In contrast to drugs the reimbursement of diagnostic methods by health insurances is more difficult, if the method has a higher price. This is due to the fact that the reimbursement is not automatically regulated if new diagnostics are put on the market.
Additionally there are other standards for diagnostics (compared to drugs) to prove the benefit of the method. These standards are not as cost-intensive than for drug development. But this results in not optimally fulfilling the standards of evidence-based medicine. Therefore the discussion about the reimbursement becomes difficult. The alternative for the diagnostics manufacturer to show the benefit of a method by using the same standards as for drug development is too expensive. The diagnostics manufacturer cannot afford it, since they make much less money than drug companies.
The challenge to solve reimbursement for higher priced diagnostics is an issue within the European Union already. In Germany the government approaches the issue by a new law (GKV-Versorgungsschutzgesetz (GKV-VStG)). This law came into force in 2012. It enables the Federal Joint Committee to decide for directives to evaluate new diagnostics. For the future the reimbursement might be within reach.
With respect to our diagnostic services we would be happy to inform you about the current status. Please contact us directly.