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The Lazio Regional Administrative Court suspends the medical device payback

Payback for medical devices, the Tar suspends the "sting" for supplier companies

Payback for medical devices, the Tar suspends the "sting" for supplier companies

It's not a definitive decision, but it's certainly a step forward that allows interested companies to take a breather.

The New – July 1, 2023

The Lazio Regional Administrative Court, with a specific order, suspended the effectiveness of the rules which would have provided for, starting yesterday, the payment of the 50% of the overrun of the expenditure ceiling budgeted annually by the 2015 to 2018 by medical device supplier companies. The administrative judges therefore stopped the so-called "payback" mechanism.

For now through a suspension of the acts challenged by dozens and dozens of companies. Instead, the council chamber has been postponed to enter fully and definitively into the merits of the matter. Postponement due to the prolongation of the complex procedures of integration of the adversarial with public proclamations with publication on the websites of the public administrations in the process of being adopted through a presidential provision and in acceptance of the requests made by the appellant companies.

The story is thorny and decidedly complex, but let's try to summarize it: to contribute to the overcoming of the regional expenditure ceiling for the years 2015, 2016, 2017 and 2018, as identified with the Ministerial Decree of 6 July 2022, the device suppliers last December doctors had received requests for payment in an amount equal to the percentage incidence of their turnover on the total expenditure for the purchase of medical devices charged to the Regional Health Service.

The individual Regions, following the government provisions of October 2022, had taken over the turnover data of each company from their respective healthcare companies and calculated the sums due. These are very significant sums that completely, or almost completely, erode the profit margins of the supplies
carried out in the four reference years by individual companies. A situation that led to a dispute before the Lazio Regional Administrative Court which found itself faced with a very complicated skein to unravel. The government had tried to take measures in the latest budget law, introducing a fund from 1.1 billion, a figure equal to 50% compared to the 2.2 billion expenditure expected to be borne by businesses.

The law provided for the possibility for companies that renounced the dispute or that had never activated it, to pay the reference region, by 30 June (deadline later extended to 31 July), the remaining quota with respect to that determined by the regional measures .

Alongside the companies, in the dispute initiated against the government and the Regions, there is Confindustria Medici which, while appreciating the government's attempt to stem the issue, had deemed the discount route to solve the problem unfeasible. Businesses are asking for a total review of a law that risks opening the door to companies sharing public spending. Rule now frozen by the provision of the Tar, waiting for the judges to fully express themselves on the legitimacy of the same.

Related news: Ordinance Regional Administrative Court for Lazio 02890/2023

Note: The appeals dispute the illegitimacy of the contested provisions due to the unconstitutionality of the primary legislation, the non-compliance with Euro-unitary law, the violation of pre-existing legal provisions, in addition to the numerous errors in calculating the invoices received from the regions. On the government front, at the moment, the latest decision concerns the extension to 31 July - defined with the recent approval of the Entities decree - of the deadline for the payment of the reduced portion (1.1 billion euros) of the contribution by the supplier companies who have not activated a dispute or want to renounce it. The game is still open.

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AIFA

Summary of payments under the Pharmaceutical expenditure plan for direct purchases for the year 2021 - Update of 03/30/2023

Update as of March 30, 2023

The Companies communicate that they have paid the Regions and Autonomous Provinces over 1.023 billion euros equal to 99% of the amount due.

The Agency has carried out a survey of the payments made by the pharmaceutical companies to date, on the basis of the information received.

From an analysis of the data, it appears that, of the 166 companies (SIS codes) – recipients of counter charges – 14 companies (SIS codes) appear to be totally or partially in default.

The companies paid a total amount of €1,023,040,257.23 (99%) out of a requested amount of €1,034,700,865.34.

The details of the payments made by each pharmaceutical company (SIS code) are made available below, sorted in increasing order by percentage of payment with respect to the requested amount.

The Agency will provide further updates following the receipt of other proofs of payment by the pharmaceutical companies receiving the scheme.

Published on: March 30, 2023

 

 

 

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco