In an industry first, the ReWalk Personal exoskeleton has been granted a CMS HCPCS Level II code. In addition to being a success for ReWalk Robotics, this is a giant leap forward for the entire exoskeleton industry. Effective October 1st, Centers for Medicare and Medicaid Services (“CMS”) has issued a  Healthcare Common Procedure Coding System (“HCPCS”) Level II Code K1007 in response to the company’s application.
HCPCS Level II Codes are reviewed and issued bi-annually. They include durable medical equipment accessories, orthotics, prosthetics, supplies, and starting in the 3rd Quarter of 2020 exoskeletons. The  HCPCS codes are used to identify medical products and supplies and, more importantly, to facilitate insurance claim submissions and processing for these items. The codes will be used to unlock further coverage and appropriate payment rates with U.S. national, state, and private payors (i.e. Medicare, Medicaid, and private insurers). Potentially, “those who meet the inclusion criteria as established by the Food and Drug Agency (FDA) and complete the training program will have a pathway to seek a ReWalk Personal Exoskeleton for use at home.”*
“We are committed to developing powered solutions for persons with lower limb disability as well as pursuing policies which make them available to those who may benefit from them,” said Andy Dolan*, Vice President of Marketing and Reimbursement at ReWalk Robotics. “We are also proud to be pioneers in this industry. This successful coding application follows previous key company achievements such as earning the first FDA clearance for an exoskeleton, the first – and to date most – positive coverage decisions by U.S. private insurers for their beneficiaries, collaboration with the Department of Defense to establish a policy for injured U.S. Veterans to have access to exoskeletons, and finalization of coverage policies and contracts with leading German insurers.”Â
Impact on the Exoskeleton Industry
In his illuminating talk during WearRAcon17 titled “Commercializing Human Mechatronic Technologies – The Long Climb” Achilleas Dorotheou, VP/Head, Human Motion Parker Hannifin Corporation (another long-time player in the exoskeleton industry) outlined the medical exoskeleton industry not as a race but as a marathon that will take place over many years. If that is the case, then today’s announcement puts the medical exoskeleton industry past the halfway mark.
From the point of view of the Exoskeleton Report, the above-mentioned marathon has three checkpoints:
- Reduce medical exoskeleton prototypes to products
- Recieve insurance codes
- Negotiate the process of reimbursement
From this point of view, exos have now reached the next goal post. The industry is at the next logical step of disturbing the current status quo of suing for medical exoskeleton coverage on a case-by-case basis.
References:
* Centers for Medicare & Medicaid Services Issues Code for ReWalk Personal Exoskeleton, ReWalk Robotics Press Release, July 15, 2020, link
Great news! The next steps are (1) obtain a positive coverage decision, based on a determination of whether or not an exo is “reasonable and necessary” for patients, and (2) get pricing from CMS. Both are major hurdles, and even apparent success can lead to catastrophic failure. Companies who fail to obtain coverage forever have the mark of “not reasonable or necessary”, and companies who don’t achieve adequate pricing (totally up to CMS) can be starved to death if the reimbursement pricing is too low. My fingers are crossed.
Hi Matt – We are underway in that process, and hopeful that the body of clinical evidence on exoskeletons, experience from over 600 devices sold, broad coverage policies in Germany and by the US VA as well as the track record of almost 50 different payors having made positive coverage decisions on a case by case basis helps result in positive developments!
A great result achieved!