Market Access and Reimbursement of Medical Devices
In Germany, reimbursement of innovative medical devices is handled differently in the outpatient and inpatient settings. New medical devices in the outpatient setting will generally only be reimbursed once they have been included into the catalogue of services provided under statutory insurance. In the inpatient setting, there is the possibility of reimbursement, provided (as long as) no new charge (NUB charge) has been applied for regarding this service, but instead reimbursement is possible within the existing DRGs (Diagnosis Related Groups). The differences in handling are related to the differential regulatory mechanisms in outpatient and inpatient care. In outpatient care, there is an authorisation requirement: reimbursement is only granted when a service has been authorised. In inpatient care, on the other hand, the prohibition proviso applies: new services are allowed until they are prohibited. This principle was abandoned with the introduction of § 137h SGB V. § 137h SGB V stipulates that a benefit assessment must be carried out by the G-BA for new medical devices of risk class 2b or 3 as soon as a NUB fee has been applied for in connection with these products by the hospitals at the InEK (Institute for Hospital Remuneration).
Recognition as an NUB (new examination and treatment method) by the InEK at the request of the hospitals is generally aimed at obtaining appropriate remuneration for a new, innovative medical product. The application simultaneously triggers a benefit assessment procedure. The procedure determines whether there is an additional benefit, the potential for an additional benefit or no additional benefit. Reimbursement for the new medical product is only granted if there is an additional benefit. If there is potential, a test can be conducted. A negative decision is made on an NUB, if no additional benefit or no potential for additional benefit is perceived in the innovative medical product. This principle of benefit assessment of new medical devices also applies in the outpatient setting. The manufacturer can apply for a trial at the G-BA under § 137e SGB V in order to review the benefit and additional benefit of the new method with potential.