AOK Funds Temporarily Extend Reimbursement for Wound Care Products Amid Legal Uncertainty
German statutory health insurers are currently continuing to reimburse a range of wound care products despite the expiration of the legal basis for such coverage. The move follows a request from the Federal Ministry of Health (BMG), which has called for insurers to maintain the status quo until a legislative resolution is achieved.
The background to this situation is the stalled passage of the so-called Bureaucracy Reduction in Care Act (BEEP), which was intended to extend the transitional period for reimbursement of certain wound dressings by statutory health insurance (GKV). Without this extension, the requirement that these products demonstrate a specific medical benefit as determined by the Federal Joint Committee (G-BA) is now in effect. Since December 2, there is no longer a formal legal provision for the reimbursement of these products, leaving many patients reliant on the goodwill of their health insurers.
In response to the legal gap, the BMG addressed health insurers, physicians, and pharmacies, expressing optimism that a compromise between federal and state lawmakers would soon be reached, allowing for an extension of the reimbursement period until the end of 2026. Until then, the BMG encouraged insurers to continue their current reimbursement practices.
Germany's substitute health insurance funds have indicated their willingness to comply with the ministry's request, and the Association of Local Health Insurance Funds (AOKen) has also confirmed that they will provisionally continue reimbursing wound care products not yet fully evaluated by the G-BA. However, the AOK's national association has emphasized that the ultimate requirement remains: manufacturers must provide evidence of the therapeutic benefit of these products within the application process at the G-BA. This stipulation has been in place since a 2020 amendment to the Pharmaceutical Directive (AM-RL). To date, only a few applications have been submitted, which has resulted in a series of transitional periods for manufacturers to ensure that approximately 300 affected products remain eligible for reimbursement.
The BEEP legislation aimed to introduce the next extension of this transitional period, including an amendment to Section 31(1a) of the Social Code Book V (SGB V). Additionally, the legislation proposed to redefine the term 'dressing material' through a separate process. This redefinition is intended to provide long-term security for the supply of dressings and wound care products for patients covered by statutory health insurance.
The AOK's national association has noted that current clinical guidelines for wound care do not recommend the use of products that are supposed to actively promote wound healing due to a lack of clear or robust evidence. This position underscores the need for further clinical research and transparent evaluation to ensure the effectiveness and safety of such products.
Amid these ongoing uncertainties, the German Pharmacists Association (DAV) has reminded pharmacies that, regardless of the shifting legal and reimbursement framework, only the designations listed in the official pharmaceutical database (ABDA-Artikelstamm) are applicable for their dispensing decisions.
The ongoing transition period and the lack of definitive regulatory clarity have placed both manufacturers and health care providers in a position of uncertainty. The outcome of the legislative negotiations will determine whether patients continue to have access to a broad selection of wound care products under statutory health insurance, or if stricter evidence requirements will limit coverage to only those products with proven benefits.
In summary, while the legal framework for the reimbursement of certain wound dressings remains unresolved, German health insurers, including AOKen, are upholding interim coverage at the request of the health ministry. The situation is expected to remain in flux until lawmakers agree on a long-term solution, which will likely include clearer definitions and evidence standards for reimbursable wound care products.