gms | German Medical Science

The background of the emergence of the concept of individual health services (IGeL), as interpreted by its founders, is the difficult economic situation of the German statutory health insurance (GKV) that led to repeated benefit cuts and increased co-payments for the insured. Practicing physicians first requested a catalogue of services not covered by the GKV in 1996. The National Association of Statutory Health Insurance Physicians (KBV), together with the medical professional associations, decided to prepare a catalogue of so-called “individual health services”. It was presented by the KBV president Winfried Schorre at a press conference on March 18, 1998.

A consistent and general definition as well as a systematization of IGeL is still lacking. The only common feature is the specification as non-GKV-services. IGeL are accepted by the insured, especially with regard to early detection and prevention. Most health insurance funds consider IGeL critical. They counsel their insurants about patients’ rights, physicians’ duties, GKV services, and give recommendations for responding to IGeL offers by physicians. There are substantial controversies about IGeL among medical practitioners. Many practicing physicians are afraid of reputation-damaging consequences by its misuse. By others, it is proposed that IGeL hold the opportunity for comprehensive service provisions despite politically restricted revenues from the GKV.

There is no independent authority controlling the quality and the appropriateness of IGeL. For most GKV services, the requirements for training and facilities are defined in detail, which is not the case for IGeL. There are no routine data for the quantitative and qualitative evaluation of these services.

The Social Code Book V constitutes the legal framework for the regulations of health care in the GKV. It defines the services that have to or can be provided by physicians in the statutory health insurance. Accordingly, insurants are entitled to benefits for prevention, (early-) detection, and treatment of disease and for rehabilitation on condition that these services are sufficient, appropriate, and efficient and do not exceed the necessary. Furthermore, the medical care must reflect the state of the art. A legal fixed catalogueue of benefits does not exist.

According to the Social Code Book V, the Federal Joint Committee (G-BA) as the decision-making body of the joint self-government of physicians, hospitals, and health insurance funds specifies the entitlements and the benefit limits. The guideline for the methods of examination and treatment in the compulsory health care system contains services that are approved after the evaluation by the G-BA and those that are explicitly excluded from the GKV health care.

The Uniform Value Scale (German: Einheitlicher Bewertungsmaßstab) for doctor’s fees determines the content of claimable services in ambulatory health care. It is enacted by the Valuation Committee, an assembly of representatives of the National Association of Statutory Health Insurance Funds and the National Association of Statutory Health Insurance Physicians. The Uniform Value Scale is an index regulating the accounting of outpatient health services within the statutory health insurance. Only services included in the Uniform Value Scale can be reimbursed by the GKV.

The GKV is based on the principle of benefits in kind. That means, presenting their electronic patient card insured patients are generally treated by the physician without direct payment. All health services are compensated by the insurance premium. However, there are exceptions such as the charges for office visits or co-payments for remedies and aids. Since 2004, insured patients can also choose the cost reimbursement principle. The insurant is treated as a privately insured patient. However, the statutory duty for the physician to provide care persists, as is the case for all GKV members. Only the reimbursement claims are addressed directly to the patient and are based on the medical fee schedule (GOÄ).

Physicians who wish to be licensed by the statutory health insurance system are bound by the regulations of the Federal Collective Agreement (BMV-Ä) that are agreed upon between the KBV and the primary funds. As health care providers they are obliged to provide members of the statutory health insurance with entitled services that are sufficient, appropriate, and efficient. Medical care, according to the GKV catalogue, can be refused only in reasonable exceptions.

In contrast to the treatment according to the GKV catalogue, a previous written agreement is obligatory for IGeL. Its purpose is to assure that the duties of patient information are fulfilled. Since GKV-insured patients are usually treated based on the electronic patient card and thus the awareness for the liability to pay can be limited, the BMV-Ä stipulates an explanation of the economic consequences of IGeL.

According to the Medical Association's professional code of conduct (MBO) the medical profession is not commercial. Through IGeL not only the self-conception but also the working conditions of the medical profession have changed. The provision of IGeL as health services puts them on par with commercial services and puts the medical profession close to any other business.

In principle the relation between physician and patient is asymmetrical. To meet the requirements of the vulnerable patient and the showed trust, the physician has to inform about the planned procedures, the benefits and risks, and to explain them to the patient, the. In many cases, the patient cannot judge whether a GKV treatment is sufficient or an additional IGeL would be better. This reinforces the asymmetry in the physician-patient-relation. The high requirements on patient information are not always met.

Different stakeholders in the German health care system hold different views and strive for different goals with regard to IGeL. Providers of care have their own agenda for freedom of therapy driven by professional and economic interests, health insurance funds seek an efficient handling of resources, and the insured want the best possible care. Thus there is a fundamental controversy about the competences and roles of the involved parties. The discussion about IGeL is to a large extent a political debate about the “right” organization of the health care system.

Binge drinking is as well defined as risky alcohol consumption. Binge drinking is the consumption of four (women) or five (men) and more standard units of alcohol at one occasion. Alcohol misuse is defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) 305.00 and in the International Statistical Classification of Diseases and Related Health Problems (ICD-10) F.10.1.

Different results are prevalent concerning the frequency of risky alcohol consumption among adolescents and young adults aged twelve to 25 as various measurements are used.

The causes of risky alcohol consumption are seen in the followings factors: social environment, personality and family factors, the influence of peers and reference groups, alcohol specific expectations and norms. Behavioural prevention and structural prevention try to influence these factors.

The following questions regarding IGeL in the outpatient health care of members of the statutory health insurance are addressed in the present report:

• What is the empirical evidence regarding offers, utilization, practice, acceptance, and the relation between physician and patient, as well as the economic relevance of IGeL?
• What ethical, social, and legal aspects are related to IGeL?
• For two of the most common IGeL, the screening for glaucoma using different ophthalmologic tests, and the screening for ovarian and endometrial cancer by vaginal ultrasound (VUS), the following questions are addressed:
• What is the evidence for the clinical effectiveness of the screening? What is the benefit-risk-balance regarding mortality, morbidity, and quality of life for the screening-program in comparison to usual care?

Are there sub-populations for whom screening might be beneficial?

The evaluation of IGeL comprises two parts. The first part is a systematic review (SR) of the above mentioned research questions about IGeL in general and includes primary studies with empirical evidence and publications with essays and reviews for the exploration of the ethical, social, and legal aspects.

In the second part, rapid assessments of clinical effectiveness will be performed for the two examples, the glaucoma screening and the VUS screening. First, a search for SR and HTA-reports is performed. Second, primary studies are searched which were published after the end of the research period of the most recent included secondary study. The two examples are chosen because they represent two of the most common IGeL.

For the general IGeL questions, cross-sectional and longitudinal surveys among the German general population, special populations or stakeholders of the health care system are included if they assess empirical data about offers, utilization, practice, acceptance, and economic relevance of IGeL.

For the identification of ethical, social, and legal questions in the context of IGeL, essays, reviews, detailed descriptions of particular topics, statements, position papers, guidelines, documentations of discussions at conferences and symposia are included. Letters to the editor, short comments, notes and summaries of original studies that are already available in full text, notes and summaries of statements, position papers, guidelines, and documentations of discussions at conferences and symposia inasmuch they are already existent as full texts, are excluded.

• The question of the clinical effectiveness of the two IGeL examples is assessed by means of the following in- and exclusion criteria:
• The study and target-population are asymptomatic adults without further age restrictions
• The diseases of interest are ovarian or endometrial cancer and primary open-angle glaucoma, respectively
• The interventions are VUS screening and different ophthalmologic tests respectively
• The comparator is no screening
• Outcomes are mortality, morbidity, health-related quality of life and harm by screening.

Adequate study designs are HTA-reports and SR as well as RCT for the update.

The literature search is conducted in the databases of the German Institute of Medical Documentation and Information (DIMDI) for all research questions. An additional Internet search on the websites of relevant stakeholders is performed for the general IGeL questions. The keywords “IGeL” or “individual health service”, respectively and “auxiliary medical service” are combined with terms for the publication type, such as evaluation, HTA, review, study report, with terms for related topics, such as economics, cost and benefit, as well as with terms for the ethical, social, and legal fields. The search terms for the two examples include terms for the disease, screening and early-detection, diagnostics, study design and publication type.

The references are screened for title and abstract and are in- or excluded by two independent reviewers. Included publications are ordered and screened for the full text and, again, in- or excluded by two reviewers. The reasons for exclusion are documented. The relevant characteristics and results are extracted from the full text and the quality of the studies is evaluated according to checklists by two reviewers. The results for the general IGeL questions are summarized and presented in synopsis tables. A qualitative content analysis is performed for the contributions to ethical, social, and legal questions to allow a categorization and a summary of the statements. The reviews of the IGeL examples are presented in report form and the results of the primary studies in evidence tables.

The literature search for the general IGeL question results in 1,345 references. After the exclusion of duplicates, 1,221 references remain. 629 of those are excluded on the basis of the title/abstract and 592 are ordered in full text or downloaded from the Internet, respectively. Twenty-one texts are not available and, therefore, 571 full texts are evaluated. 507 texts do not meet the inclusion criteria. The information synthesis considers 64 full texts of which 31 are publications of 29 empirical primary studies and 33 publications for the investigation of ethical, social, and legal issues.

The included primary studies are 19 cross-sectional studies in the form of (computer assisted) telephone interviews, written or online-questionnaires among insurants, patients, or medical practitioners. Two studies originate from a research project in patient counseling and evaluate topics of patients’ requests within a pilot project. A separate group of eight investigations studies the economic profitability of IGeL in the doctors’ practice and assesses single IGeL services on the basis of scores and ranking lists.

The studies about use and practice of IGeL do not meet all the scientific standards with regard to study design, performance, and quality of reporting. There are data from one long-term periodic survey of the scientific institute of the Local Health Care Fund AOK (WIdO). The KBV and Bertelsmann “health monitor” also repeatedly collected data on IGeL. A scientific investigation of the University of Lübeck provides valid data from 2007. Other unique surveys are conducted by consumer agencies, a government department, and an industry association. Several Internet surveys among physicians with only limited reliability represent the perspective of the provider. Approximately half of the investigations are not available as a study report or journal article, but only in the form of press releases or presentations. Twelve of the studies are based on representative random samples; however, only two of them report response rates. Direct comparability of the studies is limited since they differ in their definitions of IGeL, in the choice of single IGeL services and categories, and in the definition and assessment of outcomes.

Empirical data show that IGeL are widely-used in the outpatient health care. Between 19 and 53% of insured persons have received IGeL offers, of which 77 to 80% was actually performed. 16 to 19% of insurants asked for IGeL, themselves. Intraocular pressure measurement was the most common IGeL across several studies and represents up to 40% of all offers. It is followed by the cluster category “ultrasound scanning”, accounting for up to 25% of the offers. Moreover, cancer screening and blood/laboratory tests are prevalent offers. These also represent a major proportion of the demand (9.7 to 14%).

The ethical, social, and legal aspects that are discussed in relation to IGeL concentrate on eight subject fields:

1.

IGeL as an independent patients’ decision versus demand management by the physician

2.

Commercialization of medicine

3.

Duty of patient information

4.

Benefit and evidence and (quality) control

5.

Role and relation of physician and patient

6.

Relation of IGeL to the GKV

7.

Social inequality

8.

Legal and formally correct performance.

In addition, explicit requests for patient counseling, (quality) control, catalogue of benefits and financial concerns are expressed.

The database research results in 989 references from which 34 SR and HTA-reports are identified and 14 reports are evaluated as full text. Thereof, five reviews meet the inclusion criteria and are considered as a basis for the rapid assessment. The database search for primary studies finds 112 references that are published since 2009, after the end of the literature research of the most recent included HTA-report. After the screening of the titles and the abstracts, two papers are ordered and screened in full text but are excluded due to inapplicable research questions.

Neither the secondary studies nor the research for primary studies can identify a RCT about the clinical effectiveness of glaucoma screening. The five included HTA-reports are based on comprehensive systematic literature searches according to predefined in- and exclusion criteria. The studies from the HTA-reports uniformly show that sound evidence for the benefit of glaucoma screening is lacking. Problems for the benefit assessment and for the comparison of single studies are the heterogeneous disease definition and the absence of a diagnostic gold standard. On the basis of the current evidence, screening for glaucoma cannot be recommended.

The database research results in 1,006 references. One more reference is added after a manual search in the CRD database. By screening the titles and abstracts, 55 SR and HTA-reports are identified of which 45 are excluded because they do not meet the research question or the reporting quality. The remaining ten are ordered in full text. No secondary study of screening for endometrial cancer is found. One HTA-report of screening for ovarian cancer is identified and is considered as the basis for the rapid assessment as well as a SR that covers the research period until the end of 2002. The database research for original studies results in 437 references that are published since 2003, after the end of the research phase of the SR. By screening the titles and abstracts, 430 references are excluded according to the in- and exclusion criteria. Altogether, seven full texts reporting the study design and the results of three RCT are included in the information synthesis.

The included HTA-report and the SR are based on a comprehensive literature search with predefined in- and exclusion criteria. There are no data for the primary endpoint mortality. The HTA reports data on cancer morbidity that found a potential shift in time of diagnosis to earlier disease stages. The extent of over-diagnosis amounts to a false-positive-rate of 1.2 to 2.5%.

Three RCT (United Kingdom collaborative trial of ovarian cancer screening [UKCTOCS]; Prostate, lung, colo-rectal, and ovarian cancer screening trial [PLCO]; Shizuoka cohort study of ovarian cancer screening [SCSOCS] investigate VUS screening for ovarian cancer in postmenopausal women. Primary outcome is ovarian cancer mortality. The two first mentioned studies are ongoing to date. Both recruit asymptomatic women from population representative samples. The volunteers of the SCSOCS study come from gynecological clinics. The intervention is always screening with VUS and Cancer antigen 125 (CA125) measurement, diagnostic evaluation is performed by means of surgery. The control group receives usual care.

None of the three studies report data on mortality. Only the SCSOCS reports comparisons of cancer stage distribution between intervention- and control-group. More stage I cancers are detected in the screening-group compared to the control-group (63% and 38%, respectively). However, due to the small number of cases the difference is not statistically significant (p=0.2285). The data for diagnostics show that screening causes a high degree of over-diagnosis associated with invasive interventions. The fraction of abnormal scans that truly indicated an invasive carcinoma (i. e. the positive predictive value) ranges between 0.75 and 2.8%. The number of surgeries performed to detect one invasive carcinoma calculates to 35.2, 30.1, and 33.4 surgeries, respectively, in the three studies. The benefit of VUS screening for the early detection of ovarian carcinoma cannot be evaluated without patient related outcomes, such as mortality or quality of life.

There are no systematic records on IGeL services in the German health care system. The present HTA-report performs a systematic literature research and an Internet research. 29 studies on offers, utilization, practice, acceptance, and the relation between physician and patient, as well as the economic relevance of IGeL in the outpatient care and 33 publications on ethical, social, and legal aspects are identified. For two exemplary IGeL, a rapid assessment including a benefit assessment is conducted.

One limitation of the research for IGeL is the scarce publication of comprehensive contributions in peer-reviewed journals that is owed to the largely non-scientific discussion of the topic. Further limitations are the inconsistent indexing in literature databases and the potential selectivity of the Internet search. The included empirical investigations are partly flawed but can be accepted on an informative basis. The texts on ethical, social, and legal aspects are also not always of sound standing, but reflect the spectrum of current viewpoints and arguments.

The relatively wide distribution of IGeL is largely owed to the offers of services by physicians and does not consist of reasonable services outside the GKV catalogue, such as travel or sports medicine. The two exemplary evaluated IGeL, screening for glaucoma and VUS screening, showed that two of the most frequent IGeL are lacking evidence regarding their benefit. Although the formal regulations for the performance of IGeL should be known to the physicians, many violations are reported. The relation between patient and physician still seems to be not seriously impaired, but the public perception of the physician changes. The economic impact of IGeL as a part of the expanding “secondary health market” is estimated at 1.5 billion euro in 2010.

A great point of conflict is the lack of evidence basis for IGeL. This issue, which is unacceptable for critics, is turned against the GKV services by supporters: even in the statutory health insurance system, not all health care benefits underwent a benefit assessment according to evidence based medicine criteria. An open question is to what extent physicians can and do inform patients about the benefits and risks of IGeL. On the one hand, an in depth understanding of statistical methods is needed besides of clinical knowledge to assess risks and, on the other hand, risk communication towards the patient is challenging, especially for diagnostic examinations, such as screening. The adequate training, in that respect, of physicians who offer IGeL is in dispute.

The rejection of IGeL concerns more, in many cases, the “IGeL industry” with its magazines, congresses, and Internet platforms than single IGeL. This also stokes concerns about the commercialization of medicine, which is reinforced by the fact that IGeL are preferentially offered to members of higher social classes. The complaint that IGeL are an essential economic source for practicing physicians is unacceptable as financial needs must not be the impetus for offering health services of unknown medical justification. It is important to mention that the discussion about practitioners’ revenues is for the most part a question of allocation of resources that cannot be solved by IGeL. If health care of the population cannot be managed with the available resources, this is a structural problem that cannot be addressed by unregulated offers of privately disbursed IGeL.

IGeL are widespread in the German health care system. They account for a market of approximately 1.5 billion euro per year. The most frequent services are device based, early detection examinations. For the two assessed IGeL, the screening for glaucoma and the VUS screening, evidence for patient relevant benefit is lacking. Due to high over-diagnostics, leading to invasive interventions, harm can be caused by VUS screening.

Especially, the potential of harm for healthy people must be considered with regard to screening procedures in the general population. The balancing of risk and benefit makes high demands on the physicians’ expertise. The patients’ information must be carried out very thoroughly in order to enable them to make a competent decision. To provide transparency independent, evidence-based patient information sheets can be of value in this regard. Whether official positive and negative-lists could be an appropriate instrument to give guidance to patients and physicians should be examined.

The discussion about ethical, social, and legal aspects related to IGeL concern competent patient decisions versus obtrusion, commercialization of medicine, duty of patient information, benefit and evidence and (quality) control, role as well as the relation of physician and patient, IGeL and the GKV, social inequality and correct performance. Furthermore, explicit requests for patient counseling, (quality) control, catalogue of benefits, and financial concerns are expressed.

IGeL have to be regarded in the light of the general discussions about the future organization and development of the health care system. Different conceptions clash, demanding more or less individual responsibility and equalization of solidarity, respectively. Thus, IGeL are a part of socio-political and health care questions which cannot be answered in an HTA-report.