
Background The German statutory health insurance (GKV) reimburses all health care services that are deemed sufficient, appropriate, and efficient. According to the German Medical Association (BÄK), individual health services (IGeL) are services that are not under liability of the GKV, medically necessary or recommendable or at least justifiable. They have to be explicitly requested by the patient and have to be paid out of pocket. Research questions The following questions regarding IGeL in the outpatient health care of GKV insurants 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 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? Are there sub-populations for whom screening might be beneficial? Methods The evaluation is divided into two parts. For the first part a systematic literature review of primary studies and publications concerning ethical, social and legal aspects is performed. In the second part, rapid assessments of the clinical effectiveness for the two examples, glaucoma and VUS screening, are prepared. Therefore, in a first step, HTA-reports and systematic reviews are searched, followed by a search for original studies published after the end of the research period of the most recent HTA-report included. Results 29 studies were included for the first question. Between 19 and 53% of GKV members receive IGeL offers, of which three-quarters are realised. 16 to 19% of the insurants ask actively for IGeL. Intraocular tension measurement is the most common single IGeL service, accounting for up to 40% of the offers. It is followed by ultrasound assessments with up to 25% of the offers. Cancer screening and blood or laboratory services are also frequent and represent a major proportion of the demand. The ethical, social, and legal aspects discussed in the context of IGeL concern eight subject areas: autonomous patient decisions versus obtrusion, commercialization of medicine, duty of patient information, benefit, evidence, and (quality) control, role and relation of physicians and patients, relation to the GKV, social inequality, formally correct performance. For glaucoma screening, no randomized controlled trial (RCT) is identified that shows a patient relevant benefit. For VUS three RCT are included. However, they do not yet present mortality data concerning screened and non-screened persons. VUS screening shows a high degree of over-diagnosis in turn leading to invasive interventions. To diagnose one invasive carcinoma, 30 to 35 surgical procedures are necessary. Conclusion IGeL are a relevant factor in the German statutory health care system. To provide more transparency, the requests for evidence-based and independent patient information should be considered. Whether official positive and negative-lists could be an appropriate instrument to give guidance to patients and physicians, should be examined. Generally, IGeL must be seen in the broader context of the discussions about the future design and development of the German health care system.
GMS Health Technology Assessment; 7:Doc05; ISSN 1861-8863
Gesetzliche Krankenversicherung, Zusatzleistung, TECHNOLOGY ASSESSMENT, BIOMEDICAL, offer, Risikoabschätzung, Methodik, individual health services, biomedical technology assessment, PEER REVIEW, RISK ASSESSMENT, glaucoma/economics, ECONOMICS, MEDICAL, Effizienz, humans, specifity, report, Nachfrage, interviews as topic, Ökonomie, Übersichtsliteratur, HTA, review literature as topic, supplementary benefit, Selbstbeteiligung, self retention, technology, juricical, Kostensenkung, SOZIALÖKONOMISCHE FAKTOREN, mass screening, medical evaluation, Glaukom, Peer Review, CLINICAL TRIALS AS TOPIC, add-on benefit, ENDOMETRIAL NEOPLASMS/ECONOMICS, Article, methods, Behandlung, GOÄ, Technikfolgen-Abschätzung, biomedizinische, additional benefit, survey, health technology assessment, private health insurance, Wunschsystem, HTA-report, Individuelle Gesundheitsleistung, HTA report, Gesundheitsökonomie, screening, commercialisation, Angemessenheit, health economic studies, sensitivity, systematische Übersicht, HEALTH CARE COSTS/*ETHICS, META-ANALYSIS AS TOPIC, TECHNOLOGIE, Kosten Effektivität, REVIEW LITERATURE AS TOPIC, KONTROLLIERTE KLINISCHE STUDIEN, G-BA, VERSICHERUNGSLEISTUNGEN, evidence based medicine, costs, health care costs/*, Peer review, return of costs, sozioökonomische Faktoren, gesundheitsökonomische Studien, Therapiefreiheit, Methoden, endometrial neoplasms/economics, Kommerzialisierung, health economics, cost-benefit analyses, sozialökonomische Faktoren, EbM, cost effectiveness, Glaukomscreening, COSTS AND COST ANALYSIS, Beurteilung, Doctor's duty to give patients information, Sensitivität, clinical freedom, controlled clinical trials as topic, Kosten und Kostenanalyse, Kosten-Nutzen-Analyse, technology evaluation, sozio-ökonomische Faktoren, EFFICIENCY, EBM, TECHNIKFOLGEN-ABSCHÄTZUNG, BIOMEDIZINISCHE, EVALUATION STUDIES AS TOPIC, review, Arzt-Patient-Beziehungen/*Ethik, effectiveness, socioeconomic factors, Prävention, costs and cost analysis, HEALTH CARE COSTS/*, decision making, socioeconomics, Entscheidungsfindung, Mensch, Sozioökonomie, care, ÖKONOMIE, ÄRZTLICHE, GLAUKOM, cost control, Versicherungsleistungen, therapy, ECONOMICS, MENSCH, Technologie, medizinische, medizinische Versorgungskosten*, Federal Joint Commitee, economics, GLAUCOMA/ECONOMICS, PHYSICIAN-PATIENT RELATIONS/*ETHICS, VUS, CONTROLLED CLINICAL TRIALS AS TOPIC, evaluation studies as topic, preventive services, Endometriumtumoren, Gemeinsamer Bundesausschuss, Reihenuntersuchung, random allocation, INTERVIEWS AS TOPIC, catalogue of benefits, Angebot, diagnosis, health care costs/*standards, cost repayment, ÖKONOMIE, Technologie, THERAPY, medizinische Beurteilung, technology assessment, biomedical, co-payment, Kostenminimierung, prevention, Kostenanalyse, cost analysis, Informationspflicht, preventive benefits, IGeL, catalogue of services, INSURANCE, HEALTH, REIMBURSEMENT/*, TECHNOLOGY, MEDICAL, Glaukom/Ökonomie, Vorsorge, SOCIOECONOMIC FACTORS, Private Krankenversicherung, risk assessment, technical report, Vaginaler Ultraschall, demand, 610 Medical sciences; Medicine, vaginal ultrasound, obligation to pay, statutory health insurance, meta analysis as topic, Endometriumtumoren/Ökonomie, Kosten, Ökonomie, ärztliche, MASS SCREENING, cost-cutting, KLINISCHE STUDIEN, PKV, evidenzbasierte Medizin, cost reduction, COST-BENEFIT ANALYSIS, endometrial neoplasms, Gesundheitsfinanzierung, benefit package, randomization, medical costs, HTA Bericht, health care costs/*ethics, randomisation, DECISION MAKING, interview, Technologiebewertung, freedom of therapy, accident, technology assessment, economic aspect, GKV, ethics, glaucoma, ENDOMETRIAL NEOPLASMS, METAANALYSE, EVIDENCE-BASED MEDICINE, Kostenreduktion, Krankheitskosten, private service, efficacy, Selbstzahlerleistung, randomized controlled trials as topic, Privatleistung, ENTSCHEIDUNGSFINDUNG, Gebührenordnung, appropriateness, poll, systematic review, GLAUCOMA, medizinische Bewertung, EVALUATIONSSTUDIEN, HTA-Bericht, INTERVIEWS, Health technology assessment, medizinische Versorgungskosten/*Ethik, KOSTEN UND KOSTENANALYSE, EFFIZIENZ, TECHNOLOGIE, MEDIZINISCHE, clinical trials as topic, technology, medical, treatment, medizinische Versorgungskosten/*Standard, HEALTH CARE COSTS/*STANDARDS, RISIKOABSCHÄTZUNG, HUMANS, INSURANCE BENEFITS, medizinische Technologie, Kosteneffektivität, Kosten-Effektivität, Versicherung, Kranken-, Leistung/*, Technologiebeurteilung, social economic factors, Krankenkasse, ddc: 610, economics, medical, Screening, fee schedule, Wirksamkeit, Therapie, RANDOMIZED CONTROLLED TRIALS AS TOPIC, Ethik, ÜBERSICHTSLITERATUR, KOSTEN-NUTZEN-ANALYSE, obligation to render services, physician-patient relations/*ethics, Kostenerstattung, RANDOMISIERTE KONTROLLIERTE STUDIEN, health insurance fund, Interviews, ärztliche Aufklärungspflicht, Übersichtsarbeit, obligation to supply services, Spezifität, insurance, health, reimbursement/*, TECHNOLOGY, Versorgungsauftrag, insurance benefits, Eigenleistung, cost-effectiveness, GUTACHTENBASIERTE MEDIZIN, commercialization, medical assessment, range of benefits, random, review literature, reimbursement of costs, Wahlsystem, screening for glaucoma, ökonomischer Aspekt, efficiency, ENDOMETRIUMTUMOREN, Kostenkontrolle, REIHENUNTERSUCHUNG, gutachtenbasierte Medizin, Effektivität
Gesetzliche Krankenversicherung, Zusatzleistung, TECHNOLOGY ASSESSMENT, BIOMEDICAL, offer, Risikoabschätzung, Methodik, individual health services, biomedical technology assessment, PEER REVIEW, RISK ASSESSMENT, glaucoma/economics, ECONOMICS, MEDICAL, Effizienz, humans, specifity, report, Nachfrage, interviews as topic, Ökonomie, Übersichtsliteratur, HTA, review literature as topic, supplementary benefit, Selbstbeteiligung, self retention, technology, juricical, Kostensenkung, SOZIALÖKONOMISCHE FAKTOREN, mass screening, medical evaluation, Glaukom, Peer Review, CLINICAL TRIALS AS TOPIC, add-on benefit, ENDOMETRIAL NEOPLASMS/ECONOMICS, Article, methods, Behandlung, GOÄ, Technikfolgen-Abschätzung, biomedizinische, additional benefit, survey, health technology assessment, private health insurance, Wunschsystem, HTA-report, Individuelle Gesundheitsleistung, HTA report, Gesundheitsökonomie, screening, commercialisation, Angemessenheit, health economic studies, sensitivity, systematische Übersicht, HEALTH CARE COSTS/*ETHICS, META-ANALYSIS AS TOPIC, TECHNOLOGIE, Kosten Effektivität, REVIEW LITERATURE AS TOPIC, KONTROLLIERTE KLINISCHE STUDIEN, G-BA, VERSICHERUNGSLEISTUNGEN, evidence based medicine, costs, health care costs/*, Peer review, return of costs, sozioökonomische Faktoren, gesundheitsökonomische Studien, Therapiefreiheit, Methoden, endometrial neoplasms/economics, Kommerzialisierung, health economics, cost-benefit analyses, sozialökonomische Faktoren, EbM, cost effectiveness, Glaukomscreening, COSTS AND COST ANALYSIS, Beurteilung, Doctor's duty to give patients information, Sensitivität, clinical freedom, controlled clinical trials as topic, Kosten und Kostenanalyse, Kosten-Nutzen-Analyse, technology evaluation, sozio-ökonomische Faktoren, EFFICIENCY, EBM, TECHNIKFOLGEN-ABSCHÄTZUNG, BIOMEDIZINISCHE, EVALUATION STUDIES AS TOPIC, review, Arzt-Patient-Beziehungen/*Ethik, effectiveness, socioeconomic factors, Prävention, costs and cost analysis, HEALTH CARE COSTS/*, decision making, socioeconomics, Entscheidungsfindung, Mensch, Sozioökonomie, care, ÖKONOMIE, ÄRZTLICHE, GLAUKOM, cost control, Versicherungsleistungen, therapy, ECONOMICS, MENSCH, Technologie, medizinische, medizinische Versorgungskosten*, Federal Joint Commitee, economics, GLAUCOMA/ECONOMICS, PHYSICIAN-PATIENT RELATIONS/*ETHICS, VUS, CONTROLLED CLINICAL TRIALS AS TOPIC, evaluation studies as topic, preventive services, Endometriumtumoren, Gemeinsamer Bundesausschuss, Reihenuntersuchung, random allocation, INTERVIEWS AS TOPIC, catalogue of benefits, Angebot, diagnosis, health care costs/*standards, cost repayment, ÖKONOMIE, Technologie, THERAPY, medizinische Beurteilung, technology assessment, biomedical, co-payment, Kostenminimierung, prevention, Kostenanalyse, cost analysis, Informationspflicht, preventive benefits, IGeL, catalogue of services, INSURANCE, HEALTH, REIMBURSEMENT/*, TECHNOLOGY, MEDICAL, Glaukom/Ökonomie, Vorsorge, SOCIOECONOMIC FACTORS, Private Krankenversicherung, risk assessment, technical report, Vaginaler Ultraschall, demand, 610 Medical sciences; Medicine, vaginal ultrasound, obligation to pay, statutory health insurance, meta analysis as topic, Endometriumtumoren/Ökonomie, Kosten, Ökonomie, ärztliche, MASS SCREENING, cost-cutting, KLINISCHE STUDIEN, PKV, evidenzbasierte Medizin, cost reduction, COST-BENEFIT ANALYSIS, endometrial neoplasms, Gesundheitsfinanzierung, benefit package, randomization, medical costs, HTA Bericht, health care costs/*ethics, randomisation, DECISION MAKING, interview, Technologiebewertung, freedom of therapy, accident, technology assessment, economic aspect, GKV, ethics, glaucoma, ENDOMETRIAL NEOPLASMS, METAANALYSE, EVIDENCE-BASED MEDICINE, Kostenreduktion, Krankheitskosten, private service, efficacy, Selbstzahlerleistung, randomized controlled trials as topic, Privatleistung, ENTSCHEIDUNGSFINDUNG, Gebührenordnung, appropriateness, poll, systematic review, GLAUCOMA, medizinische Bewertung, EVALUATIONSSTUDIEN, HTA-Bericht, INTERVIEWS, Health technology assessment, medizinische Versorgungskosten/*Ethik, KOSTEN UND KOSTENANALYSE, EFFIZIENZ, TECHNOLOGIE, MEDIZINISCHE, clinical trials as topic, technology, medical, treatment, medizinische Versorgungskosten/*Standard, HEALTH CARE COSTS/*STANDARDS, RISIKOABSCHÄTZUNG, HUMANS, INSURANCE BENEFITS, medizinische Technologie, Kosteneffektivität, Kosten-Effektivität, Versicherung, Kranken-, Leistung/*, Technologiebeurteilung, social economic factors, Krankenkasse, ddc: 610, economics, medical, Screening, fee schedule, Wirksamkeit, Therapie, RANDOMIZED CONTROLLED TRIALS AS TOPIC, Ethik, ÜBERSICHTSLITERATUR, KOSTEN-NUTZEN-ANALYSE, obligation to render services, physician-patient relations/*ethics, Kostenerstattung, RANDOMISIERTE KONTROLLIERTE STUDIEN, health insurance fund, Interviews, ärztliche Aufklärungspflicht, Übersichtsarbeit, obligation to supply services, Spezifität, insurance, health, reimbursement/*, TECHNOLOGY, Versorgungsauftrag, insurance benefits, Eigenleistung, cost-effectiveness, GUTACHTENBASIERTE MEDIZIN, commercialization, medical assessment, range of benefits, random, review literature, reimbursement of costs, Wahlsystem, screening for glaucoma, ökonomischer Aspekt, efficiency, ENDOMETRIUMTUMOREN, Kostenkontrolle, REIHENUNTERSUCHUNG, gutachtenbasierte Medizin, Effektivität
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