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From cancer to newborn screening to anorexia: the new list of free treatments for citizens

The updated list of services that the National Health Service is required to provide throughout the country comes into force today

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5' min read

Translated by AI
Versione italiana

5' min read

Translated by AI
Versione italiana

From targeted breast cancer screening to nine new tests – with neonatal screening extended nationwide – to detect any rare diseases immediately after birth, as well as to identify spinal muscular atrophy (SMA), where prompt intervention makes all the difference to the lives of children and their families. From the introduction of new tests during pregnancy to the updating of radiotherapy services, again within the field of oncology.

From 1 October, citizens throughout Italia have access to the new treatments offered free of charge or subject to a patient contribution by the National Health Service: those Essential Levels of Care that had not been updated since 2017, when the then Minister of Health, Beatrice Lorenzin, in turn revised the 2001 list, drawing up a new one which, however, remained for a long time without a fee schedule; this schedule has only come into force in recent days for specialist outpatient care and prosthetics.
The new list becomes fully operational following a tumultuous process: an initial false start in 2024, blocked by protests from accredited private providers who, through a series of appeals to the Regional Administrative Court (TAR), secured a partial (upward) revision of the remuneration for the services they provide.

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There remains the ‘shortfall’ in a comprehensive package of services – for which, from 2025, a fixed allocation of 200 million is earmarked from the National Healthcare Budget – in relation to which regional governors have, over the years, repeatedly called for a massive increase in resources. The latest request came this week in the form of a document from the Health Commission of the Conference of Regions, though it focused primarily on staffing and innovation: an additional 18 billion to be found in the budget over the next three years.

Schillaci: a ‘fairer’ healthcare system

The changes come into effect today with the publication in the Official Gazette of the Prime Ministerial Decree (DPCM) and the updated Ministerial Decree (DM), which revise that ‘list’ and – comprising some 800 services this time – bear the signature of the Minister of Health, Orazio Schillaci. He promises: ‘We are writing a decisive chapter to provide citizens with a National Health Service that is more modern, fairer and better attuned to their actual healthcare needs. This is a measure I have strongly championed to guarantee all Italians, wherever they live, access to innovative treatments and services. So that there is no ‘first-class’ and ‘second-class’ healthcare, but rather a fairer National Health Service for everyone. This has been a government objective ever since we took office.”

Schillaci refers to the wide-ranging regional differences: individual local authorities are in fact permitted to provide so-called ‘extra LEA’ services, funded from their own resources, but these inevitably leave behind citizens in regions that have not introduced them. This creates the paradox that a neonatal test may be offered in one region – such as Apulia, which has made birth screening a flagship of its health policy – but not in a neighbouring region, thereby infringing upon the right to health enshrined in Article 32 of the Constitution.

The new ‘LEAs’ have also been introduced to address these disparities, although the list of new services should be continually reviewed and updated to keep pace, first and foremost, with technological innovation and the population’s changing healthcare needs, given the ageing population and shifts in epidemiological patterns. This, too, is a stated objective but one that is currently being adjusted, given the delays in its implementation.

Outdated treatments in the attic

Meanwhile, amidst criticism from those who warn that the list is “outdated even before it’s been published”, the Ministry is pressing ahead: ‘This new update is a historic achievement,’ continues Schillaci, ‘which responds to the clear political will to act swiftly on the Essential Levels of Care (LEA), ensuring that the public health service has the capacity to keep pace with innovations – which are only of value if they are genuinely accessible to everyone without having to wait decades. ‘The removal of obsolete services,’ concludes Schillaci, ‘will also help to strengthen the sustainability of our National Health Service, making it even more resilient in tackling new health challenges.’

As mentioned, the update to the Essential Levels of Care (LEA) provides for around 800 new services, treatments and therapies through the amendment, replacement and revision of previous items. Changes have been made, for example, in the fields of prevention, oncology, and rare and chronic diseases.

The main new features

It is the Ministry that is spearheading some of the most innovative initiatives: the roll-out of neonatal screening for SMA across the whole country; the introduction of new services such as non-invasive prenatal tests; and new tests for monitoring normal pregnancies to protect both the mother and the unborn child.

As for the expansion of the neonatal screening programme (NSP), which is being extended to cover a further eight metabolic and rare disorders, here is the full list: Severe combined immunodeficiencies (SCID); Adenosine deaminase deficiency (ADA-SCID) and purine nucleoside phosphorylase deficiency (PNP-SCID); Congenital adrenal hyperplasia due to 21-hydroxylase deficiency; Mucopolysaccharidosis type 1 (MPS I); X-linked adrenoleukodystrophy (X-ALD); Fabry disease; Gaucher disease – glucocerebrosidase deficiency; Pompe disease (type 2 glycogen storage disease).

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With regard to chronic and disabling conditions, new conditions have been added and new exemptions introduced, including conditions that have a significant impact on daily life, such as ulcerative colitis and Crohn’s disease.
New rare diseases eligible for exemption are also being added to the Essential Levels of Care (LEA), and “significant updates to the descriptions of rare diseases or groups of rare diseases already included” are planned, the Ministry of Health emphasises. Among other changes, the new group exemption code for ‘developmental and epileptic encephalopathies’ has been officially introduced, following the regulatory gap highlighted by associations and the scientific community.

In the field of oncology, the new measures include the introduction of services to improve the characterisation of early-stage hormone-responsive breast cancer, which will enable the most effective treatment to be administered; the launch, at national level, of a screening and surveillance programme to identify pathogenic variants of the BRCA1 and BRCA2 genes in women with a family history of breast and/or ovarian cancer who have tested positive for these two variants. For healthy women who test positive for these two variants, active surveillance programmes are planned to enable the early diagnosis of breast and ovarian cancer (for example, breast examinations, ultrasounds and mammograms); an update to radiotherapy services, providing a single pathway covering both the radiotherapy treatment itself and the preparatory stages prior to treatment.
There are also changes to specialist outpatient services, with the introduction of new services and the removal of those that are now obsolete.

In the field of eating disorders and nutrition, in addition to new laboratory tests covered free of charge, two new categories of services have been introduced: series of 10 sessions each for individual and group psychoeducational therapy.

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