Italy

In November 2024, the HTA body of the Tuscany Regional Healthcare published five rapid HTA reports (four new assessments and one reassessment) of medical devices in the cardiovascular, ophthalmology, ENT, and dermatology areas.

On November 14, 2024, the State-Regions Conference approved the Decree with the new national LEA tariffs for outpatient specialist care and prosthetic care presented by the Italian Ministry of Health. The effective date of new tariffs is December 30, 2024.

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 20315 of September 9, 2024, Tuscany Regional Healthcare published two new rapid HTA reports of medical devices in the orthopedics and surgical procedures areas.

On August 7, 2024, the National Agency for Regional Health Services (AGENAS) announced a call for applications for Health Technology Assessment (HTA) for robotic surgery systems with intended use in the following surgical specialties: general surgery, gynecology and obstetrics, and urology, as part of the 2023-2025 National Health Technology Assessment Program for Medical Devices.

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 16951 of July 22, 2024, Tuscany Regional Healthcare published five new assessments and two reassessments of medical devices in the cardiovascular, peripheral vascular, surgical procedures, and obstetrics and gynecology areas.

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 13540 of June 18, 2024, Tuscany Regional Healthcare published two new assessments and two reassessments of medical devices in the endoscopy, peripheral vascular, and ICU/OR areas.

On June 10, 2024, the National Agency for Regional Health Services (AGENAS) announced an online public consultation on the draft of the “Guidelines on the Evolutionary Pathway of Medical Systems for Telemonitoring”.

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 8521 of April 19, 2024, Tuscany Regional Healthcare published three reassessments of medical devices in the cardiovascular, peripheral vascular, and e-health areas.

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 6700 of March 27, 2024, Tuscany Regional Healthcare published three new assessments and one re-assessment of medical devices in the cardiovascular, men’s health, nephrology and urology, and surgical procedures areas.

The Essential Levels of Care (LEA) defines outpatient specialist and prosthetic care guaranteed to the Italian population. Although the LEA document was brought in 2017, the national tariffs for outpatient specialist and prosthetic care were launched in April last year after seven years of development. They were supposed to come into effect on January 1, 2024 (later postponed to April 1, 2024). However, on March 27, 2024, the need for tariff revision and the new Decree postponing the tariffs until January 2025 was announced by the Italian Ministry of Health

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 4588 of March 5, 2024, Tuscany Regional Healthcare published two new assessments and one re-assessment of medical devices in the cardiovascular, neuromodulation, and surgical procedures areas.

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 2935 of February 13, 2024, Tuscany Regional Healthcare has published assessments of four medical devices in the cardiovascular and peripheral vascular, ICU/OR, pulmonary and airways, dermatology, and robotic surgery areas.