Quick Summary:

An Administrative Law Judge ruled that Lifeward Ltd.’s ReWalk Personal Exoskeleton qualifies as a “reasonable and necessary” medical device, requiring Medicare coverage for a spinal cord injury beneficiary. This legal precedent follows the April 2024 CMS decision to finalize a Medicare reimbursement pathway for the device, strengthening access for Medicare participants and potentially spurring broader commercial payer coverage.

  • Administrative Law Judge ruled ReWalk Personal Exoskeleton is “reasonable and necessary” for Medicare coverage
  • Applies to eligible beneficiaries with spinal cord injuries
  • Builds on April 2024 CMS decision establishing lump-sum reimbursement and coding
  • Medicare reimbursement rate set between $81,929 and $109,238, with an established median of $91,032
  • FDA cleared the new ReWalk 7 model in March 2025
  • Ruling creates legal precedent likely to impact commercial insurer policy
  • Lifeward’s ReWalk is the first personal exoskeleton with Medicare coverage in this indication

Medicare exoskeleton coverage reached a pivotal milestone as an administrative law judge determined that Lifeward Ltd.’s ReWalk Personal Exoskeleton meets the “reasonable and necessary” threshold for Medicare reimbursement in spinal cord injury (SCI) patients. This legally binding decision, building on the April 2024 CMS reimbursement pathway, is poised to catalyze broader payer adoption and change the landscape for advanced mobility technologies.

Payer Ruling Unlocks New Era in Medical Exoskeleton Access

The recent judicial decision confirming Medicare exoskeleton coverage validates years of clinical advocacy and regulatory negotiation. Lifeward’s ReWalk, now formally recognized as medically necessary for eligible Medicare beneficiaries with spinal cord injuries, is the first personal exoskeleton to secure this critical U.S. payer status. The decision follows the Centers for Medicare & Medicaid Services’ 2024 action that established a defined lump-sum reimbursement rate for personal exoskeletons, providing reimbursement clarity for providers and patients alike.

With the decision effective immediately, Medicare claims for eligible individuals will be reimbursed in a defined range between $81,929 and $109,238, with the median national rate set at $91,032. This coding and payment structure offers predictable market access for both prescribers and device manufacturers, addressing longstanding market uncertainty and administrative burden.

The Medicare exoskeleton coverage milestone closely mirrors critical inflection points in the commercialization of novel rehabilitation technologies. Lifeward’s regulatory-reimbursement sequence, most recently culminating in the March 2025 FDA clearance for the ReWalk 7 model, parallels the successful payer pathways navigated by peer companies such as Ekso Bionics, whose Indego Personal device also benefited from CMS’s revised durable medical equipment policies in 2024.

In comparison, the April 2024 CMS fee schedule update for exoskeletons was a landmark moment, as it recognized these devices under a unique benefit category, enabling new payment codes and setting the stage for subsequent legal and policy decisions. Market access experts note that CMS coverage determinations often trigger a cascade effect in private commercial insurance, as commercial payers align clinical coverage criteria with federal standards. This amplification effect is expected now that Medicare exoskeleton coverage is backed by a legal precedent.

Further, Lifeward’s finalized payment level, determined via CMS’s “gap-filling” process, establishes a benchmark for economic value and reimbursement negotiations moving forward. By comparison, prior access challenges for powered exoskeletons largely centered on ambiguous coding, lack of precedent, and payer hesitancy to recognize functional benefits for community and home use.

“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. 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.”

– Mark Grant, CEO, Lifeward Ltd.

The ripple effect of Medicare exoskeleton coverage reverberates across the payer landscape. With nearly 40% of the U.S. spinal cord injury population covered via Medicare, VA, or Workers’ Compensation, groups are now eligible for reimbursement, and manufacturers can anticipate accelerated device adoption and a more rapid path to revenue realization.

Strategically, the convergence of FDA clearance, CMS reimbursement, and judicial affirmation represents the “gold standard” sequence for market access in advanced medical devices. For R&D leaders, this model exemplifies the synergistic advantage of aligning regulatory and payer milestones. For commercial and market access teams, the next imperative will be ensuring efficient claims adjudication, streamlined provider education, and proactive engagement with commercial payers who may now adopt more favorable benefit policies.

Meanwhile, other market entrants, such as Ekso Bionics and their Indego system, are expected to leverage the Medicare legal precedent in advocacy efforts with both state Medicaid agencies and private insurers. Competing technologies may seek to match the clinical evidence base and cost-effectiveness arguments now validated by both CMS and the courts.

Medicare exoskeleton coverage, now enshrined in both regulation and legal precedent, is set to drive industry growth, expand the addressable market, and spur new investment in advanced neurorehabilitation solutions.