■ Introduction
1There seems to be wide agreement across European governments on the objectives of their health care systems, namely universal access, comprehensive health care, high quality services and responsiveness to society (Oliver et al. 2005). But also common to European health systems are concerns about the costs of health care in the context of resource scarcity and competition with other sectors (such as education or social security). This creates a conflict between the primary objectives of the health care system and the main motor of health reform: cost containment.
2Concerning the comprehensiveness of health care, it could be argued that any kind of activity or service aimed at the preservation or restoration of a “state of complete physical, psychological and social well-being” [1] belongs to the “health basket”. This implies that a very broad spectrum of services could be involved to achieve this state of health in the individual, i.e. comprehensive health care. Taking this reasoning to an extreme, health care could therefore range from medical care in case of illness to any leisure activities as well as any kind of cosmetic operations or life-style drugs that may contribute to psychological and social well-being. Obviously, the spectrum of activities, services and goods financed with public money within health systems is much more restricted than that, since such an infinite comprehensiveness would threaten the financial viability of any publicly funded system.
3European health care systems have thus embarked in the definition of a more or less limited set of services, activities and goods that are considered to be essential, and, thus, the scope of reimbursement or direct service delivery. To date, comparisons of the package or “basket” of services have focused mainly on social health insurance systems and have either lacked detailed information or been limited to selected health services for selected indications (Polikowski and Santos-Eggimann 2002; Johnson et al. 2000; Kupsch et al. 2000).
In this paper we present an overview of the contents and structure of benefit baskets and on the criteria used for inclusion or exclusion of benefits in nine EU member states (Denmark, France, Germany, Hungary, Italy, the Netherlands, Poland, Spain and England). The information presented is based on the results of the “Health Benefits and Service Costs in Europe – HealthBASKET” project, [2] funded by the European Commission, which has provided in-depth description and analysis of the issue of benefit catalogues in EU member countries.
■ Methodology
4We differentiate between the terms “benefit basket” (also “benefit package”) and “benefit catalogues”. The term benefit basket refers to the totality of services, activities and goods reimbursed or directly provided by publicly funded statutory or mandatory insurance schemes (social health insurance, or SHI) or by national health services (NHS). In contrast, we define benefit catalogues as the document (s) in which the different components of the benefit basket are stated in detail, i.e. which enumerate the services, activities or goods in a more detailed way, listing even single interventions (i.e. specific health technologies [3]). Thus a benefit basket might be further defined through one or more benefit catalogues. In the absence of explicit benefit catalogues, inpatient and outpatient remuneration schemes serve as benefit catalogues, albeit less official ones.
5As shown in Figure 1, the coverage of a given population for health services can be characterised by three dimensions (Busse et al. 2006). While “breadth” can be defined as the extent of covered population and “depth” as the number and character of covered services, “height” specifies the extent to which costs of the defined services are covered by pre-paid financial resources as opposed to cost-sharing requirements. We shall mainly focus on the depth of benefit coverage (i.e. the comprehensiveness of the essential benefit basket), considering services or goods as being included in the basket independently of the level of co-payment associated with its delivery. Any service for which out-of-pocket co-payment is below 100% was included in the basket, while any service with 100% co-payment was excluded.
The three dimensions of coverage (Busse et al. 2006), with a hypothetical benefit basket shown in grey
The three dimensions of coverage (Busse et al. 2006), with a hypothetical benefit basket shown in grey
6The description of the benefit basket of each country was drawn up by local academic researchers. The researchers mainly conducted analyses of relevant documents (legal or quasi-legal) and, when needed, clarifying interviews with experts in the field (i.e. persons involved in policy and/or decision-making where health baskets are concerned). In order to approach the description of benefit packages in a systematic and comparable way, all the researchers involved followed the framework of functional categories of “health care services and goods” proposed by the OECD in its “System of Health Accounts” (OECD 2000), which was integrated into a report template (structured as an open questionnaire). To begin with, the researchers were asked to describe the benefit basket in their country according to the structure given in Table 1. They were also asked to identify the existing benefit catalogues for each functional category, as well as the players involved in decision-making and the decision criteria, using the functional categories as a guide.
Framework of health care functional categories, system of health accounts (OECD 2000)
Framework of health care functional categories, system of health accounts (OECD 2000)
■ Definition and comprehensiveness of the benefit basket
7The logic underlying the general definition of the benefit basket differs across countries, depending on the organisation of the health system.
8• In NHS countries the definition of a benefit basket is related to the duties and obligations of the national (or regional) health services, whether they act as purchaser or as direct provider of health care.
9• In contrast, in SHI countries the benefit basket is mainly related to the entitlements of the insured persons.
10Nevertheless a similar pattern in the definition of health baskets can be observed across most of the countries, on two levels:
11– On the higher level, legislation passed by the national parliaments – sometimes even rooted in the country’s constitution, e.g. Poland (Kozierkiewicz et al. 2005a) – establishes the general framework for the benefits by enumerating those areas of health care included in the health basket.
12– On a lower level, the benefit basket is defined through the specification of the procedures provided within each sector of health care as part of the benefit catalogues. The extent (i.e. level of detail) and the way in which this definition actually takes place – varies considerably from country to country and, within each country, from sector to sector of health care. The shaping of the basket draws not only on genuine catalogues, that is, explicit lists of included or excluded services (e.g. positive lists, negative lists) but also on other instruments that act as catalogues, despite their original function being other (i.e. reimbursement systems), which we might call catalogue substitutes. The content of the benefit catalogues can be determined in legislation passed by central or regional parliaments, decrees issued by national or regional governments, directives issued by self-governing bodies or by national and/or local authorities, and other documents considered as quasi-laws (i.e. non-legal rules, such as clinical guidelines).
13The benefit baskets of all the European countries studied may be considered quite comprehensive. In most of the countries, the benefit basket was established in a single document that describes the broad categories of services included and specifies exclusions. However the establishment of a clear boundary between the two levels of definition of benefits – i.e. basket and catalogues – is sometimes very difficult, since in reality the documents of the higher level may also function as benefit catalogues in the sense that they may also present a more detailed classification of services and even mention specific technologies in order to explicitly include or exclude them.
14In most of the NHS countries, a coherent legislation contains a list of areas of care to be provided by the respective health service as part of the benefit basket. In countries with a decentralised national health system, such as Italy or Spain, the legislation refers to the “regional health services”. Denmark represents an exception, since the legislation consists of separate acts concerning the categories of hospital, primary and long-term care, and pharmaceuticals (Bilde et al. 2005a). The level of explicitness varies considerably from country to country. The vaguest definition of a benefit basket might be the one of the English NHS Foundation Act (1946) and related posterior documents, where the secretary of state for health is legally required to provide services “to such extent as he considers necessary to meet all reasonable requirements” (Mason and Smith 2005). In contrast, the frameworks of the Italian and Spanish benefit baskets, which have both been established in recently implemented legal documents (governmental decree Nov. 2001; royal decree 63/1995 and law 16/2003), are structured in a more systematic way and define several categories and subcategories of services (Fattore and Torbica 2005; Puig-Junoy et al. 2005). Common to all four NHS countries studied is the differentiation between hospital care and primary care, including specialist outpatient services, as well as preventive or health promotion services. The level of explicitness is not only heterogeneous across different countries, but also within the same country. In the same document, some areas of care might be further shaped by mentioning specific subcategories, services or in some cases even specific technologies for inclusion or exclusion in the benefit basket, whereas others do not seem to deserve further detail. Thus, the definition of the benefit basket does not always follow a systematic approach of shaping a general framework by going into further detail – neither in the legal framework of the basket nor in benefit catalogues. The heterogeneous framework of the health benefit basket rather seems to reflect the perception by decision-makers of specific needs or shortcomings of the health care system at the moment of elaborating the corresponding documents of each health care system. For example, ophthalmic services are emphasised over other specialists’ services as part of the duties in the UK NHS-Foundation Act of 1946, and the inclusion of oxygen home therapy in Spain is explicitly mentioned in the royal decree 63/1995.
Health baskets in SHI countries stem from two different roots. On the one hand, SHI countries formulate the basket as an entitlement for persons insured under the respective statutory health insurance scheme. The main reason for this lies in the fact that SHI schemes have evolved from fragmented voluntary/statutory health insurance schemes not covering the whole population and only covering certain services, e.g. sickness benefits. Statutory health insurance in Germany – as well as in the Netherlands until 2005 – does still not cover the whole population (Busse and Riesberg 2005; Den Exter et al. 2004). Therefore in SHI countries, the health basket is also used to indicate the boundaries between those insured under the statutory health insurance and those insured under other schemes (the “breadth” dimension of the catalogue in Figure 1). The other root from which health baskets stem are fee catalogues, which were originally more prevalent in SHI than in NHS countries owing to the frequently used feefor-service reimbursement system – at least in ambulatory specialist care.
As observed in NHS countries, the level of explicitness also varies considerably among SHI countries. Poland has by far the most explicit benefit basket, the so-called list of procedures of the national health fund, which is a comprehensive positive list of services addressing the majority of health care categories. Germany probably has a more vague general framework for the benefit basket (the Social Code Book) but at the same time a wide number of catalogues, which altogether contribute to a quite detailed definition of the items included. In these countries, there is a wide range of benefit catalogue substitutes in place, such as grouping systems, fee schedules, guidelines, and contracts (Table 2), which have been recently, or are about to be, updated and refined.
Benefit catalogues and substitutes, in which included services are listed1
■ Benefit catalogues for curative services
15The categories of services of curative care together with those of medical goods are the areas for which the majority of benefit catalogues or substitutes were identified (Table 2). The details of the benefit catalogues for inpatient and outpatient care have been compared in more detail elsewhere (Schreyögg et al. 2005).
Inpatient services
16France and Poland have elaborated explicit benefit catalogues listing procedures grouped according to medical specialties, which act as positive lists (Bellanger et al. 2005b; Kozierkiewicz et al. 2005b). In Spain the medical specialities included have been defined, however, further development of the benefit catalogue is pending (Planas-Miret et al. 2005). In all other countries, DRG (diagnosis-related groups) (Denmark, Germany, Italy, and Hungary) or other grouping systems (England): Health Care Resource Groups; the Netherlands: diagnose behandeling combinaties, diagnosis and treatment combinations) may function as substitutes of the benefit catalogue. The main features of these grouping systems are very similar, but the number of groups differs considerably across the countries (Schreyögg et al. 2005). Their function as substitutes of explicit benefit catalogues can be illustrated with two examples. In Italy, the regional health authority of Lombardy added three additional DRGs to its system in order to specifically reimburse the use of drug-eluting stents and to encourage their utilisation (Torbica and Fattore 2005). In Germany, the development of a DRG for geriatric treatment required an explicit and detailed definition of the intervention, a geriatric assessment to be carried out, a specific number of professions involved, and a minimum number of therapy sessions (Lübke 2005). In both cases, concern had been raised about the possibility that the DRG system would be functioning as a hidden negative list, since the monetary value assigned to certain groups might have not covered the consumption of resources associated with the use of certain technologies, thus limiting its application. The creation of new DRGsn or the explicit mentioning of health technologies as part of certain DRGs entails a re-specification of at least part of the benefit catalogue for inpatient services. The group classification of diagnoses therefore acts as a benefit catalogue for two reasons: it limits utilisation of technologies not explicitly mentioned in the classification and functions as a partial positive list.
Outpatient services
17In the outpatient sector, benefit catalogues are again often substituted by grouping systems, serving remuneration purposes. In general, the benefit catalogues of the outpatient sector have a higher degree of explicitness, although with great variations among countries (Schreyögg et al. 2005). In countries where providers are remunerated on the basis of fee-for-service-schemes draw up detailed lists of individual procedures, or of services sequences (aggregated multiple procedures), since these specifications are required to regulate the financial exchanges between provider and pur
18chasers. These lists function as benefit catalogues (positive lists) since physicians are usually reimbursed only for those items listed. Some countries issue detailed lists of all procedures to be performed by physicians (e.g. the “catalogue of benefits” in Poland (Kozierkiewicz et al. 2005b) and the “common classification of medical procedures” (CCAM) in France (Bellanger et al. 2005b), while other countries list service sequences, in which the physician is responsible for setting priorities within such an ensemble of procedures (e. g. SHI – EBM or SHI – BEMA in Germany (Busse et al. 2005b) or the “health care reimbursement scheme fee schedule” in Denmark (Bilde et al. 2005b)).
In countries where physicians receive fixed budgets or capitations, the benefit catalogue (i.e. the procedures they can offer) is indirectly restricted by the amount of money allocated to them. The benefit package for outpatient care is regulated in an implicit manner through decrees issued by national or regional health authorities, which describe the obligation of physicians to provide those benefits that are considered necessary. Examples for such implicit benefit catalogues are the “health insurance treatment and services decree” for care provided by GPs in the Netherlands or the General Medical Services Contract in England. These substitutes of benefit catalogues scarcely mention specific procedures, although in the case of the Netherlands, the system of “diagnosis and treatment combinations” introduced in 2005 acts as a substitute for a benefit catalogue for inpatient care and is also used by specialists in outpatient care (Stolk and Rutten 2005b). In addition, the GP association – the Landelijke Huisartsen Vereniging – defined a basic GP benefit package in the 1980s (Groenewegen and Greß 2004).
■ Benefit catalogues for rehabilitative care
19Rehabilitation is part of the benefit package in all countries studied. It is explicitly mentioned in all the documents establishing the overall framework of the benefit basket, either as an entitlement for patients or as a duty to be fulfilled by the health services. However, specific benefit catalogues within the framework regulation for rehabilitation were not identified in France, Germany, Netherlands, Spain or England. In Hungary, two specific catalogues relating to rehabilitation are in use (Gaal 2005a). The first one, unlike other catalogues described in this project, does not specify services that might be provided, but gives indications of which rehabilitation (otherwise not further itemised) is part of the basket. The classification is based on age groups (adult/child) and differentiates among cardiovascular, locomotor, lung and endocrine diseases and others. The catalogue lists about 15 indications for which rehabilitation might be provided, also specifying the providers (i.e. clinics/ “sanatoria”) licensed to provide the rehabilitative services covered. The second Hungarian catalogue differentiates two types of rehabilitation (balneotherapy and physiotherapy services), which are further itemised into specific services (10 for baleotherapy, 13 for physiotherapy). Other catalogues differentiate among broad categories of services (ranging from two to six), according to the purpose of rehabilitation (Denmark), the intensity of the rehabilitative intervention (Italy) or the kind of services (Poland) (Bilde et al. 2005a; Fattore and Torbica 2005; Kozierkiewicz et al. 2005a). Common to all of them is their vagueness, since no further specification of the items included in each category has yet been made.
In general, rehabilitative services are handled in other benefit catalogues, mainly the ones concerning outpatient and inpatient services. Thus, even where no specific catalogue for rehabilitation exists, a detailed list of rehabilitative services included in the basket might be available elsewhere (e.g. Italy or France). In addition, in countries lacking a specific catalogue for rehabilitation services, different forms of guidelines may play an important role in the specification of the kind of rehabilitative treatments included the basket. In France, for example, mandatory clinical practice guidelines link rehabilitative interventions to specific clinical conditions (e.g. lowback pain) (Bellanger et al. 2005a). In the UK, both National Service Frameworks and clinical guidelines specify both indications as to which rehabilitation belong the basket and the types of rehabilitative services.
■ Benefit catalogues for long-term nursing care services
20Long-term nursing care, as defined by the OECD in its system of health accounts, refers to ongoing health care and nursing care delivered to patients who need assistance on a continuing basis due to chronic impairments and a reduced degree of independence in activities of daily life, explicitly excluding “social care” (OECD 2000). The boundary between what is included in the benefit basket of the health system and the benefits rooted in social protection legislation might in reality not always be as straightforward. This may be due to the fact that these kinds of services are provided initially within the health care system, but when specific circumstances arise, responsibility for the same services shifts to the social services. The circumstances in which a person loses his/her status as “patient” (i.e. under health care services responsibility) to become a client of nursing care (i.e. under social care services responsibility) seem to be difficult to define in almost all countries. In England, the Beveridge report (1942) already recommended the separation of responsibility for health and social care (Mason and Smith 2005). Since then, however, this issue has been subjected to controversy. In Germany, this boundary has been clearly set by means of creating a special statutory insurance for long-term care, while short term-care continues to be a benefit of the health basket. The boundary has been set at six months, that is, patients requiring nursing care for under six months will be covered by the health insurance scheme, while the care of those whose need of it is expected to last for six months or longer is financed by the statutory long-term care insurance, even when the services do not differ. Similarly, in the Netherlands, a specific insurance scheme for long-term care exists (AWBZ), which covers both nursing as well as social care (i.e. household help) (Stolk and Rutten 2005a).
The only explicit and detailed catalogue specific for long-term care services has been formulated in Italy (governmental decree Nov. 2001 on the coordination of health and social services), organised in four main categories of services (community outpatient and home care, semi-residential community care, residential community care and penitentiary care), for which subcategories and specific services have been further differentiated (Fattore and Torbica 2005). The catalogue also clearly defines the financial responsibilities of the health and social services. A similar situation seems to exist in France, where the nursing components of care (home or inpatient) are part of the health benefit basket, whereas others such as catering, accommodation, or household help are financed by the social services (Bellanger et al. 2005a). Also, in Spain, long-term care has been defined as a component of the benefit basket; however, it has not been yet developed in detail and the division of responsibilities between social and health services is still not very clear (Puig-Junoy et al. 2005). In Denmark, a separation of responsibilities has been established by differentiating between “specialised” long term care, which is the responsibility of health services, and “general/less specialised” long-term care, which is the responsibility of social services (the municipalities) (Bilde et al. 2005a).
■ Benefit catalogues for ancillary services to health care
21The benefit baskets of all nine countries include ancillary services performed by paramedical or medical technical personnel, with or without the direct supervision of a medical doctor, such as laboratory tests, diagnostic imaging and patient transportation. However, the inclusion of these ancillary services is not always explicit.
22In the majority of the countries (e.g. Denmark, England, Germany, Netherlands, Poland), the services of this category are items belonging to the catalogues of outpatient or inpatient services, following the logic established for these categories. In France, a separate benefit catalogue for part of the ancillary services exists, the Nomenclature des Actes de Biologie Medicale. This is a list of laboratory procedures covered by the social health insurance, subdivided into 17 groups of diagnostic procedures ranging from pathology to prenatal diagnosis. However, this list is to be integrated in the general French catalogue (CCAM) (Bellanger et al. 2005a).
23In some situations, guidelines may explicitly mention specific tests to be made by clinicians (e.g. in the English National Service Frameworks). In other countries, the availability of diagnostic technologies may lead to a de facto definition of benefits, as in the case of Denmark or Spain. The availability of technologies depends thus on the priority setting for resource allocation.
The transportation of ill people and emergency rescue are generally included in the benefit basket of the studied countries. In this subcategory, however, no specific catalogues have been defined. In most cases, the relevant regulations describe situations for which transportation or rescue are covered, i.e. the entitlement to transport depends mainly on medical need and the socioeconomic situation of the individual.
■ Benefit catalogues for medical goods
Pharmaceuticals and other medical non-durables
24In all countries this category is explicitly included in the benefit package, being the category where the greatest variety of levels of coverage (the “height” dimension in Figure 1) can be observed (both across and within countries). The majority of countries have established a general catalogue of explicitly included drugs (positive list), which might be organised following the ATC-Classification (or a similar system) (Denmark, France, Netherlands and Spain) or which contains an alphabetical list of the pharmaceutical preparations included (Italy, Hungary, Poland). The majority of these catalogues provides information on the level of co-payment and limits the coverage of some drugs to specific clinical conditions or patient characteristics. Interestingly, the benefit catalogues of this category are always applied at the national level, even in health systems with a higher level of decentralisation, as in Italy or Spain, in which the content of the benefit basket may present regional variations (Fattore and Torbica 2005; Puig-Junoy et al. 2005). In Germany, a very limited positive list exists of drugs available over the counter (OTC) that are covered if they are used for specific conditions, thus escaping the overall exclusion of OTC drugs. The formulation of a general positive list was planned twice in Germany but never implemented (Busse and Riesberg 2004). In England, local health authorities may issue positive lists of drugs available for prescription within their jurisdiction, which thus represent a kind of local benefit catalogue. Negative lists also exist ( “Black” and “Grey” lists) (Mason and Smith 2005).
Therapeutic appliances and other medical durables
25In all nine countries, therapeutic appliances and other medical durables are part of the health basket, at least to some extent. The benefit catalogues for this category are in general explicit and mostly with high levels of detail. These positive lists usually follow the ISO classification of medical devices and products. In some countries (Germany, Hungary, Italy, England), individual products are mentioned, in some cases even specifying brand names or manufacturers (Busse et al. 2005a; Gaal 2005a; Fattore and Torbica 2005; Mason and Smith 2005). In the others, the level of detail is lower, since only types of products are listed, organised in different groups according mainly to anatomical site of use and function of devices. The classification of appliances and durables usually includes around thirty different product types and ranges from prosthesis for surgical use to furniture for disabled people. A common characteristic in almost all of the studied countries is that the catalogues do not only state what is included but also under which circumstances. The coverage of the individual products is conditioned by the presence of specific clinical conditions or limited to specific age or demographic groups. The duration of use or the level of co-payment are usually also regulated in the catalogue. Furthermore, some of catalogues restrict the ability of prescription for a specific device to specific groups of providers such as certain medical specialists.
■ Benefit catalogues for prevention and public health services
26Preventive services aimed at individuals (screening for disease, vaccinations, mother – child health programmes, family planning, etc.) are part of the benefit package of all nine countries, although differences exist concerning the specific content of the services (e.g. technologies used for screening, target diseases to be screened for, specific vaccinations). Usually the inclusion of such services is made explicit at the higher level of framework regulation with different levels of detail and structure. Spain and Italy have the most developed catalogues at this level (Fattore and Torbica 2005; Puig-Junoy et al. 2005). Hungary and Poland have a specific, separate benefit catalogue for preventive services. In Hungary, the decree 51/1997 provides a list of conditions to be screened for in different age groups (Gaal 2005a). Similarly in Poland, two decrees ( “On preventive services” and “On prevention services at school”) deal specifically with services from this category (Kozierkiewicz et al. 2005a). A specific benefit catalogue for preventive services is lacking in the rest of the countries. Since the majority of preventive measures targeting individuals are provided by physicians and other health care staff in outpatient settings, these services are usually listed in the benefit catalogues for outpatient curative services. In addition, catalogue substitutes are in place, such as the binding guidelines of the “federal joint committee” in Germany, the recommendations issued by the National Screening Committee in England, or the description of specific preventive programmes (as for example in France or in the English National Services Frameworks) (Busse et al. 2005a; Mason and Smith 2005; Bellanger et al. 2005a).
The case of population health services is rather interesting, since major differences between NHS and SHI countries can be observed. Whereas activities targeting population health through food and environmental protection, food security, health promotion and education or epidemiological surveillance etc. are explicitly included in the benefit package in countries like Italy or Spain (or implicitly in the UK), these kind of activities are not mentioned in the benefit basket regulations of SHI countries (with the exception of health promotion). The inclusion of population health services in the benefit basket of a NHS is probably rooted in the close relation of the national health service to the state, be it at national or regional level. The national health service is the part of the state administration related to health issues that fulfils the state duties concerning the health of its citizens or residents. Consequently, the benefit basket has to include tasks of this category. In SHI countries, the activities of health protection, epidemiological surveillance, information, etc. are tasks assumed by state institutions (national/federal, regional, local), but which do not fall under insurance coverage. Thus, despite the recognition across all countries in our study of the state duties concerning the health protection of its population, these services and activities are only part of the benefit package in NHS countries, which is consequently more a comprehensive one ( “depth” dimension in Figure 1) as compared to that of SHI countries.
■ Benefits excluded
27In most of the studied countries, some health services are explicitly excluded from the health basket. The number and type of benefits excluded varies considerably from country to country; some exclusions are observed only in one country.
28According to Table 3, some exclusions might be stated in the regulations that organise the benefit basket. However, explicit exclusions are increasingly being made with the help of clinical guidelines or clinical recommendations, as well as with service implementation guidelines, negative lists or even contracts (as is the case in England or Germany). These quasilaws serve as instruments contributing to the continuous updating of the benefit basket.
Explicit exclusions from health baskets in studied countries1
29There are differences in the level of detail of the exclusions, ranging from broad service categories to specific interventions. For example, some countries show a kind of “blanket exclusion”, concerning “cosmetic surgery” for example (Italy, Netherlands, Poland or Spain), whereas Hungary for example lists up to ten specific cosmetic interventions to be excluded.
30Despite the differences in the level of detail (i.e. mentioning specific procedures or technologies) a considerable level of consensus exists regarding the kind of services to be excluded from the benefit basket across the studied countries. For example, broad agreement seems to exist concerning the exclusion of cosmetic interventions, (without previous accident or congenital malformation), medical certificates not relevant to patient care (i.e. for driving license), some complementary or unconventional therapies (e.g. ozone therapy) and prescription-free pharmaceuticals.
31Common to almost all studied health systems is that for some selected population groups (such as “disabled, children, elderly, chronically ill”) some of the exclusions do not operate, i.e. these groups might be provided access to services excluded for the rest of the population. In some of the countries, it is possible to cover (or provide) services otherwise excluded, when “medical necessity” is proven. Thus, no real blanket ban exists for cosmetic interventions or for certain drugs in most of the countries, and for selected technologies (e. g. bone densitometry in Italy, contact lenses in the Netherlands or PET (positron emission tomography) scans in Poland). This form of exception to exclusions may leave an open door to litigation, when an individual considers him- or herself to have a medical necessity that would justify the exception where no clear criteria for the definition of “medical necessity” have been established.
32Beside explicit exclusions, implicit exclusions exist. One might consider that any service not accounted for in a positive list is indirectly excluded. Therefore the list of excluded services is probably much longer in each country than it seems.
As already mentioned, remuneration schemes such as DRG may also act as hidden negative lists, specially if the groups are not very specific (i.e. do not reflect special procedures or technologies). In such cases, some of the technologies or procedures which could be applied to certain conditions will be de facto not available for beneficiaries of publicly financed care, if the monetary value assigned to certain groups does not cover the actual consumption of resources associated with its utilisation or if they are not listed in the reimbursement catalogues.
■ Criteria for decision-making
33In all nine countries, more or less explicit criteria governing decisions on the inclusion of specific services (or technologies) in the health basket have been defined for at least one category of health care (Table 4). Overall, the most widespread criteria are need, effectiveness, cost and costeffectiveness. Usually, these criteria are stated without further specification in the legal framework texts defining the benefit basket, and may apply to both the integration of broad areas of care and decisions related to specific technologies. Information on how the criteria are to be made operational and how they are applied, appraised and weighted in the decision-making process is, however, widely lacking. Nevertheless, the growing relevance of effectiveness and cost-effectiveness in the decisionmaking process is supported by the observation in recent years of an increasing number of institutions commissioned to conduct “health technology assessment” in Europe (Velasco-Garrido and Busse 2005), even if their true role and integration in the decision-making process has not always been clearly formalised. However, the formalisation and transparency of the decision-making process have been important targets of recent health care reform in some European countries, such as Germany and Hungary (Busse and Riesberg 2004; Gaal 2005b)
34There are major differences between the health categories in the extent to which transparent criteria are used (or at least intended to be used).
Criteria for decision making on health baskets1
Criteria for decision making on health baskets1
35The decision-making process concerning the inclusion or exclusion of pharmaceuticals is the one for which the most explicit criteria exist. These criteria are transparent (at least on paper) in most of the countries. Beside safety and effectiveness, the impact on overall expense in the health systems plays an important role in decisions regarding pharmaceuticals. In some countries (France, the Netherlands, Spain), it is even explicitly required that these aspects be appraised in relation to pharmaceuticals that are already included. New pharmaceuticals do not only need to prove they are “good”: they are increasingly required to be “better” than existing products in order to achieve full reimbursement. The degree of innovation (i.e. challenging unsolved problems, treatment of rare or “orphan” diseases, etc.) is also a criterion that is increasingly used in the specification of the benefit package. This is also the case for medical aids. New products must be compared with the ones already included, in terms of effectiveness, quality and costs in Spain (Puig-Junoy et al. 2005). The inclusion of new products is intended to be substitutive; older, less cost-effective technologies should be replaced by those included more recently. Similarly, in France, the relative improvement provided by a new technology in terms of effectiveness (utility) represents one of the relevant aspects to be taken into account in the decision-making process (Bellanger et al. 2005a). Decision criteria concerning the curative sector have been also been defined in most of the countries.
36The aspect most considered in this area is need, which is usually defined as those services needed to restore health of an individual or services needed to guarantee the health of the community or the nation. Costs or budgetary impact were also identified as relevant criteria for this category of health care. It is not always clear whether these criteria are mainly applied in the general planning of health care (e. g. planning the number and distribution of health care facilities, or deciding on the availability of big-ticket technologies, or addressing waiting lists) or in the decision-making regarding the inclusion or exclusion of specific technologies. In this sector, effectiveness is also mentioned as a decision-making criterion where single technologies are concerned.
In some SHI countries – Germany being the prime example – self-governing institutions, with sickness fund and professional representatives, play an important role in the decision-making process. These bodies are responsible for the application of the decision-making criteria and the detailed definition of the benefit basket, since they are involved in the negotiations related to catalogue substitutes (e. g. contracts, fee schedules, guidelines for service provision).
■ Discussion
37To our knowledge, the HealthBASKET project has provided the first indepth analysis of the benefit baskets and the benefit catalogues in place in nine European countries, which represent a heterogeneous mix of health care systems. The country studies have shown that information on this issue is often difficult to access, since it is highly fragmented and non-systematic. The use of a common framework and terminology to scan the different health systems incorporating benefit catalogues has allowed us to gather heterogeneous information in a highly comparative manner. The methodology followed in our study could be applied to explore and describe the health baskets and catalogues in other European as well as non-European countries.
38The main limitation of our study is the fact that we have not analysed the reasons (i.e. values, interests, cultural background) underlying the observed differences in the structure and contents of the benefit catalogues we have identified and described. The descriptions we provide are mainly based on document analyses. In most of the countries, aspects considered in the decision-making process and the ultimate reasons underlying decisions on the health basket are not transparently and systematically documented. However, other researchers may choose to draw on the detailed descriptions of the baskets and on the “maps” of decision-making bodies provided by the HealthBASKET project to design appropriate studies exploring these issues (e.g. by approaching individuals involved in the decision-making process).
39The comparative analysis of health benefits in the countries under study reveals that, despite their differences in terms of financial and organisational arrangements, there is a clear trend towards a more explicit definition of benefit baskets and benefit catalogues in European health care systems. Those countries that recently introduced new health care legislations, e.g. Italy, Poland and Spain, have more explicitly defined benefit catalogues. Other countries with older health care legislations – e.g. the UK’s English-NHS Foundation Act (1946) or Germany’s Social Code Book (1988) – have, at least at the legal level, rather implicitly defined benefit baskets. All of the countries studied, however, are moving towards a more explicit definition of benefit catalogues: be it in the form of positive and negative lists, or catalogue substitutes such as remuneration schemes, contracts or clinical guidelines.
40Explicitly defined benefit catalogues, however, require clear and transparent decision criteria for the inclusion or exclusion of benefits. This has been recognised by policymakers, as shown by the fact that sets of criteria to guide decision-making have been defined. Most countries officially state that (cost)-effectiveness is an important decision criterion. However, further enquiry often reveals that a true formalisation of the process is still lacking for many health care categories and is often restricted to one or several sectors of the health care system, e.g. pharmaceuticals or medical devices, and is not generalised across all products or services (Gibis et al. 2004). There is still insufficient transparency in the interpretation, operationalisation and application of the criteria. In this context, there is a need to strengthen the role of independent health technology assessment in the decision-making process. Participation of the public in the decision-making process of the health basket will need to be debated in the near future, since decisions relating to the basket may produce social controversy. The developments in some countries (e.g. the United Kingdom or Germany), in which patient or public representatives can be heard in the process of decision-making, are a recognition of the legitimacy of claims for greater participation of citizens in the shaping of the benefit basket. The Israeli experience with a “Health Parliament” has demonstrated that policymakers can benefit from consultation with the public on conflictive healthbasket issues (Shalev et al. 2004; Tal et al. 2004).
41Contrary to widespread opinion, the motivation behind establishing an explicit benefit basket of services is not always cost containment or rationing. In the two countries with regionalised national health services, Italy and Spain, the purpose of the definition of a health basket is to ensure equity among the regions. The devolution of health services to the autonomous (regional) governments, in the face of their existing financial constraints, highlights the need to define a minimum basket of health services common to all, in order to avoid unacceptable differences in health service provision. The regional health authorities may, however, add further benefits, provided they have covered the minimum adequately.
Harmonisation of the health baskets in EU countries does not seem realistic in the short or medium term. The desirability, need and feasibility of a minimum European health basket require careful assessment and an open debate in which the underlying reasons for existing differences – i.e. societal preferences, values – are considered, before any initiatives in this direction are taken. For this to take place, public documents should be regularly prepared by each member state giving a transparent overview of the health baskets and the decision-making criteria. A common “language” or system of classification for describe existing differences – whether these are justified by national preferences or values, or not – is, however, urgently required, and developments in this area should appear on the European agenda sooner rather than later. [4]
Notes
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[*]
Marcial Velasco-Garrido, Jonas Schreyögg, and Tom Stargardt: Research Fellows and Lecturers in the Department of Health Care Management at the Berlin University of Technology; Reinhard Busse: Professor and Director of the Department of Health Care Management at the Berlin University of Technology (Germany).
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[1]
The definition of health subscribed by the World Health Organisation in 1946.
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[2]
At a later date, the project will provide insight on the methodologies used to assess costs and prices of health services, and an assessment of the real costs of selected outpatient and inpatient services, from the perspective of the payer (www.healthbasket.org).
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[3]
Technologies include the whole range of interventions that can be provided (i.e. devices, drugs, manœuvres, operations) (Velasco-Garrido and Busse 2005).
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[4]
Acknowledgements: The results presented in this article are based on the project “Health Benefits and Service Costs in Europe – HealthBASKET” which is funded by the European Commission within the Sixth Framework Research Programme (Grant: SP21-CT-2004-501588). The authors would like to thank all project partners in the nine European countries, who contributed to this analysis with their comprehensive reports.
