Italy

On August 28, 2026, the Italian Official Gazette published a decree setting the criteria and methods for allocating €10 million annually from 2025 to transplantation activities. Of the total, €7 million per year is earmarked for medical devices used for organ perfusion and for the preservation, transport, and management of organs and tissues, while €3 million supports measures to reduce transplant waiting lists.

On August 27, 2026, three medical technologies across the in vitro diagnostics and orthopedics fields received final recommendations from the Regional HTA Commission following the appraisal stage within the Lombardy Regional HTA Program.

At the beginning of August 2026, the HTA body of the Tuscany Regional Healthcare Authority published two new rapid HTA reports on medical devices, the treatment of male urinary incontinence, and hip resurfacing arthroplasty.

The State-Regions Conference formally approved the draft Ministerial Decree updating the maximum national reimbursement tariffs for outpatient specialist services and prosthetic aids under the Essential Levels of Care (LEA) catalog. The revision covers 448 outpatient specialist services and 222 prosthetic-care codes. The draft does not revise the laboratory test tariffs.

On July 10, 2026, the HTA body of the Tuscany Regional Healthcare Authority published four new rapid HTA reports on medical devices in the cardiovascular and peripheral vascular fields, diabetic foot treatment, and cell therapies.

As of July 2026, four medical technologies across e-health, diagnostic imaging, in vitro diagnostics (IVDs), men’s health, and orthopedics fields are awaiting final recommendations from the Regional HTA Commission following completion of the assessment stage within the Lombardy Regional HTA Program.

On June 4, 2026, the HTA body of the Tuscany Regional Healthcare Authority published four new rapid HTA reports on medical devices in the cardiovascular field, dermatology, orthopedics, and postoperative pain relief.

On May 4, 2026, the HTA body of the Tuscany Regional Healthcare Authority published five new rapid HTA reports on medical devices in the cardiovascular and gastrointestinal endoscopy fields.

In April 2026, the HTA body of Tuscany Regional Healthcare released six rapid HTA reports (four new assessments and two reassessments) on medical devices in the cardiovascular, neurovascular, and dermatology fields.

In March 2026, the HTA body of Tuscany Regional Healthcare released four rapid HTA reports (three new assessments and one reassessment) on medical devices in the cardiovascular, peripheral vascular, interventional radiology, and orthopedics fields.

On February 13, 2026, the Ministry of Health published an experimental version (so-called "Gamma") of new classification systems for diagnosis and procedure coding under the NSIS-CLASS project, launching the transition from ICD-9-CM. These systems will become mandatory for coding diagnoses and procedures from January 1, 2027, following a testing phase and the release of the final (“Delta”) versions by the end of 2026, with updates planned at least every two years.

In January 2026, the HTA body of Tuscany Regional Healthcare published two rapid HTA reports (one new assessment and one reassessment) on medical devices in the cardiovascular and surgical fields.