"ZUM" Has Become the Prime Minister’s Top Priority in Healthcare

Throughout June, not only specialized healthcare media but also the mainstream media reported in detail that Prime Minister Andrej Babiš was sending letters to Health Minister Adam Vojtěch, in which he strongly urged the implementation of numerous legislative and executive measures intended to stabilize the situation in the healthcare sector. Somewhat surprisingly, this has brought into the spotlight the legislative framework for reimbursement regulation of separately billed material ("ZUM"), which has been in the works for some time. Subsequent working-level discussions then clearly showed that the prime minister is essentially demanding two fundamental things. These are a significant acceleration of the legislative process so that the relevant proposal is submitted to the government for approval by the end of 2026 at the latest. At the same time, he is requesting that the proposal include very specific changes.

ZUM represents an annual expenditure of approximately CZK 20 billion for the Czech healthcare system. This covers a wide range of diverse medical devices, from joint implants and special stents to a variety of innovative surgical instruments. Until now, decisions on the inclusion of new items have been made on the basis of highly flawed legislation, which the Constitutional Court has found to be substantively unconstitutional, as it does not guarantee a predictable and reviewable process. In practice, VZP has attempted a partial remedy through its methodology, which it has been using for the past several years.

The Ministry of Health has therefore decided to resolve this long-standing issue and is preparing a proposal that introduces clear, legally enshrined rules into the system. The State Institute for Drug Control (SÚKL) is at the heart of the entire reform. It will now take over the entire agenda and, through measures of a general nature, begin to create reimbursement categories and determine basic reporting values for ZUM items.

The proposal takes an evolutionary approach, building on a number of well-established mechanisms. For example, it is anticipated that notifying entities (suppliers of medical devices) will continue to have a choice of three different pathways. The first is the so-called “automatic” pathway, under which ZUM comparable to items already reimbursed is included in the system. The second pathway covers incremental innovations, for which specific clinical benefits are demonstrated. Finally, the third pathway allows major innovations to enter the system.

VZP’s Priorities and the Prime Minister’s Strict Requirements

Although VZP generally welcomes the transfer of authority to SÚKL, it has comments on the proposed amendment. For VZP, it is crucial that the law include a precise process for calculating reporting values. VZP also calls for the establishment of a system of regular in-depth and abbreviated reviews. These will enable a flexible response to falling market prices or technological developments. VZP proposes a temporary reimbursement scheme for highly innovative medical devices for a period of up to 36 months to collect real-world data.

The prime minister also intervened very forcefully in the preparation of the proposal with the aim of identifying internal savings amounting to billions of Czech crowns and eliminating any risks of corruption. He strictly demands the introduction of external reference pricing. He also uncompromisingly insists on the need to prevent circumvention of the approval process through Section 16 of the Act on Public Health Insurance.

Author: Jakub Král