| Health | Mobility | Education | Market Access and Reimbursement for Digital Health Apps in Germany “Apps on Prescription”: How to bring innovative digital solutions to patients in Germany IGES Institute. An IGES Group company.
The German Market and Access to it 03–09 04 Germany - Europe’s Most Important Market for Digital Health Products 06 The Regulatory Framework for Digital Health in Germany 08 Understanding the German Health Care System Reimbursement of Digital Health Applications Under the Digital Supply Act (DVG) 10–21 11 Application for Inclusion Manufacturer in the DiGA Directory by the 14 Positive Health Care Effect 16 Requirements for Positive Health Care Effect Studies 18 DiGA Pricing 20 Remuneration of Physicians and Psychiatrists Who Prescribe a DiGA Reimbursement of Digital Health Applications that Fall Outside the DVG 22–25 22 The DVG in the Context of other Regulations 23 Reimbursement Schemes for the Inpatient Sector 24 Alternative Reimbursement Schemes for the Outpatient Sector Reimbursement of Combined Products 26-27 26 The Relationship Between Different Reimbursement Rules 27 Reimbursement of a Medical Service Combined with a DiGA IGES Group 28 Glossary 29
About Us 2 IGES Institute was founded in 1980 and has become one of Germany’s most important voices for the health care sector. It is independent, and fully owned and operated by its scientists. We offer creative solutions for questions in care, quality, ﬁ nancing and shaping competition for all actors in the life sciences arena. Our clients are government organizations, NGOs and companies. We have broad access to data sources — both our own and those of other institutions. We approach all issues brought to us on the basis of data and facts, which we analyze with the best available methods. Since its foundation, the IGES Institute and the members of the IGES Group have carried out more than 4,000 research and consulting projects for commissioning parties from various areas of the health care system. Our Comprehensive Services: The IGES supports the entire process from gaining market access, to pricing and the reimbursement of digital health applications in Germany. It offers services covering the following, for example: Comprehensive strategic guidance for innovative digital health applications Development of evaluation concepts for assessments as required by the German HTA procedure Implementation of studies to demonstrate positive health care effects as required by the German HTA procedure Support in the preparation of price negotiations i About this Guide Our partners in Germany and abroad made a request for us to compile an overview of the regulation requirements for digital health applications in Germany. In this guide, we explain the basic principles of the German regulatory framework for digital health apps and other digital health solutions with a particular focus on study design, reimbursement & pricing and market access. The guide has been drawn up with the utmost care, however, cannot replace a face-to-face meeting and qualiﬁ ed professional consultancy.
The German Market and Access to it
The German Market and Access to it 4 Germany – Europe’s Most Important Target Market for Digital Health Products “Apps on Prescription” in Germany When the Digital Healthcare Act (Digitales-Versorgung-Gesetz - DVG) came into force on 19 December 2019, “apps on prescription” for patients were introduced into the German health care system. This entitles approximately 73 million people insured under the statutory health insurance system to obtain access to apps called “DiGA” (Digitale Gesundheitsanwendung) with a prescription which can be given by doctors and psychotherapists and which is reimbursed by the health insurance scheme. The prerequisite for a DiGA to be introduced is that it must have successfully undergone an assessment procedure at the Federal Institute for Drugs and Medical Devices (BfArM) and be listed in a directory of reimbursable digital health applications (DiGA directory). This directory summarizes essential information of all the DiGAs available to doctors, psychotherapists and users. The DiGA directory is thoroughly transparent, allowing for well-informed decisions to be made based on trustworthy sources of information. In addition to the DVG, other laws exist which allow the costs of a digital health application to be covered by statutory health insurance funds (SHI funds). These laws apply if the digital health application is not listed in the DiGA directory or if reimbursement is covered under other regulations. In some cases, of course, reimbursement by the statutory health insurance funds is excluded.
Europe’s ﬁ ve Largest Countries: Key Data at a Glance Country Population in m Total GDP in trillion in Euro GDP per capita in K Euro Hospital bed density per 100K inhabitants Germany France UK Italy Spain 83.0 67.0 66.4 60.4 47.4 €3.34 €2.35 €2.42 €1.77 €1.20 €40.3 800.2 €35.0 598.0 €36.5 253.7 €29.2 318.1 €25.7 297.3 Source: Population: Eurostat, data for 2019, for UK, data for 2018; GDP, Eurostat, data for 2018, hospital bed density, Eurostat, data for 2017. The Digital Health Industry in Germany 5.8 bn Gross Value Added 6.8% Share of the total gross value added of the industrial health industry 65.3K Employees 6.8% Share of the total employment market of the industrial health industry Total industrial health industry: €84.2 bn 1.0 m Employees Sales and Employment of ITC in Germany Country 2020 2021 Sales of ICT products and services Employment development in ICT 163.5 bn € (-3.3%) 1,200,000 (+/- 0) 116.7 bn € (+2.0%) 1,220,000 (+20,000) Source: Bitkom, Bundesagentur für Arbeit, BNetzA, Prognosis
The German Market and Access to it 6 The Regulatory Framework for Digital Health in Germany Digital health in Germany is subject to the general regulations of the health care system. Recently, several speciﬁc laws have also been introduced to cover technical innovations and to integrate them into the existing healthcare system. The following is an overview of the most important general and speciﬁc laws: The Social Security Code V The Social Security Code V (Sozialgesetzbuch V – SGB V) covers regulations on statutory health insurance (SHI). The SGB V regulates in detail who is insured by the SHI system and how funds for the SHI system are raised. In addition, the law determines which services are provided by the health insurance system, how the legal and economic relationships between the SHI funds and the service providers are structured and how the SHI funds are organized within the framework of their traditional principle of self-administration. Various Laws Governing the Digitization of the Health Care System The digitization of the health care system in Germany is driven by various laws and legal measures, for example, the Appointment Service and Supply Act (Terminservice- und Versorgungsgesetz - TSVG), the Act for More Security in the Supply of Medicines (Gesetz für mehr Sicherheit in der Arzneimittelversorgung - GSAV), the Digital Healthcare Act (Digitales- Versorgung-Gesetz - DVG) or the Patient Data Protection Act (Patientendaten- Schutzgesetz - PDSG). With the Appointment Service and Supply Act (TSVG), which came into force on 11 May 2019, statutory health insurance funds are obliged to provide their insured persons with an electronic patient ﬁle as of 1 January 2021. In addition, insured persons who wish to do so will in future be able to access their electronic patient ﬁle using their smartphone or tablet.
IGES Group The Knowledge Corporation 28 Independent and innovative since 1980, IGES Group focuses on research, development and consulting for life sciences and health care. CSG (Clinical Study Group) is a full-service contract research organization, offering services in planning, implementing and analyzing clinical-scientiﬁc studies. IGES Institute is the core of the IGES Group. It offers comprehensive services based on expertise: studies, reports, publications, evaluations, concepts and strategies. IMC clinicon is a consulting and services institute for the hospital sector, providing in-depth data and analysis on German hospitals. IGES Services Health Economics & Outcomes Research Value demonstration – Dossiers for early beneﬁt assessment and clinical evaluation of drugs – Health technology assessment (HTA) Health-economic evaluation AiM (Assessment in Medicine) is a health-economic consulting agency for the medical device industry, dedicated to reimbursement programs. Health technology assessment dossiers are founded on qualitative and scientiﬁc methodologies. Real-world and care provision analyses Demand and access Quality of care Utilization and expenditure HealthEcon, based in Basel, Switzerland, is a consulting ﬁrm for health technology assessment, European market access and value strategy for the pharmaceutical industry with almost 40 years of experience. Device Access, based in Southampton, UK, supports medical device manufacturers from across the world to get great technologies to NHS patients faster, through NICE approvals. Market analysis Assessment of inpatient and ambulatory sector potentials Competition and regulation analysis Strategic consultation Pricing and market access Portrayal of individual product reimbursement pathways Assistance with review processes conducted by the Federal Joint Committee (G-BA)/Institute for Quality and Efﬁciency in Healthcare; consulting for new examination and treatment methods (NUB) Optimax Access, based in Southampton, UK, provides pharmaceutical and medical devices companies with a comprehensive range of services related to Health Economics and Outcomes Research (HEOR). MediTech Access, based in Versailles, France, provides comprehensive market access and pricing strategies for France and French-speaking countries for innovative health technologies since 2012.
Glossary DIGA: Digitale Gesundheitsanwendung (Digital Health Application) DIMDI: Deutsches Institut für Medizinische Dokumentation und Information (German Institute of Medical Documentation and Information) DVG: Digitale-Versorgung-Gesetz (Digital Healthcare Act) IQWiG: Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efﬁciency in Healthcare) MDD: Medical Device Directive MDR: Medical Device Regulation NUB: Neue Untersuchungs- und Behandlungsmethoden (New Methods for Treatment and Screening) G-BA: Gemeinsamer Bundesausschuss (Federal Joint Committee) G-DRG: Diagnosis Related Group (German Modiﬁcation) GSAV: Gesetz für mehr Sicherheit in der Arzneimittelversorgung (Act for More Security in the Supply of Medicines) HTA: Health Technology Assessment ICT: Information and Communications Technology OPS: Operationen- und Prozedurenschlüssel (Surgery and Procedure Code) PDSG: Patientendaten-Schutzgesetz (Patient Data Protection Act) PHI: Private Health Insurance (Private Krankenversicherung – PKV) SHI: Statutory Health Insurance (Gesetzliche Krankenversicherung – GKV) InEK: Institut für das Entgeltsystem im Krankenhaus (Institute for the Hospital Remuneration System) TSVG: Terminservice- und Versorgungsgesetz (Appointment Service and Supply Act)
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