In its decision of 5 May 2025, the Federal Supreme Court upheld the appeals filed by CSS insurance and the Federal Office of Public Health (FOPH) regarding the decision of the Insurance Court of St. Gallen (Versicherungsgericht des Kantons St. Gallen). The Insurance Court had upheld the appeal filed by the insured person A regarding the cost coverage for treatment of adenocarcinoma of the prostate by high-intensity focused ultrasound (hochintensiver, fokussierter Ultraschall, HIFU) in part.

The Federal Supreme Court held that Art. 33 Health Insurance Act (Krankenversicherungsgesetz, KVG) provides for a system for designating reimbursable services to uphold the principles of scientifically proven effectiveness, appropriateness and cost-effectiveness (Wirksamkeit, Zweckmässigkeit, Wirtschaftlichkeit, WZW-criteria). The (here disputed) treatment of prostate cancer using HIFU was, according to the version of Section 1.5 of Annex 1 of the ordinance on benefits in compulsory health insurance list (Krankenpflege-Leistungsverordnung, KLV) in force from 1 July 2009 to 30 June 2023 (as determined by the relevant intertemporal legal principles), listed as a non-compulsory benefit. As of 1 July 2023, HIFU-therapy was set to the status of benefit obligation “under evaluation” which was to be paid for by health insurance under certain circumstances.

The Insurance Court had held that the WZW-criteria had been fulfilled even before the change of the status of the HIFU-therapy. The late change of status was not due to the criteria not being fulfilled, but rather due to the long decision-making process, making the relevant part of the KLV unconstitutional and unlawful. Hence, it decided that the respondent should be placed in the same position as if the version of Annex 1 to the KLV valid since 1 July 2023 had already been in force at the time when he sought treatment.

However, the court held that denying the application of KLV as it is in force at the relevant point in time is only lawful within very narrow limits, particularly in view of the principles of legal certainty and equality before the law. Furthermore, it held that the respondent could not derive anything in his favour from the studies submitted, since they only showed individual passages or evidence without factual context. It was not substantiated how applicable procedural rules were violated by the FOPH. Lastly, the court highlighted that even in November 2021, it was emphasised that the evidence on the oncological efficacy of the HIFU-therapy was still insufficient.

In conclusion, the court decided, that the Insurance Court had substituted its own discretion for that of the EDI without the necessary conditions being met. In doing so, it had exceeded its power of review and violated the law. Therefore, the appeal by the FOPH and CSS was upheld, the decision of the Insurance Court was overturned and the appeal decision of CSS confirmed.

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