At its meeting on January 21, 2021, the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) decided that our study concept complies with the requirements of the “Guideline of the Federal Joint Committee” („Richtlinie des Gemeinsamen Bundesausschusses“). This means it meets the key points of the trial guideline and is thus suitable for generating the data required for the method evaluation in accordance with Section 135 (1) of the German Social Code, Book V (SGB V).
We are overjoyed! The decision will soon be published on the G-BA website (www.g-ba.de).
Many thanks to all involved for the efforts and the great input!