Authors: Kateřina Slavíková, Tomáš Hric, Alžběta Pospíšilová
To tackle rising costs and other current needs in public healthcare, the Ministry of Health presented a bill in April to amend the Public Health Insurance Act. Intended to take effect on 1 January 2026, the amendment concerns the regulation of prices and reimbursement of medicinal products and medical devices, preventive care support, reimbursement of dental care services, and reimbursement of cross-border healthcare services. Read the following article to learn about all the changes in a nutshell.
Enabling earlier initiation of proceedings for a new indication
The draft amendment enables marketing authorization holders (“MAHs”) and health insurance companies to initiate new administrative proceedings to determine the price and/or reimbursement of a medicinal product with the State Institute for Drug Control (SIDC), even if the proceedings for the same product are already pending, provided that the applicant initiates the proceedings for a different indication and the pending proceedings are at least at the stage where a decision (even a non-final one) has been issued.
Exclusion of foreign reference prices in reimbursement proceedings
The draft amendment unifies the proceedings to determine the price and reimbursement of medicinal products using foreign reference prices. Under the proposed amendment, a party to the reimbursement proceedings of a medicinal product (typically an MAH) may ask the SIDC to exclude the foreign price if the party provides evidence that the reference medicinal product is not actually traded on the respective foreign market.
Significant medicinal products
To address the shortage of medicinal products significant for the provision of health care, the draft amendment proposes special procedural rules for determining the price of such medicinal products. As a result, the price determined by the SIDC for these medicinal products should be higher than that determined in the standard proceedings.
Medicinal products to which the above rules will apply will be selected by the Ministry of Health, taking into account the public interest in maintaining their availability.
Modification of the definition of highly innovative drugs (HIDs)
The draft amendment adds the progression-free survival parameter to the current definition of HIDs. Pursuant to the explanatory memorandum, the aim is to eliminate cases where a cancer medicinal product enters the public health insurance system as an HID, but due to no impact on survival and a nominally minimal impact on progression-free survival it should not profit from HID regulation, as it does not provide a significant innovation.
Promoting prevention through positive motivation of insured persons
The draft amendment also aims to encourage insured persons in maintaining their health through proper preventive self-care practices. As one of the instruments, health insurance companies are about to see a significant increase in the financing of their prevention funds, from which they will provide financial contributions to insured persons who engage in preventive self-care practices, including engaging in routine preventive health screenings or vaccinations.
The draft amendment also proposes expanding the range of healthcare services for which insured persons can draw the contribution, such as healthcare services not otherwise reimbursed, co-payment for a partially reimbursed healthcare services, services offered by providers to insured persons in connection with reimbursed healthcare services, other products and services intended to alleviate or compensate for a disability or illness of the insured, or which have a preventive function, or recreational activities.
In addition, insurance companies are to have new powers to create their own incentive programs to promote better self-care practices.
Dental care
The draft amendment also addresses systemic shortcomings in reimbursement of dental care. According to the Ministry, the current reimbursement regulations prioritize the use of inexpensive materials, which are, however, frequently viewed by dentists as outdated. Consequently, insured patients opt to pay out of pocket for more advanced treatment options rather than going for one of the options reimbursed from the public health insurance system.
To involve more dentists in the public health insurance system (currently more and more dentists opt for private practices) and to prevent further decline in the share of public spending on dental care, the draft amendment proposes some new legislative instruments, in particular the possibility of partial reimbursement in the case of costly methods. For insured persons who undergo regular preventive health screenings, it will be possible to draw a contribution from the prevention fund to cover the non-reimbursed part of the price.
Cross-border healthcare
The draft amendment allows for the authorization of healthcare services abroad at the level of foreign reimbursement, even for repeated or long-term cases (i.e. not just for one-off cases), if there is a lack of availability in a certain field in a certain region. Insurance companies will also be allowed to conclude contracts with foreign healthcare providers located near borders.
The draft amendment introduces a multitude of changes, primarily aimed at refining the efficacy and precision of the public health insurance system while avoiding significant systemic overhauls. The draft amendment has recently undergone the inter-ministerial comment procedure. As quite a lot of significant comments were raised – specifically, by 29 of 58 parties to the comment procedure, the final text of the amendment may be subject to considerable changes in the coming stages of the legislative process.
