Managed Care Systems and Emerging Infections

Challenges and Opportunities for Strengthening Surveillance, Research, and Prevention Workshop Summary

Jonathan R. Davis, Editor

Based on a Workshop of the Forum on Emerging Infections

Division of Health Sciences Policy

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
Washington, D.C.



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Managed Care Systems and Emerging Infections: Challenges and Opportunities for Strengthening Surveillance, Research, and Prevention, Workshop Summary Managed Care Systems and Emerging Infections Challenges and Opportunities for Strengthening Surveillance, Research, and Prevention Workshop Summary Jonathan R. Davis, Editor Based on a Workshop of the Forum on Emerging Infections Division of Health Sciences Policy INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C.

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Managed Care Systems and Emerging Infections: Challenges and Opportunities for Strengthening Surveillance, Research, and Prevention, Workshop Summary NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, DC 20418 NOTICE: The project that is the subject of this workshop summary was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. Support for this project was provided by the U.S. Department of Health and Human Services’ National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration; U.S. Department of State, Bureau of Oceans and International Environmental and Scientific Affairs; U.S. Department of Veterans Affairs; Abbott Laboratories; American Society for Microbiology; Applied Microbiology, Inc.; Bristol-Myers Squibb Company; Burroughs Wellcome Fund; Eli Lilly & Company; Glaxo Wellcome; Hoffmann-La Roche; Merck; Pfizer; SmithKline Beecham; and Wyeth-Ayerst Laboratories. The views presented are those of the editor and speakers and are not necessarily those of the funding organizations. This report is based on the proceedings of a workshop that was sponsored by the Forum on Emerging Infections. It is prepared in the form of a workshop summary by and in the name of the editor with the assistance of staff and consultants, as an individually authored document. Sections of the workshop summary not specifically attributed to an individual reflect the views of the editor and not those of the Forum on Emerging Infections. The content of those sections is based on the presentations and the discussions that took place during the workshop. International Standard Book Number 0-309-06828-2 Library of Congress Card Number 99-069869 Additional copies of this workshop summary are available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055. Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit the NAP’s on-line bookstore at www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu. The full text of this Workshop Summary is available on line at www.nap.edu/readingroom. Copyright 2000 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. COVER: The background for the cover of this workshop summary is a photograph of a batik designed and printed specifically for the Malaysian Society of Parasitology and Tropical Medicine. The print contains drawings of various parasites and insects; it is used with the kind permission of the Society.

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Managed Care Systems and Emerging Infections: Challenges and Opportunities for Strengthening Surveillance, Research, and Prevention, Workshop Summary THE NATIONAL ACADEMIES National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council The National Academy of Sciences is a private, non-profit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. William A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy's purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

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Managed Care Systems and Emerging Infections: Challenges and Opportunities for Strengthening Surveillance, Research, and Prevention, Workshop Summary FORUM ON EMERGING INFECTIONS JOSHUA LEDERBERG (Chair), Sackler Foundation Scholar, The Rockefeller University VINCENT I. AHONKHAI, Vice President and Director, Anti-Infectives and Biologicals, SmithKline Beecham Corporation, Collegeville, Pennsylvania STEVEN J. BRICKNER, Manager of Medicinal Chemistry, Central Research Division, Pfizer, Inc., Groton, Connecticut NANCY CARTER-FOSTER, Director, Program for Emerging Infections and HIV/AIDS, U.S. Department of State, Washington, D.C. GAIL H. CASSELL, Vice President for Infectious Diseases Research, Drug Discovery Research, and Clinical Investigation, Eli Lilly & Company, Indianapolis, Indiana GORDON H. DEFRIESE, Director and Professor of Social Medicine, Epidemiology, Health Policy, and Administration, Sheps Center for Health Services Research, University of North Carolina at Chapel Hill RENU GUPTA, Vice President, Medical Safety and Therapeutics, Covance, Princeton, New Jersey MARGARET A. HAMBURG, Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services, Washington, D.C. DIETER HINZEN, Professor and Head of Preclinical Research, Hoffmann-La Roche, A.G., Basel, Switzerland* JAMES M. HUGHES, Assistant Surgeon General and Director, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia J. STANLEY HULL, Vice President, Global Commercial Development, Glaxo Wellcome, Research Triangle Park, North Carolina SAMUEL L. KATZ, Chairman of the Board, Burroughs Wellcome Fund, and Wilburt C. Davison Professor, Department of Pediatrics, Duke University Medical Center, Durham, North Carolina KENNETH W. KIZER, Under Secretary for Health, Veterans Administration, U.S. Department of Veterans Affairs, Washington, D.C.** WILLIAM KOHLBRENNER, Director, Antiviral Research, Abbott Laboratories, Abbott Park, Illinois JOHN R. LaMONTAGNE, Deputy Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland CARLOS LOPEZ, Executive Director, Infectious Disease Research, Eli Lilly Research Laboratories, Indianapolis, Indiana STEPHEN S. MORSE, Program Manager, Defense Advanced Research Projects Agency/Defense Sciences Office, Washington, D.C. *   At the time of the workshop. **   At the time of printing, President and Chief Executive Officer, National Quality Forum, Washington, D.C.4

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Managed Care Systems and Emerging Infections: Challenges and Opportunities for Strengthening Surveillance, Research, and Prevention, Workshop Summary SOLOMON MOWSHOWITZ, Vice President, Research and Development, Applied Microbiology, Inc., Tarrytown, New York* STUART L. NIGHTINGALE, Associate Commissioner for Health Affairs, U.S. Food and Drug Administration, U.S. Department of Health and Human Services, Rockville, Maryland MICHAEL T. OSTERHOLM, State Epidemiologist and Chief, Acute Disease Epidemiology Section, Minnesota Department of Health, Minneapolis, Minnesota** DAVID M. SHLAES, Vice President, Infectious Disease Research, Wyeth-Ayerst Research, Pearl River, New York JOHN D. SIEGFRIED, Associate Vice President for Medical, Regulatory and Scientific Affairs, Pharmaceutical Research and Manufacturers of America, Washington, D.C. P. FREDERICK SPARLING, Chair of Medicine, University of North Carolina at Chapel Hill Liaisons to the Forum BARRY R. BLOOM, Investigator, Howard Hughes Medical Institute, and Albert Einstein College of Medicine, Yeshiva University, Hastings-on-Hudson, New York ENRIQUETA C. BOND, President, Burroughs Wellcome Fund, Morrisville, North Carolina GARY CHRISTOPHERSON, Principal Deputy Assistant Secretary, Health Affairs, U.S. Department of Defense, Washington, D.C. STEPHANIE JAMES, Parasitology and International Programs Brunch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland C. MICHELLE LIMOLI, Special Assistant to the Director, Office of International Affairs, Food and Drug Administration, Rockville, Maryland (member through February 1999) STEPHEN M. OSTROFF, Acting Deputy Director, and Associate Director for Epidemiologic Science, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia GARY ROSELLE, Program Director for Infectious Disease, Veterans Health Administration, U.S. Department of Veterans Affairs, Cincinnati, Ohio FRED TENOVER, Chief, Nosocomial Pathogens Laboratory Branch, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia *   At the time of printing, President, Diligen, New York. **   At the time of printing, Chairman and Chief Executive Officer, Infectious Control Advisory Network, Eden Prairie, Minnesota.

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Managed Care Systems and Emerging Infections: Challenges and Opportunities for Strengthening Surveillance, Research, and Prevention, Workshop Summary Forum Staff JONATHAN R. DAVIS, Senior Program Officer (from February 1998) POLLY F. HARRISON, Senior Program Officer (until January 1998) VIVIAN P. NOLAN, Research Associate (from August 1998) GRETCHEN G. KIDDER, Research Assistant (until February 1998) CHRISTINA THACKER, Research/Project Assistant (until July 1998) NICOLE AMADO, Project Assistant (until August 1999) Division Staff ANDREW M. POPE, Division Director SARAH PITLUCK, Research Assistant (from August 1999) ALDEN CHANG, Project Assistant (from August 1999) THELMA COX, Project Assistant (from September 1999) JAMAINE TINKER, Financial Associate (until October 1998) CARLOS GABRIEL, Financial Associate (from February 1999) LINDA DEPUGH, Administrative Assistant (until August 1999) HALLIE WILFERT, Administrative Assistant (from September 1999) Consultant KATHI HANNA Copy Editor MICHAEL HAYES

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Managed Care Systems and Emerging Infections: Challenges and Opportunities for Strengthening Surveillance, Research, and Prevention, Workshop Summary REVIEWERS All presenters at the workshop have reviewed and approved their respective sections of this workshop summary for accuracy, and Forum on Emerging Infections members who were present at the workshop have reviewed the document to ensure that it accurately reflects the workshop discussions. In addition, this workshop summary has been reviewed in draft form by independent reviewers chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the Institute of Medicine (IOM) in making the published document as sound as possible and to ensure that the document meets institutional standards. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. Although the independent reviewers have provided many constructive comments and suggestions, responsibility for the final content of this document rests solely with the Forum and IOM. The Forum and IOM thank the following individuals for their participation in the review process: Daniel L. Azarnoff, D.L. Azarnoff Associates; William Baine, Center for Outcomes and Effectiveness Research; Richard Dixon, The Lewin Group; Laura Efros, Office of Science and Technology Policy; Adel A.F. Mahmoud, Merck & Co., Inc.; and Theodore E. Woodward, University of Maryland School of Medicine.

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Managed Care Systems and Emerging Infections: Challenges and Opportunities for Strengthening Surveillance, Research, and Prevention, Workshop Summary Preface The Forum on Emerging Infections was created in 1996 in response to a request from the Centers for Disease Control and Prevention and the National Institute of Allergy and Infectious Diseases. Its goal is to provide structured opportunities for representatives from academia, industry, professional and interest groups, and government * to examine and discuss scientific and policy issues of shared interest that are specifically related to research and prevention, detection, and management of emerging infectious diseases. In accomplishing this task, the Forum provides the opportunity to foster the exchange of information and ideas, identify areas in need of greater attention, clarify policy issues by enhancing knowledge and identifying points of agreement, and inform decision makers about science and policy issues. Although the Forum seeks to illuminate issues rather than resolve them directly, it does not provide advice or recommendations on any policy pending before any agency or organization. Its strengths are the diversity of its membership and the commitment of individual members expressed throughout the activities of the Forum. A critical part of the work of the Forum is a series of workshops. The first of these, held in February 1997, addressed the theme of public-and private-sector collaboration (IOM, 1997b). The second workshop took place in July 1997 and explored aspects of antimicrobial resistance (IOM, 1998). The third workshop, on which this document reports, was held in March 1998 and examined the implications of managed care systems and the ability of those systems to address emerging infectious diseases in the age of managed care. Subsequent workshops *    Representatives of federal agencies serve in an ex officio capacity. An ex officio member of a group is one who is a member automatically by virtue of holding a particular office or membership in another body.

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Managed Care Systems and Emerging Infections: Challenges and Opportunities for Strengthening Surveillance, Research, and Prevention, Workshop Summary have addressed the core capacity of the public and private health sectors in emerging infectious disease surveillance and response (November 1998 workshop) and the international aspects of emerging infections (October 1999). Workshop summaries based on those workshops are in production. The restructuring of health care systems will have a major impact on the public health enterprise, including the prevention, monitoring, and treatment of infectious diseases. It is unrealistic to consider that managed care by itself will subsume all of the traditional public health functions, such as observation of compliance treatment regime for patients with tuberculosis or partner notification and contact investigation for patients with sexually transmitted diseases or for other disease outbreaks. Managed care needs to be integrated with a strong, functional public health system, and that integration requires partnership and appropriate incentives. For these reasons, the Forum convened a workshop to assess the opportunities and challenges confronting infectious disease surveillance, research, and prevention posed by changes in the health care environment. After a highly successful workshop characterized by discussion that was as rich and wide-ranging as would be expected of a diverse and knowledgeable assembly, a summation of the presentations and discussions were integrated into this workshop summary. The workshop summary is organized as topic-by-topic descriptions of the presentations and discussions that occurred during the workshop. Its purpose is to present lessons from relevant experience, delineate a range of pivotal issues and their respective problems, and describe some potential responses described by the workshop participants. All information reported in the text emerged from the presentations made at the workshop and the subsequent, relevant discussions. Thus, the workshop summary is not a comprehensive or exhaustive exploration of the issues involved, nor does it represent a consensus of views or opinions. Rather, it summarizes a dialogue among representatives from different sectors and their thoughts on which research may merit further attention. The names of the presenters are identified at the beginning of each section. The summary descriptive material provides context and overview of the identified presentations and was prepared by the editor. The Forum and the Institute of Medicine express their warmest appreciation to the individuals and organizations that gave valuable time to provide information and advice to the Forum through participation in the workshop. Each of the following contributed greatly: William Baine, Agency for Health Care Policy and Research; René Bowser, Georgetown University Law Center; John Burke, School of Medicine, University of Utah; Laurie Burke, U.S. Food and Drug Administration; Douglas Cocks, Eli Lilly & Company; Thomas Davies, GTE Corporation; Frank DeStefano, Centers for Disease Control and Prevention (CDC); Richard Dixon, National Independent Practice Association Coalition; Margaret Hamburg, U.S. Department of Health and Human Services; Susan Horn, Institute for Clinical Outcomes Research, Research for International Severity Information Systems, University of Utah School of Medicine; Denise Koo, CDC; David Korn, Biomedical and Health Sciences Research, Association of American Medical Colleges; Nora Morris, Healthcare Education and Research Foundation, Inc.; Richard Platt,

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Managed Care Systems and Emerging Infections: Challenges and Opportunities for Strengthening Surveillance, Research, and Prevention, Workshop Summary Harvard Pilgrim Health Care; Robert Rubin, The Lewin Group; Jerome Schentag, Millard Fillmore Health System; Anne Schuchat, CDC; Benjamin Schwartz, CDC; Lana Skirboll, Office of Science Policy, National Institutes of Health (NIH); Walter Stamm, Division of Allergy and Infectious Diseases, University of Washington School of Medicine; and Karl Western, NIH. The Forum is indebted to the IOM staff who contributed during the course of the workshop and the production of this workshop summary. On behalf of the Forum, I gratefully acknowledge the efforts led by Jonathan Davis, study director for the Forum and editor of this report, for his thoughtful and insightful approach and skill in the translating the workshop proceedings and discussion into this workshop summary. I would also like to thank the following IOM staff for their valuable contributions to this activity: Christina Thacker and Gretchen Kidder assisted with the workshop planning and logistics; Nicole Amado developed the Glossary and Acronyms list; Vivian Nolan drafted and revised various sections of the workshop summary and provided detailed support to facilitate its development; Robert Levy, a medical summer intern, drafted the appendix on the Veterans Affairs health care system; and Sarah Pitluck, Alden Chang, Thelma Cox, and Hallie Wilfert provided expert support at various developmental stages of the workshop summary. I want to especially thank Polly Harrison, who directed the Forum from its inception through two workshops, and who also dedicated much effort and time to developing this workshop's agenda. Other professional staff also provided invaluable help. Consultant and technical writer Kathi Hanna contributed significantly to the revision of the manuscript during the report review process. Paul Phelps, an independent writer, incorporated into the first draft the many pieces of written material presented during the workshop. The extensive commentary and suggestions made by the copy editor, Michael Hayes, are gratefully acknowledged. The Forum and myself also greatly appreciate the time and expertise contributed by Kenneth W. Kizer, Gary Roselle, and Larry J. Strausbaugh, all from the Veterans Health Administration, U.S. Department of Veterans Affairs, for their consultation and review of the Appendix on the Veterans Affairs health care system. Finally, the Forum and the IOM also wish to thank its sponsors, which supported this activity. Financial support for this project was provided by the U.S. Department of Health and Human Services, National Institutes of Health, Centers for Disease Control and Prevention, and U.S. Food and Drug Administration; U.S. Department of State, Bureau of Oceans and International Environmental and Scientific Affairs; U.S. Department of Veterans Affairs; Abbott Laboratories; American Society for Microbiology; Applied Microbiology, Inc.; Bristol-Myers Squibb Company; Burroughs Wellcome Fund; Eli Lilly & Company; Glaxo Wellcome; Hoffmann-La Roche; Merck; Pfizer; SmithKline Beecham; and Wyeth-Ayerst Laboratories. Joshua Lederberg Chair

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Managed Care Systems and Emerging Infections: Challenges and Opportunities for Strengthening Surveillance, Research, and Prevention, Workshop Summary Contents     SUMMARY   1 1   INTRODUCTION   6     Background   6     About the Workshop and Organization of the Workshop Summary   11 2   CONDUCTING BASIC AND CLINICAL RESEARCH IN THE MANAGED CARE SETTING   13     Perspective of Association of American Medical Colleges on Basic and Clinical Research   13     Opportunities for Population-Based Clinical Research Using Data from Managed Care Organizations   16     Conducting Clinical Research Within Managed Care Organizations   18     NIH Activities Related to Clinical Research and Managed Care   20     Summary of Challenges and Opportunities   21 3   CLINICAL PRACTICE GUIDELINES   25     Clinical Practice Guidelines for Emerging Infections and Managed Care   25     Realities of Implementing Guidelines   27     Making Guidelines Instrumental: Theory versus Practice   28     Summary of Challenges and Opportunities   30 4   SURVEILLANCE AND MONITORING   33     An Employer's Perspective   34     Managed Care and Infectious Disease Surveillance: Opportunities for Collaboration   35

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Managed Care Systems and Emerging Infections: Challenges and Opportunities for Strengthening Surveillance, Research, and Prevention, Workshop Summary     Collaborative Surveillance Efforts and Monitoring of Data   37     Latter Day Saints Hospital's System   40     Laboratory-Based Reporting and Managing Encounter-Level Data   41     Laboratory-Based Reporting Issues   44     Legal Concerns   45     Summary of Challenges and Opportunities   46 5   EDUCATION AND OUTREACH   52     Coordinating Health Plan Research and Educational Efforts   52     Impacts of Managed Care System's Educational Efforts on Control of Antibiotic Use   53     Education and Outreach Perspectives of the National Institute of Allergy and Infectious Diseases   56     Managed Care Systems and Emerging Infections: Education and Outreach   57     Summary of Challenges and Opportunities   58 6   DRUG FORMULARIES   62     Regulatory Issues   62     Relationship Between Managed Care Formularies and Treatment Outcomes   63     Bacterial Resistance, the Antibiotic Formulary, and Other Management Strategies   65     Economics of Restrictions on Pharmaceuticals   70     Summary of Challenges and Opportunities   72 7   CONCLUDING REMARKS   76     REFERENCES   79     APPENDIXES     A   Veterans Health Administration and Infectious Disease   83 B   Glossary and Acronyms   89 C   Workshop Agenda   97 D   Forum Member and Staff Biographies   103