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Medical Device Reimbursement in Belgium.

Identification and application for inclusion in the national nomenclature of medical benefits or the Budget of Financial Means (BFM) and the Belgian DRGs.

Reimbursement Landscape in Belgium

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

  • Clarify the relevant type of coding systems, such as the national nomenclature of medical benefits, relevant coverage policies under the statutory health insurance (mutualité) or the supplementary insurance, as well the relevant payment rates, applicable to 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., an application for an adjustment to the Belgian DRG system or an application for inclusion in the national nomenclature of medical benefits.
  • Identify the main decision makers, lay out the typical path towards obtaining reimbursement under the statutory / supplementary health insurance, including milestones and typical timelines and provide an initial reimbursement strategy for the device in Belgium.

Reimbursement Planning for Decision Makers in Belgium

According to the conclusions in the Reimbursement Landscape, we devise the plan for developing the required evidence for Belgian decision makers, such as the Federal Health Care Knowledge Centre (KCE), the National Institute for Health and Disability Insurance (NIHDI / RIZIV / INAMI) or the Superior Health Council (Conseil Supérieur de la Santé, CSS). 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, Belgian health insurance companies) and would serve as the basis for the Economic Model.
  • Economic Model: Highlights the economic benefits of the new device from the perspective of Belgian 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 Belgian decision makers, utilizing Mediclever's network of local clinicians, payer representatives and other stakeholders in Belgium, to obtain their feedback regarding the developed value story, the economic model and the reimbursement aspects of the planned clinical study.


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 and the Belgian Association of Physicians (Belgische Vereniging van Artsensyndicaten, BVAS) or the Belgian Association of Specialists (Groupement Belge des Specialists, GBS) to apply for new reimbursement mechanisms.
  • Other Funding Options: Collaborate with physicians and offer access program that encourage healthcare providers to seek reimbursement for their patients on a case-by-case basis.

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

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