Flyer Medical Devices

4 Reimbursement channels and evaluation institutions for medi- cal devices Fixed amounts for medical devices In accordance with Section 36 of the German Social Code, Book V, the GKV - Spitzenverband (National Association of Statutory Health Insurance Funds) determines therapeutic appli- ances for which reference prices (maximum reimbursement amounts) are set. Fixed amounts exist for the following groups in the list of therapeutic appliances and are uniform throughout Germany for the SHI funding organizations: • (group 08) insoles • (group 13) Hearing aids • (group 15) incontinence aids • (group 17) aids for compression therapy • (group 25) visual aids • (group 29) Stoma articles There are no reference prices for nursing aids. The associations of health care providers and manufacturers of therapeutic appliances (Section 36 of the German Social Code, Book V) and certain patient advocacy groups have the right to be heard when reference price groups are formed and reference prices are set. List of medical aids of the GKV health insurance funds for medical devices The inclusion of a medical device in the list of therapeutic appliances is based on an applica- tion by the manufacturer to the GKV - Spitzenverband, which makes the decision. A corres- ponding application for inclusion is required for the respective group of medical devices. The GKV Spitzenverband decides on the inclusion in the list of medical devices or nursing aids. The products that meet the requirements for inclusion in the list are each listed with a reference to the manufacturer as well as specific design features and are assigned an indivi- dual ten - digit item number. The applicant will be notified in writing by the GKV Spitzenver- band of the decision. Benefit assessment for medical devices according to § 137e SGB V For examination and treatment methods whose benefit has not yet been sufficiently proven, but which indicate the potential of a necessary treatment alternative, the Federal Joint Com- mittee (G - BA) can adopt a guideline for testing. The legislature introduced this regulation with the GKV Versorgungsstrukturgesetz (SHI Care Structure Act) with the newly created Sec- tion 137e of the German Social Code, Book V (SGB V). With § 137e SGB V, the GKV Versor- gungsstrukturgesetz created the possibility that - independent of a consultation procedure according to § 135 or § 137c SGB V - an application for the testing of a new examination or treatment method can be submitted to the G - BA. Eligible to apply are: • Manufacturers of a medical device on whose use the technical application of a new ex- amination or treatment method is significantly based, • Companies which, as providers of a new method, have an economic interest in its pro- vision at the expense of the health insurance funds.