In previous years, healthcare reform in Germany has focused on containing pharmaceutical costs, with the aim of ensuring that pharmaceutical prices would be economically efficient while not inhibiting innovation.
More recently, the focus has shifted to the medical device industry, specifically coverage, evidence, and reimbursement for devices across the ambulatory, inpatient, and home care segments.
The federal government has started initiatives for better quality in the provision of healthcare. This includes the newly established quality institute, ‘Institut für Qualitätssicherung und Transparenz im Gesundheitswesen’ (IQTIG). Currently the IQTIG is conducting 26 quality evaluations, which includes device related inpatient procedures, like carotid revasculation, implantable cardioverter defibrillators, aortic valve surgery, or hip-/knee-replacement surgery. It is expected, that this Institute will evaluate medical procedures, and develop quality metrics, which may affect payment of inpatient procedures in the future.
Since 2017, a benefit assessment is required for new notably invasive or active implants in risk classes IIb/III before being granted additional payment. The NUB - 'Neue Untersuchungs - und Behandlungsmethoden' – can support financially innovative devices in inpatient use if costs are exceeding the existing DRG payment. In the new process for notably invasive or active implants, the Federal Joint Committee (G-BA) will assess the benefit within three months of the hospitals’ application for NUB payment. Manufacturers must cooperate with the hospital during this process.
The experience in 2017 showed that the criteria regarding clinical evidence are extremely high. None of the eight products in this category (i.e., notably invasive or active implants) provided sufficient evidence to be reimbursed through the NUB process.
If you would like to discuss these developments with us, please
our Berlin office for more information.