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Section 137c of Book V of the Social Code - Evaluation of examination and treatment methods in hospitals

(1) The Federal Joint Committee in accordance with section 91 shall examine, at the request of the National Association of Statutory Health Insurance Funds, of the German Hospital Federation or of a national association of hospital owners, examination and treatment methods which are applied, or which are to be applied within hospital treatment, at the expense of the statutory health insurance funds, as to whether they are necessary for the adequate, expedient and economical care of members, taking account of the generally-recognised state of medical knowledge. If the examination reveals that the benefit of a method is not sufficiently proven and that it does not have the potential for a necessary treatment alternative, in particular because it is harmful or ineffective, the Federal Joint Committee shall issue a corresponding guideline in accordance with which the method may no longer be provided in hospital treatment at the expense of the health insurance funds. If the examination reveals that the advantage of a method is not yet adequately proven, but that it has the potential of a necessary treatment alternative, the Federal Joint Committee shall issue a guideline on trials in accordance with section 137e. On conclusion of the trial period, the Federal Joint Committee shall issue a guideline in accordance with which the method may no longer be provided within hospital treatment at the expense of the health insurance funds if the examination, consulting the information obtained through the trial, reveals that the method does not satisfy the criteria in accordance with sentence 1. Sentence 4 shall apply mutatis mutandis if no guideline on trials has been issued because agreement that is necessary in accordance with section 137e subsection (6) has not been reached.

(2) If a complaint of the Federal Ministry of Health in accordance with section 94 subsection (1) sentence 2 is not remedied within the deadline set by same, the Federal Ministry may issue the guideline. The excluded method may no longer be provided within hospital treatment at the expense of the health insurance funds from the date of the entry into force of a guideline in accordance with subsection (1) sentence 2 or 4; the implementation of clinical studies shall remain unaffected by an exclusion in accordance with subsection (1) sentence 4.

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