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COMMENTARY |
a University of Michigan Medical School
b Divisions of General Pediatrics and General Internal Medicine and Gerald R. Ford School of Public Policy, University of Michigan, Ann Arbor, Michigan
Abbreviations: ERISA, Employee Retirement Income Security Act • IOM, Institute of Medicine • VFC, Vaccines for Children • NMHPA, Newborns' and Mothers' Health Protection Act
More than 8 of 10 children in the United States have received their recommended vaccinations by 3 years of age.1 However, as the costs of immunizations increase,2 health insurance plans may be less likely to include coverage for all vaccinations recommended for children and adolescents.3 Such variations in coverage may discourage physicians from administering comparatively expensive vaccine series such as pneumococcal conjugate vaccine4 and also threaten the success of vaccination efforts regarding newly recommended quadrivalent meningococcal conjugate vaccine5 and combined tetanus-diphtheria-acellular pertussis vaccines,6 as well as vaccines that may be recommended in the near future (eg, human papillomavirus vaccine).7
Such economic barriers to childhood vaccination obstruct public health efforts to safeguard children's well-being. Moreover, recent evidence regarding varicella and pneumococcal conjugate vaccines indicates that childhood vaccination programs not only protect children's health but have dramatic positive effects on adults' health and reduce the costs of health care as well.8–13
For these reasons, insurance coverage for childhood vaccinations is the focus of increasing legislative attention. Insurance mandates regarding immunizations in many states require health plans to include children's vaccination benefits, but plans financed by employers themselves ("self-insured" plans) are exempt from such mandates under the federal Employee Retirement Income Security Act (ERISA)14 and may leave children "underinsured" for recommended vaccines. Underinsured children (recently estimated to comprise 
10% of children overall) are less likely to receive recommended vaccines than their more comprehensively insured peers.15 Other childhood immunization challenges, such as recurrent vaccine shortages and a decreasing number of vaccine manufacturers over the last several decades,16 have also been attributed in part to incomplete coverage for childhood vaccines in private insurance plans that reduce vaccine manufacturers' private-sector revenue.
In 2003, an expert panel of the Institute of Medicine (IOM) called for a new federal statute that would override ERISA and mandate coverage for all recommended childhood vaccines in all health insurance plans throughout the country.15 In considering their core recommendation for a federal coverage mandate, the IOM panel explored a variety of approaches to funding and implementing such a program, including a federal subsidy to compensate employers and insurers for covering children's vaccines, at valuation levels intended to reflect vaccines' benefits to society, and a federal voucher system for uninsured children to receive vaccines as a replacement for the current Vaccines for Children (VFC) program. These different financing approaches would have markedly distinct implications for the economic burdens borne by the public and private sectors.
Proposals to mandate childhood immunization coverage in insurance plans were introduced in the US House of Representatives and US Senate in the 2001–2002 Congressional session and never made it out of legislative committee.17,18 However, Congress does have a history of statutory override of the federal ERISA law pertaining to children's health, namely the Newborns' and Mothers' Health Protection Act (NMHPA) of 1996, which established minimum insurance coverage for postpartum stays (ie, 48 hours of hospital stay coverage after an uncomplicated vaginal delivery).19 Passage of the NMHPA has been attributed chiefly to politically powerful anecdotes from mothers and health care providers, which allowed members of Congress to highlight their good intentions in contrast to "their common demon [of the era]—managed care companies."20
To examine the potential for a federal childhood immunization mandate to become law in today's health care and political environment, we compare the NMHPA to the IOM-recommended comprehensive immunization-mandate legislation,15 which combines an insurance mandate with the government subsidy and voucher plan. We apply commonly used evaluation criteria for policy analyses to evaluate the political viability, economic and financial possibility, and technical feasibility/administrative operability of a federal childhood immunization mandate with and without accompanying subsidy and voucher programs.21 We then suggest key conditions that must be met to facilitate consideration and passage of a federal childhood immunization mandate.
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COMPARISON OF THE NMHPA AND THE RECOMMENDED IMMUNIZATION MANDATE |
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 TOP COMPARISON OF THE NMHPA... KEYS TO CONGRESSIONAL...CONCLUSIONSREFERENCES |
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In other testimony, mothers presented stories of undiagnosed neonatal jaundice and neonatal meningitis because they were discharged prematurely without adequate follow-up care. Another mother shared her story of being discharged after 72 hours, although her son had a heart condition and she was weak from a cesarean section and a lack of sleep; less than 2 weeks later, her son died.19 Although not evidence-based, such anecdotes helped generate broad support in Congress for the NMHPA bill, much as they have for other public policy issues.22,23
Immunization-mandate legislation has potentially broad appeal because it would address problems of the underinsured and help create an enhanced, more stable market for vaccines with attendant benefits and incentives for vaccine manufacturers. In support of a mandate, the IOM committee argued that such a program would potentially ensure reductions in the medical costs of diseases that are prevented, enhance length and quality of life, and improve productivity and social contributions of families who otherwise would be burdened by disease.15
However, the NMHPA history suggests that immunization-mandate legislation may not receive much attention in either house of Congress unless the individuals who stand to gain most immediately (the underinsured) are brought together to make their case. What are their anecdotes? What are the consequences of their (underinsured) condition? To be successful, proponents of this legislation will likely need to argue that it is not solely for the underinsured but, in addition, will reduce the fragility of the childhood immunization system that relies on private manufacturers, who in turn will be able to function more actively and creatively in a more stable market for their products.
Economic and Financial Possibility
The NMHPA focused on a tangible policy target, insurance coverage for clearly defined lengths of postpartum stays, which was expected to translate into appropriate health care for mothers and their newborns. At the time, there was little attempt to estimate the cost of providing longer hospitalizations for newborns, because the cost of not doing so seemed to be beyond economic measure. As a mother whose daughter died 2 days after birth as a result of undiagnosed streptococcal meningitis testified before the Senate, "[l]ife must be the consideration, not the dollar sign that our HMO [health maintenance organization] carriers have placed before anything. That little life, not yet grown, must be given the chance to make a difference."19 It was assumed that this bill would increase the national health care costs of childbirth, which is the most common reason for hospitalization annually in the United States.24
Opponents of the NMHPA argued that, if Congress truly wanted to protect the welfare of women and children, they needed to pass legislation that would guarantee basic health care services to all children and mothers and require all health plans to provide the same minimal benefits package to all subscribers rather than focus exclusively on postpartum length of stay. This plan would guarantee a minimum of care to all their patients and encourage competition among health plans on the basis of quality care and responsiveness to patients' needs.19 In the Senate proceedings, the Kaiser Permanente Medical Group of Northern California presented data to indicate that optimal outcomes for mothers and infants depend on the full range of quality services provided during pregnancy and after discharge rather than on postpartum length of stay. Before the Committee, the Kaiser Group stated their belief that legislating arbitrary standards of hospital lengths of stay would not accomplish the desired goals.19
We would expect echoes of the same debate around a federal immunization-mandate bill. The general benefits of vaccination for individuals and their communities are widely agreed on, even to the extent that vaccination rates (rather than incidence rates of infectious diseases they prevent) are viewed as the primary outcomes of programs when, in fact, they are only measures of health care process (akin to length of stay for postpartum hospitalizations). A focus on vaccination rates is critical, because the longer-term outcomes of vaccination (ie, reductions in the incidence rates of previously more common diseases) may be somewhat less tangible for the American public, which generally shows more interest in new technologies regarding treatment than in innovations regarding prevention.
In addition, the backlash against managed care that dominated Congressional consideration of the NMHPA in the mid-1990s has largely run its course, and concerns in the current health care climate are more intensely focused on curbing rapidly increasing costs than on patient autonomy. Therefore, an immunization mandate anticipated to increase federal spending will likely receive additional scrutiny, rather than unflagging support, in today's fiscal circumstances. Other major fiscal challenges include the expanding federal budget deficit and defense spending in the post-9/11 era. For these reasons, it is plausible that Congress will consider immunization-mandate legislation without the federal subsidy and voucher program (ie, a mandate that relies on fiscal support from the private sector). Although this would not be the optimal legislation from the perspective of the IOM expert committee, in part because of likely pushback from the private sector, it would more closely resemble the NMHPA in its reliance on private plans to cover additional health care expenditures anticipated as part of the mandate.
Technical Feasibility and Administrative Operability
The NMHPA was straightforward in its technical and administrative approach to mandate coverage for postpartum stays for all health plans regardless of whether they were ERISA-exempt.
If a federal immunization mandate were passed without the subsidy and voucher programs recommended by the IOM expert panel, the program would have relatively straightforward technical and administrative features similar to the NMHPA. In contrast, the mandate/subsidy/voucher combination program favored by the IOM panel would have acknowledged technical challenges and administrative complexities15 that may threaten the passage of such legislation. As members of Congress who would support an immunization-mandate bill consider their legislative strategy, they would need to weigh the potential disadvantages of proposing an administratively complicated, federally sponsored plan against the disadvantages of proposing a simplified plan with less federal spending that might face stronger opposition from employers and insurers.
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KEYS TO CONGRESSIONAL CONSIDERATION OF A FEDERAL IMMUNIZATION MANDATE |
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TOPCOMPARISON OF THE NMHPA...KEYS TO CONGRESSIONAL...CONCLUSIONSREFERENCES |
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These issues are described in detail below and are summarized along with potential points for proponents to emphasize in Table 1.
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5 million) have insurance that does not include coverage for all recommended vaccines,15 a problem that serves as an economic barrier to timely vaccination and may grow as vaccine prices continue to increase.2 Although the federal government spends more than $1 billion annually to purchase childhood vaccines, including doses for underinsured children through the VFC program, this approach has failed to ensure that economic barriers to recommended immunizations have been removed for all children.15 Creating a sense of urgency around this problem may be a formidable task, given that vaccination rates among toddlers are at peak historical levels.1 However, proponents can make a compelling case that, without a mandate, we may collectively fail to reap the benefits of newly recommended vaccines in the near future (eg, meningococcal conjugate and combined tetanus-diphtheria-acellular pertussis vaccines). Proponents will also need to argue that a mandate is the most certain way to fiscally balance the shared public and private responsibility for immunization and to ensure that the health benefits of newly recommended vaccines now and in the future will accrue to all children, not just those with insurance coverage for those vaccines.
For mandate proponents, identification of a Congressional leader for this cause and building consensus around that leader for an implementation paradigm will be the most critical steps in developing a legislative strategy for mandate proponents. A mandate program is most likely to garner the support of parents and health care providers (eg, pediatricians and community health centers) and may also receive support from vaccine manufacturers. Parents will support this legislation because it ensures that their children will receive recommended vaccinations regardless of their insurance plan. Similarly, health care providers would be able to follow recommended immunization guidelines without concerns regarding reimbursement for the services they provide. Vaccine manufacturers may benefit from such legislation also because they are assured of a consistent demand for their product.15
On the other hand, vaccine manufacturers have expressed concerns in the past that a single government purchaser for all vaccines may substantially limit their profit incentives unless the government volume discount is diminished from current levels and the price per dose more closely resembles the private-sector price. A federal vaccine mandate is also unlikely to receive support from insurers and employers who self-insure. Insurers generally resist mandates as inefficient and burdensome, and employers would indirectly bear the responsibility of ensuring that all children have access to recommended vaccinations through the health plans they provide to employees. Although the IOM mandate model bill also includes provisions for a federal subsidy to employers to offset additional costs related to a mandate, the mechanism for determining the value of the subsidy and the logistics of providing the subsidy to employers and insurers present major feasibility hurdles to developing such a program as currently conceived.
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CONCLUSIONS |
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TOPCOMPARISON OF THE NMHPA...KEYS TO CONGRESSIONAL...CONCLUSIONSREFERENCES |
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Proponents of immunization-mandate legislation will likely need to secure the support of such champions for a federal mandate to be successful. In addition, proponents will need to consider carefully how to frame the problem of underinsurance to make it maximally compelling and whether to combine the mandate with a federal subsidy to payers and a voucher for the uninsured. The former is a challenge of message, and the latter is a challenge of money and mechanics. Champions must address these challenges for federal immunization-mandate legislation to succeed.
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FOOTNOTES |
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Address correspondence to Matthew M. Davis, MD, MAPP, University of Michigan, 300 NIB, 6C23, Ann Arbor, MI 48109-0456. E-mail: mattdav{at}med.umich.edu
The authors have indicated they have no financial relationships relevant to this article to disclose.
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REFERENCES |
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TOPCOMPARISON OF THE NMHPA...KEYS TO CONGRESSIONAL...CONCLUSIONSREFERENCES |
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This article has been cited by other articles:
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  M. M. Davis Reasons and Remedies for Underinsurance for Child and Adolescent Vaccines JAMA, August 8, 2007; 298(6): 680 - 682. [Full Text] [PDF]
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 R. M. Farrell and E. S. Rome Adolescents' Access and Consent to the Human Papillomavirus Vaccine: A Critical Aspect for Immunization Success Pediatrics, August 1, 2007; 120(2): 434 - 437. [Full Text] [PDF]
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