Lessons from across the pond: What the US can learn from European immunization programs

Vaccine 25 (2007) 6148–6157

Review

Lessons from across the pond: What the US can learn from European immunization programs Gary L. Freed a,b,∗ a

Child Health Evaluation and Research (CHEAR) Unit, University of Michigan, Ann Arbor, MI, United States b Division of General Pediatrics, University of Michigan, Ann Arbor, MI, United States Received 30 March 2007; received in revised form 15 May 2007; accepted 23 May 2007 Available online 12 June 2007

Abstract Childhood immunizations are the most effective clinical preventive services ever developed. Western European countries have a variety of governmental and non-governmental agencies involved in the development and operation of their immunization programs. Because of the range of programs in place across the European continent, various components of the US system parallel specific components of a variety of countries. Examining the experiences of other countries which have attempted to address issues now faced by the US can be valuable. However, such examinations are only of value if both the country and the policy itself to be examined are placed within the context of the US health care system and US policy constraints. © 2007 Elsevier Ltd. All rights reserved. Keywords: Vaccine; Immunization; Policy

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Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.1. Selection of interviewees in each nation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.2. Data collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1. Switzerland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.1. School and day care policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.2. New recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.3. Communication with physicians . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.4. Communication with the public . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.5. Insurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.6. Federal Reimbursement Advisory Commission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.7. Vaccine purchase and administration fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.8. Adolescent immunization programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.9. Potential considerations for the US . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2. Austria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2.1. Immunization recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2.2. Vaccine administration and financing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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∗ Correspondence address: University of Michigan, 300 North Ingalls Building 6E08, Ann Arbor, MI 48109-0456, United States. Tel.: +1 734 615 0616; fax: +1 734 764 2599. E-mail address: [email protected].

0264-410X/$ – see front matter © 2007 Elsevier Ltd. All rights reserved. doi:10.1016/j.vaccine.2007.05.050

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2.2.3. School vaccination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2.4. Potential considerations for the US . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3. Spain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3.1. Vaccine delivery for children and adolescents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3.2. Informed consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3.3. New immunization recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3.4. Vaccine financing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3.5. Anti-vaccination groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3.6. Potential considerations for the US . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.4. Germany . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.4.1. Venue of vaccine administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.4.2. Immunization recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.4.3. Vaccine financing—a dominant role for private insurance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.4.4. Novel approach to administration fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.4.5. Potential considerations for the US . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acknowledgement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Childhood immunizations are the most effective clinical preventive services ever developed [1]. Their use has decreased the incidence of numerous once-feared and devastating illnesses worldwide [2–6]. However, immunization policy is not static and undergoes constant change. Such changes are reflective of several different factors including the epidemiology of diseases, the cost of vaccines, concerns over safety and efficacy, the development and revision of public programs, immunization rates, and insurance coverage. The United States is not the only western democracy to encounter the complex issues surrounding childhood immunizations. The countries of Western Europe have a variety of governmental and non-governmental agencies involved in the development and operation of immunization programs. Because of the wide range of programs in place across the European continent, various components of the US system parallel specific components of a variety of countries. While no particular county matches the US in all aspects of their immunization system, specific portion of many systems provide opportunities for analysis to guide US policymakers. The formation of the European Union resulted in some standardization among the health systems of many of these nations. However, the individual nature of each provides the opportunity for potential comparisons with specific components of the US immunization system currently in place or being considered for future policy directives. Of most immediate concern in the arena of US vaccine policy is the plethora of new immunization recommendations for adolescents [7]. Currently, a variety of different policy options for adolescent immunization financing and delivery exist in the US. This is true for both the public and private marketplaces. However, neither the states nor the federal government have significant, long-term experience in the delivery of immunizations to this patient population. Thus, the ability of policymakers at local, state, and national levels to determine the most efficient and effective mechanism to

deliver vaccine to this population will not be based on empiric evidence or experience in the US. As part of a larger project examining immunization policy and financing in the 10 largest economies of Western Europe, specific examination of the data collected was focused on countries with strong state, not federal, roles in the immunization programs and novel adolescent immunization programs. Four of these study nations were found to have both a combination of health care system structural components and adolescent immunization programs of potential interest to US policymakers. These nations are Switzerland, Germany, Austria, and Spain.

1. Methods Initially, a web and printed literature review was conducted to provide background information on the health care system of each of the countries with the 10 largest economies of Western Europe (England, France, Germany, Austria, Italy, Sweden, Switzerland, Netherlands, Spain, and Ireland). An extensive bibliography of English language information sources was established and country profiles were prepared. 1.1. Selection of interviewees in each nation The Director of the World Health Organization European office for immunization in Copenhagen sent letters to the Chief Medical Officer (CMO) in each of these nations requesting their assistance in finding appropriate persons to interview to gain greater insights into the vaccine policy and financing structure of each nation. A suggested roster of governmental agencies and non-governmental organizations (e.g., professional societies) was enclosed as well as a list of issues to be investigated in each country.

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The CMO in each nation subsequently designated an official in their Ministry of Health to assist in both identifying individuals and arranging the interviews. 1.2. Data collection Face to face interviews were conducted with several sources from government agencies involved in immunization policy and financing, professional societies and the practice community within each nation. Each interviewee was provided with structured interview questions prior to the meeting. In addition, each participant was given the option of having a translator present for their interview. Handwritten notes were taken by the investigator during each interview. Within 2 weeks of each interview, a written summary of the interview was prepared. This was sent electronically to each individual interviewee for review, additions, and/or corrections. Occasionally, follow up questions for clarification of specific interview items were sent via electronic mail. After receipt of any comments or corrections, final interview summaries were prepared and shared with the interviewee. This project was approved by the Institutional Review Board for the Protection of Human Subjects at the University of Michigan. 2. Results Findings of the four nations with relevant immunization programs are presented. 2.1. Switzerland Switzerland is a federal republic divided into 26 administrative divisions called Cantons, similar to states in the United States. The Cantons enjoy a high degree of responsibility and independence from the federal government. The health system is characterized by a statutory health insurance program which, since 1996, is mandatory for all residents of the country. The overall insurance system is comprised of three components: compulsory basic social health insurance, voluntary supplementary insurance, and sickness, old-age, and disability insurance. Ambulatory physicians are paid on a fee-for-service basis for all care provided, including that covered by the statutory insurance policies. The physicians itemize the services provided on an invoice after each appointment. All vaccines are administered in the offices of private physicians. There are no public health clinics. 2.1.1. School and day care policies Four Cantons have compulsory diphtheria recommendations. One Canton requires parents to complete a written opt out waiver or face a fine if their child is not immunized. There is no defined point of enforcement of these laws as no Canton has a specific school or day care entry law.

2.1.2. New recommendations In 2004, a new Federal Advisory Committee for Immunizations was formed. The Committee issues recommendations regarding new vaccines and changes in vaccine policy or the immunization schedule. Members of the committee are experts outside of government that provide advice to the Immunization Program and the Federal Office of Public Health (FOPH). The new committee has 15 members appointed by the Minister of Home Affairs. The members are chosen to ensure there is both gender and regional representation and are made based on the expertise required for the functioning of the committee. There is representation from the Cantons on the committee but no representation from vaccine manufacturers or the insurance industry. Meetings are held 5 times per year and are not open to the public. Minutes of the meetings are not made public. The process for evaluation of a new vaccine is highly structured. Cost-effectiveness/cost-benefit data are one component of the discussions surrounding new recommendations but not the most important factor. The committee looks at economic data from other countries but does not have a specific financial threshold for recommending a specific vaccine. A representative from the Federal Office of Social Security is a non-voting member of the committee. This person provides perspective on the impact of new recommendations on the insurance industry and the potential increase in cost of statutory insurance to the population as a result of a new recommendation under consideration. Votes are taken for new recommendations with a majority vote required for passage. The Committee cannot recommend a vaccine not approved by SwissMedic, the agency responsible for the licensing of vaccines. SwissMedic has a non-voting representative on the committee and can provide information as to where a specific vaccine may be in the licensure approval process. 2.1.3. Communication with physicians The Swiss Commission on the Question of Vaccination is a semi-independent body composed of pediatricians, GPs, internists, infectious disease specialists, epidemiologists, and federal as well as Cantonal public health officials. The Commission’s main concern is immunization policy. In addition, this body established an online service called INFO VAC to answer questions from physicians regarding immunizations. INFO VAC, funded by the FOPH, was founded in 2000 largely as a direct information and consultation service for doctors with questions about immunizations. There was an enormous demand for such a service, and now the organization runs both a web-based data system as well the telephone service. There are 1000 pediatric and 2000 general practitioner subscribers. Whenever there is a new immunization recommendation, the Immunization Program informs the Cantonal CMOs who then inform the physicians in their Canton.

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2.1.4. Communication with the public The FOPH also funds a vaccine call center (MEDGATE), which operates a hot line to assist the public with questions regarding vaccines. MEDGATE is a similar organization to INFO VAC except that it takes questions from the general public. The service runs 24 h a day, 7 days a week.

child visits, there is a separate fee schedule. The same fee schedule is used for catch-up vaccination programs. These administration fees vary by Canton. The branch of the Swiss Medical Society in each Canton negotiates with the Association of Statutory Insurance Companies in each Canton to set the administration fees.

2.1.5. Insurance Childhood vaccines are completely covered by the statutory insurance program until the age of 16. Children and adolescents are covered under the same insurance policy as their parents.

2.1.8. Adolescent immunization programs Each Canton has its own program with 16 of the 26 giving hepatitis B vaccine in the schools. Many Cantons have multiple programs, with some vaccine provided in schools and some through private physicians. Thus, there is the opportunity for children to receive vaccine either in the school or in the offices of their private physicians. This provides maximum opportunity for immunization of adolescents, regardless of their previous patterns of health care seeking behavior. Rates of adolescent immunization vary by Canton and are believed to be better in those with school programs but definitive data are lacking. Written parental consent for school immunization is required.

2.1.6. Federal Reimbursement Advisory Commission The Federal Reimbursement Advisory Commission determines what new items are included into the basket of services provided under the statutory insurance program. This Commission is advisory to the Ministry of Internal Affairs under which the statutory insurance program resides. The Commission is comprised of 21 voting members from health insurers, physicians, private/public hospitals, Cantonal governments, and patients. There is no set economic threshold a drug or procedure must meet to become included in the basket of services. Further, there are no specific criteria defined which influence coverage inclusion decisions. Cost effectiveness, efficacy, and cost-benefit analyses are reviewed but it is ultimately a judgment call of the Commission. It is the Minister who makes the ultimate decision regarding inclusion of a new vaccine in the basket of covered services. The Minister is not required to, and does not always follow the advice of the Commission. However, approximately 95% of the time the Minister follows the recommendation. The Commission usually has followed the recommendations from the Immunization Advisory Committee. However, this is not always the case. For example, hepatitis B became a school based recommendation, rather than a universal infant recommendation, as a result of pressure from the Cantons to the Commission. There is also political pressure on the Minister not to include too many new items each year into the statutory insurance program. Inclusion of multiple items will result in a politically unpopular, significant increase in premiums paid by the population for the statutory insurance. 2.1.7. Vaccine purchase and administration fees Physicians purchase vaccine for their practices from distributors. They bill their patients for the vaccine who then file claims for payment with their statutory insurance company. The price of the vaccine is set by the Federal Commission on Medical Products (FCMP). The amount physicians are allowed to bill patients is set by the FCMP and is the same across the Cantons. The administration fees are included in well child visit charges. If a vaccine is given outside of the context of well

2.1.9. Potential considerations for the US In the United States, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention approves new immunization recommendations for the country. The ACIP is also the same committee that determines whether the newly recommended vaccine will be paid for by the federal entitlement program, Vaccines for Children (VFC). The VFC program pays for vaccine for children enrolled in Medicaid, the uninsured, the underinsured (who receive vaccine at federally qualified health centers), Native Americans and Alaska natives. All other vaccine (approximately 50% of US vaccine) is mostly paid for by private insurance, with a small proportion covered by state governments. By statute, although cost-effectiveness and other economic analyses can be taken into account when making an immunization recommendation, such data cannot be taken into account when making a vote on VFC inclusion. This process is distinct from that in Switzerland where the decisions regarding the public health imperative for the recommendation is made by a separate committee from that which determines whether funding will be provided. In the US, the members of the ACIP have significant expertise and experience in public health, infectious diseases and vaccinology. It is less common for members to have significant experience in health care delivery or in health economics. The premise behind this system is the belief that national recommendations should mainly stand on the science and public health imperative of the use of a particular vaccine. However, this system recently has resulted in the recommendation of several new and expensive vaccines for the adolescent age group. While funding for VFC-eligible children is assured by vote of the ACIP, states (and some private insurers) are struggling to fund vaccine delivery for other groups of children. These recent events have led some to question whether greater emphasis should be placed on financing as part the

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deliberations regarding future immunization recommendations, whether the decisions are made by a single committee or not. Another vaccine financing issue in the US surrounds the price that private physicians pay for a specific vaccine in the private sector and the amount for which they are reimbursed by their patients’ private insurance carrier. In contrast to Switzerland where the prices by which physician’s buy and sell vaccine is regulated by the government, the US operates a free-market system. Physicians try to buy the vaccine at the lowest possible price and then seek the highest reimbursement possible from insurers. Often, providers join together to form purchasing cooperatives to achieve a more favorable bulk purchase price. However, recently some providers have claimed they are unable to negotiate sufficient reimbursement to cover their cost for the vaccine when taking into account their storage and acquisition costs. Although it is unlikely that prices would be set by the federal government, one option to address this issue may be to examine the role of government in setting some type of framework in which both price and reimbursement negotiations take place. The US is also struggling with defining the venue(s), where the newly recommended adolescent vaccines will be administered. Adolescents have fewer preventive visits to their physician than younger children. As such, there is concern that the office of the primary care physician (the venue for the provision of most childhood vaccines in the US) may not be an effective site for immunizing the majority of adolescents. Switzerland has established a system where schools and private offices both provide opportunities for adolescent immunization. Schools have been used only sparingly in the US for immunization programs. However, models for their use, especially in the adolescent age group must be explored. A better understanding of how multiple sites for immunization can both provide increased access to immunization without compromising accurate record keeping regarding immunization of status is necessary. Finally, the ability of the Swiss to provide easy individual access to vaccine information through the INFO VAC and MEDGATE programs are worthy of examination. Although no formal evaluation of these programs has been conducted, they demonstrate an openness and access to information not seen in the US. Concerns about vaccine safety reflect perception as much as, if not more than, reality [8,9]. The potential benefit to both providers and the public should be explored as part of a nationwide campaign to address vaccine safety concerns. 2.2. Austria The Austrian Health System is based on enrollment in statutory (mandatory) health insurance funds called Krankenkasse (KK). The administration of health care is organized in three tiers: federal, state, and social insurance funds.

At the federal level, health care is the responsibility of the Federal Ministry for Social Security and Generations (Bundesministerium fuer Soziale Sicherheit Generationen und Konsumentenschutz). The federal government funds approximately 2% of all health spending. This is largely because the majority of the tasks are fiscally delegated to each of the nine Laenders (states) or to the social insurance funds. The system is highly decentralized and health care administration by the federal authorities is modest. Every Laender has a state health board, and every district within that Laender has its own health department. Every health department is responsible for vaccination rates, health promotion, and the control of infectious diseases. The social insurance system (statutory insurance) of Austria is a separate body of the health system. While the federal government is responsible for legislation, implementation responsibilities are conferred to these self-governing bodies. Austria has 27 social insurance funds, which fall under the Federation of Austrian Social Security Institutions. Insurance is compulsory for Austrians, and it is estimated that 99% of people living in the country (including legal residents) are obligated to pay contributions to the statutory health insurance program. 2.2.1. Immunization recommendations The Supreme Health Board (SHB), or Oberster Sanitaetsrat, is the major organization involved in immunization policy. It serves as the overall scientific advisory body for the Minister of Health within the BMSG. The Board is made up of nineteen members with expertise in health care delivery, health care planning, and finance. The members are appointed for 3-year terms, and their primary duty is to “decide what is to be considered state of the art in medical science”. The Board meets two or three times a year to discuss issues such as vaccination programs, the maternal and child health program, dental care, and prevention priorities. In addition, the SHB has subcommittees appointed to look after each of these issues individually. Impfausschus is the vaccination subcommittee of the SHB, and its primary task is to provide advice and make proposals on vaccination programs. The Minister of Health, after hearing these proposals, makes the final decision regarding implementation. Every year the Impfausschus publishes a Vaccination Plan Booklet. 2.2.2. Vaccine administration and financing Since January 1998, all children <16 years (end of compulsory education) can receive recommended immunizations without charge. In 1998, the federal government first became involved in financing the primary immunization series via the KK. Prior to that time, there was not government financing of vaccines. Federal financing is limited to payment for the vaccine itself and its distribution to pharmacies, not physician administration fees. Payment for the cost of recommended vaccines to children is divided as follows:

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• 2/3 Ministry of Health; • 1/6 Laenders; • 1/6 Krankenkasse. Private insurance does not pay for vaccines that are not covered by the government program. For the pneumococcal vaccine, the MOH did not have the funds to pay for the recommendation from the Impfusschus to cover the cost of vaccine for all children. The MOH also spoke with representatives from several of the Laenders and they also did not have the funds to cover their portion of the vaccine if the recommendation was to be included in the government financing program. This was the first time in the 6 years of the government financing program that a recommendation from the Impfusschus was not funded. Parents can still purchase the vaccine on the private market and pay out of pocket. There was significant pressure from the public to cover the vaccine as the recommendation was publicized. However, this vaccine would have doubled the cost of the immunization program and there simply were not funds available in the 2004–2005 budget year. Informed consent is required. In physician offices, written informed consent is not required, but for vaccines administered in schools, parental signed consent is necessary. Starting in 2003, children ≥14 years must also give their consent for immunization. All vaccines, other than adolescent vaccines, are given in the offices of private physicians. 2.2.3. School vaccination DT and hepatitis B vaccines are given to adolescents in the schools by either school doctors employed by the Laenders or by community physicians on contract to provide the vaccines. Schools and the Laender authorities work together to determine the system and staffing for the provision of school based immunization. School vaccines are also paid for according to the 2/3, 1/6, 1/6 split described above. Thus, there is a system of shared financial responsibility among the three main payers for vaccines administered in the schools. 2.2.4. Potential considerations for the US The increase in adolescent immunization recommendations in the US has also raised the issue of the manner in which consent for vaccines is obtained. Laws regarding consent for medical procedures, including immunization, are the purview of the states [10]. At this time, no state has a statue requiring informed consent from adolescents for immunization. The decision by Austria to require informed consent from those ≥14 years of age raises a host of potential ethical responsibilities not currently formalized across the US. Although tacit approval/consent must practically be obtained from adolescents in order to deliver an immunization, the process is not formalized. Examination of the process by which consent is obtained as well as the rationale for the age chosen by Austria may benefit states within the US considering similar actions.

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Austria has developed a specific cost-sharing formula for immunizations that involves defined proportional contributions from federal and state governments along with a portion from private insurers. This is similar (without the private sector component) to the governmental shared financing system by which Medicaid is funded in the US via a formula of matching federal funds with state funds invested in the program. Yet, no similar defined, shared system of vaccine purchase exists in the US for the payment of immunizations for those whom are not VFC-eligible and whom do not have private insurance coverage for vaccines. A program in one of the states, Rhode Island, requires insurers to pay into a common pool to fund immunization purchase [11]. This has not been replicated in other states. Currently, the federal government provides some funding to states for vaccine purchase and infrastructure from funds made available on an annual appropriation basis through Section 317 of the Public Health Act (317 funds) [12]. However, there is no defined state matching required. As a result, there is significant variability regarding state contributions to their own immunization programs. A federal matching system would create an incentive for states to participate financially in immunization purchase. Similar to Switzerland, Austria immunizes adolescents both in schools and in the offices of private providers. These examples highlight the potential for immunization to take place as a single categorical service provided within the school to take advantage of the availability of youth in this setting. 2.3. Spain Spain’s health system has become increasingly decentralized since the 1990s. Responsibilities are divided according to the policy of devolution, with the central government assuming responsibility in central planning and basic health policy, while regional and local agencies have assumed responsibility for the of allocation of funds, implementation of national health policies, and general governance over regional health care facilities. The Ministry of Health and Consumption is responsible for the general coordination of public health and health care services, in addition to drafting health policy and any basic enabling legislation required. The Spanish Parliament allocates some resources to the 19 Autonomous Communities (Regions), of which 17 comprise geographic regions and two (Ceuta and Melilla) are cities. The governments of the Autonomous Communities are responsible for health planning and programming, financing all government programs, and maintaining direct control over health management. For the most part, the Spanish health system is financed through general taxation. This came about with the General Health Reforms of 1986 and the creation of the National Health Service. It is estimated that approximately 94% of Spanish citizens receive health care via the National Health

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Care Plan, while 6%, comprised mostly of civil servants, are covered under a special system that allows them to opt for coverage either under the National Plan or under a private insurance plan. 2.3.1. Vaccine delivery for children and adolescents As with the majority of health care for children, most vaccines in the primary immunization series are given by pediatricians. Pediatricians provide care until children are 14 years old. In small towns there may be a central clinic that provides the vaccines as ordered by the pediatrician. However, vaccines for older children, including the meningococcal vaccine, are most often given in schools. The other vaccines recommended for the adolescent age group are: Td at the 14–16 years old, hepatitis B catch-up for 10–14 years olds (three doses). A public health physician and/or nurse go to the schools to provide the vaccine. The organization and financing of school vaccination is the province of the regions. There are no school or day care requirements. All immunizations are voluntary. 2.3.2. Informed consent There are no national specifications for informed consent. Each of the Autonomous Regions is free to develop their own policy. However, informed consent is most often verbal, except in the case of vaccines given in school. For school immunization, a note is sent home with the child and the parents must sign it in order for their child to receive the vaccine. 2.3.3. New immunization recommendations The Inter-Territorial Council, made up of representatives from each of the Autonomous Regions, meets regularly to debate and discuss issues related to the health and welfare of the population and to attempt to coordinate activity among the regions. The Council has a Committee on Public Health that focuses on health care issues and priorities for the country. The decisions of the Council are not binding by law but little can be accomplished if there is not consensus among the Council. The national government does not have the power to enforce public health and health care directives nor does it provide funding for the public health activities in the regions. The Committee on Public Health, Chaired by the Director General of the Ministry of Health and Consumption (MOH), has several technical working groups that bring recommendations to the Council. The Technical Working Group on Vaccines makes the immunization recommendations for the nation. Decisions are based on technical, not financial, issues and are made by consensus; votes are not taken. Members base decisions regarding recommendations on the disease burden (epidemiology), efficacy of the vaccine and the safety of the vaccine. When decisions are made, as each Autonomous Community has participated in the decision, it is expected that all will follow and finance the recommendations. Recom-

mendations from the Working Group are then sent to the Committee on Public Health for approval before reaching the Inter-Territorial Council. There is no set threshold for costeffectiveness that a vaccine must meet to be approved. Once vaccine recommendations are approved by the Council, they are incorporated into the National Immunization Schedule. 2.3.4. Vaccine financing Each Autonomous Community is responsible for purchasing vaccine for use in their region. No national funds are provided to the Communities to purchase vaccines. Funds to pay for the vaccine come from taxes raised by each of the Communities on their populations. Autonomous Communities issue tenders each year with the manufacturers directly but do not work together to increase the volume of purchase and decrease prices. Prices paid for vaccines differ among the Autonomous Communities. Theoretically, as the Communities are responsible for purchasing vaccines, a Community might not agree to support a new vaccine recommendation in the Technical Working Group on Vaccines or in the Committee on Public Health of the Inter-Territorial Council if it could not afford the vaccine. The national immunization schedule is almost always followed by all of the Communities. However, a couple of Communities actually provide additional vaccines not on the recommended schedule (e.g., hepatitis A). Others may differ slightly on the recommended ages for a specific vaccine (e.g., viral influenza). It is very rare for a Community not to supply a recommended vaccine. Families do not make any direct payment for any recommended vaccines. They are all paid for by their Autonomous Community government. Physicians and nurses are paid on salary. There are no additional administration fees paid to physicians or nurses by either the government or by parents for providing vaccines. 2.3.5. Anti-vaccination groups There is very little anti-vaccine activity in Spain. The public is very pro-vaccine and actually lobbies to have additional vaccines added to the immunization schedule. For example, the pneumococcal conjugate vaccine (Prevnar) is not currently recommended. However, coverage is about 40% for the vaccine even though parents must pay for it out of pocket. The press does not write a lot of anti-vaccine stories and there are no organized community or interest groups that refuse vaccines. 2.3.6. Potential considerations for the US Spain is another country which makes strong use of its schools to provide immunization for adolescents despite a very well developed primary care pediatric component to the health care system. Some pediatricians in the US are concerned that providing vaccines in schools will result in a weakening of the primary care system and/or the concept of the medical home. However, this has not been the case in Spain.

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Financing is provided at the level of the Autonomous Community for school and all other immunization programs in Spain. Because there is no federal funding for vaccines, there is the potential for variability among the Autonomous Communities in both the programs for vaccine delivery as well as the specific vaccines provided. In the US, states have opined that if they pay a significant portion of the cost of specific programs that they should have significant input into their operations [13]. Although there is some variability in state immunization programs and school requirements, the basic set of recommendations from the ACIP is followed in all states. As more costly immunizations are added to the list of recommended vaccines in Spain, it is unclear if some Autonomous Communities will decide not to offer specific vaccines due to the variability in their economic status. The strong public support for immunizations and the lack of organized anti-vaccine activity is of great interest. This is in contrast to the US and to other Western European nations [9,14]. A better understanding of the social and political forces at play would be helpful to other nations struggling with this issue [15].

There is also a representative from the statutory insurance companies. Although it is not a part of the charge of STIKO to assess the cost-effectiveness of a vaccine, it is part of the discussion regarding any new recommendation. The immunization schedule recommended by STIKO is published by the Robert Koch Institute (RKI). RKI provides all administrative support to STIKO. There are no other groups or associations which publish their own immunization schedule. Although STIKO may only recommend vaccines which are licensed in Germany, these recommendations have no legal authority. Further, STIKO recommendations do not have to be approved or endorsed by the Ministry of Health. Thus, there are no official government recommendations at the national level and no mandatory vaccines. The states make the official recommendations for the populations within their geographic jurisdiction and usually follow STIKO recommendations closely. Variation from STIKO recommendations is usually associated with high-risk group designations for specific vaccines. To date, states, at a minimum, have always followed STIKO recommendation and may be more expansive.

2.4. Germany

2.4.3. Vaccine financing—a dominant role for private insurance There is no central government financing for childhood immunizations. The vast majority (90%) of vaccines are purchased in the private sector and 90% of these are paid for by statutory insurance policies. Statutory insurance is paid for by payroll taxes on employees and employers. Children are covered by their parents’ policies. This insurance package can be thought of as the “baseline” coverage provided to all policyholders. The remaining 10% of vaccines purchased in the private sector are paid by supplemental private insurance policies. The remaining 10% of administered vaccines not purchased in the private sector are provided by the states as part of special immunization programs in the schools or as part of day care catch-up programs. To treat and bill patients who are insured through the statutory insurance companies, health professionals (e.g., physicians, dentists, pharmacists) must be members of the professional administrative societies, the Kassen¨arztliche Vereinigung, within each state. Bills are sent directly from the providers to the insurance companies. Physicians in all states in Germany are paid on a fee-for-service basis. Each state has a state chapter of the Kassen¨arztliche Vereinigung which acts on behalf of the physicians in that state. These organizations are in place to provide secondary education, specialist training after the university, as well as to set profession-based ethical standards. The cost of vaccines is usually transparent to patients if the vaccine is covered by statutory insurance. Those without statutory insurance (e.g., poor, unemployed) receive insurance paid for by the social security system. However, immunizations are not a part of the mandatory benefit package of the statutory policies. Once vaccines are recommended

The German health system is highly decentralized. The 16 federal states, or Bundeslander (Bundes), have significant control over the functioning of almost every aspect of health care delivery, including immunizations. Most responsibility for public health practice is assigned to the individual states, whereas the federal government has a greater role regarding diseases that are “dangerous to public safety”, pharmaceutical products, the licensing of health professionals, and monitoring the economic status of hospitals. However, none of the states have an independent health ministry. 2.4.1. Venue of vaccine administration Approximately 90% of vaccines are given in the offices of private physicians. The remaining 10% are given in public health clinics, schools, or day care centers through special programs of the Bunder. There are no school or day care requirements regarding immunization, either nationally or in any state. 2.4.2. Immunization recommendations STIKO is the major federal authority concerned with vaccination issues. Its responsibilities include issuing advice regarding vaccines and reporting vaccine coverage rates to the federal government. They issue a yearly immunization reference guide entitled “Empfehlungen der Staendigen Impfkomission” (Recommendation of the Permanent Vaccine Committee). STIKO meets twice per year. There are 17 members selected by the Minister of Health in consultation with professional societies. Members include those with content expertise in virology, microbiology, and clinical practice.

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by STIKO, negotiations begin between each statutory insurance company and the Kassen¨arztliche Vereinigung in each state to include the immunization in the optional benefit package. Thus, each new vaccine must be added to the optional package of coverage to gain reimbursement. The decision regarding inclusion is made on a vaccine-byvaccine basis by each of the insurance companies in each state. Physicians must check the insurance carrier of each patient before administering new vaccines to ensure their company is covering the vaccine. If vaccines are not included in the statutory insurance policies, they must be paid for out of pocket by families or by states as part of their immunization programs. When there is a delay between the time of a STIKO recommendation and inclusion as a covered benefit, families must pay out of pocket if they want the vaccine. Insurance companies do not coordinate to cover the cost of a newly recommended vaccine at the same time. 2.4.4. Novel approach to administration fees Physicians charge a vaccine administration fee negotiated on their behalf by each state chapter of the Kassen¨arztliche Vereinigung with the statutory insurance companies in each state. Administration fees vary across the states with the average fees ranging from D 5.52 to D 8.98. There are different fees for each vaccine. Some states have established a fee schedule to encourage the use of specific vaccines. For example, in Bavaria, the Hexavalent and the MMR vaccines have a D 15 fee to encourage the use of combined vaccines rather than their constituent counterparts. 2.4.5. Potential considerations for the US Private physicians in the US are paid routinely by public and private insurers for the administration of each vaccine. However, one of the goals of the US immunization program is to provide combined vaccines whenever possible to minimize the number of injections required at any preventive care visit [16]. It is believed that decreasing the number of injections removes a barrier to the provision of immunizations for some families. A potential unintended consequence of increasing numbers of combined vaccines is the decrease in revenue for private practices for vaccine administration. Providers state that the actual provision of the vaccine is only a part of the justification for administration fees. They claim that they must still take the time to provide informed consent and answer parental questions regarding all of the vaccines contained within a combination product. As such, the current administration fee system in the US may act as an economic deterrent to the provisions of combined vaccines. Some areas of Germany have a novel system where different administration fees are paid for different vaccines, with combination vaccines commanding a higher administration fee. The US should explore the potential for establishing an administration fee structure that encourages and incents the use of combined products.

3. Discussion When a lack of experience in a particular policy domain exists, policymakers may have the opportunity to examine the similar experience of others in determining the best course of action. Examination of the experience of other, comparable systems addressing similar issues may provide practical and useful information regarding policy options [17,18]. Strategies being considered by the US may have been attempted in other settings thus providing the opportunity to collect data regarding “real world” trials of such options. Examination of the experience of others may demonstrate both the successes and failures of some options currently being considered. Such assessment may provide information regarding the potential advantages and drawbacks of specific options. Fortunately for the US, there are several western industrialized democracies among the nations of Western Europe with a range of gradation of public and private health care financing and delivery systems. Examination of the experience of these nations in operationalizing potential policy solutions being considered by the US will likely yield beneficial information to help guide policy decision-making. Further, because of their similarity to the US system, these nations may have developed additional policy options not considered by the US. Germany provides an example of a nation where private physicians may encounter patients whose insurance covers a new vaccine while others do not. Examination of the manner in which physicians handle such situations may be helpful to public health practitioners and physicians in the US who experience similar issues. Examination of the public perceptions of vaccines in Spain may also be instructive. Rather than always focus on how to address anti-vaccine activity, it would be instructive to understand the factors influencing the markedly pro-vaccine public sentiment in Spain. With regard to adolescent immunization, both Switzerland and Austria offer opportunities for the US to explore innovative approaches to its adolescent delivery system. School based immunization programs, with novel approaches to financing that involve multiple levels in the public sector combined with private insurance contribution could serve as models for US consideration. Examining the experiences of other countries which have attempted to address issues now faced by the US can be valuable. However, such examinations are only of value if both the country and the policy itself to be examined are placed within the context of US health care system and its policy constraints. Although this concept may appear superficially simplistic, most comparative international studies performed to inform US policy have involved nations of convenience with little or no similarities to our health care system. Because of a combination of geographic, language, and historic factors, the countries most commonly examined by US investigators or policymakers are Canada and the UK. Unfortunately, although convenient, these nations have health

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care systems so disparate from that of the US that comparative research in these domains is relatively useless [17]. As such, solutions to contemporary health policy issues found to be successful in these countries will be unlikely to help inform policy options to address similar issues faced by the US. Policymakers and researchers in the US must broaden their scope of potential information sources to take full advantage of the lessons learned and experiences of other nations. Failure to do so may result in unnecessarily uninformed policy decisions.

Acknowledgement Funded by a grant from the National Institute of Allergy and Infectious Diseases, Baltimore, Maryland, United States.

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