OBJECTIVES:

For the market access of innovative medical devices in Germany it plays a key role whether a medical device is applied in the inpatient or in the outpatient setting. There are several possible reimbursement pathways for innovative medical devices, among them Integrated Care Models – ICM (§140 a Social Code Book). Recent research suggests ICMs as a not yet spotted potential access route for medical devices and hence faster access to innovative diagnostics and treatment methods. However, the perception among stakeholders might be quite differential. The key question within the discussion is if the ICM contracts could be an opportunity for market access which might overcome potential issues for market access through regular routes.

METHODS:

ICMs have been evaluated systematically through a triangulated approach – the analysis of model concepts, the organizational set-ups and by semi-structured interviews with key stakeholders.

RESULTS:

In 2011, 6339 contracts exist, covering 1,9 Million insured persons. The actual number of ICM contracts is probably higher. An obligation to notify was established 2012. In total 8120 contracts could be reported in 2015 to the Federal Insurance office (BVA). There are two options for a manufacturer (outpatient setting): First, inclusion of a product within existing ICMs or second, setting up a new ICM with potential stakeholders as partners. The systematic development of treatment procedures associated to the product leading to professional case management structures, potentially supporting guideline developments and overall show a reasonable fast access to these innovative medical devices.

CONCLUSIONS:

ICM contracts are a positive addition to the regular reimbursement possibilities for innovative medical products in cross-sectoral, interdisciplinary care. The extended context of selective contracts makes the implementation of supply innovations possible by bridging the often lengthy and challenging procedures across sectors but primarily in outpatient care, were the current regular route is often still a deadlock.