NEWTOWN, PA — Helius Medical Technologies, Inc. (Nasdaq: HSDT) is on the brink of a significant financial milestone following the Centers for Medicare & Medicaid Services’ (CMS) announcement of proposed Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) fee schedule payment rates for its pioneering PoNS device. The device, which includes a controller and mouthpiece, is under review at the upcoming Healthcare Common Procedure Coding System (HCPCS) Public Meeting scheduled for May 29, 2024.
The PoNS (Portable Neuromodulation Stimulator) device, designed to aid in the treatment of neurological symptoms through cranial nerve stimulation, has been assigned preliminary pricing by CMS. The PoNS Mouthpiece (HCPCS code A4594) has a proposed total capped payment rate of $3,075.53, based on its cash pay price of $4,500. The controller (HCPCS Code A4593) is preliminarily set at a total capped fee of $1,206.53, aligned with existing reimbursement codes for comparable neuromuscular stimulators.
Helius President and CEO Dane Andreeff hailed CMS’s initial reimbursement determination as a crucial victory for the company. Andreeff outlined plans to advocate for higher reimbursement rates during the HCPCS Public Meeting, emphasizing the PoNS device’s unique therapeutic benefits compared to existing neuromuscular peripheral stimulation therapies.
Should these proposed rates receive final approval, effective October 1, 2024, they would represent a key step toward broader third-party payer reimbursement for the PoNS device. This in turn could significantly enhance Helius’ financial position by providing a clearer path to positive cash flow, particularly as the company seeks authorization for additional uses in the U.S., including stroke treatment.
However, it is important to note that these rates are not yet finalized and could be subject to change following the public meeting discussions. The outcome of these proceedings will be closely watched by stakeholders within the medical and investor communities alike, as it could set a precedent for the reimbursement of innovative medical technologies.
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