From May that will take BfArM Requests for reimbursement of DiGAs against, it was said at the virtual SAY Summit of health innovation hubs.
How do medical apps get reimbursed by law in Germany under the Digital Care Act (DVG)? Providers of digital health applications (DiGA) are currently dealing with this question. In the meantime, the fast-track procedure of the Federal Institute for Drugs and Medical Devices (BfArM) is taking shape a guide was recently published.
Experts explain procedures for the virtual Summit
Experts from the Federal Ministry of Health (BMG) and the BfArM discussed how this is to be applied in detail and how the procedure can be put into practice at the virtual "DiGA Summit" on April 22nd. More than 1600 participants took part in the digital event organized by the health innovation hub. (Here you can find all information on the hib-Website) One of the most important pieces of information at the event: Applications for digital apps are to be released on the homepage of the BfArM portal in May and consultations with the BfArM for approvals should be possible from May 5th. "Three months later, the first positive decision could be issued and thus start the DiGA directory," explains Sophie Matenaar, BMG officer with a focus on e-health.
Guide of the BfArM should be adaptable
The directory is the responsibility of the BfArM and a listing in it is a prerequisite for a DiGa in order to get into the statutory health insurance reimbursement procedure. The legal basis for this was created with the DiGA Ordinance (DiGAV). With the fast-track procedure described in the guide, a whole new chapter is now being opened. This is "an innovative step for the legislature," explained Gottfried Ludewig, Head of Digitization at the Federal Ministry of Health. However, he also warned that not everything could be perfect at the beginning of the DiGA regulation. The guidelines of the BfArM should also be adaptable, added representatives of the BfArM. From autumn, the first providers of DiGAs should be able to bill their products via the GKV.
Pricing not discretionary
However, there is still no framework agreement on the criteria for reimbursement prices for apps between manufacturers and the GKV. In the first year, the prices set by the manufacturer should apply. DVG spokesman Lars Hunze emphasized at the summit, however, that these cannot be determined at will and that the framework agreement will be taken into account. With a view to the final price, performance-related components such as pay-for-performance models could be used. Hunze: "It's up to the creativity of the contractual partners".
Relief from MDR postponement
A relief was also mentioned: the official certification as a medical device. This must due to the MDR shift this year no longer necessarily according to the new EU Medical Devices Regulation, but can also be based on the old MDD. A corresponding parliamentary adjustment of the DiGAs should take place in the near future. "The fact that only relatively simple Class I and IIa apps are possible does not have to stay that way in the long term," Hunze continues. However, this is a starting point for the DiGA legislation.
Number of expected applications open
How many applications are expected in May is still open. "The more, the better," says Ludewig. BfArM boss Karl Broich also did not give any specific figures, but so far there have been around 200 manufacturer inquiries to the BfArM innovation office. "This shows that there is a lot going on," says Broich.
Source: Communication from medtech Two by 23.04.2020