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