High repayment demands to DiGA manufacturer expected

The health app “M-Sense” was provisionally listed as a digital health application (DiGA) in the directory of the Federal Institute for Drugs and Medical Devices (BfArM) for over a year.

With the provisional listing the Berlin-based start-up Newsenselab was given one year to prove the medical benefit of the app and being permanently listed in the directory. Health apps that are listed in this directory can be prescribed by contracted doctors (out-patient specialists) and the costs of the app are then covered by the health insurance companies.

Newsenselab, despite an extended trial period, was unable to prove a positive health care effect for M-Sense (placebo effect only) – compared to the comparator app – and has therefore withdrawn the listing as DiGA. An arbitration board has now ruled that Newsenselab must make repayments of several hundred euros for reimbursements already received per prescription code (as reported by Handelsblatt Inside in the Digital Health Newsletter on 06.10.2022). Newsenselab has filed for insolvency.

"In our understanding, this process has confirmed the critics on the part of the medical profession and the health insurance companies and we expect improvements from the legislator with regard to the requirements for a listing in the DiGA directory" says Sven Sauermann, Managing Director of Healthcare Heads.

"This process once again clearly shows that the idea of many start-ups to "just" programme a health app and have it financed by the health insurance companies does not work. A "DiGA" is a medical device that must be carefully marketed - including the proof of benefit.

We strongly recommend that all start-ups seek professional support in the areas of reimbursement and market access.

Here you can find more information on the topic of reimbursement for medical devices in Germany.

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