Payback on medical devices: changes in the Italian regulatory framework

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On September 22, Law No. 142/2022 converting Decree Law No. 115/2022 (also known as "Decreto Aiuti-bis") came into effect, bringing the issue of medical device payback back to the forefront.

Article 18 of Decree-Law No. 115/2022 introduced Paragraph 9-bis in Article 9-ter of Decree-Law No. 78/ 2015 (conv. Law No. 125/2015), which introduced "procedures for repayment for exceeding the expenditure ceiling for medical devices and drugs."

To bring some clarity to the current regulatory framework, it should be noted that:

Law No. 111/2011 introduced in Art. 17 a cap on public spending for the purchase of medical devices, initially set at 5.2% of the Ordinary Health Fund and then reduced to 4.9% to finally be set at 4.4% as of 2014;
in 2015 it was stipulated that the Ministry of Health, in consultation with the Ministry of Economic Development (MISE), would publish by September 30 of each year a decree certifying any exceeding of the expenditure ceiling (both at the Regional and national level) for the purchase of medical devices, calculated on the basis of the final data of the previous year (Art. 9-ter, para. 8);
it was also stipulated that any overshooting of the Regional spending ceiling would be placed "at the expense of medical device companies" for a total share of 40% for the year 2015, 45% for 2016 and 50% for 2017 (para. 9);
the same paragraph also stipulated that each supplying company would contribute to the aforementioned repayment in an amount equal to the percentage incidence of its turnover on the total Regional expenditure for the purchase of medical devices, similarly to the so-called "payback" mechanism already in force for pharmaceutical expenditure (2007 Budget Law);
for about 5 years, the payback remained virtually unimplemented until two Acts passed at the State-Regions Conference (No. 181 of 7/11/2019 for years 2015, 2016, 2017 and 2018 and No. 182 for the year 2019) set the spending ceilings for each Region;
it was, however, the Ministry of Health Decree of 6 July 2022 (published on 9/15/2022) that certified the "exceeding of the medical device spending ceiling at the national and Regional level", thus activating the payback mechanism (as provided for in para. 9, Art. 9-ter of Decree-Law No. 78/2015).

Therefore, following the publication of this Decree, companies supplying medical devices to the National Health System (SSN) will have to repay:

416,274,918 € for the year 2015
473,793,126 € for the year 2016
552,550,000 € for the year 2107
643,322,535 € for the year 2018

Adding to the aggravation, the aforementioned “Aiuti-bis” Decree (Law 142/2022) stipulates on the one hand, that each Region must publish the list of supplier companies subject to the obligation of repayment for each individual year within 90 days of the publication of the ministerial decree ascertaining that the medical device spending ceiling has been exceeded. On the other hand, it introduces a mechanism such that if the supplier companies do not provide reimbursement within 30 days of the publication of said list, the Regions will have the right to offset any debts to said supplier companies, claiming reimbursements by way of payback.

As a result, given the publication of the Min. Health Decree of 6 July 2022, each individual Region will have to publish by 15 December 2023 the list of companies required to return a substantial portion of their receipts, which, if not paid by 14 January 2023, will be subject to payback!

While not wishing to engage in easy pessimism, we believe that this convoluted reimbursement mechanism will be the harbinger of numerous lawsuits (civil and administrative), both because of its late application and the lack of prior determination of the expenditure ceiling. But above all, because of the contradictory manner in which the Regional Health Services proceed with purchases of medical devices through public tenders (predetermining their needs), only to then activate a payback mechanism for exceeding the spending ceiling, which they themselves contributed to with their purchases.

Be prepared for appeals.