ReWalk Robotics Ltd. (Nasdaq: RWLK) ("ReWalk" or the "Company"), a leading provider of innovative technologies that enable mobility and wellness in rehabilitation and daily living for people with neurological conditions, today announced that the Centers for Medicare & Medicaid Services ("CMS") has added the ReWalk Personal Prosthetic Exoskeleton System to the agenda for the upcoming Healthcare Common Procedure Coding System ("HCPCS") on November 29, 2023 and submitted a preliminary payment determination of 94,171 $. November 29, 2023 and submitted a preliminary payment determination in the amount of 94,617 $.
"The inclusion of the ReWalk exoskeleton in the upcoming HCPCS agenda and the proposed provisional pricing is a tremendous step forward in our efforts to ensure broader access to exoskeletons for the significant percentage of the spinal cord injury community with Medicare coverage," said Larry Jasinski, CEO of ReWalk Robotics. "ReWalk is encouraged by the process CMS uses to set its preliminary pricing and by CMS' statements that they are open to receiving updated information on pricing that reflects the groundbreaking technological developments, including technology that enables walking on stairs and curbs, that 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."
This news follows CMS' prior determination through rulemaking that personal exoskeletons, such as the ReWalk Personal Exoskeleton, fall within the benefit category of orthotics reimbursed by Medicare on a lump sum basis. The provisional payment was made by CMS through a "gap-filling" process applied in light of CMS's determination that lower extremity exoskeletons have "revolutionary features" that cannot be described by any existing code or combination of codes. As part of the gap-filling process, CMS uses verifiable pricing information from suppliers or commercial invoices and adjusts it using a deflation and update factor methodology. In applying this formula to the code describing the ReWalk in-person exoskeleton, CMS relied on average prices from market transactions in 2020, which CMS set at $125,500, resulting in preliminary Medicare prices of $94,617.
CMS notes that it would welcome materials that include information on updated, verifiable market transactions from ReWalk, as well as from other manufacturers of similar bilateral lower limb exoskeletons, to "ensure that the Medicare payment amount for this code accurately reflects the entire market of devices classified in this code." ReWalk will be attending the upcoming HCPCS meeting on November 29, 2023 to provide additional information to ensure that the Medicare payment rate accurately reflects the exoskeleton device market, including the current ReWalk Personal Exoskeleton, which received FDA approval in March 2023 and received Breakthrough Device status from the FDA as the only commercially available exoskeleton with advanced technology to navigate paralyzed real-world environments with stairs and curbs. A final payment determination is expected in early 2024 with an effective date of April 1, 2024.
About ReWalk Robotics Ltd.
ReWalk Robotics Ltd. is a medical technology company that designs, develops and commercializes innovative technologies that enable mobility and well-being in rehabilitation and daily living for people with neurological conditions. ReWalk's mission is to fundamentally change the quality of life for these people through the creation and development of market-leading technologies. Through the recent acquisition of AlterG, Inc., ReWalk has added anti-gravity systems to its growing product portfolio. ReWalk was founded in 2001 and has offices in the United States, Israel and Germany. For more information on ReWalk systems, visit rewalk.com. For more information on AlterG systems, visit alterg.com.
ReWalk and ReStore are registered trademarks of ReWalk Robotics Ltd. in the United States and other countries. AlterG is a registered trademark of AlterG, Inc. in the United States and other countries.