Helius Medical provides update on PoNS device pricing regulation

Helius Medical (HSDT) provided updates on its efforts to achieve fair market access for its Portable Neuromodulation Stimulator – PoNS – device. “We disagree with the proposed pricing for the PoNS Mouthpiece and are disappointed CMS has once again mapped the Controller pricing to a code for fundamentally different technology,” said CEO Dane Andreeff. “In the face of this challenge our team’s response has been impressive as we continue to pursue fair market access for Medicare’s Multiple Sclerosis patients with balance and gait deficit. At the November 8th HCPCS Level 2 Public meeting we again refuted CMS’ methodology and presented compelling evidence in support of fair pricing for the PoNS device. Our diligent response and extensive evidence, outlined here today, has been successfully understood by the VA and a private payor. We are hopeful CMS can reach the same conclusions, and we will continue to support their reassessment.” CMS issued pricing determinations for both the PoNS Controller and Mouthpiece that the company believes reflect incomplete information and erroneous assessments of the technology, which currently preclude market access to PoNS device prescriptions for Medicare’s patients with balance and gait deficits. Helius has requested a meeting with CMS to occur prior to the effective date in an attempt to correct the pricing. Helius plans to request the Controller pricing to be set in tandem with the Mouthpiece on January 1st. Enduring a third review cycle for PoNS Controller pricing and the uncertain timeline has delayed access to PoNS Therapy for qualified MS patients and delayed Helius’ commercial launch. The process has impacted the company’s market value and impeded its ability to access public markets to finance its operations, leading to the pursuit of strategic alternatives.