Helius Announces CMS Payment Determination of Reimbursement for PoNS

NEWTOWN, Pennsylvania,—Helius Medical Technologies, Inc., a neurotech company focused on delivering a therapeutic neuromodulation approach for balance and gait deficits, announced that the Centers for Medicare & Medicaid Services (CMS) posted proposed Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) fee schedule payment rates for the PoNS Controller and Mouthpiece to be discussed at the bi-annual Healthcare Common Procedure Coding System (HCPCS) Public Meeting, scheduled for May 29, 2024.

For the PoNS Mouthpiece (HCPCS code A4594), CMS-based pricing on the cash pay price of $4,500, resulting in a total capped payment of $3,075.53. For the PoNS Controller (HCPCS Code A4593), CMS preliminarily set pricing by mapping reimbursement to existing code E0745, (Neuromuscular stimulator, electronic shock unit), resulting in a total capped fee of $1,206.53.

“CMS’s preliminary determination of reimbursement for both the PoNS Controller and Mouthpiece is a significant win for Helius,” stated Helius’ President and Chief Executive Officer, Dane Andreeff. “We intend to present at the HCPCS Public Meeting on May 29, 2024, and expand on how PoNS differs, mechanistically and therapeutically, from any neuromuscular peripheral stimulation therapy. We will present arguments to support a higher reimbursement rate for the PoNS Controller using the gap-filling methodology, along with advocating for reimbursing the PoNS Mouthpiece through the lump sum payment structure at a higher rate than the one established in the preliminary determination.

“Once the decision is finalized, the payment rates will be effective Oct. 1, 2024. We believe Medicare price determination will allow us to expand reimbursement across third-party payers and give us a pathway to positive cash flow as we continue pursuing authorization for stroke in the U.S,” Andreeff said. 

The preliminary payment determinations published by CMS for discussion at the Public Meeting are only proposed fee schedule rates. The company cannot provide any assurance that these rates will be finalized and adopted in their current amounts, or at all.