On Monday 19 June 2023, another meeting of the platform at the Ministry of Health took place, where representatives of regulators, health insurers and industry associations are looking for all-round acceptable solutions of price and reimbursement regulation of medical devices. The main topic was the modification of the price regulation of medical devices and IVDs, which should set a limit for the maximum year-on-year price increase for 2024. The representatives of suppliers proposed that the price regulation should fully reflect inflation and presented an analysis of price increases between November 2022 and June 2023. With regard to the availability of the open data on the packaging consumption of individual items of medical devices (on voucher and ZUM) on the website of the Association of Health Insurance Companies in MS Excel format and the high percentage of compliance with the VZP-ZP Reimbursement Catalogue, the data of the Association of Health Insurance Companies were preferred for the purposes of this analysis. The maximum code price, the so-called MFC, was increased for 9,748 items out of a total of 48,417 during the last 6 months, which represents 20.1 %. However, the health insurance companies' codebooks contain a large proportion of completely unreported medical devices (dead souls). Thus, if the analysis is limited to available items for which consumption and reimbursement of at least 1 item was reported in 2022, then MFC was increased for 5,670 products out of a total of 19,430, or 29.2 %. Participants agreed on the need for a more detailed analysis also reflecting the specific nominal MFC amounts that were increased, as well as their unit consumption. This will allow for the calculation of a weighted average in terms of the actual increase in MFCs across health insurance company formularies. The second half of the meeting was devoted to the reimbursement regulation of the ZUM. The discussion revolved mainly around ZUMs used in the context of healthcare covered by the CZ-DRG. Representatives of the Ministry answered questions about the relevance of budget impact analysis for such medical devices that represent only minor incremental innovations and at the same time do not generate so-called material outliers. At the end of the meeting, the representatives of the VZP presented the current developments regarding the number of proposals for inclusion of new ZUMs in the codebook, the speed of their processing and the most common errors they encounter. The next meeting of the platform will take place on 24 August 2023. Author: Jakub Král
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