New Legislation for Separately Billed Devices (ZUM)

Since 2017, when the Constitutional Court issued a groundbreaking ruling overturning previous regulations on reimbursable medical devices prescribed by voucher, experts have been discussing the urgent need for a new legislative framework governing the inclusion of separately billed material (ZUM) in public health insurance reimbursements. In the interim, VZP has developed a relatively transparent methodology designed to temporarily bridge the gaps in the inadequate legal framework. Currently, however, MZ, SÚKL, health insurance companies, and industry associations are actively preparing the foundations for future legislation.

What is already clear? SÚKL will be responsible for managing this agenda. Medical devices will enter the ZUM reimbursement system through three different pathways, namely the so-called automated classification based on the European Medical Device Nomenclature (EMDN), minor innovations, referring to slight modifications of already reimbursed ZUM, handled through percentage-based bonuses and major innovations, which will require a more complex approval process.

The inclusion of innovative ZUM should take place alongside the introduction of a new medical procedure or a modification of an existing one. In the case of major innovations, MZ anticipates requiring health-economic analyses (at a minimum, a BIA and possibly a cost-effectiveness analysis). Additionally, it intends to apply external price referencing, a measure that supplier representatives have long opposed.

Each medical device classified as ZUM will be listed in SÚKL’s database, with both a maximum price determined by price regulation and a highest reportable value for standardized reporting by healthcare providers to insurance companies. This value will initially be based on the UHR column from the VZP-ZP Reimbursement Catalog (ZUM) and will apply uniformly to all devices within the same reimbursement group.

Such a reimbursement group should be the lowest level of the EMDN groups (where manufacturers will have to include all their medical devices, including legacy devices, from 2026 onwards, with the information on the classification being publicly available in the Eudamed database). In justified cases, suppliers may propose additional subgroups, which SÚKL may establish in collaboration with the Institute of Health Information and Statistics (ÚZIS). We will continue to monitor the preparation of this new regulatory framework closely and keep you updated on further developments.

Autor: Jakub Král