NEWTOWN, PA — Helius Medical Technologies, Inc. (Nasdaq: HSDT) has announced ongoing efforts to secure fair market access for its Portable Neuromodulation Stimulator (PoNS) device. Moreover, the company expressed dissatisfaction with the recent pricing determinations from the Centers for Medicare & Medicaid Services (CMS).
Helius CEO Dane Andreeff voiced concerns over CMS’s pricing methodology, particularly the mapping of the PoNS Controller to a code for different technology. “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,” Andreeff stated.
The company argues that the CMS pricing, set to take effect in early 2025, fails to consider complete information and misclassifies the PoNS device technology, limiting its availability for Medicare patients with multiple sclerosis (MS) who suffer from balance and gait deficits. Helius has requested a meeting with CMS to address these discrepancies before the pricing becomes effective.
Helius’s response includes presenting evidence at a recent HCPCS Level 2 Public meeting, which has been recognized by the Veterans Affairs (VA) and a private payor, demonstrating a compelling case for reevaluating the PoNS pricing. The company remains hopeful that CMS will reassess their methodology and align with these findings.
The ongoing pricing challenges have delayed the commercial launch of the PoNS Therapy® and affected the company’s market valuation, restricting access to financing options. As a result, Helius is exploring strategic alternatives to enhance its operational capabilities and stockholder value.
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