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 (but the figure could be higher with the inclusion of construction and management concession contracts in the list of contracts to be renegotiated).

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.

Outside the conditions of disbursement, the services will be charged entirely to the patient. When prescribing, the doctor must indicate the condition of availability or priority indication next to the prescribed service.

Ad hoc checks will also be activated and if it appears that a doctor has prescribed a service without complying with the conditions and limitations mentioned, the local health authority or the hospital, after asking the doctor himself the reasons for non-compliance, where he deems unsatisfactory of the reasons given, will adopt the provisions of its competence by applying a reduction of the ancillary economic treatment to the doctor employed by the NHS in compliance with the procedures set out in the national contract and to the doctor affiliated with the NHS a reduction of the variable amount through the procedures provided by the reference national collective agreement.

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.

The amount of savings for these measures against inappropriateness had been estimated at around 106 million euros, 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.

To do this, AIFA will define the methods for identifying and evaluating therapeutically similar medicines; will identify the groupings of therapeutically similar medicines; identify, within each grouping, the subgroups of packages that allow the same treatment intensity (understood as the total number of days of therapy for each package), setting the maximum reimbursement price by the NHS in correspondence with the package with the lowest price to the public. 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. AIFA is given the power to renegotiate downwards with pharmaceutical companies the price of a biotechnological medicine the day after its patent or complementary protection certificate expires, in the absence of a concomitant price negotiation for a biosimilar or therapeutically similar medicine . 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). Again AIFA has the power to renegotiate with pharmaceutical companies a reduction in the price of a medicine subject to conditional reimbursement after at least two years of marketing, when the benefits found in the AIFA monitoring registers are lower than those expected and certified . At the moment, however, the amount of possible savings from this measure has not been quantified.

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. The proposal of the Regions to consider the cost of innovative drugs for the purpose of balancing territorial pharmaceutical expenditure is partially passed. In fact, the new proposal of understanding provides that the expenditure exceeding the amount financed with the innovation fund, established by the stability law, contributes to the achievement of the spending ceiling of the local pharmaceutical company. As is known, the innovation fund amounts to 500 million euros for 2015. We also recall that companies whose turnover for the production of an innovative drug exceeds 300 million are already required to pay back 20% of any breakthrough of the Fund.

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) evaluation of the possibility of creating a national center of expertise in the drafting of specifications for the acquisition of goods and services:

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.