Extended transition period for reimbursement for many modern wound dressings in Germany
On February 28, 2025, the German Healthcare Reinforcement Act (GVSG) came into force, which retroactively extended the transition periods for the reimbursement of numerous wound care products once again. This means that the so-called “other products for wound care” such as our Silveron flex will continue to be reimbursed by the statutory health insurance funds (GKV) as dressings until December 1, 2025. These transitionally reimbursable products will be marked in the IFA database from April 1, 2025 with the product feature 'other products for wound care' as well as 'dressings' in order to identify the products for prescribers during the transition period.
Our wound dressings from the Zorflex range are not affected by the regulation; they are based on activated carbon fibers and therefore remain reimbursable as dressings.
Legal situation in transition
In 2017, the legislature decided to define the term "wound dressing" more clearly. Until then, all products that were classified as wound dressings by the manufacturer were also reimbursed by statutory health insurance companies. For the first time, so-called main effects have been defined which a product must provide in order to be classified as a wound dressing and thus reimbursed at a flat rate. This includes covering wounds and/or absorbing fluids, but also fixing other wound dressings or products for immobilizing body parts as well as compression products. For this purpose, the "Medicinal and Aids Supply Act" (Heil- und Hilfsmittelversorgungsgesetz, HHVG) made corresponding changes to § 31 Paragraph 1 SGB V. In mid-August 2019, the "Law for Greater Safety in the Supply of Pharmaceuticals" (Gesetz für mehr Sicherheit in der Arzneimittelversorgung, GSAV) came into force, which sets out a new definition of the "therapeutic" additional effect of dressings. It states: "The property as a dressing does not cease to apply if an object has additional effects that serve to heal wounds without a pharmacological, immunological or metabolic effect in the human body, for example by keeping a wound moist, cleaning it, binding odors, being antimicrobial or metal-coated." The G-BA was commissioned to differentiate dressings from other products for wound treatment within 12 months, namely by August 31, 2020. The G-BA fulfilled its task and published its resolution to amend the Pharmaceuticals Directive (AM-RL) on August 20, 2020. According to this, products that have an independent therapeutic effect are no longer classified as reimbursed dressings, but as "other products for wound treatment". A therapeutic effect is achieved by one or more components through a pharmacological, immunological or metabolic mode of action and can therefore have an active influence on wound healing. The G-BA press release cites wound dressings containing silver as an example of other products for wound treatment, in which the silver is in direct contact with the wound and/or in which antimicrobial silver ions are released into the wound. Products that meet this description must be checked by the G-BA for their medical benefit. They can only be prescribed if they are proven to be beneficial for wound healing. The G-BA resolution was accepted and adopted in its current form by the Federal Ministry of Health on October 20, 2020. The publication and thus the entry into force of the amended AM-RL took place on December 1, 2020. According to Section 31 Paragraph 1a of the Social Code Book V, the manufacturers of wound care products that fall outside the developed dressing definition had a transition period of a further 12 months after this date to subject their products to a benefit assessment. The Law on the Further Development of Health Care (Gesetz zur Weiterentwicklung der Gesundheitsversorgung , GVWG) subsequently extended this transition period from 12 months to 36 months. Due to the difficult initial situation caused by the corona pandemic, it was even more difficult for manufacturers to generate the necessary evidence for a benefit assessment. This should be taken into account with the extended transition period.
As part of the Drug Supply Shortage Control and Supply Improvement Act (Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetzes, ALBVVG), the German Bundestag extended the transitional arrangement by a further 12 months on June 23rd, 2023. In addition, the manufacturers were given a right to consultation by the GBA. However, the benefit assessment intended by the legislature by the Federal Joint Committee (GBA) is currently hardly possible due to the lack of clear specifications on the endpoints of the required clinical study. The Institute for Quality and Efficiency in Health Care (IQWiG) was commissioned by the G-BA to provide acceptable endpoints, but will not publish corresponding proposals for these criteria until 2025. However, without agreement on the endpoints of a study, its planning and implementation is not possible. The planned further extension of the transition period until clear evidence criteria are available failed in November 2024 with the end of the governing traffic light coalition (Ampel Kolalition).
On February 14, 2025, the Federal Council passed the Healthcare Reinforcement Act (Gesundheitsversorgungs-Stärkungsgesetzes, GVSG). As part of this, the transition period was once again retroactively extended until December 2025. With the entry into force of the GVSG by publication in the Federal Law Gazette (BGBl. 2025 I No. 64 of 28.02.2025), this extension is now legally binding with retroactive effect.
The Informationsstelle für Arzneispezialitäten (IFA) GmbH is an information service provider for the pharmaceutical market and supplies physicians, pharmacies, pharmaceutical wholesalers and health insurance companies with relevant technical and legal information on medicinal products and medical devices via third-party providers. Among other things, IFA assigns the pharmaceutical central numbers (Pharmazentralnummern, PZN) and maintains the corresponding product databases. In a letter dated February 28, 2025, the IFA informed the manufacturers about the appropriate labeling of the products that fall under the transitional regulation:
Other products for wound treatment that fall under the transitional provision of Section 31 para. 1a sentence 5 SGB V (market launch before 02.12.2020) can continue to be provided at the expense of statutory health insurance when the GVSG comes into force until the planned deadline of 01.12.2025. They must each be reported with the value 1 in the “other product for wound treatment” and “dressing” indicators. This combination of labels with the additional reporting of the value 1 in the "dressing" label for another product for wound treatment that falls under the transitional provision serves exclusively to assign this article to the transitional provision of Section 31 para. 1a sentence 5 SGB V; beyond this, no legal consequences can be derived from the temporarily permissible labeling of such articles as "dressing", in particular no classification as a dressing agent within the meaning of Section 31 para. 1a sentences 1 to 3 SGB V.
For other products for wound treatment that do not fall under the transitional provision in accordance with Section 31 (1a) sentence 5 SGB V, the "other product for wound treatment" indicator must be reported with the value 1 = yes and the "dressing" indicator with the value 0 = no.
Due to the editorial deadlines, such an indicator is possible from April 1, 2025 and gives prescribers an orientation as to which products - such as our Silverlon flex - fall under the transitional period.
Current reimbursement of our products
The Act for More Safety in the Supply of Medicines (GSAV) has been in force since mid-August 2019. Most of our products are still classified as dressings in the GSAV, their effect is purely physical and without the release of any active ingredients to the wound. Our wound dressings from the Zorflex range are based on activated charcoal fibers and are and will therefore remain reimbursable as dressings.
However, as a result of the G-BA's decision, our Silverlon products will be classified as “other wound care products” in future. The current extension of reimbursement for these products now applies until December 1, 2025, and legally binding labeling is possible.Our wound dressings from the Silverlon range will therefore continue to be reimbursable as dressings until the end of the transition period on December 1, 2025.