But here is a summary of the new proposal of understanding sent this morning by the Ministry of Health.

Goods and services
The renegotiation of the purchase contracts, including the construction and management concession contracts, is expected to reach an average discount of 4%. The amount of renegotiable contracts for 2014 is estimated at approximately 16.3 billion and the savings associated with the reduction of the average 4% of unit supply prices (excluding drugs and medical devices), deriving from the application of Legislative Decree 35/2013 and of Legislative Decree 66/2014, had been estimated at a value of 652.5 million euros (ma la cifra potrebbe essere più alta con l’inserimento dei contratti di concessione di costruzione e gestione nell’elenco dei contratti da rinegoziare).

Medical devices
PFor medical devices, the renegotiation of contracts is also envisaged, but an average discount percentage is not indicated. In any case, according to previous calculations by regional and government technicians, lthe amount of savings associated with this measure will be 845 million euros, as the difference between the current expense value and the value of the ceiling which remains fixed at 4.4% in any case. The forecast of regional expenditure ceilings is then identified, without prejudice to the national one, to be fixed consistently with the public-private composition of the offer, according to methods to be defined within the ambit of a State-Regions technical table.

It is then foreseen that the medical device manufacturers will have to compete, since 2015, in proportion to the incidence of one's turnover on total expenditure, to the level of any breach of the planned ceiling in the amount of 30% from 2015, 40 from 2016 and 50% from 2017.

Still on the subject of medical devices, the possible impact (but without quantifying it) that will derive from the obligation for PA bodies to use electronic invoicing in force from 31 March 2015 is also being evaluated. and the price of medical devices sold to NHS entities.

And precisely to monitor the billing flow, the price observatory of medical devices should become operational at the Ministry of Health for the support and monitoring of the contracting stations, with the task of checking the consistency of the auction-based prices with respect to the prices defined by ANAC or at the unit prices available in the consumption flow of the NHS information and statistical system.

Appropriateness. Inappropriate specialist services paid by the citizen and penalties for doctors who prescribe them
It is another of the pillars of the maneuver. The Government and the Regions are convinced that it is possible to affect specialist and rehabilitative services that are not necessary but are still prescribed by doctors. It will be a ministerial decree to identify, within 30 days of the agreement, the conditions of disbursement and the priority indications for the appropriate prescription of the services of specialist outpatient care at high risk of inappropriateness.

Al di fuori delle condizioni di erogabilità le prestazioni saranno poste a totale carico dell’assistito. All’atto della prescrizione, il medico dovrà riportare al lato della prestazione prescritta l’indicazione della condizione di erogabilità o indicazione prioritaria.

Saranno anche attivati controlli ad hoc e qualora risulti che un medico abbia prescritto una prestazione senza osservare le condizioni e le limitazioni citate, l’azienda sanitaria locale o l’azienda ospedaliera, dopo aver richiesto al medico stesso le ragioni della mancata osservanza, ove ritenga insoddisfacente le motivazioni addotte, adotterà i provvedimenti di competenza applicando nei confronti del medico dipendente del Ssn una riduzione del trattamento economico accessorio nel rispetto delle procedure previste dal contratto nazionale e nei confronti del medico convenzionato con il Ssn  una riduzione della quota variabile mediante le procedure previste dall’accordo collettivo nazionale di riferimento.

Sanctions also for the general director of local health authorities or hospitals who have not applied the penalizing measures to doctors to be evaluated when verifying management results.

On this the Regions had proposed more penalizing measures for doctors going to affect their assets, but the measure was not accepted by the Government like many other regional proposals.

In relation to these interventions, the Regions will then be required to redefine the annual expenditure ceilings of accredited private providers of specialist outpatient services, ensuring an average reduction of the 1% of the value of existing contracts.

L’ammontare del risparmio per queste misure contro l’inappropriatezza era stato stato stimato in circa 106 mln di euro, of which 69 million euros as an effect deriving from the reduction of consumption in the accredited private sector and 37 million euros from the efficiency improvement of the public sector through the consequent reduction of variable costs.

Reduction of rehabilitation admissions at high risk of inappropriateness
Another ministerial decree expected, always within 30 days of the agreement, which will identify the criteria of appropriateness of hospital rehabilitation hospitalizations, with reference to the clinical correlation of hospitalization with the type of acute event, the temporal distance between hospitalization and the acute event and, in hospitalizations not consequent to an acute event, the type of potentially inappropriate cases.

For clinically inappropriate ordinary and daytime hospitalizations, a reduction equal to 50% of the rate set by the Region would be applied, or the average rate set by the same Region would be applied for extensive rehabilitation admissions to non-hospital rehabilitation facilities. For all clinically appropriate hospitalizations beyond the threshold, the tariff remuneration for ordinary and day hospitalizations is reduced by 60% for the days beyond the threshold.
The amount of savings estimated for this measure is 89 million euros, as an effect deriving from the reduction of hospitalizations and the relative tariff valorisation in the accredited private sector.

Application of the new hospital standards
An estimated saving of 10 million euros from the zeroing of hospitalizations in affiliated facilities with fewer than 40 places bed (intended for closure according to the new standards except for monospecialist clinics).

Other savings are expected on staff costs, following the reduction of complex structures and simple structures following the reorganization of the hospital network with the consequent reduction of simple and complex structure assignments, to which, the ministerial and regional technicians point out, specific salary items are associated which, according to current legislation would flow into the funds of the supplementary contract. Furthermore, the resources relating to ancillary treatment freed up following the reorganizations related to compliance with hospital standards would not contribute to the total amount of funds allocated annually to ancillary treatment. The amount of savings is estimated at 68 million euros, as an effect deriving from the reduction of 2,069 complex hospital structures (the only ones conditioned by the parameter of beds envisaged by the hospital regulation) and 8,718 simple structures (conditioned by the number of complex structures) in the regions required to reduce the number of simple and complex structures compared to the standard calculated on the basis of the application of the regulation.

A progressive reduction in the number of 118 Operations Centers is also envisaged, again following the reorganization of the hospital network. M the saving deriving from this reduction has not yet been quantified.

Territorial and hospital pharmaceuticals
Sti expect the introduction of reference prices in the pharmaceutical handbook. In this regard it is foreseen that by 30 June 2015 AIFA provides for the extraordinary redefinition of the national pharmaceutical handbook by providing for the introduction of reference prices relating to the maximum reimbursement by the NHS of therapeutically similar medicines.

Per farlo l’Aifa definirà le modalità di individuazione e valutazione di medicinali terapeuticamente assimilabili; individuerà i raggruppamenti di medicinali terapeuticamente assimilabili; individuare, nell’ambito di ogni raggruppamento, i sottogruppi di confezioni che consentono la medesima intensità di trattamento (intesa come numero totale di giornate di terapia di ogni confezione), fissando il prezzo massimo di rimborso da parte del SSN in corrispondenza della confezione con il prezzo al pubblico più basso. The amount of savings is estimated at 400 million euros on an annual basis.

Reform of the discipline defining the price of biotechnological medicines after patent expiry. All’Aifa viene dato il potere di rinegoziare in ribasso con le aziende farmaceutiche il prezzo di un medicinale biotecnologico all’indomani della sua scadenza brevettuale o del certificato di protezione complementare, in assenza di una concomitante negoziazione del prezzo per un medicinale biosimilare o terapeuticamente assimilabile. The amount of savings is estimated at 35 million euros in 2015 and 105 million euros in 2016.

Introduction of regulation of the revision of the prices of medicinal products subject to conditional reimbursement procedures (payment-by-result, risk-cost-sharing, success fee). Sempre all’Aifa il potere di rinegoziare con le aziende farmaceutiche in riduzione il prezzo di un medicinale soggetto a rimborsabilità condizionata dopo almeno due anni di commercializzazione, quando i benefici rilevati nell’ambito dei Registri di monitoraggio AIFA siano inferiori rispetto a quelli attesi e certificati. Al momento non è stato però quantificato l’ammontare del possibile risparmio di tale misura.

Reduction in funding level and impact on planned drug spending levels. As a result of the reduction of the 2015 health fund by 2.352 billion, the impact of this reduction on the amount of resources allocated to local and hospital pharmaceuticals was finally calculated.
Without prejudice to the current ceilings on territorial and hospital pharmaceutical expenditure (equal respectively to 11.35% and 3.5%), planned spending levels will decrease by approximately €310 million.

The "regional" ceilings are coming for the territorial and the hospital. Also for the pharmaceutical ceilings, the proposal of understanding provides, similarly to what is foreseen for medical devices, the identification of regional ceilings which will be entrusted to a State-Regions technical table, without prejudice to the current national ceilings.

Breakthrough fund for pharmaceutical innovation falls within the territorial ceiling. Passa in parte la proposta delle Regioni di considerare ai fini del ripiano della spesa farmaceutica territoriale anche il costo per i farmaci innovativi. Nella nuova proposta di intesa viene infatti previsto che la spesa eccedente l’importo finanziato con il fondo per  l’innovazione, istituito dalla legge di stabilità, concorre al raggiungimento del tetto di spesa della farmaceutica territoriale. Come è noto il fondo per l’innovazione ammonta per il 2015 a 500 milioni di euro. Ricordiamo inoltre che le aziende il cui fatturato per la produzione di un farmaco innovativo sfori i 300 mln sono già oggi tenute a un pay back del 20% dell’eventuale sfondamento del Fondo.

New measures for the governance of the health system
In addition to these measures, the Government and the Regions agree on the need to introduce new governance measures to ensure greater efficiency of the health system to be considered in the context of the spending review work underway by the Government.

In particular:
1) reorganization and rethinking of the public company system in a logic of evaluation and improvement of productivity, understood as the relationship between the value produced (in quantitative and economic terms) and the production factors used (in quantitative and economic terms);
2) identification and use of standard indicators relating to the management of the properties, instrumental and otherwise, of public healthcare companies;
3) evaluation and enhancement of experiences and initiatives in the field of supra-company services, with the aim of quickly and effectively disseminating best practices;
4) valutazione della possibilità di realizzazione di un centro di competenza nazionale in materia di stesura dei capitolati per l’acquisizione di beni e servizi:

defensive medicine
Lastly, the Government and the Regions appear to be determined to give a decisive push to the introduction of regulatory changes on the civil and penal liability of health professionals, in order to favor prescriptive appropriateness and limit the effects of defensive medicine. As is known at the moment, there are already several bills on the subject being examined by the Chamber but the definition of a single text is still awaited.