Important Dates

Notification

Notification to the medical device reimbursement agenda is currently only done through the Medical Device Information System (ISZP).

Excel templates were cancelled as of February 18, 2024.

It is possible to notify a medical device to a reimbursement group or a group of interchangeable devices:

• Inclusion of a medical device
• Exclusion of a medical device
• Change of reimbursement group

Other notifications

• Year-on-year increase in the originator’s price
• Other additional changes / updates to documents / attachments

New notifications of inclusion of a medical device in a reimbursement group

If the notification is error-free and all comments have been resolved, the medical device (hereinafter referred to as the “MD”) is included in the list of all medical devices reimbursed on the basis of a prescription for a voucher (hereinafter referred to as the “List of MD”) 4 months after the notification was submitted.

Deadlines for notifications in 2025:

If your MD is not in the draft List of MD or the requested change to the draft List of MD has not been reflected, you can send as comments by the twenty-second day of the calendar month (in which the draft List of MD was issued). We will check your comments and, if necessary, make corrections.

Change notifications (annual increase in the price of the originator, reduction in the price, change in the name supplement, etc.) pursuant to Section 39r, paragraph 6 of the Health Insurance Act

Change notifications pursuant to Section 39r, paragraph 6 of Act No. 48/1997 Coll. on public health insurance and on amendments and supplements to certain related acts (hereinafter referred to as the “ZoVZP”) can be submitted by the end of the month preceding the publication of the draft list. For example, you will report an annual increase in the price of the originator during July. It will be reflected in the draft list of MD issued on August 15, i.e. in the list of MD issued on August 24, which is effective on September 1.

Processing of notifications pursuant to Section 39r, paragraph 6 of the Health Insurance Act submitted by the 10th day of the calendar month:

We will also process notifications submitted by the 10th day of the month in which the draft list of MD is issued without any claim, taking into account our workload and capacity. However, these notifications cannot be submitted at the last minute with the right to be included in the draft list of MD. If their processing is possible, they will be reflected in the next edition of the List of MD.

Publication of change notifications

Notifications concerning changes mentioned above are not published on the Institute’s official bulletin board.

Notification of MD exclusion from the reimbursement group

For reasons of patient protection and to enable the sale the market, submit the notification no later than the end of the month preceding the publication of the draft list of MD. For example: You will notify the exclusion during July, on the 10th day of the following month, on August 10, the announcement will be posted on the official noticeboard of the Institute, the exclusion will be reflected in the draft List of MD issued on August 15, and in the final List of MD issued on August 24, which is effective from September 1.