Background Close, continuous and efficient collaboration between different professions and sectors of care is necessary to provide patient-centered care for individuals with mental disorders. The lack of structured collaboration between in- and outpatient care constitutes a limitation of the German health care system. Since 2012, a new law in Germany (§64b Social code book (SGB) V) has enabled the establishment of cross-sectoral and patient-centered treatment models in psychiatry. Such model projects follow a capitation budget, i.e. a total per patient budget of inpatient and outpatient care in psychiatric clinics. Providers are able to choose the treatment form and adapt the treatment to the needs of the patients. The present study (EVA64) will investigate the effectiveness, costs and efficiency of almost all model projects established in Germany between 2013 and 2016. Methods/design A health insurance data-based controlled cohort study is used. Data from up to 89 statutory health insurance (SHI) funds, i.e. 79% of all SHI funds in Germany (May 2017), on inpatient and outpatient care, pharmaceutical and non-pharmaceutical treatments and sick leave for a period of 7 years will be analyzed. All patients insured by any of the participating SHI funds and treated in one of the model hospitals for any of 16 pre-defined mental disorders will be compared with patients in routine care. Sick leave (primary outcome), utilization of inpatient care (primary outcome), utilization of outpatient care, continuity of contacts in (psychiatric) care, physician and hospital hopping, re-admission rate, comorbidity, mortality, disease progression, and guideline adherence will be analyzed. Cost and effectivity of model and routine care will be estimated using cost-effectiveness analyses. Up to 10 control hospitals for each of the 18 model hospitals will be selected according to a pre-defined algorithm. Discussion The evaluation of complex interventions is an important main task of health services research and constitutes the basis of evidence-guided advancement in health care. The study will yield important new evidence to guide the future provision of routine care for mentally ill patients in Germany and possibly beyond. Trial registration This study was registered in the database “Health Services Research Germany” (trial number: VVfD_EVA64_15_003713).

Während die Bestechung und Bestechlichkeit von, in öffentlichen Krankenhäusern angestellten Ärzten, als Folge des „Herzklappenskandals“ und der darauf beruhenden Reform des Korruptionsstrafrechts bereits seit 1997 nach den §§ 331 ff. StGB strafbar sind, unterfielen niedergelassene Vertragsärzte auch nach der Rechtsprechung des Großen Strafsenats bis zum Inkrafttreten der §§ 299a ff. StGB am 04.06.2016 nicht den Korruptionsdelikten. Thematisch damit verbunden war und ist die Frage, ob Vorteilsgewährungspraktiken in diesem Bereich vom Tatbestand der Untreue erfasst sein könnten. Ihrer Beantwortung dient der erste Teil der Arbeit. Der zweite Teil fokussiert die Relevanz der Korruptionsvorschriften für das gewählte Arbeitsthema. Die Einbettung der Gesamtthematik in den Kontext der Korruptionsdelikte führt die Ausgangsbetrachtungen zur Untreue fort und ergänzt diese durch eine Bewertung nach den neuen Gesetzesregelungen. Das gewählte Arbeitsthema zeigt, wie wesentlich die Beschäftigung mit den relevanten Normen des Rechts der Gesetzlichen Krankenversicherung für die strafrechtlichen Bewertungen in diesem Bereich ist. Dies gilt umso mehr, wenn mit sozial- und beziehungsweise oder berufsrechtlichen Verstößen strafrechtliche Konsequenzen einhergehen und die fehlerhafte Anwendung der einschlägigen Rechtsnormen anderer Rechtsbereiche zwangsläufig auch zu falschen strafrechtlichen Schlussfolgerungen führt. Dieser Kritik sieht sich auch die Rechtsprechung des Bundesgerichtshofes zur sogenannten Vertragsarztuntreue ausgesetzt. Auch hier wurden die Besonderheiten des Sozialversicherungsrechts nicht mit der notwendigen Sorgfalt eruiert und stattdessen eine - seit mehreren Jahren - nicht mehr vertretene Rechtsprechung des Bundessozialgerichts zur Grundlage der strafrechtlichen Bewertungen gemacht. Dass dies weder den Anforderungen des Bundesverfassungsgerichts entspricht, noch mit den sozial- und strafrechtlichen Vorgaben vereinbar ist, zeigen die Ausführungen der Arbeit. In der Form eines kritischen Ausblicks werden abschließend, die Grenzen zulässiger verordnungsbezogener Vergütungen durch die Krankenkassen aufgezeigt und deren strafrechtliche Relevanz eingeordnet. Letzteres erfolgt am Beispiel eines Vertrags zur Förderung sog. biosimilarer Arzneimittel durch die Zahlung einer prozentualen Einsparbeteiligung als Gegenleistung für deren bevorzugte Verordnung. Die Konstellation verdeutlicht, dass auch die monetäre Einflussnahme der Krankenkassen auf das Verordnungsverhalten der Vertragsärzte strafrechtsrelevante Wirkung haben kann, wenn sie zu unberechtigten Wettbewerbsverzerrungen führt. / As a consequence of the so-called “heart valve scandal”, and the reform of the German criminal law on corruption that followed in the wake of the scandal, it has been a criminal offence under sections 331 et seqq. of the German Criminal Code [Strafgesetzbuch – StGB] since 1997 to give bribes to medical practitioners employed in public hospitals, or for such medical practitioners to take bribes. However, until sections 299a et seqq. StGB entered into force on 4 June 2016, acts committed by medical practitioners in private practices were not deemed to be corruption offences under the Criminal Code. This was also affirmed by the case-law of the Grand Criminal Panel of the German Federal Court of Justice [Großer Senat für Strafsachen]. A topic that has been repeatedly discussed in connection with the aforementioned issue is whether the practice of granting benefits in healthcare might constitute an offence of embezzlement. The first part of this dissertation provides an answer to that question. The second part focuses on the significance that corruption provisions have for the topic discussed herein. Following the initial analysis of the issue of embezzlement mentioned, this issue is expanded by a discussion of the overall topic in the context of corruption offences, supplemented by an assessment of the topic in the light of new legislation introduced. An analysis of the topic chosen for this dissertation shows how important it is to study the relevant legal provisions of the law on statutory health insurance in order to be able to carry out an assessment of the topic from the perspective of criminal law. This applies all the more so in cases where a breach of social law and/or the law of professional rules and regulations might have consequences under criminal law, and the faulty application of applicable legal rules from legal areas outside criminal law would inevitably also lead to wrong conclusions being drawn on the basis of criminal law. The case-law of the German Federal Court of Justice [Bundesgerichtshof] on so-called “embezzlement by medical practitioners in private practice” [Vertragsarztuntreue] has been criticised in this respect. The Federal Court of Justice did not take account of the specifics of German social security law in a sufficiently diligent manner, and instead used outdated case-law of the German Federal Social Court [Bundessozialgericht] as a basis for its criminal-law assessment—precedents that were overruled by the Federal Social Court itself many years ago. This dissertation shows that this does not meet the requirements of the German Federal Constitutional Court [Bundesverfassungsgericht] and that such an approach is incompatible with requirements under social and criminal law. Finally, the limits of admissible prescription-related remuneration by health insurances are discussed and demonstrated from a critical, future-oriented perspective, together with the significance these limits have from a criminal law perspective. The significance of such limits is discussed using as an example a selective-agreement model designed to promote so-called “biosimilar medicines” by paying medical practitioners a percentage of the savings achieved in return for practitioners prescribing such medicines rather than more expensive ones. The circumstances discussed illustrate that the monetary influence that health insurances exert over the way in which medical practitioners in private practice prescribe such things as medicines may have consequences under criminal law if such influence may lead to competition being distorted. In the light of the above, health insurances should not be provided with additional criminal-law-related exceptional provisions that would enable them to exert further influence over the neutrality of decision-making in the area of medical prescriptions.