A key factor to success
In Germany, the out-patient sector works differently regarding Reimbursement of therapies than the in-patient setting. In general, the out-patient sector is differentiated between the Reimbursement system for the statutory health insurance (EBM) and private insurances (GOÄ).
Typically, the German out-patient sector makes greater demands on the benefit assessment of medical devices. In the in-patient sector, the “permission with prohibition reservation” is valid whereas it is the “prohibition with permission reservation” in the out-patient sector. The later says that services are not allowed to be performed on the account of the statutory health insurances if these are not explicitly approved.
A typical approval is the inclusion of a medical device into the medical aid catalogue (“Hilfsmittelverzeichnis”, HMV). If your product is part of the HMV, it can be prescribed by so-called “Vertragsärzte” (physicians having a contract with the Association of statutory health insurances registered physicians if they work in their own practice) for more than 70 million statutory insurants and therefore can access the first healthcare market in Germany. If your product is listed and prescribed by a corresponding physician (“Vertragsarzt”), the statutory health insurances are paying for the treatment.
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