ReWalk Robotics Exoskeleton Deemed Medically Necessary by I.M.R Organisation

By 16/02/2016June 4th, 2021No Comments
ReWalk Robotics Ltd. (Nasdaq: RWLK) (“ReWalk” or “Company”), the leading global exoskeleton developer and manufacturer, announced today that a commercial health plan in the Northwest region of the United States has approved coverage and reimbursement for a ReWalk Personal exoskeleton system, following the ruling of an external independent review organization that overturned the health plan’s initial denial of coverage. The beneficiary of the ReWalk device is a surgeon who suffered a spinal cord injury and currently uses a manual custom wheelchair 11 hours a day at work. Use of the ReWalk will permit the beneficiary to stand up and ambulate both at work and in the home.

The health plan provider’s coverage approval follows the ruling of an external independent review organization, which overturned the health plan’s initial denial of coverage. After a review of the beneficiary’s case, and a review of the most up-to-date published studies and clinical evidence demonstrating the clinical benefits that stem from use of the ReWalk, the review organization directed the health plan to cover and reimburse the ReWalk system

Importantly, the independent medical review organization determined that the ReWalk system is not an experimental or investigational technology, citing “sufficient evidence found in current peer-reviewed medical literature to support the use of the ReWalk device in patients with spinal cord injury.”

Furthermore, the independent medical review organization’s report concludes that clinical literature documents the safety and benefit of the ReWalk system. The report also states that, “powered exoskeletons like the ReWalk provide non-ambulatory individuals with spinal cord injury such as the patient the ability to walk at modest speeds.” Therefore, the report concludes that the ReWalk is medically necessary for the beneficiary.

“The ruling by the independent medical organization marks an important moment for exoskeletons being accepted as protocol technology for those with spinal cord injury,” said Larry Jasinski, ReWalk CEO. “Health benefit providers have historically been hesitant to acknowledge the clinical benefits in their case assessments. This ruling, and subsequent coverage and reimbursement will help ReWalk in our efforts to facilitate greater patient access to the device.”

ReWalk continues to make inroads in its efforts to make the Personal exoskeleton system available to all eligible patients, working diligently with health coverage providers on individual patient cases, as well as in the development of general coverage policies. A

growing number of health plans and health systems worldwide have recognized the benefits of exoskeletons, and provided coverage and reimbursement to beneficiaries.

The Company worked extensively with both the patient and the health plan in this case, further demonstrating ReWalk’s dedication to facilitating increased patient access to its device.

This commercial health plan approval follows the recent news that the U.S. Department of Veterans Affairs (“VA”) issued a national policy for the evaluation, training and procurement of ReWalk Personal exoskeleton systems for all qualifying veterans across the United States.

ReWalk is the only FDA cleared exoskeleton technology for individuals with spinal cord injury. ReWalk has Class II FDA clearances for exoskeleton use in the rehabilitation and personal setting, with the latter intended for home and community use.

ReWalk is working with the recipient and the health plan provider to deliver the Personal exoskeleton system in the coming weeks. The recipient will be able to utilize the technology immediately, having completed all necessary training modules.