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Market access for medical technologies in Germany

A brief overview of key market access pathways and challenges for medical devices, in-vitro diagnostic tests in Germany

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Key topics

There are three key themes describing market access for medical technologies in Germany:

  • Reimbursement: payment mechanism via DRG system, add-on reimbursement via ZE in hospital settings; payment via EBM catalog in out-patient settings
  • Funding: coverage decisions within statutory health insurance by the Federal Joint Committee (G-BA)
  • Health technology assessment: assessments by IQWiG in relation to the creation of out-patient reimbursement codes

Germany has a number of innovative payment schemes for medical technologies. 

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Reimbursement

Reimbursements for hospital procedures are made solely via a German-diagnosis-related group (G-DRG) system. All cases of hospitalization with at least one overnight stay are reimbursed via DRG. Day cases and out-patient care are completely separate from hospital care provisions and are reimbursed via a fee-for-service model (EBM catalog within the statutory health insurance).

The DRG system has the following components:

Diagnosis-related groups

  • DRGs are determined by the combination of a procedure code (OPS) and diagnosis code (ICD-10-GM). OPS nomenclature is maintained by the BfArM Cologne Office (ex DIMDI) and released annually
  • Most DRGs have a national tariff, which is determined by the administrator of the DRG system, the Institute for the Hospital Remuneration System (InEK)

Add-on reimbursement (Zusatzentgelt, ZE)

  • Add-on reimbursement is provided for expensive devices, procedures, and drugs
  • ZE might or might not have a national tariff.

The G-DRG system is approved annually.

Innovation funding (NUB) is not formally part of the DRG system. NUB is granted by InEK for a period of less than a year, based on the review of applications made by hospitals. Approved status (status 1) gives hospitals the opportunity to negotiate additional reimbursement with sickness funds. However, it does not guarantee reimbursement, as sickness funds may question the sufficiency of the evidence provided and decide not to pay for the technology.

In out-patient settings, procedures are reimbursed via a fee-for-service mechanism via the EBM Catalog. There are specifics of reimbursement for surgical procedures in day case settings. 

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Funding

From 2016, the national policy-maker, the Federal Joint Committee (Der Gemeinsame Bundesausschuss, G-BA), may initiate a “benefit assessment” procedure for applications dealing with devices from high-risk classes (IIb and III). This would ensure that the level of evidence is sufficient for the device’s use in the German statutory health insurance system. 

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Health technology assessment

HTA is almost exclusively limited to assessments by IQWiG in relation to the creation of out-patient reimbursement codes.

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Specifics for IVD tests

In-vitro diagnostic tests are reimbursed using a fee-for-service mechanism via the EBM Catalog in out-patient settings.

MTRC has experience with more than 323 projects in Germany

News and insights

Ninety-one applications for innovation funding of the projects for new forms of care were received in Germany

On May 27, 2024, the Innovation Committee at the Federal Joint Committee (G-BA) announced that ninety-one applications (project ideas) for innovation funding of the projects for new forms of care were received.

The G-BA Innovation Committee recommends transfer to standard care for another three completed projects in Germany

On May 17, 2024, the Innovation Committee at the Federal Joint Committee (G-BA) published the decisions recommending the transfer to standard care for another three completed projects. The projects were dedicated to the topics of booster vaccination against meningococci of serogroup C, reduction of antibiotic resistance, and dual pilot structure for diagnosis clarification in centers for rare diseases.

Forty-eight applications for innovation funding for healthcare research projects were accepted in Germany

On May 17, 2024, the Innovation Committee at the Federal Joint Committee (G-BA) announced that forty-eight applications for innovation funding of healthcare research projects were accepted.

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