MCIT Concerns. The Centers for Medicare and Medicaid Services (CMS) has announced it is planning to scrap the proposed Medicare Coverage of Innovative Technology (MCIT) payment rule that would have allowed four years of Medicare coverage for breakthrough device designated technologies. While an unfortunate setback, we do not believe the potential loss of MCIT to be material to the Helius story.Not Quite Dead Yet. While CMS may be looking to scrap MCIT following a 30 day comment period, the proposal was recently included in a discussion draft for the 21st Century Cures Act which is expected to come up in next year's legislative calendar. So a form of MCIT may be revised shortly in any case.MS Distribution. The vast majority of people who get MS are in the 20-50 year range, not yet eligible for Medicare coverage, although we do acknowledge having Medicare coverage could make it easier for Helius to obtain private insurance coverage for the PoNS device.Economics Work In Helius Favor. Studies indicate the lifetime cost of MS at $4.1 million or $30,000-$100,000 annually, with significant out of pocket costs incurred for specialty drugs not covered by insurance. Use of the PoNS device may reduce these annual costs. Helius was expecting all cash pay for the MS rollout in the 1H22. And recall, the big prize is stroke, which is more a 2024 event, plenty of time to validate the PoNS product for insurance coverage, in our view.Maintaining Outperform Rating. We are maintaining our Outperform rating and $20.00 12-month price target on HSDT shares. Through its PoNS device and treatment program, we believe Helius has a first mover advantage in using the tongue for neurostimulation to reduce symptoms of neurological disease or trauma. Read More >>