NEWTOWN, PA — Helius Medical Technologies, Inc. (Nasdaq: HSDT) has voiced strong objections to the newly announced Medicare payment rates for its PoNS Mouthpiece, set by the Centers for Medicare & Medicaid Services (CMS). The rate, established at $2,963.30 and effective January 1, 2025, is part of CMS’s Durable Medical Equipment fee schedule. Additionally, CMS deferred its decision on the PoNS Controller payment rate to the next cycle, citing the need for further evaluation.
Dane Andreeff, President and CEO of Helius, expressed dissatisfaction with CMS’s pricing approach, stating, “We strongly disagree with CMS’ methods, rationale, pricing and deferral for determining the payment rates for both the PoNS Mouthpiece and the PoNS Controller.” He emphasized that the PoNS technology, recognized by the FDA as a Breakthrough Device, offers significant clinical benefits that justify higher reimbursement rates.
The PoNS Mouthpiece, a critical component of Helius’s neuromodulation system, had its payment classification adjusted to a lump sum, which Andreeff acknowledged as progress. However, he criticized CMS for using outdated temporary pricing as a baseline, arguing it does not reflect current market rates negotiated with major institutions like the VA, DoD, and private insurers.
CMS has also provisionally set the PoNS Controller’s reimbursement at $519.80, drawing comparisons to a TENS device, which Helius contests. “Now, under the new preliminary decision, CMS has pivoted to improperly find the PoNS Controller to be comparable to a TENS device,” Andreeff noted, indicating that Helius plans to challenge this classification at an upcoming public meeting.
Helius aims to persuade CMS to adjust its pricing using the gap-filling methodology based on market-established rates. Andreeff remains hopeful, stating, “We remain hopeful that CMS will properly set pricing for the PoNS Controller using the gap filling methodology that works off the government contract and insurance pricing.”
The company emphasizes that achieving fair reimbursement is crucial for expanding patient access to its PoNS technology, which could significantly benefit individuals with gait deficits, including those with multiple sclerosis.
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