Administrative Law Judge Determines ReWalk Personal Exoskeleton is “Reasonable and Necessary” for Medicare Beneficiary

Rhea-AI Summary

Lifeward (NASDAQ:LFWD) announced a significant legal victory as an Administrative Law Judge (ALJ) ruled that the ReWalk Personal Exoskeleton must be covered by Medicare as a "reasonable and necessary" medical device for individuals with spinal cord injury (SCI). This ruling follows CMS's April 2024 decision establishing a Medicare reimbursement pathway for personal exoskeletons.

The decision reinforces the medical necessity of ReWalk's technology and is expected to influence coverage decisions by commercial insurers. The ReWalk 7, the company's latest innovation and the only personal exoskeleton capable of navigating stairs and curbs, received FDA clearance in March 2025 and is now commercially available in the United States.

Positive

• Medicare coverage approval establishes legal precedent for ReWalk Exoskeleton reimbursement
• Potential expansion of coverage through commercial payors following Medicare decision
• Recent FDA clearance for ReWalk 7, offering unique stair and curb navigation capabilities
• Established Medicare reimbursement pathway through CMS decision in April 2024

Negative

• None.

Insights

Healthcare Policy & Reimbursement Expert

Medicare ruling establishes ReWalk exoskeleton as medically necessary, opening significant reimbursement pathways that should accelerate adoption and revenue growth.

The Administrative Law Judge ruling represents a landmark reimbursement victory for Lifeward's ReWalk technology. This decision—coming at the highest level of Medicare appeals—establishes legal precedent that the exoskeleton meets Medicare's critical "reasonable and necessary" standard for medical devices.

The ruling builds upon the April 2024 CMS decision that created a reimbursement pathway, now strengthened by this case-specific approval. This dual regulatory achievement creates a formidable foundation for coverage expansion.

From a market access perspective, this decision carries implications beyond just Medicare beneficiaries. The Medicare precedent typically triggers coverage cascades through commercial insurance markets, as private payers often align policies with CMS determinations. The "reasonable and necessary" designation effectively validates both the clinical utility and economic value proposition of the technology.

The timing is particularly strategic, coinciding with the March 2025 FDA clearance of the ReWalk 7 model. This regulatory-reimbursement sequence represents the ideal commercialization pathway for advanced medical technology.

What distinguishes this victory is its difficulty—Medicare coverage for advanced mobility technologies has historically faced significant hurdles. The spinal cord injury population represents a small but clinically significant market with substantial per-unit economics, making reimbursement approval the critical gatekeeper to commercial viability.

The competitive advantage of being the only exoskeleton capable of navigating stairs and curbs positions Lifeward uniquely in this emerging market segment. With both regulatory clearance and reimbursement pathways now established, the company has effectively removed the two primary barriers to market expansion.

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.

To learn more about the ReWalk 7 Personal Exoskeleton, please visit https://golifeward.com/rewalk7

About Lifeward

Lifeward designs, develops, and commercializes life-changing solutions that span the continuum of care in physical rehabilitation and recovery, delivering proven functional and health benefits in clinical settings as well as in the home and community. Our mission at Lifeward is to relentlessly drive innovation to change the lives of individuals with physical limitations or disabilities. We are committed to delivering groundbreaking solutions that empower individuals to do what they love. The Lifeward portfolio features innovative products including the ReWalk Exoskeleton, the AlterG Anti-Gravity System, the ReStore Exo-Suit, and the MyoCycle FES System. Founded in 2001, Lifeward has operations in the United States, Israel, and Germany.

Lifeward^®, ReWalk^®, ReStore^®, and Alter G^® are registered trademarks of Lifeward Ltd. and/or its affiliates.

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 the Company's future performance and other statements that are not statements of historical fact 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," "should," "would," "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 the Company’s control. Important factors that could cause the Company’s actual results to differ materially from those indicated in the forward-looking statements include, among others: the acceptance of the ReWalk 7 Personal Exoskeleton by healthcare professionals and patients; uncertainties associated with future clinical trials and the clinical development process, the product development process and FDA regulatory submission review and approval process; the Company's ability to have sufficient funds to meet certain future capital requirements, which could impair the Company's efforts to develop and commercialize existing and new products; the Company's ability to maintain and grow its reputation and the market acceptance of its products; the Company's ability to achieve reimbursement from third-party payors, including CMS, for its products; the Company's limited operating history and its ability to leverage its sales, marketing and training infrastructure; the Company's expectations as to its clinical research program and clinical results; the Company's expectations regarding future growth, including its ability to increase sales in its existing geographic markets and expand to new markets; the Company's ability to obtain certain components of its products from third-party suppliers and its continued access to its product manufacturers; the Company’s ability to navigate any difficulties associated with moving production of its AlterG Anti-Gravity Systems to a contract manufacturer; the Company's ability to improve its products and develop new products; the Company's compliance with medical device reporting regulations to report adverse events involving the Company's products, which could result in voluntary corrective actions or enforcement actions such as mandatory recalls, and the potential impact of such adverse events on the Company's ability to market and sell its products; the Company's ability to gain and maintain regulatory approvals; the Company's ability to maintain adequate protection of its intellectual property and to avoid violation of the intellectual property rights of others; the risk of a cybersecurity attack or breach of the Company's IT systems significantly disrupting its business operations; the Company's ability to use effectively the proceeds of its offerings of securities; and other factors discussed under the heading "Risk Factors" in the Company’s annual report on Form 10-K, as amended, for the year ended December 31, 2024 filed with the SEC and other documents subsequently filed with or furnished to the SEC. Any forward-looking statement made in this press release speaks only as of the date hereof. Factors or events that could cause the Company’s actual results to differ from the statements contained herein may emerge from time to time, and it is not possible for the Company to predict all of them. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Lifeward Media Relations:
Kathleen O’Donnell
Vice President, Marketing & New Business Development
Lifeward Ltd.
E: media@golifeward.com

Lifeward Investor Contact:
Mike Lawless
Chief Financial Officer
Lifeward Ltd.
E: ir@golifeward.com

FAQ

What did the Administrative Law Judge rule regarding ReWalk's exoskeleton for Medicare coverage?

The ALJ ruled that the ReWalk Personal Exoskeleton must be covered and reimbursed by Medicare as a 'reasonable and necessary' medical device for individuals with spinal cord injury.

When did Lifeward (LFWD) receive FDA clearance for ReWalk 7?

The ReWalk 7 Personal Exoskeleton received FDA clearance in March 2025 and is now commercially available in the United States.

What makes ReWalk's exoskeleton unique compared to competitors?

ReWalk is the only personal exoskeleton that enables paralyzed individuals to navigate stairs and curbs, in addition to walking in everyday environments.

How does the Medicare coverage decision affect LFWD's market potential?

The decision establishes a legal precedent that is expected to expand access through commercial payors and increase availability for the entire paralyzed community.

When did CMS establish the Medicare reimbursement pathway for personal exoskeletons?

The Centers for Medicare & Medicaid Services (CMS) finalized a Medicare reimbursement pathway for personal exoskeleton use in April 2024.