Wound treatment materials and products are considered medical devices. The GVWG (§31 (1a) SGB V) from 2 December 2020 introduced a new classification:
Bandage materials can be prescribed and are reimbursed by SHI funds as soon as they are available in the German market.
On the other hand, other products for wound treatment can actively influence the healing of the wound through a pharmacological, immunological, or metabolic mode of action. They are treated like other medical devices used in outpatient care. The G-BA needs to first assess the medical benefit for patients, and add the product for appendix V of the drug directive. Only then, physicians can offer the product and it will be reimbursed by the SHI funds.
Bandage materials
Section P of the drug directive defines when a product is considered a bandage material that is immediately reimbursed. Appendix Va of the directive lists these product groups.
- Unambigous bandages are, for example, compression bandages and absorbent pads. Products in this category cover the wound and / or absorb wound secret. In addition, these products can also stabilize, immobilize or compress parts of the body. However, these products must not have any other properties. Part 1 of Appendix Va lists the product groups in full.
- Bandages with additional properties include, for example, moisturizing products such as hydrofibres. In addition to the bandage properties of the unambiguous bandages (see above), products in this category have additional properties for wound healing without any pharmacological, immunological or metabolic mode of action. Part 2 of Appendix Va contains standard examples for product groups of bandages with additional properties.
Manufacturers of these products do not need to request their reimbursement.
Other products for wound treatment
Other products for wound treatment can develop a therapeutic effect based on a pharmacological, immunological, or metabolic mode of action through one or more components. Thus, they have an active effect on wound healing. Part 3 of Appendix Va contains standard examples for these product groups.
Manufacturers have to request the reimbursement of these products. This follows the same application process as for other medical devices. The G-BA decides on each application within 90 days. Once approved, they are listed in Appendix V of the drug directive.
Exception
Until 2 December 2023, other products for wound treatment that were already available and reimbursed by SHI funds before 2 December 2020, will continue to be prescribed and reimbursed by SHI funds without prior approval by the G-BA and without addition to appendix V.