German Social Court Ruling Deems ReWalk Exoskeleton Medically Necessary as Medical Aid for Recipient with Spinal Cord Injury
Social Welfare Court Decision in Germany: Reimbursement Approved on Appeal
YOKNEAM ILIT, Israel and MARLBOROUGH, Mass., Aug. 4, 2016 /PRNewswire/ — ReWalk Robotics (NASDAQ: RWLK), the leading developer and manufacturer of exoskeletons, announced the first ruling by the Social Welfare Court of Speyer declaring the ReWalk exoskeleton system was medically necessary and should be covered by insurance for an individual with spinal cord injury (SCI). The ruling, which was delivered in late July, overturned the original denial of the claim by the payor, a statutory health insurance entity.
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The claimant, Philip Hollinger, is a 44 year old father of two who suffered a spinal cord injury in a car accident in 2006 that left him paralyzed with a T6 level injury. Mr. Hollinger has been relegated to the use of a wheelchair in the 10 years since the accident. He was introduced to ReWalk’s exoskeleton technology at the Rehacare trade show in Dusseldorf in September 2013 and he successfully completed the trial and training process at Asklepios Klinik in Falkenstein.
In August 2014, Hollinger submitted a claim to his statutory health insurance for coverage of a ReWalk Personal System to help him stand and walk at home and in his community. When the insurer denied his claim, Mr. Hollinger appealed to the Social Welfare Court of Speyer, which overturned the insurer’s denial.
“Only an individual with a spinal cord injury can fully appreciate the moment of pure happiness when you are able to stand up and walk again,” said Philip Hollinger. “The decision of the Social Welfare Court of Speyer offers hope to other people with SCI, and confirms what I and other ReWalk users have experienced: this technology returns to me many of the things I have lost with my disability. Now, I am able to stand and walk again independently, and to see the world at eye level.”
The ruling delivered by the Social Welfare Court of Speyer1 included several key decisions regarding exoskeleton technology for spinal cord injured individuals that will serve as precedent for future cases. The Court determined:
•ReWalk is a medical aid that compensates the malfunction of the body directly. As such, it does not require a positive recommendation by the German Joint National Committee (GBA) or a listing in the German catalogue of medical aids (Hilfsmittelverzeichnis).
•The ReWalk exoskeleton technology is not comparable to wheelchairs as only ReWalk enables the insured to walk again. Therefore, the principle of efficiency pursuant to Section 12 of Book V of the German Social Security Code (SGB V) is not applicable.
•The reimbursement of a ReWalk Personal Exoskeleton System cannot be denied based upon the argument that the supply of a wheelchair is sufficient because a wheelchair does not compensate the malfunction of the body completely.
•The fact that the insured still needs assistance when using the ReWalk Personal System does not justify the denial of the payor to cover the cost of the system.
•The insured still needing a wheelchair in addition to a ReWalk does not qualify as a basis for denial because exoskeleton technology gives the insured the possibility to stand up for a few hours per day.
“This ruling is a milestone for insurance coverage of exoskeleton technology, both in Germany and around the world,” said ReWalk Robotics CEO Larry Jasinski. “With each decision approving coverage of the ReWalk, we make key advances in the effort to ensure every eligible ReWalk user has access to and coverage of their system.”
ReWalk Robotics Personal 6.0 is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with spinal cord injury to stand upright and walk. ReWalk is the first exoskeleton system to receive FDA clearance for use in the home as well as in the rehabilitation setting. ReWalk received FDA clearance in June 2014, and a CE mark in June 2010.
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. For more information on the ReWalk systems, please visit http://www.rewalk.com.
ReWalk® is a registered trademark of ReWalk Robotics Ltd. in Israel.
Forward Looking Statements
In addition to historical information, this press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the U.S. Securities Act of 1933, and Section 21E of the U.S. Securities Exchange Act of 1934. Such forward-looking statements may include projections regarding ReWalk’s future performance and, in some cases, may be identified by words like “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “future,” “will,” “seek” and similar terms or phrases. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of ReWalk’s control. Important factors that could cause ReWalk’s actual results to differ materially from those indicated in the forward-looking statements include, among others: ReWalk’s expectations regarding future growth, including its ability to increase sales in its existing geographic markets and to expand to new markets; ReWalk’s ability to maintain and grow its reputation and to achieve and maintain market acceptance of its products; ReWalk’s ability to achieve reimbursement from third-party payors for its products; ReWalk’s expectations as to its clinical research program and clinical results; ReWalk’s ability to improve its products, develop new products; ReWalk’s ability to maintain adequate protection of its intellectual property and to avoid violation of the intellectual property rights of others; ReWalk’s ability to repay its secured indebtedness; ReWalk’s ability to gain and maintain regulatory approvals; ReWalk’s ability to maintain relationships with existing customers and develop relationships with new customers; and other factors discussed under the heading “Risk Factors” in ReWalk’s Annual Report on Form 10-K for the year ended December 31, 2015 filed with the U.S. Securities and Exchange Commission on February 29, 2016 and other documents subsequently filed with or furnished to the U.S. Securities and Exchange Commission. Any forward-looking statement made in this press release speaks only as of the date hereof. Factors or events that could cause ReWalk’s actual results to differ from the statements contained herein may emerge from time to time, and it is not possible for ReWalk to predict all of them. Except as required by law, ReWalk undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
1 The period to file an appeal of the Social Welfare Court’s decision has not yet expired.
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SOURCE ReWalk Robotics
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