The National Recovery and Resilience Plan (NRRP), which was drafted and approved by the Italian Government earlier this year, outlines the development of advanced telemedicine ecosystems, which are aimed at strengthening territorial healthcare and improving the standard of care for Italian citizens and residents.
In compliance with the content of this plan, the home care sector, which until now has been poorly regulated, is destined to undergo a legislative revolution next year.
As a matter of fact, in the wake of Covid, the Budget Law 2021 (Law 178/2020) has foreseen a mandatory health authorisation for the so-called home care. To implement this provision, the State-Regions Conference published the new Agreement on August 4th, 2021 on the minimum structural, technological and organisational requirements for the authorisation and specifies the additional requirements for the accreditation of home care.
Using this document as a basis the Italian regions will need to rewrite authorisation rules over the next 12 months. In other words, all those agents providing home care services will have to comply with specific requirements (which may somewhat differ from one region to region) and obtain a respective healthcare authorisation.
Below are some important aspects contained in the agreement that will be included in the regional resolutions:
- In this sense, if the activity falls within the term “home care” (Art. 22 of the Prime Minister’s Decree of January 12th, 2017 – Essential Levels of Care), it should be subject to authorisation (and likely accreditation). For example, according to a so-called digital Patient Support Program (PSP), the provision of home care is usually established by the physician as part of a clinical plan, but the care is delivered at the patient’s home by the so-called provider. In this case, the provider is supposed to obtain authorisation and, most probably, accreditation, if the clinical plan originates in a public structure;
- The scope of authorisation and accreditation is widened to include areas, which until now have not been properly considered as “healthcare”. And namely Annex B outlines a series of specific and detailed requirements for premises of the “organisational headquarters” and “operational headquarters”, which differ significantly from the “traditional” outpatient hospitals;
- Annex B also sets out some specific requirements of technological, organisational, and procedural nature;
- Finally, Annex C sets out all the requirements for accreditation, which for the most part strengthen and reinforce authorisation requirements.
It may be concluded that the area of home care in Italy is facing a major turning point. In the next 12 months, the regions will adopt indications of the State-Regions Conference and issue the legislative and/or administrative acts for commencing the authorisation and accreditation processes.
These and other structural changes envisaged by the NRRP entail a phase of reorganisation and redefinition of services, also (and above all) from a digital perspective, associated with healthcare facilities, healthcare professionals, pharmaceutical and medical device companies.