The way into the German reimbursement system for improved medical devices is still too complex and time-consuming, explain the four associations of the medical technology and diagnostics industry BVMed, SPECTARIS, VDGH and ZVEI. Although the potential of innovative medical devices can be better exploited with the entry into force of the new rules of procedure of the Federal Joint Committee (G-BA), the goal has not yet been reached. It must be ensured that improved diagnosis and therapy options quickly find their way into standard care and thus benefit patients more quickly.
The required scientific evidence tools continue to pose enormous practical and methodological problems for manufacturers if they provide the required proof of the medical benefit of methods based on the use of their products in healthcare. Solutions are needed, for example for studies, which clearly demonstrate patient benefits and are also feasible for the manufacturer.
The legal requirements and those issued via ordinances (from the Implant Register Act and the Appointment Service and Supply Act), which the G-BA recently transferred to the processes of self-administration, relate in particular to regulations on "trials" and "benefit assessment with medical devices of high risk classes" for methods of hospital area. The four associations honor the fact that the scope of action for manufacturers of medical devices has been expanded to initiate and carry out their own method evaluation procedures according to set standards for their products. But these possibilities would also have to be expanded in a next step.
Revised guidelines for associations provide clarity for medical device manufacturers
In order to achieve more transparency for the reimbursement system within the framework of statutory health insurance for manufacturers of medical devices, the associations have theirs Guide "Access to the German reimbursement system" updated. The third edition of the publication addresses the possibilities and hurdles in remuneration in the private sector and in hospitals.
Source: Press release Spectaris from November 18.11.2020th, XNUMX