ReWalk, Myomo could benefit from proposed new Medicare rule

The MyoPro (left) and Personal Exoskeleton (right) could benefit from a proposed Medicare ruling. [Images from ReWalk Robotics and Myomo]

A new proposed rule from the Centers for Medicare and Medicaid Services (CMS) could benefit companies like ReWalk Robotics (Nasdaq:RWLK) and Myomo (NYSE:MYO).

The proposed rule would establish a new regulatory definition of “brace.” In Myomo’s case, it aims to classify the L8701 and L8702 HCPCS codes as “brace.”

Adding the definition of brace would expedite coverage and payment for newer technology and powered devices, according to CMS. This potentially enables faster access to the newer technologies, like those made by ReWalk and Myomo.

CMS released the proposal on June 30.

How ReWalk Robotics benefits from the proposed Medicare ruling

ReWalk said in a news release that it “applauds” the CMS proposal, which includes personal exoskeletons in the Medicare benefit category for braces. Benefits would extend to the ReWalk Personal Exoskeleton platform, which allows paralyzed patients to stand and walk.

Once finalized, the benefit category would cover leg, arm, back and neck braces, with payments on a lump sum basis.

During the 60-day comment period ending Aug. 29, 2023, stakeholders can submit comments and feedback on the proposal. ReWalk expects its finalization to come in early November.

“CMS has used this Proposed Rule to identify a path forward to provide this life-changing technology to beneficiaries with SCI,” said ReWalk CEO Larry Jasinski. “Proposing a clear Medicare benefit pathway for personal exoskeletons eliminates one of the largest barriers preventing Medicare beneficiaries from access to these innovative devices. The inclusion of a policy addressing personal exoskeletons in this Proposed Rule is a significant milestone for the SCI community.”

How Myomo benefits

Myomo said its request to CMS to classify its MyoPro as a brace, has been published for public comment. MyoPro is a wearable medical robotics platform. It offers increased functionality for those suffering from neurological disorders and upper-limb paralysis.

Currently, MyoPro falls under the HCPCS billing codes L8701 and L8702. Coverage falls on consideration of each patient’s medical necessity for a powered arm brace. In June 2022, Myomo appealed to CMS to change the benefit category from durable medical equipment (reimbursed as a rental) to a brace. This would enable it to fall under the lump sum payment category that applies to ReWalk.

The 60-day comment period applies to Myomo as well. CMS intends to publish a fee for MyoPro codes in an upcoming public meeting. Myomo expects that meeting to take place in late 2023 or early 2024.

“This proposed rule represents the culmination of a multi-year effort to obtain the proper classification for the MyoPro as a brace. We are pleased with this outcome and intend to work with CMS and others in the orthotics and prosthetics industry to support the proposed rule, which, if enacted, is expected to support health equity by providing access to the MyoPro for medically-qualified Medicare Part B beneficiaries,” said Myomo CEO Paul Gudonis.

Myomo also filed initial claims with CMS’ billing contractors, which remain under detailed review. The company said it can’t predict whether the CMS proposed rule impacts the review of the initial claims.