In the field of reimbursement and regulation of foods for special
medical purposes (FSMP) reimbursed from public health insurance within
outpatient care, significant changes will take effect from 1 January 2026 based
on the amendment to the Public Health Insurance Act.
New rules for FSMP reimbursement
- FSMP will newly
be classified into reimbursement groups listed in the categorisation tree
attached to the Act, based on their composition and intended use (similarly to
medical devices).
- The rules for
price and reimbursement regulation are also changing, the new system will take
into account whether a product is categorised (i.e., can be included in the
categorisation tree and is substitutable with reimbursed FSMP) or
non-categorised (i.e., cannot be included in the categorisation tree and is not
substitutable with reimbursed FSMP).
- The reimbursement
amount for specific FSMP will be derived from the base reimbursement set by a
measure of general nature for the respective reimbursement group.
- A new obligation
is introduced to notify the actual placing on the market and to maintain
detailed records of FSMP.
Transitional period
- FSMP reimbursed
at the end of 2025 will continue to be reimbursed under the same conditions and
at the same reimbursement level.
This applies until the State Institute for Drug Control (SÚKL) publishes their
new reimbursement within the new system.
- The
manufacturer/importer (notifier) of FSMP reimbursed in 2025 must submit a
notification to SÚKL by the end of September 2026, otherwise, the respective
FSMP will cease to be reimbursed.
- All
administrative proceedings concerning FSMP that have not been concluded under
the previous legislation will be discontinued as of 1 January 2026.
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