Market access for medical devices

We find solutions for complex questions on market access and reimbursement

Reimbursement and benefit assessment of medical devices

The reimbursement landscape is becoming increasingly complex and the evidence requirements for medical devices are increasing. Since the GKV-Versorgungsstärkungsgesetz has been in place, the Federal Joint Committee (G-BA) is involved in the procedure at an early stage and evaluates the benefits of new examination and treatment methods with high-risk medical devices.

We offer orientation, whether it is on method evaluation/testing regulations according to sections 137h, 137c, 137e of the SGB V (the German social security code); reimbursement via the DRG (German diagnosis-related groups system), NUB (new examination and treatment methods); inclusion in the list of medical devices; Annex V of the AM-RL; reimbursement of material costs (EBM); or selective contracts. With our expertise, we offer competent advice on which reimbursement strategy is best for your medical device.

After jointly determining the best strategy, we provide comprehensive support on the path to reimbursement. With a wealth of experience in evidence-based medicine and benefit communication with relevant stakeholders, our physicians, physicists and engineers optimally present the clinical evidence for your medical device. This is how we can achieve rapid acceptance of your medical device in the SHI system and the highest possible reimbursement amount.

How you can benefit from our services:

  • Comprehensive advice on the optimal reimbursement method and support during implementation
  • Support of your hospital clients with NUB applications
  • Compilation of the scientific evidence in NUB applications for high-risk devices
  • Extensive support in the procedures for method evaluation and testing according to sections 137h, 137c, 137e of the SGB V: analysis of previous procedures; preparation and implementation of consultations with the Federal Joint Committee (G-BA) for medical devices in high risk classes; preparation of all applications; support during the statement procedure