Coverage of a Lymphovenous Anastomosis (LVA) by the Health Insurer: Remittal for Further Clarification of the Facts and Burden of Proof

Facts

The insured person, born in 1973 (appellant), was compulsorily insured for health care with CSS Krankenversicherung AG (respondent). After the successful surgical removal of a breast carcinoma, a lymphedema of the right arm occurred in 2018, which was initially treated conservatively with manual lymphatic drainage and compression stockings. In 2019 the swelling increased, and the treating specialist in plastic, reconstructive and aesthetic surgery diagnosed lymphedema stage II and recommended a lymphovenous (bypass) anastomosis (LVA).

The insured person requested cost coverage on 18 January 2019. CSS rejected the request on 4 February 2019 and maintained this position after a request for reconsideration. It based its position on the assessment of its medical advisor, according to which no long-term experience values existed for the LVA. By decision of 9 April 2019, confirmed by the objection decision of 26 July 2019, CSS refused to cover the costs of the LVA performed on 30 April 2019.

The Lucerne Cantonal Court dismissed the appeal by judgment of 23 September 2020. The insured person then lodged an appeal in public law matters with the Federal Supreme Court. She requested that the cantonal judgment be set aside and that CSS be ordered to cover the LVA, including follow-up treatment, as well as the costs of the private expert opinion of Dr. med. [C.] dated 7 May 2019 (CHF 915.35). In the alternative, she requested remittal for the obtaining of a court-ordered expert opinion. The cantonal court and CSS requested dismissal; the Federal Office of Public Health waived a response.

The question to be decided was whether the lower court violated federal law by denying CSS's obligation to pay for the LVA that had already been performed.

Considerations

Under Art. 24 para. 1 HIA and Art. 25 para. 1 HIA, compulsory health care insurance covers the costs of services for the diagnosis or treatment of an illness. According to Art. 32 para. 1 HIA, these services must be effective, appropriate and economical (WZW criteria), and effectiveness must be demonstrated by scientific methods. The WZW criteria must be fulfilled cumulatively and are reviewed periodically (Art. 32 para. 2 HIA).

Art. 33 HIA is based on a system of negative listing: the Federal Council may designate services provided by physicians or chiropractors that are not reimbursed or are reimbursed only under conditions. This negative list is exhaustive. For medical treatments that are not excluded, the law presumes that they meet the requirements for cost coverage. If a health insurer wishes to reject such a therapy as ineffective, inappropriate or uneconomical, it must, within the scope of the investigative principle, clarify the circumstances (for example by means of an expert opinion) and subsequently issue a decision in the individual case. The presumption of mandatory benefits may therefore be rebutted in an individual case by the insurer or, by means of an exhaustive negative list, by the regulator.

In social insurance proceedings the investigative principle applies. The court must decide on the basis of the standard of proof of predominant probability; mere possibility is not sufficient. A burden of proof of the parties exists only insofar as the absence of proof works to the detriment of the party that seeks to derive rights from the unproven facts. However, this rule of evidence applies only once it is impossible to establish a probable state of facts through the assessment of evidence.

The Federal Supreme Court found that the lymphedema has disease value (Art. 25 para. 1 HIA in conjunction with Art. 3 para. 1 GSSLA) and that the LVA is not regulated in Annex 1 HIBO. Accordingly, there is in principle an obligation to provide benefits, unless the insurer proves in the individual case that the therapy is ineffective, inappropriate or uneconomical, contrary to the statutory presumption.

The lower court relied on an Austrian study by the Ludwig Boltzmann Institute (2018), according to which only one non-randomised controlled study existed and effectiveness was not proven owing to a lack of high-quality evidence. It concluded from this that effectiveness was not demonstrated with predominant probability and that economic efficiency was not shown. The Federal Supreme Court held that merely casting doubt on the WZW criteria is not sufficient to refuse benefits. In the event of non-proof, the statutory presumption of effectiveness, appropriateness and economy would apply,…