Ministry of Health Decree dated July 2022 certified that “the spending cap concerning medical devices either at national or local level has been exceeded” thus, as per law 21/9/2022 n. 142 regarding the conversion of the so-called Aid-bis Decree which entered into force on September 22nd 2022, the payback mechanism is about to initiate. The preparatory guidelines useful to issue the regional provisions are due to arrive by October 30th , so that each individual Region will have to publish as by December 15th the list of companies required to pay back.
This Memo provides a first reading of the rules and illustrates some considerations on the critical aspects and illegitimacy profiles. The tool that companies of the relative sector will be able to activate in order to challenge the maneuver is to appeal within November 14th 2022 before Lazio Regional Administrative Court against the Ministerial Decree ascertaining the exceeding of spending caps.
Tonucci &Partners assists companies in the sector by providing its highly specialized skills.