The Italian National Health Service (Servizio Sanitario Nazionale) was set up in 1978, with universal coverage, solidarity, human dignity, and health needs as its guiding principles. It is regionally based and organized at the national, regional, and local levels. Under the Italian constitution, the central government controls the distribution of tax revenue for publicly financed health care and defines a national statutory benefits package to be offered to all residents in every region—the “essential levels of care” (livelli essenziali di assistenza, or LEA). The 19 regions and two autonomous provinces have the responsibility to organize and deliver health services through local health units. Regions enjoy significant autonomy in determining the macro structure of their health systems. Local health units are managed by a general manager appointed by the governor of the region, and deliver primary care, hospital care, outpatient specialist care, public health care, and health care related to social care.
Publicly financed health care: The National Health Service (NHS) covers all citizens and legal foreign residents. Coverage is automatic and universal. Since 1998, undocumented immigrants have access to urgent and essential services. Temporary visitors receive health services by paying for the costs of treatment.
Public financing accounted for 75.8 percent of total health spending in 2014, with total expenditure standing at 9.1 percent of GDP.1 The public system is financed primarily through a corporate tax (approximately 35.6% of the overall funding in 2012) pooled nationally and allocated back to regions, typically in proportion to their contributions (there are large interregional gaps in the corporate tax base, leading to financing inequalities), and a fixed proportion of national value-added tax revenue (approximately 47.3% of the total in 2012) collected by the central government and redistributed to regions whose resources are insufficient to provide essential levels of care.2
The regions are allowed to generate their own additional revenue, leading to further interregional financing differences. Every year, the Standing Conference on Relations between the State, Regions, and Autonomous Provinces (with the presidents of the regions and representatives from central government as its members) sets the criteria (usually population size and age demographics) to allocate funding to regions. Local health units are funded mainly through capitated budgets.
Since the National Health Service does not allow people to opt out of the system and seek only private care, substitutive insurance does not exist, but complementary and supplementary private health insurance are available (see below).
Privately financed health care: Private health insurance plays a limited role in the health system, accounting for roughly 1 percent of total spending in 2014. Around 6 million people are covered by some form of voluntary health insurance (VHI), which generally covers services excluded under the LEA, offering a higher standard of comfort and privacy in hospital facilities and wider choice among public and private providers. Some private health insurance policies also cover copayments for privately provided services or a daily rate of compensation during hospitalization.3 Tax benefits favor complementary over supplementary voluntary insurance.
There are two types of private health insurance: corporate, for which companies cover employees and sometimes their families, and noncorporate, with individuals buying insurance for themselves or their families. Policies, either collective or individual, are supplied by for-profit and nonprofit organizations. The market is characterized by three types of nonprofit organizations: voluntary mutual insurance organizations and corporate and collective funds organized by employers or professional associations for their employees or members. There is no information on the number of policies sold by each type of VHI provider, but nonprofit insurers cover the majority of the insured.4
In 2010, around 5.5 percent of the population had individual VHI coverage (1.33 million families), while around 2.5 million people had group coverage.5
Services: Primary and inpatient care are free at the point of use. Positive and negative lists are defined using criteria related to medical necessity, effectiveness, human dignity, appropriateness, and efficiency in delivery. Positive lists identify services offered to all residents; examples include pharmaceuticals, inpatient care, preventive medicine, outpatient specialist care, home care, primary care, and hospice care. Negative lists identify services not offered to patients, such as cosmetic surgery; services covered only on a case-by-case basis, such as orthodontics and laser eye surgery; and services for which hospital admissions are likely to be inappropriate, such as cataract surgery. Regions can offer services not included at the essential levels of care but must finance them themselves.
Prescription drugs are divided into three tiers according to clinical effectiveness and, in part, cost-effectiveness. The first tier (classe A) includes lifesaving drugs and treatments for chronic conditions and is covered in all cases; the second (classe C) contains all other drugs and is not covered by the NHS. There is an additional tier (classe H) comprising drugs that can be delivered only in a hospital setting. The three tiers are updated regularly by the National Pharmaceutical Agency based on new clinical evidence. For some categories of drugs, therapeutic plans are mandated, and prescriptions must follow clinical guidelines.
Dental care is generally not covered, except for children up to 16 years old, vulnerable populations, and people in economic and emergency need.
Cost-sharing and out-of-pocket spending: Procedures and specialist visits can be prescribed either by a general practitioner (GP) or by a specialist. While there are no user charges for GP consultations and hospital admission stays, patients pay a copayment for each prescribed procedure or specialist visit up to a ceiling determined by law—currently at EUR36.15 (USD48.00).6 Therefore, a patient who receives two separate prescriptions (e.g., for an MRI scan and for a consultation with a gastroenterologist) pays EUR36.15 (USD48.00) for each prescription.
To address rising public debt, in July 2011 the government introduced, along with other economic initiatives, an additional EUR10 (USD13) copayment for each prescription. Copayments have also been applied to outpatient drugs at the regional level, and a EUR25 (USD33) copayment has been introduced for “unnecessary” use of emergency services (although some regions have not enforced this copayment). No other forms of deductibles exist. Public and private providers under a contractual agreement with the National Health Service are not allowed to charge above the scheduled fees.
All individuals with out-of-pocket payments over EUR129 (USD172) in a given year are eligible for a tax credit equal to roughly one-fifth of their spending, but there are no caps.
In 2015, 22 percent of total health spending was paid out-of-pocket, mainly for drugs not covered by the public system and for dental care.7 Out-of-pocket payments can be used to access specialist care and, to a lesser extent, inpatient care delivered in private and public facilities to paying patients.
Safety net: Exemptions from cost-sharing are applied to people under age 6 and over age 65 who live in households with a gross income below a nationally defined threshold (approximately EUR36,000, or USD48,000); people with severe disabilities, as well as prisoners, are exempt from any cost-sharing. People with chronic or rare diseases, people who are HIV-positive, and pregnant women are exempt from cost-sharing for treatment related to their condition. Most screening services are provided free of charge.
Primary care: Primary care is provided by self-employed and independent physicians, general practitioners, and pediatricians, under contract and paid a capitation fee based on the number of people on their list.8 Local health units also can pay additional allowances for the delivery of planned care to specific patients (e.g., home care to chronically ill patients), for reaching performance targets (e.g., to reward effective cost containment for prescribed pharmaceuticals, laboratory tests, and therapeutic treatments), or for delivering additional treatments (e.g., medications, flu vaccinations). Capitation is adjusted for age and accounts for approximately 70 percent of overall payment. The variable portion comprises fee-for-service payment for specific treatments, including minor surgery, home care, preventive activities, and care of chronically ill patients. On average, the gross income of a GP ranges between EUR80,000 (USD107,000) and EUR120,000 (USD160,000), depending on list size.
The payment levels, duties, and responsibilities of GPs are determined in a collective agreement signed every three years by consultation between central government and the GPs’ trade unions. In addition, regions and local health units can sign contracts covering additional services.
In 2012, there were approximately 53,000 GPs and pediatricians (33.6% of all practitioners working for the NHS) and 104,600 hospital clinicians (66.4%).9 Patients are required to register with a gatekeeping GP, who has incentives to prescribe and refer only as appropriate: in most cases, incentives are awarded only to those GPs and pediatricians who fall below a predetermined spending maximum or consumption target. People may choose any physician whose list has not reached the maximum number of patients allowed (1,500 for GPs and 800 for pediatricians) and may switch at any time.
In recent years, the solo practice model has been progressively modified toward group practice, particularly in the northern part of the country. Legislation encourages GPs and pediatricians to work in three ways: base group practice, in which GPs from different offices share clinical experiences, develop guidelines, and participate in workshops that assess performance; network group practice, which functions like base group practice but allows GPs and pediatricians to access the same patient electronic health record system; and advanced group practice, in which GPs and pediatricians share the same office and patient health record system and are able to provide care to patients beyond individual catchment areas. In 2012, approximately 70.3 percent of GPs and 61.2 percent of pediatricians were working in a team.10 Group practices typically range from three to eight GPs.
General practitioners working in base group practices receive an additional EUR2.58 (USD3.70) for each patient registered in their list, while GPs in a network practice receive EUR4.70 (USD6.30) (the payment for pediatricians is EUR8.00, or USD11.00). Lastly, GPs working in a group practice receive EUR7.00 (USD10.00) and pediatricians EUR9.00 (USD12.00). General practitioners or pediatricians receive an additional payment of EUR4.00 (USD6.70) for employing a nurse and EUR3.50 (USD4.70) for a secretary.
Some regions are promoting care coordination by asking their GPs to work in groups comprising specialists, nurses, and social workers. The aim is for each group to be in charge of all the health needs of its assigned population. This arrangement is encouraged by additional payments to GPs per patient and by supplying teams with personnel.
Outpatient specialist care: Outpatient specialist care is generally provided by local health units or by public and private accredited hospitals under contract with them. Once referred, patients are given a choice of any public or private accredited hospital but are not given a choice of specialist. Outpatient specialist visits are generally provided by self-employed specialists working under contract with the National Health Service. They are paid an hourly fee contracted nationally between the government and the trade unions; the current rate is approximately EUR32 (USD43). Outpatient specialists can see private patients without any limitations, whereas specialists employed by local health units and public hospitals cannot. Multispecialty groups are more common in northern regions of the country.
Administrative mechanisms for paying primary care doctors and specialists: Patient copayment is limited to outpatient specialist visits and diagnostic testing, while primary care visits are provided free of charge. Copayments are usually paid by the patient before the visit or test.
After-hours care: In the case of after-hours emergency care, or when a consultation with a GP is not possible, service is provided by the emergency medical service (guardia medica), staffed by “continuous-care physicians” (medici di continuità assistenziale). The hourly rate, negotiated between the GP trade unions and the government, is approximately EUR25 (USD33). Following examination and initial treatment, the doctor can prescribe medications, issue employees’ medical certificates, and recommend hospital admission. The service normally operates at night and on weekends.
Information on a patient’s visit is not routinely sent to the patient’s GP. To improve accessibility, government and GP associations are trying to promote a model whereby GPs, specialists, and nurses coordinate to ensure 24-hour access and avoid unnecessary use of hospital emergency departments. Implementation is uneven across regions.
Hospitals: Depending on the region, public funds are allocated by local health units to public and accredited private hospitals. In 2012, there were approximately 187,000 beds in public hospitals and 45,500 in private accredited hospitals.11 Public hospitals either are managed directly by the local health units or operate as semi-independent public enterprises. A diagnosis-related group–based prospective payment system operates across the country and accounts for most hospital revenue but is generally not applied to hospitals run directly by local health units, where global budgets are common. Rates include all hospital costs, including those of physicians. Teaching hospitals receive additional payments (typically 8% to 10% of overall revenue) to cover extra costs related to teaching. There are considerable interregional variations in the prospective payment system, such as how fees are set, which services are excluded, and what tools are employed to influence patterns of care. However, all regions have mechanisms for cutting fees once a spending threshold is reached, in order to contain costs and as an incentive to increase admissions.
In all regions, a portion of funding is administered outside the prospective payment system (e.g., funding of specific functions such as emergency departments and teaching programs).
Hospital-based physicians are salaried employees. Public-hospital physicians are prohibited from treating patients in private hospitals; all public physicians who see private patients in public hospitals pay a portion of their extra income to the hospital.
Mental health care: Mental health care is provided by the National Health Service in a variety of community-based, publicly funded settings, including community mental health centers, community psychiatric diagnostic centers, general hospital inpatient wards, and residential and semiresidential facilities. In 2012, there were 1,938 residential facilities and 819 semiresidential facilities, providing care to approximately 69,000 patients.12 The promotion and coordination of mental illness prevention, care, and rehabilitation are the responsibility of specific mental health departments in local health units. These are based on a multidisciplinary team, including psychiatrists, psychologists, nurses, social workers, educators, occupational therapists, people with training in psychosocial rehabilitation, and secretarial staff. In most cases, primary care does not play a role in the provision of mental health care; a few regions have experimented with assigning the responsibility of low-complexity cases (mild depression) to general practitioners.13
Long-term care and social supports: Patients are generally treated in residential (approximately 180,000 beds in 2012) or semiresidential (14,000 beds) facilities or in home care (approximately 634,000 cases). Residential and semiresidential services provide nurses, physicians, specialist care, rehabilitation services, medical therapies, and devices. Patients must be referred to receive residential care. Cost-sharing for residential services varies widely according to region but is generally determined by patients’ income.
Community home care is funded publicly, whereas residential facilities are managed by a mixture of public and private, for-profit and nonprofit organizations. Community home care is designed not to provide physical or mental care services but to provide additional assistance during a treatment or therapy. In spite of government provision of residential and home care services, long-term care in Italy has traditionally been characterized by a low degree of public financing and provision as compared with other European countries.
Financial assistance for patients can take two forms:
- Accompanying allowance: Awarded by the National Pension Institute to all Italian citizens who need continuous assistance. The allowance, which is related to need but not to income or age, amounts to approximately EUR500 (USD714) per month.
- Care vouchers: Awarded by municipalities on the basis of income, need, and clinical severity only to residents of those municipalities offering the service. The amount ranges between EUR300 and EUR600 (USD426 to USD857) per month.
Voluntary organizations still play a crucial role in the delivery of palliative care. A national policy on palliative care has been in place since the late 1990s and has contributed to an increase in services such as hospices, day care centers, and palliative care units within hospitals. In 2012, there were 176 hospices, with approximately 1,800 beds. But much still needs to be done to ensure the diffusion of palliative care services because disparities persist: northern regions cared, on average, for 54 patients per 100,000 residents, while in central and southern regions the rate fell to 27 patients.
The Ministry of Health is currently divided into 12 directorates that oversee specific areas of health care (health care planning; essential levels of care and health system ethics; human resources and health professionals; information systems; pharmaceuticals and medical devices) or supervise the main institutions related to the Ministry of Health (e.g., the National Health Council, the National Institute of Health).
Key nongovernmental entities supporting the Ministry of Health include the National Health Council (which provides support for national health planning, hygiene and public health, pharmacology and pharmaco-epidemiology, continuing medical education for health care professionals, and information systems) and the National Institute of Public Health (which provides recommendations and control in the area of public health).
The National Committee for Medical Devices develops cost-benefit analyses and determines reference prices for medical devices. The Agency for Regional Health Services is the sole institution responsible for conducting comparative-effectiveness analysis and is accountable to the regions and to the Ministry of Health.
The National Pharmaceutical Agency is responsible for all matters related to the pharmaceutical industry, including prescription drug pricing and reimbursement policies. It is accountable to the Ministry of Health and the Ministry of Economy and Finance.14
Payment rates for hospital and outpatient specialist care are determined by each region, with national rates (determined by the Ministry of Health) as a reference.
Some regional governments have established agencies to evaluate and monitor health care quality and to provide comparative-effectiveness assessments and scientific support for regional health departments (see below). Regional governments periodically sign “Pacts for Health” (Patto per la Salute) with the national government linking additional resources to the achievement of health care planning and expenditure goals (see below).
The safeguarding of patients’ rights has not been uniform and has depended on the level of effort of individual regions. Regions have implemented different models of empowerment: some through standing committees, which include members from citizens’ associations as an institutional means of patient involvement, others by emphasizing systematic patient satisfaction surveys.
Each public institution has an office for public relations (Ufficio Relazioni con il Pubblico) providing information to citizens and, in many cases, monitoring the quality of services from the citizen’s point of view.
Government at both the national and regional levels are responsible for upholding quality and ensuring that services included in the essential levels of care are provided and that waiting times are monitored. Several regions have introduced programs for prioritizing delivery of care on the basis of clinical appropriateness of services prescribed and patient severity.15 All doctors under contract with the National Health Service must be certified, and all National Health Service staff participate in compulsory continuing education. The National Commission for Accreditation and Quality of Care is responsible for outlining the criteria used to select providers and for evaluating regional accreditation models (including private hospitals), which vary considerably across the system. These models do not usually include periodic reaccreditation.
Legislation passed during the 1990s covers three main components of quality: input (quality of infrastructure and human resources); process (appropriateness and timeliness of interventions); and outcome (health status and patient satisfaction).16
National legislation requires all public health care providers to issue a “health service chart” with information on service performance, quality indicators, waiting times, quality assurance strategies, and the process for patient complaints. These charts have also been adopted by the private sector for its accreditation process and must be published annually, although dissemination methods are decided regionally. Most providers disseminate data through leaflets and the Internet. Nurses and other medical staff are offered financial performance incentives (linked to manager evaluations but not to publicly reported data).
The National Plan for Clinical Guidelines (Piano Nazionale Linee Guida) has been implemented in recent years and has produced guidelines on topics ranging from cardiology to cancer prevention and from appropriate use of antibiotics to cesarean delivery.
Some regions have introduced disease management programs, are experimenting with chronic care models (refer to the section on coordination), and are maintaining registries, mainly for cancer patients and diabetes. No national registries exist. Patient surveys are not used for quality control.
Interregional inequity is a long-standing concern. The less affluent south trails the north in the number of beds and availability of advanced medical equipment, has proportionally fewer public versus private facilities, and has less-developed community care services; this gap in availability is increasing. Income-related disparities in self-reported health status are significant, though similar to those in the Netherlands, Germany, and other European countries.17
The regions receive a proportion of funding from an equalization fund (Fondo Perequativo Nazionale), which aims to reduce inequalities. Aggregate funding for the regions is set by the Ministry of the Economy and Finance, and the resource allocation mechanism is based on capitation adjusted for demographic characteristics and use of health services by age and sex.
There is no systematic public reporting of health and health access variation, although several public and private institutions publish reports with analysis of health care variation (e.g., ISTAT, Ministry of Health, Catholic University of Rome).
Integration of health and social care services has recently improved, with a significant shift of long-term care from institutions to the communities and an emphasis on home care. Community home care establishes a home care network that integrates the competencies of nurses, GPs, and specialist physicians with the needs and involvement of the family. General practitioners oversee the home care network, liaise with social workers and other sectors of care, and take responsibility for patient outcomes.
The regions have chronic care management programs, dealing mainly with high-prevalence conditions such as diabetes, congestive heart failure, and respiratory conditions. All programs involve different competencies. Some regions are also trying to set up disease management programs based on the chronic care model, although the degree of organization varies across regions.
The most recent Pact for Health, signed in July 2014, is a significant step toward care integration (see below): all regions must establish Primary Care Complex Units (Unità Complesse di Cure Primarie) involving GPs, specialists, nurses, and social workers.
Given that, traditionally, Italian GPs work in solo practice, shifting to this new organizational arrangement will require considerable effort. To further promote integration and adoption of multidisciplinary teams, medical homes are being encouraged in some regions, such as Tuscany and Emilia-Romagna, where there are collectively 81 medical homes currently providing multispecialty care to approximately 1.7 million people.
The New Health Information System (Nuovo Sistema Informativo Sanitario) has been implemented incrementally since 2002, with the goal of establishing a universal system of electronic records connecting every level of care. It provides information on services, resource use, and costs, but does not encompass all areas of health care; in particular, primary care is not included, while hospital, emergency, outpatient specialist, residential, and palliative care, as well as pharmaceuticals, are. It currently registers administrative information on care delivered, but medical information appears to be more difficult to gather. No unique patient identifier exists at the national level.
A core component of the New Health Information System is the nationwide clinical coding program known as “bricks,” (mattoni) one of the most mature elements of Italy’s developing electronic health program. It aims to define a common language for classifying and codifying concepts; to share methodologies for measuring quality, efficiency, and appropriateness of care; and to allow an efficient exchange of information between the national-level and regional authorities.
Some regions have developed computerized networks to facilitate communication between physicians, pediatricians, hospitals, and territorial services and to improve continuity of care. These networks allow the automatic transfer of patient registers and of information on services provided, prescriptions for specialist visits and diagnostics, and laboratory and radiology test outcomes. A few regions have also developed a personal electronic health record, accessible by the patient, that contains all of his or her medical information, such as outpatient specialty care results, medical prescriptions, and hospital discharge instructions. Personal electronic health records are meant to provide support to patients and clinicians across the whole process of care, but diffusion is still limited.
There is also a slow shift under way from paper to electronic prescriptions. By the end of 2014, 80 percent of all prescriptions (drugs and specialist care) were to be issued electronically, but only five regions declared that they had reached the goal on time.
Containing health care costs is a core concern of the central government, as Italy’s public debt is among the highest of the industrialized nations. Fiscal capacity varies greatly across regions. To meet cost-containment objectives, the central government can impose recovery plans on regions with health care expenditure deficits. These identify tools and measures needed to achieve economic balance: revision of hospital and diagnostic fees, reduction of the number of beds, increased copayments for pharmaceuticals, and reduction of human resources through limited turnover.
The Agency for Regional Health Services, in collaboration with the Ministry of Health, has the authority to conduct health technology assessments and apply its findings at the regional level, but the assessments are not yet formalized or undertaken systematically. Few regional health technology assessment agencies currently exist, and their primary function is to evaluate individual technologies. Assessments are not mandatory for innovative procedures and devices. However, reference prices for medical devices and pharmaceuticals are set according to cost-effectiveness studies carried out by the National Committee for Medical Devices and the National Drugs Agency. Furthermore, the National Pharmaceutical Formulary bases coverage decisions in part on clinical effectiveness and cost-effectiveness. Prices for reimbursable drugs are set in negotiations between government and the manufacturer according to the following criteria: cost-effectiveness where no effective alternative therapies exist; comparison of prices of alternative therapies for the same condition; costs per day compared with those of products of the same effectiveness; financial impact on the health system; estimated market share of the new drug; and average prices and consumption data from other European countries. Prices for nonreimbursable drugs are set by the market.
Because of the regionalization of the health system, most innovations in the delivery of care take place at the regional rather than the national level, with some regions viewed as leaders in innovation.
In April 2015, the Ministry of Health approved a decree for the reorganization of hospital care. The decree classifies public hospitals into three groups:
- Base hospitals (for populations of 80,000–150,000 residents), with emergency wards, internal medicine, general surgery, orthopedics, and on-call availability of radiology, laboratory testing, and blood bank
- First-level hospitals (150,000–300,000 residents), with the same wards as base hospitals and, in addition: obstetrics (based on the number of deliveries per year), pediatrics, cardiology with intensive care unit, neurology, psychiatrics, oncology, ophthalmology, otolaryngology, and urology
- Second-level hospitals (600,000–1,200,000 residents), with advanced emergency wards and facilities for treating highly complex patients (or conditions)
In addition, the decree introduces, for a few procedures, minimum levels of activity and quality thresholds. Examples include at least 75 surgical interventions per year for femoral fractures in second-level hospitals, and the requirement that at least 60 percent of patients age 65 and older admitted for femoral fractures must be operated on within 48 hours. Many of the law’s provisions are in the process of being implemented, and the effects have not yet been evaluated.
In January 2017, the government approved an updated version of the “essential levels of care.” The new document introduces significant public health changes: vaccination programs; outpatient specialist care, with a substantial revision of the treatments that can be delivered by the National Health Service; and hospital care, with a further shift of treatments to outpatient settings. The government estimates an additional expenditure of EUR 800 million (USD 860 million) per year.
The author would like to acknowledge Sarah Jane Reed and David Squires as contributing authors to earlier versions of this profile.
1Organisation for Economic Co-operation and Development (OECD), OECD Health Statistics, 2016.
2Ministero dell’Economia e delle Finanze, Relazione Generale Sulla Situazione Economica Del Paese 2012 (2012).
3A. Sagan and S. Thompson, Voluntary Health Insurance in Europe—Country Experience, no. 42 (European Observatory on Health Systems and Policies, 2016).
6Please note that, throughout this profile, all figures in USD were converted from EUR at a rate of about EUR0.75 per USD, the purchasing power parity conversion rate for GDP in 2015 reported by OECD (2016) for Italy.
7OECD, OECD Health Statistics.
8A. Lo Scalzo, A. Donatini, L. Orzella et al., Italy: Health System Review (European Observatory on Health Systems and Policies, 2016).
9ISTAT, Health for all Italy. OECD Health Statistics.
10Ministero della Salute, Annuario statistico del Servizio Sanitario Nazionale (Roma, 2015).
11Ministero della Salute, Annuario statistico del Servizio Sanitario Nazionale, 2015.
12Ministero della Salute, Annuario statistico del Servizio Sanitario Nazionale, 2015.
13A. Lo Scalzo, Italy: Health System Review, 2016.
14A. Lo Scalzo, Italy: Health System Review, 2016.
15G. France, F. Taroni, A. Donatini, “The Italian Health-Care System,” Health Economics, Sept. 2005 14(Supp1):S187–202.
16A. Lo Scalzo, Italy: Health System Review, 2016.
17E. Van Doorslaer and X. Koolman, “Explaining the Differences in Income Related Health Inequalities Across European Countries,” Health Economics, July 2004 13(7):609–28.