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 provided updates on its efforts to achieve fair market access for its Portable Neuromodulation Stimulator (PoNS) device and announced plans to host a business update call today at 9:00am ET.
“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 Dane Andreeff, Helius’ President and Chief Executive Officer. “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 (MS) 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.”
Recent Reimbursement Updates
- 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 (MS) patients with balance and gait deficits
- Mouthpiece pricing to take effect January 1, 2025 does not reflect recent market pricing in the gap-filling analysis. Helius has requested a meeting with CMS to occur prior to the effective date in an attempt to correct the pricing
- Proposed Controller pricing incorrectly maps to a TENS device code as PoNS does not involve peripheral stimulation, and acts through neural plasticity and therefore is not grounded on the gate control theory of pain
- Timing for the pricing determination and reimbursement implementation of the Controller on April 1st, three months after the Mouthpiece, an accessory required for use of the device. 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
- Process has impacted the Company’s market value and impeded its ability to access public markets to finance its operations thus leading to the pursuit of strategic alternatives
Business Update Call
Helius management plans to host a conference call to discuss recent business updates and its efforts to achieve fair market access for the PoNS device at 9:00am ET today, November 18, 2024. Interested parties may access the live and recorded webcast here or on the “Events” page under “News & Events” on the Helius investor relations website.
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