Among the hurdles for exoskeletons and wearable robotics is government approval of reimbursements. Last week, Myomo Inc. said it had received Medicare Provider authorization from the Centers for Medicare & Medicaid Services under the U.S. Department of Health and Human Services. Myomo is now in the Medicare.gov supplier directory, and it can now directly bill Medicaid when it provides its MyoPro powered orthosis in 39 states and the District of Columbia. The Cambridge, Mass.-based company said it is working to meet the requirements of the remaining states.

MyoPro is designed to support the arm and restore function to the weakened or paralyzed arms of patients suffering from CVA stroke, brachial plexus injury, traumatic brain or spinal cord injury, ALS, or other neuromuscular disease or injury. Myomo claimed that it is the only device currently on the market that uses a patient’s own electromyography (EMG) signals through non-invasive sensors on the arm to restore an individual’s ability to perform basic activities. These include feeding themselves, carrying objects, and doing household tasks. Many patients are able to return to work, live independently, and reduce their cost of care, it said.

Medicare certification a milestone for Myomo

“This certification is very important to Myomo,” stated Micah Mitchell, chief commercial officer of the company. “Not only does it allow us to bill Medicare directly in the future, it also opens the door to applying for in-network contracted coverage from many private commercial insurance companies, as well as state Medicaid plans.”

“Today, reimbursement for the MyoPro orthosis is approved on a case-by-case basis by many Medicare Advantage plans, state Blue Cross/Blue Shield plans, certain Medicaid and commercial insurance plans, worker’s compensation plans, and the Veterans Administration,” said Paul R. Gudonis, CEO of Myomo. “Obtaining broader coverage would allow us to potentially better serve the qualifying beneficiaries of Medicare and other plans who suffer a paralyzed or weakened arm caused by stroke or nerve injury.”

However, more steps remain, Gudonis noted.

“I want to emphasize that we have not yet received coverage or reimbursement terms from CMS, and in fact there is no guarantee those terms will be forthcoming soon, but Provider status is an important step following on to our receiving Healthcare Common Procedure Coding System (HCPCS) codes from CMS last year,” he added. “We will continue to advocate for MyoPro coverage to help appropriate candidates obtain this useful technology for use at home, at work, and in school.”

Exoskeleton standards and approvals

In other exoskeleton news, ASTM International last week announced that its committee on exoskeletons and exosuits is developing a proposed standard to allow for digital modeling tools to evaluate existing designs and design new human-exoskeleton collaborative tasks. This would accelerate development because it would reduce the need to build expensive physical prototypes for each task, said the West Conshohocken, Pa.-based organization.

In addition, Samsung Electronics said yesterday that it is the first company in South Korea to obtain ISO 13482 certification for its Gait Enhancing and Motivating System (GEMS) Hip, an assistive personal care robot. The company also received ISO 13849 certification for GEM Hip’s safety feature limiting the maximum torque of the system’s motor.

“The acquisition of this international certification of safety is an important milestone for us,” said Sungchul Kang, senior vice president and head of the Robot Center at Samsung Research. “The certification will allow us to bring robots closer to our daily lives and enhance their accessibility and utility. We will utilize this momentum to further drive our commitment in robotics research.”