Financing Vaccines in the 21st Century Assuring Access and Availability (2004) / Chapter Skim
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2 Origins and Rationale of Immunization Policy
2 Origins and Rationale of Immunization Policy
Pages 39-62
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From page 39... ...
iEligible populations include children in Medicaid, uninsured children aged 18 and under, Native Americans and Alaska Natives, and all children vaccinated in federally qualified health centers (FQHCs)
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From page 40... ...
, CDC grantee reporting and evaluation process, registries State school entry laws, state nursing home requirements, state child day care requirements, travel requirements VFC, Veterans Administration Department of Defense/ CHAMPUS CDC Section 317 grants to states State employee coverage, universal purchase programs, other state purchases National stockpile program Linking producers, state health officials, providers, CDC National Vaccine Injury Compensation Fund Massachusetts vaccine production program
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From page 41... ...
Between VFC, the Veterans Administration, the Department of Defense, and state governments, the public sector purchases the majority of vaccines sold in the United States. This deep public involvement in the national immunization system is based in part on the public-good properties and spillover effects that characterize vaccines (see Box 2-1~.
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From page 45... ...
It is unlikely that this system can effectively serve the public in the future without undergoing substantial change. As context for the remainder of the report, this chapter examines the legislative origins of the current system, explains the shared federal and state responsibility for financing of vaccine purchases and the shared public and private responsibility for immunization coverage, describes public and private immunization delivery systems, reviews private vaccine production, and summarizes the process used for setting national vaccine policy.
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From page 46... ...
The first bulk purchases of vaccines under a federal contract occurred in fiscal year 1966, when the federal government purchased polio and measles vaccines under consolidated contracts and provided them in lieu of financial grants to state and local public health agencies. The purpose of this policy change was to offset the costs incurred by state and local public health agencies, since the bulk purchase of vaccines under a federal contract led to substantial price reductions.
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From page 47... ...
CDC negotiates federal contracts for the public purchase of vaccines for the VFC program and state purchase, which account for more than half of childhood vaccines sold in the United States. CDC also determines Section 317 funding to state grantees, maintains the national vaccine stockpile, and supports state immunization program offices.
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From page 48... ...
Starting in the early 1990s, a handful of states established universal purchase programs that use state funds to purchase vaccines for all citizens, regardless of insurance status. Fourteen states now have such programs, although several have excluded the most expensive vaccines.
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From page 49... ...
States continue to perform the public health and administrative functions associated with immunization (Freed and Cowan, 2002~. SHARED PUBLIC AND PRIVATE RESPONSIBILITY FOR COVERAGE Prior to the last several decades, employer-based private insurance provided limited coverage for preventive services, including immunization.
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From page 50... ...
and indemnity plans provide immunization coverage less frequently (Wood, 2003~. Since PPOs are gaining in market share relative to HMOs (Kaiser Family Foundation and Health Research and Educational Trust [KFF-HRET]
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From page 51... ...
enrollees, and (2) delivery of safety net services within the "medical home or usual source of care." Thus, VFC expanded the safety net provider base from roughly 3,300 public clinics to more than 40,000 public and private provider sites (IOM, 2000a)
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From page 52... ...
Examples of issues that have created tensions include the need for protection from lawsuits over vaccine injury, which resulted in the adoption of the National Vaccine Injury Compensation Program; the removal of thimerosal (a mercury-based preservative) from recommended vaccines; the passage of VFC, which resulted in a larger public share of vaccine purchases and lower average prices; the introduction of the FDA's Team Biologics regulatory regime, which increased the burden of regulatory compliance for producers; the higher industry pricing model for new vaccines, such as varicella and pneumococcal conjugate; unprecedented vaccine shortages; and the increasing burden of proof required for vaccine approval and entry into the U.S.
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From page 56... ...
' 1 THE SETTING OF NATIONAL VACCINE POLICY The vaccine enterprise has experienced unprecedented turmoil and change in areas ranging from pricing and shortages to globalization and technological developments. Thus, the validity of key assumptions that have guided national vaccine policy to date is eroding.
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From page 57... ...
Its roles include negotiating federal vaccine contracts, providing grants and assistance to states, conducting immunization surveillance, studying vaccine safety, and coordinating public health programs nationally. · Advisory Committee for Immunization Practices (ACIP)
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From page 58... ...
DEMAND Public and Private Purchasing Providers Payment Systems Pricing Access The recommendation process begins with FDA approval for licensure of a new vaccine product. ACIP then begins considering whether and under what circumstances the vaccine should be recommended for use by the public.
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From page 59... ...
In the case of pneumococcal conjugate vaccine, ACIP delayed publication of its recommendation until a price could be negotiated with the manufacturer; as a result, states and providers were financially responsible for vaccine purchases (Fairbrother and Haidery, 2002~. Private insurers may also face difficulties in paying for new vaccines not included in their annual budgets or premium calculations.
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From page 60... ...
. For vaccines included in the VFC program, only a few state Medicaid programs will reimburse private clinicians for the use of privately purchased vaccine that is available under the federal contract, even in the case of shortages when publicly purchased vaccine may not be available.
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From page 61... ...
Also, there is a trend toward vaccines that target conditions other than contagious diseases and thus do not possess the traditional spillover effects characteristic of the majority of vaccines that prevent highly contagious diseases. Some new vaccines may have lessfavorable cost-benefit profiles, and new combination vaccines may have costs and benefits not captured in traditional cost-benefit analysis.
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