Next to the United States, Germany often is one of the top countries that innovative MedTech and digital health SMEs seek to enter. Germany is by far Europe’s largest MedTech, with a market volume of over 35 billion euros (2020) and 25,6% of the European medical devices market. This makes the German market attractive for growth-minded entrepreneurs. Sooner or later, reimbursement in Germany will be on the agenda. Obtaining reimbursement is a critical step for successful market entry into a new country. This article discusses five common reimbursement routes that you may come across when entering the German market.
1. Care provider reimbursement route
The reimbursement of healthcare services in Germany is largely based on the German Diagnose-Related Group (G-DRG) system. This activity-oriented system increases efficiency, transparency, and quality of healthcare delivery. The G-DRG system incentivizes care providers, such as hospitals, to invest in process optimization and innovations that increase efficiency. Common examples include shortening the length of stay and reducing complications after surgery. When you can prove a positive business case or if your innovation can be covered under a DRG code, hospitals may be willing to invest in your innovation from the hospital budget. The increased efficiency could lead to higher output at lower costs, increasing the hospital’s profitability. The evidence of your business case should extend beyond theoretical or literature- based savings. Examples include data-driven care platforms, prediction of complications through Artificial Intelligence (A.I.), as well as other types of A.I., for example solutions for medical imaging.
2. NUB Application
For novel, highly innovative inpatient treatments, no applicable DRG tariff may exist. In this case, a possible route towards structural reimbursement is to apply for a new G- DRG code. The G-DRG system is maintained and updated by the Institute for the Hospital Remuneration System (InEK – in German: “Institut für das Entgeltsystem im Krankenhaus”). Innovative medical devices have limited clinical efficacy data and often lack real-word evidence, making them ineligible to successfully apply for modification of an existing G-DRG tariff or the creation of an entirely new one. To fill this ‘innovation gap’, Germany adopted the NUB process (in German: “Neue Untersuchungs- und Behandlungsmethoden”). If approved, participating hospitals receive temporary reimbursement to offer a procedure or treatment that relies on a new device that is not covered by an existing DRG code. Innovations that have been granted temporary NUB remuneration will subsequently be regarded for structural integration into the G-DRG system.
- Only German care providers (e.g. hospitals) can submit NUB applications. Manufacturers rely on ambassadors at partnered hospitals to apply on their behalf.
- NUB applications can be submitted annually between September 1st and October 31st.
- After approval, the hospital will negotiate with insurers to establish the tariff of the new DRGcode.
3. DiGA
The Germans started to pave the way for digitization when they adopted the Digital Healthcare Act (DVG – in German: “Digitale-Versorgung-Gesetz”) in 2019. This act enables the structural reimbursement of “apps on prescription”, or in other words, healthcare through digital health applications (DiGAs – in German: “Digitale Gesundheitsanwendungen”). Manufacturers of CE-marked (MDR class I or IIa) digital treatments can enter a fast-track application process to be included in the directory of reimbursable digital health applications. The assessment is completed by the Federal Institute for Drugs and Medical Devices (BfArM – in German: “Bundesinstitut für Arzneimittel und Medizinprodukte“).
- DiGAs must be centered around patients. Digital innovations that are not used by patients independently or by patients and healthcare providers together are not eligible for the DiGA fast-track.
4. Medical Aids Directory
Is your innovation a medical aid or nursing supply? Then the Medical Aids Directory (HMV – in German: “Hilfsmittelverzeichnis”) is worth investigating. The directory is maintained and updated by the National Association of Statutory Health Insurance Funds (in German: “GKV-Spitzenverband”). The application process is an administrative procedure that requires meticulous preparation, as incomplete documents and non-conformities in the documentation are common pitfalls. Applicants must demonstrate functionality, safety, and medical benefit, and fulfil indication-dependent requirements. Before submitting your application, it is recommended to examine the directory to identify similar devices. This helps you understand the requirements you must fulfil. Each device included in the directory carries a unique ten-digit identification number, describing the product category, place of application, subcategory, and product type. New product subcategories may be created if no eligible subcategory or product type exists. Examples include Orcam MyEye and Munevo DRIVE.
- With the right preparation, the application process can be relatively straightforward and fast. The GKV-Spitzenverband communicates its initial decision after four to twelve weeks.
- In case your application is classified as incomplete, there is a window of opportunity during which you are permitted to improve your application.
5. Direct contracting Reimbursement
Germany is home to 97 Statutory Health Insurers (GKV – in German “Gesetzliche Krankenversicherung”) and 43 Private Health Insurers (PKV – in German “Private Krankenversicherung”). To address special (regional) or innovative treatments, health insurers can agree on benefits or care programs outside of the collective contracts. These additional agreements are a form of direct contracting (in German: “Selektivvertrag”). Such contracts can be established between health insurers and specific care providers, groups of care providers or manufacturers of medical devices. It can be a lengthy process to engage with health insurers and interest them in entering into a Selektivvertrag with you. However, the awareness about innovation has grown in recent years, and health insurers – some more than others – can be supportive of your innovation.
- Directing contracting is an interesting instrument, but the impact is often limited to a specific region or target group. Other health insurers are not obliged to follow the Selektivvertrag.
- Private health insurers in theory have a higher need to positively distinguish themselves from their competitors, however these players do not always have a structured innovation process in place.
Germany has historically been regarded as a conservative market, with strict privacy regulations and a high degree of bureaucracy. This – albeit still true to some extent – has been changing in recent years. The Germans are very aware of the importance of innovation in keeping the healthcare system sustainable and affordable. Policy and funding instruments like the Hospital Future Act (KHZG – in German: “Krankenhauszukunftsgesetz”) and the Digital Healthcare Act paved the way for more innovation in the German healthcare system.
Would you like to know which reimbursement route would be appropriate for your product? Or are you looking to enter the German market? Feel free to contact Robin Toorneman, via robin@medscaler.com or +49 151 29472421. To schedule an expert meeting to talk about the reimbursement of your product, please click here.
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