Several recent national-level policy changes highlight an accelerating digital transformation of healthcare in Germany, building on the Digital Healthcare Act (DVG) of 2020.

In January 2021, the German Federal Government passed the draft of a law that aims to now include digital nursing and elderly care applications (DiPAs) into statutory health insurance coverage complementing coverage for digital health apps (DiGAs).  Coverage for DiGAs for patients under statutory health insurance was introduced in 2020.  DiGAs are healthcare apps intended to help identify, monitor, treat or alleviate diseases, and are considered low-risk medical devices that can be prescribed.  The German Medical Agency (BfArM) assesses the apps and specifies those that are approved in the DiGA directory for prescription coverage.

Regulations for reimbursement of the apps was finalized in March 2021. The prescription of DiGAs that are permanently listed in the directory of the BfArM will be paid on top of the budget. The prescription can be billed via a code in the fee-for-service scale EBM (2 Euros). In addition, specific higher-paid codes were added for apps that require more effort at the physician practice level. 10 DiGAs have been listed so far and the largest SHI fund estimates expenditures of about 5 Million Euro for digital health apps for its 10.8 million insured members in 2021.

Implications for Innovators

The introduced reimbursement of digital health apps was successful and expansion to apps for organizing and coping with everyday nursing and special nursing situations adds more opportunities for manufacturers of innovative digital health solutions. Germany is a forerunner for the implementation of health apps into the statutory healthcare system, and both apps and processes are watched closely by other countries. Favorable market access in Germany could ease the adoption in other markets.

The BHA European office in Berlin, Germany supports manufacturers and developers in market access of their digital health products and offers both strategic and operational guidance in the process. To learn more about the digital health app reimbursement and implications for innovators please contact us here.