Federal immunization policy and funding

Federal Immunization Policy and Funding A History of Responding to Crises Kay A. Johnson, MPH, EdM, Alice Sardell, PhD, and Barbara Richards, MPP Background: This article outlines the history of federal immunization policy and funding, with a focus on discretionary federal funding under Section 317 of the Public Health Service Act, paying particular attention to the role of Congress in shaping the program in the past 2 decades. This review of funding trends and initiatives indicates that when both a presidential administration and key congressional actors viewed immunization as a priority and made sufficient funds available to support the public health delivery system and its infrastructure, coverage levels would continue to rise and disease levels continue to decline. From the beginning, immunization financing was explicitly structured as a federal–state–private-sector partnership. Section 317 program’s statute has not changed much in 35 years, despite significant changes to the health care delivery system, other federal immunization activities, and rates of immunization coverage. Although the creation and implementation of the Vaccines for Children (VFC) program in the mid-1990s resulted in some congressional deliberations over immunization policies, no explicit restructuring of the 317 program occurred as a result. The Section 317 program retains its traditional authority and mission to address urgent needs, sustain public delivery systems, and provide funds for purchase of vaccines. The question remains whether the resources to sustain progress in immunization can be secured during times with no crisis, to ensure constant “readiness” in immunization (as in defense), or whether another epidemic must occur before the federal government is willing to commit optimal resources. Medical Subject Headings (MeSH): immunization; financing, government; Centers for Disease Control, economics/legislation and jurisprudence; public policy/policy making; United States Public Health Service/history/legislation and jurisprudence; vaccines (Am J Prev Med 2000;19(3S):99 –112) © 2000 American Journal of Preventive Medicine

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he federal government today plays a central role in the effort to eliminate vaccine-preventable childhood disease. This stream of activity flows from basic scientific research to immunization in the health care delivery system. The federal role evolved over the past century and has increased steadily since 1950. This was not necessarily the most likely course of development, however. The U.S. Constitution reserves for the states the authority to protect against dangers to public health (known as the “police powers”).1 State legislatures enact the laws that mandate immunization before school entry or requirements for reporting vaccine-preventable diseases. Still, since the discovery and use of the first polio vaccine in the 1950s, the From the Department of Pediatrics, Dartmouth-Hitchcock Medical Center (Johnson), Lebanon, New Hampshire; Department of Urban Studies, Queens College (Sardell), Flushing, New York; and District of Columbia Public Benefits Corporation (Richards), Washington, DC Address correspondence and reprint requests to: Kay A. Johnson, Research Assistant Professor, Department of Pediatrics, DartmouthHitchcock Medical Center, One Medical Center Drive, Lebanon, NH 03756. E-mail: [email protected].

federal government has continued to expand its role in support of state programs for childhood immunization incrementally over the past 4 decades.2 From the beginning, immunization financing was explicitly structured to be a federal–state–private-sector partnership. Federal policymakers never expected federal funds to be sufficient to cover the full cost of vaccine purchase and delivery. Typically, federal funds for immunization have been appropriated for specific purposes and increased over the years to target specific problems. The federal approach to immunization grant funding— creating initiatives to meet emerging needs, filling gaps, and responding to crises— has contributed to many successes in childhood immunization. Subject to the changing will of presidential administrations and key congressional committees, particularly the Committees on Appropriations, however, federal dollars have not always been a reliable source of funding. This approach has also contributed to unnecessary outbreaks of disease, limited our nation’s ability to eliminate vaccine-preventable disease, and stifled implementation of strategies that could sustain our successes.

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A key federal program is the Section 317 immunization program.3 This program (so named because it is authorized under Section 317 of the Public Health Service Act) provides grants to states and localities for the purchase of vaccines and other activities to improve immunization coverage among children, adolescents, and adults. The 317 program consists of two major types of support: a line of credit for the direct purchase of vaccines (Direct Assistance); and grants to support immunization infrastructure including outreach, service delivery, surveillance, outbreak control, public education, and the development of registries (Financial Assistance). The Centers for Disease Control and Prevention (CDC) administers the program as part of its National Immunization Program. This article outlines the history of federal immunization policy and funding, with a focus on discretionary federal funding under Section 317 and attention to the role of Congress in making substantive changes to the 317 program over the past 2 decades. It considers both the federal program authorization (i.e., the law that determines the maximal level of funding and the purposes for which those funds may be spent) and program appropriations (the level of funding enacted on a yearly basis). Other immunization programs and activities are discussed primarily in the context of how they led to, or otherwise affected, immunization funding through the Section 317 program. This article addresses the following questions: ● ● ● ●

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What led to expansion of the federal role in immunization policy? How has the immunization public delivery system and infrastructure been maintained? What was the impact of the 1989 –1991 measles epidemic on federal policy? What congressional decisions have affected the Section 317 program since the Vaccines for Children (VFC) Program was created in 1993? Why did immunization issues appear on the federal policy agenda at some times and not at others?

The Expansion of the Federal Role in Immunization Policy Regulatory Authority: First a Focus on Safety The federal government was first involved in regulating the safety of vaccines and has carried out this role since 1902, when Congress passed the Virus Serums and Toxins Act “to regulate the sale of viruses, serums, toxins, and analogues products. . .” in interstate and foreign commerce.4 (1902 was also the year that druggists and doctors signed a petition to stop sales of diphtheria and tetanus antitoxins by the New York City Department of Health. Sales, in fact, ceased, but the Department of Health continued to distribute these antitoxins free to physicians for the treatment of the 100

poor.5) Under the 1902 Act, the Secretary of the Treasury issued licenses and regulated vaccines in accordance with standards developed by an interagency board. Under the direction of this board, the laboratory of the Public Health Service was authorized to conduct inspections and to ensure the safety of these products. In 1948, this authority was given to the National Institutes of Health and, in 1972, these responsibilities were transferred to the U.S. Food and Drug Administration.

The Federal Role Expands in Response to the Polio Crisis Active federal involvement with the prevention and control of childhood diseases began in the 1950s with a focus on polio. The research and testing for the polio vaccine was done in the private sector, primarily with funds from the March of Dimes (National Foundation). With fear of the disease at very high levels, a majority of the general public supported immunization of susceptible children as quickly as possible. Despite this popular support, the American Medical Association opposed any direct distribution of polio vaccine by federal programs.4 When the Salk (inactivated) vaccine became available, Congress responded to the public pressure and public health advice with passage of the Poliomyelitis Immunization Assistance Act of 1955 (P.L. 84-377), which authorized grants to states for the purchase of vaccine for the free immunization of children and pregnant women. A total of $53.6 million was appropriated in 1956 and 1957 for this purpose. In 1960, Congress approved a special appropriation of $1 million for the federal purchase of a stockpile of polio vaccine against an epidemic (this time the Sabin activated oral polio vaccine). During fiscal years (FYs) 1961 and 1962, several million doses of oral polio vaccine were purchased by the federal government and provided to states and communities. This further expansion of federal involvement was again in response to a crisis, that of polio outbreaks among unvaccinated children in mostly low-income families. The last outbreak of polio and the last case of paralysis because of wild poliovirus in the United States was in 1979, and global eradication of the disease is the current target.6

The Creation of Section 317: New Vaccines Bring New Federal Strategies Following the success of efforts to stop polio epidemics, the federal government was presented with opportunities to prevent additional childhood diseases with vaccines. The Kennedy Administration, with the support of groups such as the American Medical Association and the American Public Health Association (APHA), launched an immunization initiative with a focus on mass campaigns and maintenance programs, but with-

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out a long-range plan for sustaining this effort. This initiative emphasized state and local program funding, not vaccine purchase. The Immunization Assistance Act (P.L. 87-868) was passed in 1962, and in 1963 the federal government began to provide support to state- and community-level immunization programs. These were primarily intensive immunization programs using oral polio vaccine but also supported diphtheria, pertussis, and tetanus (DPT) immunization. There was no direct federal purchase of vaccines at that time.7,8 In 1965, the Immunization Assistance Act was amended to authorize measles immunization programs, including grants to states for purchase and widespread delivery of measles vaccine. This Act established a federal presence in financing childhood vaccines, but not direct purchase. Congress did not establish a financial matching requirement; state and local governments were instead expected to cover other costs associated with immunization and to provide vaccines for children aged ⬎5 years.9 Between 1965 and 1975, federal immunization policy changed substantially. In FY 1966, the federal government first directly purchased polio and measles vaccines under consolidated contracts and provided them in lieu of financial grants to state and local public health agencies.10 The bulk purchase of vaccines under a federal contract led to substantial reductions in price and savings for federal, state, and local governments. In 1969, the federal government added rubella to the vaccine contract and, in 1975, the combined measles, mumps, and rubella vaccine. From this point on, the federal government sequentially added new vaccines that were recommended for routine use in childhood to the federal bulk purchase contract. The purpose of this policy was to offset the costs incurred by state and local public health agencies. Notably, as late as 1982, the DPT vaccines were not being purchased under the federal contract because their prices were low and potential savings, therefore, were limited. Exploring approaches to immunization program funding in 1966 and 1967, Congress replaced several categorical programs with a block grant authority under Section 314 of the Public Health Service Act (P.L. 89-749 and P.L. 90-174).10 This legislation provided for block grants to states allocated according to a formula, and for a program of project grants to be used for specific initiatives and activities. These new authorities were intended to provide more flexibility for public health programs to respond to local health priorities. Within a few years, however, when it became clear that this approach was not effective in targeting assistance to states and communities to immunize children, the block grant approach was abandoned. In particular, federal and state public health officials believed that the block grant approach did not permit sufficient flexibility to direct funds to disease outbreak control or

to similar urgent needs. The alternative granting approach adopted next is essentially intact today. In 1970, Congress again took action in response to outbreaks of preventable disease. That year, Dr. David Sencer, Director of the Centers for Disease Control (now the Centers for Disease Control and Prevention) testified before Congress regarding increases in the incidence of diseases such as measles, mumps, and pertussis that were attributed to deficiencies in federal funding and the capacity to assist state and local health agencies’ increase of coverage levels. In response, Congress enacted the Communicable Disease Control Amendments of 1970 (P.L. 91-464) and thereby created a new Section 317 of the Public Health Service Act. Section 317 authorizes the federal government to assist state and local governments in the prevention and control of communicable diseases through the purchase of vaccines and other forms of assistance. The program provides discretionary grants-in-aid to support state operations.

The Carter Administration: Governors’ Wives Lead the Way to Higher Coverage Although many children had been immunized in the efforts of the 1950s and 1960s, surveys showed that many children were inadequately immunized. Preschool immunization levels were low, and populationwide (so called “herd”) immunity had not been achieved for all target diseases. As a result, outbreaks of disease continued. The 1976 election brought renewed emphasis to childhood immunization efforts. The wives of two former governors moved to Washington, DC, and took with them a vision for achieving high immunization rates for all children. Betty Bumpers, the wife of Arkansas Governor Dale Bumpers, had led efforts in the state to achieve higher childhood immunization rates. Rosalynn Carter had also helped to make childhood immunization a policy focus in Georgia. With Bumpers elected to the Senate (where he would become the “Immunization Senator”) and Jimmy Carter elected President, Mrs. Bumpers and Mrs. Carter had the opportunity to bring the momentum of energetic state immunization efforts to the new administration. In April 1977, Joseph Califano, Jr., Secretary of Health, Education, and Welfare announced a nationwide initiative with the goals of reaching immunization levels of 90% in the nation’s children by October 1979 and establishing a permanent system to provide comprehensive immunization services to the 3 million children born in the United States each year.9,10 The Carter Administration knew that despite federal leadership, states held the key to the success of this initiative. The primary tool for raising immunization levels was to target children entering school and bring them up-to-date on immunizations. States were encouraged Am J Prev Med 2000;19(3S)

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to take action, and state legislatures enacted laws that required proof of immunization as a condition of school entry or attendance. All 50 states and the District of Columbia put such laws into place, and local enforcement of these laws was a priority. Immunization coverage levels for children entering school were increased from 60% in the mid-1970s to ⬎90% by 1980. A year later, the Carter Administration announced an initiative to eliminate indigenous measles by October 1982 by raising immunization coverage levels, developing effective surveillance systems, and responding aggressively to the occurrence of disease. Together, these strategies led to a large measure of success; measles cases declined from ⬎57,000 cases in 1977 to a low of 1497 cases by 1983. Measles was not eradicated or eliminated, however, and would return within the decade. Federal funding for state immunization grants through the Section 317 program administered by CDC increased steadily during the Carter Administration, growing from $5 million in 1976 to $35 million in 1979. Most of the additional funds were used to meet the increasing cost of vaccines or to pay for additional doses of existing or new vaccines.9 Efforts to provide “catchup” doses of vaccine to children as they entered school and fully immunizing an increasing number of children substantially increased vaccine costs. However, vaccine purchase is only part of the cost of immunizing a child. Funding was also needed by state and local authorities to operate immunization programs to ensure that vaccines actually reached low-income and uninsured children. With approximately 30 million doses of vaccine administered by the public sector, this was a sizable effort. The 50 state public health agencies and ⬎3000 local health departments (LHDs) were the primary agents to carry out these labor-intensive activities, such as “kindergarten round-up days” before the start of school or investigation of a disease outbreak. Other federal health programs (e.g., the newly created Community Health Centers and National Health Service Corps) supported state and local efforts.

potential of these changes was never realized. The Medicaid fees paid to private physicians who provided immunizations through EPSDT/Medicaid started out low in most states, did not keep pace with soaring medical care and vaccine price inflation, and did not cover the cost of purchasing vaccine in the private sector and delivering it through a private office visit. Even for local health department clinics, the administrative cost associated with the Medicaid billing process was sometimes more than the ESPDT reimbursement for immunization visits. In addition, local health departments frequently did not take advantage of Medicaid financing because it did not fit their routine operations or organizational culture. To identify Medicaid beneficiaries, health departments would have to ask parents about their income and insurance status, a practice that was antithetical to their policies of providing free vaccines to all who sought them. Moreover, many erroneously believed that the clinics would be required to bill everyone for immunizations if they were billing Medicaid when, in fact, they had only to adopt a schedule of fees. Immunization policy during the Carter Administration demonstrated that when both an administration and key congressional actors viewed immunization as a priority and made sufficient funds available to support the public health delivery system and its infrastructure, coverage levels would continue to rise and disease levels continue to decline:

Revising Immunization Policy in the Child Health Component of Medicaid

In making immunization policy decisions, states are wedged between federal program requirements on one side and local providers and consumers on the other. In the early 1980s, states had to meet expanding expectations for disease prevention while grappling with decreased federal resources. State–federal relationships developed under the Califano/Carter initiatives were challenged by proposals for block grants, declining value of immunization dollars in the face of vaccine price and medical care inflation, and eroding support for the public health infrastructure.7,8 President Reagan’s FY 1982 budget proposed folding the Section 317 program into a block grant with reduced funding. After Congress and public health leaders expressed immediate and strong opposition,

The Carter Administration’s immunization initiatives also addressed a problem with the child health component of Medicaid: the Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) program. EPSDT was enacted in 1967, but the original 1971 regulations that implemented EPSDT did not specifically include immunization as a covered service. Revised regulations first permitted (in 1977) and then required (in 1979) states to pay for immunization screening and services as a part of EPSDT. This created a new source of federal/state entitlement funding for immunization. However, the full 102

With the infusion of federal support, states were propelled to more systematically deliver vaccines as a public health function. Each state combined whatever resources it had at hand to meet national goals: cooperative private physicians, state and local health department personnel, state funds for health departments and federal funds for immunization, maternal and child health services, Medicaid, and community health centers.9

A Challenge to Maintaining the Immunization Infrastructure

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the Reagan Administration withdrew the block grant proposal and asked instead for a 34% cut in the categorical funding.10 The Omnibus Budget Reconciliation Act of 1981 (P.L. 97-35) established four block grants, including the Maternal and Child Health (MCH) Services Block Grant and the Preventive Health and Health Services Block Grants, but continued the Section 317 authority as a separate categorical program administered by the federal government. Later, President Reagan signed the Preventive Health Amendments of 1984 (P.L. 98-555) to extend the Section 317 authority for an additional 3 years and amended the program to include adult immunization efforts. While the 317 program primarily financed purchase of vaccines, cuts in other public health programs also had an impact on the provision of immunizations. During the 1980s, public health programs were first cut and then funded at levels that did not keep pace with inflation. Shrinking federal dollars for community health centers and the MCH Block Grant led to reduced numbers of local clinics available for child health, including immunization services. The public health infrastructure built in the 1960s and 1970s eroded during the 1980s.11 The Section 317 funding decisions of the early 1980s illustrate the type of challenges the immunization program has faced in the political process of congressional appropriations or when administration support is limited. In FY 1980 and FY 1981, the 317 program was level-funded at $24.1 million. For FY 1982, in opposition to President Reagan’s budget proposal, Congress increased the appropriation to $27.8 million. Next, the Administration proposed a budget reduction to $21.9 million for FY 1983. This came at a time when the value of vaccine purchase funds was eroding as vaccine prices increased. The CDC reported to Congress that, whereas the FY 1981 funding had been adequate to support immunization of 6.3 million children, the FY 1983 proposed level would be sufficient to reach only an estimated 3.4 million to 3.8 million children. The Reagan Administration argued that a smaller number of doses would be sufficient because the “catch-up” efforts (launched in the Carter era) had been completed and the initial backlog of children immunized (House Appropriations Committee hearing, April 14, 1985). Supporters of the program, including APHA and the American Academy of Pediatrics (AAP), argued that sustained federal funding was needed to immunize the 3.5 million children born each year and to identify and immunize the 3 million children who were behind on immunizations at the time. The program’s supporters were able to secure additional immunization funds by using both a supplemental appropriations bill for FY 1982 that passed over President Reagan’s veto in September 1982 and the continuing budget resolution that authorized $27.4 million for immunization grants to states.

A Vaccine Liability Crisis and the Federal Response The decade of the 1980s was marked by dramatic increases in vaccine prices. Vaccine manufacturers told Congress that two factors, product liability concerns and the cost of research and development, accounted for vaccine price inflation in the early 1980s.12 The childhood vaccine liability issue emerged in 1982. It was brought to the public when a television reporter documented the increasing number of parents who believed that their children had experienced injuries or death associated with “whole cell” pertussis vaccines intended to prevent disease.4 Some “adverse events” did, and do, occur as a result of vaccines; however, media coverage and other publicity escalated public and parental concern to a crisis level. When Congress investigated parental claims and the courts required vaccine manufacturers to produce internal documents, it became evident that the companies had known about adverse reactions for years but had failed to invest in improvements to make vaccines safer.4 Parents across the country organized to express their concern about vaccine adverse events. Newly formed parent organizations felt that safety concerns were too low on the immunization policy and program agenda. They created headlines from the facts of their cases and publicity led to erosion of public confidence, which in turn led other parents to abstain from having their children immunized. The number of pertussis cases nearly doubled between 1982 and 1985, and this round of outbreaks was linked to reduced levels of DPT immunizations. Dr. Martin Smith, then president of the AAP, believed that parents might be delaying immunization because of recent publicity about the safety of DPT and tried to counterbalance that message, saying: “Parents who fear the effects of this vaccine fail to understand that the disease itself causes the same damage, but in far more children.”13 This was a true product liability crisis. Between January 1980 and March 1985, a total of 299 suits were filed against vaccine producers, each seeking compensation for injuries alleged to be due to childhood vaccines, and more than half of them related to DPT combination vaccine. Fifty-two lawsuits were settled. Perhaps more importantly, insurers increased liability insurance costs for manufacturers by tens of millions of dollars.10 A number of public health and political leaders feared that vaccine manufacturers would leave the market. The dependability of the supply of vaccines was in question. This was not an idle fear. Although the CDC maintained stockpiles of vaccine, these were only useful as an interim measure. A shortage of DPT vaccine led to vaccine rationing when one manufacturer stopped shipment of a failed batch of vaccine (something that can happen in any manufacturing Am J Prev Med 2000;19(3S)

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process), another company could not get liability insurance, and a third abandoned the business. The National Childhood Vaccine Injury Act of 1986 (P.L. 99-660) addressed the vaccine-liability crisis. This law created a system for compensating children for injuries received from routine pediatric immunizations. The Vaccine Compensation Amendments of 1987 (P.L. 100-203) provided a source of payment and launched this “no-fault” compensation system, and the Vaccine Injury Compensation technical amendments in 1989 further clarified the process, particularly the role of the U.S. Court of Claims. An excise tax, as a surcharge on selected childhood vaccines, prospectively financed the compensation program. Congressional appropriations were to be the source of funds for retrospective claims. Federal authority was expanded during the mid1980s. The federal government responded to a series of needs and crises by increasing funding for state vaccine purchase and by creating a new vaccine compensation program. However, these were largely stopgap measures and did not address underlying problems in the nation’s immunization system. These problems would emerge and come into focus during the late 1980s, and would lead to new vaccine policies.

The Complexity of Problem Definition and Its Impact on Policy During the late 1980s there were drastically different characterizations of the immunization problems and different views as to which aspect of the problem was most important (e.g., the cost of vaccines or parental attitudes). At a time when scientists believed that we were entering the “golden age” of vaccine development, experts debated the causes of low coverage levels among the youngest U.S. children. Lack of clear problem definition led to differing opinions about the policy and public program solutions. Although all agreed that low coverage levels led to unnecessary outbreaks of disease, there was no consensus about how to improve coverage levels. Coupled with budget pressures at the federal, state, and local levels, the complex problem definition led to an environment in which small, rather than sweeping, policy changes were proposed.

Documenting the Problem in an Era of Complacency By 1987, the combination of Reagan-era budget austerity and the vaccine-liability crisis had taken its toll. More parents feared injury to their children, and it is believed that more parents abstained from immunization mandates. State and local public health agencies had vaccine, but not always a sufficient and reliable supply; and these agencies had to piece together dollars from various other public programs to support the opera104

tional costs of their immunization programs. With vaccine prices at or near an all-time high, the Democratic Congress appropriated more for immunization and got less for the federal dollar. Vaccine manufacturers were preparing for a new generation of vaccines but were wary of the market. Immunization coverage levels were high after school entry, but the youngest children were not adequately immunized. In December 1987, the Children’s Defense Fund publication Who is Watching Our Children’s Health (a report based on unpublished statistics from the CDC) created a ripple effect.14 The report claimed that the nation would fail to meet many of the Surgeon General’s 1990 Health Objectives for the Nation in the area of immunization; immunization coverage levels for preschool children had worsened or showed no improvement in the first half of the decade; and upturns in the number of cases of measles and pertussis were an indicator of the potential for larger outbreaks of disease. The report argued that the erosion of funding for key federal programs (e.g., the Section 317 program, the MCH Block Grant, and Community and Migrant Health Centers) was the primary cause of low immunization coverage rates. In March 1988, the Senate Committee on Appropriations, Subcommittee on Labor, Health and Human Services, and Education (Labor-HHS) held a special hearing chaired by Senator Bumpers who, in his opening remarks, noted: …some troubling trends: continued increase in vaccine prices which in turn cause shortfalls in federal and state immunization funding; stagnation or decline in immunization levels for preschool children; and an inability to guarantee American children access to recently developed vaccines which protect against childhood diseases. . . In short, any complacency is misplaced. We have problems that demand our immediate attention.15 Witnesses told Senator Bumpers that the President’s budget request included funding to provide the same number of doses of vaccine as were purchased in the previous year. Moreover, they said that the CDC was seeking more effective ways to motivate parents in lower socioeconomic areas of about 20 counties across the country. The Association of State and Territorial Health Officials testified that, as a result of the shortfall in proposed federal funding, 32 states would not receive sufficient funds to cover the increased cost of vaccines. The views of public health officials were summarized as follows: Public health officials attribute the problem to a society grown complacent because the threat of widespread disease has eased. They also say many people are either unaware of the need for immu-

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nizations or unable to afford them. The official concerns are compounded by problems with money. Vaccine costs are soaring, largely because of liability coverage and lawsuits, and even many middle-class parents are relying on free immunizations offered by public health agencies. Federal financing is not keeping pace . . . In some states, public health officials warn that they could simply run out of vaccines by summer without more money.16 Similar hearings and policy debates about the need for increased immunization-related funding were held throughout the late 1980s. Typically, state officials and public health advocates called for more or more stable funding in the 317 program. The role of and strategies for improving the Medicaid program were more and more often discussed through 1994. The need for more funding for the National Vaccine Injury Compensation Program was also a recurrent theme. In describing the nature of the problem, CDC and other public health officials and pediatricians believed that parental behavior— either middle-class parents’ fear of adverse reactions or low-income parents’ failure to make immunizations a priority—was a primary cause of low coverage rates. Other possible causes cited were the cost of vaccines and vaccine failures. The lack of consensus about three factors (i.e., the nature of the problem, the role of federal financing, and the policies needed to improve immunization coverage and reduce disease) was evident in these hearings, and strongly affected federal policy discussions and decisions throughout the late 1980s and early 1990s.

The Measles Epidemic: Responding to a New Crisis with New Strategies Descriptions Lead to Recommendations for Action Measles reached a record low in 1983 (1497 cases), a 97% reduction from the ⬎57,000 cases reported in 1977. The goal of the Carter Administration’s Measles Elimination Program had been to eliminate measles in the United States by 1982. However, measles was not eliminated and this success was not sustained. Other priorities and pressure on immunization financing had moved measles to a low-priority position on the program and policy agenda. In 1984 and 1985, outbreaks occurred among older children, including college-aged youth who had entered school before the vaccine was in routine use. A new pattern emerged in 1986 when outbreaks occurred among preschool children and were concentrated in inner-city, low-income neighborhoods in 20 U.S. counties. Sporadic outbreaks of disease became a measles epidemic in 1989 –1991. With a reservoir of unimmunized and underimmunized preschool-aged children,

the disease spread rapidly through several cities, including Chicago, Los Angeles, Milwaukee, and Washington, DC. The CDC’s findings on selected cities were used to develop a response to contain the epidemic as well as new strategies to raise immunization rates. The CDC found that half of the children who had had measles were not immunized, even though many of them had seen a health care provider. Researchers dubbed these visits “missed opportunities” for immunization, and reducing missed opportunities became a priority. The CDC also found that more than one in five of the non-immunized children who contracted measles were also enrolled in the Aid to Families with Dependent Children (AFDC) program, Medicaid, or the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). It became clear that underimmunized children could be identified through other publicly funded programs, and CDC developed demonstration projects to improve immunization levels among WIC clients. Some policymakers proposed that the mandatory and exclusionary approach of school entry laws be applied to the AFDC program (i.e., denying cash assistance if children were overdue for immunizations). Proponents claimed that families would be motivated to protect their children under the threat of losing cash benefits, whereas opponents argued that such penalties were inappropriate and perhaps unethical where affordable immunization services were not readily accessible. Moreover, opponents argued that the school entry laws were a universal measure, not one targeted at a selected group of disadvantaged children. In Congress, the WIC-incentive programs won greater favor than the AFDC-penalty proposals. More recently, though, some states have adopted immunization requirements as a part of welfare reform. While the CDC conducted the laboratory and epidemiologic studies of the measles epidemic, the federal response to the epidemic also was shaped by a new force in policy analysis, the National Vaccine Advisory Committee (NVAC). Created by Congress in 1986 as part of the National Vaccine program, this body was designed to be an independent advisor to the Assistant Secretary for Health. By 1990, the Bush Administration had appointed an active group of advisors, and the measles epidemic led this group to take unprecedented leadership.17 With the support of the CDC and National Vaccine Program Office (NVPO) staff, the NVAC prepared a Measles White Paper, which made key recommendations for responding to the measles epidemic.18 Following release of the White Paper, a federal Interagency Coordinating Committee was formed to outline an implementation plan involving 11 federal agencies. This committee met on a quarterly basis for 18 months, creating a “Public Health Service Action Plan to Improve Access to Immunization Services.” The Plan set out 14 goals with 120 action steps for improving immunization services by: (1) increasing coordination among Am J Prev Med 2000;19(3S)

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federal health income, housing, education, and nutrition programs; (2) reducing policy and management barriers that limit access to delivery systems; and (3) strengthening the delivery infrastructure.19 The estimated price tag for the plan was $72 million in increased federal appropriations (approximately $50 million above the President’s budget for FY 1993). This action plan received attention in the national press. The White House response to the plan was summarized in the New York Times as follows: In a Rose Garden ceremony last week, President Bush said he was sending a team of senior officials to six cities “to learn why kids aren’t getting immunized”… But now the White House has deferred action on an emergency plan to buy vaccines and distribute them to cities and states… the Administration has decided to wait at least until next year to request money for the program.20 To gather information about the measles epidemic and to assess policy options, Congress held several hearings in Washington and one field hearing in Los Angeles where the outbreak was particularly bad. Members of Congress wanted to identify the contributing factors that led to the outbreak and possible responses. Testimony at those hearings reflected the different definitions of the problem, remedies being proposed, and priorities for funding. For example, at a 1990 hearing in the U.S. House of Representatives for “Childhood Immunization Program Reauthorization,” Dr. Alan Hinman, director of the Center for Prevention Services, CDC, said: “The major goals of [the Infant Immunization Initiative] are to define the magnitude of the problem by developing assessment techniques to measure coverage at both the national and local levels, and to learn the most cost-effective methods to achieve and maintain high age-appropriate immunization levels.”21 At the same hearing, the Children’s Defense Fund recommended FY 1991 funding at $150 million, with $30 million for the Infant Immunization Initiative and $20 million for state operations funding to improve the program infrastructure. Asked about immunization funding priorities, Dr. Georges Peter, representing the AAP, said: “Mind you, you cannot field a baseball team without nine players. So you are asking me how I would establish the lineup. . . the single most important program is the measles reimmunization. . . I think the state operations money is critical to ensuring that children receive the other vaccines.”21 In June of 1991, Dr. William Roper, as director of the CDC, testifying along with other witnesses, suggested that the measles “epidemic still affects predominantly unvaccinated preschool racial and ethnic minority children in inner cities.”22 Other public witnesses expressed the view that low-income working families 106

living in communities across the country faced financial barriers to immunization access.

Increased Appropriations to Respond to the Measles Epidemic A year later, President Bush (alongside his Secretary of Health and Human Services, Dr. Louis Sullivan) held a Rose Garden ceremony to announce the Infant Immunization Initiative and that model immunization plans would be developed in several areas of the country as the beginning of a national effort to ensure adequate and timely immunization of infants and young children. This ultimately resulted in the preparation of Immunization Action Plans by states, territories, and large cities.9 President Bush recommended increased funding for the 317 program, and members of Congress concurred. The House and Senate Subcommittees Labor-HHS Appropriations, which determine annual funding for the 317 program, targeted funds for FY 1990 through FY 1993 to address the measles epidemic.

Entitlement Programs to Finance Childhood Immunizations Financing Immunizations through Medicaid As a result of the Medicaid eligibility expansions of that occurred between 1984 and 1990, an increasing number of infants and preschool children were eligible for and enrolled in Medicaid. By 1993, more than one third of all U.S. infants were eligible for Medicaid (in some states, more than half) and more than one quarter of children aged 1 through 6 years.23 Pressure mounted on both the federal and state governments to address the shortfalls in Medicaid immunization policies and reimbursement rates. In June 1992, the Subcommittee on Health for Families and the Uninsured, Committee on Finance held a hearing on “The Impact of Medicaid on Child Immunization.” The focus was “The Comprehensive Child Health Immunization Act,” introduced by Senators Donald Riegle (D-MI) and Christopher “Kit” Bond (R-MO). This bill would have established Medicaid demonstration projects and a nationwide computerized information system (i.e., immunization registries). The Bush Administration opposed the bill on the grounds that it duplicated existing federal and state efforts in Medicaid. Nevertheless, this and similar discussions of Medicaid policy options laid the policy framework for the federal legislation that would be adopted in 1993. State Medicaid agencies had begun to implement “vaccine replacement” policies to reduce their expenditures for immunization and to encourage participation among private physicians on their own initiative. States would buy additional vaccine at the federal bulk purchase contract price and distribute the vaccines (in

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advance or on a replacement basis) at no cost to private physicians who, in turn, would dispense the vaccines to children in Medicaid programs. In 1993, the U.S. General Accounting Office surveyed 22 states that were still using traditional fee-for-service reimbursement for immunization services, and estimated that at least $12.7 million could be saved if these programs were converted to replacement programs.24 The NVPO and NVAC also were studying immunization finance strategies. In April 1992, the NVAC forwarded a report, Improving Access to Childhood Vaccines, which focused on four major goals: (1) to secure adequate financing for vaccines, (2) to ensure vaccine supply and the capacity to immunize, (3) to increase demand for services, and (4) to monitor immunization coverage levels. In response to this report, the NVPO and CDC commissioned a study, “The Economic Underpinnings of Vaccine Supply.”25 The authors summarize their findings as follows: ● ●

●

●

The demand for childhood vaccines is constant but not rapidly growing. Similar to other pharmaceutical products, the economic factors in vaccine manufacturing involve large initial investments in product research, development, and testing. However, in contrast to most prescription drugs, vaccines are not considered highly profitable products. The vaccine market is different from many others because it has dual public and private price structures, as well as an excise tax related to vaccine safety/liability. Probably the most important difference is that government is a major buyer of vaccine.

The Clinton Proposal and Differing Views Between 1990 and 1993, the definition of the immunization problem and the policy remedies proposed varied widely. As stated above, some believed that more federal funding for underserved areas was the solution; others believed that the high cost of vaccines created a much larger problem; and still others held the view that parental behavior was the primary cause of low coverage rates. This lack of consensus about the problem led to diverse views about the solutions (e.g., money for clinics, increased third-party payments for vaccines, or health education for parents). At the start of the Clinton Administration, the President made a proposal that would harden these views and sharpen the debates regarding remedies. President Clinton first announced his immunization initiative in February 1993 and requested new funding in his economic stimulus package early in his administration. This stimulus package would have added $300 million for immunization activities, $225 million earmarked for grants to states and cities and $75 million for research, registries, a vaccine stockpile, and ensur-

ing the safety of vaccines.26 The House passed this funding bill, but it failed to pass in the Senate. As a result, the White House had to pursue a legislative strategy for advancing its immunization proposal. President Clinton introduced the “Comprehensive Childhood Immunization Initiative Act of 1993” on April 1, 1993. This legislation was intended to ensure that all U.S. children are protected against vaccinepreventable disease. This legislation had five basic components: (1) a new program guaranteeing free immunizations for all children; (2) increased discretionary appropriations for improving the public delivery system; (3) reauthorization of the Vaccine Injury Compensation Act revenue provisions; (4) establishment of immunization tracking systems nationwide; and (5) expanded education and mobilization efforts aimed at providers, payers, and parents. The universal vaccine-purchase provision—which created a new entitlement program—was the most controversial and overshadowed any other immunization topic in the Congress. Originally, Clinton intended that the federal government would provide immunizations to all children regardless of income, but opposition from Capitol Hill narrowed this approach to low-income and uninsured children.27 After President Clinton submitted his Childhood Immunization Initiative to Congress, members of the House and Senate grappled with how to react to the President’s initiative. Lawmakers debated whether the price of vaccines or access to them posed the biggest barriers to immunization. In a joint hearing held in April of 1993, members of the House Energy and Commerce Committee and Senate Labor and Human Resources Committee debated the merits of the President’s proposal. Senate Republicans including Nancy Kassebaum (R-KN), John Danforth (R-MO), and David Durenberger (R-MN) thought that the President’s plan was misguided. Senator Kassebaum conveyed her thoughts as follows: “The President’s plan is based on the premise that the rising cost of vaccines is the major cause of our low immunization rates. But that is not the case. I agree that the cost of vaccines may be one facet of the problem for some parents. But the National Vaccine Advisory Committee, former Surgeon General Koop, and most public health officials across the Nation find that the major causes of low immunization rates are the lack of parental education about the continued importance of immunizing their children, the failure of health professionals to use every opportunity to vaccinate children, our overburdened public health clinics where immunization services are not readily accessible, and the lack of private physician participation in Medicaid due to unreasonably low Medicaid reimbursement rates.”28 Am J Prev Med 2000;19(3S)

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Leading senators focused on access to vaccines as the largest deterrent to parents, whereas House immunization leaders thought that price remained the major barrier.27 The competing House and Senate bills reflected these differing perspectives on the problem and its solution. Overall, the House version followed the outline of the President’s initiative. The House bill would have created a new Section 21 in the Public Health Service Act for childhood immunizations, establishing entitlement for the purchase and delivery of vaccines. The House language required outreach and education, as well as coordination between state Medicaid agencies and other federal programs. The Senate bill had similar coordination language, but it went further by outlining efforts to rebuild the public health infrastructure and conduct outreach activities. The Senate version stipulated that state Medicaid agencies could establish a bulk purchase program or a vaccine replacement program. The Senate language limited the price of vaccines of the new program to the price that was already in effect through existing CDC contracts, whereas the House bill would have repealed the Section 317 program.29 The VFC Program was enacted as an amendment to the Medicaid statute (Title XIX of the Social Security Act) on August 10, 1993, as part of the Omnibus Budget Reconciliation Act of 1993 (P.L. 103-66).30 The House–Senate conference agreement represented a compromise related to whom would be covered under the new program, and certain provisions (including the creation of registries and expansion of clinic hours) were dropped because of constraints in the Senate parliamentary procedure under which it was passed. The new law: ●

●

●

●

Established a limited immunization entitlement for the purpose of vaccine purchase and distribution to children who are Medicaid-eligible, uninsured, or underinsured and receive services at federally qualified health centers or rural health clinics, and to Indian children; Explicitly stated that the Section 317 program would be preserved and that any funds not needed for vaccine purchase could be diverted to infrastructure; Reinforced the notion that free vaccines must be provided in conjunction with improvements in essential immunization infrastructure such as longer clinic hours, more outreach workers, better parent education, and higher physician payments; Allowed the Secretary of Labor, Health and Human Services, and Education (Labor-HHS) to enter into contracts with vaccine manufacturers for purposes of this program. The prices of existing vaccines were not to exceed those negotiated by the CDC in existing contracts, but the prices of new vaccines were not constrained; and

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●

Required the CDC to maintain a 6-month supply (stockpile) of vaccines.

The program was slated to take effect on October 1, 1994. The NVPO (then directed by Dr. Anthony Robbins), CDC, and HCFA were to implement the program collaboratively. Modeled after the existing federal program for bulk, discount purchase, the program would be administered primarily through the CDC and state health departments.

Political and Practical Challenges to VFC Implementation Even a few months into the implementation phase of the program, skepticism about the value of VFC in solving the childhood immunization problems continued to plague the program. Congressional inquiries surrounding VFC began shortly after its passage, when Senator Bumpers and Representatives Scott Klug and Ron Wyden asked the General Accounting Office (GAO) to investigate and report about the program. In June 1995, the GAO concluded with the suggestion that: “Congress may want to consider refocusing VFC’s goal from the improvement of general immunization rates to the achievement of higher rates in pockets of need, where conditions are ripe for disease outbreaks among underimmunized children.”31 Another congressional committee (the one that had adopted the legislation the prior year) held an oversight hearing inquiring about the efficacy of the VFC program. The Senate Finance Committee held a hearing in May 1995 to examine the findings of the GAO report. In his opening statement, Chairman Bob Packwood (R-OR) said: “The evidence seems to be that the cost of vaccine does not seem to be the problem with children getting vaccinated. There may be other problems, but that does not seem to be a problem or even the principal problem.”32 Senator Riegle, ranking minority member of the Subcommittee on Families and the Uninsured of the Senate Finance Committee, defined the problem more as one related to health coverage and proposed a compromise that would have required every family health insurance policy (including self-insured health plans) to include coverage for children’s preventive health care and provide first-dollar coverage for childhood immunizations and well child care (as defined by the AAP). This proposal reflected Riegle’s interest in expanding health coverage for children and his view that immunization financing could be achieved through public and private health plans. Although the creation of VFC resulted in some congressional deliberations over federal immunization policies, no explicit restructuring of the Section 317 program occurred as a result. The President’s initiative did not focus on the Section 317 program. Instead,

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members of Congress who had historical interest in the Section 317 program, particularly Senator Bumpers, protected this program throughout the VFC debate. Ultimately, it seems that supporters of VFC and of the Section 317 program both believed that the programs would co-exist.

Adaptation of the Section 317 Program in a Changing Health Policy Environment The Section 317 statute has not changed much in 35 years, despite significant changes to the health care delivery system, other federal immunization activities, and rates of immunization coverage. Congress first appropriated funds for this program in 1963 and has continued to appropriate discretionary funds annually.9 The 317 program that emerged in the early 1960s responded to immediate needs and narrow objectives. Although the Department of Health and Human Services and the CDC have developed their own guidance, Congress has not specified expectations for this program in the statute. From time to time, members of the House and Senate Committees on Appropriations have offered guidance, but few statutory changes have been pursued. When members of Congress had the opportunity to examine and to update the Section 317 program’s statute during its reauthorization (most recently in 1998), they opted not to make major revisions.

The Appropriations Committees Set Policy Priorities The U.S. House of Representatives and Senate Committees on Appropriations, Subcommittees on LaborHHS played a large role in the growth and shape of the Section 317 program throughout the last decade. Notwithstanding the creation of VFC, the congressional appropriators made a bigger impact on the 317 program than their counterpart authorizing committees (the latter having jurisdiction over the nature of the program but not over the annual level of support). As a longtime member of the Labor-HHS Appropriations Subcommittee, Senator Bumpers held a keen interest in expanding immunization coverage rates for children, and played an instrumental role in the 317 program’s development. In the past decade, congressional appropriators reshaped the 317 program in response to changes in political will, immunization service delivery, and administration. Taken together, these changes reflect changing views about how to address problems with immunization coverage and how best to use federal dollars. In the early 1990s, Congress viewed the Section 317 program as the best vehicle to respond to the measles epidemic. Appropriators consequently increased program funding dramatically. The Section 317 program funding level jumped from approximately $160 million

to $528 million between FY 1990 and FY 1994. From this high-water mark, program funding eroded in subsequent years. By 1995, the era of flat and decreasing funding had begun. The congressional appropriators’ views of the 317 program shifted when the measles epidemic subsided and constraints on federal discretionary spending took hold. With fewer discretionary dollars to spend and other competing priorities, appropriators looked to the Section 317 program as a place to make cuts. Appropriators stopped increasing the program in FY 1996 and FY 1997 and cut the program in FY 1998. In addition to changing funding levels, Congressional appropriators set changing priorities for the use of 317 funds. Over the last decade, legislative changes included in the Labor-HHS Committee Reports have been far reaching. The sheer number and specificity of Appropriations Committee recommendations from FY 1994 through FY 1999 reflect their interest in oversight of the Section 317 program. Although Appropriations Committee members are responsible primarily for the level of support given the program, they (often at the behest of Senator Bumpers) made programmatic adjustments through funding priorities almost every year during the past decade (see Table 1). Through their efforts and direction, the 317 program has grown, adapted, and gained new responsibilities over time. In recent years, Committees on Appropriations have responded to tight federal budget caps and pressure to shift discretionary spending among categories. The existence of carryover dollars in the 317 program led to questions about the necessary funding levels for 317 and about the relationship between VFC entitlement and the 317 appropriated grants program.

Few Amendments Made to the Legal Authority of Section 317 In contrast to the Committees on Appropriations, the authorizing committees, the House Committee on Energy and Commerce (now the Commerce Committee), and the Senate Committee on Labor and Human Resources (now the Health, Education, Labor, and Pension Committee) made few revisions to the Section 317 program during the 1990s (Table 2). The Vaccine and Immunization Amendments of 1990 (P.L. 101-502) authorized Section 317 program appropriations of up to $205 million for FY 1991 and “such sums as necessary” through FY 1995. (In authorization bills, this term indicates that the funding level is at the discretion of Congress throughout the authorization period.) These Amendments established new immunization demonstration projects intended to improve the immunization rates of children aged ⬍2 years who had low levels of coverage, targeting the children most affected by the measles epidemic: those who were low-income, high-risk, or from certain geographic arAm J Prev Med 2000;19(3S)

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Table 1. Highlights of recent recommendations made by U.S. House of Representatives and Senate Committees on Appropriations Fiscal year

Committee report

Description of recommendation

1990

House Rep. 101-274

1990

House Rep. 101-493 (Supplemental)

Stipulated that $10 million of the immunization grants should be spent on the measles outbreak. A 1990 supplemental funding bill (designed to provide resources for the Persian Gulf War) allocated an additional $30.5 million for measles outbreak and control, and the purchase of a second measles immunization. The language also directed CDC to reprogram $5 million from other immunization activities for measles. President Bush’s budget proposal requested an increase of $7.9 million in Section 317 program funds to support the Infant Immunization Initiative and a total of $130.9 million in Section 317 funding. Continued to expand funding for the Section 317 program in 1991 with funds for measles outbreak and control and a second measles immunization. The House–Senate Appropriations Conference Report (compromise) language added $46 million to ensure that vaccines were available for children under the age of 2. Recommended that the CDC spend $10 million of the immunization funds on the purchase of a second dose of the measles, mumps, and rubella vaccine. Urged funding for outreach activities targeted at hard-to-reach populations, especially those in large, urban areas. Initiated bonus payments to be awarded to certain states that improved their immunization rates of 2-year-olds. Allowed Section 317 funds to be spent on improving vaccine delivery infrastructure. States could spend their money to hire more health professionals, expand clinic hours, and stay open at night and on weekends. Encouraged Aid to Families with Dependent Children waivers that tied recipients’ benefits to their children’s immunization status. Stipulated that infrastructure funds could be spent on the development of registries. Focused on trying to improve immunization coverage rates among high-risk populations by specifically directing the CDC to reserve 10% of Immunization Action Plan funds for immunization assessment and referral services at WIC sites. (The Senate continued to recommend an allocation of Section 317 funds for such WIC linkages every year through 1999.) Initiated community-based demonstration projects designed to improve immunization coverage of underserved children. Provisions stipulated that demonstration projects should be located in a federally designated health professional shortage area (HPSA), and that these projects should link immunization efforts with each child’s source of primary care. Requested the CDC to prepare a report on carryover funds. Reflected continued concern about carryover funds.

1991 1991 1992

House Rep. 102-282

1992

House Rep. 102-182

1992

House Rep. 102-282

1994

Senate Rep. 103-143

1994

Senate Rep. 103-143

1994

Senate Rep. 103-143

1995 1996

Senate Rep. 103-318 Senate Rep. 104-145

1996

Senate Rep. 104-145

1996 1998

Senate Rep. 104-145 Senate Rep. 105-58 House Rep. 105-205 Senate Rep. 105-58 House Rep. 105-205

1998

1998 1999

Senate Rep. 105-58 Senate Rep. 105-300

1999

Senate Rep. 105-300

1999

House Rep. 105-635

Disagreed with the Clinton Administration’s recommendation that the National Vaccine Injury Compensation Program excise tax be waived for federal vaccine purchase. The Clinton Administration proposed waiving the National Vaccine Injury Compensation Act excise tax on the purchase of vaccines for those doses purchased with Section 317 funds in FY 1998. Neither the House nor the Senate accepted this proposal. Urged the CDC to build greater accountability mechanisms into the program. Expressed concern about the funding of the Section 317 program. The Senate Committee Report language stated that the, “Committee is interested in evaluating the relationship between funding levels over the past five years.” The language also said, “of particular concern are the manner in which immunization program funds are distributed among states and the degree to which funds within states are targeted at high-risk populations.” The Committee Report directed the CDC to contract with the Institute of Medicine to conduct a study on these and other issues. The Senate Committee Report language also expressed concern about Administration plans to require states to purchase vaccines for the Vaccines for Children program with Section 317 funds. The House language expressed its displeasure with the inaccuracy of vaccine purchase estimates presented to Congress by the CDC.

CDC, Centers for Disease Control and Prevention; WIC, Supplemental Nutrition Program for Women, Infants, and Children

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Table 2. Key laws that affect the Section 317 Immunization Program Title Vaccine and Immunization Amendments of 199033 OBRA 1993 Health Professions Education Partnerships Act of 199834

Date enacted

Legislative reference

11/3/90

P.L. 101-502

8/10/93 11/13/98

P.L. 103-66 P.L. 105-392

Description 317 Reauthorization increased authorization level established demonstration for children aged ⬍2 years. Enacted the Vaccines for Children (VFC) program 317 Reauthorization reauthorized the program until 2002

OBRA, Omnibus Budget Reconciliation Act

eas. The legislation also continued the authorization of a 6-month stockpile of vaccines in case of a shortage in supply. Finally, the legislation made technical changes to the Vaccine Injury Compensation Program by extending the deadline for filing claims, as well as authorizing appropriations for the compensation program. In 1998, Congress reauthorized the Section 317 program and made one technical change to the statute. The Health Professions Education Partnerships Act, P.L. 105-392, became the legislative vehicle for reauthorization of the Section 317 program and other public health programs. The legislation made a minor— but significant— change to Section 317 that dropped the word “individuals” and substituted “children, adolescents, and adults” to define who can receive vaccines purchased with program funds. This change did not make any difference to the functioning of the program, but it did make an explicit reference to two age groups that were not usually associated with the program (i.e., adolescents and adults). The legislative language also extended the program’s authorization from FY 1998 through FY 2002. Although the authorizing committees had the opportunity to make broad statutory changes during the 1998 reauthorization of the Section 317 program, they did not do so. The reasons why the authorization committees opted not to deal with questions raised by the appropriators, such as carryover funds or priority to underserved areas, are not clear. What is clear is that lawmakers did not choose to restructure the 317 program.

Repeating the Cycle Over the past 4 decades, the congressional perspective on the Section 317 program has evolved. In times of crisis, such as when there is an epidemic or a new vaccine, the 317 program has served as the primary emergency response vehicle. When a problem is well defined (e.g., poor rates of coverage among some the youngest and poorest children), Congress and the presidential administrations have approved significant funding increases to address unmet needs. In 1982, Dr. William H. Foege, as director of the CDC, described the Section 317 program in testimony to Congress, saying: “The program has not only been

effective, it has provided an ideal example for federal, state, and local partnership, as well as partnership between government and the private sector.” Since the 1960s, federal immunization funding decisions assumed that the available state or private-sector dollars would be sufficient to meet the remaining need. Unfortunately, this has not always been the case. When private health insurance does not include immunization benefits or state legislatures fail to appropriate needed funds, gaps in immunization coverage result. The momentum of the polio epidemics gave way to complacency in the early 1970s. By the late 1970s, immunization coverage levels were low, and the issue once again was placed at the top of the political agenda. The Carter Administration’s initiatives aimed to raise coverage and to eliminate measles but stopped short of success. When these goals were largely ignored during the 1980s and federal public health funding did not keep pace with medical care and vaccine price inflation, a measles epidemic occurred. That epidemic generated the momentum that led to a large infusion of Section 317 funds for state and local public health programs and to enactment of the VFC program. Dramatic improvements in immunization coverage were achieved during the 1990s, but momentum has been lost. Moreover, unpredictable expansions and contractions of Section 317 funding levels have led to instability in this program. The result will likely be another outbreak or, at a minimum, the inability to expand state programs that are targeting the elimination of vaccine-preventable diseases. In November 1998, the NVAC issued a report, Strategies to Sustain Success in Childhood Immunization. This recent White Paper calls for action in four areas: financing, surveillance, provider practice, and parent/community involvement. However, in contrast to the NVAC Measles White Paper, these policy recommendations arrive at a time when there is no epidemic or apparent coverage crisis. Although the report documents the need for action to sustain success and makes recommendation for action, no policy action has been taken to implement the recommendations. The Section 317 program retains its traditional authority and mission to address urgent needs, sustain public delivery systems, and provide funds for the purchase of vaccines. The key questions are: Can the Am J Prev Med 2000;19(3S)

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resources to sustain progress in immunization be secured during times with no crisis, or must another epidemic occur before the federal government is willing to commit optimal resources? Will the Congress appropriate and the President approve funds to ensure constant “readiness” in immunization, as they do to ensure readiness in defense? Can the nation learn from the past, or must the cycle of disease outbreaks and remediation be repeated?

References 1. Rosen G. A history of public health. New York: MD Publications, 1958. 2. Freeman P, Johnson K, Babcock J. A health challenge for the states: Achieving full benefit of childhood immunization. Boston: McCormack Institute of Public Affairs, University of Massachusetts at Boston, 1993. 3. Section 317 of the Public Health Service Act. 42 USC Section 247b. 4. Freeman P, Robbins A. The elusive promise of vaccines. The American Prospect 1991(Winter):93. 5. Starr P. The social transformation of American medicine. New York: Basic Books, 1982:187. 6. Hinman AR. Progress over the last decade, 24th National Immunization Conference, May 21, 1990. 7. Hinman AR. Testimony before the Senate Committee on Labor and Human Resources, Subcommittee on Investigations and General Oversight. July 22, 1982. 8. Hinman AR. A new U.S. initiative in childhood immunization. Bull Pan Am Health Organ 1979;13:169 –76. 9. Orenstein WA, Hinman AR, Rodewald LE. Public health considerations— United States. In: Plotkin, Orenstein, eds, Vaccines, 3rd ed. Philadelphia: WB Saunders, 1999. 10. Committee Report on Childhood Immunization. Subcommittee on Health and the Environment, Committee on Energy and Commerce, U.S. House of Representatives. Committee Print 99-LL. Washington, DC: U.S. Government Printing Office. 1986. 11. Institute of Medicine. The future of public health. Washington, DC: National Academy Press, 1988. 12. Testimony of Robert B Johnson, President, Lederle Laboratories Division, American Cyanamid Company. December 19, 1984. 13. AAP News. Vol. 1, Number 12. December 1985. 14. Johnson K. Who’s watching our children’s health. Washington, DC: Children’s Defense Fund. 1987. 15. Bumpers D. Senate Hearing before the Committee on Appropriations. 100th Congress, Second Session. Special Hearing (S. Hrg 100-829). 16. Gimmicks promote vaccines in young: Public health agencies trying contests and other ways to increase immunity. New York Times. Sunday, March 20, 1998.

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17. A shot in the arm for vaccine advocates. Medicine and Health Perspectives. July 30, 1990. 18. National Vaccine Advisory Committee. The measles epidemic: the problems, barriers, and recommendation. JAMA 1991;266:154 –52. 19. The Interagency Committee to Improve Access to Immunization Services. The public health service action plan to improve access to immunization services. Public Health Reports 1992;104:243–51. 20. Pear R. Bush defers an emergency plan to provide vaccines for children. New York Times. June 23, 1991:1. 21. Testimony before the House Committee on Energy and Commerce, Subcommittee on Health and the Environment. March 7, 1990. (Serial No. 101-134). 22. Roper W. Testimony before the Committee on Appropriations. United States Senate. June 20, 1991. Washington, DC, U.S. Government Printing Office, S. Hrg. 102-298. 23. Johnson K. Families, babies, and Medicaid: a report to the Speaker of the House. White Plains, NY: March of Dimes Birth Defects Foundation; 1995. 24. U.S. General Accounting Office. Childhood immunizations: opportunities to improve immunization rates at lower cost. Washington, DC: U.S. Government Printing Office; 1993. 25. Pauly M, Robinson CA, Sepe SJ, Sing M, Willian MK. Supplying vaccine: an economic analysis of critical issues. Washington, DC: IOS Press, 1996. 26. Healey J, Rubin A. Spending increases come first in rush to pass package. Congressional Q 1993;February 20:365– 8. 27. Rubin AJ. Competing immunization bills seek increased vaccinations. congressional Q 1993;July 17:1884. 28. Kassebaum N. Prepared statement before a joint hearing of the Senate Committee on Labor and Human Resources and the House Energy and Commerce Committee. U.S. Congress. April 21, 1993. Washington, DC: U.S. Government Printing Office, S. Hrg. 103-169. 29. Conference Report on Medicaid Pediatric Immunization Provisions. Congressional Record - House, August 5, 1993, 19370-5. U.S. Government Printing Office, Washington, DC. 30. Omnibus Budget Reconciliation Act of 1993. P.L. 103-66. Signed into law August 10, 1993. 107 Stat. 636. 31. U.S. General Accounting Office. Vaccines for Children: Reexamination of program goals and implementation needed to ensure vaccination. June 1995 (GAO/PEMD-95-22). 32. Packwood R. Statement before the Senate Finance Committee. U.S. Senate. May 4, 1995. Washington, DC: U.S. Government Printing Office, S. Hrg. 104-82. 33. Vaccine and Immunization Amendments of 1990. P.L. 101-502. Signed into law November 3, 1990. Bill and legislative status obtained via Library of Congress, Thomas website. Available at: http://thomas.loc.gov. 34. Health Professions and Education Partnerships Act of 1998. P.L. 105-392. Signed into law November 13, 1998. Bill and legislative status obtained via the Library of Congress, Thomas website. Available at: http://thomas.loc.gov.

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