Reimbursement of digital health applications

In the future, the reimbursement of digital health applications (DiGA), also known as medical apps, is planned by the statutory health insurance (SGB V, § 33a). This is regulated in the Digital Care Act (DVG). A precondition for reimbursement is the inclusion in the DiGA registry (SGB V, § 139e) of the Federal Institute for Drugs and Medical Devices (BfArM). Ecker + Ecker provides consulting on all aspects of the market access and reimbursement of DiGA.

Reimbursement strategy

  • Review of requirements as per German Social Code (SGB V), § 139e, para. 2, sentence 2
  • Analysis of studies required to prove positive effects on care provision
  • Early consultancy with involvement of BfArM

Support and review of reimbursement potential

  • Supporting the inclusion into the DiGA register to be set up by BfArM as per SGB V, § 139e
  • Compilation of application documents for the assessment of the reimbursement potential
  • Analysis of ongoing assessment procedures

Supporting the reimbursement potential

  • Generation of evidence
  • Evaluation and development of study designs
  • BfArM application

Negotiation of reimbursement price

  • Negotiation of reimbursement price with the National Association of Statutory Health Insurance Funds (GKV-SV)
  • Support in potential arbitration procedures
  • Price modelling
  • Concepts for direct contracts with health insurance funds

Please contact

Dr. Claudia Pütz
Tel. +49 (40) 41 33 081-12
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