German National Health Insurance Agency Announces Addition of ReWalk 6.0 System to National Medical Device Directory
German GKV-Spitzenverband to Provide Exoskeleton Devices for all Qualifying Beneficiaries in Landmark National Policy Decision
MARLBOROUGH, Mass. and BERLIN, Feb. 1, 2018 /PRNewswire/ -- GKV-Spitzenverband, the head office of German statutory health insurance (SHI), confirmed their decision to list the ReWalk (Nasdaq: RWLK) Personal 6.0 Exoskeleton System in the German Medical Device Directory (MDD, Hilfsmittelverzeichnis), according to §139 SGB V. The MDD is a comprehensive list of all medical devices which are principally and regularly reimbursed by German SHI providers. This decision means that ReWalk will be listed among all medical devices for compensation, which SHI providers can procure for any approved beneficiary on a case-by-case basis.
The ReWalk Personal will be classified as "an innovative device for the immediate compensation of a handicap" in the MDD, and will be listed under a new subcategory for product group 23. The official publication of the MDD, which is issued annually, is expected within the next three months.
Addition to the MDD is a significant policy milestone, allowing for any eligible German SHI beneficiary in the country to seek procurement of a ReWalk system to stand and walk again. If their assessment is approved by physical exam, the SHI will then reimburse for purchase of a system. Ninety percent of the German population are beneficiaries under SHI coverage, which creates the potential for thousands of individuals with spinal cord injury (SCI) in Germany to have access to exoskeleton devices for the first time.
"We are pleased to see the German healthcare system embracing biotechnology innovations that will be life changing for beneficiaries nationwide," said ReWalk CEO Larry Jasinski. "This is a landmark decision—one of progressive policy by SHI in Germany, and one that will be critically important to SCI individuals across the country. We are excited to announce that patients and O&P shops will soon be able to access ReWalk systems as a part of the standard reimbursement process."
The GKV decision follows a similar policy issuance by German accident insurer BG in 2017, which provided for rental and procurement of ReWalk 6.0 Personal Systems for qualifying beneficiaries. Receiving its CE Mark in 2012, ReWalk has been working with insurers across the EU on policy development for SCI beneficiaries. There are more than 400 ReWalk systems in use worldwide today.
To learn more about the ReWalk 6.0 System, please visit: www.rewalk.com
About ReWalk Robotics Ltd.
ReWalk Robotics Ltd. develops, manufactures and markets wearable robotic exoskeletons for individuals with spinal cord injury. Our mission is to fundamentally change the quality of life for individuals with lower limb disability through the creation and development of market leading robotic technologies. Founded in 2001, ReWalk has headquarters in the U.S., Israel and Germany.
ReWalk® is a registered trademark of ReWalk Robotics Ltd. in Israel.