CMS Sets Preliminary Reimbursement Level for ReWalk Exoskeleton

ReWalk Robotics, a provider of technologies that enable mobility and wellness in rehabilitation and daily […]

ReWalk Robotics, a provider of technologies that enable mobility and wellness in rehabilitation and daily life for those with neurological conditions, today announced that the Centers for Medicare and Medicaid Services (CMS) has included the company’s personal prosthetic exoskeleton system in the agenda for the upcoming Healthcare Common Procedure Coding System (HCPCS) meeting at the end of November, providing a preliminary payment determination of $94,617.

The announcement comes only days after CMS finalized its Calendar Year 2024 Home Health Prospective Payment System Rule CMS-1780 which now formally includes exoskeletons in the Medicare brace benefit category. The rule, issued Nov. 1, will take effect on Jan. 1, 2024.

CMS determined through rulemaking that personal exoskeletons such as ReWalk’s device fall within the brace benefit category, which is reimbursed by Medicare on a lump sum basis.

Previously, purchasers of the device have received reimbursement in only certain cases. In 2015, the Veterans Association (VA) issued a national policy for the evaluation, training, and procurement of ReWalk personal exoskeleton systems for all qualifying veterans across the United States. The VA policy was the first national coverage policy in the US for qualifying individuals with spinal cord injury. According to a Form 10-K submitted by the company in 2015, in some cases, insurance companies provided reimbursement upon request, but other insurance companies categorized ReWalk as an experimental therapy and therefore did not provide coverage. Medicare and Medicaid also provided reimbursement for ReWalk rehabilitation sessions, but the coverage saw limits to frequency of treatment sessions. Private insurance companies reimbursed on a case-by-case basis.

Then in July of 2020, ReWalk received CMS HCPCS level II code K1007 for its 6.0 exoskeleton system, which became effective on Oct. 1 of that year and marked the first such code for an exoskeleton medical device. Also in October, the company announced it had received authorization from CMS as a Medicare provider. The authorization means that ReWalk is able to bill Medicare directly for the procurement of its device for Medicare beneficiaries.

Now, the news of the CMS preliminary payment determination means the company will be able to provide access to a broader population of individuals. The payment determination was made through a “gap filling process applied in light of CMS determining that lower extremity exoskeletons incorporate ‘revolutionary features’ that cannot be described by any existing code of combination of codes,” according to a press release.

CMS uses verifiable supplier or commercial invoice pricing information and adjusts according to deflation and update factor methodology. When applying this formula to the code for the ReWalk device, CMS relied on average prices from 2020 market transactions, which were determined to be $125,500, resulting in the preliminary Medicare pricing of $94,617. The service stated that it welcomes materials providing information on updated verifiable market transactions from the company as well as any other makers of similar products to “ensure that the Medicare payment amount for this code accurately reflects the full market of devices that would be classified in this code.”

The final payment determination for ReWalk is expected in early 2024 with an April 1, 2024, effective date.

“The inclusion of the ReWalk Exoskeleton within the upcoming HCPCS agenda and the proposed preliminary pricing is a tremendous step forward in our efforts to ensure broader access to exoskeletons for the substantial percentage of the spinal cord injury community with Medicare coverage,” said Larry Jasinski, CEO of ReWalk, in the company press release. “ReWalk is encouraged by the process used by CMS to determine its preliminary pricing, and by the statements from CMS that they are open to receiving updated information on pricing that reflects the breakthrough technological developments, including technology that enables ambulation on stairs and curbs, which have been implemented since ReWalk’s 2020 application. We look forward to continuing to work with CMS at the upcoming HCPCS meeting later this month.”

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