Control Bionics gains official US approval for NeuroNode as reimbursable medical device

Control Bionics (ASX: CBL) has announced that the US Centers for Medicare & Medicaid Services (CMS) have approved a new healthcare common procedure coding system (HCPCS) that identifies the NeuroNode wireless and wearable sensor as a reimbursable medical device.

NeuroNode has been created for patients with degenerative neurological diseases, spinal cord injuries, cerebral palsy and other conditions that result in movement restrictions.

The device acts as a switch, which is translated into a mouse click to manipulate a patient’s communication and control software.

Device recognition

Unlike traditional input devices such as joysticks and buttons, NeuroNode utilises electromyographic signals and 3D spatial movements to provide precise control over a patient’s speech-generating device—such as a computer, phone or tablet.

The functionality is believed to be crucial for those who cannot use standard input devices and offers a transformative solution for communication and control.

The newly-established HCPCS Level II code E2513 – designating it accessory for speech-generating device, electromyographic sensor – recognises NeuroNode as a durable augmentative and alternative communication device.

When the code takes effect in October, Control Bionics will be able to access a US$4,300 reimbursement for each unit, representing a substantial opportunity for the company to build a wholesale distribution model in the region.

Enhanced access

Chief executive officer Jeremy Steele said the code would enable healthcare providers to accurately report the use of NeuroNode, making it easier to process claims and enhancing patient access to the technology.

“While Control Bionics and its US customers have been reimbursed for the NeuroNode for many years, this has been done through a general ‘Accessories’ code, which resulted in reduced gross margins for the business,” he said.

“The introduction of this new code will allow for the direct billing of all components provided as part of our solutions.”

“We expect that the separation of NeuroNode into its own code […] will result in increased sales through our existing channels.”

He said the company would commence negotiations with private insurers for NeuroNode to be covered as an in-network device with reference to the new code.