German reimbursement system for medical devices and IVD tests
This online on-demand 30-minute seminar gives a comprehensive understanding of the hospital reimbursement landscape for medical devices in Germany. Additional modules cover reimbursement of IVD tests, screening methods, and out-patient reimbursement system
Available as a pre-recorded webinar or full presentation in Acrobat PDF
Germany is one of the key markets for medical devices in Europe. Many medical devices companies start commercialization of their products in Germany.
Hospital care is the most attractive segment for the introduction of medical technologies. All hospital care (except capital equipment) is funded via diagnosis-related groups (DRGs). Most procedures can be initially coded using existing procedure codes and receive some reimbursement. Update of the DRG system is a clear and straightforward process, administered by the Institute for Hospital Remuneration System (InEK). While the development of DRG reimbursement is in process, innovative expensive devices and procedures can utilize innovation funding via NUB.
However, for some high-risk medical devices, NUB pathway became complicated due to the “early benefit assessment” process of the Federal Joint Committee (G-BA). Also, many companies fail NUB process due to a lack of understanding of key criteria for granting innovation funding. Decisions of G-BA about coverage of hospital procedures within statutory health insurance is another important, but not a well-understood aspect of market access in Germany.
It is essential for medical device and IVD companies to understand the pathways to the ultimate goal of reimbursement (integration into DRG and add-on reimbursement) and opportunities and requirements for innovation funding in Germany. We offer a seminar on critical elements of the hospital reimbursement system for medical devices that can guide your decision-making in this complex country.
What topics are reviewed?
Key stakeholders and their role in reimbursement processes
Key stakeholders are reviewed, including payers, number of policy-makers, advising organizations (IQWiG), manager of procedural classification (BfArM) and DRG system (InEK)
Money flow, hospital payment system, the process of development of the DRG system, innovation funding
Money flow and distribution of funds, an overview of the hospital payment system (DRG system), add-on reimbursement (ZE), innovation funding (NUB), and process of development of DRG system
Coverage of services within the statutory health insurance
Overview of a general funding framework in German system, role of G-BA in deciding about coverage of devices within statutory health insurance, summary of key directive of G-BA about hospital coverage (in accordance with § 137c of the Social Code Book V), “early benefit assessment” process in connection with innovation funding for high-risk medical devices (§137h of the Social Code Book V)
Additional modules
Reimbursement system for in-vitro diagnostic tests
A separate comprehensive overview of the reimbursement system for IVD tests in Germany
Organization and financing of screening methods
A separate comprehensive overview of the organizational and financing framework of screening methods (e.g. breast and cervical cancer screening) in Germany
German outpatient reimbursement system
A separate comprehensive overview of the German outpatient reimbursement system
What topics are not covered?
Some topics are not specifically covered in this seminar: reimbursement model in out-patient settings, reimbursement for medical aids (devices for home use), funding of capital equipment, government co-sponsored studies according to the §137e of the German Social Code Book V, Innovation Fund at the Federal Joint Committee (G-BA)
The introductory presentation also does not include details of reimbursement application processes (for example application form, requirements, details of the process for the creation of OPS code, DRG change or obtaining innovation funding)
Topics that are not covered in this seminar will be included in the future courses. You can subscribe to our newsletter and inform us about your particular interests at the main page of the Market Access Academy
How is the seminar delivered?
Option #1: Pre-recorded webinar
One option is to watch the seminar, which is provided as a pre-recorded webinar. The duration of the webinar is 32 minutes. Seminar is available for 6 months
Option #2: Presentation in Acrobat PDF
You can also access just the educational material - the full presentation of the seminar in Acrobat PDF
View extract from the seminar
This 1-minute extract presents overview of two aspects of market access in Germany
Updates of the seminar
December 2022: Update of the overview of the German hospital reimbursement system (updated the slide with the money flow (introduced the Central reallocation pool, Gesundheitsfonds, introduced a new slide describing the Contract Transparency Office, CTO)
Update of the overview of the German hospital reimbursement system (updated the slide with the money flow (introduced the Central reallocation pool, Gesundheitsfonds, introduced a new slide describing the Contract Transparency Office, CTO)
July 2020: Update of the overview of the German IVD reimbursement system (clarified the roles of the relevant stakeholders, added info about evaluation of conceptually new methods)
Update of the overview of the German outpatient reimbursement system (introduced concepts of selective contracts and individual health care (IGeL) services)
September 2020: Update of the overview of the German outpatient reimbursement system (introduced the framework and clarified the roles of the G-BA and the Evaluation Committee in the assessment of the new services to be included in the EBM)
October 2020: Update of the overview of the German hospital reimbursement system (regarding early benefit assessment, the hospitals must submit the scientific dossier in agreement with the medical device manufacturer)
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