End of reimbursement for many modern wound dressings in Germany
Some of the previously reimbursed wound dressings will no longer be reimbursed starting December 2, 2024. This affects all of our silver-containing wound Silverlon dressings, for which reimbursement as dressings by health insurance companies will no longer be possible starting December 2, 2024.
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.
Both the "Law for Greater Safety in the Supply of Pharmaceuticals" (Gesetz für mehr Sicherheit in der Arzneimittelversorgung, GSAV), which came into force in mid-August 2019, and the resolution of the Federal Joint Committee (G-BA) on the amendment of the Pharmaceuticals Directive (AM-RL) of August 20, 2020, which is based on the law, provide for corresponding restrictions. After the Federal Ministry of Health (BMG) approved the proposed G-BA resolution and the change was published in the Federal Gazette on December 1, 2020, manufacturers were granted a transition period of 12 months to subject their products to a benefit assessment. With the introduction of the "Act on the Further Development of Health Care" (Gesetzes zur Weiterentwicklung der Gesundheitsversorgung , GVWG), this transition period was extended to a period of 36 months. On June 23, 2023, the Bundestag extended the transitional arrangement by a further 12 months as part of the "Drug Supply Shortages Control and Supply Improvement Act" (Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetzes, ALBVVG). However, a planned benefit assessment of individual products by the G-BA is currently hardly possible due to the lack of clear specifications on the endpoints of a necessary clinical study. However, the planned further extension of the transition period until clear evidence criteria were available failed in November 2024 with the end of the governing traffic light coalition (Ampel Kolalition).
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 1st, 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).
Current reimbursement of our products
The "Law for Greater Safety in Drug Supply" (Gesetz für mehr Sicherheit in der Arzneimittelversorgung, GSAV) has been in force since mid-August 2019. Most of our products are still predominantly classified as dressings in the GSAV; their effect is purely physical and without releasing any active ingredients into the wound. Our wound dressings from the Zorflex range are based on activated carbon fibers and therefore remain reimbursable as dressings.
However, due to the decision of the G-BA, our Silverlon products will in future be classified as "other wound care products". However, corresponding labeling is not yet possible in the relevant directories (Lauer-Taxe) as of November 2024. With the expiration of the transition period on December 2, 2024, the reimbursement for our Silverlon products will end