Website: http://www.ahip.org/default.aspx

CENTER FOR MEDICAL TECHNOLOGY POLICY

Founded in January 2006 by former chief medical officer and director of the Office of Clinical Standards andQuality at CMS, Dr. Sean Tunis, the Center for Medical Technology Policy (CMTP) is a private, non-profitorganization (operated and managed under the auspices of the Health Technology Center (San Francisco) thatprovides a neutral forum in which patients, clinicians, payers, manufacturers and researchers can work togetherto design and implement prospective, real world studies to inform health care decisions. The primary goal ofCMTP is to improve the process for generating reliable and credible information about the real world risks,benefits and costs of promising new medical technologies. By developing a center focused on the real-worldquestions asked by health care decision makers, the CMTP intends to address:

• Comparative effectiveness of new technologies against current standards of care

• Studies of procedures or technologies not regulated by the FDA (such as surgical procedures and somepharmacogenomic tests)

• Outcomes not typically measured in regulatory trials, such as quality of life and health care utilization

• Drug/device complication rates/side effects in real world settings

• Risks/benefits of common off-label uses

• Risks/benefits to important patient subgroups or those excluded from trials


The specific objectives of the CMTP are to:

• Fully incorporate the perspectives of health care decision makers in research priorities and study design.

• Ensure the rapid development and adoption of valuable technologies, and the efficient and appropriate useof these technologies.

• Limit the adoption and use of technologies of limited or uncertain benefit.

• Maintain incentives for innovators and investors to develop new high value technologies.

• Develop a collaborative model of health care research for other organizations interested in expanding thesupply of relevant and reliable evidence for decision makers.

CMTP’s primary activities during the development phase are to design and begin implementation of clinicalstudies for three pilot project topics. As part of this process, CMTP will develop methods for priority settingamong potential high value new technologies. CMTP will also create a robust organizational structure ofadvisory committees to support its work. Lastly, steps will be taken to develop a sustainable long-term fundingmodel to support the CMTP and its designed study protocols. Initial funding for CMTP has been provided bythe California HealthCare Foundation and the Blue Shield of California Foundation.

In May of 2006, CMTP held the first meeting of its steering committee, which led to the selection of fivepotential pilot project topics, based on specific pre-established criteria. The topics selected were: 1) radiationtherapy for prostate cancer, 2) delivery of ICU care through telemedicine, 3) minimally-invasive bariatric surgery,4) gene expression profiling tests for early stage breast cancer, and 5) CT angiography for diagnosis of coronaryartery disease.

CMTP is also:

• Working with several patient advocacy organizations and physician groups to explore collaborativemechanisms for priority setting.

• Convening a series of in-person and conference-call meetings of organizations working in the area ofevidence-based technology policy: the Technology Policy Collaborative, a forum for communication andcollaboration among a group of leaders currently focused on evidence-based health technology policy.

Sean Tunis, MD, MScFounder and Director

Wade Aubry, MDAssociate Director

Linda Bergthold, PhDSenior Advisor

Gail Wilensky, PhDSenior Policy Advisor

Molly Coye, MDSenior Advisor

Steven Pearson, MD, MScSenior Advisor

Rita Redberg, MD, MSc, FACCClinical Advisor

* Staff biographies are included in Appendix F.

TABLE 7. Center for Medical Technology Policy Staff

Center for Medical Technology Policy Staff*


• Convening a workshop focused on pragmatic clinical trials, cluster-randomized trials, quasi-experimentaldesigns and other methods intended to increase the speed and affordability of prospective clinical studies.

• Drafting a 5-year strategic plan, including options for medium and long term funding.

In addition, CMTP has developed active working relationships with key regional and national decisionmakers, stakeholders and experts. CMTP has also established links with other organizations focused ontechnology policy and evidence development, including the National Institutes of Health (NIH), the Food andDrug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), the Institute of Medicine(IOM), the New England Healthcare Institute (NEHI), the HMO Research Network (HMORN), the IntegratedHealthcare Association (IHA), the Institute for Clinical and Economic Research (ICER), the Critical PathInstitute (C-PATH) and others.

INSTITUTE FOR CLINICAL AND ECONOMIC REVIEW (ICER)

In June 2006, Dr. Steven Pearson was awarded a grant from the Blue Shield Foundation of California to launchthe Institute for Clinical and Economic Review (ICER) to develop and test new methods of technology appraisalfor US decision-makers. ICER produces appraisals of the clinical effectiveness and cost effectiveness of medicalinnovations, with the goal of providing new information to decision makers intent on improving the value ofhealth care services.

Pearson has also recently received grant support to develop and test a new format for technology assessmentthat can integrate clinical and cost-effectiveness reviews. The use of cost-effectiveness in policy decision makinghas raised many ethical and political issues in the past, and Pearson’s project is an explicit attempt to forge a newmethod that can overcome these difficulties and provide decision makers with the information on health carevalue that can support a more equitable and sustainable health care system.

The mission of the Institute for Clinical and Economic Review (ICER) is to be the most trusted source ofinformation to help fill this evidence gap for the benefit of all stakeholders in health and the health care system.ICER produces rigorous assessments of new medical interventions, and translates its findings into integratedratings specifically formatted to support value-based insurance benefit designs, coverage and reimbursementpolicy, and patient-clinician decision support tools.

Website: http://www.icer-review.org/


IV. INDEPENDENT EVIDENCE-BASED MEDICINE INITIATIVES

INSTITUTE OF MEDICINE’S (IOM) ROUNDTABLE ON EVIDENCE-BASED MEDICINE

Chartered in 1970 as a component of the National Academy of Sciences, the Institute of Medicine (IOM) is anonprofit organization specifically created for the purpose of providing unbiased, evidence-based, andauthoritative information and advice concerning health and science policy to policy-makers, professionals,leaders in every sector of society, and the public at large. Operating outside the framework of government toensure scientifically informed analysis and independent guidance, the IOM’s mission is to serve as adviser to thenation to improve health.

Roundtables are a specific type of convening activity of The National Academies intended to enable dialogueand discussion among key leaders and representatives in a particular field. Roundtables are prohibited by theNational Academies from producing reports that provide advice or recommendations.

The IOM Roundtable on Evidence-Based Medicine brings together key stakeholders from multiple sectors —patients, health providers, payers, employers, manufacturers, policy makers, and researchers — for cooperativeconsideration of the ways that evidence can be better developed and applied to drive improvements in theeffectiveness and efficiency of medical care in the United States. The objectives of the IOM Roundtable includeboth finding ways to generate better evidence on which to base clinical decisions, and prompting stronger publicand provider commitment to putting evidence into practice. Specific issues and agenda topics will span a broadrange of issues in research, medical care, and health policy. Examples include:

• Assessment priorities. Which interventions do stakeholders feel are the highest priorities for evaluation? Bywhat criteria? How can they best be assessed? How can coordination be improved for assessment activities.

• Assessment approaches. What criteria should guide choices among various assessment tools — e.g. registries,other observational data (natural experiments), randomized clinical trials, practical clinical trials, modeling?How can these methods be improved and the lessons shared? What decision criteria should guidedeterminations on the sufficiency of evidence?

• Data issues. What are the constraints, issues and opportunities to advancing the public good aspect of healthdata? How should the protection requirements mandated under HIPAA (the Health Insurance Portabilityand Accountability Act) be engaged to expedite collection of evidence on medical effectiveness? What isneeded for electronic health records to generate real-time evaluative information? Can an interoperablenetwork of integrated health system data be developed to expedite assessment of new interventions?

• Policy issues. How can policies on coverage and regulation better foster evidence generation? How can theethical and confidentiality issues be best addressed? How can sustained support be developed for studiesneeded on comparative effectiveness of diagnostics and treatment interventions?

• Translation strategies. What are the most promising opportunities to accelerate the application of proveninterventions in health care? What communication strategies might be most effective in translating to thepublic the nature of evolving science and medicine?

• Cooperative arrangements. What mechanisms might facilitate cooperative pooling of resources andinformation to generate better evidence on which to base clinical decisions?


To address these issues, the Roundtable will work over the next three years in formal meetings, expert panels,workshops, and symposia. There are four working groups, with 5–7 members each, focusing on the followingfour main areas: (1) evidence development; (2) sustainable capacity; (3) evidence applications; and (4) vision.

The Roundtable’s first event was a workshop entitled “The Learning Healthcare System.” This workshop wasthe first in a series and considered how health care is structured to develop and to apply evidence – from healthprofessions training and infrastructure development to advances in research methodology, patient engagement,payment schemes, and measurement – and highlighted opportunities for the creation of a sustainable, learninghealth care system that gets the right care to people when they need it and then captures the results forimprovement. The most pressing needs for change identified in The Learning Healthcare System are thoserelated to:

• Adaptation to the pace of change

• Stronger synchrony of efforts

• New clinical research paradigm

• Clinical decision support systems

• Tools for database linkage, mining, and use

• Notion of clinical data as a public good

• Incentives aligned for practice-based evidence

• Public engagement

• Trusted scientific broker

• Leadership

The second workshop in the Learning Healthcare System series, titled Judging the Evidence: Standards forDetermining Clinical Effectiveness, was held on February 5, 2007 and involved discussions surroundinginconsistencies in evidence standards, variations in the evidence threshold in certain situations, and new formsof evidence that have recently appeared on the horizon and how they can be applied clinically.

The third workshop in the Learning Healthcare System series, titled Leadership Commitments to Improve Valuein Health Care: Toward Common Ground took place on July 23 and 24, 2007. The workshop provided a settingfor a rich exchange of ideas about how various stakeholder sectors can work, both individually andcollaboratively, to foster the development of a learning health care system.

The fourth workshop in the Learning Healthcare System series, titled Redesigning the Clinical EffectivenessResearch Paradigm: Innovation and Practice-Based Approaches, was held on December 12-13, 2007. Participantsexamined the role of innovative research designs and tools that can expedite the development of evidence onclinical effectiveness by streamlining approaches and bringing research and practice closer together. In thecontext of existing evidence gaps and a need for a substantially improved understanding of comparative clinicaleffectiveness of health care interventions, this workshop explored opportunities presented by emerging researchnetworks and data resources, innovative study designs, and new methods of analysis and modeling that willaddress the existing evidence gap and the need for a substantially improved understanding of comparativeclinical effectiveness of health care interventions. Presentations and discussion focused on how these tools andmethods can be engaged in a new generation of studies that better address current challenges in clinicaleffectiveness research.


The fifth workshop in the Learning Healthcare System series, titled Clinical Data as the Basic Staple of HealthLearning, took place on February 28-29, 2008, and explored the transformational opportunities that could beavailable by evolving large and potentially interoperable clinical and administrative data sets, held in multipleactivities and many institutions.

The sixth workshop, entitled Engineering a Learning Healthcare System: A Look at the Future, took place onApril 28-29, 2008, and focused on how to engineer the development of a learning health care system to bestructured in a way to keep the patient constantly in focus, while continuously improving quality, safety,knowledge, and value in health care.

The seventh workshop, scheduled for July 29-30, is titled Learning What Works: Infrastructure and ClinicalPriorities for Learning Which Care is Best. This workshop will discuss what infrastructure is needed to expand thescope of current comparative effectiveness research. Specifically, this will involve clarifying the “nature of thework; assess future capacity needs related to workforce, research method innovation, data linkage andimprovement, and coordination of efforts.”

In January 2008, the IOM published a report entitled, “Knowing what works in health care: A roadmap forthe nation.”2 In this comprehensive review, the IOM-convened Committee on Reviewing Evidence to IdentifyHighly Effective Clinical Services provides a guide for how the United States can “assess the effectiveness ofclinical services and to provide credible, unbiased information about what really works in health care.“

THE JAMES LIND ALLIANCE

The James Lind Alliance was started by Sir Iain Chalmers, founder of the Cochrane Collaboration, in orderto bring physicians and patients together to identify gaps of evidence in health services research for effectivenessof treatments. The purpose is to both “identify and prioritize the unanswered [research] questions” as well as tocontribute perspectives and critical research needs from patients and physicians.

The Alliance utilizes a Database of Uncertainty about the Effectiveness of Treatments (DUETs) to “identifyand publish uncertainties reflected in patients’ and clinicians’ questions about the effects of treatments whichcannot be answered by referring to up-to-date systematic reviews of existing research evidence.” This database isbeing developed in partnership with Oxford University and is funded by the UK Medical Research Council andthe UK Department of Health.

http://www.lindalliance.org

THE COCHRANE COLLABORATION

The Cochrane Collaboration, founded in 1993, is an international non-profit and independent organization,dedicated to making up-to-date, accurate information about the effects of health care readily availableworldwide. It produces and disseminates systematic reviews of health care interventions and promotes the searchfor evidence in the form of clinical trials and other studies of interventions. It is now the largest organization inthe world engaged in the production and maintenance of systematic reviews. The major product of theCollaboration is the Cochrane Database of Systematic Reviews, which is published quarterly as part of TheCochrane Library.

Those who prepare the reviews are mostly health care professionals who volunteer to work in one of the manyCochrane Review Groups, with editorial teams overseeing the preparation and maintenance of the reviews, aswell as application of the rigorous quality standards for which Cochrane Reviews have become known. The

2 Footnote: Institute of Medicine (IOM). 2008. Knowing what works in health care: A roadmapfor the nation. Washington, DC: The National Academies Press.)


Cochrane Collaboration is supported by hundreds of organizations from around the world, including healthservice providers, research funding agencies, departments of health, international organizations and universities.There are currently more than 10,000 people contributing to the work of The Cochrane Collaboration from over80 countries, and this involvement continues to grow.

ECRI INSTITUTE

ECRI Institute (formerly the Emergency Care Research Institute) is a nonprofit health services researchagency and a Collaborating Center of the World Health Organization (WHO). In addition, it is designated as anEvidence-based Practice Center (EPC) by AHRQ. ECRI’s mission is to promote high standards of safety, quality,and cost-effectiveness in health care to benefit patient care through research, publishing, education andconsulting. Its focus is health care technology, health care risk and quality management, patient safetyimprovement and health care environmental management. ECRI provides information services and technicalassistance to more than 5,000 hospitals, health care organizations, ministries of health, government and planningagencies, voluntary sector organizations, associations, and accrediting agencies worldwide. It offers more than30 databases, publications, information services, and technical assistance services.

ECRI’s services alert readers to health care system and technology-related hazards with strategies to correctthem; disseminate the results of medical product evaluations and health technology assessments; provide expertadvice on technology acquisitions, staffing, and management; report on hazardous materials management policyand practices; and supply authoritative information on risk control in health care facilities and clinical practiceguidelines and standards.

ECRI has served as an AHRQ-designated EPC since 1997. While most EPCs are located within academicinstitutions, ECRI’s evidence-based medicine and health technology assessment activities are funded in a public-private cooperative model that relies on a variety of Federal and State government funding, as well as commercialsales of ECRI’s evidence-based health policy resources, available through its Health Technology AssessmentInformation Service (HTAIS). The resources of ECRI’s technology assessment work are used by a wide varietyof constituencies, including public and private payers, providers, clinical specialty societies, regulators, industry,and patients and their families.

In addition to its capabilities in traditional health technology assessment methodology, the staff of the ECRIEPC also has expertise in research design and evaluation, outcomes data analysis and modeling, horizonscanning, and health policy analysis.

ECRI’s other activities include such diverse areas as:

• Methodology support for clinical practice guideline development.

• Development of evidence-based information for patients and their families.

• Patient safety program development.

• Adverse event reporting systems.

• Health technology planning and engineering evaluation.

• Technology acquisition and procurement assistance.

• Accident and forensic investigation.


HAYES, INC. – THE HEALTH TECHNOLOGY ASSESSMENT COMPANY

Hayes, Inc. is an independent health technology assessment organization that specializes in robust, clinicallyfocused health technology assessment reports for health care organizations, including health plans, managed carecompanies, hospitals, and health networks. Hayes’ medical research analysts assess such technologies as medicaland surgical procedures, drugs, biologics, diagnostic and screening tests, medical devices and equipment, andcomplementary and alternative therapies. Hayes offers several professional health technology assessmentproducts including a tool for monitoring emerging medical technologies; a service focused on medical literaturedatabase searches with brief reports; health technology briefs for decision makers; and a directory containingover 350 reports assessing a variety of new and emerging medical technologies.

Website: http://www.hayesinc.com/

ACADEMYHEALTH SUPPORT OF COMPARATIVE EFFECTIVENESS RESEARCH

On May 15, 2007, AcademyHealth issued a press release that expressed the organization’s support of H.R.2184 (see above). According to that statement, “AcademyHealth believes increased funding for comparativeeffectiveness research will provide evidenced-based and data-driven solutions to our most pressing health policychallenges.” This expression of support is directly in-line with AcademyHealth’s 2007 vision and priorities forhealth services research policy, which states: “Congress should increase and expand the sources of funding forconducting and coordinating a wide spectrum of comparative effectiveness research, including systematicreviews of existing literature, analysis of administrative data and clinical registries, and pragmatic, prospective,head-to-head trials. Doing so would ultimately help patients, providers, payers, and policymakers make rationalchoices about new and existing health services. Since the findings of the research would benefit all people, itssources of funding should be broad based. Independence and scientific integrity should be emphasized.”

AcademyHealth is essentially supporting a broad range of health services research methodologies as theyrelate to the larger comparative effectiveness discussion that is taking place in the US. By keeping its focus onimproving both the health of patients as well as the system of health services through the application of a widerange of methodologies (as opposed to just head-to-head clinical trials), AcademyHealth has positioned itselffirmly on the side of best scientific practice within the larger debate while avoiding any support for a specificinstitute or organization to carry out that research.

Website: http://www.academyhealth.org/index.htm

ACADEMY OF MANAGED CARE PHARMACY’S FORMAT FOR FORMULARY SUBMISSIONS

In October of 2000, AMCP developed the Format for Formulary Submissions to help ensure that theutilization of pharmaceutical drugs and vaccines were appropriate, and that information was available on therelative effectiveness and cost-effectiveness of newer drugs introduced to the market. The drug dossiers that aredeveloped according to the Format are intended to be transparent and credible, and document researchprotocols, study designs, modeling, and results analysis.

The Format has become an industry standard for reporting economic and clinical evidence on efficacy, safety,and comparative economic value. It seeks to provide pharmacy and therapeutics committees with the necessaryinformation in a digestible standard format to evaluate the value of a drug and its potential economic impact tothe health care organization. To date, the Format has been used by government agencies such as the Departmentof Defense, Medicaid programs, pharmacy benefit managers, health plans, and hospitals as the adopted standardfor policy documentation and determinations.


V. CONSUMER – FOCUSED INITIATIVES

CONSUMER REPORTS BEST BUY DRUGS

Launched in December 2004, Consumer Reports Best Buy Drugs is a public education project of ConsumersUnion, the publisher of Consumer Reports. The organization produces drug reports that combine an expertreview of the scientific evidence on prescription drugs with their prices. Evaluations are based on reviews bythe aforementioned Oregon Health & Science University-based Drug Effectiveness Review Project (DERP). Theproject’s overriding purpose is to translate the DERP’s findings for consumers and, combining that with drugprice and cost data, to produce an independent and unbiased resource on the comparative effectiveness andvalue of prescription drugs (Findlay, 2006). The reports compare and contrast prescription drugs by category– that is, drugs in the same class that are used to treat a specific condition or illness such as high blood pressure,high cholesterol, allergies, coronary-artery disease, heartburn, or depression. Physicians and pharmaceuticalexperts serve as professional peer reviewers of the drug reports. The following table presents a list of reportscurrently available.

The Consumers Union emphasizes that their findings are intended to assist consumers in discussing withtheir doctors which medicines are best for them. Best Buy picks are based on assessments of all the drugs in aclass, and a comparison of the drugs in that class to each other. The main criteria used are a drug’s effectiveness,it’s safety, the side effects it may cause, it’s convenience of use (for example, how many pills you have to take eachday), its track record in studies and actual use, and of course how much it costs relative to others drugs. There isno set formula for choosing Best Buys. The factors differ in each category, and some of those factors are quitesubtle. However, in general, Best Buys are chosen because they are: (a) as effective as all the other drugs in thecategory, or more so; (b) as safe and cause no more - and usually fewer - side effects than other drugs in thecategory; and (c) cost less on average than other drugs in the category. That is not always true, though. Several of

High Blood Pressure, Heart Failure – The ACE Inhibitors Asthma and Lung Disease – Inhaled Steroids

Attention Deficit Hyperactivity Disorder Drugs Sleeping Pills for Insomnia

Alzheimer’s Disease Drugs Migraine Headache Drugs – The Triptans

Schizophrenia, Bipolar Disorder Osteoarthritis, Pain – The NSAIDs

Antidepressants Overactive Bladder

High Cholesterol, Heart Disease – The Statins Menopause – Female Hormones

Allergies, Hay Fever, and Hives – Antihistamines Heart Disease and High Blood Pressure – Beta Blockers

Treating Heart Disease, Heart Attacks, Angina, High Blood Pressure – Calcium Channel Blockersand Stroke – Antiplatelets

Drugs for Heartburn, Acid Reflux Disease – The PPIs Opioids – Treating Chronic Pain

Treating Bipolar Disorder, Nerve Pain Treating Type 2 Diabetes – The Oral Diabetes Drugsand Fibromyalgia – The Anticonvulsants

* Staff biographies are included in Appendix F.

TABLE 8. Consumers Reports Best Buy Drug Report

Consumer Reports Best Buy Drug Reports


the Best Buys have been chosen because of their superior effectiveness or safety profile even though they costmore. Overall, a drug’s effectiveness is the most important criteria in choosing Best Buys.

The project is funded by grants from the Engelberg Foundation and the National Library of Medicine and seeksguidance from members of its advisory board, who are listed in the following table.

According to their website, the project is aimed at helping the uninsured, seniors without any drug coverage,insured people with high co-pays, employers, insurance companies, unions and anyone interested in getting abetter value for their health-care dollar. As such, multiple organizations have partnered with the ConsumersUnion to educate their members about the Best Buy Drugs project and include:

• AFL-CIO

• Alliance for Retired Americans

• American Federation of State, County and Municipal Employees

• American Public Health Association

• American Medical Student Association

• Common Cause

• Consumer Federation of America

• Families USA

• National Committee to Preserve Social Security and Medicare

• National Education Association

• U.S. Public Interest Research Group

Nancy Wilson Ashbach, MD, MBAFamily Physician-Former Member Board of DirectorsAmerican Academy of Family Physicians

Jerry Avorn, MDAssociate Professor of Medicine Harvard Medical School

Georges C. Benjamin, MDExecutive Director American Public Health Association

Roger Herdman, MDSenior Scholar Institute of Medicine National Academy of Sciences

Sharlea Leatherwood, PDPresident National Community Pharmacists Association

Jay BhattPresidentAmerican Medical Students Association

Lisa Schwartz, MD, MS Associate Professor of Medicine VA Outcomes Group Dartmouth Medical School

Steven Woloshin, MD, MSAssociate Professor of Medicine VA Outcomes Group Dartmouth Medical School

TABLE 9. Members of Consumers Reports Best Buy Drugs Advisory Board

Member of Consumer Reports Best Buy Drugs Advisory Board


AMERICAN ASSOCIATION OF RETIRED PERSONS (AARP) RESEARCHRX

AARP now offers an online consumer guide that provides comparative information about the effectivenessand safety of brand-name and generic drugs within nine prescription drug classes. AARP’s conclusions foundon the site are based on an independent review and assessment of the available medical evidence undertakenby the Drug Effectiveness Review Project of Oregon Health & Science University’s Center for Evidence-based Policy.

Website: http://www.aarp.org/health/comparedrugs/

ALLIANCE FOR BETTER MEDICINE

The Alliance for Better Medicine (ABM) is a California-based coalition of patient advocacy groups, physicianexperts and ethnic health care organizations working together to make sure patients receive appropriate,individualized medical care. ABM’s most urgent priority is to ensure that the evolving concept of evidence-basedmedicine, or EBM, is defined and implemented in a way that protects the most appropriate treatment for theindividual patient or consumer.

The mission of ABM is to “Educate policymakers and the public to achieve the best and most cost effectiveoutcomes in health care utilizing the best available science and information developed in consultation withresearchers, practitioners and recipients of care, that considers the differences in responses to specificmedications or procedures, based upon factors such as age, sex, race, ethnicity and co-occurring disorders.” Toachieve this mission, ABM promotes the use of analyses that focus on disease management and that consider thetotal costs of treatment. The Alliance is wary of analyses that examine particular procedures, treatments, orclasses of medicine without considering their impact on other costs and services. It is opposed to the notion thatEBM should be used to justify limited access to medications and restrictive policies which do not consider thespecific needs of the individual patient or clinical experience of the physician.

ABM hosted an Educational Summit on Evidence-Based Medicine in August 2005 in order to engage groupsand individuals to discuss the best ways to use evidence to improve health outcomes. The group has submittedpublic comments to the Oregon Evidence-Based Practice Center’s DERP questioning the methodology of itsdrug review reports and to CMS and the Consumers Union questioning the applicability of the “Best Buy Drug”reports to the Medicare population. ABM’s other activities include the proposed California HealthcareAccountability Center (CHAC) and Governor Schwarzenegger’s California Health Reform.

Member organizations of ABM include numerous national health associations and California chapters ofnational health organizations such as the Alzheimer’s Association, the Asthma and Allergy Foundation ofAmerica, Epilepsy Foundation, and many others. The 18-member Steering Committee consists of physicians,academics, and representatives of health and patient advocacy organizations. (For a complete list of SteeringCommittee members, please see: http://www.allianceforbettermedicine.org/members/steering.html.)

Website: http://www.allianceforbettermedicine.org/

NATIONAL WORKING GROUP ON EVIDENCE-BASED HEALTHCARE

In January 2006, Mental Health America (MHA) convened the National Working Group on Evidence-BasedHealth Care to help ensure greater patient-focused, consumer knowledge and involvement in national and state-focused initiatives seeking to promote a better quality of care. The group functions as an education and advocacyorganization that represents consumers, caregivers, practitioners and researchers committed to promotingaccurate and appropriate evidence-based policies and practices that improve the quality of health care services in


the U.S. A core activity of many of the group’s initiatives is the review, interpretation, and dissemination ofinformation about scientific research.

The four major categories of the EBM initiatives on which the Working Group focuses include: measuringvalue in health care; payer adoption of EBM principles; generation of medical information and evidence; anddefining clinical research priorities. The group was formed with the objective of addressing challenges andraising concerns associated with evidence-based health care (EBH) initiatives and serves as a centralizedinformation resource and forum for consumers, voluntary health organizations, providers, researchers and otherinterested stakeholders. Its most recent activities included hosting a public forum on the central role patientsshould play in EBH featuring patients and expert panelists who discussed trends and approaches for includingpatients in health care decision making. The group also drafted a letter to Health Affairs in August 2006 giving aconsumer’s perspective on DERP and making tangible recommendations for improving the development anduse of DERP reports.

Members of the Working Group include over 30 organizations such as the Alliance for Better Medicine,American Psychiatric Association, Easter Seals, and the FDA Office of Special Health Issues. A complete list ofmember organizations can be found at the following address:http://www.evidencebasedhealthcare.org/index.cfm?objectid=7FBE8DB3-1372-4D20-C8E764D83B9A1A61

Website: http://www.evidencebasedhealthcare.org/index.cfm

U.S. COCHRANE COLLABORATION’S CONSUMERS UNITED FOR EVIDENCE-BASED HEALTHCARE (CUE)

Initial funding from the Agency for Healthcare Research and Quality (AHRQ), has enabled the United StatesCochrane Center (USCC) to develop Consumers United for Evidence-based Healthcare (CUE). CUE is apioneering effort to improve consumers’ ability to engage in and demand high quality health care. CUE startedin 2003 as a partnership between consumer health advocacy groups and scientists involved in evidence-basedhealth care (EBHC). CUE is a national coalition of health and consumer advocacy organizations and representsa consumer advocate-scientist partnership.

The mission of CUE is to promote the health of populations and the quality of individual health care byempowering consumers, public health policy makers, and health care providers to make informed decisionsbased on the best current evidence through research, education, and advocacy. As key stakeholders in health and health care decision making, consumers need access to high quality health information and criticalappraisal tools.

• Consumers are bombarded with health care information from the print media, TV, radio, Internet and theirhealth care providers.

• Interpreting the accuracy and validity of information is often difficult, as reports can be conflicting andevidence may seem to change over time.

• Consumers and consumer advocates need the tools to interpret, analyze, and understand this influx ofinformation.

United by a common interest in integrating understanding and interpretation of EBHC into their advocacyactivities, the 27 CUE member-organizations work to strengthen the voice of consumers and provide leadershipin health care research. A list of the participating organizations for 2007 is provided in the following table.


TABLE 10. Consumers United for Evidence-based Healthcare: 2007 Member Organizations*

Consumers United for Evidence-based Healthcare: 2007 Member Organizations

Annie Appleseed Project http://www.annieappleseedproject.org/

National Coalition for Lesbian, Gay, Bisexual and Transgender Healthhttp://www.lgbthealth.net/

* Note: a list of updated 2008 Member Organizations has not been posted to their website.Marianne Hamilton, MPA, serves as the US Cochrane Center’s Consumer Coordinator.

Black Women’s Health Imperative http://www.blackwomenshealth.org/

National Consumers League http://www.nclnet.org/

Center for Medical Consumers http://www.medicalconsumers.org/

National Council on Aginghttp://www.ncoa.org/

National Breast Cancer Coalition http://www.natlbcc.org/

National Center for Transgender Equalityhttp://www.nctequality.org/

Young Survival Coalitionhttp://www.youngsurvival.org/

Center for Science in the Public Interest http://www.cspinet.org/

National Environmental Education & Training Foundation http://www.neetf.org/

Cherab Foundationhttp://www.cherab.org/

National Mental Health Consumers’ Self-Help Clearinghouse http://www.mhselfhelp.org/

Childbirth Connectionhttp://www.childbirthconnection.org/

National Partnership for Women & Familieshttp://www.nationalpartnership.org/

Citizens for Healthhttp://www.citizens.org/

National Vaccine Information Centerhttp://www.909shot.com/

Citizens Health Alliance for Truth http://www.chatdc.org/

National Women’s Health Networkhttp://www.nwhn.org/

Consumers Union http://www.consumersunion.org/

Our Bodies Ourselveshttp://www.ourbodiesourselves.org/

Faces and Voices of Recoveryhttp://www.facesandvoicesofrecovery.org/

Rhode Island Breast Cancer Coalition1-800-216-1040

Lamaze Internationalhttp://www.lamaze.org/

SafeMindshttp://www.safeminds.org/

Mautner Project, the National LesbianHealth Organizationhttp://www.mautnerproject.org

TMJ Association, Ltd. http://www.tmj.org/


VI.MEASURING VALUE IN HEALTH CARE: STANDARDIZING METRICS

NATIONAL COMMITTEE FOR QUALITY ASSURANCE (NCQA)

The National Committee for Quality Assurance is a nonprofit organization dedicated to improving healthcare quality. The organization is frequently referred to as a watchdog for the managed care industry, but NCQAalso recognizes individual doctors and medical groups. It also provides information to employers and consumersto help them make more informed health care choices.

NCQA’s programs and services reflect a straightforward formula for improvement: Measure. Analyze.Improve. Repeat. NCQA makes this process possible in health care by developing quality standards andperformance measures for a broad range of health care entities. These measures and standards are the tools thatorganizations and individuals can use to identify opportunities for improvement. The annual reporting ofperformance against such measures has become a focal point for the media, consumers, and health plans, whichuse these results to set their improvement agendas for the following year.

NCQA began accrediting managed care organizations (MCOs) in 1991 in response to the need forstandardized, objective information about the quality of these organizations. Although the MCO accreditationprogram is voluntary and rigorous, it has been well received by the managed care industry. More than half theHMOs in the nation, covering three-quarters of all HMO enrollees, have been reviewed by NCQA. Many largeemployers will not do business with a health plan that has not earned NCQA’s seal of approval. Thirty statesrecognize NCQA Accreditation as meeting certain regulatory requirements for health plans, eliminating the needfor a separate state review. For an organization to become accredited by NCQA, it must undergo a rigoroussurvey and meet certain standards designed to evaluate the health plan’s clinical and administrative systems. Inparticular, NCQA evaluates health plans in the areas of patient safety, confidentiality, consumer protection,access, service and continuous improvement.

During a survey, plans are reviewed against more than 60 different standards, each of which focuses on animportant aspect of the health plan. These standards fall into five broad categories:

• Access and Service – Do health plan members have access to the care and service they need? Does the health plan resolve grievances quickly and fairly?

• Qualified Providers – Does the health plan thoroughly check the credentials of all of its providers?

• Staying Healthy – Does the health plan help people maintain good health and avoid illness?

• Getting Better – How well does the plan care for people when they become sick?

• Living with Illness – How well does the help people manage chronic illnesses?

Accreditation surveys are conducted by teams of physicians and other experts. The process is rigorous; ahealth plan must be aggressively managing quality to achieve NCQA Accreditation.

Since 1997, NCQA has produced an annual State of Health Care Quality report, an overall assessment of theperformance of the health care system. The report is issued right before the annual “open enrollment” season,when most Americans choose their health plan for the following year. Consequently, the report generates anenormous amount of media attention.


The Health Plan Employer Data and Information Set (HEDIS)NCQA also sponsors, supports, and maintains The Health Plan Employer Data and Information Set

(HEDIS), a tool used by nearly all health plans to measure performance on important dimensions of care andservice. HEDIS is a set of standardized performance measures designed to ensure that purchasers and consumershave the information they need to reliably compare the performance of managed health care plans. Theperformance measures in HEDIS are related to many significant public health issues such as cancer, heart disease,smoking, asthma and diabetes. HEDIS also includes a standardized survey of consumers’ experiences thatevaluates plan performance in areas such as customer service, access to care and claims processing. Altogether,there are more than 60 different measures in HEDIS. Because HEDIS data are collected by such a large portionof the market, and because the measures are so specifically defined, HEDIS makes it possible to compare theperformance of managed health care plans on an “apples-to-apples” basis. Health plans also use HEDIS resultsthemselves to see where they need to focus their improvement efforts.

PHARMACY QUALITY ALLIANCE

Formed in April 2006 and officially launched in April 2007, the Pharmacy Quality Alliance (PQA) is anunprecedented collaborative effort among the pharmacy community, health plans, government, employers,physicians, and consumer groups aimed at improving health care quality and patient safety in pharmacy practice.Founding members include the National Community Pharmacists Association (NCPA), the NationalAssociation of Chain Drug Stores, America’s Health Insurance Plans, and CMS.

The mission of the Pharmacy Quality Alliance is to improve health care quality and patient safety through acollaborative process in which key stakeholders agree on a strategy for measuring performance at the pharmacylevel; collecting data in the least burdensome way; and reporting meaningful information to consumers,pharmacists, employers, health insurance plans, and other health care decision-makers to help make informedchoices, improve outcomes, and stimulate the development of new payment models. The approach beingutilized by PQA is similar to the AQA and the Hospital Quality Alliance that have involved a broad array ofstakeholders with the goal of producing a standardized set of measures to improve the quality of health care.

Interest in pharmacy quality measures has grown accordingly in recent years, with employers andpolicymakers leading the call for a means to measure and compare pharmacy quality. Most notably, Congressenacted the Medicare Modernization Act in 2003, which created the Medicare Part D drug benefit and expandedaccess to needed medications for the nation’s 43 million Medicare beneficiaries. The legislation also called fordevelopment of quality standards and measures.

In November 2006, PQA, in collaboration with a broad array of stakeholders, approved a starter set of 35 keyareas for quality measurement for pharmacies and pharmacists practicing in a variety of settings. The starter setof defined areas is intended to provide pharmacists and pharmacies with a set of indicators that may be utilizedfor quality improvement, public reporting and pay-for-performance programs. The uniform starter setcomprises several key areas for measurement that include: 14 cardiovascular disease measures, 3 measures indiabetes, 2 measures in hyperlipidemia, 4 measures in the area of respiratory disorders, 9 measures in the area ofpatient safety and 3 measures in the generic efficiency area. Areas designated for measurement includemedication adherence and persistence, generic efficiency measures, and safe, efficient and appropriatemedication use. This effort will lead to a uniform set of measures for pharmacy care that can focus quality effortsand give consumers data they need to make more informed health care decisions. In March 2007, PQAannounced the selection of the National Committee for Quality Assurance (NCQA) to further develop and testthese performance measures in alpha and beta testing as well as validation through pilot testing withinpharmacies.


In addition to approving the initial set of measures, the PQA also endorsed two sets of principles put forth bythe PQA Reporting Workgroup: The PQA Principles for Public Reports, and The PQA Principles for Reporting toPharmacists and Pharmacy Practices. The next steps for the Reporting Workgroup will be to develop draftreporting templates and also pilot test reports for use by pharmacies, pharmacists and consumers. Both sets ofprinciples are posted on the PQA website.

The PQA is guided by a Steering Committee committed to improving health care quality and patient safety andpharmacy practice, and appointed to a three-year term of service, whose members are listed in the followingtable.

Judith CahillExecutive DirectorAcademy of Managed Care Pharmacy

Carolyn Clancy, MDDirectorAgency for Healthcare Research and Quality

John Gans, PharmDExecutive Vice President and CEOAmerican Pharmacists Association

N. Lee Rucker, MSPHStrategic Policy Advisor, Public Policy Institute, AARP

Karen IgnagniPresident and CEOAmerica’s Health Insurance Plans

Steven AndersonPresident and CEONational Association of Chain Drug Stores

John L. Fish, Vice PresidentChannel Management & Pharmacy SolutionsGlaxoSmithKline

David MarshallVice President, Commercial OperationsTeva Pharmaceuticals USA

Jack Mahoney, MDCorporate Medical DirectorPitney Bowes

Mark McClellan, MD, PhDVisiting Senior FellowAEI Brookings Joint Center

Edmond Weisbart, MDChief Medical OfficerExpress Scripts, Inc.

Bruce Roberts, RPhExecutive Vice President and CEONational Community Pharmacists Association (NCPA)

Rebecca Snead, RPhExecutive Vice President and CEONational Alliance of State Pharmacy Associations

John FeatherExecutive Director & CEOAmerican Society of Consultant Pharmacists

Jeffrey Kelman, MDCenter for Beneficiary ChoicesCenters for Medicare and Medicaid Services

TABLE 11. Members of Pharmacy Quality Alliance Steering Committee

Members of Pharmacy Quality Alliance Steering Committee


VII. INTERNATIONAL

U.K.’S NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE (NICE)

Established as a part of the British National Health Service in 1999, NICE reviews all types of medicaltechnologies, including drugs, that are likely to have a sizable health or budgetary impact or otherwise to becontroversial, and provides guidance to the NHS on the use of new and existing technologies. The actualevaluation and assessment of the technology is done by a technical committee called the Technology AppraisalCommittee (TAC), which includes a large group of academic experts, clinicians, patient advocates, and industryrepresentatives. An academic group does the actual assessment; the TAC reviews it and publishes arecommendation, which can be appealed. The recommendation is then submitted to NICE. The NICE appraisalprocess has been estimated to take a year or more. NICE is not bound by the TAC’s recommendations; however,drugs recommended by NICE are required to be funded by the government. NICE’s Citizens Council helps tointegrate broad social values judgments of the general public into the guidance NICE prepares.

Website: http://www.nice.org.uk/

CANADIAN AGENCY FOR DRUGS AND TECHNOLOGIES IN HEALTH (CADTH)

The Canadian Agency for Drugs and Technologies in Health (CADTH) is an independent, not-for-profitagency funded by Canadian federal, provincial, and territorial governments to provide credible, impartial adviceand evidence-based information about the effectiveness of drugs and other health technologies to Canadianhealth care decision makers. Activities include:

• Assessing drugs and health technologies: Health Technology Assessment (HTA)HTA provides high-quality information about the clinical effectiveness, cost-effectiveness, and broaderimpact of drugs, medical technologies, and health systems. The impartial, rigorous, and comprehensiveassessments examine four questions: (1) How will this health technology affect the health of Canadians? (2)How does it compare with alternatives? (3) Does it provide value for the investment? (4) Are there otherhealth service implications to consider?

• Reviewing clinical evidence on new drugs: Common Drug Review (CDR) In 2003, Canada introduced a coordinated process for reviewing drug coverage applications, the CommonDrug Review (CDR). The CDR reviews only new chemical entities and new combination products. Thereviews, which are not binding, are done for government drug plans in all provinces other than Quebec. Anadvisory committee of experts, appointed by the deputy ministers of health from each province, makesrecommendations to the CDR based on assessments by reviewers, who can be either internal or external tothe CDR. The advisory committee sends the initial recommendation to the manufacturer, which can appealthe decision. A summary of the recommendation and the rationale is posted, although neither the data northe assessment is made public.

• Identifying and promoting best practices in drug prescribing and use: Canadian Optimal MedicationPrescribing and Utilization Service (COMPUS)Through its COMPUS program, CADTH identifies and promotes evidence-based, clinical and cost-effectiveness information on optimal drug prescribing and use and is focused on improving health outcomes.Strategies, tools, and services are provided to encourage the use of evidence-based clinical and cost-effectiveness information in decision making among health care providers and consumers.

Website: http://www.cadth.ca/index.php/en/home


AUSTRALIA’S PHARMACEUTICAL BENEFITS ADVISORY COMMITTEE (PBAC)

PBAC is an independent statutory body established on 12 May 1954 under section 101 of the National HealthAct 1953 to make recommendations and give advice to the Minister about which drugs and medicinalpreparations should be made available as pharmaceutical benefits based on data and economic analysessubmitted by drug companies. PBAC is required by the Act to consider the effectiveness and cost of a proposedbenefit compared to alternative therapies. In making its recommendations PBAC, on the basis of communityusage, recommends maximum quantities and repeats and may also recommend restrictions as to the indicationswhere Pharmaceutical Benefits Scheme (PBS) subsidy is available. When recommending listings, the Committeeprovides advice to the Pharmaceutical Benefits Pricing Authority (PBPA) regarding comparison with alternativesor their cost effectiveness.

No new drug may be made available as a pharmaceutical benefit unless PBAC has so recommended. The finaldecision is made public, but not the rationale for the decision or the relevant clinical or cost-effectiveness data.There is no formal process for appeal.

GERMANY’S INSTITUTE FOR QUALITY AND EFFICIENCY IN HEALTH CARE (IQWIG)

The Institute for Quality and Efficiency in Health Care is an independent scientific institute that evaluatesthe quality and efficiency of health care. The Institute investigates what therapeutic and diagnostic services are feasible and valuable, and communicates its findings to the health care professions, patients and the general public.

On 1 June 2004, the Institute was established as part of Germany’s Health Care Reform overhaul as aninstitution of the Foundation for Quality and Efficiency in Health Care in order to undertake commissions fromthe Federal Joint Committee and the Federal Ministry of Health. Institute is financed by a tax on inpatient andoutpatient health care services, which are mainly reimbursed by the statutory health insurance (SHI) funds.

The Institute’s tasks include the evaluation of pharmaceuticals, surgical procedures, diagnostic tests, clinicalpractice guidelines and aspects of disease management programs, following the principles of evidence-basedmedicine. It also publishes health information for patients and the general public. The Institute’s primary goal isto contribute to improvements in health care in Germany.

The Institute currently has eight departments. Professor Dr. Peter T. Sawicki, who assumed office on 1 September 2004, is the Institute’s Director.

THE INTERNATIONAL NETWORK OF AGENCIES FOR HEALTH TECHNOLOGY ASSESSMENT (INAHTA)

The International Network of Agencies for Health Technology Assessment (INAHTA) was established in1993 and has grown to 45 member agencies linked to national and regional governments from 23 countriesincluding North and Latin America, Europe, Australia, and New Zealand. All members are non-profitorganizations who produce health technology assessments. INAHTA’s mission is to provide a forum for theidentification and pursuit of interests common to health technology agencies in order to facilitate exchangeand collaboration among agencies, promote information sharing and comparison, and prevent unnecessaryduplication of activities.


The INAHTA membership meets yearly (in conjunction with the HTAi conference) and participates invarious working groups throughout the year. The organization’s website serves as its key form ofcommunication, where its reports, briefs, newsletter and other projects are available. In addition, INAHTAparticipates in international conferences, workshops, exhibitions, educational activities and seminars todisseminate its work. Currently, INAHTA’s individual working groups are collaborating on external partnershipswith such organizations as WHO, HTAi, OECD, and PAHO, as well as such issues as industry relations, qualityassurance, education and training, among others. The group plans to continue to enhance its function throughmore systematic exchange of work among its members, more training opportunities, and by improving itscollaboration with other organizations.

Website: http://www.inahta.org/inahta_web/index.asp

HEALTH TECHNOLOGY ASSESSMENT INTERNATIONAL (HTAI)

HTAi is an international membership organization that focuses uniquely on health technology assessment(HTA). HTAi seeks to support the development, communication, understanding and use of HTA around theworld as a means of promoting the introduction of effective innovations and effective use of resources in healthcare. The group serves as a forum for individuals from the worlds of health care, academia, and business whoare interested in the science, development and application of HTA. HTAi’s activities include publication of thequarterly International Journal of Technology Assessment in Health Care (IJTAHC) and an annual conference.

Website: http://www.htai.org/index.php?id=121

THE OECD HEALTH CARE QUALITY INDICATORS PROJECT

Run by the Organization for Economic Cooperation and Development (OECD), the HCQI Project is the onlyinternational, multicondition project examining quality measurement and improvement issues. AHRQ hasprovided ongoing technical guidance and leadership on this effort since 2001.

The OECD brought together a group of international leaders in the field of quality measurement to guidedevelopment of a conceptual framework for the HCQI Project as well as develop a set of 85 indicators across 5priority condition areas. This framework and these indicators will serve as the basis for the Project’s work onimproving data systems and tracking quality of care for many years. The supplement concludes with a lookforward at improving international quality measurement and reporting over the long term.

Ongoing support for the HCQI Project is provided by the European Commission and the CommonwealthFund, a national, private foundation based in New York City that supports independent research on health andsocial issues. Technical and project leadership by AHRQ and these partners has helped ensure a solid foundationfor the HCQI Project and its goal of developing indicators and data systems that can be used to raise questionson quality of care internationally.


Organization: The Health Industry Forum, Brandeis University

Event: Coverage Policy in an Era of Personalized Medicine: Evaluating and Paying for Genetic Testing Services

Date: October 12, 2006

Location: Washington, D.C.

Description: N/A – see agenda at link below

Website: http://healthforum.brandeis.edu/meetings.htm

http://healthforum.brandeis.edu/October%2012,%202006/Agenda_Web%2010.12.06.pdf

Organization: Society for Medical Decision Making

Event: The 28th Annual Meeting of the Society for Medical Decision Making

Date: October 15-18, 2006

Location: Boston, MA

Description: N/A

Website: http://smdm.confex.com/smdm/2006ma/techprogram/MEETING.HTM

Organization: The Chochrane Collaboration

Event: 14th Cochrane Colloquium


Location: Dublin, Ireland

Description: As we approach the 3000th full Cochrane review, the challenges of making their findings moreaccessible are ever increasing. This session will describe initiatives to help meet these challenges.We will hear about ways to distil the information in Cochrane reviews into shorter summaries andto combine multiple reviews into new, umbrella reviews. Other means of dissemination are alsoimportant. There will be talks from the perspective of a long-standing print journal keen to helpmake the message in Cochrane reviews more available and about an initiative between TheCochrane Collaboration and Wiley to produce a new journal based heavily on Cochrane reviews.

Website: http://www.cochrane.co.uk/colloquium/welcome.htm

VIII. EVIDENCE-BASED MEDICINE CONGRESSES

A search was conducted to develop a comprehensive list of recently completed and upcoming meetings andconferences being held on issues related to health technology assessment (HTA), evidence-based medicine(EBM), and/or comparative effectiveness (CE), including conferences which may only have specific sessionsconcentrated in one or both of these areas. The search included meetings and conferences that have occurred orare scheduled to occur within the next year within North America, Europe, and elsewhere.

The results are included below.

OCTOBER 2006

NOVEMBER 2006



Event: Comparative Effectiveness Forum

Date: November 30, 2006


Description: The Comparative Effectiveness Forum, held in Washington, D.C. on November 30, 2006,brought together leading thinkers from academia, industry, and government to examine invery practical terms how to make broadly available comparative effectiveness research areality in the U.S. This report summarizes the Forum’s four discussion sessions, highlightingkey points from each. Note: The Forum convenes small leadership conferences focusing oninnovative strategies for improving the quality and effectiveness of health care. Participationis by invitation only.


http://healthforum.brandeis.edu/NOVEMBER%20HTA%2030,%202006/ExecBriefCompEffectiveForum113006.pdf

Organization: International Society for Pharmacoeconomics and Outcomes Research (ISPOR)

Event: ISPOR 9th Annual European Congress


Location: Copenhagen, Denmark


Website: http://www.ispor.org/congresses/denmark1006/CongressProgram.pdf

Organization: Organized in conjunction with ISPOR

Event: Regional Conference on Cost-Effective Healthcare 2006


Location: Singapore

Description: N/A

Website: http://www.cehealth2006.com/

OCTOBER 2006 continued


FEBRUARY 2007

Organization: University of Queensland

Event: 4th Queensland Biohumanities Conference: Evidence-Based Medicine

Date: January 8-9, 2007

Location: Brisbane, Australia

Description: N/A

Website: http://www.representinggenes.org/biohumanities/podcasts/4QBC_podcast.htm

JANUARY 2007

Organization: Massachusetts Health Data Consortium

Event: 2007 Healthcare Information Technology Conference

Date: February 2, 2007

Location: Burlington, MA

Description: N/A – please see agenda at link below

Website: http://www.mahealthdata.org/forums/events/2007/HIT_0202/registration.html

Organization: Asia Pacific Center for Evidence-Based Medicine

Event: 5th Asia Pacific Evidence-Based Medicine Workshop & Conference

Date: February 4-7, 2007

Location: Singapore

Description: N/A – please see agenda at link below

Website: http://www.nuh.com.sg/nuh_apebm/5th%20APEBM_Home.html

http://www.nuh.com.sg/nuh_apebm/5th%20APEBM_WorkshopInformation(2).html#Programme


MARCH 2007Organization: National Council for Community Behavioral Healthcare

Event: 37th Annual National Council Conference

Date: March 26-28, 2007

Location: Las Vegas, NV

Description: Session of interest: Evidence-Based Depression Treatment: Making an IMPACT (03/27-28)

Website: http://conference.nccbh.org/

Organization: Avalere Health

Event: Audio Conference on Presenting Comparative Treatment Information to Consumers: Impact on Patients and Manufacturers

Date: March 28, 2007

Location: Audio conference

Description: The Agency for Healthcare Research and Quality (AHRQ) recently began producing consumer-oriented versions of its evidence-based comparative effectiveness research reports; the guidespublish costs of various over-the-counter and prescription drugs in addition to other decision-makinginformation. Audio conference participants learned how these guides were developed, how theyhave impacted the physician-patient relationship, and talked about the government’s role ininfluencing decision-making at the patient level.

Website: http://www.avalerehealth.net/conferences/effective_health_care.html

Organization: Old Dominion University/Center for Medicine in the Public Interest

Event: Improving Healthcare Quality and Value: The Role of Comparative Effectiveness Research

Date: March 29, 2007

Location: Washington, D.C. (National Press Club)

Description: N/A

Website: http://hs.odu.edu/hs/newsevents/nfhkm_agenda.pdf


APRIL 2007


Event: Developing an Effective Long Term Strategy for Post-Marketing Surveillance of Medical Products

Date: April 11, 2007




Organization: National Working Group on Evidence-Based Health Care

Event: Public forum on the central role patients should play in evidence-based health care

Date: April 19, 2007

Location: Webcast



Organization: Canadian Agency for Drugs and Technologies in Health (CADTH)

Event: 2007 CADTH Symposium - Informing Policy, Influencing Practice, Improving Health

Date: April 22-24, 2007

Location: Ottawa, Ontario

Description: Multiple relevant sessions on HTA and EBM — see event program for full descriptions.

Website: http://www.cadth.ca/index.php/en/events/sympos-2007


MAY 2007

Organization: BIO® Biotechnology Industry Organization

Event: BIO International Convention

Date: May 6-9, 2007


Description: Sessions of interest - Science for Payment: A Payer Perspective of Technology Assessment (05/07);The Cost of Effective Care for Rare Diseases (05/07); The Value of Innovation: A Patient-CenteredAgenda in Pricing & Reimbursement? (05/08); The Fourth Reimbursement Hurdle: Cost-Effectiveness; Safe or Effective? FDA’s, the Industry’s and the Patient’s Regulatory Dilemma.

Website: http://www.bio2007.org/

Organization: Blue Cross and Blue Shield Association

Event: Luncheon Briefing: BCBSA Announces New Initiative For Comparative Effectiveness Research

Date: May 7, 2007

Location: Washington, D.C. (National Press Club)

Description: Blue Cross and Blue Shield Association announces a proposal for a new, independent entity to explore the effectiveness of new and existing medical procedures, drugs, devices, and biologics.

Website: http://www.bcbs.com/news/press/luncheon-briefing-bcbsa.htm

Organization: Jefferson Medical College

Event: The Disease Management Colloquium

Date: May 7-9, 2007

Location: Philadelphia, PA

Description: Session of interest: Evidence-Based Medicine and Disease Management (05/07).

Website: http://www.dmconferences.com/

Organization: European Science Foundation (ESF)

Event: The International Regulation of New Medical Technology, Germany

Date: May 7-11, 2007


Description: Salzau Castle, Salzau (near Kiel), Germany

Website: http://www.esf.org/conferences/07237

Organization: National Health Service (NHS)

Event: Service Delivery and Organization R&D Programme (SDO) – Sixth National SDO Conference: Delivering Better Health Services

Date: May 9, 2007

Location: London, UK

Description: A one day conference for all those concerned with the delivery and management of effective, evidence-based health care – service users, health service managers, health professionals, researchers and policy makers.

Website: http://www.healthcareevents.co.uk/tabid/63/Default.aspx/?conferenceId=99

MAY 2007 continued


Organization: National Quality Forum (NQF)

Event: NQF Spring Meetings

Date: May 9-11, 2007

Location: Chicago, IL

Description: The demand for reporting quality-related data to increase the transparency and accountability of health care is growing, and the NQF is convening its 2007 Healthcare Quality ImplementationConference to support providers in overcoming the challenges of performance measurement andreporting. A vanguard of users of NQF-endorsed TM consensus standards is proving that it can be done. Their stories demonstrate that consensus standards can be implemented successfully, to the ultimate benefit of patients.

Website: http://www.qualityforum.org/about/meetings/spring_meeting07.asp

http://www.qualityforum.org/pdf/meetings/ag04-18-07.pdf

Organization: American Psychiatric Association

Event: APA 160th Annual Meeting

Date: May 19, 2007

Location: San Diego, CA

Description: Sessions of interest: Evidence-Based and Guideline Approaches to Psychiatric Treatments (05/22); Uneasy Partners: The Pharmaceutical Industry and the Psychiatric Profession (05/22); several other discussions on evidence-based practices in particular areas of psychiatry.

Website: http://www.psych.org/edu/ann_mtgs/am/07/index.cfm


Event: ISPOR 12th Annual International Meeting

Date: May 19-23, 2007

Location: Arlington, VA

Description: New Tools, New Audiences for Health Outcomes Research – Sessions of interest: Health CareComparative Effectiveness in the United States Symposium (05/20); Raising the Bar in the U.S.: The Impact of Heightened Awareness of the Need for Health-Economic Data in the Absence of a Regulatory Mandate (05/21); Do Physicians Use Cost-Effectiveness Research? Should They? (05/22); Health Technology Assessment in Evidence-Based Reimbursement (05/22); What isUncertainty in Cost-Effectiveness Analysis? How Should We Characterize It? (05/22); numerousposters and podium presentations.

Website: http://www.ispor.org/Events/Index.aspx?eventId=11

MAY 2007 continued


Organization: Avalere Health

Event: Evidence-Based Medicine: Set Your Sights

Date: May 22, 2007


Description: Recent developments in evidence-based medicine are generating a wave of transformation in healthcare – are you ready to take it on? Join experts from government, industry, and academia to discussthe latest trends in value-based purchasing, comparative effectiveness, and insurance coveragedecision-making. Find out how developments in EBM may further influence productcommercialization strategy, how to engage in the redefinition of the clinical research enterprise, andwhether payment reform will include paying for quality improvement.

Website: http://www.avalerehealth.net/conferences/evidence2007.html

Organization: Institute of Medicine (IOM) Forum on the Science of Health Care Quality Improvement and Implementation

Event: Workshop on Conduct of Healthcare Quality Improvement Research

Date: May 24-25, 2007

Location: Irvine, CA

Description: N/A – see agenda at links below

Website: http://www.iom.edu/CMS/3809/38607/42075.aspx

http://www.iom.edu/Object.File/Master/42/842/Draft%20Public%20Agenda%20Workshop%202-%205%203%2007.pdf


JUNE 2007 Organization: AcademyHealth

Event: Annual Research Meeting 2007

Date: June 3-5, 2007

Location: Orlando, FL

Description: AcademyHealth’s Annual Research Meeting brings together health services researchers, providers,and key decision makers to address the critical challenges confronting the health care deliverysystem. The meeting provides opportunities to present and hear about cutting-edge research,debate timely policy issues, and learn about new methods and funding sources. Sessions ofinterest: Expanding the Capacity for Comparative Effectiveness Research in the United States(06/03); Gift Horse or Trojan Horse: The Increasing Controversy Surrounding Evidence-BasedMedicine (06/04); Issues in Cost-Effectiveness Analysis (06/05).

Website: http://www.academyhealth.org/arm/index.htm

Organization: Canadian College of Health Service Executives (CCHSE)/ Canadian Association for Health Services and Policy Research (CAHSPR)

Event: National Healthcare Leadership Conference/2007 Annual CAHSPR Conference

Date: June 11-12, 2007

Location: Toronto, Canada


Website: http://www.healthcareleadershipconference.ca/default1.asp

Organization: University of York Centre for Health Economics

Event: York Expert Workshops in the Socio Economic Evaluation of Medicines 2007

Date: June 13-15/18-22/25-27, 2007

Location: York, UK

Description: Session of interest: Meeting Decision-Makers’ Requirements: Advanced Methods for Cost Effectiveness Analysis (06/18-22).

Website: http://www.york.ac.uk/inst/che/training/expert.htm

Organization: The European League Against Rheumatism (EULAR)

Event: EULAR Congress 2007

Date: June 13-16, 2007

Location: Barcelona, Spain

Description: The EULAR congress is the venue for scientific presentation of basic, clinical and translationalresearch. Hopefully, new knowledge can be translated into improved prevention of the rheumaticdiseases and into better treatment and rehabilitation of patients with these disorders. The congress is also a meeting point for rheumatologists, health professionals and patients where they cometogether, exchange ideas, and develop plans for future collaborative research or educationalactivities. Sessions of interest: Evidence-Based Practice in Non-Pharmacological Care – from Vision to Reality (06/13)

Website: http://www.eular.org/scientificprogramme/


JUNE 2007 continuedOrganization: Asia Pacific Center for Evidence-Based Medicine

Event: Annual Evidence-Based Medicine Workshop: How to Practice and Teach Evidence-Based Medicine

Date: June 14-17, 2007

Location: Antipolo City, Philippines


Website: http://www.apebm.com/

Organization: Health Technology Assessment International (HTAi)

Event: HTAi 2007: HTA For Evidence-Based Public Health

Date: June 17-20, 2007

Location: Barcelona, Spain

Description: The International Regulation of New Medical Technology: Health Technology Adoption in theEuropean Union, the US, East Asia and in the Developing World - Our conference comprises fivethematic sessions with invited presentations and additional short talks and poster viewing sessions.(1) Theory and Policy Issues, (2) Health Technology Adoption and Regulation in the European Union,(3) Health Technology Adoption and Regulation in North America, (4) Health Technology Adoptionand Regulation in East Asia, (5) Health Technology Adoption and Regulation in Low and MiddleIncome Countries.

Website: http://www.esf.org/conferences/07237

Organization: Drug Information Association (DIA)

Event: 43rd Annual Meeting

Date: June 17-21, 2007

Location: Atlanta, GA

Description: The DIA Annual Meeting is the event of the year for the pharmaceutical and related industries. Noother industry event can rival the breadth and depth of experience that this meeting delivers. Withmore than 1,000 speakers from the FDA, EMEA, and other regulatory agencies, 27 content-areatracks, and nearly 400 sessions, the presentations are geared to attendees of all experience andfunctional levels. The DIA Annual Meeting, above all others, offers valuable professional cross-functional learning, continuing education credits, and networking experiences. Sessions of interest:Personalized Medicine: A Perspective Beyond Science (06/18); The Emergent Role of the MedicalScientist in the Evidence-based Payer Environment: A Fundamental Source for Qualitative andQuantitative Information (06/20); Defining the Value of Pharmaceuticals (06/20).

Website: http://www.diahome.org/DIAHome/FlagshipMeetings/home.aspx?meetingid=11362


JUNE 2007 continuedOrganization: America’s Health Insurance Plans (AHIP)

Event: AHIP Institute 2007

Date: June 20-22, 2007


Description: Institute, AHIP’s Annual Meeting offers attendees from all arenas within the health insuranceindustry and stakeholders in health care the opportunity to explore the latest cutting-edgetechnologies, marketplace changes, new models of delivery and care, and other leading challengesand opportunities facing the health care industry. Thousands of leaders attend the Institute eachyear, including Presidents and CEOs, COOs, CFOs, CIOs, CMOs/Medical Directors, Vice Presidents,Medical Program Managers, Product and Plan Design Professionals, Account Managers, andConsultants. Session of interest: Translating Comparative Effectiveness Into Value-Based Benefit andReimbursement Designs (06/20).

Website: http://www.ahip.org/links/institute2007/

Organization: The NHS Confederation

Event: Annual Conference and Exhibition 2007

Date: June 20-22, 2007

Location: London, UK

Description: The NHS Confederation’s annual conference and exhibition bridges the gap between day-to-dayreality and the politicians’ vision for the future. Themed this year around serving patients and thecommunity, the event will deliver a programme that is relevant to every sector and stakeholder inthe health service. Session of interest: quality and efficiency strand.

Website: http://www.nhsconfed.org/about/about-2405.cfm

Organization: Faculty of Public Health

Event: The Faculty of Public Health Annual Conference 2007

Date: June 26-28, 2007

Location: Eastbourne, UK

Description: N/A - see agenda at link below

Website: http://www.publichealthconferences.org.uk/annual/


JULY 2007 Organization: International Health Economics Association (iHEA)

Event: iHEA 6th World Congress: Explorations in Health

Date: July 8-11, 2007

Location: Copenhagen, Denmark

Description: Sessions of interest: Coverage of new health care technologies in the US: an investigation ofprinciples, processes and the use of cost-effectiveness information (07/09); The ACE (Assessing CostEffectiveness) Approach to Priority Setting (07/09); The research-policy interface: better evidence forbetter health policies in Europe (07/09); From Best Evidence to Best Practice - Effect of Guidelines-Based Practice on Patient Outcomes and Health Care Utilization (07/09); Systematic reviews andeconomic evaluations in technology appraisals conducted for NICE in the UK: A game of two halves?(07/10); Expected value of information and decision making in HTA (07/11).

Website: http://www.healtheconomics.org/congress/2007/

Organization: Advanced Medical Technology Association (AdvaMed)

Event: Medical Technology Reimbursement Specialist Workshop

Date: July 10-13, 2007



Website: http://www.advamedmtli.org/mtli/mtg07-21.cfm

Organization: The Cochrane Collaboration

Event: Summer Institute for Evidence-Based Practice: Quality and Safety

Date: July 12-14, 2007

Location: San Antonio, TX


Website: http://news.cochrane.org/view/item/review_one.jsp?j=754

http://www.acestar.uthscsa.edu/institute/su07/agenda.html


AUGUST 2007 Organization: The Department of Preventive Medicine and the

Rocky Mountain Prevention Research Center

Event: 9th Rocky Mountain Workshop on How to Practice Evidence-Based Health Care

Date: August 5-9, 2007

Location: Colorado Springs, CO

Description: This five-day, hands-on workshop is held annually in the summer at one of the beautiful resorts inthe Rocky Mountains. It features a cadre of world-renowned teachers, practitioners and researchersfrom the arena of evidence-based health care. Funded in part by a grant from AHRQ, this five-dayworkshop will focus on teaching the basics of, and developing further insights into, theconscientious use of current best evidence in making decisions about the care of individual patientsor the delivery of health services.


Organization: Strategic Research Institute

Event: 5th Annual Disease Management Conference



Description: Mark your calendars for a state-of-the-industry featuring various key issues, challenges, newdevelopments and implications for major stakeholders. The sessions will cover the following majorareas and offer timely and practical advice to practitioners and key health care players. Implicationsand developments relating to: employers, managed care organizations, consumer-driven health care,new technologies, disease management vendors, government agencies, evidence and outcomesresearch, public and private consumer engagement strategies.

Website: http://www.srinstitute.com/conf_page.cfm?instance_id=27&web_id=913&pid=520

Organization: São Paulo Center for Health Economics at the Federal University of São Paulo(Centro Paulista de Economia da Saúde – CPES)

Event: 7th International Symposium on Health Economics - Health Technology Assessment: Challenges for a Responsible Decision


Location: São Paulo, Brazil

Description: N/A

Website: http://www.ispor.org/meetings/other/7simposio_ingles.pdf

http://cpes.org.br/


SEPTEMBER 2007 Organization: International Society for Pharmacoeconomics and Outcomes Research (ISPOR)

Event: ISPOR 1st Latin America Conference

Date: September 9-11, 2007

Location: Cartagena, Colombia

Description: Session of interest: 2nd Plenary Session: Health Care Technology Assessment: Developing & Using the Evidence in Health Care Decisions (09/11)


Organization: International Society for Quality in Health Care (ISQua)

Event: 24th Conference for the International Society for Quality in Health Care (ISQua)

Date: September 30 – October 3, 2007


Description: The International Society for Quality in Health Care conference focus is on the methodologies thatfacilitate safe, quality health care. From invited plenary presentations, selected panels, oral andposter presentations, participants will have opportunities to explore collaborative approaches toquality improvement among users, providers and funders, and to examine new systems and ideas.With the theme of Transforming Healthcare in the Electronic Age, this multidisciplinary quality healthcare program will be of value to all health policy makers, planners, professionals, administrators,researchers, educators and their representatives.

Website: http://www.isqua.org/isquaPages/boston07.html


Organization: Advanced Medical Technology Association (AdvaMed)

Event: 2007 Med Tech Conference



Description: N/A – TBD

Website: http://www.advamed2007.com/

Organization: Institute of Medicine (IOM)

Event: 37th Annual Members Meeting

Date: October 8, 2007


Description: Theme: Evidence-Based Medicine and the Changing Nature of Health Care.

Website: http://www.iom.edu/


Event: Joint conference on comparative effectiveness (ECRI/Milbank/Kaiser/EBRI/Health Affairs)


Location: N/A

Description: N/A

Website: http://www.iom.edu/CMS/2957.aspx

Organization: Society for Medical Decision Making

Event: The 29th Annual Meeting of the Society for Medical Decision Making


Location: Pittsburgh, PA

Description: N/A

Website: http://www.smdm.org/


Event: ISPOR 10th Annual European Congress


Location: Dublin, Ireland

Description: Expanding European Horizons for Pharmacoeconomics and Outcomes Research – Sessions of interest: First Plenary Session: Is Small Beautiful? Challenges Facing Ireland in Adopting the “Fourth Hurdle” (10/21); Second Plenary Session: Patient Reported Outcomes: A European Perspective (10/22).


OCTOBER 2007


OCTOBER 2007 continuedOrganization: America’s Health Insurance Plans (AHIP)

Event: 2007 Medical Leadership Forum: Evidence-based Solutions to Health Care’s Challenge


Location: Phoenix, AZ

Description: This year’s Forum offers a unique opportunity to discuss key health issues that challenge the delivery and financing of care with nationally recognized leaders.

Website: http://www.ahip.org/links/medmgt2007/

Organization: Q1 Productions

Event: Evidence-Based Medicine Conference: Examining the Best Practices in Data Analysis, Review and Collection to Support Labeling and Reimbursement Claims through Strategic Evidence-Based Medicine Practices


Location: Baltimore, MD

Description: Through addressing a range of topics related to the best practices in evidence-based medicine, thisconference program will provide attendees with the need to know information related to healtheconomics and outcomes research within the pharmaceutical and biotechnologies industry. Buildingupon early Q1 successes including the PRO 2006 conference as well as the Phase IV ClinicalResearch and Patient Registries conferences, this program will be a meeting of the minds and willaddress both strategic and tactical questions related to improving overall health quality of lifethrough evidence-based medicine.

Website: http://www.q1productions.com/events_EvidenceBasedMedicine.htm


Event: 15th Cochrane Colloquium: Evidence-based health care for all


Location: São Paulo, Brazil

Description: Over the past fifteen years, the Cochrane Collaboration has grown rapidly and Colloquia (theannual international conferences of the Cochrane Collaboration) are evolving to meet needs of anexpanding spectrum of participants. The Cochrane Library now includes a breadth of knowledgethat is relevant to a wide range of different types of health professionals, policy makers andconsumers. It is important that we continue to develop the quality and quantity of this evidenceand ensure that it is accessible to decision makers to support “evidence-based health care for all“-the theme of this year’s Colloquium.

Website: http://www.colloquiumbrasil.info/php/index.php


JANUARY 2008

DECEMBER 2007

Organization: The National Institute for Health and Clinical Excellence (NICE)

Event: NICE 2007 Annual Conference and Exhibition: Evidence into Practice

Date: December 5-6, 2007

Location: Manchester, UK

Description: NICE 2007 will address how NICE uses expert advice and evidence to develop guidance, and will offer practical and realistic examples for those working in the NHS and wider public health community on the best ways to turn recommendations into reality.

Website: http://www.nice2007.co.uk/

Organization: Health Economists’ Study Group (HESG)

Event: 72nd Meeting of the Health Economists’ Study Group


Location: Norwich, UK

Description: N/A

Website: http://www.hesg.org.uk/news.php?PHPSESSID=00649792cbf58669454fa9d0eb4117b1

Organization: University of Birmingham

Event: Methodological Basis of HTA


Location: Birmingham, UK

Description: This two-week course provides a detailed overview of the methodological basis of undertaking asystematic review/health technology assessment. Technologies considered include interventions,clinical, diagnostic test accuracy and other types of HTA. Areas that will be covered include:scoping/focusing of questions, literature searching methods, publication and related biases, qualityassessment of studies, approaches to data extraction, interpretation of results, data synthesis andanalysis methods including meta-analysis. The course is practically based and participants will havethe opportunity to work with example data sets including their own.

Website: http://www.pcpoh.bham.ac.uk/publichealth/programmes/hta/short-courses.htm

Organization: The Institut D’Economie Industrielle

Event: Health Economics and the Pharmaceutical Industry


Location: Toulouse, France

Description: Industry Regulation and Consequences; Industrial organization of the drug industry (and of other parts of the health sector); Health System Reform, with a special emphasis on European health systems; Economics and Value of Health

Website: http://www.irdes.fr/EspaceDoc/Documents/CalendrierDesColloques/ConfHealthEconomics25janv08.pdf


FEBRUARY 2008Organization: AcademyHealth

Event: 2008 National Health Policy Conference



Description: Get perspective on 2008 policy priorities directly from the policymakers.

Website: http://www.academyhealth.org/nhpc/agenda.htm

Organization: World Congress

Event: The World Congress Leadership Summit on Evidence-Based Medicine


Location: Alexandria, VA

Description: The Evidence-Based Medicine Summit will convene senior level executives from health plans, health systems, hospitals, government agencies and academia to discuss the utilization of evidence-based medicine to develop a clinical guideline policy. Thought leaders will share bestpractices in using the guidelines to improve cost and quality of care and the tools and techniquesrequired to assess the validity of the data. The issues of coverage and reimbursement models willalso be discussed as health care moves towards value based medicine.

Website: http://www.worldcongress.com/events/HL08007/index.cfm?print=true&TheConfCode=HL08007

Organization: AdvaMed

Event: Medical Technology Reimbursement Specialist Workshop



Description: Session of note: Technology Assessments

Website: http://www.advamedmtli.org/go.cfm?do=Page.View&pid=50

Organization: National University Hospital of Singapore, Asia Pacific Centre for Evidence-Based Medicine

Event: 6th Asia Pacific Evidence-Based Medicine/Nursing Workshop and Conference


Location: Singapore

Description: Conference highlight: Post-conference symposium for heads of departments: “Why Bother with Evidence-Based Medicine?“

Website: http://www.nuh.com.sg/nuh_ebm/ebm_apebm.htm


MARCH 2008

Organization: America’s Health Insurance Plans (AHIP)

Event: National Policy Forum

Date: March 4-6, 2008


Description: N/A

Website: http://www.ahip.org


Event: 2008 Canadian Cochrane Symposium

Date: March 6-7, 2008

Location: Edmonton, AB, Canada

Description: N/A



Event: Leadership Colloquium and Quality Award Gala; Board of Directors Meeting

Date: March 14-15, 2008


Description: N/A

Website: http://www.qualityforum.org/


Event: Spring Membership Meeting and Implementation Conference on Care Coordination; Board of Directors Meeting

Date: March 26-28, 2008

Location: Atlanta, GA

Description: N/A



APRIL 2008

Organization: Centre for Evidence-Based Medicine

Event: 3-Day Workshop on Evidence-Based Practice

Date: April 7-9, 2008

Location: Oxford, UK

Description: This workshop is aimed at clinicians and other health care professionals, including those involved in mental health, who want to gain knowledge of critical appraisal and experience in the practice of evidence-based health care. The workshop is intended to serve as an introduction to evidence-based medicine itself.

Website: http://www.cebm.net/index.aspx?o=1475

Organization: Institute of Medicine

Event: Roundtable on Evidence-Based Medicine Workshop on Engineering a Learning Healthcare System

Date: April 28-29, 2008


Description: Increasing complexity in health care is likely to accentuate current problems unless reform effortsgo far beyond financing, to foster significant changes in the culture, practice, and delivery ofhealth care. If the effectiveness of health care is to keep pace with the opportunity of diagnosticand treatment innovation, system design and information technology must be structured to assureapplication of the best evidence, continuous learning, and research insights as a natural by-product of the care process. In effect, the nation needs to engineer the development of a learninghealth care system—one structured to keep the patient constantly in focus, while continuouslyimproving quality, safety, knowledge, and value in health care. Striking transformations haveoccurred through systems and process engineering in service and manufacturing sectors—e.g., banking, airline safety, and automobile manufacturing. Despite the obvious differences thatexist in the dynamics of mechanical versus biological and social systems, the current challenges in health care compel an entirely fresh view of the organization, structure, and function of thedelivery and monitoring processes in health care.

Website: http://www.iom.edu/CMS/28312/RT-EBM/52747.aspx


MAY 2008Organization: National Council for Community Behavioral Healthcare

Event: 38th National Council Conference

Date: May 1-3, 2008


Description: From scientific advances to leadership training, we’re planning a robust curriculum featuring an array of tools and insights to help community behavioral health providers enhance businessoperations and revenue and improve clinical outcomes. Attendees also benefit from engagingpresentations from world-renowned motivational speakers, incomparable opportunities for personal and career growth, and more — all wrapped in a spirit of community, camaraderie, and caring.

Website: http://www.thenationalcouncil.org/cs/boston


Event: ISPOR 13th Annual International Meeting

Date: May 3-7, 2008

Location: Toronto, ON, Canada

Description: Vive la Différence - Enhancing/Expanding Outcomes Research One Country at a Time


Organization: American Psychiatric Association

Event: 2008 APA Annual Meeting

Date: May 3-8, 2008


Description: Our Voice in Action: Advancing Science, Care, and the Profession

Website: http://www.psych.org/edu/ann_mtgs/am/08/index.cfm

Organization: National and Gulf Center for Evidence-Based Medicine

Event: 4th Saudi Annual Workshop; Systematic Review Workshop; 4th Saudi Annual Conference

Date: May 7-8, 2008

Location: Riyadh, Saudi Arabia

Description: N/A

Website: http://www.ngha.med.sa/ebm/Events/2008/index.htm?L2ID=2004


Event: 8th Annual International C2 Colloquium

Date: May 12-14, 2008

Location: Vancouver, BC, Canada

Description: N/A

Website: http://www.campbellcolloquium.org


MAY 2008 continued

Organization: Jefferson Medical College

Event: 8th Disease Management Colloquium at Jefferson

Date: May 19-21, 2008


Description: The Colloquium seeks to better educate government agencies, the health care industry (including health plans and providers), employers, and the general public about the important role disease management programs play in improving health care quality and outcomes for persons subject to chronic conditions.

Website: http://www.dmconferences.com/overview.html

Organization: Geneva Health Forum

Event: Strengthening Health Systems and the Global Health Workforce

Date: May 25-28, 2008

Location: Geneva, Switzerland

Description: N/A

Website: http://www.genevahealthforum.org/


JUNE 2008Organization: Society for Medical Decision Making

Event: SMDM Europe 2008


Location: Engleberg, Switzerland

Description: The conference will bring together researchers and practitioners in a variety of areas within medical decision-making. Participants will be exposed to theoretical developments, applications,and implementation in practice.

Website: http://www.smdmeurope2008.com

Organization: Canadian Healthcare Association, Canadian College of Health Service Executives

Event: National Healthcare Leadership Conference


Location: Saskatoon, Saskatchewan, Canada

Description: Regionalization: Lessons Learned or Lessons Lost?

Website: http://www.healthcareleadershipconference.ca/default1.asp

Organization: AcademyHealth

Event: Annual Research Meeting

Date: June 8-10, 2008


Description: AcademyHealth’s Annual Research Meeting (ARM) has brought together health services researchers, providers, and key decision makers to address the critical challenges confronting the nation’s health care delivery system.

Website: http://www.academyhealth.org/arm/themes.htm

Organization: Biotechnology Industry Organization

Event: BIO International Convention 2008

Date: June 17-20, 2008

Location: San Diego, CA

Description: N/A

Website: http://bio2007.org/


JUNE 2008 continuedOrganization: America’s Health Insurance Plans (AHIP)

Event: Institute 2008 – AHIP’s Annual Meeting

Date: June 18-20, 2008

Location: San Francisco, CA

Description: N/A

Website: http://www.ahip.org

Organization: The National Health Service (NHS) Confederation

Event: Annual Conference and Exhibition

Date: June 18-20, 2008

Location: Manchester, UK

Description: A major program of work with members and partners in advance of the conference will look ahead to anticipate what will be different in the future and what the opportunities for progress will be. The thinking from this work will be discussed at the conference with a number ofprovocative questions debated in the plenary and strand sessions. We expect to address challenges of consumerism and user empowerment, health improvement and communitydevelopment, productivity, compassion in care, a new relationship between the medical profession and management, clinical futures and the future workforce.

Website: http://www.nhsconfed.org/issues/about-2801.cfm

Organization: American Society of Health Economists

Event: 2nd Biennial Conference

Date: June 22-25, 2008

Location: Durham, NC

Description: Equity and Efficiency in Health and Healthcare

Website: http://www.healtheconomics.us/conference/


JUNE 2008 continued

Organization: The University of York Centre for Health Economics

Event: York Expert Workshops in the Socioeconomic Evaluation of Medicines 2008

Module 1: Foundations of Economic Evaluation in Health Care

Date: June 23-27, 2008

Location: York, UK

Description: N/A


Organization: European Health Management Association (EHMA)

Event: 2008 EHMA Annual Conference

Date: June 25-27, 2008

Location: Athens, Greece

Description: N/A

Website: http://www.ehma.org/annual_conference/default.asp?NCID=83



Module 2: Meeting Decision-makers’ Requirements: Advanced Methods for Cost-Effectiveness Analysis

Date: June 30 – July 5, 2008

Location: York, UK

Description: N/A



JULY 2008

Organization: Health Technology Assessment International (HTAi)

Event: Fifth Annual Meeting of HTAi

Date: July 6-9, 2008

Location: Montreal, Canada

Description: Supporting decision making in health systems is the raison d’être of HTA. The conference willdevelop the theme Health Technology Assessment in Context by focusing specifically on the linksbetween governance and HTA, the role of HTA in hospitals, and the role of HTA in enabling theintroduction of promising technologies. This first Annual Meeting of HTAi in North America,birthplace of HTA, will provide a unique forum for researchers, practitioners and decision makers to share experiences and knowledge on best practice in HTA for decision making for health.

Website: http://www.htai2008.org/en_home.phtml



Module 3: Quality of Life

Date: July 7-9, 2008

Location: York, UK

Description: N/A


Organization: Athens Institute for Education and Research

Event: 7th International Conference on Health Economics, Management, and Policy

Date: July 10-13, 2008

Location: Athens, Greece

Description: N/A

Website: http://www.atiner.gr/docs/Health.htm

Organization: European Congress on Health Economics (ECHE)

Event: 7th European Conference on Health Economics

Date: July 23-26, 2008

Location: Rome, Italy

Description: The theme chosen for the ECHE Roma 2008 Conference raises the hope that health economicsbecomes the centre of a global process of renewal based on development stemming from newknowledge in the scientific field but also paying due attention to the experience and knowledgepreviously accumulated.

Website: http://www.echeroma2008.eu/home/

SEPTEMBER 2008



Event: ISPOR 3rd Asia-Pacific Conference


Location: Seoul, South Korea

Description: Evidence-Based Health Care Decision Making in Asia Pacific: The Application of Pharmacoeconomics and Outcomes Research


Organization: Centre for Evidence-Based Medicine

Event: 5-Day Workshop on Teaching Evidence-Based Practice


Location: Oxford, UK

Description: This workshop is aimed at clinicians and other health care professionals, including those involved inmental health, who already have some knowledge of critical appraisal and experience in thepractice of evidence-based health care and who want to explore issues around teaching evidence-based medicine. The workshop is NOT intended to serve as an introduction to evidence-basedmedicine itself.

Website: http://www.cebm.net/index.aspx?o=1080

Organization: AdvaMed

Event: The MedTech Conference 2008



Description: N/A

Website: http://www.advamed2008.com


OCTOBER 2008


Event: 16th Cochrane Colloquium: Evidence in the area of globalisation


Location: Freiburg, Germany

Description: The Cochrane Colloquium 2008 offers an outstanding opportunity to interact with central players active in evidence-based health care, global knowledge management and systematicreviews. Catch up on current international developments and perspectives and attend workshopsto delve further into individual topics.

Website: http://www.cochrane.de/en/colloquium2008.htm


Event: 2008 IOM Annual Meeting


Location: Washington, D.C

Description: N/A

Website: http://www.iom.edu/CMS/2951/16671/16689.aspx


Event: 2008 Annual Meeting and Policy Conference on Quality; Board of Directors Meeting


Location: Washington, D.C., Arlington, VA

Description: N/A


Organization: International Society for Quality of Life Research (ISOQOL)

Event: 15th Annual Scientific Meeting


Location: Montevideo, Uruguay

Description: N/A

Website: http://www.isoqol.org


NOVEMBER 2008

Organization: European Network for Health Technology Assessment (EUnetHTA)

Event: EUnetHTA Conference 2008: HTA’s Future in Europe

Date: November 20, 2008

Location: Paris, France

Description: N/A

Website: http://www.eunethta.net/

MARCH 2009


Event: 2009 Spring Membership Meeting and Implementation Conference; Board of Directors Meeting

Date: March 27-29, 2008

Location: Cleveland, OH

Description: N/A



ON-GOING

Organization: Institute of Medicine (IOM) Roundtable on Evidence-Based Medicine

Event: Project meetings and workshops

Date: Various


Description: The IOM Roundtable on Evidence-Based Medicine brings together key stakeholders from multiplesectors — patients, health providers, payers, employers, manufacturers, policy makers, andresearchers — for cooperative consideration of the ways that evidence can be better developed and applied to drive improvements in the effectiveness and efficiency of medical care in the UnitedStates. Recent session: Judging the Evidence: Standards for Determining Clinical Effectiveness(02/05/07). Others: Leadership Commitments to Improve Value in Health Care - workshop (07/24);Roundtable meeting (09/24); Practice-Based Research: Redesigning the clinical effectiveness research paradigm – workshop (12/12-13); Creating a Public Good: Clinical data as the basic staple of health care improvement – workshop (02/28-29/2008)

Website: http://www.iom.edu/CMS/28312/RT-EBM.aspx


Event: Ongoing project: Reviewing Evidence to Identify Highly Effective Clinical Services

Date: Various


Description: The Robert Wood Johnson Foundation has funded this study to address problems in our system forevaluating clinical evidence and to propose changes in the way we marshal evidence and apply it toendorse the most effective clinical interventions. The IOM committee is specifically charged withrecommending a sustainable, replicable approach to identifying and evaluating the clinical servicesthat have the highest potential effectiveness.

Website: http://www8.nationalacademies.org/cp/projectview.aspx?key=HCSX-H-05-09-A


APPENDIX A: AHRQ Staff Bios

Carolyn M. Clancy, MDDirectorAgency for Healthcare Research and Quality (AHRQ)Department of Health and Human Services

Contact information: Agency for Healthcare Research and Quality540 Gaither Road, 3rd FloorRockville, MD 20850Phone: 301–427–1200Fax: 301–427–1201Email: [email protected]

Background: Carolyn M. Clancy, MD, who is a general internist and health services researcher, was appointedDirector of the Agency for Healthcare Research and Quality (AHRQ) on February 5, 2003. Prior to herappointment, Dr. Clancy had served as AHRQ’s Acting Director since March 2002 and previously was Directorof the Agency’s Center for Outcomes and Effectiveness Research (COER). Before joining AHRQ in 1990, she wasalso an assistant professor in the Department of Internal Medicine at the Medical College of Virginia inRichmond. Her medical specialties include primary care medicine and women’s health.

Dr. Clancy holds an academic appointment at George Washington University School of Medicine (ClinicalAssociate Professor, Department of Medicine) and serves as Senior Associate Editor, Health Services Research.Dr. Clancy has served on multiple editorial boards (currently Annals of Family Medicine, American Journal ofMedical Quality, and Medical Care Research and Review; formerly Journal of General Internal Medicine,American Journal of Public Health, and Journal of Evaluation in Clinical Practice.)

Dr. Clancy has published widely in peer-reviewed journals and has edited or contributed to seven books. Inaddition, she has presented multiple research papers at academic conferences and spoken to diverse audiencesand the media on health care issues. Dr. Clancy was elected a Master of the American College of Physicians in2004 and is an elected member of the National Academy of Social Insurance. She has also held leadershippositions in multiple other professional organizations, including the Society of General Internal Medicine. She isa member of the Institute of Medicine.

Education: Dr. Clancy holds a bachelor’s of science (BS), magna cum laude, in math and chemistry from BostonCollege (1975) and a doctorate of medicine (MD) from the University of Massachusetts School of Medicine(1979).

Her postdoctoral training includes: the Kennedy Institute of Bioethics Intensive Course at GeorgetownUniversity in 1989; the Stanford Faculty Development Program in Clinical Teaching in 1988; and, the HenryKaiser Family Foundation Fellow in General Internal Medicine from 1982–84 at the Hospital of the Universityof Pennsylvania.

Research interests: Her major research interests include various dimensions of health care quality and patient,including women’s health, primary care, access to care services, and the impact of financial incentives onphysicians’ decisions.


Kathie Kendrick, MS, CS, RNDeputy DirectorAgency for Healthcare Research and Quality (AHRQ)Department of Health and Human Services

Contact information: Agency for Healthcare Research and Quality540 Gaither Road, 4th FloorRockville, MD 20850Phone: 301–427–1700Fax: 301–427–1639Email: [email protected]

Background: Ms. Kendrick joined AHRQ in 2000 as the Director of Planning, Evaluation, and ProgramDevelopment where she is actively involved in developing and guiding AHRQ’s strategic planning processes andprogram development and evaluation activities. She now serves as deputy director of AHRQ. Prior to joiningthe AHRQ staff, she was a Senior Health Policy Analyst in the General Accounting Office (GAO) Health CareIssue area. Ms. Kendrick has over 25 years experience in Health Care Administration, most recently as the Chief,Mental Health Outpatient Programs at the VA Medical Center in Washington, DC.

Education: Ms. Kendrick received a BS in Nursing from Keuka College and a MS in Child and Adolescent MentalHealth from the University of Maryland. She is currently a PhD candidate in program evaluation at theUniversity of Maryland.


Helen R. Burstin, MD Center for Primary Care, Prevention, & Clinical Partnerships, DirectorAgency for Healthcare Research and Quality (AHRQ)Department of Health and Human Services


Background: Dr. Burstin, MD, MPH, has served as the Director of the Center for Primary Care, Prevention, andClinical Partnerships at the Agency for Healthcare Research and Quality (AHRQ) since January 2000. Prior toher appointment at AHRQ, Dr. Burstin was an Assistant Professor at Harvard Medical School and Director ofQuality Measurement at Brigham and Women’s Hospital.

Dr. Burstin is the author of over 60 articles and book chapters and is board certified in Internal Medicine. Sheis a deputy editor of the Journal of General Internal Medicine. She is President of the American Medical StudentAssociation (AMSA) Foundation Board of Directors and a member of the Board of Directors of La Clinica delPueblo, a free Latino clinic in Washington, DC, where she is a volunteer staff physician.

Education: Dr. Burstin is a graduate of the State University of New York at Upstate College of Medicine and theHarvard School of Public Health. Dr. Burstin completed a residency in primary care internal medicine at BostonCity Hospital. After residency, she completed AHRQ-funded fellowship training in General Internal Medicineand Health Services Research at Brigham and Women’s Hospital and Harvard Medical School.

Research Interests: Dr. Burstin’s research focuses on primary care topics such as patient-providercommunication; disparities in access and quality for vulnerable populations; and safety and quality ofambulatory care.


David C. Lanier, MDCenter for Primary Care, Prevention, & Clinical Partnerships, Deputy DirectorAgency for Healthcare Research and Quality (AHRQ)Department of Health and Human Services


Background: David Lanier, MD, is the Associate Director of the Center for Primary Care, Prevention, andClinical Partnerships (CP3). In addition to assisting the Director in planning, developing, and managing allCenter activities, Dr. Lanier heads CP3’s extramural research program and also directs the Center’s initiativesupporting primary care practice-based research networks (PBRNs).

Prior to joining AHRQ (then named the Agency for Health Care Policy and Research) in 1993, Dr. Lanier wason the family practice faculty of the University of California at Irvine and then was named residency director andchief of the division of family medicine at Georgetown University. From 1993 to 1995, he worked in the Agency’sForum for Quality and Effectiveness in Health Care before joining the staff of the Center for Primary CareResearch. In 1996, he led a special research initiative on referrals from primary to specialty care. From September1998 to January 2000, he served as the Center’s Acting Director, and since 2003 has served as Associate Directorof the Center for Primary Care, Prevention, and Clinical Partnerships (CP3).

Dr. Lanier directs the Agency’s initiative on primary care practice-based research networks (PBRNs), whichhas provided funding for over 45 networks across the country, and also serves as the director of extramuralresearch for CP3. He has completed research and published articles on numerous subjects, including low backpain, the ecology of medical care, and physician accountability. Dr. Lanier provides medical care to HIV-infectedpatients one half-day per week as a volunteer physician at the Whitman-Walker Clinic.

Education: A graduate of the medical school of the University of North Carolina at Chapel Hill, Dr. Laniercompleted residency training in family medicine in the University of Rochester (NY)/Highland Hospitalprogram and later completed fellowship training in academic family medicine at Baylor University.

Research interests: Dr. Lanier has been working actively with leaders of AHRQ-funded primary care practice-based research networks to analyze data descriptive of the practice of primary care across the United States. ThePRImary care Network Survey (PRINS) is a NAMCS-like database including demographic information foralmost 1,000 primary care providers/practices as well as data describing over 20,000 patient encounters.


Therese Miller, DrPH Project Coordinator, USPSTFCenter for Primary Care, Prevention, & Clinical PartnershipsAgency for Healthcare Research and Quality (AHRQ)

Contact information: Center for Primary Care, Prevention, & Clinical PartnershipsAgency for Healthcare Research and Quality540 Gaither Road Rockville, MD 20850Phone: 301–427–1585Fax: 301–427–1597Email: [email protected]

Background: Tess Miller began her career at a New York City advertising agency as a Media Specialist. However,her interest eventually turned to social marketing and public health. She has over 10 years experience managingpublic health projects including the Hospital-Based Rural Health Care Program, Pathways to Adulthood: A ThreeGeneration Urban Study, and the National Evaluation of The Healthy Steps for Young Children Program.

Education: She attended the Johns Hopkins University Bloomberg School of Public Health, earning a doctoraldegree in Public Health and a Certificate in Health Communications.

Research interests: Adolescent reproductive health, child development, community-level interventions, andbehavior change.


Jean R. Slutsky, MS, CS, RNCenter for Outcomes and Evidence (COE), DirectorAgency for Healthcare Research and Quality (AHRQ)Department of Health and Human Services


Background: Ms. Slutsky has directed the Center for Outcomes and Evidence (COE), AHRQ, US Departmentof Health and Human Services since June 2003. Prior to Ms. Slutsky’s appointment as director of COE, she servedas acting director of the Center for Practice and Technology Assessment at AHRQ. She oversees the Evidence-based Practice Center program; Technology Assessment Program; extramural and intramural research portfoliosconcerning translating research into practice, outcomes and effectiveness research, including pharmaceuticaloutcomes, and cost-effectiveness analyses; and the National Guideline, Quality Measures and Quality ToolsClearinghouses.

Prior to becoming acting director of the Center for Practice and Technology Assessment, Ms. Slutsky directedthe development of the National Guideline Clearinghouse (NGC) Project. The NGC is an Internet-basedrepository (www.guideline.gov) for comparative information on evidence-based clinical practice guidelines. Inaddition, Ms. Slutsky served as project director of the U.S. Preventive Services Task Force, an internationallyrecognized panel of experts who make evidence-based recommendations on clinical preventive services. Inaddition, she is a member of the executive board of the Guidelines International Network and a Society forMedical Decision Making Advisory Task Force Member.

Education: Ms. Slutsky received her BS at the University of Iowa, a MS in Public Health (Health Policy andAdministration) from the University of North Carolina at Chapel Hill, and trained as a Physician Assistant at theUniversity of Southern California.

Research interests: Ms. Slutsky is particularly interested in the translation of complex scientific information forhealth care decision-makers. Most recently, she has been implementing a comparative effectiveness researchprogram that includes evidence synthesis, evidence generation and evidence communication.


Beth Collins Sharp, PhD, RNActing Director, Evidence-Based Practice Centers (EPC) ProgramCenter for Outcomes and Evidence (COE)Agency for Healthcare Research and Quality (AHRQ)

Contact information: Center for Outcomes and EvidenceAgency for Healthcare Research and Quality540 Gaither Road, Suite 6000Rockville, MD 20850Phone: (301) 427-1503Fax: (301) 427-1520 E-mail: [email protected]

[Bio not available.]


Lynn A. Bosco, MD, MPHProgram Officer, Centers for Education and Research on TherapeuticsDirector, Pharmaceutical Studies

Contact information: Director, Pharmaceutical Studies Center for Outcomes and Evidence Agency for Healthcare Research and Quality540 Gaither Road, 6th FloorRockville, MD 20850Phone: 301–427–1600Fax: 301–427–1520E-mail: [email protected]

Background: Lynn A. Bosco, MD, MPH, is Director, Pharmaceutical Studies, and Program Officer for theCenters for Education and Research on Therapeutics (CERTs). Dr. Bosco represents AHRQ to the U.S.Pharmacopeia (USP). She holds an academic appointment at the University of Maryland School of Medicine(Adjunct Associate Professor, Department of Epidemiology and Prevention). Before working at AHRQ, Dr.Bosco was a Section Chief, Epidemiology Branch, in the Center for Drug Evaluation and Research, Food andDrug Administration (FDA). While in that position, she headed a group responsible for research, of adverse drugreaction and drug utilization information. Dr. Bosco has been a commissioned officer in the U.S. Public HealthService since 1984 and holds the rank of Captain. She represents AHRQ on the Physicians’ Professional AdvisorCommittee (PPAC) which advises the Surgeon General on issues related to government physicians. She is anactive member of the Commissioned Corps Readiness Force (CCRF).

Education: Dr. Bosco received a BA in psychology from the University of Illinois and an MD from Rush MedicalCollege, in Chicago. She interned at the Los Angeles County Hospital and completed a residency in preventivemedicine within the Department of Epidemiology, at the Johns Hopkins School of Hygiene and Public Health,where she also received an MPH Dr. Bosco is Board Certified in Preventive Medicine and in ClinicalPharmacology.

Research interests: Her research interests are focused in the area of pharmacoepidemiology, and have resulted inpeer-reviewed publications using both Medicaid and drug marketing data.


APPENDIX B: National Advisory Council for Healthcare Research and Quality Bios

Jane F. Barlow, MD, MPH, MBA (2009)Dr. Barlow is responsible for the delivery of health care for over 600,000 employee, retirees and dependents in theU.S. at a cost of over $1.7 billion annually. She has an extensive background in creating and implementing healthcare benefits and health program for employees and is a strong advocate for patient centered care. Previously Dr.Barlow served as Federal Aviation Administration (FAA) Senior Aviation Medical Examiner for the TexasRehabilitation Commission, Medical Director for the Family Health Center in Del Rio, Texas, Director ofOccupational and Environmental Health at the Department of Veterans Affairs Medical Center and flightsurgeon at Beal Air Force Base California. She currently co-chairs the National Committee on Evidence-basedBenefit Design, National Business Group on Health. She has published frequently on keeping healthy in theworkplace and is a national speaker on patient-centered care.

Dale W. Bratzler, DO, MPH (2008)Dale W. Bratzler is QIOSC Medical Director, Oklahoma Foundation for Medical Quality and Adjunct AssociateProfessor, Department of Health Administration and Policy, College of Public Health, Oklahoma UniversityHealth Sciences Center. Dr. Bratzler currently serves as Chair of both the Health Care Information AdvisoryCommittee and the Hospital Advisory Committee of the Oklahoma State Department of Health. Dr. Bratzler isimmediate past President of the American Health Quality Association (AHQA). He is the recipient of the 2002Excellence in Physician Leadership Award presented by the James Q. Cannon Memorial Endowment, and theAmerican College of Osteopathic Internists Researcher of the Year. He is also currently working with theMedicare National Pneumonia Quality Improvement Project and the CMS/CDC National Surgical Site InfectionProject. Dr. Bratzler graduated summa cum laude with a B.S. in Biology from Central Missouri State University;received his doctor of osteopathy at the College of Osteopathic Medicine (1st in class), University of HealthSciences, Kansas City, Missouri; and, received his MPH with a 4.0 GPA at the University of Oklahoma.

Timothy J. Brei, MD (2009)Dr. Brei, a recognized expert on diagnosing and treating children with disabilities, has written and presentedextensively on the subject. Dr. Brei himself has Spina Bifida and serves on the Board of many national, regionaland local committees, including DAMAR Homes, Inc., for children and adolescents with severe disabilities andbehavior disorders, and the Spina Bifida Association of America. He is a Fellow of the American Academy ofPediatrics and the American Academy of Cerebral Palsy and Developmental Medicine.


Patricia Flatley Brennan, PhD, RN, FAA, FACMI (2008)Patricia Flatley Brennan is the Moehlman Bascom Professor of Nursing and Industrial Engineering, School ofNursing and College of Engineering, University Wisconsin-Madison. Dr. Brennan’s area of expertise is the nexusof engineering principles and health care. Dr. Brennan has been a recipient of many awards and honors. In 2001,she was elected to the Institute of Medicine in 2002, she was named distinguished nurse researcher by theNational Institute of Nursing Research. During 2005, she is Distinguished Lecturer, University of Missouri-St.Louis, and Lazerow Lecturer, University of Minnesota. Dr. Brennan serves as associate editor of the Journal of theAmerican Medical Informatics Association and reviewer for many other publications. She serves on the MarkelFoundations Personal Health Technology Council and the Robert Wood John Foundation Personal HealthSystem. Dr. Brennan has been a guest lecturer for health care informatics internationally and she has publishednumerous articles on health care and informatics. Dr. Brennan is an in-demand consultant with hospitalsnationwide. She received a BS in nursing from the University of Delaware; an MS in Nursing from the Universityof Pennsylvania; and an MS and PhD in Industrial Engineering from the University of Wisconsin-Madison.

Andrew J. Fishmann, MD, FCCP, FAC (2009)Dr. Fishmann is an experienced hospitalist, as well as, co-founder and Board Member of Cogent Healthcare, Inc.In addition, Dr. Fishmann is the Director of the Intensive Care Unit, Good Samaritan Hospital in Los Angeles,and is in private practice with California Lung Associates. Dr. Fishmann received his BA in Biology from Franklinand Marshall College and his MD from the Temple University Medical School, and his Pulmonary/Critical CareFellowship from the University of California, San Diego.

Robert S. Galvin, MD (2010)Board certified in internal medicine, Dr. Glavin is responsible for medical services internationally of 225 clinics,750 physicians and nurses and 1.5 million patient visits including oversight of wellness and disease managementprograms and occupations medicine programs. He is also adjunct professor at Yale University School ofMedicine. Among his many accomplishments, Dr. Glavin co-funded the Leapfrog Group and Bridges toExcellence. He is a member of the National Commission on Quality Accreditation. He served on the Departmentof Defense (DoD) Task Force on the future of Military Health Care, and the Commonwealth Fund Commissionon a Highly Effective Health Care Systems. He has been a member of the Institute of Medicine (IOM)Committees and has reviewed IOM Reports. He has been asked to testify and present on the issues of health carecosts and quality before both Congress and Secretaries of Executive Departments. Dr. Galvin received his MD atthe University of Pennsylvania and his MBA at the Boston University School of Management.

M. Carolina Hinestrosa, MA, MPH (2009)Ms. Hinestrosa is a leader in representing cancer patients and cancer survivors. Her expertise has been calledupon by the Institute of Medicine, the National Quality Forum, and the National Cancer Institute, to serve on avariety of committees involving detection and treatment of cancer. Previously, she founded and was executivedirector of Nueva Vida, Inc., a non profit organization delivering comprehensive support to Latinas with breastand cervical cancer. Ms. Hinestrosa also coordinated the development of the Latina Health Radio Network thatbroadcast a daily Spanish language program on health promotion and disease prevention and is a well knownspeaker at the World Conferences on Breast Cancer Advocacy.


Ada Sue Hinshaw, PhD, RN (2008)Ada Sue Hinshaw is Dean and Professor, University of Michigan, School of Nursing, Ann Arbor. Dr. Hinshaw isa health services educator and researcher who has received many academic awards and honors in the fields ofclinical nursing and nursing administration as well as in the development and testing of health evaluation andcost models. Dr. Hinshaw is a member of Sigma Theta Tau, Honorary Nursing Society at the Universities ofKansas, Arizona and Michigan; Sigma Xi and the Scientific Research Society of North America. She is a memberof the Institute of Medicine and the National Academies of Practice. She has been a Visiting Professor in both inthe US and internationally, most recently at Peking and Tanjin Universities. Dr. Hinshaw was recognized in a 2004book by Houser, B.P. and Player, K.N., Pivotal Moments in Nursing: Leaders Who Changed the Path of aProfession, and in 2005, received an Honorary Doctor of Science from Binghamton, University. She received aB.S. in Nursing from the University of Kansas; a MSN. from Yale University; and an MA and PhD in Sociologyfrom the University of Arizona. Dr. Hinshaw previously served on the National Advisory Council in 1997.

Carlos Roberto Jaen, MD, PhD (2008)Dr. Jaen is Professor and Chairman, Department of Family and Community Medicine, University of TexasHealth Science Center—San Antonio, TX. He also holds the Dr. M. Smith Professorship. Dr. Jaen’s researchinterests are in behavioral health counseling, Latino health issues, primary care, and smoking cessation. He hasauthored numerous abstracts, book chapters, and journal articles on these subjects. In 2004 he was honored byWho’s Who Among America’s Teachers; received the Unsung Hero Presidential Award from the Texas Academyof Family Physicians; awarded the degree of Fellow from the American Academy of Family Physicians; and wasnamed in the Best Doctor’s in America. His research has been supported by the Robert Wood JohnsonFoundation, The National Board of Medicine Examiners, and the American Cancer Society. Dr. Jaen serves as areviewer for a number of medical publications including the Annals of Family Medicine, the American Journalof Public Health, and JAMA. He is a member of the America Family Medicine Organizations Committee onResearch Capacity and of the Society of Teachers of Family Medicine Research Committee. Dr. Jaen received aBS (cum laude) in Biology and an MS in Oncology from Niagara University, a PhD in Epidemiology andCommunity Health, and his MD at the State University of New York.

Brent James, MD (2008)Dr. James is the Executive Director, Institute for Health Care Delivery Research and Vice President, MedicalResearch and Executive Director of its Institute for Health Care Delivery Research which leads IHC’s clinicalimprovement efforts. An interest in cancer led him to spend several years with the American College of Surgeonswhere he helped support the Commission on Cancer and designed and staffed the College’s first in-housemainframe computer system. He later served as a biostatistician in the Eastern Cooperative Oncology Groupwhile an assistant professor in the Department of Biostatistics at the Harvard School of Public Health. Dr. Jamesreceived an undergraduate degree in Computer Science, a Master of Statistics degree, an MD degree, and trainingin general surgery from the University of Utah.


Wishwa N. Kapoor, MD, MPH (2010)Dr. Kapoor is an expert in health services research, most recently examining the outcomes and evaluation ofsyncope, and outcomes, cost, and quality of pneumonia. As the Director of the Center for Research on HealthCare, he has developed the Clinical Research Training Program and teaches research methodology courses in theprogram. Dr. Kapoor has extensive experience in mentoring fellows and junior faculty. He is a member of theAmerican Society for Clinical Investigation, an American Academy of Pediatrics, Past President of Society ofGeneral Internal Medicine (SGIM) and recipient for the Robert J. Glaser award for Exceptional Achievement inTeaching and Research. Dr. Kapoor has been a member of the grant review committee for the National HeartLung and Blood Institute (NHLBI) and has testified before Congress on Residency Programs. He has publishedhundreds of research papers in peer reviewed professional and scientific publications and is on the editorialboards of the Journal of Medicine and the Journal of International Medicine. Dr. Kapoor received his BS inChemical Engineering, and his MD at Washington University, St. Louis, and his MPH in Epidemiology at theUniversity of Pittsburgh.

Munr Kazmir, MD (2008)Dr. Kazmir is founder and CEO of Direct Meds, Inc. in Leonia, New Jersey. Direct Meds, Inc. is a companylicensed to provide prescription medicines thought the United States. He is also the founder and CEO of QualityHome Care, a company that serves over 200,000 patients in the diverse New York, New Jersey metropolitan areato ensure that indigents, homeless, HIV patients and children of neglect receive appropriate medical care. Dr.Kazmir is the recipient of many international humanitarian awards. The State of New Jersey Child ProtectionCommission and Children’s Trust Fund honored him for his fundraising efforts to combat Juvenile diabetes.Keren-Or, an organization in Jerusalem devoted to the care and rehabilitation of multi-handicapped blindchildren, awarded Dr. Kazmir the Maimonides Award in recognition of his generous support. Dr. Kazmir wasborn in Pakistan and graduated from the University of Punjab in LaHore where he received his MBBS/MD. Hecompleted a one-year internship at the Mayo Hospital in LaHore and a two year residency at Holy FamilyHospital in Rawalpindi, Pakistan. Upon arriving in the United States, Dr. Kazmir successfully completed hisinternal medicine internship at the White Plains Hospital — Montefiore Medical Center and pursued additionalmedical studies at the Methodist Hospital in Houston. He completed his third year residency at SUNYDepartment of Medicine. Dr. Kazmir speaks six languages.

Kathleen Lohr, PhD (2010)Dr Lohr is also Research Professor at the School of Public Health, University of North Carolina, Chapel Hill.Previously, Dr. Lohr’s served as the director for the Division of Health Care Services for the Institute of Medicine,Technical Information Specialist in the Bureau of Health Professions, Department of Health Education andWelfare, and was a researcher at the Johns Hopkins School of Medicine and School of Hygiene and Public Health.She has published countless, articles, monographs and books and is in demand as a member of diverse advisorypanels for both the public and private sector. She is the 2005 recipient of the Avedis Donabedian OutcomesResearch Lifetime Achievement Award, given by the International Society of Pharmacoeconomics and OutcomesResearch, and a Fellow of the Association for Health Services Research. Dr. Lohr received her B.A. and M.A. fromStanford University, and her PhD from RAND Graduate Institute, Santa Monica, CA.


Thomas P. Miller, JD (2009)Mr. Miller is a senior policy professional with 30 years experience in economic and regulatory policy,communication and legal issues in health policy, among other expertise. He has participated in health careforums including consumer driven health care, insurance deductibles and Health Savings Accounts (HSAs), theuninsured and long term care. He directed health policy studies at the CATO Institute and has been a journalistin both broadcast and print media. He graduated Phi Beta Kappa from New York University and received his JDdegree from Duke Law School.

Neil R. Powe, MD, MPH, MBA (2009)Dr. Powe is Professor of Medicine in the Department of Medicine at the Johns Hopkins University School ofMedicine and Director of the Welch Center for Prevention, Epidemiology and Clinical Research, amultidisciplinary research and training center at Johns Hopkins focused on clinical and population-basedresearch. He also is Professor of Epidemiology and Health Policy and Management at Hopkins’ BloombergSchool of Public Health. He directs the Clinical Research Scholars Program, the Predoctoral Clinical ResearchTraining Program and the Clinical Epidemiology Program at Hopkins which has trained a cadre of physiciansand population scientists in clinical research. He has published over 270 articles on the prevention, diagnosis andtreatment of diseases, value of health care technologies, and the effectiveness of the health care system. His majorareas of interest and expertise are kidney and cardiovascular diseases; effectiveness and outcomes research and;economic evaluations in health care. He has studied physician decision making and other determinants of use ofmedical practices including payers’ decisions about insurance coverage for new medical technologies, the effectof financial incentives on the use of technology, efficiency and outcomes in for-profit versus non-profit healthcare institutions, and the relation between hospital volume, technology and outcomes. Dr. Powe is author ofmore than 270 articles and among his many honors are membership in the Institute of Medicine, the John M.Eisenberg National Award for Career Achievement in Research from the Society of General Internal Medicineand the Distinguished Educator Award from the Association of Clinical Research Training.

Michael K. Raymond, MD (2010)As CMO for the Rush North Shore Medical Center, Dr. Raymond implemented a quality improvement paradigmthat established an effective process for collecting measures and reporting performance and encouragingemployee feedback. Previously, Dr. Raymond served as Medical Director of the Physicians Hospital Organization(PHO) of the Rush North Shore Medical Center. In that capacity he managed all aspects of care, includingcontracting, utilization management, and pay-for-performance initiatives and outcomes measurement. Duringhis tenure, PHO has consistently exceeded its performance targets. Under his leadership the Rush North ShorePHO became one of the first integrated delivery systems in Illinois to implement a Clinical Integration programusing physician profiles and report indicators of performance. Dr. Raymond is also an expert in the keyperformance indicators (KPI) from Medicare commercial payors and other external review agencies. Dr.Raymond received his B.S. from Bradley University, and his MD, from the Universidad Autonomo De Ciudad,Juarez, Mexico.


James J. Rohack, MD, FACC, FACP (2008)Dr. Rohack is a senior staff cardiologist with the Scott & White Clinic and Professor of Medicine at Texas A&MHealth Science Center (TAMRHSC) College of Medicine. He serves as Medical Director for System Improvementfor the Scott & White Health Plan, a nonprofit community based health plan with a national recognition forquality medical care delivery as well as the Director for the Center for Healthcare Policy at Scott and White. Heis chair of the American Medical Association Board of Trustees as well as being Secretary of the Board ofCommissioners of the Joint Commission on Accreditation of Healthcare Organizations.

Dr. Rohack has had a long involvement with medical education and accreditation standards. He serviceincludes the Council on Medical Education of both the Texas Medical Association and American MedicalAssociation; the National Board of Medical Examiners; the Accreditation Council on Continuing MedicalEducation; the Liaison Committee on Specialty Boards and the Liaison Committee on Medical Education whichaccredits programs leading to the MD degree in the U.S. and Canada. He is a nationally recognized speaker onmedical education and the financing and delivery of health care. He has served on External Advisory committeesfor the George Bush School of Public Policy and the MD Anderson Cancer Center, and currently serves on theTAMUHSC School of Rural Public Health. He is the recipient of numerous awards and recognition includingWho’s Who in Medicine and Health Care, America and the World, and the Golden Nugget DistinguishedAlumnus Award from the College of Liberal Arts at the University of Texas El Paso (UTEP).

Dr. Rohack attended the UTEP as a Stevens Scholar and graduated with highest honors. He obtained hismedical degree (M.D) with honors from the University of Texas Medical Branch (UTMB). He continued histraining at UTMB with a residency in Internal Medicine, an additional year as Chief Resident, and a clinicalfellowship in Cardiology.

David L. Shern, PhD (2010)Dr. Shern is Professor and Dean of the Louis de la Parte Florida Mental Health Institute, University of SouthFlorida. He is a member, Steering committee, Annapolis Coalition on Behavioral Health Workforce, NationalInstitutes of Health Reviews Reserve — Ad Hoc Reviewer, Ad Hoc Grant Reviewer, Veterans Administration,Robert Wood Johnson Foundation, National Advisory Board, Boston University Center for PsychiatricRehabilitation. Many consultative positions including University of South Carolina Program on Research onPublic Psychiatry, Missouri Institute of Mental Health. He is a member of the Governor’s Task Force on SuicidePrevention and Who’s Who in America (2002-Present). Dr. Shern has written and published technical reports,papers, articles, chapters, and newsletters for professional and trade journals. He serves on the editorial board ofAdministration and Policy in Mental Health and Mental Health Services Research. Dr. Shern received his BA,MA, and PhD from the University of Colorado, Boulder.

William Smith, PharmD, MPH, PhD, FASHP (2010)Dr. Smith has been Professor of Pharmacy and Executive Associate Dean for the past 10 years. He serves as amember of the Virginia Commonwealth University (VCU) School of Pharmacy Executive Committee, Non-traditional PharmD Program and Curriculum Committee, as well as a member of the Research Grants ProgramSelection Plan of the American Society of Hospital-base Pharmacists (AHSP). In his previous positions, Dr.Smith served as Vice President, Research Administration, where he was responsible for administrations ofresearch programs and Assistant Dean for the Long Beach Memorial Medical Center. He was also Chair,Department of Pharmacy Practice, Bouve College of Pharmacy and Health Science, Northeastern University. Dr.Smith received his PharmD from the University of California, San Francisco, and his PhD in PharmaceuticalScience from Auburn University.


Myrl Weinberg, CAE (2010)Ms. Weinberg is president of the National Health Council, an umbrella organization whose members are 50 ofthe leading voluntary health agencies committed to quality health care, and representing over 100 millionindividuals with chronic disease and /or disabilities. For over 30 years Ms. Weinberg’s career has focused onhealth, medical research, and long-term care and she has held managerial and leadership positions in manydifferent health care organizations including, the American Diabetes Association and the Joseph P. Kennedy, Jr.Foundation. She was selected to serve on the congressionally mandated Institute of Medicine (IOM) Committeeto assess how research priorities are established at the National Institutes of Health (NIH), and has served onnumerous boards. Ms. Weinberg pursued advanced graduate study at Purdue University, holds an MA in SpecialEducation from Georgia Peabody College, Nashville, Tennessee, and holds a BA in Psychology from theUniversity of Arkansas.

Anthony C. Wisniewski, JD (2009)As Executive Director for Health Policy for the U.S. Chamber of Commerce, Mr. Wisniewski is responsible forhealth policy issues pending before the U.S. Congress and federal agencies. Previously, he served as head of publicpolicy for the biotechnology company MedImmune, Inc. Mr. Wisniewski received his JD from Notre DameUniversity and his BA from the Catholic University of America.


APPENDIX C: U.S. Preventive Services Task Force Bios

Bruce Nedrow (Ned) Calonge, MD, MPH (Chair)Dr. Calonge, the Chief Medical Officer of the Colorado Department of Public Health and Environment, is alsothe State Epidemiologist and the Executive Director of State Bioterrorism Preparedness. He is an AssociateProfessor of Family Medicine and of Preventive Medicine and Biometrics at the University of Colorado HealthSciences Center. Dr. Calonge is also the President of the Colorado Board of Medical Examiners, which licensesand provides regulatory oversight for physicians and physician assistants. Dr. Calonge serves on the Board ofDirectors for the Colorado Academy of Family Practice (President), the Colorado Foundation for Medical Care(Board Chair), and the Colorado Prevention Center. At the Colorado Medical Society, he chairs the Health AffairsCommittee. He is a member of the Colorado Patient Safety Coalition.

Diana B. Petitti, MD, MPH (Vice Chair)Dr. Petitti is Senior Scientific Advisor for Health Policy and Medicine at Kaiser Permanente Southern CA,Pasadena, CA. She is a member of the American Public Health Association, the Society for EpidemiologicResearch and the American Epidemiologic Society and is a Fellow of the American Heart Association Council onEpidemiology. Dr. Petitti serves on the editorial board of Epidemiology, American Journal of PreventiveMedicine, and American Journal of Medicine. She is also currently a member of the Institute of Medicine, NewApproaches to Early Detection of Breast Cancer; the California Office of Statewide Planning on Health, TechnicalAdvisory Committee; and the Kaiser Permanente National Research Council, Kaiser Permanente.

Allen J. Dietrich, MDDr. Dietrich, a board-certified family physician, is a professor of community and family medicine at DartmouthMedical School and a member of the Institute of Medicine of the National Academy of Sciences. He is alsoassociate director for population sciences at the Norris Cotton Cancer Center at Dartmouth-Hitchcock MedicalCenter and serves as chair of the John D. and Catherine T. MacArthur Foundation Initiative on Depression andPrimary Care.

Thomas G. DeWitt, MDThomas G. DeWitt, MD is the Carl Weihl Professor of Pediatrics, Director of the Division of General andCommunity Pediatrics, and Associate Chair for Primary Care, in the Department of Pediatrics, at the Children’sHospital Medical Center, Cincinnati, Ohio. Since the mid-1980s, he has served as the Project Director for theBureau of Health Professions (BHPr) grants in General Pediatrics Residency Training and Faculty Development,both at Children’s Hospital Medical Center Cincinnati and at the University of Massachusetts Medical Center.For 10 years, Dr. DeWitt served on the Board of Directors of the Ambulatory Pediatric Association (APA), servingas president from 1993–1994. He was instrumental in the APA’s role in developing BHPr supported educationalguidelines in general pediatrics for both medical students and residents. In 1996, Dr. DeWitt also served as Chairof the Planning Committee for the first national conference on faculty development, jointly sponsored by theBHPr and the American Association of Medical Colleges. He has published and presented extensively on thesubject of community-based education and faculty development for community preceptors.


Kimberly D. Gregory, MD, MPHDr. Gregory is Director of Maternal-Fetal Medicine and Director of Women’s Health Services Research at Cedars-Sinai Medical Center, Los Angeles, CA. She is an Associate Professor at the David Geffen School of Medicine atUCLA, Department of Obstetrics & Gynecology and at the UCLA School of Public Health Department ofCommunity Health Sciences. She is President of the Perinatal Advisory Council, Los Angeles Communities andhas served on numerous advisory boards, including the Office of Statewide Health Planning and Development— California Health Policy and Data Advisory Commission on Lowering Cesarean Sections; the DepartmentHealth Services Maternal & Child Health Branch; Department of Health Services Office of Women’s Health; theCalifornia Perinatal Quality Care Collaborative; and the March of Dimes. Dr. Gregory is a member of manyprofessional organizations, including the American College of Obstetrics and Gynecology where she is currentlyon the OB Practice Committee and ACOG District IX Legislative Committee.

David Grossman, MDDr. Grossman, a board-certified pediatrician recognized for his research on injury prevention and NativeAmerican health, is medical director of preventive care at Group Health Cooperative in Seattle. He is also a seniorinvestigator at the Group Health Center for Health Studies and a professor of health services and adjunctprofessor of pediatrics at the University of Washington. He serves on the Secretary’s Advisory Committee onInjury Prevention and Control for the Centers for Disease Control and Prevention. In 2007, the AmericanAcademy of Pediatrics awarded Dr. Grossman the Native American Child Health Advocacy Award.

George J. Isham, MDDr. Isham is Medical Director and Chief Health Officer for HealthPartners, a large health care organization inMinnesota, representing nearly 800,000 members. Dr. Isham is responsible for quality, utilization management,health promotion and disease management, research, and health professionals’ education at HealthPartners. Heis active in strategic planning and policy issues. He is an experienced primary care clinician and was chair of theInstitute of Medicine committee that produced the report, Priority Areas for National Action: Transforming HealthCare Quality.

Michael L. LeFevre, MD, MSPHDr. LeFevre is a Professor in the Department of Family and Community Medicine at the University of MissouriSchool of Medicine, Columbia, Missouri. He is the Medical Director for Family Medicine at Missouri UniversityHealth Care; is Director of the Missouri University Health Care Electronic Medical Record project; Chair of theCredentialing Committee for the Department of Family Medicine; and Director of Clinical Services at theDepartment of Family Medicine. He has served on the Commission on Clinical Policies and Research of theAmerican Academy of Family Physicians. Dr. LeFevre is a researcher, a published author and consultant, and hasbeen invited to give many presentations across the country.

Rosanne Leipzig, MD, PhD Dr. Leipzig, a board-certified internist and geriatrician is a professor in the departments of Geriatrics and AdultDevelopment, Medicine, and Health Policy at Mount Sinai School of Medicine in New York. She also serves asvice chair of Education in the Departments of Education and Geriatrics and Adult Development at Mount Sinai.She has been a recipient of the American College of Physicians Richard and Hinda Rosenthal award, given forthe notable contribution her work in evidence-based medicine has made to improve clinical care in internalmedicine.


Lucy N. Marion, PhD, RNDr. Marion is the new Dean and Professor at the Medical College of Georgia School of Nursing in Augusta,Georgia, after several years as Associate Dean for Academic Nursing Practice at the University of Illinois atChicago College of Nursing. As a researcher, clinician (family nurse practitioner), published author, andinternational consultant, Dr. Marion has received numerous honors and awards. She has served on state andnational advisory groups concerning mental health care, environmental risks to children, the genetics workforce,and the practice doctorate for nurses, and belongs to several professional organizations. Her NIH-fundedtranslational research focuses on sexual risk reduction interventions for high risk minority populations. InChicago, she developed a nurse-managed system in partnership with Thresholds Psychosocial RehabilitationAgency for the delivery of integrated primary and mental health care for people with severe and persistent mentalillness.

Bernadette Melnyk, PhD, RN, CPNP/NPPDr. Melnyk is dean and distinguished foundation professor in nursing at the Arizona State University College ofNursing & Healthcare Innovation. She is a pediatric and psychiatric nurse practitioner whose research focuses onimproving mental health outcomes in children, teens, and parents. She directs the National Association ofPediatric Nurse Practitioners’ KySS mental health promotion program. She served on the American Academy ofPediatrics Mental Health Task Force in 2006 and the Institute of Medicine’s working committee on evidence-based practice in 2007. For her dedication to innovative programming leading to health care solutions, theAmerican Academy of Nursing named her a 2006 Edge Runner.

Virginia A. Moyer, MD, MPHDr. Moyer is Professor of Pediatrics and Internal Medicine at the University of Texas—Houston Medical Schooland is the Associate Director of the Center for Clinical Research and Evidence-Based Medicine at the UT HealthScience Center. She is a member of the Evidence-Based Medicine Working Group, which has produced theJournal of the American Medical Association “Users’ Guides to the Medical Literature” series, a member of theExecutive Committee of the AAP Section on Epidemiology, and is on the International Advisory Board for theCochrane Child Health Field. Dr. Moyer is Editor in Chief of the recently published book, Evidence-BasedPediatrics and Child Health. She is Editor in Chief of Current Problems in Pediatrics and is on the editorialboards of The Journal of Pediatrics and AAP Journal Club.

Judith K. Ockene, PhD, MEdDr. Ockene is a clinical psychologist with an appointment as Professor of Medicine at the University ofMassachusetts Medical School, where she is also the Barbara Helen Smith Chair, Chief, and founder of theDivision of Preventive and Behavioral Medicine. Dr. Ockene has extensive experience in both research andevaluation of evidence-based methods in the area of disease prevention and health promotion. Dr. Ockene hasserved on numerous advisory panels and review groups, has served as scientific editor on two Surgeon GeneralReports on smoking, and is president-elect of the Society of Behavioral Medicine. She has over 140 publicationsin preventive and behavioral medicine and serves as a reviewer for several journals, including Journal of theAmerican Medical Association, New England Journal of Medicine, Archives of Internal Medicine, HealthPsychology, and Preventive Medicine.


George F. Sawaya, MDDr. Sawaya is an Associate Professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences andthe Department of Epidemiology and Biostatistics at the University of California, San Francisco (UCSF). Dr.Sawaya has received many honors and awards; is an active researcher and lecturer; is a published author; andcurrently serves on two Expert Panels for the Centers for Disease Control and Prevention focusing on detectionof ovarian, breast, and cervical cancers. He developed and teaches the required curriculum in evidence-basedmedicine and clinical decision making at UCSF. Dr. Sawaya serves as a peer reviewer for several journals,including the New England Journal of Medicine, Journal of the American Medical Association, Annals of InternalMedicine, and Obstetrics and Gynecology.

J. Sanford (Sandy) Schwartz, MDDr. Schwartz, a board-certified internal medicine specialist, is the Leon Hess Professor of Medicine, HealthManagement, and Economics at the University of Pennsylvania School of Medicine and Wharton School. He ispast president of the American Federation of Clinical Research and the Society for Medical Decision Making,former Executive Director of the Leonard Davis Institute of Health Economics, and past Editor of the AmericanJournal of Managed Care. An expert in the evaluation of medical practices and guidelines, Dr. Schwartz hasserved on the National Institutes of Health and Institute of Medicine committees in these areas. He is a memberof the Centers for Medicare and Medicaid Services Medical Care Advisory Committee and the Blue Cross andBlue Shield Associations Medical Advisory Panel.

Timothy Wilt, MD, MPHDr. Wilt, a board-certified internal medicine specialist, is a professor in the Department of Medicine at theUniversity of Minnesota and the Minneapolis VA Medical Center. As an investigator in the Minneapolis VAHealth Services Research and Development Center for Chronic Disease Outcomes Research, his research interestsinclude evidence-based chronic disease prevention and management. Dr. Wilt served on the Outcomes Research& Epidemiology Task Force in 1997 and currently sits on the editorial board of the American Journal of Medicine.


APPENDIX D: Evidence – Based Practice Centers Bios

Blue Cross and Blue Shield Association, Technology Evaluation Center

Naomi Aronson, PhDDirector, BC/BS Evidence-based Practice CenterExecutive Director, Technology Evaluation Center Blue Cross Blue Shield Association225 North Michigan AvenueChicago, IL 60601Phone: (312) 297-5530 Fax: (312) 297-6827E-mail: [email protected]

Dr. Aronson is the Executive Director of the Blue Cross and Blue Shield Association Technology EvaluationCenter (TEC). She has overseen TEC’s development as a nationally recognized technology assessment programand an Evidence-based Practice Center (EPC) of the Agency for Healthcare Research and Quality (AHRQ). Dr.Aronson has directed over 300 technology assessments and 10 evidence reports for AHRQ. She has publishedarticles in Annals of Internal Medicine, Journal of the National Cancer Institute, Cancer, Journal of the AmericanCollege of Surgeons, Academic Radiology, Journal of Family Practice, and Gastrointestinal Endoscopy. Sherepresented the private sector on a US Agency for International Development team providing technical assistanceto the Hungarian government on building evidence-based medicine capacity in the national health insurancesystem. She is a member of the Institute of Medicine Forum on Drug Discovery Translation and Development,and the Steering Committee of the Chicago-Area DEcIDE Research Center and the National Business Group onHealth Committee on Evidence-Based Benefit Design.

Previously, Dr. Aronson was a member of Northwestern University faculty, specializing in sociology of scienceand medicine. She was also a post-doctoral fellow in the Science, Technology and Society Program at theMassachusetts Institute of Technology and received research awards from the National Science Foundation andthe American Council of Learned Societies. Dr. Aronson’s academic research focused on how the organizationof scientific specialties in biomedical and clinical research affects the process of scientific discovery.


Duke University

David B. Matchar, MDDirector and Professor of Medicine Duke Center for Clinical Health Policy Research 2200 W. Main Street, Suite 220 Tower Durham, NC 27705 E-mail: [email protected]

Dr. Matchar’s research relates to clinical practice improvement — from the development of clinical policies totheir implementation in real world clinical settings, and most recently, cerebrovascular disease, disablingneurological conditions, cardiovascular disease, and cancer prevention.

Dr. Matchar served as principal investigator for the Stroke Prevention Patient Outcome Research Team(PORT). Funded by the AHCPR, the PORT involved 35 investigators at 13 institutions. The Stroke PORT hasbeen highly productive and has led to a stroke prevention project funded as a public/private partnership by theAHCPR and DuPont Pharma, the Managing Anticoagulation Services Trial (MAST). MAST is a practiceimprovement trial in 6 managed care organizations, focusing on optimizing anticoagulation for individuals withatrial fibrillation.

Dr. Matchar also serves as consultant in the general area of analytic strategies for clinical policy development,as well as for specific projects related to stroke (e.g., acute stroke treatment, management of atrial fibrillation, anduse of carotid endarterectomy.) Dr. Matchar has worked with AHCPR (now AHRQ), ACP, AHA, AAN, RobertWood Johnson Foundation, NSA, WHO, and several pharmaceutical companies.

Research interests: clinical policy development and implementation, evidence synthesis, disease modeling, healtheconomics, practice improvement trials.

Douglas C. McCrory, MD, MHSc Head, Evidence-based Practice Center and Associate Professor Duke Center for Clinical Health Policy Research2200 W. Main Street, Suite 220 TowerDurham, NC 27705 E-mail: [email protected]

Dr. McCrory has also worked in health care policy development, working with professional and otherorganizations translate evidence into clinical recommendations. Such projects include the RAND carotidendarterectomy appropriateness project, the American College of Physicians’ Clinical Efficacy AssessmentProject recommendations for medical treatment for stroke prevention and a joint ACP-ASIM/ACCP guidelinedevelopment on management of acute exacerbation of COPD.

Research interests: meta-analysis, clinical practice guideline development, systematic review methodology.


John W. Williams Jr., MDProfessor of Medicine & PsychiatryScientific Editor, NC Medical JournalDuke University and Durham VA Medical Center2424 Erwin RoadSuite 1105, Hock PlazaDurham, NC 27705Phone: (919) 668-0300 Fax: (919) 668-1300E-mail: [email protected]

Dr. William’s is a Professor in the Department of Medicine and an Associate Professor in the Department ofPsychiatry at Duke University. His research interests include implementing best practices, mental illness inprimary care with a focus on depression and dementia, quality indicators, systematic reviews, and effectivenesstrials.

ECRI

Karen Schoelles, MD, SMDirector, ECRI Evidence-based Practice CenterECRI5200 Butler PikePlymouth Meeting, PA 19462Phone: (610) 825-6000, ext. 5337Fax: (610) 834-1275 E-mail: [email protected]

Vivian H. Coates, MBA Vice President for Information Services and Technology AssessmentPrincipal InvestigatorECRI5200 Butler PikePlymouth Meeting, PA 19462-1298Phone: (610) 825-6000Fax: (610) 834-1275 E-mail: [email protected]

Vivian H. Coates, MBA, is ECRI’s vice president of information services and technology assessment. Ms. Coatesdeveloped and directs ECRI’s technology assessment program and works to enhance the program’s contributionto the health care community. She initiates and fosters relationships with the users of technology assessmentinformation to promote the use of evidence-based medicine in health care delivery, coverage, and clinical practiceguideline development. She directs the translation and dissemination of technology assessments into forms thatcan be used by constituents throughout the health care community, including policy makers, consumeradvocates, and patients and their families. Ms. Coates oversees ECRI’s Evidence-based Practice Center (EPC),which conducts technology assessments and develops evidence reports for the Agency for Healthcare Research


and Quality (AHRQ). She also is responsible for ECRI’s technology assessment contract with TRICAREManagement Activity, the Department of Defense agency that administers the health benefits for the U.S. ArmedServices personnel and their families, reservists, and retirees.

Ms. Coates has developed a number of health care and health technology-related information resources,including ECRI’s Healthcare Standards print directory database, and TARGET, a searchable Web-deployeddatabase of evidence reports on emerging medical technologies. Ms. Coates is project director for ECRI’s contractwith AHRQ to develop, implement, and maintain the National Guideline Clearinghouse™, an Internet-accessibledatabase of summaries of clinical practice guidelines and related documents. She also directs ECRI’s contractwith AHRQ to develop, implement, and maintain the National Quality Measures Clearinghouse™, a database ofhealth care quality measures and supporting documentation.

Ms. Coates is responsible for the continuous development and promulgation of ECRI’s Universal MedicalDevice Nomenclature System™ (UMDNS™), a controlled vocabulary and coding system for classifying medicalproducts and indexing clinical, regulatory, and technical information. It has been adopted by many nations andby the European Union as the interim standard for medical devices in support of the Medical Devices Directives.Ms. Coates was a member of the Project Council for the European Union project to develop the Global MedicalDevice Nomenclature.

Since 1991, she has directed ECRI’s work with the National Library of Medicine (NLM) to index uniquehealth services research literature for NLM’s bibliographic databases and to incorporate UMDNS into NLM’sUnified Medical Language System. She represents ECRI on several international medical informatics standardscommittees, such as ISO TC 210 and CEN TC 257, and has been a member of the Global Harmonization TaskForce Study Group 2 on Vigilance and Postmarket Surveillance.

Johns Hopkins University

Eric B. Bass, MD, MPHDirector, Johns Hopkins Evidence-based Practice CenterAssociate Professor of Medicine and Health Policy &ManagementThe Johns Hopkins Medical Institutions1830 Building, Suite 8068Baltimore, MD 21205Phone: (410) 955-9871Fax: (410) 955-0825E-mail: [email protected]

Karen A. Robinson, MScCo-Director, EPCEmail: [email protected]


Jonathan M. Samet, MD, MSCo-Chair of Scientific Advisory CommitteePhone: (410) 955-3286Email: [email protected]

Dr. Jonathan Samet is one of the world’s leading scientific experts on the health effects of active and passivesmoking. He has been contributed to many of the Surgeon General’s reports in the US and is the senior scientificeditor for the 2004 and 2006 reports on active and passive smoking respectively. He was also responsible for thefirst surveillance efforts to track the tobacco epidemic in China.

Neil R. Powe, MD, MPH, MBACo-Director, EPC and Co-Chair of Scientific Advisory CommitteeDirector, Welch Center for Prevention, Epidemiology and Clinical Research 2024 E. Monument St.Suite 2-600Phone: (410) 955-6953 Fax: (410) 955-0476Email: [email protected]

Education: BA, Princeton University, 1976; MD, Harvard Medical School, 1981; MPH, Harvard School of PublicHealth, 1981; MBA, The Wharton School, University of Pennsylvania, 1986

Research and Professional Experience: Dr. Powe’s research involves prevention and screening, clinicalepidemiology, patient outcomes research, technology assessment, and cost-effectiveness analysis. He hasworked on many important diseases with substantial morbidity including kidney disease, cardiovasculardisease, diabetes, thyroid disease, depression, and eye disease. He has also conducted projects on healthdisparities, managed care, access to care, and quality of care. His research has used prospective methods ofrandomized controlled trials and cohort studies, cost-effectiveness analysis, meta-analysis, retrospectiveanalyses of administrative databases, and survey research.Dr. Powe has studied the relation between volume, technology, and outcomes of patients with myocardialinfarction, thrombolytic therapy in the elderly, and ethnic differences in cardiovascular procedure use in patientswith chronic kidney disease. Dr. Powe is principal investigator of the CHOICE study, a study of the outcomes ofend-stage renal disease patients funded by the agency for Healthcare Research and Quality (AHRQ) and theNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). This is a national study of patientoutcomes in chronic kidney disease. He has extensive experience in developing and measuring outcomes in thispopulation using data from prospective studies, the United States Renal Data System (USRDS), Medicarerecords, and patient surveys.


Steven N. Goodman, MD, MHS, PhDCo-Director, EPCDepart of OncologyDivision of BiostatisticsJohn Hopkins School of Medicine1103 550 BuildingPhone: (410) 955-4596 Fax: (410) 614-2325Email: [email protected]

Steven N. Goodman, MD, MHS, PhD, is an Associate Professor of Oncology in the Division of Biostatistics of theJohns Hopkins Kimmel Cancer Center, with appointments in the Departments of Pediatrics, Biostatistics andEpidemiology in the Johns Hopkins Schools of Medicine and Public Health. Dr. Goodman received a BA fromHarvard, MD from NYU, trained in Pediatrics at Washington University in St. Louis, and received an MHS. inBiostatistics and PhD in Epidemiology from Johns Hopkins School of Public Health. In the Oncology Center hedirects the Biostatistics cores of the SPORE grants in GI and Head and Neck Cancer and consults on numerousclinical research projects. As part of the Head and Neck SPORE, he is overseeing the production of HAND (HeadAnd Neck Database), which will integrate clinical, pathologic, molecular, genetic and epidemiologic informationon all patients with these types of cancer seen at Johns Hopkins. This is being designed to conform to cross-institutional standards developed within the EDRN - Early Detection Research Network.

In addition to his activities in oncology, Dr. Goodman is an active leader and teacher in a variety ofdepartments and programs within the Johns Hopkins Medical Institutions. He is co-director of the PhD programin the Department of Epidemiology and of the Johns Hopkins Evidence-Based Practice Center, and is on the corefaculties of the Johns Hopkins Bioethics Institute, the Center for Clinical Trials, and the Graduate TrainingProgram in Clinical Investigation (GTPCI). He directs Project ImpACT (Important Achievements of ClinicalTrials), a project to identify, compile and profile the 100 most important clinical trials ever performed, across alldisciplines of medicine and public health. He runs a yearlong doctoral seminar for all epidemiology PhDstudents, teaches a course on Meta-analysis in the Epidemiology department, and is a director of the 2 weekMethods in Clinical Research course taught every summer under the auspices of the GCRC (General ClinicalResearch Center) and GTPCI. He is a regular lecturer in several courses on research ethics and research methodsgiven throughout the year. He chairs the Department of Epidemiology curriculum committee and serves as astatistician for the pediatric clinical research unit of the GCRC.

Dr. Goodman is very active outside of Johns Hopkins in a variety of editorial and advisory capacities. He isthe Editor-in-chief of Clinical Trials: Journal of the Society for Clinical Trials, and has been Statistical Editor ofthe Annals of Internal Medicine since 1987. He has served on a wide variety of national panels, including theInstitute of Medicine’s Committee on Veterans and Agent Orange, Committee on Immunization Safety, theMedicare Coverage Advisory Commission, and the Surgeon General’s committees to write the 2001 and 2002reports on Smoking and Health. He served as a consultant to the President’s Advisory Commission on HumanRadiation Experiments. He chairs a national panel on the health outcomes of children born using assistedreproductive technologies, sponsored by the American Academy of Pediatrics and the American Society forReproductive Medicine. He represents the American Academy of Pediatrics on the Medical Advisory Panel of the


National Blue Cross/Blue Shield Technology Evaluation program, and was recently appointed to succeed Dr.David Eddy as scientific advisor to the group. He is on the Board of Directors of the Society for Clinical Trialsand was co-director of the Baltimore Cochrane Center from 1994-1998. He writes and teaches extensively onevidence synthesis, and inferential, methodological and ethical issues in epidemiology and clinical trials.

Education: PhD, Johns Hopkins University; MD, New York University; MHS, Johns Hopkins University

American Academy of Pediatrics Appointee to the Blue Cross and Blue Shield Association Medical AdvisoryPanel

Member of several IOM panels (Agent Orange, Immunization Safety) and committees for Surgeon General’sreports (2001, 2002)

Member of Medicare Coverage Advisory Committee (MCAC)

Research and teaching focus on inferential and ethical issues in clinical research, peer review, meta-analysis

Board-certified by the American Board of Pediatrics

Co-Scientific Advisor to the Association’s Medical Advisory Panel

McMaster University

Dr. Parminder Raina, PhD Director, McMaster Evidence-based Practice CenterAssociate Professor, Department of Clinical Epidemiology & BiostatisticsMcMaster University1280 Main Street West, Courthouse T-27, 3rd floorHamilton, Ontario, Canada L8S 4L8 Phone: (905) 525-9140, ext. 22197Fax: (905) 546-7681E-mail: [email protected]

In addition to his appointments at McMaster University, Parminder Raina has an appointment at the Institute ofPopulation Health at Hamilton General Hospital. Dr. Raina also holds joint faculty appointments in theDepartment Health Care and Epidemiology at UBC, and Centre for Community Child Health Research(CCCHR), BC Children’s Hospital.

Dr. Raina received his undergraduate degree from the University of Saskatchewan, Canada in 1989. He movedto University of Guelph, Ontario to start his PhD program in epidemiology in 1991. He completed his PhD in1995. After completing his PhD, he was appointed as an Assistant Professor (part-time) in the Department ofClinical Epidemiology and Biostatistics, Faculty of Health Sciences, McMaster University. In Guelph andHamilton he was involved in the investigation of social support and health care use among seniors, epidemiologyof dementia, health of caregivers of dementia patients, SES and health of seniors, injuries among seniorsdisability among seniors and development of motor growth curves among children with cerebral palsy. Duringhis time at McMaster, he was also involved in methodological studies related to the presentation of meta-analysisdata, framing of effects sizes and quality of primary studies used in M-A.


In 1997, Dr. Raina took a faculty position at UBC and CCCHR. During his stay (1997-2001) in Vancouver, hedeveloped a research agenda in population health and injuries and directed BC Injury Research and PreventionUnit. He continues to hold the position of Director of BC Injury Research and Prevention Unit. His focus oninjury research is to initiate the implementation of an emergency room surveillance system in British Columbia,as well as examining the determinants of injuries in children and youth and older populations. In 1999, he wasalso awarded a 5-year CIHR/NHRDP Investigator Award in the area of population health and injuries, and in2003 he has been awarded a CIHR Investigator Award in the area of Healthy Aging.

Since moving to Hamilton in 2001, he has continued to work in the area of geriatric epidemiology, injuriesand methods related to M-A, systematic reviews, and knowledge transfer. He is also co-leading the developmentof the Canadian Longitudinal Study on Aging. The overall aim of the CLSA is to examine aging as a dynamicprocess. This study will investigate the inter-relationship among intrinsic and extrinsic factors from mid life toolder age, capturing transitions and trajectories that will allow us to clarify the concept of healthy aging. Once inplace, the CLSA will provide infrastructure and build capacity for the ongoing conduct of high quality researchon aging in Canada.

Oregon Health & Science University

Mark Helfand, MD, MS, MPHOregon Evidence-based Practice Center, DirectorProfessor of Medicine and Medical Informatics & Clinical Epidemiology, OHSUAssistant Professor, School of MedicineDivision of Medical Informatics and Outcomes Research3181 SW Sam Jackson Park RoadPortland, OR 97201-3098Phone: (503) 494-4277Fax: (503) 494-4551E-mail: [email protected]

As Oregon Evidence-based Practice Center (EPC) Director, Dr. Helfand is responsible for the quality andscientific integrity of all aspects of producing Oregon EPC reports. The Oregon EPC conducts systematic reviewsof health care topics for federal and state agencies and private foundations. These reviews report the evidencefrom clinical research studies and the quality of that evidence for use by policy makers in decisions on guidelinesand coverage issues.

Education:1990 MS in Health Services Research, Stanford University1984 MD, University of Illinois at Chicago1984 MPH in Health Resources Management, University of Illinois at Chicago1979 BA, English Language and Literature, Stanford University1979 BS, Biology, Stanford University


Evelyn P. Whitlock, MD, MPHOregon Evidence-based Practice Center, Co-Director & Liaison to Kaiser PermanenteSenior Investigator and Director for Research-Health Care Integration, KPCHRClinical Associate Professor of Public Health and Preventive Medicine, OHSUOregon Health & Science UniversityOregon Evidence-based Practice Center3181 SW Sam Jackson Park RoadMail code: BICCPortland, Oregon 97239-3098Phone: (503) 418-5409Fax: (503) 418-3332E-mail: [email protected]

Dr. Whitlock is a Senior Investigator at Center for Health Research, a board-certified preventive medicinephysician, and the Director of Research-Healthcare Integration. As Director of Research-Healthcare Integration,she oversees translational research collaborations between CHR and Kaiser Permanente Northwest, particularlythose focused on evidence-based medicine. Dr. Whitlock is also an active member of CHR’s Leadership Team.

Dr. Whitlock is Associate Director of the Oregon Evidence-based Practice Center (EPC), a multi-institutecollaboration between CHR, Oregon Health & Science University (OHSU), and the Portland Veterans AffairsMedical Center. The Oregon EPC is under a multi-year contract to the Agency for Healthcare Research andQuality (AHRQ) to produce evidence syntheses based on systematic reviews, lead methodological developmentfor systematic reviews, and support the increased application of systematic reviews and other evidence-basedproducts into policy and practice. Dr. Whitlock serves as the Principal Investigator for the United StatesPreventive Services Task Force (USPSTF), an EPC program that systematically reviews the evidence for a givenpreventive service, so the USPSTF can develop recommendations for clinical preventive services.

She is also co-Principal Investigator of AHRQ’s Scientific Resource Center for its Effective HealthcareProgram and leads the Topic Nomination group, which generates topics for systematic evaluation. Dr. Whitlockis a member of the senior faculty of the Oregon Clinical and Translational Research Institute (OCTRI), one of 12NIH-funded awards for Clinical and Translational Sciences, and has helped develop and direct OCTRI’sTranslation of Research into Policy and Practice Program. She serves as the Portland Clinical Site MedicalDirector, medical adjudicator, and co-investigator for the Women’s Health Initiative. Dr. Whitlock has significantexperience conducting epidemiological studies and health-services research using large observational datasets,survey data, and administrative datasets. Other recent research includes collaboration with the CDC that createdand validated an algorithm to determine pregnancy episodes and their outcomes within Kaiser PermanenteNorthwest, with ongoing work investigating important public health issues during pregnancy.

In addition to her appointment at CHR, Dr. Whitlock is an adjunct associate professor in OHSU’sDepartment of Medical Informatics and Clinical Epidemiology. She also serves as a clinical associate professor inthe Department of Health and Preventive Medicine at OHSU, where she directed the Residency Program from1993-1997.


Roger Chou, MDScientific Director, Oregon Evidence-based Practice CenterInternal Medicine & GeriatricsSam Jackson Hall, 3rd Floor3181 S.W. Sam Jackson Park RoadPortland, OR 97239Phone: (503) 494-8562

Dr. Chou received his medical degree from Northwestern University Medical School and completed an internalmedicine residency at OHSU. He is board certified in internal medicine. Chou’s research interests includedevelopment of evidence-based guidelines for health screening and management of pain conditions. He has ledresearch for the U.S. Preventive Services Task Force, the Drug Effectiveness Review Project, the American PainSociety and the Agency for Healthcare Research and Quality’s Comparative Effectiveness Program. In his freetime, he enjoys rock climbing, mountaineering, hiking and photography.

Professional Education:Degree(s): MD Northwestern University, Chicago, 1995 Residency: Oregon Health & Science University, Portland Fellowships: General Internal Medicine-Veterans Affairs Medical Center, Portland

RTI International – University of North Carolina

Kathleen N. Lohr, PhDDirector, EPCDirector, Health Services and Policy ResearchRTI International 3040 Cornwallis Road, P.O. Box 12194 Research Triangle Park, NC 27709-2194 Phone: (919) 541-6512 or (919) 541-7480 Fax: (919) 990-8454E-mail: [email protected]

Expertise: Quality of Care and Clinical Practice Guidelines; Evidence-Based Practice and Methods; Health Statusand Quality of Life Assessment

Education: PhD, Public Policy Analysis, RAND Graduate Institute; MA, Education, Stanford University; BA,Sociology, Stanford University.

Background: Dr. Lohr has more than 30 years of experience in health care services and health policy research.She also directs the RTI International-University of North Carolina Evidence-based Practice Center. In 2000, shewas named a Chief Scientist at RTI after four years of directing a broad program of health services research andpolicy analysis. In addition, Dr. Lohr holds the rank of Research Professor, Health Policy and Administration,UNC School of Public Health; Senior Investigator, UNC Program on Health Outcomes; and Senior ResearchFellow at the UNC Cecil G. Sheps Center for Health Services Research. Dr. Lohr spent nine years at the Instituteof Medicine, National Academy of Sciences, where she directed the Division of Health Care Services portfolio ofstudies. During 12 years at The RAND Corporation, she led or worked on numerous health care studies,including the RAND Health Insurance Experiment. She has written or edited dozens of reports and nearly 100peer-reviewed articles.


Meera Viswanathan, PhDDirector, RTI-UNC Evidence-based Practice CenterRTI International 3040 Cornwallis RoadP.O. Box 12194 Research Triangle Park, NC 27709-2194 Phone: (919) 316-3930 Fax: (919) 541-7384E-mail: [email protected]

Timothy S. Carey, MD, MPHProfessor of MedicineDirector, Cecil G. Sheps Center for Health Services ResearchDeputy Director, UNC Program on Health OutcomesUniversity of North Carolina at Chapel Hill725 Airport Road, Campus Box 7590Chapel Hill, NC 27599-7590Phone: (919) 966-7101Fax: (919) 966-5764 E-mail: [email protected]

Southern California

Paul Shekelle, MD, PhDDirector, Southern California EPC-RAND1700 Main StreetSanta Monica, CA 90401Phone: (310) 393-0411, ext. 6669Fax: (310) 451-6917E-mail: [email protected]

Expertise: Complementary and alternative medicine, quality of care

Education: MD, Duke University; PhD, University of California, Los Angeles

Background: Currently an Associate Professor of Medicine at the UCLA School of Medicine, and a staff physicianat the VA Medical Center in West Los Angeles. Research focus has been in the application of innovative methodsto the assessment and improvement of the quality of care. Co-directs the Assessing Care of the Vulnerable Elderlyproject, which seeks to develop a comprehensive set of quality tools to assess care for this population. As anAtlantic Fellow in Public Policy, studied how quality of care was being assessed in the National Health Service inthe United Kingdom.


Tufts University – New England Medical Center

Joseph Lau, MDDirector, Principal InvestigatorCenter for Clinical Evidence SynthesisDivision of Clinical Care ResearchTufts-New England Medical Center750 Washington Street, Box 63Boston, MA 02111Phone: (617) 636-7670Fax: (617) 636-8628E-mail: [email protected]

Dr. Lau is Professor of Medicine at the Division of Clinical Care Research at the Tufts-New England MedicalCenter. He is the Director of one of AHRQ Evidence-based Practice Centers (EPC) and the Director of the NewEngland Cochrane Center (Boston Office). He also heads an AHRQ funded program to train “Evidence-BasedPractitioners.” He has published extensively on the methodologies and clinical applications of meta-analysis. Hehas given many lectures and short courses on meta-analysis nationally and internationally. He is a member of theeditorial board of Clinical Evidence. His earlier work in cumulative meta-analysis of acute myocardial infarctiontreatment trials has won the distinction of being included in a proposed 27-articles core-canon of the westernmedical literature by the editor of the Lancet in 1997.

University of Alberta

Terry P. Klassen, MD, MSc, FRCPCDirector, ARCHE/EPCProfessor and Chair, Department of Pediatrics Phone: (780) 407-7084 Fax: (780) 407-8538E-mail: [email protected]

Dr. Terry Klassen founded the Alberta Research Center for Child Health Evidence (ARCHE) out of an eagernessto generate evidence and expand the knowledge base for decisions in child health. Dr. Klassen’s interest inevidence-based practice developed while working in the pediatric emergency department at the Children’sHospital of Eastern Ontario and trying to determine what was the best management for the acutely ill andinjured children he was assessing. This led him to actively research emerging issues through randomized trialsand systematic reviews. Dr. Klassen’s two major research interests have been in the areas of acute respiratorydisease and injury prevention and control.

Recognizing the limitations of single centre research, he was the founding member of Pediatric EmergencyResearch of Canada (PERC). This organization, which involves all the pediatric emergency departments acrossCanada, aims to foster collaborative research addressing the major health issues in pediatric emergency medicine.It also has a major emphasis on mentoring young investigators in this field. This vibrant research group has majorfunding from the Canadian Institutes of Health Research (CIHR) and has published in the major medicaljournals, including British Medical Journal (BMJ), the Journal of the American Medical Association (JAMA), andthe New England Journal of Medicine (NEJM).


In keeping with his enthusiasm for evidence-based practice, Dr. Klassen led the Child Health Field of theCochrane Collaboration into existence in 1999. The Cochrane Collaboration is an international organizationthat aims to synthesize all the available evidence in health. The mandate of the Child Health Field is to ensurethat the child health area is addressed in a comprehensive and relevant way within the collaboration.

As part of a collaborative effort, involving key researchers from the University of Alberta and Capital Health,he is currently the Director of the University of Alberta Evidence-based Practice Center (U of A EPC). This centerhas been involved with evidence reports regarding Biventricular Pacing for Congestive Heart Failure, Melatoninfor Sleep Disorders, and Occupational Asthma.

Since 1999, Dr. Klassen has been the Professor and Chair of the Department of Pediatrics at the University ofAlberta and Clinical Leader for the Child Health Program of Capital Health, which is home for the StolleryChildren’s Hospital. In 2003, in recognition for his lifetime achievement in research in pediatrics, he was awardedthe Research Award from the Ambulatory Pediatric Association.

Brian H. Rowe, MD, MSc, CCFP(EM), FCCPAssociate Director, University of Alberta EPCResearch Director, Division of Emergency MedicineProfessor, University of AlbertaRoom 1G1.43 WMCUniversity of Alberta Hospital8440-112th StreetEdmonton, Alberta, Canada T6G 2B7Tel: (780) 407-6707Fax: (780) 407-3982Email: [email protected]

Lisa Hartling, BScPT, MScAdministrative Director, EPCAdministrative DirectorUniversity of Alberta Evidence-based Practice CenterDepartment of PediatricsUniversity of AlbertaAberhart Centre One, Room 942411402 University AvenueEdmonton, AlbertaCanada T6G 2J3Phone: (780) 492-6124Fax: (780) 407-6435E-mail: [email protected]

Lisa Hartling is the co-director of ARCHE and the University of Alberta Evidence-based Practice Center. Herresponsibilities include: overseeing the activities of the ARCHE/EPC group, participating in systematic reviews,and assisting clinicians and other professionals in conducting systematic reviews.

Through her education in epidemiology (MSc Community Health and Epidemiology, Queen’s University,1995) and her clinical experience as a physiotherapist (BScPT, University of Alberta, 1990), Lisa developed an


acute awareness of the need for quality research to justify and support health care activities. Lisa is interested inresearch at all levels from designing studies and implementing research protocols to analyzing and interpretingresults and making these available in a form that is meaningful to the intended audience. Her specific researchinterests include injury epidemiology, methodological issues, surveillance and child health.

Donna Dryden, PhDAssociate Director, EPCPhone: (780) 492-1273Fax: (780) 407-6435E-mail: [email protected]

Dr. Dryden is the Associate Director of the University of Alberta/Capital Health Evidence-based Practice Center.Donna received her Masters and PhD in Medical Sciences — Public Health Sciences (Epidemiology) from theUniversity of Alberta. Her doctoral research was an examination of spinal cord injury in Alberta, including theepidemiology, utilization of health services and direct health care costs. She recently (July 2005) completed a PostDoc with the British Columbia Rural and Remote Health Research Institute at the University of Northern BritishColumbia. Donna’s primary research interests are injury epidemiology and the use of administrative data toexplore health outcomes and patterns of health service utilization for specific illnesses and injuries. She is theauthor of a number of peer-reviewed papers and published abstracts. As a researcher, she has conducted severalsystematic reviews and has also been involved in teaching critical appraisal and evidence-based medicine. Priorto becoming an epidemiologist, Donna was a health sciences librarian.

University of Connecticut

C. Michael White, PharmDAssociate Professor of Pharmacy PracticeUniversity of ConnecticutSchool of Pharmacy, Room 34269 North Eagleville Road, Unit 3092Storrs, Connecticut 06269-3092Phone: (860) 486-4697 Fax: (860) 545-2415E-mail: [email protected]

C. Michael White earned his BS and PharmD at the Albany College of Pharmacy in Albany, NY, and served afellowship at the UConn School of Pharmacy/Hartford Hospital in 1998. His professional interests includearrhythmia detection, prevention, and treatment; the impact of drugs, herbs, and natural products onimplantable cardiac devices and electrophysiology; and pleiotrophic effects of antihyperlipidemic agents.


Craig Coleman, PharmDAssistant Professor of Pharmacy PracticeUniversity of ConnecticutSchool of Pharmacy, Room 34669 North Eagleville Road, Unit 3092Storrs, Connecticut 06269-3092Phone: (860)545-2096Fax: (860)486-1553E-mail: [email protected]

Craig Coleman earned a BS in Biology from Clark University, and a BS in Pharmacy Studies along with hisPharmD from the University of Connecticut. His professional interests include: assessment of the clinical andpharmacoeconomic outcomes of cardiovascular drugs including drugs used in the diagnosis and evaluation ofcoronary artery disease and to prevent atrial fibrillation after cardiothoracic surgery; evaluation and modeling ofthe cardiovascular effects of non-cardiovascular drugs; pharmacoeconomic evaluations of programs, devices,and interventions designed to increase the appropriate and safe use of medications; and teaching outcomesassessment and internal medicine pharmacotherapy to students, residents, and research fellows.

University of Ottawa

David Moher, PhDDirector, UO-EPCChalmers Research GroupChildren’s Hospital of Eastern Ontario Research Institute401 Smyth RoadOttawa, OntarioCanada K1H 8L1Phone: (613) 738-3591Fax: (613) 738-4800E-mail: [email protected]

The CRG team is led by David Moher, Director of Clinical Research at CHEO. Dr. Moher founded the ThomasC. Chalmers Centre for Systematic Reviews in January 1998 and he has established an international reputationregarding the methodology of systematic reviews and meta-analysis. His leadership led to the development of theCONSORT standard for reporting randomized controlled trials, adopted by approximately 500 health carejournals internationally. David Moher has spearheaded over 30 systematic reviews, receiving national andinternational funding. He has over 100 scientific papers in respected health care journals such as The Lancet andJAMA. He is an Assistant Professor of Pediatrics, Medicine, and Epidemiology and Community Medicine, at theUniversity of Ottawa. David Moher is on the editorial board of several medical journals.


Chantelle GarrittyUO-EPC Coordinator, CRG Systematic Reviews ManagerChalmers Research Group Children’s Hospital of Eastern Ontario Research Institute401 Smyth Road Ottawa, OntarioCanada K1H 8L1 Phone: (613) 737-7600, ext. 4117Fax: (613) 738-4800 E-mail: [email protected]

University of Minnesota

Robert L. Kane, MDPrincipal InvestigatorMinnesota Chair in Long-Term Care and AgingUniversity of Minnesota School of Public HealthMayo Mail Code 197Minneapolis, MN 55455Phone: (612) 624-1185Fax: (612) 624-8448E-mail: [email protected]

Robert Kane, MD, Co-Director, is a physician with a background in preventive medicine, health services research,and geriatrics, is a professor in the Division of Health Services Research and Policy and holds an endowed chairin Long-term Care and Aging. Dr. Kane combines experience in aging and long-term care with expertise in policyanalysis and outcomes measurement. He has directed numerous large-scale research and evaluation projects ina variety of fields related to health services research and directs the University’s Center on Aging.

Most recently, his larger efforts have examined the outcomes of Medicare patients discharged from hospitalsto assess the role of both hospital care and post-hospital care. He directed a study to examine the quality of homecare and another to develop an information system to examine the outcomes of mental health care in managedbehavioral care. These projects demonstrate not only his background in outcomes research but also his ability todesign and direct large scale, multi-site, longitudinal research efforts.

With regard to managed care, he also developed a process to assess the quality of care for PACE, which offerscapitated care to high risk older persons and he directs the team that is providing the technical assistance toestablish the second generation of Social HMOs. As part of the second generation SHMO demonstration, Dr.Kane has been instrumental in designing the geriatric intervention for the demonstration and developingscreeners and triggers to be used in care management of the elderly SHMO enrollees. Dr. Kane is well known forhis abilities to design and carry out large-scale projects and for his general expertise in long-term care financingand delivery and in quality of care. He is the editor of Understanding Health Care Outcomes (Aspen, 1997).


Vanderbilt University

Katherine E. Hartmann, MD, PhDDirector, Vanderbilt University Evidence-based Practice CenterDeputy Director, Institute for Medicine and Public HealthVanderbilt UniversitySixth Floor, Suite 6002525 West End AvenueNashville, TN 37203Phone: (615)936-8320 Fax: 615-936-8290 E-mail: [email protected]

Dr. Hartmann is the Director of the Vanderbilt University EPC. She is also the Deputy Director of the Institutefor Medicine and Public Health at Vanderbilt University Medical Center (VUMC), where she serves as Directorof Women’s Health Research, and as the Lucius M. Burch Vice Chair of Research in Obstetrics and Gynecology.Dr. Hartmann is a health care and reproductive epidemiologist. She received her medical training as well as hera master’s degree in science writing from Johns Hopkins University. She completed her residency and doctoraltraining in epidemiology at the University of North Carolina. She was the founding director of the Center forWomen’s Health Research at the University of North Carolina before joining the faculty of Vanderbilt Universityin 2006.

Melissa McPheeters, MPH, PhDDr. McPheeters is the Associate Director for Operations. She is an Assistant Professor in the Departments ofObstetrics and Gynecology and General Medicine and Public Health. She is also the Deputy Director forWomen’s Health Research at Vanderbilt and Director of Communications at the Institute for Medicine andPublic Health. She is trained in scientific writing and research, with a bachelor’s degree in professional writing,an MPH in maternal and child health, and a PhD in Epidemiology. Dr. McPheeters has more than a decade ofexperience managing proposal teams, conducting research and communicating complex concepts to a range ofaudiences, including clinicians, policy makers, and the public.

Sandra Micucci, MSCMs. Micucci is the Associate Director for Methods. She holds an undergraduate degree in industrial relations andeconomics, as well as a master’s in Health Research Methodology, and is currently completing a PhD in medicalgeography. Her expertise crosses numerous methodological lines, including quantitative, evidence-based,qualitative, mixed, geographical and economic methods of research. In her role with the Effective Public HealthPractice Project, a joint McMaster University and City of Hamilton project, she oversaw multiple reviewssimultaneously, integrating content experts and research staff from numerous locations. She has authored or co-authored nine systematic review in public health and two systematic reviews in cancer care.


APPENDIX E: Effective Health Care Program’s Stakeholder Group Bios

Darrell R. Abernethy, MD, PhDChief Science Officer at the United States Pharmacopeia

Dr. Abernethy assumed the position of Chief Science Officer at the United States Pharmacopeia in June, 2007.Dr. Abernethy received his MD (AOA) and PhD (Pharmacology) degrees from the University of Kansas Schoolof Medicine in 1976. Further clinical training was in Internal Medicine at Jackson Memorial Hospital/Universityof Miami through Board Certification in Internal Medicine. He then did post-doctoral fellowship training inClinical Pharmacology at the Massachusetts General Hospital. Dr. Abernethy joined the faculty at TuftsUniversity School of Medicine as Assistant Professor of Psychiatry and Medicine in 1981. He moved to BaylorCollege of Medicine in 1983 where he advanced to Associate Professor of Medicine in the Division ofHypertension and Clinical Pharmacology. In 1986 he moved to Brown University School of Medicine as Chief ofthe Division of Clinical Pharmacology. He was subsequently promoted to Professor of Medicine at Brown. In1994 Dr. Abernethy became the Francis Cabell Brown Professor and Director of the Division of ClinicalPharmacology at Georgetown University School of Medicine, where he served until 1999. He then moved tobecome Chief of the Laboratory of Clinical Investigation at the National Institute on Aging and was at this postuntil June, 2007, at which time he assumed his current post.

Dr. Abernethy has contributed to understanding of mechanisms of peripheral distribution of drugs and drug disposition and effect in obesity. He also has contributed to the knowledge base inpharmacokinetic/pharmacodynamic relationships of cardiovascular drugs in aging and has advanced theconcept that the pathophysiology of aging must be considered when interpreting drug effects in the aged patient.Currently Dr. Abernethy is studying the role of genetic polymorphisms of drug effectors that effect responses tocardiovascular drugs. These studies include both phenotypic changes and genotypic changes which contribute toaltered phenotype and nongenotypic splice variant transcriptional changes which result in phenotypic changes.Presently these studies are focusing on endothelial nitric oxide synthase and the L-type calcium channel.These efforts have resulted in 187 publications of original research and over 50 book chapters and reviews.

Dr. Abernethy has participated in, and continues to participate actively in service and organizational activitieswhich promote the safe and effective use of medications in aged patients. As an extramural investigator, he servedon the NIGMS Pharmacological Sciences study section (1988-1992), the FDA generic drugs (1990-1992) and cardiorenal (1992-1996) advisory committees, and served as chair of the VA merit review Geriatricssubcommittee (1998-2000). As an educator, he served on the National Board of Medical ExaminersPharmacology Test Committee (1992-1996), was chair of the NBME (now called USMLE) AppliedPharmacology Committee (1997-2000), the Step 1 Test Committee (2006) and presently serves on the USMLEbiostatistics task force. Editorial activities include membership on the editorial boards of Clinical Pharmacologyand Therapeutics, the Journal of Clinical Psychopharmacology, Drugs, as Associate Editor of the Journal ofPharmacology and Experimental Therapeutics, and he served as Editor-in-Chief of Pharmacological Reviews(2001-2006). Organizational and public service have included serving as President of the American Society ofClinical Pharmacology and Therapeutics (1991-1992) and on the Gerontology Committee of the United StatesPharmacoepia (1990-2005) that he subsequently chaired (1999-2005). He also served on the USP MedicareMedication Guidelines committee, a group designated by the US Congress to establish the basis for the MedicarePrescription Drug Benefit (2004-2005). In 2005 he was elected President of the USP Convention for the 2005-2010 cycle.


Wade M. Aubry, MDAssociate Director of the Center for Medical Technology Policy and Senior Medical Advisor to the California Technology Assessment Forum

Dr. Aubry is Associate Director of the Center for Medical Technology Policy and Senior Medical Advisor tothe California Technology Assessment Forum. CMTP is a new nonprofit organization based in San Franciscowhose mission is to generate new evidence on important technologies to meet the needs of decision makers. Hehas an extensive background in technology assessment and coverage decision making as former Senior VicePresident and Chief Medical Officer for Blue Shield of California and former Chairman of the Blue Cross BlueShield Association’s TEC Medical Advisory Panel. Dr. Aubry has also been a Medicare Part B Carrier MedicalDirector for Northern California and has served two terms on the CMS Medicare Evidence Development andCoverage Advisory Panel. He has been a member of numerous national advisory committees related to medicaltechnology, clinical research, and evidence-based medicine for the IOM, NIH, NCQA, ACRIN, and others. Healso has experience in health care consulting as a former Vice President for the Lewin Group.

Dr. Aubry received his B.S. degree from Stanford University and his MD degree from the UCLA School ofMedicine. Trained as an internist and endocrinologist at Cedars-Sinai Medical Center in Los Angeles, he practicesmedicine at Saint Francis Memorial Hospital in San Francisco, where he is Chairman of the hospital’sInstitutional Review Board. He is also Associate Clinical Professor of Medicine at the UCSF Institute for HealthPolicy Studies, where he serves on the faculty task force for the California Health Benefits Review Program andteaches in clinical medicine and health policy. He is co-author of “False Hope: Bone Marrow Transplantation forBreast Cancer”, which details the rise and fall of a controversial procedure that continues to have an impact onpolicies related to the dissemination of new medical technology.

Jennifer L. Bright, MPAExecutive Director, Society for Healthcare Epidemiology of America (SHEA) and Founder, National Working Groupon Evidence-Based Healthcare

Ms. Bright leads the efforts of the National Working Group on Evidence-Based Healthcare, a group foundedin January 2006 that represents patient organizations, caregivers, physicians and consumers who are committedto educating stakeholders, facilitating engagement in evidence-based health care initiatives and dialogue andpromoting inclusion of patient/consumer and caregiver contributions and perspectives in all aspects of evidencegeneration, translation, dissemination and implementation to the practice of medical care.

Ms. Bright is currently the Executive Director for the Society for Healthcare Epidemiology of America(SHEA), a professional society of clinical experts in hospital infection control and epidemiology. From 2000 to2007, Ms. Bright was Vice President at Mental Health America, where she oversaw policy initiatives affectingpatients/consumers and families for over six years. This work included extensive review of comparativeeffectiveness research conducted by OHSU’s Drug Effectiveness Review Project as well as the AHRQ EffectiveHealthcare program. Ms. Bright’s past career experience in state government relations and consulting withStateside Associates and Booz-Allen & Hamilton has focused on a variety of health policy issues includinginformation privacy, screening, adverse event reporting, FDA reform, Medicaid and Medicare, mental health,insurance reform, health IT, and scope of practice.

Ms. Bright earned a bachelor’s degree in Political Science from Trinity College, Washington, D.C., and aMasters of Public Administration from The George Washington University.


W. Gary Erwin, PharmDSenior Vice President, Professional Services, Omnicare, Inc., and President, Omnicare Senior Health Outcomes

Dr. Erwin’s responsibilities include development, management and measurement of clinical programs forOmnicare Senior Pharmacy services; business development in the areas of clinical initiatives for retireepopulations; and performance of outcomes studies and database reporting.

Dr. Erwin received his B.S. Pharmacy degree from Auburn University in 1976 and his Doctor of Pharmacydegree from the University of Kentucky in 1981. He also completed a hospital pharmacy residency at theUniversity of Kentucky Medical Center in 1981. Prior to joining Omnicare, Dr. Erwin served as Vice Presidentfor Professional Programs, and Professor of Clinical Pharmacy, Philadelphia College of Pharmacy and Science.In addition, he was on the faculty at the University of Georgia, where he specialized in geriatric pharmacotherapyand long-term care.

Omnicare, Inc., a Fortune 500 company based in Covington, Kentucky, is a leading provider ofpharmaceutical care for the elderly. Omnicare serves residents in long-term care facilities and other chronic caresettings comprising approximately 1,419,000 beds in 47 states, the District of Columbia and Canada. Omnicareis the largest U.S. provider of professional pharmacy, related consulting and data management services for skillednursing, assisted living and other institutional health care providers as well as for hospice patients in homecareand other settings. Omnicare’s pharmacy services also include distribution and patient assistance services forspecialty pharmaceuticals. Omnicare offers clinical research services for the pharmaceutical and biotechnologyindustries in 30 countries worldwide.

Patricia M. Hart, MD, FACPPrivate Practice, Brooklyn, New York

Patricia M. Hart, MD is board certified in both Internal medicine and Nephrology. In addition to practicingmedicine in a private medical practice, Dr. Hart is recognized for her expertise in innovative health strategies andpolicies specifically involving minority health.

Dr. Hart received her BA in Biology from Fordham University. She received her medical doctorate from theState University of New York at Buffalo. Dr. Hart completed her internship and residency training at the HarlemHospital Center in New York City. She completed a fellowship in Nephrology also at the Harlem Hospital Center.Dr. Hart is a Fellow of the American College of Physicians.

Dr. Hart has not limited her career to clinical practice but rather is an advocate for improved health care andhas worked tirelessly within organized medicine. She has been appointed and elected to several local and nationalpositions of the National Medical Association including membership on the Board of Trustees. She has alsoserved on committees of the American College of Physicians and is a member of the Association of BlackCardiologists and the Association of Minority Nephrologists. Dr. Hart is also involved with and supports severalnonprofit foundations and organizations.


Maria Carolina Hinestrosa, MA, MPHExecutive Vice President for Programs and Planning at the National Breast Cancer Coalition, and Co-founder of Nueva Vida

Carolina Hinestrosa is the Executive Vice President for Programs and Planning at the National Breast CancerCoalition, and co-founder of Nueva Vida, a support network for Latinas with cancer in the Washingtonmetropolitan area. A two-time breast cancer survivor, Ms. Hinestrosa is a member and former Chair of theIntegration Panel of the Department of Defense Breast Cancer Research Program. She has served on variousnational committees at the National Cancer Institute, the Institute of Medicine, National Quality Forum, theEthical Force of the American Medical Association, among others. She is a sought-after speaker on breast canceradvocacy in research, access and quality care. Born in Bogotá, Colombia, Ms. Hinestrosa came to the UnitedStates in 1985 as a Fulbright scholar. She holds graduate degrees in economics and public health. She has broadexperience in strategic planning and nonprofit management in Colombia, New Zealand and the United States.

Peter Juhn, MD, MPHVice President, Evidence and Regulatory Policy, Johnson & Johnson

Peter Juhn is responsible for shaping evidence-based medicine policies at the J&J Corporate level, especiallyas payers use evidence-based medicine as a basis for decisions on reimbursement and coverage ofpharmaceuticals and medical devices. He works with the various J&J operating companies on a global basis toanticipate the methods and types of evidence needed in this evolving payer and regulatory environment. He alsoprovides policy coverage for developments in the Health Information Technology initiatives as well as quality-based “pay-for-performance” activities. He serves as the industry representative to the Medicare EvidenceDevelopment and Coverage Advisory Committee at CMS and is the coordinator of the manufacturer sector atthe IOM Roundtable on Evidence-based Medicine.

Most recently, he was Vice President, Health Improvement Resources, at WellPoint Health Networks, wherehe managed the disease management programs for all the operating units. He also held senior positions at KaiserPermanente, including founding Executive Director, Care Management Institute, which is Kaiser’s corporatedisease management and clinical policy entity, and President and CEO of CareTouch, Inc., an e-health start-upventure. He has a BA from the University of Chicago, an MD from Harvard, and an MPH from the University ofWashington, where he was a Robert Wood Johnson Clinical Scholar. He completed his Internal Medicineresidency at the University of Pennsylvania.

Dick Justman, MDNational Medical Director of UnitedHealthcare

Dick Justman is national medical director of UnitedHealthcare, a national health service delivery company.He works in the Clinical Advancement division. Dick is accountable for medical technology assessment, clinicalsupport of pharmacy programs and clinical support of benefit administration. He has been withUnitedHealthcare since 1993. Dick received his bachelor’s degree from Cornell University and his MD degreefrom the State University of New York at Buffalo. He is board-certified in pediatrics, and received hispostgraduate training at The University of Chicago Hospitals and Clinics and the Johns Hopkins Hospital. Dickpracticed pediatrics in Minneapolis, Minnesota for fifteen years before joining UnitedHealthcare.

He has served on the Institute of Medicine Forum on Drug Discovery, Development and Translation; theInstitute of Medicine Committee to Identify Highly Effective Clinical Services; the American Medical AssociationCPT-5 Project; the American Medical Association Initiative to Transform Medical Education (ITME); and an


expert panel developing an Evidence Report on diabetes education for children with type I diabetes,commissioned by the Agency for Healthcare Research and Quality (AHRQ).

Sharon Levine, MDAssociate Executive Director, The Permanente Medical Group, Inc.

Sharon Levine, MD, is a nationally respected expert and frequent speaker on issues of health policy, drug usemanagement, and the design and delivery of health care services. As Associate Executive Director for ThePermanente Medical Group of Northern California since 1991- the largest medical group in the country – Dr.Levine has responsibility for the recruitment, compensation, clinical education, management training andleadership development for the group’s physicians; government and community relations, health policy andexternal affairs; and pharmacy policy and drug use management

A board certified (American Board of Pediatrics) pediatrician, Dr Levine has practiced with The PermanenteMedical Group since 1977. During that time she has held multiple leadership roles within the Medical Group,including Chief of Pediatrics, Chief of Quality, and Physician in Charge of the Fremont Medical Center.

Dr. Levine began her medical career at the Montgomery-Georgetown Pediatric Comprehensive Care Clinic,and Georgetown University Community Health Plan. In addition, she has held academic appointments at TuftsUniversity School of Medicine and Georgetown University School of Medicine, and spent two years as a ClinicalAssociate at the National Institutes of Health, Institute of Child Health and Human Development, doing researchon infant nutrition.

Dr. Levine is a member of the American College of Physician Executives, California Medical Association, andAmerican Medical Association. She serves on the Boards of Directors of the Integrated Healthcare Association,The California Association of Physician Groups, The California Hospital Association, The Public Heath Instituteof California, and the Women’s Foundation of California.

A native of Boston, Dr. Levine received her undergraduate degree from Radcliffe College at HarvardUniversity, and her MD degree from Tufts University School of Medicine. Dr. Levine is married and lives in PaloAlto, Ca.

Kaiser Permanente is America’s leading integrated health plan. Founded in 1945, it is a not-for-profit, grouppractice prepayment program with headquarters in Oakland, California. Kaiser Permanente serves the healthcare needs of over 8.2 million members in 9 states and the District of Columbia. Today it encompasses the not-for-profit Kaiser Foundation Health Plan, Inc., Kaiser Foundation Hospitals and their subsidiaries, and the for-profit Permanente Medical Groups, as well as an affiliation with Group Health Cooperative based in Seattle.Nationwide, Kaiser Permanente includes approximately 136,000 technical, administrative and clerical employeesand over 11,000 physicians representing all specialties.

David B. Lorber, MDVice President of Medical Affairs for Caremark

David Lorber, MD, is Vice President of Medical Affairs for Caremark. He has been with the Company since2000. Dr. Lorber is responsible for clinical oversight of Caremark programs, focusing on clinical productdevelopment and eBusiness initiatives. In addition, he provides clinical support to account management teamsand for Medicare Part D initiatives.

Prior to joining Caremark, Dr. Lorber was Medical Director at Blue Cross Blue Shield of New Mexico inAlbuquerque. His responsibilities included utilization management, disease management, provider profiling,pharmacy and therapeutics committee, credentialing and liaison to the State Medical Society and New Mexico


Department of Health. In addition, he served as the medical director for the Indian Health Service ContractHealth Services, a national entity managed by Blue Cross Blue Shield of New Mexico.

Before that, Dr. Lorber was a private practitioner in pulmonary, critical care and internal medicine and heldnumerous positions in community leadership and professional organizations including President of the NewMexico Chapter of the American Thoracic Society. He has held faculty appointments as Assistant ClinicalProfessor of Medicine with the University of New Mexico School of Medicine, and as Assistant Professor with theUniversity of Arizona Medical Center in Tucson and the Tucson VA Hospital.

In addition, Dr. Lorber serves on both the Pulmonology Expert Committee and the Therapeutic DecisionMaking Expert Committee of United States Pharmacopeia.

He received a Bachelor of Arts with distinction in biology from the University of Virginia and earned a Doctorof Medicine degree from the Virginia Commonwealth University, Medical College of Virginia. He is boardcertified in internal medicine, pulmonary disease. He is a Fellow of the American College of Chest Physicians anda member of the American College of Emergency Physicians.

Caremark is a leading pharmaceutical services company that provides, through its affiliates, comprehensivedrug benefit services to more than 2,000 health plan sponsors and their plan participants throughout the United States.

Doris H. Lotz, MD, MPHMedicaid Medical Director for the State of New Hampshire

Since July 2002, Dr. Lotz has been the Medicaid Medical Director for the State of New Hampshire. Sheprovides clinical guidance for policy and program development and strategic planning. She is the programdirector for the NH Medicaid disease management program provides plenary and implementation leadership tothe State’s Enhanced Care Coordination program. Additionally, she provides oversight to the program’s $80million pharmacy program and directs the development and maintenance of the state’s preferred drug list. Dr.Lotz has been responsible for the development, procurement and contracting of the State’s Medicaid PharmacyBenefits Management program, Outpatient Diagnostic Imaging Prior Authorization initiative and IndependentReview Organization program. She provided clinical leadership to the State’s selective contracting initiative in thedevelopment of preferred network of Medicaid providers. She has become the Medicaid program’s resource for“pay-for-performance” and quality measurement. Dr. Lotz is the State of New Hampshire’s lead contact for threeAHRQ initiatives on Quality Based Purchasing, Medicaid Care Management and the Medicaid Medical DirectorNetwork. As a part of the Quality Based Purchasing initiative, Dr. Lotz is developing a Medicaid Report Card anda provider incentive program. As well, she is the State’s contact for a CHCS Medicaid Value Program on DiabetesEducation. Dr. Lotz remains actively engaged Medicaid quality improvement and in maintaining balancebetween clinical and business priorities.

Doris Lotz, MD completed her medical degree at Ohio State University in 1986, her Emergency Medicineinternship and residency at Harbor-UCLA Medical Center in Torrance, California in 1989 and a Masters inPublic Health from Johns Hopkins Bloomberg School of Public Health in 2005. She has worked clinically in bothprivate practice and managed care settings in both southern and northern California and Atlanta, Georgia whileremaining active in quality related issues. In 1998, Dr. Lotz became the Associate Medical Director for a largemanaged care company in New Hampshire where she was primarily responsible for inpatient utilizationmanagement, case management, predictive modeling, local disease management and quality issues. Dr. Lotz wassubsequently promoted to the regional position of New England Quality Medical Director for CIGNA HealthCare with oversight of clinical programs, including regional disease management, operations and accreditationfor a 5 state New England region.


George Lundberg, MDEditor in Chief of MedGenMed, Editor in Chief of Medscape Core, and Editor in Chief of eMedicine

A 1995 “pioneer” of the medical internet, Dr. Lundberg was born in Florida, grew up in rural southernAlabama and holds earned and honorary degrees from North Park College, Baylor University, the University ofAlabama (Birmingham and Tuscaloosa), the State University of New York, Syracuse, Thomas Jefferson Universityand the Medical College of Ohio. He completed a clinical internship in Hawaii and a pathology residency in SanAntonio. He served in the US Army during the Vietnam War in San Francisco and El Paso, leaving as a lieutenantcolonel after 11 years. Dr. Lundberg was then Professor of Pathology and Associate Director of Laboratories atthe Los Angeles County/USC Medical Center for 10 years, and for five years was Professor and Chair of Pathologyat the University of California-Davis.

Dr. Lundberg has worked in tropical medicine in Central America and Forensic Medicine in New York,Sweden and England. His major professional interests are toxicology, violence, communication, physicianbehavior, strategic management and health system reform. He is past President of the American Society ofClinical Pathologists. From 1982 to 1999, Dr. Lundberg was at the American Medical Association as Editor inChief, Scientific Information and Multimedia with editorial responsibility for its 39 medical journals, AmericanMedical News, and various Internet products, and the Editor of JAMA.

In 1999 Dr. Lundberg became Editor in Chief of Medscape, the leading source of online health informationand education for physicians and health care professionals and the founding Editor in Chief of both MedscapeGeneral Medicine and CBS HealthWatch.com. In 2002, Dr. Lundberg became Special Healthcare Advisor to theChairman and CEO of WebMD. Today, he serves as the Editor in Chief of MedGenMed www.medgenmed.com,the original open access general medical journal, on Medline/PubMed since 2000, available exclusively on thewww.Medscape.com publishing platform. Dr Lundberg also serves as Editor in Chief of Medscape Core, and,beginning in 2006, Editor in Chief of eMedicine, the original open access comprehensive medical textbook. Afrequent lecturer, radio and television guest and host in the past, and current webcasting moderator, host andeditorialist, and a member of the Institute of Medicine of the National Academy of Sciences, Dr. Lundberg holdsacademic appointments as a professor at Stanford and Harvard. In 2000, the Industry Standard dubbed Dr.Lundberg “Online Health Care’s Medicine Man”.

Newell McElwee, PharmD, MSPHVice-President of Evidence-Based Strategies at Pfizer

Newell McElwee is Vice-President of Evidence-Based Strategies at Pfizer where he leads a group of scientistsfocused on Evidence-Based Medicine, Health Technology Assessment, the use of observational data for assessingclinical effectiveness, and the application of evidence to coverage decisions. He has worked in the pharmaceuticalindustry since 1992 following a career in academia. His educational background is in pharmacy (BS, Universityof Louisiana; PharmD, Mercer University) and epidemiology (MSPH, University of Utah). Newell also completeda clinical pharmacy residency and a research fellowship in clinical pharmacology and toxicology. His experiencehas spanned the evidence continuum, from identification and prioritization of research topics to generation ofevidence to answer specific research questions to application of evidence in practice. He believes that in order toimprove the effectiveness and efficiency of our health care system, there must be a shared responsibility amongall stakeholders and decision-makers. To that end, Newell’s breadth of experience allows him to understand theunique needs of public and private payers, clinicians, patients, researchers, policy decision-makers, anddevelopers of new technologies so that collectively they can address the challenges facing our health care system.


G. Gregory Raab, MA, PhDPresident, Raab & Associates, Inc.

Greg Raab is an independent consultant specializing in technology innovation, reimbursement requirements,and health policy. His clients include medical technology associations and groups, as well as medical technologycompanies.

Before beginning his consulting practice in 2000, Dr. Raab held senior government affairs and health policypositions at AdvaMed, the Advanced Medical Technology Association, for more than seven years, and atMedtronic, Inc. for close to ten years. From 1981 to 1983, Dr. Raab staffed Senator Max Baucus (D-MT) in hisrole as the Ranking Democratic Member of the Senate Finance Committee’s Health Subcommittee,concentrating on Medicare policies and hospital reimbursement reform. He also worked for several years atHCFA (now the Centers for Medicare and Medicaid Services) on a wide range of legislative and policy matters,as well as the U.S. Public Health Service. He earned his M.A. and PhD. from the University of Virginia.

Alan B. Rosenberg, MDVice President of Medical Policy, Technology Assessment and Credentialing Programs for WellPoint, Inc.

Alan B Rosenberg, MD is the Vice President of Medical Policy, Technology Assessment and CredentialingPrograms for WellPoint, Inc. Among his responsibilities, Dr. Rosenberg leads WellPoint’s program (across all ofits affiliated Brands) for medical policy, technology assessment, credentialing, and Clinical Health Policy training.He is also President of Anthem UM Services, Inc. and of Anthem Credentialing Services Inc. Prior to his currentposition, he has served as Chief Medical Officer for Rush Prudential Health Plans; Director in HealthcareBusiness Consulting for Arthur Andersen; and Vice President of Medical Affairs and Medical Director for AetnaUS Healthcare of the Midwest, Inc.

Dr. Rosenberg received his undergraduate training from Columbia University in New York and received hismedical degree from New York University Medical School. He completed his residency in Internal Medicine atthe University of Chicago, Michael Reese Hospital.

Dr. Rosenberg is a Fellow of the Institute of Medicine of Chicago, serves as a Board Member of AmericanAssociation of Preferred Provider Organizations (AAPPO), member of the Blue Cross Association TEC MedicalAdvisory Panel and Medical Policy Panel, several America’s Health Insurance Plan (AHIP) committees, and theAgency for Healthcare Research and Quality Effective Healthcare Program Stakeholder Group.


Eric M. Wall, MD, MPHSenior Medical Director of Qualis Health

Eric M. Wall, MD, MPH is recently appointed Senior Medical Director of Qualis Health, a private, nonprofithealth care quality improvement organization based in Seattle, WA. He is responsible for supervision of theMedical Services Department and implementing key strategic goals of the organization. Prior to his currentposition, Dr. Wall was the Regional Medical Director for LifeWise Health Plan of Oregon and Premera Blue Crossin Alaska for 8 years. Dr. Wall is a practicing family physician who taught at the Oregon Health & SciencesUniversity for 22 years with appointments in the Department of Family Medicine, Public Health and PreventiveMedicine, and the School of Nursing. He was Associate Professor and the first Director of Research in the OSHUFamily Medicine department between 1985 and 1995.

Dr. Wall received his MD degree from the Catholic University of Louvain in Belgium and completed his familymedicine residency at the University of Miami-Jackson Memorial Hospital. He completed his Masters in PublicHealth at the University of Washington. His research interests have been in the areas of clinical decision-making,development and implementation of clinical practice guidelines, and evidence-based maternity care.

Dr. Wall served as the Chair of the American Academy of Family Physician’s Commission on Science from2005-2007. He currently serves on the American Medical Association’s Performance Measures and EvaluationSubcommittee. He has participated on numerous guideline development panels and most recently worked on theAmerican Pain Society/American College of Physicians Low Back Pain Guideline Advisory Panel.

Anthony C. Wisniewski, Esq.Executive Director for Health Care at the U.S. Chamber of Commerce

Anthony C. Wisniewski is executive director for health care at the U.S. Chamber of Commerce, where he isprimarily responsible for developing Chamber policy on health and life sciences and advocating those policiesbefore Congress and the federal agencies.

He joined the Chamber in September 2006 from biotechnology company MedImmune, Inc., where he servedas head of public policy and policy counsel, overseeing the development and implementation of policy strategiesfor federal, state, and international government affairs matters.

Prior to MedImmune, Wisniewski served as senior director of state policy for the Pharmaceutical Researchand Manufacturers of America (PhRMA), managing state policy operations for several regions across the UnitedStates. Before that, Wisniewski was in private legal practice, most recently with Tydings & Rosenberg LLP inBaltimore, Maryland. His practice focused on commercial business transactions as well as government affairs onlocal, state, and federal levels.

Wisniewski is admitted to the bars of both Maryland and the District of Columbia. He received his JurisDoctorate from the University of Notre Dame and a Bachelor of Arts from the Catholic University of America,majoring in politics, with minors in philosophy and history.

Wisniewski was appointed by President George W. Bush to the Christopher Columbus Fellowship FoundationBoard of Trustees as well as by U.S. Secretary of Health and Human Services Michael O. Leavitt to the Agency forHealthcare Research and Quality (AHRQ) National Advisory Council. Currently, Wisniewski also serves theUniversity of Maryland Biotechnology Institute Board of Visitors, the Quality Alliance Steering Committee, andthe Hospital Quality Alliance. He is a former gubernatorial appointee to the board of the Maryland TechnologyDevelopment Corporation.


APPENDIX F: Center for Medical Technology Policy Staff Bios

Sean S. Tunis, MD, MScFounder and Director of Center for Medical Technology Policy; CHP/PCOR Adjunct Associate

Contact information:Center for Medical Technology Policy4712 Keswick RdBaltimore, MD 21210(410) [email protected]

Sean Tunis, MD, MSc. is the Founder and Director of the Center for Medical Technology Policy in SanFrancisco, where he is working with health care decision makers and stakeholders to support the rapid evaluationand effective use of new medical technologies. He is also a Principal at Rubix Health, which consults with early-stage life sciences companies on reimbursement strategy deigned around developing reliable evidence of productvalue.

Through September of 2005, Dr. Tunis was the Director of the Office of Clinical Standards and Quality andChief Medical Officer at the Centers for Medicare and Medicaid Services (CMS). In this role, he had leadresponsibility for clinical policy and quality for the Medicare and Medicaid programs, which provide healthcoverage to over 100 million US citizens. Dr. Tunis supervised the development of national coverage policies,quality standards for Medicare and Medicaid providers; quality measurement and public reporting initiatives,and the Quality Improvement Organization program. As Chief Medical Officer, Dr. Tunis served as the senioradvisor to the CMS Administrator on clinical and scientific policy. He also co-chaired the CMS Council onTechnology and Innovation

Dr. Tunis joined CMS in 2000 as the Director of the Coverage and Analysis Group. Before joining CMS, Dr.Tunis was a senior research scientist with the Lewin Group, where his focus was on the design andimplementation of prospective comparative effectiveness trials and clinical registries. Dr. Tunis also served as theDirector of the Health Program at the Congressional Office of Technology Assessment and as a health policyadvisor to the U.S. Senate Committee on Labor and Human Resources, where he participated in policydevelopment regarding pharmaceutical and device regulation.

He received a BS degree in History of Science from Cornell University, and a medical degree and masters inHealth Services Research from the Stanford University School of Medicine. Dr. Tunis did his residency trainingat UCLA and the University of Maryland in Emergency Medicine and Internal Medicine. He is board certified inInternal Medicine and holds adjunct faculty positions at Johns Hopkins and Stanford University School ofMedicine.


Wade Aubry, MDAssociate Director, Center for Medical Technology [email protected]

Wade M. Aubry, MD is a medical technology consultant, health policy researcher, and clinician based in SanFrancisco. He is Senior Advisor for the Health Technology Center (HealthTech), where his work involvesforecasting the impact of emerging technologies on the health care system. He is responsible for HealthTech’smethodology committee, health plan initiatives program, and federal liaison work, as well as for overseeing theproduction and updating of technology forecast reports. He is also Associate Director of the Center for MedicalTechnology Policy. Dr. Aubry has extensive experience with the Blue Cross Blue Shield system and Medicare,especially in technology assessment, coverage decisions, CPT coding, and quality initiatives. He is currently anadvisor to the Blue Shield of California Foundation’s California Technology Assessment Forum and to the BlueCross Blue Shield Association on CPT coding issues. He is Associate Clinical Professor of Medicine at the UCSFInstitute for Health Policy Studies and a practicing endocrinologist at Saint Francis Hospital in San Francisco,where he chairs the hospital’s Institutional Review Board. Previously, he was Vice President of the Lewin Group,a health care consulting firm, Senior Vice President and Chief Medical Officer for Blue Shield of California,Medicare Part B Medical Director for Northern California, and National Medical Consultant for the BCBSA,where he chaired its Technology Evaluation Center’s national Medical Advisory Panel for 6 years.

Dr. Aubry received his BS degree Phi Beta Kappa from Stanford University, his MD degree from the UCLASchool of Medicine, and his postgraduate training at Cedars-Sinai Medical Center in Los Angeles. He has servedas a member of the AMA’s committee overseeing the revision of the CPT procedure coding system, NIHcommittees related to clinical trials and managed care, the IOM Committee on Technologies for the EarlyDetection of Breast Cancer (reported 2001), and the IOM Committee on Establishing a National Cord BloodStem Cell Program (reported 2005). Currently, he is a member of the CMS Medicare Coverage AdvisoryCommittee, the American College of Radiology Imaging Network (ACRIN) Advisory Panel, and the NationalCommittee for Quality Assurance (NCQA) Geriatrics Measurement Advisory Panel, where he recently helpeddevelop a new national performance measure for physical activity in Medicare health plans. His research interestsare in medical technology assessment and coverage decision making. Currently, he is a member of the UCSFEffectiveness Center for the California Health Benefits Review Program (CHBRP), which produces evidencereports on proposed health insurance mandates in California. He has lectured internationally and publishednumerous articles on medical technology and managed care topics. He is co-author of a comprehensive casestudy on bone marrow transplants for breast cancer which will be published in 2006 by Oxford University Pressentitled False Hope vs. Evidence-Based Medicine: Bone Marrow Transplantation for Breast Cancer.


Linda Bergthold, PhDLinda Bergthold is a senior advisor to the Center on Medical Technology Policy. Linda has more than 20 years

of experience in health care consulting and research to public and private purchasers and providers.Prior to establishing her own consulting and research practice, she was a senior consultant and national

thought leader for the health care practice in the Los Angeles office of Watson Wyatt Worldwide, focusing onevidence-based benefit design for large employers.

She has also been a vice president and head of the California office of The Lewin Group, a national healthpolicy consulting firm. At Lewin, she focused on strategic planning, benefit design and technology assessment,and a principal with the William M. Mercer human resources consulting firm as the leader of their WesternRegion managed care practice and national coordinator for health reform. She has been an Adjunct Professor atthe Center for Health Policy at Stanford University doing research on medical necessity and coverage issues inmanaged care.

Linda worked on the benefit package for the Health Security Act as co-chair of the Benefits Working Groupfor the White House Health Care Reform Task Force in 1993. She currently serves as a consumer representativeon the Medicare Evidence Development and Coverage Advisory Committee in Washington, D.C. She is a boardmember of the California Technology Assessment Forum and the National Partnership for Women and Familiesand has represented Watson Wyatt on the Integrated Healthcare Association board and the National BusinessGroup on Health’s Evidence-based Benefit Design Committee in Washington D.C.

Linda holds a BA from the University of California at Los Angeles, and an MA and PhD in Sociology fromthe University of California. She was a Pew Health Policy Doctoral Fellow at the Institute for Health Policy, UCSF.She is a widely published author on benefit design, medical necessity and purchasing strategies, including“Medical Necessity: Do We Need It?” in Health Affairs 1995. Her book, Purchasing Power in Health waspublished by Rutgers Press in 1990.

Molly J. Coye, MD, MPHFounder and CEO, HealthTech

Dr. Molly J. Coye is founder and CEO of the Health Technology Center (HealthTech), a non-profit educationand research organization established in 2000 to advance the use of beneficial technologies in promotinghealthier people and communities.

Today HealthTech provides objective technology forecasts, innovative decision-making tools, and expertlearning networks for 45 Partner organizations. Partners include nearly 25 percent of the nation’s hospitals, aswell as the country’s leading health plans and the Centers for Medicare and Medicaid, which together cover morethan half of all insured Americans.

Dr. Coye has extensive experience in both the public and private sectors. She served as Commissioner ofHealth for the State of New Jersey and Director of the California Department of Health Services, in addition toheading the Division of Public Health at the Johns Hopkins School of Hygiene and Public Health, leadingmarketing and product development for interactive health communication and disease management atHealthDesk Corp, serving as Executive Vice President for the Good Samaritan Health System, and directing TheLewin Group’s West Coast office.

As a member of the Institute of Medicine, Dr. Coye co-authored the reports To Err is Human and Crossingthe Quality Chasm, chaired the Committee on Access to Insurance for Children, and co-chaired the Committeeon Patient Safety Data Standards.

Dr. Coye is on the Board of Trustees of the American Hospital Association and the Program for AppropriateTechnology in Health (PATH), one of the largest and most creative nonprofit organizations working in


international health. She was a founding board member of The California Endowment, the largest private healthcare philanthropy in California.

Dr. Coye has her MD and MPH degrees from Johns Hopkins University and is board certified by theAmerican College of Preventive Medicine. In 2005, she was selected one of the 100 most influential leaders inhealth care - and the 25 most influential women in health care - by Modern Healthcare magazine.

Steven Pearson, MD, MSc, FRCPSteven D. Pearson, MD, MSc, FRCP is a general internist and Associate Professor of Ambulatory Care and

Prevention at Harvard Medical School. Dr. Pearson received his BA from Stanford University and his MD fromthe University of California at San Francisco. He was a medical intern and resident at Brigham and Women’sHospital in Boston, following which he completed a fellowship in health services research and received a Mastersof Science in Health Policy and Management from the Harvard School of Public Health.

Dr. Pearson’s work examines the scientific and ethical foundations of evidence-based policy making in healthcare. His published work includes the book No Margin, No Mission: Health Care Organizations and the Questfor Ethical Excellence, published in 2003 by Oxford University Press. Dr. Pearson serves on the managementcommittee of the International Society for Priority Setting in Health Care, and in 2004 he was awarded anAtlantic Fellowship to pursue policy studies at the National Institute for Clinical Excellence in London, England.He returned to the US to serve from 2005-2006 as Special Advisor, Technology and Coverage Policy, at theCenters for Medicare and Medicaid Services.

In June, 2006 he was named Senior Fellow at America’s Health Insurance Plans (AHIP) to perform researchand policy analysis on issues related to evidence-based medicine. In 2006, Dr. Pearson also received grantfunding to support the Institute for Clinical and Economic Review (ICER). ICER is a new initiative, created tointegrate appraisals of the clinical effectiveness and cost-effectiveness of medical innovations, with the goal ofproviding new information to decision makers’ intent on improving the value of health care services.

Gail Wilensky, PhDGail Wilensky, an economist, and a Senior Fellow at Project HOPE (an international health education

foundation) analyzes and develops policies relating to health care reform and to ongoing changes in the healthcare environment.

Dr. Wilensky is a Commissioner on the President’s Commission on Care for America’s Returning WoundedWarriors, the WHO’s Commission on the Social Determinants of Health, is co-chair of the Department ofDefense task force on the Future of Military Health Care, is Vice Chair of the Maryland Health Care Commissionand serves as a trustee of the Combined Benefits Fund of the United Mineworkers of America and the NationalOpinion Research Center. She is an elected member of the Institute of Medicine and has served two terms on itsgoverning council. She is a former chair of the board of directors of Academy Health, a former trustee of theAmerican Heart Association and a current or former director on numerous other organizations. She is also adirector on several corporate boards.

From 1990 - 1992, she was Administrator of the Health Care Financing Administration, directing theMedicare and Medicaid programs. She also served as Deputy Assistant to President (GHW) Bush for PolicyDevelopment, advising him on health and welfare issues from 1992 to 1993.


From 1997 to 2001, she chaired the Medicare Payment Advisory Commission, which advises Congress onpayment and other issues relating to Medicare, and from 1995 to 1997, she chaired the Physician Payment ReviewCommission. From 2001 to 2003, she co-chaired the President's Task Force to Improve Health Care Delivery forOur Nation's Veterans, which covered health care for both veterans and military retirees.

Dr. Wilensky testifies frequently before Congressional committees, acts as an advisor to members of Congressand other elected officials, and speaks nationally and internationally before professional, business and consumergroups. She received a bachelor's degree in psychology and a PhD in economics at the University of Michigan

Rita Redberg, FACC, MD, MScDirector, Women's Cardiovascular Services

Contact information: UCSF Medical CenterDivision of Cardiology 505 Parnassus Avenue San Francisco, CA 94143-0124Telephone/Fax/Email:Phone: (415) 476-6874Fax: (415) 502-8627 Email: [email protected]

Dr. Rita Redberg is a cardiologist specializing in heart disease in women. She earned her medical degree fromthe University of Pennsylvania School of Medicine, in Philadelphia. She completed her residency at Columbia-Presbyterian Medical Center in New York, where she went on to complete a fellowship in cardiology. Then shecompleted a fellowship in non-invasive cardiology at Mount Sinai Medical Center, also in New York. In addition,Redberg has a masters of science in health policy and administration from the London School of Economics inEngland. Also she is currently a Robert Wood Johnson health policy fellow.

Redberg has written, edited and contributed to many books, including You Can Be a Woman Cardiologist,Heart Healthy: The Step-by-Step Guide to Preventing and Healing Heart Disease and Coronary Disease inWomen: Evidence-Based Diagnosis and Treatment.