The GKV-Spitzenverband (National Association of Statutory Health Insurance Funds) and the Kassenärztliche Bundesvereinigung (National Association of Statutory Health Insurance Physicians) have signed a new Änderungsvereinbarung (amendment agreement). This updates the Rahmenvorgaben nach § 106b Abs. 2 SGB V für die Wirtschaftlichkeitsprüfung ärztlich verordneter Leistungen (Framework specifications for the economic efficiency audit of physician-prescribed services).
This change marks a significant shift in how Germany manages the 'economic efficiency' of medical prescriptions. The update implements key provisions of the Medizinforschungsgesetz (Medical Research Act), a legislative package designed to make Germany more attractive for pharmaceutical innovation. The primary change is the formal introduction of the 'consultation before recourse' principle across all regional health districts.
Previously, doctors who exceeded their annual prescription budgets faced retrospective financial penalties – known as Regresse – which often led to a cautious prescribing culture. Under the revised framework, these penalties are being largely superseded by advisory measures. For the first time, specific data regarding the use of innovative medicines and biosimilars will be excluded from the automatic statistical audits that compare a doctor’s total costs against a peer group average.
The new rules ensure that physicians are not penalised for adopting modern treatments that may be more expensive than older generics but are clinically superior or mandated by guidelines. These data are now treated as 'special characteristics' that justify cost overruns. This removes the bureaucratic and financial pressure that has historically stifled the uptake of niche and high-cost therapies.
These measures apply immediately to all ongoing and future audit cycles. This periodic update reflects a strategic doctrine to improve patient access to medical breakthroughs by removing non-clinical barriers. The likely impact is an accelerated volume growth for innovative products and biosimilars as practitioners gain greater legal certainty.
Source: GKV-Spitzenverband
Link: Economic efficiency audit of physician-prescribed services
Date: 20 November 2025