National catalogue overhaul

The Italian government published a Prime Ministerial Decree and ministerial decree in the Gazzetta Ufficiale on 1 October, enacting a revised catalogue of Essential Levels of Assistance (LEA). The measure introduces approximately 800 new, modified, or replaced medical services, therapies, and diagnostic tests provided free of charge or through co-payments by the National Health Service (SSN). The revisions target several key areas of medicine, including disease prevention, oncology, radiotherapy, pregnancy examinations, and rare and chronic conditions. Patients suffering from chronic illnesses receive access to updated exemptions for clinical tests and specialised treatments. Obsolete medical procedures have also been removed from the schedule to streamline resource allocation across public facilities.

Expanded neonatal and disease screening

A core component of the revised list expands early diagnostic capabilities for newborns and cancer patients across all Italian regions. The new rules add nine diagnostic tests to the national neonatal screening programme, standardising early identification for conditions such as spinal muscular atrophy (SMA) where rapid clinical intervention directly affects patient outcomes. The update also integrates dedicated procedures for the characterisation of breast cancer. Previously, access to advanced diagnostics varied depending on regional funding, as individual regional administrations used local budgets to finance optional "extra LEA" programmes. Autonomous regional initiatives, such as neonatal screening schemes previously pioneered in Puglia, are now incorporated into the mandatory national baseline under Article 32 of the Italian Constitution.

Ministerial objectives and equity

Health Minister Orazio Schillaci presented the decree as an effort to eliminate structural inequalities between regional health administrations. Schillaci emphasised the need to ensure equal access to medical innovation across the country without reliance on separate regional tiers.

“With the publication of the new LEA in the Official Gazette, we write a decisive chapter to give citizens a National Health Service that is more modern, fairer, and closer to their real health needs. This is a measure I strongly wanted to ensure that all Italians, wherever they live, have access to innovative services and treatments. So that there is no first-class healthcare and second-class healthcare, but a fairer National Health Service for everyone. This has been a government goal since our inauguration.”

Schillaci added that updating the list rapidly helps the public health system keep pace with scientific developments while phasing out outdated treatments.

“The elimination of obsolete services will contribute, then, to strengthening the sustainability of our Health Service, making it even more resilient in facing new health challenges.”

Regulatory path and tariff disputes

The regulatory revision follows prolonged administrative delays in updating Italy's public healthcare entitlements. The initial LEA schedule was established in 2001 and underwent an overhaul in 2017 under then-Health Minister Beatrice Lorenzin, though that version remained largely inactive due to the absence of an accompanying tariff decree. A planned rollout faced obstacles in 2024 when accredited private healthcare providers filed appeals before the Regional Administrative Court (TAR), prompting an upward revision of remuneration rates for outpatient specialist care and prosthetic assistance. The updated tariffs and ministerial regulations took formal effect on 1 October, completing the implementation of the expanded service roster nationwide.