PoNS device wins accreditation needed to be covered by Medicare

Stimulator is FDA-approved to help improve walking ability in MS

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The PoNS device — officially the Portable Neuromodulation Stimulator, designed to help improve walking ability in people with multiple sclerosis (MS) — has been granted the accreditation needed for Medicare and Medicaid coverage in the U.S., according to Helius Medical Technologies, which makes the device.

That designation, called the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) accreditation, was given by The Compliance Team. That team is authorized to give the accreditation by the Centers for Medicare and Medicaid Services (CMS) — the U.S. government agency that administers health insurance to older people and those with certain medical conditions and below designated income levels.

A prerequisite for billing Medicare, which provides health insurance to the elderly in the U.S., that accreditation certifies that the PoNS device meets certain standards for manufacturing and distribution, and what resources are available to patients.

“We are thrilled that PoNS has been awarded DMEPOS accreditation. Not only does the certification underscore our commitment to quality and patient care, but it is also a crucial part of our U.S. reimbursement strategy,” Dane Andreeff, CEO of Helius Medical Technologies, said in a company press release.

“Organizations that wish to bill Medicare must have accreditation from an approved agency and it’s become a standard with other funding sources as well,” Andreeff said, adding that “this certification establishes that Helius is an exemplary provider and our PoNS device has already met and exceeded CMS quality standards.”

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PoNS is non-invasive medical device that’s placed on the tongue to deliver mild electrical stimulation to the brain. This is thought to promote brain plasticity, or the brain’s ability to essentially rewire itself as new information is learned.

The device is approved in the U.S. for short-term use, in conjunction with physical therapy or supervised exercise programs, to help improve walking ability for people with MS, ages 22 and older. The device also has been authorized for use in MS patients in Canada and Australia.

Not only does the certification underscore our commitment to quality and patient care, but it is also a crucial part of our U.S. reimbursement strategy.

Clinical trial data showed that MS patients using the device for about three months experienced significant improvements in walking skills and balance relative to those using a sham device providing no electrical stimulation.

PoNS has been awarded a breakthrough therapy designations in MS in the U.S.

According to Helius, the new accreditation for the device has particular relevance in light of legislation, dubbed Transitional Coverage for Emerging Technologies, that’s now being considered in the U.S.

The aim of that legislation is to provide faster access to new, innovative medical technologies for people who are insured through Medicare. Available in all 50 U.S. states, Medicare provides health coverage to certain individuals and families, including those with disabilities, elderly people with certain income levels, some pregnant people, and children in some cases.

“If passed as currently proposed, companies with a breakthrough designation could be covered by Medicare for up to four years, allowing time to gather the necessary clinical data to prove the efficacy of their products,” Andreeff said.