The G-BA accelerates the process of determining appropriate overhead costs for co-funded § 137e study trials
The Federal Joint Committee (G-BA) made significant changes to the 2nd chapter and its appendix of its rules of procedure. The process of determining the appropriate overhead costs for § 137e study trials and the companies covering them will now occur sooner in the overall 137e process. This should accelerate the process of releasing a study trial guideline by the G-BA. The reason for the changes is the tight deadlines of a § 137h process for high-risk medical devices.
Under these changes, interested companies must declare their willingness to cover the costs of a study trial once the G-BA decides that the method is eligible for an assessment instead of once the consultation over a guideline begins. With this measure, it is hoped that any delays until an ultimate decision is made are reduced.