[Social security law and evidence-based health care in Germany]. / Sozialrecht und evidenzbasierte Gesundheitsversorgung in Deutschland.

ABSTRACT

The present contribution examines whether German Social Security Law requires or allows the German health care system to follow the principles of evidence-based health care. The discussion will be based on the relevant example of statutory health insurance (Book of Social Code V-SGB V). According to Sect. 2 SGB V health care provision has to follow medical standards, acknowledging medical progress. It has to be effective and efficient. Special therapies are not outlawed, but also have to follow these principles. Efficiency is defined (Sect. 12 SGB V) by the benefits being sufficient and necessary. The responsibility for achieving these goals and supplying the benefits for all people according to need lies with the health care insurance funds along with the physicians' associations (Kassenirztliche Vereinigung) and the hospitals (Sect. 70 SGB V). These organisations cooperate in the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA, Sect. 92 SGB V), where they have to hear organisations of patients and of the disabled also. The G-BA is allowed by law to exclude therapies not meeting the SGB V criteria. The Institute for Quality and Efficiency in Health Care (IQWiG) advises the G-BA and is also responsible for generating evidence. A major political and constitutional controversy has been triggered on the legitimation of the Federal Joint Committee. In its statute the G-BA recurs on evidence-based health care. It examines therapies according to the degree of available evidence and the usability of the evidence in the respective supply setting. The Federal Social Court (Bundessozialgericht, BSG) decided that the decisions of the G-BA could not be challenged for being medically incorrect. In 2005, the Federal Constitutional Court (Bundesverfassungsgericht-BVerfG) decided that a stricter control over the G-BA by the social courts was needed and that in the case of serious disease a lower evidence level might be sufficient. BSG and G-BA will continue to accept the results and methods of Evidence-based Medicine.