Jeffrey Mathiesen
CFO at Helius Medical Technologies
Specifically, in April, we partnered with Lovell Government Services and SBA-certified service-disabled veteran-owned small business to make PoNS Therapy accessible to MS patients treated at the VA and through our other federal agencies. The VA is the largest integrated healthcare system in the United States and home to a network of multiple sclerosis centers of excellence. The VA estimates that between 55,000 and 70,000 veterans in the U.S. live with MS. As the only portable and readily accessible therapy that may lead to neuroplasticity, PoNS is a potential game changer for these veterans and their families, and we're happy to be a preferred provider and help more service members access this treatment. Shortly thereafter, in May, PoNS was approved for inclusion in the VA Federal Supply Schedule and the General Services Administration Advantage contracts at pricing of $23,843.72 and $7,344.97 for the PoNS device and the PoNS mouthpiece, respectively. Also in May, we received the first third-party reimbursement of $23,900 from a major insurance carrier for a PoNS device. Then in July, PoNS was approved for inclusion in the DAPA contract for the Department of Defense at $23,724.50 and $7,308.25 for the PoNS device and the PoNS mouthpiece, respectively. These were all important accomplishments in establishing market pricing for PoNS as we pursue reimbursement at CMS and third-party payers. Last quarter, CMS assigned HCPCS codes covering the PoNS controller and mouthpiece, and in May, released its preliminary Medicare payment determinations for both. This was a significant reimbursement and access milestone for Helius, and we were gratified to know that CMS understood the benefits of this innovative treatment. We were pleased with this development, but believe there is a strong argument for higher reimbursement rates for both the mouthpiece and controller, which we presented at the CMS public meeting on May 29, as well as in subsequent written communications. First, we argued that it was appropriate to categorize the mouthpiece as a supply item to be reimbursed on a lump sum payment structure. As a reminder, the mouthpiece has a 14-week life and involves application to a patient's tongue. So therefore, we believe a 13-month cap rental structure is not appropriate. Additionally, we provided recent contract pricing and invoices to support the market pricing at pricing levels I previously discussed, to be used for setting of the reimbursement using the gap-filling method. We also articulated how PoNS is not a neuromuscular peripheral stimulation therapy, and therefore it is not appropriate to map pricing to such devices. Instead, we argued reimbursement for the controller should be established using the gap-filling methodology based on market pricing. CMS is expected to publish final reimbursement rates in the coming weeks. Once finalized, the payment rates will be effective October 1, 2024. We are also actively assisting several MS patients as they submit claims with other third-party payers on a one-off basis in attempts to secure reimbursement. Beginning in June, we began building out a sales rep organization to service the VA sites throughout the U.S. To date, we have established sales representatives covering 13 states, including Texas and Florida, plus Puerto Rico. We believe having boots-on-the-ground representatives focused on neurological disorders and that have established relationships with the individual VA sites, will be critical to building out sales across the VA facilities in the U.S. I'll pause for a second and just see if Dane has rejoined.
