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Table of contents :
Preliminary Considerations Regarding Federal Investments in Vaccine Purchase and Immunization Services
Copyright
INDEPENDENT REPORT REVIEWERS
Contents
Preliminary Considerations Regarding Federal Investments in Vaccine Purchase and Immunization Servic ...
SUMMARY
INTRODUCTION
THE CARRYOVER ISSUE IN SECTION 317 EXPENDITURES
THE IMPACT OF THE STATE CHILDREN'S HEALTH INSURANCE PROGRAM
NEXT STEPS
REFERENCES
NOTES
APPENDICES
COMMITTEE BIOGRAPHIES

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Preliminary Considerations Regarding Federal Investments in Vaccine Purchase and Immunization Services Interim Report on Immunization Finance Policies and Practices

Committee on Immunization Finance Policies and Practices Division of Health Care Services INSTITUTE OF MEDICINE

Washington, D.C. May 1999

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National Academy Press 2101 Constitution Avenue, N.W.Washington, D.C. 20418 NOTICE: The project that is the subject of this report 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. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. The Institute of Medicine was chartered in 1970 by the National Academy Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. Support for this project was provided by the Centers for Disease Control and Prevention. (Award Number 200199900023). The views presented are those of the Institute of Medicine's Committee on Immunization Finance Policies and Practices and are not necessarily those of the funding organization. Additional copies of this report are available in limited quantities from the Division of Health Care Services, Institute of Medicine, 2101 Constitution Avenue, NW, Washington, DC 20418. The full text of the report is also available on-line at: www.nap.edu For more information about the Institute of Medicine, visit the IOM home page at www.national-academies.org/iom. Copyright 1999 by the National Academy of Sciences . All rights reserved. Printed in the United States of America

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COMMITTEE ON IMMUNIZATION FINANCE POLICIES AND PRACTICES BERNARD GUYER, MD(Chair), Professor and Chair, Department of Population and Family Health Services, Johns Hopkins School of Hygiene and Public Health DAVID SMITH, MD (Vice Chair), President, Texas Tech University Health Sciences Center, Lubbock, TX E. RUSSELL ALEXANDER, MD, Professor Emeritus, Department of Epidemiology, University of Washington GORDON BERLIN, MA, Senior Vice President, Manpower Demonstration Research Corporation, New York, NY STEVE BLACK, MD, Co-Director, Vaccine Study Center, Kaiser Permanente, Oakland, CA SHEILA BURKE,MPA, RN, Executive Dean, John F. Kennedy School of Government, Harvard University JANET CURRIE, PhD, Professor, Department of Economics, University of California, Los Angeles BARBARA DeBUONO, MD, MPH, Chief Executive Officer, New York Presbyterian Healthcare Network, New York, NY GORDON DeFRIESE, PhD., Professor of Social Medicine, Epidemiology, Health Policy, and Administration, University of North Carolina WALTER FAGGETT, MD, Pediatric Consultant, Medlink Hospital, Washington, DC SAMUEL L. KATZ, MD, Wilburt C. Davison Professor Emeritus, Department of Pediatrics, Duke University Medical Center SARA ROSENBAUM, JD, Director, Center for Health Policy Research, School of Public Health and Health Services, George Washington University CATHY SCHOEN, MA, Vice President, Research and Evaluation, The Commonwealth Fund, New York, NY JANE SISK, PhD., Division of Health Policy and Management, Joseph L. Mailman School, Columbia University Institute of Medicine Staff ROSEMARY CHALK, Study Director JANE DURCH, Senior Project Officer HEATHER SCHOFIELD, Project Assistant

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INDEPENDENT REPORT REVIEWERS

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INDEPENDENT REPORT REVIEWERS

This report has been reviewed by individuals 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 authors and the Institute of Medicine in making the published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The content of the review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their participation in the review of this report: Barbara J. McNeil, MD, PhD, Department of Health and Care Policy, Harvard Medical School; Velvet Miller, PhD, Children's Futures, Princeton, NJ; Fitzhugh Mullen, MD, Contributing Editor, Health Affairs, Bethesda, MD; Neal Vanselow, MD, Rio Verde, AZ; and Virginia Weldon, MD, Center for the Study of American Business, Washington University, St. Louis, MO. The individuals listed above have provided many constructive comments and suggestions, but responsibility for the final content of this report rests solely with the authoring committee and the Institute of Medicine.

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CONTENTS

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Contents

SUMMARY

1

INTRODUCTION

2

THE CARRYOVER ISSUE IN SECTION 317 EXPENDITURES

5

THE IMPACT OF THE STATE CHILDREN'S HEALTH INSURANCE PROGRAM

7

NEXT STEPS

9

REFERENCES

11

NOTES

12

APPENDIXES

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Table 1

Annual Awards and Expenditures of Section 317 Direct Assistance (DA Vaccine Purchase Funds (in millions)

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Table 2

Annual Awards and Expenditures of Section 317 Financial Assistance (FA) Immunization Program Funds (in millions) Amount of New Funding Awarded as Section 317 Direct Assistance (DA) and Financial Assistance (FA), 1990–1999 Amount of Total Annual Awards of Section 317 Funds, Direct Assistance (DA) and Financial Assistance (FA), 1990–1999 Section 317 Grant Allocations from CDC to State and Local Immunization Programs, 1988– 1999 COMMITTEE BIOGRAPHIES

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Figure 1 Figure 2 Figure 3

17 17 18 19

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SUMMARY

1

Preliminary Considerations Regarding Federal Investments in Vaccine Purchase and Immunization Services: Interim Report on Immunization Finance Policies and Practices

SUMMARY

Immunization provides valuable individual protection and an essential community benefit by preventing serious disease. Even high levels of primary care, however, do not guarantee that individuals are immunized. Building and sustaining an effective delivery system that can uniformly and consistently achieve high levels of immunization coverage (> 90 percent) for increasing numbers of vaccines presents both clinical challenges as well as complex management tasks. Finance strategies to address this challenge must constantly adapt to new scientific developments; changes in social, health, and economic conditions (including population migrations); and shifting roles in the balance of federal, state, and local responsibilities in the administration of health care systems. The Institute of Medicine (IOM) has been asked by the U.S. Senate Appropriations Committee to examine the nature and cost of the federal role in supporting a national immunization policy. The IOM study, to be completed in May 2000, will review the impact of federal funds on immunization rates and will eventually recommend an appropriate level of future federal investment in achieving national immunization goals, especially in the area of infrastructure support beyond vaccine purchase and delivery. As part of this effort, the committee has been asked by the Centers for Disease Control and Prevention (the study sponsor) to address two specific concerns in an interim report: ( 1) the experience with carryover (unobligated funds) in the administration of the Section 317 program; and (2) the impact of the new Children's Health Insurance Program on the need for federal Section 317 funds for both core function initiatives and vaccine purchase. During the past decade Congress has reconfigured the federal involvement in national immunization policy through a series of initiatives focused on two objectives: (1) the improvement of vaccine purchase and delivery systems for disadvantaged children, and (2) the strengthening of infrastructure efforts in areas such as disease surveillance, public education, information management, public–private sector collaboration, and performance assessment. As a result of these initiatives, federal funding went through a major and rapid

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INTRODUCTION

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upward transition. For various reasons, states were unable to respond immediately to use this expanded federal support, especially in the area of infrastructure. Over time, however, state efforts have matured and state requests for assistance now exceed the level of available federal funding. Although immunization coverage rates in children are currently high, recent cuts in the federal budget for immunization infrastructure have caused states to reduce the scale of their immunization outreach, performance assessment, and information management efforts. Many states are also reformulating their immunization efforts, including greater reliance on managed care programs to serve Medicaid populations, the development of immunization registries to track vaccine coverage rates within the public and private sectors, and the emergence of new Children's Health Insurance Programs (CHIP) within the states. The implementation of the state Children's Health Insurance Program is in its early stages. Although the CHIP program may bring larger numbers of disadvantaged children into the private primary care system for immunization services, it is too soon to determine the impact of this program on immunization coverage rates or the need for stand-alone vaccination services for uninsured children in the public sector. Furthermore, CHIP is not designed to finance population-wide services such as disease surveillance, immunization education and outreach, or assessment. In the interim, state CHIP variations and the emergence of managed care in Medicaid have created new demands for data collection and program oversight at the state and national levels so that immunization levels can be monitored within a variety of health care delivery systems. It is premature at this time for the Institute of Medicine to recommend the federal or state funding requirements for investments in immunization infrastructure services. As interim guidance, the Committee observes that • the Nation's immunization efforts are important and deserve careful attention; • the current state of flux in new federal programs (such as CHIP) is generating considerable uncertainty about the role of governmental efforts in supporting and financing immunization services; • as an insurance program, CHIP is not designed to support population-wide services in areas such as assessment of immunization coverage, professional and public education about new vaccines, record assessment, or the development of immunization registries; and • states have the capacity to use at least the current level of federal support from the national immunization program productively; any further reductions would threaten the provision of needed immunization services and would add further instability to a system in flux.

INTRODUCTION

The prevention of infectious disease through the use of vaccines is one of the most powerful health care and public health achievements in this century. In the early part of the 20th century, diseases such as measles, diphtheria, polio, influenza, and pertussis were responsible for thousands of deaths among children and adults. As we approach a new cen

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INTRODUCTION

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tury, a substantial amount of the infectious disease burden has been reduced because of successes in vaccine development and immunization coverage for each new cohort of children, adolescents, and adults. Since 1900, vaccines have been licensed for use against 21 diseases; 11 of these vaccines have been recommended for use in all U.S. children (Centers for Disease Control and Prevention, 1999a).1 In 1997, basic immunization coverage2 nationwide was 91 percent or higher in children 19–35 months of age; adult influenza coverage in persons 65 and older reached 66 percent (Centers for Disease Control and Prevention, 1999b: 7). At the request of the U.S. Senate Appropriations Committee, the Institute of Medicine's Committee on Immunization Finance Policies and Practices is examining the nature and cost of the federal role in supporting a national immunization policy.3 The IOM study will review the impact of federal funds on immunization rates and will eventually recommend an appropriate level of future federal investment in achieving national immunization goals, especially in the area of infrastructure support, which represents the set of diverse services and systems separate from vaccine purchase and delivery.4 In this interim report, the committee has been asked by CDC to examine two specific concerns regarding Section 317 of the Public Health Services Act, which provides federal funds to the states for vaccines and immunization infrastructure efforts: • the experience with carryover (unobligated funds) in the administration of the Section 317 program; and • The impact of the new Children's Health Insurance Program on the need for federal Section 317 funds for both core function initiatives and vaccine purchase. Immunization serves two important purposes: protection of the individual and protection of the community by reducing and, in some cases, eliminating the spread of infectious agents. Recognizing that the control of vaccine preventable disease is a national policy matter, the Congress and the federal government have launched a comprehensive strategy over the past four decades to improve immunization rates throughout the nation. This strategy is grounded in the following premises: • Vaccines are one of the most cost effective public health interventions of the 20th century. For example, CDC estimates that the U.S. saves over $13 for every dollar invested in measles/mumps/rubella vaccination—a savings of approximately $4 billion each year (CDC, 1999b: 8). Research and science continue to expand and improve our ability to reduce the disease burden against new infectious agents. • Each day approximately 11,000 infants are born who should receive between 19 and 23 doses of vaccines to be fully immunized, most of which should be administered by 18 months of age. • Although a significant proportion of the general population may be fully immunized at a particular time, coverage rates are uneven and life-threatening disease outbreaks can and do occur. In a highly mobile society, the presence and movement of even small numbers of unimmunized individuals can foster

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INTRODUCTION

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situations in which unprotected children, adolescents, and adults can be unexpectedly exposed to vaccine preventable diseases. • Immunization coverage rates require persistent monitoring because declines in immunization status serve as early warnings of greater susceptibility to infectious disease. The federal effort in supporting immunization services has expanded in the past as a result of vaccine preventable disease epidemics or outbreaks (e.g., the emergence of the Salk vaccine for polio in the mid-1950s and the measles outbreak in 1989–1990). What remains uncertain is the scope of an adequate federal investment in immunization services in the absence of a disease outbreak or epidemic. Maintaining an adequate data collection and monitoring system and developing strategies to improve immunization rates in areas of need are key components of our national immunization policy, but the scale of the federal role in these efforts, and the extent to which outreach responsibilities and surveillance of disease rates and vaccine records should be shared between the states and the federal government, remains uncertain. • Immunization is an important component of comprehensive primary care. A freestanding immunization system may be necessary at times to improve immunization levels in underserved communities or during disease outbreaks. But ideally, a primary care medical home provides the best opportunity for consistent, up-to-date immunization coverage. However, primary care services are not designed to address population-wide concerns in areas such as disease surveillance, public and professional education, performance monitoring, and vaccine safety. Our nation's immunization program originated in 1955, when Congress appropriated funds to help states and local communities buy and administer the recently licensed inactivated polio vaccine. The adoption of the Vaccination Assistance Act in 1962, along with other policy changes, institutionalized a federal role in the area of childhood immunization and expanded this role to include vaccines against diphtheria, pertussis, tetanus, and measles as well as polio.5 In the late 1970s, the Carter Administration launched the Childhood Immunization Initiative consisting of new legislation, large public education programs, and support for the creation and enforcement of school entry immunization requirements. Federal efforts declined in the 1980s, including the discontinuation of the National Immunization Survey in 1985. An outbreak of measles in several parts of the country in 1989–1990 drew public attention and support for strengthening federal efforts in immunization services. First the Bush Administration and later the Clinton Administration worked with Congress to implement a national effort designed to increase immunization rates and to improve the operation of the nation's immunization system. This effort involves an intricate public/private partnership focused on two objectives (NVAC, 1991): (1) The development of an effective vaccine purchase and delivery system that can supplement private sector efforts and assure access to vaccines for disadvantaged families, and

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THE CARRYOVER ISSUE IN SECTION 317 EXPENDITURES

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(2) The design and implementation of an effective disease surveillance and immunization system, including assessment, education, performance monitoring, and information services that benefit and protect the population as a whole. The federal government pursues these objectives through several initiatives. In the first area of vaccine purchase and delivery, the federal government plays major roles in the financing of vaccines, the negotiation of vaccine purchase prices on behalf of the states, and the delivery of vaccines to service providers who administer the vaccines to disadvantaged children. The principal federal programs in this area are the Vaccines for Children (VFC) program (created by the Omnibus Budget Reconciliation Act as Section 1928 of the Social Security Act in 1993) and the vaccine purchase system authorized under Section 317 of the Public Health Services Act. The federal government also helps finance the delivery of immunization services though Medicaid (which provides coverage for vaccines for adults as well as for recommended vaccines that are not yet covered through a VFC contract) and most recently, the new State Children's Health Insurance Program (CHIP). Finally, federal grants programs that support primary health care and preventive health services in uninsured and disadvantaged communities are another component of a national immunization strategy. The second area involves a more diverse, less well understood, but important series of federal, state, and local public health efforts, to which the Section 317 program alone contributes programmatic guidance and financial assistance. Federal initiatives in this area (such as the National Immunization Survey; the incentive awards for communities that demonstrate significant improvements in immunization rates; linkages with the Women, Infants, and Children (WIC) program; and support for the development of immunization registries) are designed to supplement and strengthen state efforts in developing disease surveillance, immunization oversight, and performance monitoring activities. Both federal and state programs have increasingly focused on the importance of education, outreach, assessment, and information exchange to improve immunization coverage rates in the entire population.

THE CARRYOVER ISSUE IN SECTION 317 EXPENDITURES

Congressional appropriations for the Section 317 program experienced significant increases and decreases in the period 1991–1999 (see Figure 1 and Figure 2; Table 1 and Table 2) during a time when public health agency grantees also had to adapt to changing roles and to assume new responsibilities for performance monitoring in the community (IOM, 1997). The sudden and unplanned growth in federal investment in state immunization programs in the early part of this period (1992–1995) occurred at a time when many states had restraints on their hiring and procurement practices, making it difficult for them to launch broad programmatic initiatives. During some years, federal funds were awarded late in the state budgetary years (CDC, 1999c). As a result of these administrative delays, large amounts of Section 317 federal funds were not obligated within the 12-month grant award cycles in 1994–1996.6 These shifts in the availability of resources have caused both

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THE CARRYOVER ISSUE IN SECTION 317 EXPENDITURES

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CDC and the state health agencies to experiment with different approaches in supporting disease surveillance and immunization assessment, education, monitoring, and information efforts in the public and private sectors (see Figure 3). Section 317 funds are awarded for two primary categories of support: vaccine purchase and state immunization program activities. Funding for vaccine purchase is referred to as “direct assistance” (DA); other funds awarded through the Section 317 program (referred to as “financial assistance” or FA) support a varied array of program activities. Congress appropriates separate funds within each category; CDC retains this distinction in state grant awards. DA funding allows grantees to purchase vaccines at reduced prices negotiated by the federal government with vaccine manufacturers. Prior to the creation of the Vaccines for Children (VFC) program, Section 317 DA funds were the only federal vaccine purchase program available for the states. The Section 317 funds are used today to purchase vaccine for children, adolescents, and adults who are not eligible for VFC. Unlike most grant awards, these funds remain with CDC rather than being transferred to the grantees, and represent a “line of credit” for vaccine purchase. DA funds may also be used to appoint CDC personnel within the states who provide technical expertise for the state's immunization project. Section 317 DA funding showed some variation at mid-decade when the VFC program began, but in general funding awards have remained relatively stable during the past decade, remaining close to about $130 million per year in the period 1996–1999 (see Table 1). In 1995, the first year for full implementation of vaccine purchase under the VFC program, the proportion of total grantee expenditures of Section 317 DA award funds dropped below 60 percent.7 Since then, state expenditure levels have risen steadily to 95 percent for 1998. Financial assistance (FA) funds awarded through the Section 317 program support a more complex array of program activities. In contrast to the DA funding history, rapid increases and sudden decreases in the level of FA funds are the source of most of the budgetary variation in the Section 317 program over the past decade. In 1990 and 1991, FA funding and state expenditures were about one-fourth the level of those for DA (Table 1 and Table 2). At mid-decade, FA levels increased substantially, rising to twice the levels for DA. New money for FA grants awards increased more than seven-fold from a total of $37 million awarded for 1990 to $261 million for 1995. In the aftermath of the rapid and unplanned build-up of Section 317 FA funds, significant amounts of carryover emerged within the state immunization budgets. Although the states had acquired extensive experience over several decades in working with the federal DA vaccine purchase funds, the large increases in support for additional immunization services appeared in areas that required new efforts (such as outreach, record assessment, performance measures, and the development of immunization registries) without careful consideration of how these funds would be used within existing state administrative and management systems.8 Although unable to respond immediately, states experimented with and built new immunization programs that drew upon federal resources. High rates of immunization coverage were sustained in the wake of these efforts, even with the addition of new vaccines to the childhood immunization schedule. However, the delay in expenditures during the start-up period, accompanied by mid-decade pressures to reduce the costs of federal discretionary programs, led Congress

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THE IMPACT OF THE STATE CHILDREN'S HEALTH INSURANCE PROGRAM

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to make significant reductions for Section 317 FA funds in the period FY 1996–1998.9 By the end of the decade new money for FA grants declined to $117 million per year for awards for 1998 and 1999 (a 55 percent decrease). In 1998, the two forms of immunization assistance (DA and FA funds) were roughly comparable. During this period of reductions in Section 317 FA awards, state expenditure rates have gradually increased, suggesting that the states have improved their capacity to use federal funds for immunization services. Expenditure rates during 1997 and 1998 are in the range of 86 percent and 96 percent, respectively; total carryover of funds is currently estimated at less than $10 million for 1998 Section 317 FA awards. CDC and state officials now report that the current level of federal funds for Section 317 infrastructure support FA funds (requested at $117 million for FY 2000) is no longer sufficient to support their needs.10 New management and administrative services require time to be put into place, particularly when consensus needs to be developed about how parents, providers, payers, and health departments should share responsibility for ensuring that children receive appropriate health care.11 State efforts to foster public awareness of the importance of immunization coverage are particularly challenged in the current environment with the addition of new vaccines to the childhood immunization schedule, the addition of new population groups (adolescents and adults) to the immunization system, public concerns about vaccine safety, and diminished public perception of the importance of timely immunization coverage in the absence of disease outbreaks (Orenstein et al., in press). Although vaccine coverage rates are currently high, recent federal budget cutbacks have caused states to reduce the scale of their immunization assessment, outreach, performance monitoring, program linkages, and information management efforts.12 Their flexibility to detect and respond quickly to sudden disease outbreaks is threatened. Their ability to continue outreach to underserved communities and to build linkages with communitybased programs such as local WIC programs is diminished. New financing sources may eventually emerge to provide a stable platform for essential services that benefit and protect the health of the community, but at present state and local health agencies are experiencing significant instability in immunization efforts during times of transition and change in the health care system.

THE IMPACT OF THE STATE CHILDREN'S HEALTH INSURANCE PROGRAM

Changes in the organization of health care services for disadvantaged families appear to have significant impact on the structure of the vaccine delivery system in many underserved communities, but this impact is uneven and its effect on actual immunization coverage rates remains uncertain. Several shifts are occurring simultaneously: (1) Responsibility for primary care services (including immunization) for disadvantaged families is migrating from publicly funded health programs to other care settings, including private managed care arrangements; (2) An enhanced governmental role in national immunization policy and practice is evolving through federal and state collaboration; (3) Medicaid is enrolling larger numbers of children than ever before (especially in the period 1990–1995);

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THE IMPACT OF THE STATE CHILDREN'S HEALTH INSURANCE PROGRAM

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and (4) The new state Children's Health Insurance Program (CHIP) is emerging in a health plan niche between Medicaid and private insurance (IOM, 1998). The confluence of these changes may eventually sustain and improve immunization rates by increasing access to private health care providers but it is premature to determine how CHIP enrollments will influence immunization coverage rates among disadvantaged families. As an insurance program, CHIP does not provide for surveillance, population and vaccine monitoring, professional training, or public education efforts that are commonly funded through infrastructure efforts and benefit the community as a whole. CHIP plans are supposed to conform to federal Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) requirements that include the provision of the required immunizations for children. State plans are expected to provide data that hold them accountable for supporting the performance of these services. But CHIP is not expected to monitor levels of vaccine use among the state population as a whole, nor does it have the mandate to provide surveillance for vaccine-related phenomena. Section 317 funds have traditionally supported these efforts in addition to providing direct vaccine purchase and administration services. What remains uncertain, at this time, is the public cost of and need for the population-wide assessment, data surveillance, and education services as states shift increasingly larger shares of the responsibility for direct health services from the public sector to private health care plans. This topic will be a critical component for consideration in the IOM committee's final report. Certain factors deserve consideration at this time: • Larger numbers of uninsured children are eligible for health care coverage under CHIP but enrollment remains low. Although CHIP makes childhood immunization a basic benefit, the extent to which the program has penetrated the 0–2 age population is unknown at this time. Service utilization patterns have not yet been established or evaluated for new birth cohorts that could provide information about the extent to which these plans are able to meet the immunization needs of eligible families with young children. • Although a few states are monitoring immunization rates for the commercial and the Medicaid managed care programs (e.g., New Jersey, Connecticut, and Massachusetts), no regional or national datasets exist that can reveal the extent to which such individuals enrolled in managed care plans receive one or more immunization services from out-of-network publicly funded providers. • Public health clinics may often provide an important source of immunization services for young children when a family's insurance status is uncertain, interrupted, or limited in coverage. • VFC-eligible families may no longer qualify for vaccine discounts under some non-Medicaid CHIP programs.13 Therefore, the relationship of managed care payment status to access to vaccine services in private medical offices deserves special consideration, particularly if individuals or families who once relied upon VFC in private health care centers are now referred to public health clinics. • Many CHIP plans do not offer continuous service eligibility. If significant numbers of enrollees shift among Medicaid, CHIP, uninsured status, and pri

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NEXT STEPS

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vate insurance plans as their children mature (a process known as “cycling”), public health centers that provide a stable source of health services within communities may continue to play essential roles in serving disadvantaged groups. • Vigilant attention to early childhood immunization coverage rates is necessary during the implementation stages of CHIP, since infants will immediately require immunization services. As a result, vaccines will still be needed in public health settings for needy families and others who do not qualify for, or are uncertain about their eligibility for, CHIP or Medicaid coverage. • The complexity of the state CHIP plans; the intersection of CHIP programs, Medicaid, and the VFC program; and the emergence of managed care services within Medicaid increase the need for performance monitoring measures and information management resources at the state and national levels. As an insurance program, CHIP does not have the capacity to provide important immunization data collection, education, or program linkage services that offer population-wide benefits. Efforts to determine levels of immunization coverage within the state CHIP populations will need to draw upon datasets and measures (such as immunization registries and audits of public and private health records) supported by Section 317 infrastructure funds. • Several external factors may influence the effectiveness of CHIP in meeting the immunization needs of underserved groups. For example, the vaccine discount rates negotiated through the VFC program represent important cost savings in the implementation of CHIP services. In addition, the initial negotiation of state contracts with managed care organizations in the implementation of CHIP includes several discretionary features regarding the scope of immunization services and record monitoring requirements. This variation in cost, coverage rates, and datasets yields significant uncertainty about the extent to which CHIP, by itself, will be able to improve immunization rates among disadvantaged families.

NEXT STEPS

The IOM committee plans to engage in data collection efforts during the next 12 months to determine how state programmatic efforts contribute to an effective immunization system and how to finance productive efforts in the future. The committee's work will include a series of background papers, an analysis of state immunization policies and practices, and a state expenditure survey to identify areas of current investment in immunization efforts and to examine how federal budgetary practices influence state efforts. A series of site visits will also be conducted to provide additional documentation of state activities. The IOM committee will recommend federal and state funding requirements for immunization programs in our final report in May 2000. As interim guidance, the Committee observes that:

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NEXT STEPS

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• the Nation's immunization efforts are important and deserve careful attention, • the current state of flux in new federal programs (such as CHIP) is generating considerable uncertainty about the role of governmental efforts in supporting and financing immunization services, • as an insurance program, CHIP is not designed to support population-wide services in areas such as assessment of immunization coverage, professional and public education about vaccines, record assessment, or the development of immunization registries; and • states have the capacity to use at least the current level of federal support from the national immunization program productively; any further reductions would threaten the provision of needed immunization services and would add further instability to a system in flux. The task of immunizing the population of the United States is the responsibility of individual medical practitioners, state and local governments, and private organizations that constitute the decentralized health care system within this country. Reliance upon a patchwork health care system to provide immunization, and uneven and inconsistent investments in public health infrastructure foster circumstances in which ample opportunity exists for confusion and uncertainty in sustaining high levels of immunization coverage. Interactions among federal entitlements and discretionary programs, cost reimbursement policies, tax revenues, market forces, regulatory practices, and financial incentives all can contribute to—or impede—improvements in immunization rates. The committee's role will fbe to identify relevant knowledge and datasets that can illuminate the ways in which these interactions occur and guide future federal and state finance strategies for immunization efforts. The committee recognizes that the mixture of public and private resources that undergirds the Nation's vaccine delivery system provides important lessons regarding the appropriate scope and limitations of public finance efforts. Increasingly, the public demands that we carefully balance governmental interventions against the role of the private health care sector. Some approaches may be more effective than others in achieving improvements in immunization coverage rates, and activities that are more appropriate for performance within the private sector should not be duplicated within government. Not all infrastructure efforts within the states require federal investments, but at present no strong methodology is available to distinguish among the priorities and areas of need included in the state budgetary requests. The committee's final report will seek to identify knowledge about and experience with infrastructure roles and practices so that federal investments in immunization can be guided by data analysis, experience, and informed insights.

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REFERENCES

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REFERENCES

Centers for Disease Control and Prevention 1999a Achievements in public health, 1900–1999: Impact of vaccines universally recommended for children—United States, 1990–1998. MMWR 48(12):243–248. 1999b Immunization: Leading the way to healthy lives. Atlanta, GA: National Immunization Program. 1999c Immunization grant financial assistance carryover. Background paper. Atlanta, GA: National Immunization Program. 1999d Select grantee reports of impact of budget reductions. Materials distributed to the National Vaccine Advisory Committee, May 14. Atlanta, GA: National Immunization Program. Institute of Medicine 1994 Overcoming Barriers to Immunization. A workshop summary. J.S. Durch, ed. Washington, DC: National Academy Press. 1997 Improving Health in the Community: A Role for Performance Monitoring. J.S. Durch, L.A. Bailey, M.A. Stoto, eds. Washington, DC: National Academy Press. 1998 America's Children: Health Insurance and Access to Care. M. Edmunds and M.J. Cove, eds. Washington, DC: National Academy Press. National Vaccine Advisory Committee 1991 The measles epidemic. Journal of the American Medical Association. 266(11):1547–52. Orenstein, W.A., A.R. Hinman, and L.E. Rodewald In press Public health considerations—United States. S. Plotkin and W. Orenstein (eds). Vaccines. 3rd edition. Philadelphia, PA: W.B. Saunders Co. Richardson, S. 1998 Letter to state health officials. May 11. Washington, DC: Health Care Financing Administration. Thompson, F. E. 1999 Letter to Secretary Donna Shalala. December 23. Washington, DC: Association of State and Territorial Health Officials. Vivier, P. 1996 National policies for childhood immunization in the United States: An historical perspective. Ann Arbor, MI: UMI dissertation services.

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NOTES

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NOTES

1The

diseases are: diphtheria, pertussis, tetanus, poliomyelitis, measles, mumps, rubella, Hepatitis B, Haemophilus influenza type b, varicella, and rotavirus. Ten other vaccines have been recommended for use only in selected populations at high risk because of area of residence, age, medical condition, or risk behaviors. Vaccines are also available against rabies, typhoid, cholera, plague, and smallpox, but are not widely used today (Orenstein et al., in press).

2Defined

as 3 or more doses of diphtheria, tetanus, pertussis (DTP), polio, and Hib vaccines, and one dose of measles, mumps, and rubella (MMR) vaccine.

3The

IOM study was requested in U.S. Senate Report 105-300 to accompany S. 2440 (Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations Bill), which directed the Centers for Disease Control and Prevention to contract with the Institute of Medicine to conduct an evaluation of the recent successes, resource needs, cost structure, and strategies for immunization efforts in the United States.

4The

committee's final report, scheduled for publication in May 2000, will address six questions that frame the charge for this study: (1) an assessment of overall spending by all sources for immunization in the United States during the 1990s; (2) how new federal immunization funds were spent by the States and to what extent States maintained their own level of effort over the past 5 years; (3) current and future funding requirements for childhood immunization activities and how those requirements can be met through a combination of State funding, federal immunization funding, and funding available through the Children's' Health Insurance Program; (4) how federal grant funds should be distributed among the States; (5) how funds should be targeted within States to reach high-risk populations without diminishing high levels of coverage in the overall population; and (6) the role and financing level for efforts by the Center for Disease Control and Prevention in supporting state immunization activities to vaccinate adults and achieve national goals for influenza and pneumococcal vaccines.

5A

comprehensive history, of the evolution of federal immunization policy in the period 1955–1981 is included in a John Hopkins University doctoral dissertation by Patrick Vivier (Vivier, 1996).

6State

reports indicate significant amounts of carryover funds: $119,553,727 (1994), $141,203,007 (1995), and $123,433,995 (1996). In each of these years states spent only slightly more than half of their total financial assistance Section 317 grant awards (see Table 2). 7In 1995, CDC transferred approximately $60 million from excess 317 vaccine into infrastructure and awarded it in September of that year. Although this transfer was made with congressional authority and approval, the arrival of the awards late in the grant year further exacerbated the carryover problem since states were required to obligate these funds before the end of the calendar year (Centers for Disease Control and Prevention, 1999c). 8Between

1992 and 1995, CDC awarded nearly all carryover in addition to, rather than in lieu of, newly appropriated funds, thus compounding the problem in grantee areas having difficulty expending funds efficiently. During these years CDC reports that the National Immunization Program was trying to resolve the carryover issue by encouraging states to continue to build and sustain the systems needed to raise immunization coverage levels with new funds while using the carryover funds for one-time expenses (Centers for Disease Control and Prevention, 1999c: 3).

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NOTES

9The

13

amount of funds available for infrastructure services within the Section 317 grants in 1997 and 1998 is less than half of what was appropriated in 1996. See Table 2. 10F.E. Thompson, 1998. Letter to DHHS Secretary Shalala. December 23. Washington, DC: Association of State and Territorial Health Officials. 11Institute of Medicine. 1994. Overcoming Barriers to Immunization. Washington, DC: National Academy Press. p. 3. 12See, for example, letter from the Association of State and Territorial Health Officials to Secretary Donna Shalala (Thompson, 1998): “The severe cuts (upwards of 60%) to infrastructure over the last two years have resulted in major cutbacks on the state level including: reductions in every aspect of programs, from development of materials to staffing of clinics; cancellations of contracts with WIC, private providers, community health centers, TANF, and community coalitions; severe reductions in registry development and maintenance; reductions in clinic hours and the delivery of shots; and cancellation of assessment programs, evaluation and surveillance improvements. In addition the severe cutbacks do not allow for states to plan and implement the institutionalization of vaccine delivery strategies that work…”. Washington, DC: Association of State and Territorial Health Officials. Proposed reductions in state efforts have also been described in materials provided by the CDC to the National Vaccine Advisory Committee (CDC, 1999d). 13See for example, S. Richardson, 1998, letter to state health officials. May 11. Washington, DC: Health Care Financing Administration.

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APPENDICES 14

APPENDICES

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APPENDICES

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TABLE 1. Annual Awards and Expenditures of Section 317 Direct Assistance (DA) Vaccine Purchase Funds (in millions) New Funds Rewarded Fundsa Total Award Expenditures Percentage of Total Award Expendedb Year 1990 $149.0 $0.0 $149.0 $106.3 71% 1991 $112.9 $37.5 $150.3 $102.5 68% 1992 $156.2 $26.8 $183.1 $121.6 66% 1993 $171.2 $43.9 $215.1 $156.0 73% 1994 $136.2 $86.3 $222.5 $172.4 78% $85.3 $77.0 $162.3 $96.3 59% 1995 c 1996 $133.3 $11.0 $144.2 $111.2 77% 1997 $124.0 $34.7 $158.7 $128.4 81% $108.2 $34.9 $143.1 $135.6 95% 1998d $128.0 $6.0 $134.0 1999e aFunds

awarded in previous years but not obligated. on year-end unobligated balances for 1990-1997 reported to CDC as of 4/1/99. c$53 million rescinded from unobligated balances in FY96 (comprised of funds from 1993, 1994, and 1995). dCDC estimates for expenditures and percentage of 1998 award expended. eProjected amounts for 1999. bBased

NOTES: (a) CDC notes that 1990 was the first year that grants were administered centrally, instead of by regional offices. There is limited background information on which to substantiate these amounts and as a result their accuracy is questionable. (b) In 1994, an additional $30,672,686 in appropriated vaccine purchase funds was paid directly to the Treasury for floor stocks excise taxes on behalf of all the grantees when the Vaccine Compensation Act was reauthorized.

SOURCE: Data provided by CDC.

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APPENDICES

TABLE 2. Annual Awards and Expenditures of Section 317 Financial Assistance (FA) Immunization Program Funds (in millions) Year New Funds Rewarded Fundsa Total Award Expenditures Percentage of Total Award Expendedb 1990 $36.9 $0.0 $36.9 $25.8 70% 1991 $37.0 $6.3 $43.3 $32.2 74% 1992 $92.3 $5.9 $98.2 $43.0 44% 1993 $98.2 $42.2 $140.4 $81.8 58% 1994 $227.6 $27.3 $254.9 $135.4 53% 1995 $261.4 $75.2 $336.6 $195.4 58% 1996 $179.7 $191.4 $371.1 $247.7 67% 1997 $159.4 $121.7 $281.1 $241.8 86% $116.8 $77.8 $194.6 $186.1 96% 1998c 1999d $117.0 $13.0 $130.0 $130.0 100% aFunds awarded in previous years but not obligated. bBased on year-end unobligated balances for 1990-1997 reported to CDC as of 12/21/98. cCDC estimates for 1998 expenditures and percentage of 1998 award expended. dProjected amounts for 1999.

SOURCE: Data Provided by CDC.

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APPENDICES

Figure 1. Amount of New Funding Awarded as Section 317 Direct Assistance (DA) and Financial Assistance (FA), 1990-1999

Figure 2. Amount of Total Annual Awards of Section 317 Funds, Direct Assistance (DA) and Financial Assistance (FA), 1990-1999

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Figure 3. Section 317 Grant Allocations from CDC to State and Local Immunization Programs, 1988-1999

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APPENDICES 18

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COMMITTEE BIOGRAPHIES

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COMMITTEE BIOGRAPHIES

Bernard Guyer,MD, MPH (IOM), (Chair), is chairman of the Department of Population and Family Health Sciences in the Johns Hopkins School of Hygiene and Public Health. He also holds joint appointments in Pediatrics in the Johns Hopkins School of Medicine and in International Health in the Vaccines Sciences Program. He is the co-editor (with H. Grason) of the text Assessing and Developing Primary Care for Children: Reforms in Health Systems (National Center for Education in Maternal and Child Health, 1995). David R. Smith, MD, (Vice-Chair), was appointed the President of the Texas Tech University Health Sciences Center in 1996, following a 5-year term as the Commissioner of the Texas Department of Health. He previously served as senior vice president of Parkland Memorial Hospital in Dallas and chief executive officer and medical director of Parkland's Community Oriented Primary Care Program. E. Russell Alexander, MD, is a pediatrician who recently retired as the Chief of Epidemiology with the Seattle-King County Health Department (1990-98). He previously served in the Division of Sexually Transmitted Diseases of the Centers for Disease Control and Prevention (1983-89) and was an epidemic intelligence service officer for the CDC in 1955-57 and 1959-60. Dr. Alexander is also professor emeritus for the University of Washington School of Public Health (1969-79 and 1990-98). Gordon Berlin, MA, is vice president of the Manpower Demonstration Research Corporation (a social policy research and demonstration intermediary that develops and manages large-scale, multi-site demonstration projects designed to test new social policies in the areas of work, training, income support, and social services for at-risk populations). He also was the founding executive director of the Social Research and Demonstration Corporation, a sister organization operating in Canada. Previously he was the executive deputy administrator for management, budget and policy for the New York City Human Resources Administration. Mr. Berlin has also served as a program officer and deputy director of the Urban Poverty Program of the Ford Foundation. Steve Black, MD, is Co-Director of the Kaiser Pediatric Vaccine Study Center in Oakland, California. The Center was established in 1984 for the pre-licensure and post-licensure evaluation of adult and pediatric vaccine safety, immunogenicity, efficacy and cost-effectiveness. Dr. Black is also a pediatric infectious disease specialist at the Kaiser Permanente Medical Center in Oakland. In addition, he is an associate clinical professor of pediatrics at the University of California, San Francisco. Sheila Burke, MPA, RN, FAAN currently the Executive Dean and a Lecturer in Public Policy at the John F. Kennedy School of Government, most recently served as the Chief of Staff to former Senate Majority Leader Bob Dole (1986-96). She was also elected to serve as Secretary of the Senate in 1995. Ms. Burke served as Deputy Chief of Staff to the Senate Majority Leader (1985-86), and was a professional staff member of the Senate Finance Committee (1979-80) and Deputy Staff Director of the Senate Finance Committee (1981-1985).

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COMMITTEE BIOGRAPHIES

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Janet Currie, PhD, is a professor in the Department of Economics at UCLA (1996-present) where she has served on the faculty from 1988-91 and 1993-present. Her recent work examines the effects of welfare programs on poor children. In particular, she has focused on the Head Start program (an enriched preschool program for poor children) and Medicaid (health insurance for low income women and children). Her books include Welfare and the Well-Being of Children (Harwood Academic Publishers) and Caring for Kids: Pubilc Policy and Child Health (under review at Harvard University Press). Barbara DeBuono, MD, MPH, is the former Commissioner of Health for New York State (1995-98) and has recently been appointed as the chief executive of the New York Presbyterian Healthcare Network and executive vice president of the New York Presbyterian Healthcare System. Prior to joining the New York State Department of Health, Dr. DeBuono was the Director of Health for the state of Rhode Island (1991-95), also serving as a medical and state epidemiologist and medical director in that state (1986-91). Gordon H. DeFriese, PhD (IOM), is Professor of Social Medicine, Epidemiology, Health Policy and Administration at the University of North Carolina at Chapel Hill. For the past 25 years, he has also held an appointment as Director of the Cecil G. Sheps Center for Health Services Research at UNC-Chapel Hill. Dr. DeFriese is a past president and distinguished fellow of the Association for Health Services Research. He was also the editor (1983-96, now editor emeritus) of the journal Health Services Research. In 1990 he joined with others to form a new national organization called Partnership for Prevention, a coalition of private sector business and industry organizations, voluntary health organizations and state and federal public health agencies based in Washington, DC. Walter Faggett, MD, is a pediatric consultant in the Washington DC area and chairs the pediatric section of the National Medical Association. He also serves as NMA's liaison to the Advisory Committee on Immunization Practices. He has extensive experience in working with managed care organizations that serve disadvantaged families. He has recently served as the medical director for Grady Health Care, Inc. in Atlanta; medical director for Omnicare HMO in Memphis, TN; and was the assistant medical director and pediatrician for Medlink Hospital's Primary Care Center in Washington, DC. In addition he is a retired United States Army colonel, having served 21 years. Samuel Katz, MD (IOM) For 22 years (ending in 1990) Dr. Katz was Chairman of the Department of Pediatrics at Duke University School of Medicine. His career has been devoted to infectious disease research, focusing principally on vaccine research and development. Dr. Katz's research included an extensive collaborative effort with Nobel Laureate John F. Enders, during which time they developed the attenuated measles virus vaccine now used throughout the world. Dr. Katz has chaired the Committee on Infectious Diseases of the American Academy of Pediatrics (the Redbook Committee), the Advisory Committee on Immunization Practices (ACIP) of the CDC, the Vaccine Priorities Study of the IOM, and several NIH, WHO and CVI vaccine and HIV panels. He has been president of the American Pediatric Society and of the Association of Medical School Pediatric Department Chairmen. He is the co-editor (with A. Gershon and P. Hotez) of a textbook (now in its 10th edition) on infectious diseases. Currently he co-chairs, with Dr. Louis Sullivan, the Vaccine Initiative of the Infectious Diseases Society of America and the Pediatric Infectious Diseases Society.

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COMMITTEE BIOGRAPHIES

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Sara Rosenbaum, JD, is director of the Center and professor in the Department of Health Services Management and Policy in the School of Public Health and Health Services at The George Washington University. Ms. Rosenbaum also holds appointments in the Schools of Law and Medicine and Health Sciences. Ms. Rosenbaum has worked extensively in the areas of health law for the poor, health care financing and managed care, and maternal and child health. During 1993 and 1994 she worked with the White House Domestic Policy Council and the United States Department of Health and Human Services, where she directed the legislative drafting of the Health Security Act for the President. She has served on policy advisory boards for the United States Congress Office of Technology Assessment, the United States Public Health Service, and the Health Care Financing Administration. Cathy Schoen, MA joined The Commonwealth Fund in September 1995 as director of research and evaluation. Prior to joining the Fund, she was director of special projects at the University of Massachusetts Labor Relations and Research Center. She also serves as program director of the Fund's Health Care Coverage and Quality Program, a policy and research grant program established to help inform national and state health insurance and delivery system policy decisions. Jane Sisk, PhD, is Professor of Public Health and Director of the Master's Program in Effectiveness and Outcomes Research at Columbia University. Her current research is focusing on the cost-effectiveness of health care interventions, including pneumococcal vaccination for elderly people, implementation of evidence-based guidelines, and evaluation of Medicaid managed care. Before coming to Columbia in 1990, Dr. Sisk directed health policy projects at the Congressional Office of Technology Assessment, where she was a Senior Associate and Project Director in the Health Program. Rosemary Chalk, BA (Study Director) has been a member of the professional staff of the Institute of Medicine and the National Research Council since 1987. She has directed studies and edited reports on family violence, child abuse and neglect, child welfare, youth development, research ethics, and education finance. Jane Durch, MA, (Project Officer) joined the staff of the Institute of Medicine in 1990. She has participated in studies on children's health, immunization, vaccine development, monitoring the health of Gulf War veterans, and performance measurement in public health programs and in community health improvement activities.