Berlin – The Federal Joint Committee (G-BA) is obliged to decide on the entitlement of SHI insured persons to medical or medical-technical examination and treatment methods. The G-BA examines which new examination and treatment methods (NUB) are required for adequate, appropriate and economical care of the insured within the framework of a structured assessment procedure (§ 137c SGB V).
If certain conditions are met, NUB that can be provided in an inpatient setting and that are largely based on the use of a high-risk medical device must also be evaluated by the G-BA (§ 137h SGB V). However, since in some cases the study situation is not sufficient to conclusively assess the benefit and medical necessity, further knowledge can be gained by testing a NUB (§ 137e SGB V).
Our
Workshop
Market Access for Innovations | §§ 137 c, e and h
The NUB procedure with medical devices of high risk classes in the hospital evaluation procedure and the new test regulation
June 27, 2023 | 10:00 a.m. to 4:00 p.m. | Berlin
The application-oriented workshops addresses the following questions, among others:
- How can the dialogue with the G-BA be structured?
- How can the sometimes tight time framework be anticipated?
- What about the demand for patient-relevant endpoints and the acceptance of surrogate endpoints in practice?
- What did the G-BA actually accept from the submitted study designs for the proof of benefit?
Program, conditions and registration at: www.bvmed.de/innovationen137-2023
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