Berlin. According to the recently released Verdict of the Federal Social Court on the calculation of differential costs for the use of medicines, the KBV is now asking the Federal Minister for Health, Lauterbach, for clarification. Even in the case of regulations complying with guidelines for off-label use, professional representation recommends that any claims for reimbursement from health insurance companies be limited to the difference in cost compared to the most economical alternative.
KBV had already tried in vain to take legal action over the calculation of differential costs, mainly for off-label use. In 2022, the arbitration board enshrined a requirement in the framework agreement for performance audit, according to which differential costing is permitted for regulations that are only uneconomical, but must generally be excluded for regulations that are impermissible. This requirement was initially confirmed by the Potsdam State Social Court and finally by the Federal Social Court.
“Urgent requests for extension of the regulation”
Now there is only the possibility of adapting the relevant passage of the Social Security Code (Article 106b, paragraph 2a SGB V). “We therefore urgently ask for an extension of the regulation on the calculation of differential costs in operational auditing, which goes beyond purely quantitative inefficiencies and also includes cases of off-label use of medicines in accordance with the guidelines”, is the content of the KBV letter to the minister.
Using the example of MS therapy with CD20 antibodies, the professional representation also highlights that “medicines used for off-label use may even be cheaper than an approved comparative therapy”. For example, annual therapy with ocrelizumab costs around 25 thousand euros. The treatment alternative rituximab, which is also recommended in a guideline but not approved for MS, costs only around 8,600 euros per year.
“However, if the audit body does not subsequently recognize the use of rituximab during an operational audit, the doctor will reimburse the costs in full (8,600 euros). However, if the differential cost method were used, the credit would no longer be applicable”, he states for clarification. (cw)