Abstract:
The Standing Committee of Statutory Health Insurance Physicians and Sickness Funds is the legal body that makes decisions on reimbursement for health care services in the German ambulatory health care sector. In 1994, the Committee declined the reimbursement of hyperbaric oxygen therapy (HBO). In 1999, a new deliberation of the efficacy, appropriateness and cost-effectiveness of HBO was initiated as the proponents of this technology claimed that the efficacy of HBO had since been proven in clinical trials. The deliberation was announced and published in the journal of the German Medical Association (Deutsches Arzteblatt) and the federal register (Bundesanzeiger). All institutions, groups, and interested individuals were given the opportunity to provide a written statement. The statements and, in particular, the scientific literature cited in those statements, were critically appraised by the Committee. In addition, the Committee conducted a thorough review of the literature, guidelines and status of the therapy in other health care systems. More than 40 potential indications for the use of HBO were reviewed by the committee. One indication was for diabetic foot ulcers. Most clinical trials related to this field represented only retrospective case series, which, in view of the established therapies, cannot be used as a sound basis for the acceptance of HBO as a new technology for the therapy of diabetic foot ulcers. Some studies were planned as randomized controlled trials but had serious methodological flaws in conduct and analysis. The main problems were the low numbers of patients included and serious inbalances of important and well known prognostic factors between the treatment groups. Systematic reviews that were published in the international literature after the decision of the Committee drew similar conclusions in view of the methodological flaws in the clinical trial data. In summary, the Committee decided once again to decline coverage of HBO in German ambulatory health care.
Gawlik, Schmacke, Gibis, Sander, Rheinberger, , , , (2001). [Reimbursement and importance of hyperbaric oxygenation for diabetic foot ulcers in German publically funded ambulatory health care]. Zeitschrift fur arztliche Fortbildung und Qualitatssicherung, 2001 Nov;95(10):715-8. https://www.ncbi.nlm.nih.gov/pubmed/11778324