The National Association of Statutory Health Insurance Funds in Germany (GKV-Spitzenverband) hat weitere Produktgruppen des list of medical aids (Hilfsmittelverzeichnis, HMV) which includes a review and, if necessary, revision of the definitions, the product subgroups and the product types, including the indications.
Requirements, verification procedures and entire structures and categorisations can change during an update. It is worth regularly checking whether a product that was rejected yesterday cannot be listed today. On the other hand, you must ensure that your products are not deleted as a result of an update.
The following changes were recently made to the product groups
09 - Electrostimulation devices,
12 - Aids for tracheostomy and laryngectomy
31 - Shoes
Significant changes are:
PG 09:
- New test method 09-03 09/2021 MDS-Hi (replaces test methods 09-01 03/2007 MDS-Hi and 09-02 03/2007 MDS-Hi)
- A product sample must now be submitted for all product subgroups
- New requirement in the product subgroups: 09.37.01 to 09.37.04: "Output of positive and negative pulses or pulse half-waves actively generated by the pulse generator"
- Minor changes to the indications
- Editorial changes/precisions
- Changes to the service requirements to align the product groups
PG 12:
- New application site 23 Larynx, new UG 12.23.01 Voice replacement aids for laryngectomy and new PA 12.23.01.0 Shunt valves for laryngectomy (replacement prostheses)
- Shift of subgroups: 12.24.01 to 12.24.08
- New PA 12.99.09.2 Cleaning cans
- New PA 12.99.09.3 Cleaning powders/concentrates
- Requirements of the new UG 12.23.01 Voice replacement aids for laryngectomy
- New requirements of the UG 12.24.04 Tracheostomy tubes with speaking valve, blocked
- New requirements of the UG 12.24.07 Tracheostomy tubes with 15 mm connector, blocked
- Minor changes to the indications
- Editorial changes/precisions
- Changes to the service requirements to align the product groups
PG 31:
- Changes to the definition section of the product group
- Adaptation to the new regulations introduced by the Medical Devices EU Adaptation Act (MPEUAnpG).
- Adaptation of the indication of PA 31.03.08.0 to the current medical status, taking into account the currently valid international guideline of the IWGDF 2019
- Clarifications
- Changes to the service requirements to align the product groups
It is important to keep an eye on updates, both for new applications and for existing listings. Updates can be used, for example, to reassess the chances of success of paused applications or to start them in the first place.
If your products are already listed, you must pay appropriate attention to the updates in the list of medical aids and the associated requests from the GKV-Spitzenverband to update the documentation
Please note that anyone who does not react to the change in requirements of various kinds will experience the listed products being removed from the list of medical aids. Difficulties with cost reimbursement are then almost inevitable.
The National Association of Statutory Health Insurance Funds also intends to update product group 30 "Assistive products for glucose management" in the list of assistive products and has initiated the commenting process by submitting the draft product group. Patient interest groups have been granted the right to participate in the consultation process. They have until 28 October 2022 to submit their comments.
Contact uswe will be happy to discuss your situation and advise you on the appropriate course of action.
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