Italy

On 30 September 2026, Italy published two decrees updating the national Essential Levels of Care (Livelli Essenziali di Assistenza, LEA). The changes combine an approximately €149.5 million expansion of nationally covered services, including new screening programmes, IVD tests and prosthetic aids, with resource-neutral revisions to existing coding, nomenclature and prescribing requirements. Together, the measures expand coverage for selected technologies while updating the conditions governing access to existing services.

On September 22, 2026, the Italian Agency for Regional Healthcare Services (AGENAS) updated the application form and process details for the National HTA Program for Medical Devices (PNHTA-DM) 2026-2028. Applications may be submitted throughout the year by multiple stakeholders, including MedTech companies. Prioritization meetings will be held twice a year: in July, to review submissions received by May 15, and in December, to review submissions received by October 15.

On September 21, 2026, the Ministerial Decree updating the maximum national reimbursement tariffs for outpatient specialist services and custom-made prosthetic care provided under the Essential Levels of Care (LEA) came into force. The key changes concern diagnostic procedures, dialysis, rehabilitation, and custom-made prosthetic aids.

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.