The Official Journal has published the Dpcm, accompanied by the ministerial decree, updating the Essential Levels of Care (LEA), introducing more than 800 new services, benefits, and therapies. The measure represents one of the most significant updates to Italy’s National Health Service in recent years, spanning many care areas—from prevention to oncology, including rare and chronic diseases.
According to the Ministry of Health, the revision includes modifications, substitutions, and updates of existing services, as well as the introduction of new diagnostic and therapeutic pathways.
Schillaci’s Comment
«This update is a historic achievement that guarantees all Italians, wherever they reside, access to innovative services and treatments — says Health Minister Orazio Schillaci —. We are writing a decisive chapter to give citizens a National Health Service that is more modern, more equitable, and closer to the real health needs of Italians. This has been a government objective since our administration began».
From the Tariff Decree to the New Update
The latest update to the LEA dates back to 2017. However, full implementation of the measures became possible only in 2024 with the approval of the Tariff Decree, a measure awaited for over seven years and considered essential to operationalize many of the planned services.
The completion of that regulatory path opened the way for the new revision, aimed at aligning the public health offering with the evolution of scientific knowledge and health technologies.
Neonatal Screening and New Prenatal Services
Among the major novelties introduced by the measure is the expansion of neonatal screening. Specifically, nationwide adoption of screening for spinal muscular atrophy (SMA) is foreseen.
The Extended Newborn Screening Program (SNE) is also expanded to include eight additional metabolic and rare diseases.
New prenatal diagnostic services enter the LEA, including non-invasive prenatal testing, and the checks provided for physiological pregnancy are updated to strengthen maternal and fetal health protection.
New Exemptions for Chronic and Rare Diseases
The update adds new conditions to the list of chronic and disabling diseases that qualify for exemption, along with additional services dedicated to patients already included in care pathways.
Significant changes also concern the rare disease sector, with the inclusion of new exempt conditions and the updating of the classification and description of certain rare diseases or groups of rare diseases already included in the LEA.
Oncology: Focus on Breast Cancer and BRCA Genes
In the oncology field, the measure provides new services for a more precise characterization of early-stage hormone receptor–positive breast cancer, with the goal of improving therapeutic appropriateness and supporting the selection of the most effective treatment.
Among the novelties is also the launch of a national screening and surveillance program dedicated to identifying pathogenic variants of the BRCA1 and BRCA2 genes in women with a family history of breast and ovarian cancer.
For healthy women found to carry these genetic variants, active surveillance pathways are planned for early diagnosis, through tools such as breast examinations, ultrasounds, and periodic mammography.
Radiotherapy and outpatient Specialty Care
The LEA update also includes a review of radiotherapy services, defining a single pathway that encompasses both the radiotherapy treatment and the necessary preparatory procedures.
There are also changes to outpatient specialty care, where new services are introduced in line with evolving clinical practices and those deemed obsolete or no longer aligned with current care standards are removed.
An Update Aiming at Equitable Access
With more than 800 interventions across new services, revisions, and substitutions, the LEA update aims to strengthen equity of access to care and to make the National Health Service more responsive to emerging health needs, with particular emphasis on prevention, early diagnosis, and the management of chronic, rare, and oncological diseases.
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