The Italian Prime Minister has signed and approved new regulation on Essential Levels of Care (LEAs)

On January the 13th, the Italian Prime Minister Paolo Gentiloni signed and approved the new List of Essential Levels of Care (so-called LEAs) developed by the Ministry of Health and the Regions in the last months. LEAs is a positive list of healthcare basket benefits defined in term of standards and services of care which are mandatory for provision by regions to all the people living in the national territory.
After more than 15 years of stagnation at the national level, the new Law will substitute completely the Decree of November 2001, the most recent update of the same basket of benefits.
Among important news, the Law reviews the List of 108 DRGs at risk of inappropriateness, that is the list of DRGs related to hospitalization that may lead to clinical and economic inefficiencies when delivered in in-patient normal stay setting and that shall be preferably moved to the one-day case setting. It also identified those surgical one-day cases that shpuld be preferably moved to the out-patient setting, for similar efficiency issues.

From a public health perspective, new LEAs enlarges the number of vaccines provided by the National Health Service (SSN), including the pneumococcal vaccine, the meningococcal vaccine and the papillomavirus vaccine, which is also extended to male adolescents, and reviews and updates the list of chronic diseases (with introduction of thalidomide syndrome, chronic osteomyelitis, chronic kidney disease, autosomal dominant polycystic kidney disease, endometriosis of stages "moderate" and "severe", chronic obstructive pulmonary disease of stage "moderate", "severe" and "very severe") and the list of rare diseases (with introduction of many new diseases, including sarcoidosis, progressive systemic sclerosis, and severe myasthenia). Both lists make patients affected by such diseases exempted from co-payment for use of out-patient services related to their conditions. 
The new regulation also introduces neonatal screening for congenital deafness and congenital cataracts, and enlarges neonatal screening to the whole population of newborns.
Most important, the new LEAs updates and reviews the List and coding of out-patient care as well as the Nomenclature of Aids and Orthoses for disabled. With regards to out-patient services, new LEAs removes outdated services and includes new and technologically advanced procedures that were so far excluded from the national nomenclature, which was last updated in 1996.

The new regulation introduces a number of specific codes for medically assisted procreation, which would previously be performed only in in-patient setting, and many other innovative procedures such as hadron therapy, enteroscopy with ingestible camera, stereotactic radiotherapy. It also identifies more detailed and specific coding for nuclear medicine services. In total, more than 900 new codes were included and around 800 obsolete procedures were removed.
With regards to the Nomenclature of Aids and Orthoses for disabled, which was updated for the last time in 1999, new LEAs introduces new computer aids for communication (including ocular communicators and adapted keyboards for people with serious disabilities), new hearing aids with digital technology, alarm and remote assistance devices, new and advanced artificial limbs and systems for speech recognition and eye-tracking, cutlery and furniture adapted to physical disabilities, four-wheel scooters for disabled, wheelchairs with vertical system.

Finally, the new regulation also envisages the constitution of a new Commission within the Ministry of Health, which will be in charge of reviewing LEAs annually, so that innovation and new standards can be included on time.
The central government allocated 800 million euro for realization and implementation of new LEAs.  
It is important to stress that before entrance into force of the new regulatory text, review and approval by the Italian Court of Auditors is needed. The Court, in particular, will have to validate and confirm sustainability of the reform, based on resources earmarked by the national government. After validation by the Court of Auditors and publication into the Official Journal, which according to the Ministry of Health may happen by the end of January, new LEAs will enter officially into force.
Assobiomedica, the Italian Association of the Medical Device Industry, announced its consensus to the reform and hoped for new LEAs to be a first important step towards modernization of the SSN.