Administrative Law Judge Determines ReWalk Personal Exoskeleton is “Reasonable and Necessary” for Medicare Beneficiary
Decision at the highest levels of appeal in the Medicare process establishes medical necessity of the ReWalk Exoskeleton for enabling paralyzed individuals to stand and walk in everyday environments.
MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, June 24, 2025 (GLOBE NEWSWIRE) -- Lifeward Ltd., (Nasdaq: LFWD) (“Lifeward” or the “Company”), a global leader in innovative medical technology to transform the lives of people with physical limitations or disabilities, today announced the recent ruling by an Administrative Law Judge (“ALJ”) in favor of an appeal by a Medicare beneficiary that their ReWalk Personal Exoskeleton shall be covered and reimbursed by Medicare as a “reasonable and necessary” medical device that enables walking after spinal cord injury (“SCI”). The ruling establishes a legal basis that the ReWalk system constitutes a reasonable and necessary medical intervention for paralyzed individuals.
“The clinical basis for a reasonable and necessary definition of the ReWalk technology is supported by the scientific literature regarding the health benefits of being able to ambulate in everyday life,” said Keith Rose, M.D., Vice President, Medical Affairs of Lifeward. “Our focus is to work with clinicians in expanding the data and programs to broaden utilization for the health and well-being of the paralyzed community.”
“This ruling is a meaningful step in establishing a legal precedent of access for those who can benefit from being able to walk in everyday life once again,” said Mark Grant, CEO of Lifeward. “By reinforcing that personal exoskeletons are a reasonable and necessary intervention for people living with spinal cord injury, this ruling not only clarifies access for Medicare beneficiaries, but also paves the way for broader coverage through commercial payors, ultimately expanding access for the entire paralyzed community.”
The ALJ ruling builds upon the April 2024 decision by the Centers for Medicare & Medicaid Services (“CMS”) to finalize a Medicare reimbursement pathway for personal exoskeleton use, further expanding access to the ReWalk Exoskeleton for more individuals living with SCI. The ReWalk Exoskeleton is the only personal exoskeleton that enables paralyzed individuals to navigate stairs and curbs, in addition to walking in everyday environments. The latest ReWalk innovation, the ReWalk 7, received FDA clearance in March 2025 and is commercially available in the United States.