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Medical Device Reimbursement in Italy.

Identification of comparable products in the national statutory benefits package (LEA) and Italian DRGs, applications for reimbursement or add-on funding by regional and local health agencies (ASRs / ASLs).

Reimbursement Landscape in Italy

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

  • Clarify the relevant type of coding systems and guidelines, applicable for the specific device or to any comparable products, issued on a national level or by regional health agencies (Agenzia Sanitaria Regionale, ASR) or local health agencies (Azienda Sanitaria Locale, ASL).
    Clarify the reimbursement status in the reimbursement catalogs of supplementary health insurance providers.
  • 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.
  • Identify the main decision makers, lay out the typical path towards obtaining national, regional or local reimbursement, including milestones and typical timelines and provide an initial reimbursement strategy for the device in Italy.

Reimbursement Planning for Italian Decision Makers

According to the conclusions in the Reimbursement Landscape, we devise the plan for developing the required evidence for Italian decision makers, such as the National Health Council (CSS), the National Agency for Regional Health Services (AGENAS) the National Institute of Health (ISS) or regional and local health agencies (ASRs / ASLs). 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 and would serve as the basis for the Economic Model.
  • Economic Model: Highlights the economic benefits of the new device from the perspective of Italian 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 decision makers 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 scientific research institutes (IRCCS) to apply for new reimbursement mechanisms, such as add-on funding on top of DRG rates, allocated budgets for specific technologies/devices or participation in national/regional tenders.
  • Pilot Projects: Initiate pilot projects with regional health agencies (Agenzia Sanitaria Regionale, ASR) or local health agencies (Azienda Sanitaria Locale, ASL).

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

Local Presence and Experience in:

  • Sweden
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  • Denmark
  • Other
  • Australia
  • Israel