Social insurance code (SGB V)
Within the area of the SGB V we advise and represent pharmaceutical enterprises as well as producers and distributors of medicinal products on all issues regarding the statutory health insurance. In addition to reimbursability and price regulation we offer advice whether a product should be included on the list of reimbursable medical devices or the OTC-exception list. By request we become involved at the early stage of product development in order to avoid pitfalls during the process of benefit assessment and negotiations to determine the introductory price.
This also applies during the procedure for setting fixed amounts, for exclusion of benefits or reimbursement and for exchangeability within the aut-idem-regulation. We represent our clients in these questions not only in court, but also against the institutions of self-administration (“Gemeinsamer Bundesausschuss”, “GKV-Spitzenverband”) with which we stay in good and close contact.
We have also successfully attacked regulations of the medicinal products guideline. Beyond that the consulting service and development of selective agreements with health insurances (e.g. agreements for particular patient-centred care, innovations fonds) belong to our business operating area.
Apart from companies we also represent individuals in disputes with their statutory health insurance, e.g. if it has to deal with the reimbursement of medicinal products or different therapy concepts as well as questions around membership. We have also successfully represented jurisdictionally the interests of insured persons through all instances.
Areas of focus
- Reimbursability of pharmaceutical drugs and medicinal products
- Exclusion of benefit claims and reimbursement claims
- Price regulations, especially the determination of fixed amounts
- Manufacturer discounts (§ 130a SGB V)
- Discount agreements and tender calls in compliance with procurement law
- Benefit assessment at an early stage and negotiations of refund claims
- Selective agreements (i.e. contracts for special care, innovation funds)
- Inclusion on the lists of OTC-exceptions or medicinal products
- Off-label use
- Recourse due to improper prescription
- Digital Health Applications (DiGA)
- Client-specific in-house training