Guide Through the Healthcare System
Do you have any questions about the requirements and regulations of the German healthcare system? In the following, you will find and overview.
We will first give you an overview of the structure and basic framework conditions of the German healthcare and health insurance market.
Primary and Secondary Healthcare Markets
The German healthcare system is divided into two sections: the primary and secondary healthcare markets. The primary healthcare market - also called the ‘SHI market’ here for short - comprises classic healthcare financed by statutory health insurance (SHI) funds and private health insurance (PHI) companies, and includes long-term care insurance. The benefits provided in the primary healthcare market are legally regulated by the Germany Social Security Code, Book 5 (SGB V).
The secondary healthcare market - also called the ‘private’ or ‘self-pay’ market -covers all privately financed products and services related to health. The health-related market is thus relatively broad and, in addition to over-the-counter medicines and individual health services, also includes fitness and wellness programmes and services as well as health tourism, for example. Only a few legal framework conditions and regulations apply to services provided by the secondary healthcare market; this free market is regulated by supply and demand.
Legal Mandate of the SHI
The framework conditions of the SHI are regulated by the German Social Security Code, Book 5 (SGB V). Pursuant to this code, the SHI has an extensive mandate that spans from health promotion and prevention up to medical treatment and rehabilitation. In general terms, SGB V defines which types of services and benefits the SHI funds must make available to the insurees for these purposes. Along with these standard benefits, which apply to all health insurance funds, individual funds also have the option of offering their own selective additional benefits. These ‘individual contracts’ (also called ‘selective contracts’ or ‘direct contracts’) can be an important step in making innovations accessible more quickly and, in the long term, integrating them in standard care. You can find out more about the different access routes to the SHI market further below on this page.
The economic efficiency principle always applies to the benefits offered by the SHI funds: the benefits must be sufficient, appropriate and cost-effective; they may not exceed what is necessary. The health insurance funds are not allowed to approve benefits that are not necessary or are not cost-effective (Section 12 (1) SGB V).
To enter the primary healthcare market, your innovation has to meet specific access requirements. The most important requirements are described below:
Data Privacy and Protection
TK imposes strict data privacy and protection requirements on cooperation partners in order to provide high-quality care for insurees that complies with data protection laws. The legal foundations in the General Data Protection Regulation (GDPR), the German Social Security Code (SGB) and the German Federal Data Protection Act (BDSG) apply to all cooperations.
Proof of Efficacy
You must be able to demonstrate and substantiate the benefit and effectiveness of your medical product or medical solution in a robust and significant study. The proof of the positive effects on healthcare must be aligned with recognised scientific standards in the sense of evidence-based medicine (EBM).
TIP: The German Federal Institute for Drugs and Medical Devices (BfArM) provides helpful guidelines and information about the general requirements concerning studies that must demonstrate positive healthcare effects of digital health applications (DiGA), extending beyond the DiGA application procedure as well. You should also check the DiGA Directory to get an impression of proof of efficacy documents. For the medical products and devices that are included in the directory, the relevant supporting studies are stored in the extended information section.
To obtain market approval for a medical product or device in Germany and Europe, the product must be affixed with the CE mark by a notified body as part of a ‘conformity assessment procedure’. The type and scope of the conformity assessment procedure depends on the risk classification (I, IIa, IIb, III) of your product.
TIP: The BfArM provides guidance that clarifies the difference between mere wellness or fitness applications and genuine medical devices that are required to be certified.
Guidelines for Prevention
If your product or device falls within the scope of primary prevention or health promotion according to Section 20 SGB V, it is subject to the eligibility and exclusion criteria specified in the Guidelines for Prevention published by the German National Association of Statutory Health Insurance Funds (GKV-SV). These guidelines apply to measures for individual behaviour-based prevention, health promotion and prevention in living environments (daycare centres, schools, universities, communities, municipalities) as well as occupational health promotion. Measures that do not conform with the scope and criteria of the guidelines may not be implemented or promoted by the health insurance funds.
Access Paths I - Statutory Standard Care
Pursuant to SGB V, all statutory health insurance funds are required to reimburse their insurees for statutory standard care medical services. The various ways to get into the ‘SHI benefits catalogue’ are described here.
New Examination and Treatment Methods
Sections 135, 137c, 137h SGB V
The Federal Joint Committee (G-BA) is the highest decision-making body with regard to which specific services are included in the SHI benefits catalogue on the basis of SGB V.
Outpatient and inpatient services are treated differently: While outpatient examination and treatment methods are not included in the benefits catalogue as long as the G-BA has not yet decided about a positive benefit of the treatment (reservation of authorisation), inpatient examination and treatment methods can only be excluded from reimbursement after the G-BA has explicitly decided about the negative benefit of the treatment (reservation of prohibition).
More information about the assessment procedure for new examination and treatment methods (NUBs) in outpatient and inpatient care and with high-risk medical devices can be found on the G-BA website. For NUBs in the inpatient sector, the application procedure for the negotiation of NUB remuneration at the Institute for the Hospital Remuneration System (InEK) is also useful.
The regular access route into the healthcare system via the G-BA is a lengthy process that can take several years. However, for certain product groups (digital health applications, medical aids, preventive measures), there are additional options for access into the standard care system. The next sections will provide more information on this.
Digital Health Applications
Sections 33a, 139e SGB V
The German Digital Health Care Act (DVG) introduced ‘apps on prescription’. This means that physicians and psychotherapists can now prescribe appropriately certified apps, called digital health apps (DiGA), to their patients. The costs are then paid by the SHI.
In order for an app to be included in the DiGA Directory and be prescribed at the expense of the SHI, it first has to be assessed by the BfArM. The procedure is designed as a quicker ‘fast track process’; the assessment period for the BfArM is three months after receipt of the application. The aim is to bring digital medical devices into the healthcare system more quickly.
The ‘app on prescription’ has to meet the following requirements:
- It must be a medical device classified as Risk Class I or II a.
- The main function of the DiGA is based on digital technologies.
- The medical purpose is mainly achieved by way of its digital function.
- The DiGA supports the recognition, monitoring, treatment or alleviation of diseases or the recognition, treatment, alleviation or compensation of injuries or disabilities.
- The DiGA is used by the patient alone or by the patient and healthcare provider together.
Sections 32, 139 SGB V
All medical aids to be paid by the SHI funds are listed in a systematic, structured list prepared and updated by the National Association of Statutory Health Insurance Funds (GKV-SV). Therefore, costs for medical aids can only be covered by SHI if the products are included in the list of aids.
A list of long-term care aids is also maintained as an annex to the list of aids (Section 78 SGB XI). Long-term care aids are reimbursed by the long-term care insurance fund.
To be included in the list, the medical aid has to be approved in a separate approval process as prescribed by law. In the first step of the process, the manufacturer must submit an application to the GKV-SV. Detailed information on the application process and the requirements for inclusion in the list of aids can be found on the GKV-SV website. Click here to go directly to the GKV-SV’s online list of medical aids.
TIP: More information on the provision of medical aids and current TK medical aid contracts can be found here.
Individual-based Prevention Services and Programmes
Section 20 (4) SGB V
Individual-based prevention services and programmes are covered by the SHI if they are certified by the Zentrale Prüfstelle Prävention (ZPP), the central inspection authority in Germany. The ZPP is a cooperative association of the statutory health insurance funds that issues certifications according to the criteria in the Guidelines for Prevention.
Individual-based prevention services and programmes that focus on exercise, nutrition, stress management, relaxation, and drug and substance use are eligible for free certification by the ZPP. After successful certification, your programme or service will be issued a seal of approval for a period of three years and thus will be eligible for full or at least partial reimbursement by all statutory health insurance funds.
The exact review criteria and much more information can be found on the ZPP website.
Access Paths II - Selective (Individual) Contracts with Health Insurance Funds
In addition to the statutory standard benefits, various types of contracts for additional benefits specific to individual health insurance funds (‘selective contracts’) are provided for in SGB V. The following information provides an overview of these
Section 140a SGB V
The aim of contracts for special care is to link different service sectors with each other and to facilitate interdisciplinary, multidisciplinary and cross-sector care. Health insurance funds can conclude these contracts with various contractual partners. These include, for example, physicians, hospitals, care facilities, pharmaceutical companies and manufacturers of medical products and devices. The contractual partners have relatively free rein to agree on the provision and billing of services.
Please note: The ‘integrated care’, ‘structure contracts’ and ‘special outpatient physician care’ contract types, which were previously separately regulated in different sections of SGB V, are now consolidated under the term ‘special care’.
Section 63 et seg. SGB V
To improve the quality and efficiency of healthcare, health insurance funds have the option of implementing pilot projects. These projects can focus on services and benefits for the prevention and early detection of diseases, on medical treatments, or on pregnancy and maternity.
Pilot projects are usually limited to a maximum of eight years and have to be scientifically validated and evaluated. The evaluation report is prepared by independent experts and must be published.
Example: Acupuncture benefits are a successful example of the expansion of the SHI benefits catalogue as a result of a pilot project. Since 2007, following a resolution by the Federal Joint Committee (G-BA), acupuncture treatments for defined indications have been covered by all health insurance funds.
Section 92a SGB V
The Innovation Fund offers another route into the SHI market. It is managed by the G-BA and aims to further develop and enhance the quality of SHI-based care in Germany. Innovations that are successfully promoted and funded via the Innovation Fund can subsequently be designated as standard care measures. A successful application to the G-BA requires a consortium of participating partners (service providers, health insurance funds, medical product or device manufacturers) and an accompanying comprehensive evaluation - usually by one or more university institutions.
Funding is provided for projects in the area of new forms of healthcare and health services research. Innovations of a purely technical nature are expressly not funded.
TIP: A start-up or medical product device manufacturer can never be the sole official applicant and consortium leader for an innovation fund project. Strong partners from the fields of science, service providers and health insurance funds are essential and required.
Section 11 (6) SGB V
Optional benefits that an individual health insurance fund can offer beyond the legally required benefits within the scope of its mandate are referred to as ‘non-statutory benefits’. In order to promote competition among the statutory health insurance funds, the funds are given a great deal of leeway with regard to reimbursements here. In addition to special member-specific benefits, benefits related to in-home healthcare, rehabilitation measures and medical aids can also be offered as additional non-statutory benefits.
Disease Management Programme (DMP)
Section 137 et seg. SGB V
To ensure structured care for insurees in defined disease areas, the statutory health insurance funds have special, very intensive healthcare programmes called ‘structured treatment programmes’ or ‘disease management programmes’ (DMPs).
Innovative solutions are required in this area with the aim of improving the success of the treatment and/or increasing the quality of life of the patients (in a scientifically verifiable way) or avoiding unnecessary complications, hospital stays and consequential damage from the disease. The medical and organisational requirements and documentation rules for DMPs are specified in the Guidelines on DMP Requirements developed by the G-BA.
Currently, there are disease management programmes in place for the following diseases and disorders:
- Bronchial asthma
- Breast cancer
- Chronic obstructive pulmonary disease (COPD)
- Chronic cardiac insufficiency
- Chronic back pain
- Diabetes mellitus Type 1 and Type 2
- Coronary heart disease (CHD)
Primary Care Physician Model
Section 73b SGB V
As a provider of new services or medical products or devices, in terms of the primary care physician (PCP) model, it is important to know that it is always the PCP who decides whether to use an innovation in his or her practice. This is because in the PCP contract model, the PCP acts as a central ‘pilot’ for the insuree. The PCP coordinates the treatment, can involve specialists if necessary, and arranges the supply of medications, therapeutic devices and remedies, or even hospital admissions. Innovative treatment methods can be contractually integrated as part of the contract with the health insurance funds.
Please note: The special aspect of the PCO model is the far-reaching legal requirements compared to the legal basis for other selective contracts. Therefore, there is a debate over whether PCP contracts should actually count as selective individual contracts at all.
Promotion of the Development of Digital Innovations
Section 68a (1) SGB V
According to the law, digital innovations include digital medical products and devices, telemedicine methods and IT-supported healthcare procedures. Health insurance funds can develop digital innovations in cooperation with third parties or commission them to develop them. In particular, manufacturers of medical devices, companies in the information technology sector, research institutions and service providers or associations of service providers are considered third parties.
The funding is provided either through a content- and subject-specific cooperation or through the acquisition of shares in investment funds in accordance with Section 263a SGB V, insofar as it is associated with a content- and subject-specific cooperation between the health insurance fund and the capital management company.
Supplementary Benefits for Rehabilitation
Section 43 SGB V
To achieve the patient’s rehabilitation goal, supplementary benefits for rehabilitation can be provided in addition to standard rehabilitation benefits. These include, for example, patient education measures for chronic illnesses and diseases, rehabilitation exercises and sports, and functional training or sociomedical aftercare measures for chronically ill and seriously ill children and adolescents.
Development of Electronic Communication
Section 67 SGB V
This essentially includes any developments aimed to improve the digital infrastructure of a health insurance fund or the SHI system. These include, for example, the digital health record (eHR) and the electronic health card (‘elektronische Gesundheitskarte’ or eGK for short).