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Market access for medical technologies in Italy

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

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Key topics

There are two key themes describing market access for medical technologies in Italy:

  • Reimbursement: payment mechanism via DRG system, add-on reimbursement 
  • Health technology assessment: assessments by national and regional HTA organizations
     
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Reimbursement

Reimbursement of hospital care in Italy depends on the “ownership” status of hospitals and includes diagnosis-related group (DRG) and global budget mechanisms. 

Reimbursement of the hospital activity is made solely through a diagnosis-related group (DRG) system. Italy does not have its own system and adopted the CMS DRG version 27. The system is very rigid at the national level, with no updates made since the adoption of the DRG system. 

DRGs are determined by the combination of a procedure code (ICD-9-CM from the 2007 year) and a diagnosis code (ICD-9). Procedure codes have not been updated since 2007, and many innovative technologies cannot be appropriately coded in the Italian system.

Regions can establish their own tariffs and can innovate on the structure of the DRG system. This includes the creation of DRG sub-categories (DRG split mechanism) or add-on reimbursement for expensive procedures or devices. 

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Health technology assessment

HTAs are performed at the national level by AGENAS and in several regions. A National Program for HTA is emerging (expected in 2024). 

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Specifics for IVD tests

In-vitro diagnostic tests are reimbursed using a fee-for-service mechanism via the regional reimbursement catalogs (using ICD-9-CM classification) in out-patient settings.

MTRC has experience with more than 226 projects in Italy

News and insights

08 Feb 2024

National tariffs for outpatient specialist care postponed to April 2024 in Italy

The LEA catalog was brought in 2017, but the tariffs were approved in 2023. The new tariffs for outpatient specialist care were supposed to enter into force on January 1, 2024, but the adoption of new tariffs was postponed to April 1, 2024, due to the technical inability of the Regions to implement the change in time.
19 Jan 2024

Rapid HTAs of three medical devices released in Tuscany

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 26990 of December 18, 2023, Tuscany Regional Healthcare has published assessments of three medical devices in the peripheral vascular, orthopedic, and dermatology areas.
01 Dec 2023

Rapid HTAs of two medical devices released in Tuscany

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 24192 of November 15, 2023, Tuscany Regional Healthcare published one assessment and one re-assessment of medical devices in the cardiovascular and men's health areas.

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