The update includes the review and, if necessary, the revision of the definition, the product subgroups as well as the product types including the indications.
The Assistive products, and nursing aids directory is divided into a total of 45 product groups (PG). The homecare products that are listed there have an easier time being reimbursed by health insurance companies. In order to have a product listed there, an application must be submitted to the National Association of Statutory Health Insurance Funds in Germany (GKV-Spitzenverband) and provide evidence of the requirements made. The product groups are updated and the requirements adapted as necessary.
The GKV-Spitzenverband has updated further product groups in the list of medical aids. An update includes the 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 worthwhile regularly checking whether a product that was rejected yesterday is perhaps listable today.
The following changes have recently been made to product groups 09 - Electrical stimulation devices, 12 - Tracheostomy & laryngectomy aids and 31 - Footwear.
Significant changes are:
PG 09 Electrostimulation devices
- 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 Aids for tracheostomy & laryngectomy
- New application site 23 Larynx, new subgroup (UG) 12.23.01 Voice replacement devices for laryngectomy and new product type (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 Shoes
- 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 in the medical aids directory, 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, if you do not react to changes in requirements of various kinds, the listed products will be removed from the list of medical aids. Difficulties with 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 comment process for this by submitting the draft product group. Patient interest groups have been granted the right to participate in the consultation process. They have until 28 Oktober 2022 to submit their comments.
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