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DECISION MAKERS AND DECISION-MAKING PROCESSES DIAGRAM
Italy has a population of 60.3 million citizens (1), residing in
20 Regions plus 2 Autonomous Provinces (Trento and Bolzano), hereafter collectively indicated as the Regions
The National Healthcare System (Servizio Sanitario Nazionale - SSN) provides healthcare coverage to the population, combining public financing with a mixture of public and private provision (2). Legally placed under the central responsibility of the Ministry of Health, the system is largely decentralized resulting in three levels:
- National level: The Ministry of Health formulates every three years a healthcare plan PSN (Piano Sanitario Nazionale) which is set to determine general healthcare policies.
- Regional level: The Regions are due to implement the PSN with their own resources and can adjust to local needs or policies. As a consequence, some geographic disparity in terms of healthcare access or level of co-payments exists.
- Local level: Local health units ASL (Azienda Sanitaria Locale) provide health care services – e.g. primary medical services, specialist care, and coordination of all non-emergency admissions to public hospitals. This level also includes AO (see below) and IRCCS (large teaching and/or research hospitals) which provide highly specialized hospital services.
In short, provided that the essential levels of care (Livelli Essenziali di Assistenza – LEA) defined by the Ministry are fulfilled, the 21 regional health agencies (Agenzia Sanitaria Regionale - ASR), head of which are nominated by the Regional Cabinets (Giunte Regionali), and/or the Regional Governments (Assessorato alla Sanità Regionale), are in charge of regulating access to hospital and ambulatory care and medico-social care, in coordination with the ASLs.
The overall (public + private) health care expenditure in 2008 amounted to 135 billion €, i.e. 8.6% of GDP (3). Public (SSN) health care expenditure was 107.1 billion € and 6.8 % of GDP (4).
Responsibility for delivering hospital and community services rests with the ASLs, which are funded by the SSN through a per capita budget which is transferred from the centre to the Regions and from these to the ASLs. 79% of
public hospitals are managed by the ASLs; whilst 105 major hospitals are qualified as public enterprises (Azienda Ospedaliera - AO), with an independent legal status similar to the one of British Trust Hospitals (AO and IRCCS are funded by DRG Tariffs, as explained below). Inpatient care, 2008 data, accounts for 48% of total public health-care expenditure nationally, and in some regions for almost 54%.
Primary care: According to the rule of universal coverage which represents one of the founding principles of the SSN, all Italian residents must be listed with a General Practitioner or a Pediatrician (for children up to 12 years of age) who acts as gatekeeper to the system, thus allowing access to specialist care, hospital visit or admission, or other types of medical care (under SSN coverage). There were 46961 office-based general practitioners (on average, one every 1114 patients) in 2007, and 7657 pediatricians (average 1:827) (5). GPs’ and Pediatricians are paid through a National Collective Contract which is negotiated at the central level, and whose responsibility for local adaptation and application rests with the ASLs.
Hospital care: there were 1271 hospitals in Italy in 2007, 52% public (including 105 AOs), 43% private hospitals acknowledged by the SSN (privato-accreditato) and the remaining 5% of private ownership offering services only for out-of-pocket patient payment (privato-privato) (6). Since 19944 funding through DRGs is implemented and applied to both public and private hospitals, with different tariff levels. The number of admissions has leveled around 13 million cases in the years 2001-2006 and declined in the following years, down to 11.7 million in 2009, possibly as a result of local efforts of the ASLs to reduce the use of expensive inpatient care in favor of more patient oriented and less costly home care programs; the weighted average length of stay is currently leveled at 6.7 days/stay (6).
Public and private healthcare providers (whether they provide in-patient and/or out-patient care) are remunerated through a fee-for-service system based on two Formulary Lists, both based on the ICD9-CM WHO Classification of Diseases and Procedures:
- the NTPA (Nomenclature Tariffario delle Prestazioni Ambulatoriali), i.e. an out-patient formulary list of medical acts and procedures which can be delivered in out-patient facilities under SSN’ funding (7), and
- the NTPO (Nomenclatore Tariffario delle Prestazioni Ospedaliere) which is a DRG based in-patient formulary list (8), covering all hospital activity from acute or day-hospital admissions to long-term care and nursing home assistance;
By this system, providers are funded through pre-determined tariffs which are established by the Regions or, in the absence of specific regional legislation, by tariffs defined at the central level by the Ministry of Health.
An estimate of the economic impact of Medical Devices on healthcare expenditure is available for 2007: according to CEIS, public expenditure for DMs ranges from €23 (Calabria) to €146 (FriuliVG) per person in the population (Italian average €65/person) with a nationwide estimate of 3.8 €billion (9). Another recent report indicates that expenditure for MDs is about 4% of total public healthcare expenditure, corresponding to 4.5 €billion (10). Uncertainty about the economic impact of this relevant segment of healthcare delivery is going to be possibly reduced by a recent Ministerial Decree introducing the duty for hospitals to transmit MD consumption data to the Regions, thus allowing the institution of a national observatory.
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DECISION MAKERS AND INFLUENCERS
Ministry of Health - General Directorate of Medicines and Medical Devices(Direttorato Generale Farmaci e Dispositivi medici – DGFDM) performs the following functions: (a) supervision on, and relations with, the Italian Drug Agency (b) regulation of sales of medicinal products (c) advertising of medicinal products of self-medication, medical devices and other authorized products (d) medical devices, including vigilance and evaluation of clinical trials (e) in vitro diagnostic, including vigilance and supervision over blood products (f) secretarial assistance for the CUD (see below) (g) inspections (h) production and trade of medical devices; implementation of community legislation on biological products (i) cosmetic products; equipment for aesthetic use (l) production, trade and management of psychotropic substances
CUD (Commissione Unica Dispositivi Medici): the Ministerial Decree 28/12/2005 included in the 2006 Financial Act (art. 1, c. 290), established that the CUD is in charge of “exerting a consulting role on any issue regarding MDs for the Ministryand/or for the DGFDM”; though, the CUD represents the key consulting body of the Ministry for MDs. The 2007 Financial Act (art. 1, c. 96, lett. V), empowered the CUD to elaborate a list of MDs whose expenditure represents more than 50% of the global expenditure for MDs; based on this list, the Ministry was set in charge of defining reference prices to represent the baseline for tenders and purchases under SSN’ contracts; also, under this rule, the CUD was empowered to set up studies of appropriateness of use of specific MD typologies, as well in terms of cost-comparison vs. adequate alternatives. The results of these studies was to be published in the Ministry-CUD website
AGENAS (Agenzia Nazionale per i Servizi Sanitari Regionali): is a national body which plays a role of liaison and decision support for the Ministry of Health and the Regions on strategies for development of the National Health Service. Its function covers: evaluation of effectiveness of the essential levels of assistance; analysis of cost levels; preparation of proposals for the organization of health services; analysis of system innovations, quality and costs of assistance; development and dissemination of safety systems; monitoring of waiting times; management of procedures for continue education in medicine. In collaboration with the DGFDM the Agency in 2007 has coordinated a comprehensive collection of prices of DMs throughout the country. Also, the Agency is coordinating the production and publication of HTA report on Medical Devices as well as of Medical Procedures, some of which have already been published in the Agency’s website (http://www.agenas.it/innovazione_sperimentazione_sviluppo.html). Recently the Agency has activated an open forum, primarily with the aim to establish interactive communication between the stakeholders of new health technologies; among its main objectives is to facilitate the exchange of information and to improve coordination between the components of the Italian Network of HTA (RIHTA): “the Forum is a step towards the creation of a virtual platform which favors the growth and the consolidation of a system of relations for the use of integrated scientific evidence as a basis for the innovation of health services”. The platform is developed in the context of a Government sponsored research project "Hr&i Transfer" (analysis and development of a system of relations for the use of integrated scientific evidence as the basis for innovation of health services). (http://hta.agenas.it/).
Reimbursement: Central Decision Makers
Medical Devices in Italy are not subject to P&R negotiation at the central level, thus funding must be queried at the local level (see below).
Reimbursement: Regional And Hospital Bodies
Agenzie Sanitarie Regionali (regional health agencies): their role is to plan hospital and ambulatory resources in the region according to population needs, to implement national health plans at regional level, to contract with hospitals for optimizing provision of health care to the population and negotiate hospital budgets for the part not financed by the DRGs. Part of the contracts are related to appropriate utilization of costly drugs and medicals devices. Regional Health Agencies may also play a role in defining appropriate funding (extra-payments) for expensive medical devices, whose technical value is supported by adequate clinical and economic evidence, which may not be sufficiently covered by the specific DRG Tariff.
Commissioni Regionali Dispositivi Medici (Regional MD Committees). According to local specificities, the Regions and the ASRs may envisage the need to set up technical committees with the aim to evaluate MDs and issue recommendations on their use. Examples of this are found in EmiliaRomagna, with the institution in 2008 of the CRDM (11), in Veneto where the CTRDM (Commissione Tecnica Repertorio Unico Regionale Dispositivi Medici) and CTDM (Commissione Tecnica Dispositivi Medici di Area Vasta) were set up in 2009 (12)
Commissione Prontuario Terapeutico Ospedaliero (CPTOs): A hospital drug committee is empowered in all hospitals in Italy. Its role is to monitor drug prescription consumption and delivery, to decide for enlisting drugs on the hospital formulary, which is mainly based on national references and sometimes completed by economic assessments. Concerning MDs the situation is quite different as some, but not all, CPTOs monitor the use and decide on enlistment/purchase of medical devices: as explained below, due to the fact that the cost of MDs falls into the hospital budget, and with the hospital being funded through DRG Tariffs, the responsibility of the local committees in the acquisition process, may be considerably larger for MDs, in comparison with drugs; again, this largely depends by regional legislation and organization (13).
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Regulatory Pathway/Market Approval Process
The essential step to ensure market access of a medical device in Italy is its certification by a notified body in order to obtain the CE mark. Based on the New Approach, rules relating to the safety and performance of medical devices were harmonized in the EU in the 1990s. The core legal framework consists of 3 directives: Directive 90/385/EEC regarding active implantable medical devices, Directive 93/42/EEC regarding medical devices and Directive 98/79/EC] regarding in vitro diagnostic medical devices. They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market. These 3 main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC.
CE mark ensures that medical devices are in accordance to these European directives and represents the only mandatory step to market access in Italy.
However, as this does not guarantee any specific SSN’ reimbursement, funding of MDs is basically related to the capability of local providers to effectively manage hospital admissions or out-patient treatments - that imply the use of one or more MDs - within the pre-determined Tariffs.
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Reimbursement and Coverage/Payment Flow Map and Procurement Process
Unlike drugs, whose approval for SSN’ funding follows a well established pricing and reimbursement path, funding of Medical Devices appears largely unregulated and purchase decisions are in practice left to individual providers (hospital Committees and managers). Because public and private healthcare providers are remunerated through a fee-for-service system based on the NTPA and NTPO, three possible pathways may apply for both hospital and ambulatory delivered MDs (exhibits 1 and 2); remarkably these paths equally apply to both sectors with the only difference that in the case of in-patient treatment the hospital-DRG Tariff is used, whilst for ambulatory (out-patient care) providers are remunerated through the relevant ambulatory Tariff (NB: being the use of MDs in the out-patient setting very limited, the paths described in exhibit 2 occur very less frequently):
If the new MD is used in the course of a new procedure (i.e. for which ICD-9CM diagnosis and/or procedure codes are not available) it becomes necessary to find out an appropriate codification analogue that most closely resembles the characteristics of the new procedure, especially in terms of resources consumption; this may be done by representatives of a scientific society, group of physicians, or patient association or manufacturers and should be done in collaboration with the Regions. Afterwards, the new procedure may be listed in the National Formulary List at the time of the next revision (for DRGs the List should be updated by the Ministry every two years).
If the new MD is used as part of an existing procedure, the willingness of purchasers to fully adopt the new technology will ultimately rest on its price level; in fact, depending on the weight of the price, versus the DRG or Ambulatory tariff, two funding mechanisms would eventually apply:
DRG funding: The DRG Hospital Tariff System has been applied in Italy since 1994, in both the public and private hospital sectors. The first set of DRG tariffs was set by the Ministry of Health at the national level; because the Regions were empowered to establish and release their own tariffs (based on local analysis of hospital production costs) Regional DRGs were subsequently made available by many Regions. In December 2008 the Ministry of Health formally adopted the 24th version of the ICD9-CM DRG classification: 18/21 Regions acknowledged this change; 3 Regions (Lazio, Lombardia & Sicilia) still use the 19th version. Consequently, apart from the differences in the level of funding attributed to a specific DRG by the different Regions, this issue may also lead to different Regional coding for the same procedure. According to this hospital funding system, most devices are included in the DRG tariffs and thus, fully covered by the SSN. In such case, hospitals are purchasers in the context of public tender regulation. It is the role of CPTOs to run the assessment for the enlistment on the hospital formulary and/or the decision of purchase. Hospitals and ASLs are increasingly grouping in procurement organizations (Commissioni Terapeutiche di Area Vasta - CTAV) (12) to obtain better prices and prompted to do so by the Regions.
EXTRA-PAYMENTS Some innovative and/or costly devices are not included in DRG funding and may be reimbursed separately from a specific Regional budget. In that case, prices or extra-tariff-funding is to be negotiated at the Regional level. Examples of this approach may be found in some specific Regional Deliberations, like in the case of Emilia Romagna or Sicilia where, every time that the Regional-DRG-List is updated, an appendix is also included containing the updated list of the types of medical devices that benefit from an extra-payment. Another interesting example is found in Lombardia, where a comprehensive HTA process is currently being set up with particular focus on Medical Devices whose cost may fall out of the DRG tariff. The Region has empowered an HTA programme “to assess, also in view of DRG-tariff adjustments, innovative healthcare technologies that have already concluded their clinical trial programme in accordance with applicable regulations and are EC marked” (14). The Region is currently running the training phase of this programme for the experts who will sit in the evaluation committees and great expectation has surged towards this innovative and well laid out approach to the evaluation of technologies. The Regions who are mostly active in enlisting and updating extra-payments for MDs are Piemonte; Lombardia, Veneto, EmiliaRomagna, FriuliVG, Sicilia. The extra-payment may be set as a precise figure (in Euros) specifically set to fund the device or as a percentage of the cost of the device; in this latter case reimbursement will be given to the hospital upon presentation of the purchase invoice.
Exhibit 1: Market access pathway for medical devices in Italy – Hospital (in-patient) setting
Exhibit 2: Market access pathway for medical devices in Italy – Ambulatory (out-patient) setting
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Regional Bodies (ASRs; CTDM; CTRDM). Due to the extreme fragmentation of decision processes, a common path to the evaluation of MDs is hardly found in Italy. At the regional level, although there is general consensus towards the application of HTA methodologies (including the need for economic evaluation, whether in the form of cost-minimization; cost-effectiveness/utility; budget impact analysis), the literature is scarce and mainly limited to individual excellence centers, like the examples of the HTA programme of Lombardia (still in a run-in phase) (14), the HTA programme of the UVEF in Veneto (15-16), the experience of the Laboratorio SIFO in Toscana (17-18) or the PRIER programme in Emilia Romagna (19-21).
CPTO. The evaluation of a new MD at the local hospital level is usually prompted by the request of one or more physicians who are interested in introducing the new device into their clinical practice. Thus, the CPTOs usually require the physicians to submit a formal request which may be supplemented by data which may, in total or in part, be provided to the physicians by the manufacturer: usage forecasts, clinical evidence versus existing alternatives, also supplemented by economic analysis (usually cost-minimization vs. alternatives). Cost/effectiveness analysis or budget impact analysis are not formally required but they can be considered by the CPTOs in their decision process.
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AGENAS - Agenzia Nazionale per i Servizi Sanitari Regionali
AO - Azienda Ospedaliera
ASL - Azienda Sanitaria Locale
ASR - Agenzia Sanitaria Regionale
CPTO - Commissione Prontuario Terapeutico Ospedaliero
CTAV - Commissione Terapeutica di Area Vasta
CTRDM - Commissione Tecnica Repertorio Unico Regionale Dispositivi Medici
CTDM – Commissione Tecnica Dispositivi Medici di Area Vasta
CUD - Commissione Unica Dispositivi medici
DGFDM - Direttorato Generale Farmaci e Dispositivi medici
DRG - Diagnosis Related Groups
GDP - Gross Domestic Product
IRCCS – Istituto di Ricerca e Cura a Carattere Scientifico
LEA - Livelli Essenziali di Assistenza
NTPA - Nomenclatore Tariffario delle Prestazioni Ambulatoriali
NTPO - Nomenclatore Tariffario delle Prestazioni Ospedaliere
RIHTA – Rete Italiana HTA
SSN - Servizio Sanitario Nazionale
UVEF - Unità di Valutazione dell’Efficacia del Farmaco
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- ISTAT 2010 Population as of Dec 31st, 2009 available at http://demo.istat.it/bil2009/index.html
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- Ministero della Salute. Annuario Statistico del Servizio Sanitario Nazionale Anno 2007. December 2009.
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AUTHORS & CONTRIBUTORS
Patrizia Berto, President PBE Consulting, Verona Italy email@example.com
Stefania Lopatriello, Senior Project Coordinator PBE Consulting, Verona, Italy
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