In its decision of 16 December 2024, the Federal Supreme Court dismissed the appeal of the marketing authorization holder for the medicinal product Kalcipos-D3. The appeal was directed against the decision of the Federal Administrative Court, which had rejected the marketing authorization holder's appeal against the ruling of the Federal Office of Public Health (FOPH). Introducing a change in practice which had been in place for 25 years, the FOPH had restricted reimbursement of Kalcipos-D3 under the compulsory health insurance (obligatorische Krankenpflegeversicherung, OKP) to therapeutic applications only and excluding prophylactic use as an indication.

Case law sets high standards for the permissibility of practice changes, which the Federal Supreme Court examined.

The FOPH affirmed the permissibility of the practice change, referring to Art. 12b lit. b of the Health Insurance Benefits Ordinance (Krankenpflege-Leistungsverordnung, KLV). This provision permits reimbursement solely for the prophylaxis of rickets in the first year of life, not for broader prophylactic uses. The FOPH stated that the practice change was based on improved insights and thereby ensured the correct application of Art. 12b lit. b KLV as well as compliance with the principle of cost-effectiveness. The FOPH maintained that, although the previous unlawful practice had been in place for 25 years, the proper application of the law constituted a compelling reason for the change. Furthermore, the FOPH asserted that the practice change was of a fundamental nature, as it applied not only to Kalcipos-D3 but to all affected vitamin D preparations. It contended that the interest in the correct application of the law outweighed the interest in legal certainty. Additionally, it argued that public health considerations did not preclude the change, given the lack of scientific evidence supporting a broad benefit of vitamin D supplementation. The FOPH further claimed that it had not violated the principle of good faith, emphasizing that it had informed the appellant of the intended limitation and granted it the right to be heard. It also pointed out that the practice change had been implemented simultaneously for all affected products. Finally, the FOPH took the position that the principle of legality generally takes precedence over the protection of legitimate expectations.

The Federal Supreme Court did not support the objections raised by the appellant. According to the court, the fact that a practice had been followed for a long period did not preclude a change; it merely required compelling reasons. Since Art. 12b lit. b KLV provided for reimbursement exclusively for rickets prophylaxis during the first year of life, the binding and exhaustive nature of the positive list in Art. 12b KLV generally excluded all other prophylactic uses of vitamin D from mandatory insurance coverage. According to the court, Art. 12b lit. b KLV did not contradict Art. 26 of the Federal Health Insurance Act (Krankenversicherungsgesetz, KVG). Art. 26 KVG did not mandate the inclusion of all beneficial preventive measures in the catalog; rather, the legislator had to decide on a limited number of medical preventive measures. If a preventive measure was not included in this catalog, it was unlikely to constitute a genuine legislative gap that could be filled by judicial interpretation.

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