On November 7, 2019 the German parliament (Deutscher Bundestag) established the Act on better care through digitalization and innovation (Gesetz für eine bessere Versorgung durch Digitalisierung und Innovation – DVG). Amongst others, this act provides for German Statutory Healthcare Funds (Gesetzliche Krankenversicherungen – GKV) reimbursing health apps. This part of the DVG on the reimbursement of health apps shall enter into force on January 1, 2020.
Consequently, German physicians may prescribe health apps for patients insured with one of the GKV. The GKV covers approximately 90% of the German population. Such apps may facilitate measuring blood pressure, heart functions or may be used to ensure the compliance of a therapy involving medicinal products. The legislator intends to establish an easy market access for such health apps involving less administrative measures as it is the case for medical products or medical devices.
Following a positve evaluation by the Federal Institute for Medicinal Products and Medical Devices (Bundesinstitut für Medizinprodukte und Arzneimittel – BfArM) taking into account its safety, functionality, quality, data safety and data privacy physicians may prescribe a medical app.
Within the first year the GKV has to reimburse the price fixed by the manufacturer of the health app. Based on the price fixing process established in 2010 by the Act on Reordering the Medicinal Products Market (Gesetz zur Neuordnung des Arzneimittelmarktes – AMNOG) after one year the manufacturer has to prove to BfArM that the health app improves the care of patients. Based on this data the manufacturer negotiates a reimbursement price with the the Federal Joint Committee (Gemeinsamer Bundesausschuss – GBA) for the future. The GBA is an umbrella organization of the GKV taking care of, e.g. reimbursement questions.
The DVG offers a great business opportunity for national and international pharmaceutical and medical device manufacturers as well as health app producers on the German market. Following the evaluation by BfArM the GKV has to reimburse the health app for one year based on the price fixed by its manufacturer. Very often this corresponds to the life cycle of an app. Many life sciences companies do already use apps as an additional tool to facilitate the use of its medicinal products and medical devices, but with no reimbursement in the past.
Please get in contact with us in case you need more detailed information on how your health apps may be reimbursed by GKV in Germany.