German
Reimbursement

Understanding your market access journey

Market access can be started at any stage. But the earlier a strategy is implemented, the sooner a new technology or treatment method can be appropriately adopted. Each European country has its own unique healthcare system that is locally managed and structured.Use our interactive map below to learn more about the German reimbursement pathway and understand how your technology may gain reimbursement.

What type of product do you have?
Is your device considered a 'classic dressing' (primary claim of product is that it covers the wound and/or absorbs body fluids and does not involve pharmacological, immunological or metabolic mode of action)?
Is your device considered a 'classic dressing' (primary claim of product is that it covers the wound and/or absorbs body fluids and does not involve pharmacological, immunological or metabolic mode of action)?
In the German Healthcare system 'conventional wound dressings' are generally reimbursed by the Statutory Health Insurance Funds and can immediately be prescribed by physicians to patients under SHI.
Contact us to understand if your product is classified as a 'classic dressing', or view our FAQ's or services page for more information.
Has your product been through a successful Health Technology Assessment (HTA) with the G-BA?
Has your product been through a successful Health Technology Assessment (HTA) with the G-BA?
The German Healthcare system is currently reviewing how 'other dressings' are reimbursed. The pathway is expected to be finalised in 2020. If your technology has successfully gone through a Health Technology Assessment (HTA) by the G-BA (as it is related to a unique treatment method) this may speed up the reimbursement process once the pathway is finalised. It is anticipated that technologies outside of the 'classic dressing' criteria will be required to go through a G-BA HTA procedure to show the benefit they provide to patient care before they are approved for reimbursement by the Statutory Health Insurance Funds (GKV).
Contact us to understand if your technology fits into this category and for the latest information on the new reimbursement pathway, or view our FAQ's or services page for more information.
Has your product been through a successful Health Technology Assessment (HTA) with the G-BA?
The German Healthcare system is currently reviewing how 'other dressings' will be reimbursed. The pathway is expected to be finalized in 2020. Wound care devices that fit into this category will most likely need to go through a G-BA Heath Technology Assessment (HTA) procedure to show the benefit they provide to patient care before they are approved for reimbursement in the outpatient setting by the Statutory Health Insurance Funds (GKV).
Contact us to understand if your technology fits into this category and for the latest information on this new reimbursement pathway including how to prepare for a HTA, or view our FAQ's or services page for more information.
How will your product be used?
Does your technology fit into an existing treatment method described in an OPS code (Operationen-und Prozedurenschlüssel)?
Does your technology fit into an existing treatment method described in an OPS code (Operationen-und Prozedurenschlüssel)?
If your device has been designed alongside a new procedural technique a new OPS code will need to be applied for. This will require submission of an application to DIMDI which can happen once per year.
Contact us to discuss how we can support your company through this process, or view our services or FAQs for further information.
Is your new technology more expensive than current technologies in this OPS code?
Is your new technology more expensive than current technologies in this OPS code?
As your technology already fits into a treatment method described by an OPS code and it is no more expensive than current treatment methods it may be possible to have immediate access to reimbursement by the statutory health insurers allowing your product to be rapidly adopted. This is possible by the reservation of prohibition principle in the inpatient sector in Germany.
Contact us to discuss if your technology can receive immediate reimbursement in Germany, and ways we can support your local market access efforts or FAQs for further information.
Would your technology be considered a 'new and innovative treatment method' in Germany?
Would your technology be considered a 'new and innovative treatment method' in Germany?
For some medical technologies, hospitals can invoice a ZE charge (Zusatzentgelt) on top of the G-DRG. This additional payment is not restricted to innovations and can be invoiced by all hospitals applying the relevant procedure.
Contact us to find out if a ZE charge is a viable process for your technology to gain appropriate reimbursement in the German healthcare market, or view our services or FAQ's
Would your technology be considered a 'new and innovative treatment method' in Germany?
A NUB-procedure (New methods for treatment and screening) may be right for your technology. The NUB-procedure is a payment scheme for the reimbursement of high cost, innovative technologies and services that are used in addition to an approved G-DRG code.
Contact us to find out if your technology is suitable for a NUB-procedure, or view our services or FAQ's to find out more.
Does your technology fit into an existing treatment method described in an OPS code (Operationen-und Prozedurenschlüssel)?
The German inpatient healthcare system is based on a DRG system that uses case-related coding rules combining the diagnoses of the patient (ICD-10) with the procedure(s) being performed (Operations and Procedure codes - OPS).
Contact us to find out if your technology fits into an existing OPS code and can be reimbursed in the German healthcare system or if additional reimbursement is required (e.g through a new OPS code or a NUB-procedure). You can also view our services or FAQ's for more information
Does your technology fit into a treatment method described in an existing GOÄ tariff (Private Health insurance) and / or EBM code (statutory health insurance)?
Does your technology fit into a treatment method described in an existing GOÄ tariff (Private Health insurance) and / or EBM code (statutory health insurance)?
Most Medical materials are not included in the cost of a GOÄ tariff or EBM code as these simply describe an approved treatment method. Typically, local negotiations need to take place to secure reimbursement for each device prior to use. This may or may not include the medical device manufacturer, depending on the type of device, the users of the device and the exact treatment setting (physician office, hospital etc).
Contact us to discuss how we can support your company with these negotiations from introduction to the local payers to development of supporting documents, or visit our services or FAQ page for more information.
Does your technology fit into a treatment method described in an existing GOÄ tariff (Private Health insurance) and / or EBM code (statutory health insurance)?
If your device does not fit into an existing GOÄ tariff and / or EBM code each will need to be applied for through the relevant authorised bodies (Federal government for GOÄ, and DIMDI for EBM code) prior to the device being used in the private or statutory outpatient system. If your device receives a new treatment method the G-BA may need to conduct a health technology assessment (HTA) is undertaken to determine its benefit before approving coverage within the SHI scheme.
Contact us to discuss the most effective routes to apply for a new GOÄ tariff and / or EBM code and how to correctly prepare for an HTA assessment or visit our services page or FAQ page for more information.
Does your technology fit into a treatment method described in an existing GOÄ tariff (Private Health insurance) and / or EBM code (statutory health insurance)?
In the German Healthcare System outpatient treatments performed by physicians are reimbursed through EBM codes (statutory health care) and / or GOÄ tariffs (private health care). The treatment methods that have a code have demonstrated benefit to patients and are therefore authorised to be used.
Contact us to understand if your technology fits into an existing GOÄ or EBM tariff and the next steps to gaining reimbursement in the outpatient setting, or visit our services or FAQ page for more information.
What type of product do you have?
DIGITAL TECHNOLOGY
The reimbursement pathways for digital technologies in the German healthcare system are being developed. In July 2019 a draft of the new digital care law (Digitalisation and Innovation Act) was approved by the Federal Cabinet which if passed will allow for the reimbursement of certain digital apps through the SHI.
Contact us to discuss how to prepare your technology for reimbursement once the new digital care law is passed and for more up to date information on its progress, or view our services for more information.
Is your device currently listed on the Medical Aids registry?
Is your device currently listed on the Medical Aids registry?
If your device is not currently registered in the 'Medical Aids Registry' an application can be made to the Federal Statutory Health Insurers (SHI) Association for its inclusion. If your device has been developed alongside a new treatment method which has not been reviewed by the G-BA, a Health Technology Appraisal (HTA) may be required.
Contact us to find out if your device is suitable for inclusion in the Medical Aids Registry and the most efficient route to secure reimbursement in the outpatient setting, or view our FAQ's or services page for more information
Is your device currently listed on the Medical Aids registry?
Devices registered in the 'Medical Aids registry' can usually be prescribed by physicians for patients under statutory insurance but the reimbursement fee is subject to different mechanisms such as agreements with local Statutory health insurers(SHI / GKV-SV).
Contact us to find out how we can support the adoption of your device through approved suppliers of the medical aids registry.
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