6.1. Analysis of recent reforms

Table6.1 gives an overview of the most recent health reforms from 2005 to 2022. Details on other past reform measures can be found in Ferrè et al. (2014). While no major reforms have changed the fundamental structure of the SSN over the last 15 years, most regional health systems have been consolidating their governance, planning and delivery mechanisms. At the national level, the government has brought about important changes in the areas of prevention and hospital care as well as in rationalizing the national benefits package (LEA). Specific attention has also focused on financial probity, with the introduction of a special regime for regions that overshoot their health budget and/or do not deliver the guaranteed core services of the national benefits package.

Table6.1

6.1.1. Prevention

The Ministry of Health released a National Vaccination Plan for 2017–2019 to expand vaccination coverage and targeted populations, increase the number of vaccines to be offered to the population and set up an online vaccination registry. In the last decade, in fact, Italy had been experiencing a decline in coverage of children’s vaccination (Ricciardi, Boccia & Siliquini, 2018). In 2017, national legislation increased the number of compulsory vaccines from four to 10 (see section 5.1.1), with an additional four recommended and free of charge. The government’s decision was contested by a tiny minority of the population and, initially, by a major political movement (Movimento 5 Stelle), but a large majority of the Italian Parliament voted in favour to reintroduce compulsory vaccination. In hindsight, it appears that the policy was effective in increasing coverage (Ricciardi, Boccia & Siliquini, 2018).

Through Law 24/2017, also known as the “Gelli Law”, the Italian Government enhanced the preventive role of patient safety, as endorsed by scientific bodies and patient associations. In addition, while recognizing safety as a right for everyone accessing health services, the new law also protects health care professionals from being sued if guidelines and safe practices accepted by the ISS have been followed, even in cases of adverse outcomes. In fact, professionals can be prosecuted only in cases of wilful misconduct or gross negligence (Bellandi et al., 2017).

6.1.2. Hospital care

A Ministerial Decree targeting hospital care was issued by the Ministry of Health in 2015 (Ministerial Decree 70/2015). This major and ambitious planning document took a long period to develop, during which time there was no detailed planning of the hospital system. The document sets standards for the main characteristics of SSN and private-accredited hospitals and their activities; for example, it sets a minimum number of beds each hospital should have and classifies hospitals into different categories. It indicates that regions should aim for 90% hospital bed occupancy rates, 160 admissions per 1000 patients and 3.7 hospital beds per 1000 inhabitants: 3.0 for acute care and 0.7 for rehabilitation or medical long-term care. These figures are calculated using detailed standards for each specialty, using national experience and international evidence. These standards aim to incentivize the use of ambulatory care for appropriate treatments (e.g. for cataract surgery) and reduce inappropriate admissions (e.g. those of frail patients without an acute episode who should be cared for in other settings). The most innovative element of Ministerial Decree 70/2015 relates to the use of volume standards for planning hospitals’ sizes and their reconfiguration (see below). Based on systematic reviews on the relationship between volumes and outcomes, the Ministerial Decree sets minimum standards for specific surgical procedures, generally expressed as a number of cases per year (e.g. for cardiology at least 100 and 200 cases per year should be treated for acute myocardial infarction and coronary artery bypass graft, respectively).

These provisions face two major constraints, one institutional and the other geographical. The difference in population size among regions limits the full implementation of the decree without formal agreements between regions for the different categories of hospitals (see Chapter 5 and section 4.3). Moreover, the decentralized nature of the SSN makes these agreements sometimes difficult: the geographical constraints mean that some villages can be more than a 45 minutes’ drive away from the closest hospital, very often with limited means of public transport. It is not surprising, then, that reorganizing hospital care for these communities is challenging and that Ministerial Decree 70/2015 faces strong resistance from the population and their political representatives as hospitals are staffed with local people and they are important political and social symbols for local communities (Healy & McKee, 2002). For this reason, the decree also leaves open the option of maintaining small hospitals that do not comply with the targets presented above (e.g. because they are in the minor islands or mountain areas) and envisions the development of community hospitals, i.e. small facilities providing low and medium intensity care with no more than 40 beds.

Another important innovation of the decree is the introduction of hospital networks. These are inter-organizational arrangements aimed at coordinating different levels of care and facilitating the movement of patients to appropriate clinical and organizational settings. The decree identifies 10 networks, including oncology, acute myocardial infarction, stroke, paediatrics, traumatology and rare diseases (see Box5.5) with defined catchment areas. Special attention is paid to conditions for which the timing of the intervention is essential to ensure clinical results.

Box5.5

While the decree sets national standards, it leaves regions a degree of flexibility for implementation (e.g. which hospitals had to be closed), taking into account their spatial specificities. In this respect, the degree of compliance is very heterogeneous with some regions being very active in reorganizing their hospital systems (e.g. Emilia-Romagna and Veneto) and others progressing at a slower pace (e.g. Calabria and Campania). This diversity in the transposition of national directives into regional legislation and implementation stems from the diversity of socioeconomic contexts, political attitudes and institutional capacities available within regions. For example, in southern regions, where the unemployment rate is very high (in some areas above 20%), SSN organizations are often the largest employers and are often primarily regarded by the population as an opportunity for jobs rather than providers of services. Moreover, certain medical professionals needed to redesign health services are particularly lacking in some regions due to unfavourable employment conditions in regional departments of health (the employees of regions have different contracts from those offered by the SSN).

6.1.3. Recovery plans

Legislation in 1992 and the 2001 constitutional reform transferred some legislative and administrative power in the area of health and health care from the central government to the regions. As a result, the SSN was largely decentralized and health care became the main government function held by regions (in some regions over 80% of the budget is for health care) (Longo, 2016). The first years of implementation of these new arrangements (2007–2010) led to large budgetary deficits in several regions (about 10 out of 20, mainly in the south). This prompted the central government to partially recentralize the SSN through a new institutional and policy framework. Initially, the central government made it mandatory for regions in financial deficit to agree on a set of measures of recovery (these were referred to as internal “stability pacts”). These pacts envisioned that regions have to cover their deficit, information systems had to be strengthened to monitor financial performance and the central government had to bear part of the extra costs provided that the regions acted according to agreed interventions. In 2005, legislation transformed these pacts into recovery plans (piani di rientro), which were implemented from 2007; they have had a profound impact on the SSN (Bobini et al., 2019) (see also Chapter 3).

Recovery plans are intergovernmental arrangements targeted towards regions that overspend and/or fail to deliver the guaranteed services in the national benefits package to their residents. Regions fall into this region-specific regime when they overspend more than 5% of their health budget or in the case of deficits under 5%, if automatic budgetary mechanisms that are triggered are not sufficient to balance the books. The automatic mechanisms consist of: 1) raising IRAP (the earmarked regional corporate tax and the regional components of personal income taxes; 2) not replacing employees who retire; and 3) banning any discretional expenditure for services that are not strictly related to the national benefits package. Regions have to submit a recovery plan (a formal document) that needs to be approved by the Council of Ministers on the proposal of the Ministry of the Economy and Finance. These plans should report all main actions aimed at balancing budgets. The implementation of the plans is a precondition to receiving funding from the government to cover the budgetary imbalance and is monitored on a quarterly basis (Tavoli di Monitoraggio) through a sophisticated information system. In the most severe situations, all political prerogatives are taken by the President of the Region who acts as a commissioner (Commissario ad acta). If, despite this, the region’s financial situation remains critical, the national government can appoint an extraordinary commissioner who centralizes all regional political power (in short, authority is taken away from the regional parliament and government). In addition, the top managers of the entire regional health care system are dismissed and replaced by national government appointees. Finally, the regions which are put under the authority of an extraordinary commissioner are subject to significant fiscal penalties.

Recovery plans, which apply to all SSN organizations and private-accredited providers, target cost reduction in six areas (Ministero dell’Economia e delle Finanze, 2009; Arcà, Principe & Van Doorslaer, 2020):

1. hospital care: reduction of the number of beds and hospitals, more use of day hospitals and ambulatory care to substitute for ordinary admissions;
2. pharmaceutical care: direct distribution by hospital pharmacies to non-hospitalized patients, electronic monitoring of prescribing behaviour;
3. personnel: suspension of hiring unless in exceptional situations, freeze on staff turnover;
4. private-accredited providers: caps on their SSN budgets;
5. purchasing: centralization of purchasing and better monitoring of tenders;
6. appropriateness of pharmaceutical prescriptions made by GPs and specialists.

This major policy has reshaped the governance of the SSN in two ways. First, at the central level it redistributed power in favour of the Ministry of the Economy and Finance, which has developed the internal capacity to govern the economic side of the system and has taken a leading role in the processes of recovery plans (e.g. in managing the discussion with the regions). The Ministry of Health plays a secondary role when discussing financial issues. In this respect, it is significant that no Ministry of Health division has the word “economics” or “finance” in its name. Second, this re-centralization has been asymmetric as it relates to some regions only. Despite national attempts to have a greater grip over all regional systems, centralization of budgetary control has occurred only in regions that were subjected to recovery plans. The other regions have maintained administrative, organizational and financial autonomy to a much larger extent. As of September 2022, seven regions (Abruzzo, Calabria, Campania, Lazio, Molise, Puglia, Sicily) are still functioning under recovery plans (Ministero della Salute, 2022).

On paper, regions should be monitored for both their financial performance and the performance of the health system in terms of population health outcomes and the delivery of services. However, financial concerns dominate. The delivery of the national benefits package is indeed monitored (see Chapter 7) but, so far, plans have included few interventions aimed at improving the performance of the SSN. This is not only due to the dominance of cost-containment objectives, but also to the difficulties in identifying adequate metrics to monitor the delivery of services and health improvement. Despite these difficulties, however, Italy has made important progress in establishing a national system to monitor the regions and their organizations with a number of indicators that are collected robustly and reliably. This monitoring system, called the NSG, consists of 88 indicators. They are built on the basis of data collected by the SSN, ISTAT and other institutions. For the first time, with this system, the SSN includes equity indicators to monitor its performance (e.g. in addition to mean regional values, intraregional variability indicators are used) (see Chapter 7). Overall, the available evidence shows that recovery plans have contained health care expenditure, mainly through cuts of hospital beds and freezing of personnel hiring, and thus have contributed to the financial stability of the SSN. However, some of this evidence, but not all, also shows that citizens living in regions under recovery plans (mainly in the south) experienced worse health outcomes (Aimone Gigio et al., 2018; Depalo, 2019; Arcà, Principe & Van Doorslaer, 2020, 2020; Bordignon et al., 2020).

The 2016 National Budget Bill (Legge di Stabilità 2016) extended the requirement of financial recovery plans to the SSN’s public hospital trusts with budget deficits and, in 2017, to local health authorities. In cases where there is a deficit equal to 10% of the difference between costs and revenues or, in absolute values, greater than €10 million, general directors have three years to rectify the deficit or risk being replaced. Specifically, for hospitals, the recovery criteria also include non-compliance with certain parameters of quality and outcomes of care (Mauro, Maresso & Gugliemo, 2017). Furthermore, all SSN facilities are required to publicly post their financial statements on their website and activate quality monitoring systems (de Belvis, 2016).