The Centers for Medicare & Medicaid Services (CMS) in the US has set a preliminary payment determination of $94,617 for ReWalk’s personal prosthetic exoskeleton.
The pricing comes as the agency included the device on the agenda for the upcoming Healthcare Common Procedure Coding System (HCPCS) meeting on 29 November.
The news comes hot on the heels of the exoskeleton’s inclusion within the brace benefit category for reimbursement, which is paid on a lump sum basis. The addition of exoskeletons to the category followed a rule change released by the CMS on 1 November 2023, with it going into effect on 1 January 2024.
The CMS reached the payment determination through a ‘gap filling’ process – necessary for devices that incorporate new technology that cannot be described by existing codes. After analysing 2020 market transactions of ReWalk’s personal exoskeleton – which was found to be $125,000 – the CMS adjusted for deflation and updated adjustment factors to reach $94,617.
A final payment determination is expected in early 2024, with 1 April 2024 listed as the effective date.
ReWalk’s exoskeleton received US Food and Drug Administration (FDA) clearance for use on stairs and kerbs in March 2023. This made it the first personal exoskeleton in the country to receive FDA support for this kind of use. The device has already been available for some years to patients with paralysis in Europe since its initial CE mark in 2012.
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ReWalk stated it will participate in the upcoming meeting after the CMS said it welcomed additional information “to ensure that the Medicare payment amount for this code accurately reflects the full market of devices that would be classified in this code.”
ReWalk Robotics CEO Larry Jasinsk suggested the company will discuss pricing further, highlighting the expanded clearance for stairs and kerbs that was authorised after ReWalk’s original application to CMS.
Jasinsk stated: “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 kerbs.”
The rule change by CMS also meant Myomo’s MyPro upper-limb paralysis brace was added to the category. Ekso Bionics’ Indego personal exoskeleton could also be covered; the company has a pending application to confirm its applicability.