Italian reimbursement system for medical devices and IVD tests

This online on-demand seminar gives a comprehensive understanding of the hospital reimbursement landscape for medical devices in Italy. Additional modules cover reimbursement of IVD tests, medical aids, and screening methods

Provided in the form of a presentation in Acrobat PDF

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Italy is one of the biggest medical device markets in Europe. However, market access is very complicated in this country.

At the hospital level, funding is performed using a global budget or diagnosis-related groups. As no changes to the DRG system are possible at the national level, regions should work on the implementation of reimbursement changes (e.g., DRG split or add-on reimbursement). The lack of structured processes and the need to address regions individually makes market access processes very complex and lengthy.

Another aspect of market access in Italy is acceptance by payors. Italy has a very diverse and complex decision-making structure, including national, regional and hospital-based health technology assessment organizations and Technical Committees for medical devices. Obtaining endorsement from these stakeholders is another essential element of the market access strategy in Italy.

Our seminar can help you to navigate the hospital-based reimbursement environment for medical devices in Italy.

What topics are reviewed?

Key stakeholders and their role in reimbursement processes

Key stakeholders are reviewed, including payers (ASLs), policy-makers (Ministry of Health, regions, Steering Committee for HTA), advising organizations (HTA and Technical Commissions for Medical Devices)

Nationally guaranteed services

The concept of Essential Levels of Care (LEA), update of the LEA catalogue, process and stakeholders involved

Payment model

Payment model in the hospital sector (global budget and DRG), specifics of DRG system, the activity of regions in relation to amendments of DRG system (DRG split and add-on reimbursement)

Decision-making framework and role of HTA

HTA stakeholders and processes, the role of HTA in the adoption of medical technologies, a brief overview of the emerging national process for HTA

Additional modules

Reimbursement system for in-vitro diagnostic tests

A separate comprehensive overview of the reimbursement system for IVD tests in Italy

Organization and financing of screening methods

A separate comprehensive overview of the organizational and financing framework of screening methods (e.g., breast and cervical cancer screening) in Italy

Reimbursement system for medical aids

A separate comprehensive overview of the reimbursement system for medical aids in Italy

What topics are not covered?

Some topics are not specifically covered in this seminar: reimbursement model in out-patient settings, reimbursement for medical aids (devices for home use) and in-vitro diagnostic tests, funding of capital equipment.

The introductory presentation also does not include details of reimbursement application processes (for example, application form, requirements, and details of the process for HTA processes nationally and regionally)

Topics that are not covered in this seminar will be included in future courses. You can subscribe to our newsletter and inform us about your particular interests on the main page of the Market Access Academy

How is the seminar delivered?

Presentation in Acrobat PDF

At the moment, you can only access the educational material as the full presentation of the seminar in Acrobat PDF

How is the seminar delivered?

December 2022: Update of the overview of the Italian hospital reimbursement system (completely updated the slide explaining the guaranteed basket of services (LEA), introduced a slide on the status of the de novo It.DRG system, updated the status of the HTA bodies in Veneto, Emilia Romagna, and Lombardy, added two slides describing the HTA body in Tuscany)

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