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Section 135 of Book V of the Social Code - Evaluation of examination and treatment methods

(1) New examination and treatment methods may only be provided in contract healthcare and contract dental care at the expense of the health insurance funds if the Federal Joint Committee has – on application by a non-partisan person in accordance with section 91 subsection (2) sentence 1, by a National Association of Statutory Health Insurance Physicians, by an Association of Statutory Health Insurance Doctors, or by the National Association of Statutory Health Insurance Funds – submitted recommendations in guidelines in accordance with section 92 subsection (1) sentence 2 No. 5 regarding

1. the recognition of the diagnostic and therapeutic benefit of the new method as well as its medical necessity and economic viability – including in comparison with methods already being provided at the expense of the health insurance funds – according to the respective state of scientific knowledge in the respective therapy system,

2. the necessary qualification of the doctors, the requirements in terms of apparatus, as well as requirements as to quality assurance measures in order to ensure the proper application of the new method, and

3. the necessary records of the medical treatment.

The Federal Joint Committee shall examine the contract healthcare and contract dental care benefits provided at the expense of the health insurance funds as to whether they satisfy the criteria in accordance with sentence 1 No. 1. Should the examination reveal that these criteria are not satisfied, the benefits may no longer be provided as contract healthcare or contract dental care benefits at the expense of the health insurance funds. If the Federal Joint Committee has not yet taken a decision in a procedure to evaluate a new examination and treatment method on expiry of six months since the evaluation of the scientific knowledge necessary for the decision becoming available, the parties entitled to apply in accordance with sentence 1, as well as the Federal Ministry of Health, may demand that the Federal Joint Committee take the decision within a period of a further six months. If no order is handed down within this period, the examination and treatment method may be provided in contract healthcare or contract dental care at the expense of the health insurance funds.

(2) For medical and dental benefits which require special knowledge and experience because of the requirements as to their execution or because of the novelty of the procedure (proof of expertise), special equipment of the surgery or other requirements as to the quality of care, the partners to the Federal Skeleton Agreements (Bundesmantelverträge) may uniformly conclude corresponding requirements for the execution and settlement of these benefits. Where equivalent qualifications for the necessary knowledge and experience which must be required as a qualification are introduced in provisions under the Land law on the exercise of the medical profession, in particular provisions of the law on specialist physicians, with the same content nationwide and with regard to the prerequisites for quality in accordance with sentence 1, these shall constitute the necessary and adequate requirement. If the provision of medical benefits is made dependent on a qualification for the first time, the contracting partners may transitionally introduce qualifications for doctors who have not acquired appropriate qualifications during further training, and these must correspond to the state of knowledge and experience of the regulations for specialist physicians. In derogation from sentence 2, in accordance with sentence 1, the contracting partners may hand down arrangements in order to ensure the quality and the economic viability of the provision of benefits in accordance with which the provision of specific medical and technical benefits is reserved for the specialist physicians for whom these benefits form elements of the core of their specialist area. The organisations that are recognised in accordance with the legal ordinance in accordance with section 140g shall be involved in the consultations between the contracting partners prior to the conclusion of agreements in accordance with sentence 1; the organisations shall designate expert persons to this end. Section 140f subsection (5) shall apply mutatis mutandis. The contracting partners shall agree on the details of the procedure in accordance with sentence 1. Section 87 subsection (6) sentence 9 shall apply mutatis mutandis to the agreements in accordance with this subsection.

(3) to (6) (repealed)

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