The digital care act passed the German parliament and includes especially also the reimbursement of health care apps by German statutory health insurance funds. The process for market access will include an evaluation and registration at the German registration institution BfArM and thereafter a price negotiation with the Head Association of the Statutory Health Insurance Funds (GKV-SV). How these various steps will be detailed is still open. However, now the milestones are made public when the process steps will be published.
- The draft legal framework will be published by the Ministry of Health in January. There will also be the opportunity of commenting the draft.
- BfArM guidance on the details about the process, procedure, method and requirements are bing Mae available in February
- The final framework and BfArM guidance is planned to be available in March 2020
- From April 2020 onwards the BfArM online platform as well as the option for consultations will be up and running and also fast track submissions are then possible.
So, get started and prepared for reimbursement of digital apps in Germany.
MArS has experience in the AMNOG process which might be quite similar to the BfArM process and especially the price negotiations with the GKV-SV. MArS has also developed the MArS Negotiation Boot Camp utilizing latest technology including Virtual Reality in order to be optimally prepared for a successful price negotiation. Contact us!