I don’t want to come across as a know-it-all at this point. But after my remarks on the Mollii Suit have caused excitement, I would like to briefly address the most recent court rulings on this topic.
The starting point for a lawsuit by an MS patient was the rejection of care with the neuromodulation suit “Exopulse Mollii Suit” by the health insurance company. The insurer had refused to cover the costs on the grounds that aids prescribed at the expense of statutory health insurance (SHI) require evidence of therapeutic benefits. Currently, this is not the case for the Mollii Suit. The plaintiff contradicted this refusal, arguing that it had led to a demonstrably improved compensation for her disability.
Aids with therapeutic purpose
The Munich Social Court rejected the lawsuit on 28.11.2024. The court stated in its decision that the specific application or duration of wear and the mode of action of the Mollii Suit indicate that it is an aid that serves therapeutic purposes: According to the manufacturer, the suit should be used “every other day”, “best in conjunction with physiotherapy, training or similar activities”. Accordingly, according to the manufacturer’s intention, the suit does not serve to compensate for disability (similar to a walker or wheelchair), but therapeutic purposes are intended. The suit serves, according to the manufacturer, “to relax spastic and tense muscles, to activate weak muscles and to alleviate associated pain”. The combined effect of relaxing tense muscles and activating weak muscles enables users “a more active daily life with less pain”. According to the manufacturer, the suit aims to “relieve the typical symptoms associated with neurological diseases (…)”.
Evaluation of the GBA required for aids
Thus, the Mollii Suit (contrary to the plaintiff’s view) does not compensate for disability, but serves therapeutic purposes. According to the case law of the Federal Social Court, aids that are inseparably linked to a new treatment method are subject to the reserve for method evaluation by the Joint Federal Committee (GBA). A positive evaluation of the Mollii Suit by the GBA is not yet available, and therefore, in the court’s opinion, the distribution of such aids in outpatient care is also blocked.
The evaluation of a treatment method by the GBA is required when it shows significant, previously untested changes compared to established therapies in terms of medical benefit, possible risks, and economic efficiency (BSG, judgment of 14.06.2023 – B 3 KR 8/21 R -, para. 14, juris).
In short: after the manufacturer has announced a therapeutic effect of his neuromodulation suit, the court demands that data be provided to support these claims. Only then can a positive evaluation by the GBA take place and reimbursement at the expense of health insurance companies (and thus the solidarity community) can occur. The Social Court thus consistently follows the opinions of experts who do not recommend the use of the Exopulse Mollii Suit for MS sufferers, as the data situation is insufficient. Therefore, the manufacturer is again asked to submit controlled studies with a sufficient number of MS patients that scientifically substantiate the manufacturer’s claims about his product. As long as this is not the case, MS sufferers should expect that they will not be reimbursed for the costs of the Mollii Suit.
(Judgment of the SG Munich: https://www.sozialgerichtsbarkeit.de/node/177142)
This post was translated from German to English with the help of AI.
