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Section 137e of Book V of the Social Code - Trial of examination and treatment methods

(1) If the Federal Joint Committee concludes when verifying examination and treatment methods in accordance with section 135 or section 137c that a method has the potential of a necessary treatment alternative, but that its advantage is not yet sufficiently proven, the Federal Joint Committee may suspend its evaluation procedure and adopt a guideline on trials in order to obtain the necessary knowledge for the evaluation of the benefit ensuing from the method. On the basis of the guideline, the examination or treatment method shall be provided at the expense of the health insurance funds during a limited period within medical treatment or early diagnosis.

(2) The Federal Joint Committee shall regulate in the guideline in accordance with subsection (1) sentence 1 the indications to be included in the trial and the factual, staffing and other requirements of the quality of the provision of benefits within the trial. It shall furthermore establish requirements as to the implementation, research accompaniment and evaluation of the trial. For hospitals which do not take part in the trial, the Federal Joint Committee may regulate requirements as to the quality of the provision of benefits in accordance with section 137.

(3) Healthcare providers participating in contract healthcare, and hospitals registered in accordance with section 108, may participate in the trial of an examination or treatment method to the necessary extent if they prove to the research institution in accordance with subsection (5) that they satisfy the requirements in accordance with subsection (2).

(4) The benefits provided and prescribed by the healthcare providers in accordance with subsection (3) within the trial shall be paid for by the health insurance funds directly. In case of fully and partly in-patient hospital treatment, this shall be paid for through fees in accordance with section 17b or section 17d of the Hospital Financing Act or in accordance with the Federal Ordinance on Hospital and Nursing Charges (Bundes¬pflegesatz¬ver¬ordnung). If no agreement in accordance with section 6 subsection (2) sentence 1 of the Hospital Charges Act (Kranken¬haus¬entgelt¬gesetz) relating to the entire trial period or in accordance with section 6 subsection (2) sentence 1 of the Federal Ordinance on Hospital and Nursing Charges for a new examination or treatment method which cannot yet be properly settled with blanket per diem rates in accordance with section 17 subsection (1a) of the Hospital Financing Act, is reached within three months after the award of the contract by the Federal Joint Committee in accordance with subsection (5), its content shall be established by the arbitration body in accordance with section 13 of the Hospital Charges Act, or in accordance with section 13 of the Federal Ordinance on Hospital and Nursing Charges. With regard to methods which can also be applied on an out-patient basis, the amount of the remuneration for the out-patient provision of benefits by the contracting partners shall be agreed in accordance with section 115 subsection (1) sentence 1. If no agreement in accordance with sentence 4 is reached within three months of issuance of the commission by the Federal Joint Committee in accordance with subsection (5), its content shall be established within six weeks by the expanded arbitration body in accordance with section 115 subsection (3). Court actions against the stipulation of the content of the contract shall not have any suspensory effect.

(5) The Federal Joint Committee shall commission an independent academic institution for the research accompaniment and evaluation of the trial. The healthcare providers participating in the trial shall be obliged to document the data required for the research accompaniment and evaluation and to provide them to the commissioned institution. Where members’ personal data are required therefor, their prior consent must be obtained. The healthcare providers participating in the trial shall receive suitable compensation from the commissioned institution for the additional effort in connection with the implementation of the trial.

(6) If the technical application of the method is largely based on the use of a medical device, the Federal Joint Committee may only issue a resolution on trial in accordance with subsection (1) if the manufacturers of this medical device or enterprises which otherwise act as suppliers of the method which have an economic interest in provision at the expense of the health insurance funds have previously declared to the Federal Joint Committee that they will assume the costs of the research accompaniment and evaluation incurred in accordance with subsection (5) to a suitable degree. The manufacturers or other enterprises shall agree on details with regard to the assumption of the costs with the commissioned institution in accordance with subsection (5).

(7) Independently of advisory proceedings in accordance with section 135 or section 137c, manufacturers of a medical device on the use of which the technical application of a new examination or treatment method is largely based, and enterprises which, as providers of a new method, otherwise have an economic interest in their being provided at the expense of the health insurance funds, can apply to the Federal Joint Committee for the latter to adopt a guideline to the trial of the new method in accordance with subsection (1). The applicant shall submit informative documents revealing that the method has sufficient potential for a trial, as well as submitting an undertaking in accordance with subsection (6). The Federal Joint Committee shall decide within three months of application on the basis of the documents submitted by the applicant as reasoning for its application. If the Federal Joint Committee opts for a trial, after the trial has been carried out it shall decide, on the basis of the information that has been obtained, on a guideline in accordance with section 135 or section 137c.

(8) The Federal Joint Committee shall advise manufacturers of medical devices and other enterprises within the meaning of subsection (7) sentence 1 on the requirements of the provision of an examination or treatment method at the expense of the health insurance funds. Details, including the refunding of the costs incurred for this advice, shall be regulated in the rules of procedure.

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