Helius Medical Technologies is challenging recent decisions from the U.S. Centers for Medicare & Medicaid Services (CMS) regarding reimbursement for its Portable Neuromodulation Stimulator (PoNS) device. Designed to aid mobility in individuals with multiple sclerosis (MS), the PoNS device’s long-term accessibility may be limited by the reimbursement framework established by these public health insurance programs.
Starting in 2025, CMS plans to reimburse approximately $3,000 for the mouthpiece of the PoNS device, while a preliminary reimbursement of slightly over $500 has been indicated for its controller, pending a final decision in the next payment cycle. Helius argues that these coverage levels could restrict access for MS patients who could benefit from this innovative technology. The company intends to engage with CMS to advocate for a more equitable reimbursement scheme before the changes take effect.
Company Position on CMS Decisions
Dane Andreeff, president and CEO of Helius, expressed strong disagreement with CMS’s rationale and pricing methods. In a press release, he highlighted that the company has invested millions in research and development for a device recognized as a breakthrough by the U.S. Food and Drug Administration (FDA). Approved for use in MS patients in 2021, the PoNS device is available at a list price of $25,700, reduced to a cash price of $14,500 after an instant rebate.
Andreeff stated, “We are hopeful that we will be able to finalize fair reimbursement for the PoNS mouthpiece and controller with CMS in the near future.”
Reimbursement Challenges
The PoNS device, a short-term treatment option for adults aged 22 and older with mild to moderate mobility issues related to MS, is utilized in conjunction with supervised physical rehabilitation. The system features a mouthpiece that delivers electrical signals through the tongue, and its efficacy is linked to enhancing physical therapy outcomes.
When determining coverage, CMS considers factors such as market pricing and the value of similar technologies. Initially, Helius subsidized the device to facilitate patient access while negotiating reimbursement agreements. However, CMS based its current reimbursement decision on that earlier pricing, which does not reflect actual market values. Helius has successfully secured higher reimbursement rates from other major insurers, including the U.S. Department of Veterans Affairs (VA).
Recently, Helius reached its first third-party reimbursement agreement for PoNS, with the payer agreeing to cover $16,554 for the controller and $7,347 for the mouthpiece. The VA also committed to paying $23,843 for the entire PoNS device and $7,344 for the mouthpiece, significantly higher than the proposed CMS reimbursements.
Future Engagement with CMS
Andreeff confirmed plans to approach CMS prior to the implementation of the new pricing to advocate for adjustments that reflect market values established through negotiations with other insurers.
Regarding the controller, CMS’s initial pricing has been labeled as insufficient, particularly as it likens the PoNS controller to transcutaneous electrical nerve stimulation (TENS) devices meant for pain management, which the company disputes. The final pricing decision is expected in the next payment cycle, with a public meeting scheduled for November to further discuss the issue. Helius plans to present the unique advantages of the PoNS controller during this meeting.
With ongoing negotiations and advocacy efforts, Helius Medical Technologies continues to seek a resolution that guarantees fair reimbursement rates for the PoNS device, ultimately benefiting MS patients in need of innovative mobility solutions.
