CLINICAL ASSESSMENT OF THE REFUNDABILITY OF MEDICAL DEVICES BY GKV
In the outpatient area, a reservation of authorization applies to the distribution of medical devices at the expense of the statutory health insurance. They may only be sold to the statutory health insurance after a positive decision of the Joint Federal Committee (G-BA) in accordance with § 91 SGB V.
In the hospital sector, conversely, the principle of permission with prohibition reservation applies. This means that new examination and treatment methods are generally applicable as long as they have not been excluded by the G-BA according to §137 c SGB V. Since January 2016, an additional benefit assessment procedure for new examination and treatment methods (NUB) with medical technologies with high-risk medical devices in accordance with § 137 h SGB V. Medical technologies, which are based on a new theoretical-scientific concept and are particularly invasive, is undergoing an additional evaluation Evaluation at the G-BA. Sometimes. a benefit study is commissioned.
Clinical Evaluation and Writing.
The Clinical Assessment Body Prof. Zenner and Partners can provide clinical evaluation and documentation for G-BA / NUB procedures.