DiGA consultation meetings: Prescription and use
What we took from the last online meeting with the hih of the Federal Ministry of Health? Here is a short and concise summary:
The BfArM has held consultation meetings with about 50 DiGA manufacturers and received 14 applications for inclusion in the DiGA directory (as of 16.07.20). At the end of August 2020, the first
DiGAs that are listed in the directory can be expected. For the time being, the ordinance will be based on "Muster 16"; the basis for use and invoicing will be a 16-digit prescription code. Price
negotiations will be held between the manufacturer and the GKV-SV after successful #evaluation. Relevant principles on pricing and remuneration are regulated in the framework agreement and
More information is available at in our German speaking sites.
With the Digital Care Act (DVG), structures were created to establish regular reimbursement for digital health applications (DiGA) in Germany. What evidence is
necessary to convince the Federal Institute for Drugs and Medical Devices (BfArM)? How do I effectively conduct a consultation with the authority and what are the minimum requirements for an
evaluation concept? We answer these and other questions based on our first experiences with the new regulations and, if necessary, we will be happy to network with our customers. Request a catalogue of criteria and further practical informatio or
learn more on DiGA in the German
Since 2016 and until 2019, the innovation fund has been promoting new forms of care within the German statutory health insurance system. New forms of managed care as well as the generation of
real world evidence is funded with an annual volume of 300 million euros. 225 million euros are provided for the promotion of new forms of managed
care and 75 million euros for real world evidence. The innovation committee set up at the
Federal Joint Committee (G-BA) defines the priorities and criteria for funding in so-called funding notices, carries out for expression-of-interest procedures and decides on the applications for
funding. The legal basis for the work of this innovation committee, are §§ 92a and 92b, Fifth Book of the Social Code (SGB V).
Read the full article here (in
German) or contact us for the article in English and for more information on the innovation funds and what you need to do to apply.