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Helius Medical Technologies, Inc. Announces Reimbursement Payment Determination Updates from CMS for its Portable Neuromodulation Stimulator (PoNS®) Controller and Mouthpiece
-- Reimbursement Determination for the PoNS Mouthpiece (HCPCS code A4594) set at $2,963.30 on Lump Sum Payment to be challenged by Helius -- -- National
About this update from Solana Company
[{"type":"text","content":"-- Reimbursement Determination for the PoNS Mouthpiece (HCPCS code A4594) set at $2,963.30 on Lump Sum Payment to be challenged by Helius -- -- National Reimbursement Payment Determination from CMS for its PoNS Controller Deferred to the Next Cycle -- NEWTOWN, Pa., Oct. 14, 2024 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced that the Centers for Medicare & Medicaid Services (CMS) posted final Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies fee schedule payment rates for the PoNS Mouthpiece (HCPCS code A4594) at $2,963.30 to be implemented January 1, 2025 and deferred final national determination of the payment rate for the PoNS Controller (HCPCS Code A4593) to the next payment cycle. “We strongly disagree with CMS’ methods, rationale, pricing and deferral for determining the payment rates for both the PoNS Mouthpiece and the PoNS Controller. Helius has spent millions of dollars in R&D to develop technology that the FDA designated a Breakthrough Device and cleared nearly four years ago. Further, the clinical and recent claims data supports fair pricing levels that would provide value for all stakeholders. This evidence will again soon be presented to CMS in efforts to establish appropriate pricing that would facilitate market access for the millions of MS patients who continue to suffer from gait deficit without the potential benefit of PoNS. We are hopeful that we will be able to finalize fair reimbursement for the PoNS Mouthpiece and Controller with CMS in the near future,” commented Helius’ President and Chief Executive Officer, Dane Andreeff. “We believe that increased patient access to our PoNS technology will support revenue growth and as we scale, we intend to establish a pathway to positive cash flow generation as we continue pursuing authorization for stroke in the U.S.” CMS has corrected the reimbursement for the PoNS Mouthpiece as an essential accessory for which payment is made on a lump sum basis, as opposed to the preliminary determination of making monthly rental payments. The methodology used for setting the price remained the gap filling approach. “We are pleased with the progress in correctly classifying th...