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Medical Device Reimbursement in Germany.

Identification and application for OPS, EBM or GOÄ codes, German Diagnosis-related groups (G-DRGs) and NUB reimbursement, and inclusion in the German Medical Aids Directory.

Reimbursement Landscape in Germany

The purpose of this step is to understand the current reimbursement environment in Germany, relevant for your medical device. To do so, we will:

  • Clarify the relevant type of coding systems (OPS, EBM or GOÄ), coverage policies, limitations and guidelines, relevant type of payment mechanisms (G-DRG, EBM or GOÄ) and payment rates, applicable for the specific device or to any comparable products.
  • Locate any specific reimbursement mechanisms that could be utilized by the device, as-is, or recommend on whether new mechanisms will have to be developed and if so, which mechanisms (e.g., a new EBM or GOÄ code, NUB reimbursement or an application for inclusion in the Medical Aids Directory).
  • Identify the main decision makers, lay out the typical path towards obtaining statutory (GKV) or private (PKV) reimbursement, including milestones and typical timelines and provide an initial reimbursement strategy for the device in Germany.

Reimbursement Planning for German Decision Makers

According to the conclusions in the Reimbursement Landscape, we devise the plan for developing the required evidence for German decision makers, such as the Joint Federal Committee (G-BA), the Agency for the Hospital Payment System (IneK) or the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband). This includes the development of:

  • Value Story: Puts forward the claims for clinical and economic benefits associated with the use of the new device in the eyes of the relevant decision makers (healthcare providers, German sickness funds) and would serve as the basis for the Economic Model.
  • Economic Model: Highlights the economic benefits of the new device from the perspective of German decision makers. May identify specific outcomes data that should be added to future clinical study protocols.
  • Clinical Data: Recommendations for adjustments and modifications of any planned clinical studies in order to generate the required reimbursement-related evidence for decision makers.
  • Decision Makers' Feedback: Conduct interviews with the identified German decision makers to obtain their feedback regarding the developed value story, the economic model and the reimbursement aspects of the planned clinical study.

Implementation

Depending upon the existence, or the lack of, applicable reimbursement mechanisms (as identified in the Reimbursement Landscape step), we will conduct the following activities:

  • Billing Guide: Develop a set of instructions guiding physicians and other healthcare providers how to obtain reimbursement following the use of the new device.
  • Reimbursement Applications: Work with the relevant medical societies to apply for new reimbursement mechanisms, such as OPS, EBM or GOÄ codes, NUB reimbursement or inclusion in the German Medical Aids Directory.
  • Pilot Projects: Initiate pilot projects with local German sickness funds.
  • Other Funding Options: Apply for other or interim funding options such as Experimental Coverage or the German Innovation Fund.

Flat fees, concrete timelines, and support through your entire reimbursement process

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