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A National Perspective on the Immunization System s noted in Calling the Shots, the federal and state governments built a dynamic and flexible immunization system during the 1990s that _ ~ has adapted to extensive changes in the science of vaccines, in de- mographic patterns, and in service delivery patterns in the health care sector. The report describes the national immunization system as "a na- tional treasure that is too often taken for granted." The "system" actually consists of an intricate maze of public- and private-sector activity, some of which is extensively coordinated through governmental policies and pro- grams, but much of which occurs independently through immunization efforts within private medical offices. Within this system, vaccines are either sold directly to health care providers or are purchased by public health agencies and then distributed to the providers through state-ad- . - m~n~sterecr ~mmun~zahon programs. THE NATIONAL IMMUNIZATION PARTNERSHIP David Smith, vice chair of the Institute of Medicine (IOM) Committee on Immunization Policies and Practices and chancellor of the Health Sci- ences Center of Texas Tech University, opened the Washington, DC work- shop with an overview of the national immunization system and the findings and recommendations of the IOM study. He observed that child- hood immunization rates are the highest on record: more than 90 percent of all U.S. children have completed the recommended series of immuni- zation by the time they are ready to enter school, and 79 percent of all 6

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A NATIONAL PERSPECTIVE ON THE IMMUNIZATION SYSTEM young children are up to date by age 2. Despite these achievements, the national childhood immunization rate still falls short of the recommended goal of 90 percent coverage for all 2 year olds. Adult rates, though im- proving, are especially low among those with chronic health conditions (such as heart and lung disease or diabetes), and those adults are espe- cially vulnerable to communicable disease. Furthermore, although na- tional- and state-level disparities in immunization levels among racial and ethnic groups have declined, persistent gaps remain among the most disadvantaged populations of children. For example, one study of chil- dren in East Los Angeles indicated that only 49 percent of young children in a very poor neighborhood were up to date with their immunizations, compared with 71 percent of all children in the Los Angeles area (Shaheen et al., 2000~. Similar findings were reported in Chicago, where 29 percent of African-American children in public housing were up to date com- pared with 59 percent of children from the same racial group nationwide (Kenyon et al., 1998~. Dr. Smith noted that one million 2 year olds are not fully immunized in the United States, and the challenge is to reduce this gap, given the birth cohort of 11,000 new babies each day. Focusing on key immunization challenges for the future, Dr. Smith called attention to the growing complexity of the immunization schedule, the development of new vaccines that will need to be integrated into the health care system, and concerns about vaccine safety. He illustrated the number of changes that occurred in the immunization schedule from 1975 to 2000 (Figure 1) and cited additional examples of vaccines that are in early stages of research or development (Table 1~. Organizing a system to deliver the growing number of vaccines for children and adults in the public and private sectors has required a na- tional immunization partnership consisting of multiple interests, includ- ing federal and state health agencies, clinicians, health care plans, and employers. The highly decentralized nature of this system is also one of its strengths, Dr. Smith noted. Its flexible nature has allowed the immuni- zation system to adapt to different needs and resources within local health care environments. However, the instability of federal and state roles within this system has grown in recent years, diminishing the capacity of health care providers to adapt to patterns of rapid acceleration in vaccine science, the emergence of new health care arrangements for disadvan- taged populations (such as the creation of the new State Children's Health Insurance Plan), and the immunization needs of adolescents and adults. In her comments, IOM committee member Sara Rosenbaum from The George Washington University observed that the leadership exerted by the federal government in allocating funding for immunization programs within the states needs to be carefully reexamined within the new concep- tual framework developed in the IOM study. Taking the Section 317 grant

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8 :5~ : - :~ :~ SETTING THE COURSE ~ hi: FIGURE 1 Changes in the childhood vaccine schedule, 1975-2000. program from a pure federal allocation process, for example, to a newer partnership with both the public and private sectors requires a renegotia- tion of guiding assumptions, shared roles, and new responsibilities. She indicated that stimulating a dialogue about financing health programs with the states will be difficult during periods of fiscal restraint and de- creasing revenues. Yet the findings of the report deserve periodic revisit- ing and updating to address new and unexpected circumstances within the national immunization system. William Schaffner from Vanderbilt University, a member of the pro- gram committee for the IOM workshops, commented that the expectation of a prompt response from the states in addressing problems within the immunization infrastructure may be unrealistic. The lack of cultural memory of disease outbreaks, in particular, leads to passivity and com- placency in supporting ongoing immunization efforts. In addition, ad- dressing the vaccine needs of the adult population within a system that is designed primarily for pediatric groups is challenging. Nevertheless, the vast majority of vaccine-preventable disease occurs annually among

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A NATIONAL PERSPECTIVE ON THE IMMUNIZATION SYSTEM 9 adults, and an insufficient amount of resources exists to build an ad- equate infrastructure to meet their needs. Furthermore, many private and public health insurance plans for adults do not include benefits for rou- tine vaccines or provide extremely low reimbursement fees for physicians who administer vaccines. For example, Medicare does not include com- pensation for the administration of vaccines for adults under age 65. THE INSTITUTE OF MEDICINE STUDY The U.S. Senate Committee on Appropriations commissioned the IOM study in 1999 to examine recent trends that affect the level of resources available for the national immunization system. IOM was asked, in par- ticular, to focus on the history of the Section 317 program, a federal public health grant activity administered by the Centers for Disease Control and Prevention (CDC) that supports state-administered immunization pro- grams. The Section 317 program consists of two types of awards: vaccine purchase and infrastructure support. Although resources for vaccine pur- chase awards have remained relatively stable during the 1990s (total an- nual awards to the states average about $160 million), the level of support for infrastructure has experienced rapid increases, followed by dramatic declines. The baseline annual average for FY 1994-1999 for the infrastruc- ture awards was $271 million, compared to a level of $123 million for FY 2000. As a result, much uncertainty remains about the level of federal funding that is adequate to support a national immunization infrastruc- ture program and the types of incentives that will encourage states to support these efforts. Dr. Smith summarized the conclusions of the IOM report: The repetitive ebb and flow cycles in the distribution of public resources for immunization programs have created instability and uncer- tainty that impeded project planning at the state and local levels in the late 1990s and delayed the public benefit of advances in the development of new vaccines for both children and adults. This instability now erodes the continued success of immunization activities. Immunization policy needs to be national in scope. At the same time, the implementation of immunization policy must be flexible enough to respond to special circumstances that occur at the state and local levels. Federal and state governments each have important roles in sup- porting not only vaccine purchase, but also infrastructure efforts that can achieve and sustain national immunization goals. Private health care plans and providers have the capacity to do more in implementing immunization surveillance and preventive pro- grams within their health practices, but such efforts require additional

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10 TABLE 1 Vaccines in Widespread Use, 1985-2020 SETTING THE COURSE 1985 2000 2020a Adult influenza Adult influenza Adult influenzas Adult pneumococcal Adult pneumococcal Adult pneumococcal polysaccharide polysaccharide polysaccharide Diphtheria, pertussis, Diphtheria, tetanus, DtaPC tetanus, and components acellular pertussis, and comnonent.sU Measles, mumps, and rubella (MMR) Oral poliovirus r MMRb Inactivated poliovirusb H. influenzue type bb Hepatitis Ab Hepatitis Bb Varicellab Pediatric conjugate of pneumococcal polysaccharide Borrelia burgdorferi Meningococcal polysaccharide A,C,Y,W-135 Measles, mumps, rubella, and varicellaC Eradication of polio expected Hibc Hepatitis Ac Hepatitis Be Varicella with MMR Pediatric conjugate of pneumococcal polysaccharideC Borrelia burgdorferi Conjugated meningococcal polysaccharide A,B,C,Y,W-135C Adult tetanus, diphtheria, acellular pertussis, and componentsC Chlamydia Coccidioides immites Cytomegalovirus Enterotoxigenic E.coli Epstein-Barr assistance, oversight, and incentives. At the same time, comprehensive insurance and high-quality primary care services do not replace the need for public health infrastructure. Building from these conclusions, the IOM committee developed a conceptual framework that identifies six key roles for the national immu- nization system (Figure 2~. This framework subsequently provided the organizational structure for recommendations in the IOM report (Box 1~. The recommendations call for additional public investments at the fed- eral and state levels to strengthen the immunization infrastructure and to expand the system beyond a childhood population to reach adults at risk of vaccine-preventable disease.

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A NATIONAL PERSPECTIVE ON THE IMMUNIZATION SYSTEM TABLE 1 Continued 11 1985 2000 2020a Helicobacter caloric Hepatitis cC Herpes simplex Histoplasma capsulatum Human papillomavirusC Child influenzas Insulin-dependent diabetes mellitus (therapeutic) Melanoma (therapeutic) Multiple sclerosis (therapeutic) Mycobacterium tuberculosis Neisseria gonorrhea Neisseria meningitidis B ParainfluenzaC Respiratory syncytial virusC Rheumatoid arthritis (therapeutic) RotavirusC Shigella Streptococcus, Group Ac Streptococcus, Group B aPriority candidate vaccines, drawn from IOM, 2000b. bVaccines covered by Vaccines for Children (VFC) as of February 2000. CVaccines likely to be recommended for universal use (including VFC coverage for child- hood vaccines). NOTE: Lahn disease names are in italics. RESPONSE FROM THE CENTERS FOR DISEASE CONTROL AND PREVENTION Walter Orenstein, Director of the National Immunization Program of the CDC, described the IOM report as a great success and offered his thanks to IOM for the efforts involved. He described actions taken within Congress and CDC in response to the report's recommendations. Congress appropriated about half of the recommended funds to sup- port the Section 317 operations grants infrastructure in FY 2001 ($42.5 million), and an additional $18.7 million was expected in FY 2002. These increases were expected to bring the annual grant award budget for the Section 317 infrastructure program to about $182 million, which is a sub-

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2 SETTING THE COURSE Surveillance of Vaccine Coverage and Safety FIGURE 2 Six roles of the national immunization system (IOM, 2000a). stantial increase over recent funding, but still below the $200 million an- nual level recommended by the Calling the Shots report. In addition, CDC has convened a group of stakeholders to consider the merits of improving the allocation of discretionary infrastructure grants by considering the critical elements described by IOM. Key part- ners in this effort include the Association of State and Territorial Health Officials and the Association of Immunization Managers. This advisory group is considering ways to implement the criteria recommended by IOM a base-level award for each state, plus additional amounts that reflect calculations of need, capacity, and performance. CDC is further refining these criteria to identify specific measures that might yield an index indicator in each area. Under estimates of need, for example, mul- tiple measures might be included in the following areas: population size, birth cohort, percentage of immigrants, rurality, level of poverty, and immunization levels. CDC has also reduced federal grant reporting requirements from 18

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A NATIONAL PERSPECTIVE ON THE IMMUNIZATION SYSTEM 13 to 8 component areas that are more closely aligned with the 6 fundamen- tal roles outlined in IOM's conceptual framework (Figure 2~. To foster more consistent and comparable immunization measures, CDC is looking into harmonizing the Health Plan Employer Data and Information Set (HEDIS) methodology with that used in the National Immunization Sur- vey (NIS). This effort involves several discrete activities, including the updating of HEDIS measures, the development of HEDIS-like measures within the NIS, the addition of an insurance module to the NIS, and the piloting of an adult office-based assessment of immunization coverage. Dr. Orenstein observed that several topics emerging in the regional workshops based on the IOM report have also drawn attention from CDC.

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4 SETTING THE COURSE For example, he noted that confusion about health insurance immuniza- tion benefits in ERISA-exempt (Employee Retirement Income Security Act) plans had surfaced, and CDC is now developing a brochure for benefits managers to address questions about the variation in immuniza- tion benefits within health plans. In addition, a number of providers had raised concerns about the complexity of multiple vaccine sources and funding streams, and the cost disincentives associated with immuniza- tion. CDC is sponsoring a new study on vaccine finance within IOM that will address some of these concerns. The new vaccine finance study will examine the roles and responsibilities of the public and private health sectors in the purchase and administration of vaccines, and will consider alternative finance strategies from multiple perspectives, including the role of such strategies in achieving national health goals, in the service delivery mechanisms for various vaccines and population groups, in de- livering recommended vaccines to underserved populations, in reducing the time lag and disparities associated with the introduction of new vac- cines to the recommended schedule, and in addressing the effects of mul- tiple new vaccine products. This study will begin in late 2000 and is expected to produce a final report in 2003. In conclusion, Dr. Orenstein stated that infrastructure is a vital part of the immunization program and that access to increased resources will help rebuild state and local programs. Although federal investments are essential, states also bear fundamental responsibilities in sustaining an immunization infrastructure.