Prepared by Felice De Lillo and Saverio Mantini
With the art. 9-ter, Legislative Decree N. 78/2015, have been introduced a rule aimed to rationalizing and containing the expenditure for medical devices for the National and Regional Health Service, so-called MedTech payback.
In particular, paragraph 9 provides that exceeding the regional expenditure ceiling for the purchase of medical devices is charged to the companies supplying medical devices for an amount equal to 40%-50% for the years 2015 – 2017 and 2018.
With the Ministry of Health decree of 6 July 2022, the exceeding of the expenditure ceiling for medical devices was certified and quantified at a national level and for each region for the years from 2015 to 2018, whose overall burden on companies was around to 2.2 billion euros.
Within 90 days of the publication of the decree, the regions and autonomous provinces had to adopt a provision showing the list of supplier companies called to contribute. Within 30 days of the adoption of the provision, these companies should have paid the amount assigned to them by the plan.
Nothing had been established by the legislator or clarified by the Revenue Agency on the VAT implications, although on the basis of the article 9-ter, paragraph 8, of Legislative Decree 78/2015, both the detection of exceeding the expenditure ceiling, and the calculation of the share of the shelf pertaining to the individual company, must be based on the gross turnover of VAT.
With Law Decree 30 March 2023, No. 34 the relevant provisions are in force starting from 31 March 2023.
As already occurred for the pharmaceutical payback, the Government has provided for:
- (possible) “discount” of the pending amounts due as MedTech payback for suppliers of medical devices, which have not activated any litigation procedure or which have waived from it, are allowed to pay to the relevant Region and Autonomous Province an amount equal to 48 per cent of the remaining/pending sums as calculated in the regional and provincial acts, by next 30 June 2023 (instead of the 30th April 2023);
- for suppliers of medical devices that do not waive the litigation procedure activated, no reduction is provided and thus said companies are required to pay the full amount as determined by the above-mentioned regional or provincial acts;
- MedTech payback considered a “rebate” and VAT recovery procedure: considering that the ceilings of the regional and national spending for medical devices are calculated gross of VAT, MedTech suppliers are allowed to deduct VAT on the payments carried out according to the principles regulating the recovery of VAT through credit notes under Article 26, paragraphs 2 and 5 of the Presidential Decree No. 633/1972.
For this purpose, it is provided that VAT can be separated from the gross amount of the payments carried out in accordance with the procedures set forth in Article 27 of the Presidential Decree No. 633/1972;
The right of VAT deduction arises at the time of the MedTech payments and for exercising the right of VAT deduction, MedTech suppliers issue a “specific accounting document” (internal and not to be issued electronically through the SdI System) including the details of the regional and provincial acts providing the amounts due (under Article 39 of the Presidential Decree No. 633/1972).
For Income tax and regional business tax purposes, the costs related to the above-mentioned payments are deductible in the fiscal year in which the payments are carried out.
What still remains unclear is the complex identification of the method for separating VAT from amount due by the companies, considering that the transfers of medical devices can be subject to different VAT rates.
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