German Parliament (Bundestag) extends deadline for reimbursement of wound care products until 2 December 2025

On 30 January 2025, the German Bundestag decided to extend the reimbursement period for wound care products as part of the German Healthcare Strengthening Act (GVSG). According to the decision, "other products for wound treatment" will continue to be reimbursable by statutory health insurance without formal proof of therapeutic benefit in the Joint Federal Committee (G-BA) procedure. These include wound dressings containing silver or polyhexanide as well as hydrogels, which are used in particular for chronic wounds and wounds that are difficult to heal.

Background

The German Medicinal Products Directive (AM-RL) issued by the Federal Joint Committee (G-BA) on the basis of Section 92 para. 1 sentence 2 no. 6 German Social Code V (SGB V) regulates the prescription of medicinal products, material medical devices and dressings in statutory health care in Germany. Annex Va of the AM-RL contains detailed regulations on dressings and other products for wound treatment. While the latter were previously reimbursable by statutory health insurance even without formal G-BA proof of benefit, from 2 December 2024 these products should only reimbursable if their use is medically indicated.

As there were fears of gaps in supply due to the expiry of reimbursability without formal proof of therapeutic benefit, it was agreed at a political level to extend the deadline for the regulations by 18 months. However, due to the break-up of the "traffic light coalition", the planned deadline extension could not be agreed before the original deadline expired on 2 December 2024, meaning that the conditions for the products' further reimbursability were unclear.

Extension of the deadline

On 30 January 2025, as part of the German Healthcare Strengthening Act (GVSG), the German Bundestag passed the resolution that had previously been omitted and extended the deadline for reimbursement of wound care products. Even without formal G-BA proof of benefit, "other products for wound treatment" will therefore continue to be reimbursable by statutory health insurers. In contrast to the originally planned extension of the deadline by 18 months, however, the agreed deadline extension ends on 2 December 2025. It was also agreed that the deadline extension would apply retroactively from the original deadline.

Prospect

The extension of the deadline is suitable for the time being to close the threatening gap in care for people with chronic wounds. However, due to the lack of assessment criteria from the G-BA, it is still unclear how manufacturers are to provide the necessary proof of the therapeutic benefit of their products by the end of the extended deadline. It is therefore now up to the G-BA to create clear evaluation criteria in a timely manner that will enable manufacturers to provide the proof of benefit required for reimbursement by 2 December 2025.