Germany has removed the legal basis for agreeing new nationwide ‘practice particularities’ as part of AMNOG reimbursement agreements, changing one of the mechanisms previously available to connect negotiated reimbursement terms with prescribing controls. The change follows the Statutory Health Insurance Contribution Rate Stabilisation Act covered by LiSAH in July.
The National Association of Statutory Health Insurance Funds (GKV-Spitzenverband, GKV-SV) confirmed on 13 August that, since the law entered into force on 30 July, it no longer has authority to agree new national practice particularities under §130b SGB V.
These arrangements could identify defined prescribing circumstances that should receive particular recognition when physicians were assessed for economically appropriate prescribing. They therefore provided a route for protecting use of selected medicines from routine prescribing-audit pressure where agreed conditions were met.
Existing national practice particularities in force on 29 July remain valid until a terminating event occurs. GKV-SV identifies the conclusion of a new §130b reimbursement agreement after 29 July and expiry of patent and data protection among the circumstances that can bring them to an end. Regional agreements on practice particularities remain possible.
The July law has placed a related protection within the new §130e rebate-contract framework. Where sickness funds establish groups of therapeutically comparable patent-protected medicines and conclude rebate contracts, prescriptions for contracted products must be recognised as practice particularities in prescribing-efficiency reviews.
The clarification narrows the scope for future AMNOG reimbursement agreements to influence prescribing-audit treatment at national level. The main statutory protection now sits instead with the new payer contracting mechanism for therapeutically comparable patent-protected medicines.
Source: National Association of Statutory Health Insurance Funds, GKV-SV
Link: Rechtsgrundlage für die Vereinbarung von Bundespraxisbesonderheiten entfallen (Legal basis for agreeing nationwide practice particularities removed)
Date: 13 August 2026
Source: Federal Ministry of Justice
Link: § 130e SGB V – Rabattverträge für Arzneimittel mit patentgeschützten Wirkstoffen mit therapeutisch vergleichbarer Wirkung (§ 130e SGB V – Rebate contracts for medicines with patent-protected active substances having therapeutically comparable effects)
Date: 30 July 2026
