DiGA: The path to reimbursement of an "app on prescription" by statutory health insurers Apps / Medical law

The route to the DiGA is via the so-called fast-track procedure. An application must first be submitted to the BfArM. Receipt must be confirmed within fourteen days and any missing documents must be submitted subsequently. The BfArM must then decide within three months. The BfArM examines the application in two separate steps.

In the first step, the BfArM examines whether the requirements from Sections 3 to 6 DiGAV regarding safety, functionality, quality, data protection and information security have been implemented.

If these requirements are met, the BfArM checks in a second step in accordance with Sections 8 ff DiGAV whether there is evidence of a positive supply effect. The manufacturer must therefore prove that the app has a medical benefit, for example by improving the state of health, shortening the duration of an illness, prolonging life or increasing the quality of life. If this proof is provided via a study, the app is included in the directory as a DiGA, can be prescribed by doctors and is reimbursed by statutory health insurance companies.

It is important to note that proof of a positive effect on care does not have to be available at the time of application. Rather, the app can also be provisionally included in the DiGA directory. The manufacturer then generally has up to one year (in exceptional cases up to two years) to prepare the study.

The advantage of this is that the app can already be used and advertised. It may also be possible to recruit test subjects for the study via the prescribed app. However, this is not automatic. Rather, the test subjects must be recruited separately, although this may be easier due to the app already being prescribed and better known.

If the proof of a positive effect on care fails, a waiting period of one year must be observed until the next application. In addition, there must be evidence that proof is now possible. Repeated provisional inclusion in the DiGA directory is not possible.

The GKV-Spitzenverband must agree remuneration amounts for DiGA with the DiGA manufacturers and with effect for all health insurance funds in accordance with Section 134 (1) SGB V. To this end, the National Association of Statutory Health Insurance Funds must conclude a framework agreement at federal level with the relevant umbrella organizations of DiGA manufacturers on the standards for agreeing remuneration amounts in accordance with Section 134 (4) SGB V.