At the end of October, the Ministry of Health presented a draft amendment to Act No. 48/1997 Coll., which, among other changes, aims to replace the current system for determining the prices and reimbursement of medical devices covered as separately charged materials (ZUM), based on the VZP Methodology, with a new statutory framework.
🔎 New System for the Categorisation of Separately Charged Medical Devices
Under the proposal, responsibility for the Categorisation of Separately Charged Medical Devices (the proposed new designation for the ZUM category) would be transferred to the State Institute for Drug Control (SÚKL), which already manages the reimbursement system for medical devices supplied on prescription vouchers.
Through administrative proceedings, SÚKL would assign medical devices to reimbursement categories based on the European Medical Device Nomenclature (EMDN), taking into account their intended purpose, functional and technical characteristics, and mutual comparability.
The proposal introduces a base reported value per unit of measurement for each reimbursement category, which would be used to calculate the reported value and maximum reported value of individual medical devices. A device could also be granted an increased reported value through a reimbursement bonus.
For innovative medical devices, the proposal establishes three reimbursement pathways: permanent reimbursement, temporary reimbursement and a verification pathway.
💡 Reimbursement Reviews and Administrative Fees
According to the proposal, the sustainability of the system would be supported by regular reviews of the established reported values, conducted through both abbreviated and full reviews.
Communication within administrative proceedings would take place through the Medical Devices Information System (ISZP) and SÚKL's official notice board.
Applicants would be required to pay administrative fees for selected procedures.
⏱️ When Could the New Rules Take Effect?
The proposal envisages an effective date of 1 July 2027, with a gradual transition to the new system. Existing reimbursement conditions would be maintained during the transitional period until the relevant new rules are implemented.
The proposal has not yet completed the legislative process, and its final wording may change. Until then, the current VZP rules, including Methodology version 3.0 effective from 1 September 2026, remain relevant for the inclusion of ZUM in the reimbursement system.
We will continue to monitor the proposed legislative changes.
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The English translation was prepared using the latest available ChatGPT model.