Market access for medical technologies in Italy

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. 

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.