Italy Expands LEA Coverage for Screening, IVD Tests and Prosthetic Aids, with €149.5 Million in Additional Funding

On 30 September 2026, Italy published two decrees in the Official Gazette, introducing changes to the national Essential Levels of Care (LEA). Both decrees are scheduled to enter into force on the 30th day following publication.

The LEA framework defines the healthcare services guaranteed to the Italian population. Annex 4 (LEA catalogue) provides an exhaustive list of outpatient services, including IVD tests, while hospital services are defined more broadly.

The two decrees address different aspects of the LEA framework:

1. Ministerial Decree (DM): Modernisation of existing services without additional expenditure

The Ministerial Decree introduces resource-neutral revisions, primarily targeting outpatient, prosthetic and disposable-device nomenclatures, coding structures, prescribing-appropriateness requirements, care settings and eligibility conditions.

Key changes include:

• Reorganisation of radiotherapy services into bundled care packages;
• Revisions to terminology, descriptions, codes, notes and supply conditions for prosthetic and disposable-device nomenclatures;
• Replacement of the existing list of Diagnosis-Related Groups (DRGs) at high risk of inappropriateness in ordinary inpatient care with a revised list;
• Updates to prescribing requirements and exemption rules.

These changes are to be implemented without additional public expenditure.

2. Decree of the President of the Council of Ministers (DPCM): Expansion of nationally covered services

The DPCM introduces approximately €149.5 million in additional expenditure, financed through resources earmarked for LEA updates. It expands national coverage across screening programmes, specialist outpatient diagnostics, molecular and pharmacogenetic services, and prosthetic aids.

Notable additions include:

• Non-invasive prenatal testing (NIPT): Introduction of national reimbursement for testing based on cell-free fetal DNA in maternal blood for chromosomes 13, 18, 21, X and Y;
• Hereditary cancer screening: Establishment of a screening and surveillance programme for women at hereditary-familial risk of breast and/or ovarian cancer;
• Newborn screening: Expansion of the national screening programme to include eight additional conditions;
• Prosthetic aids: Addition of new aids to List 1 (custom-made aids) and List 2B (ready-to-use aids).

The updates also introduce associated national tariffs for the newly covered services.

What does it mean for the industry?

The two decrees have distinct implications for market access in Italy. The DPCM expands national coverage for selected diagnostic and medical technologies, establishing reimbursement opportunities for services newly included in the LEA framework. The Ministerial Decree, meanwhile, revises the coding, prescribing and eligibility conditions governing existing services, without allocating additional funding.

Manufacturers should assess the implications of both decrees for their specific products, including potential changes to national coverage, applicable tariffs, coding and access conditions. The impact will depend on the individual technology and its existing reimbursement arrangements.

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