Helius Medical Technologies Fights for Fair PoNS Device Reimbursement
Helius Medical Technologies Disputes PoNS Device Reimbursement Rates
Helius Medical Technologies, Inc. (NASDAQ: HSDT), based in Newtown, has recently raised concerns regarding the reimbursement rates set by the Centers for Medicare & Medicaid Services (CMS) for its innovative PoNS Mouthpiece. The reimbursement for the device, identified by HCPCS code A4594, has been placed at $2,963.30, with this rate commencing from a future date. Meanwhile, the CMS has decided to defer the reimbursement decision for the PoNS Controller to a later cycle.
Significance of the PoNS Device
Helius’s mission revolves around addressing balance and gait issues through neuromodulation therapies. The company believes that the current reimbursement rate does not reflect the extensive research and development investments that qualified the PoNS device for Breakthrough Device status from the FDA. They plan to support this claim by providing further evidence to CMS arguing that the price should adequately represent its value, especially for patients grappling with conditions like multiple sclerosis (MS).
Leadership's Vision
Dane Andreeff, the President and CEO of Helius, remains optimistic about obtaining a more favorable reimbursement policy for both the PoNS Mouthpiece and Controller. A better reimbursement structure could enhance access for patients while bolstering the company's financial performance and revenue. Helius is also pursuing authorization to expand the device's use in treating strokes, which further emphasizes their commitment to improving patient outcomes.
CMS's Current Position and Helius's Challenges
The CMS has classified the PoNS Mouthpiece as a critical accessory, applicable for lump-sum payment. However, Helius strongly believes that the historical temporary pricing should not dictate the current reimbursement rate. They advocate for a payment structure aligned more closely with negotiated rates across various government and private entities, including the Veterans Affairs (VA) and Department of Defense (DoD).
Future Evaluations and Potential Appeals
As CMS defers the reimbursement evaluation for the PoNS Controller, they have preliminarily likened it to a transcutaneous electrical nerve stimulation (TENS) device. Helius is preparing to contest this comparison in an upcoming public meeting, and hopes to provide a clearer perspective on the device's unique benefits.
Innovation in Neuromodulation Therapy
Recognized for the Portable Neuromodulation Stimulator (PoNS), Helius offers a non-invasive therapy tailored for patients with specific neurological conditions. Currently, the device has secured authorization for sale not just in the United States but also in Canada and Australia for various medical guidelines.
Recent Studies and Financial Outlook
In recent developments, Helius has generated buzz with the initial results from the PoNSTEP study. This crucial study focuses on the PoNS Therapy’s effectiveness in improving gait among MS patients. Early findings illustrate a notable improvement in Dynamic Gait Index (DGI) scores, along with a significant correlation between adherence to therapy and increases in DGI scores, particularly in the second phase of the study that was conducted at home.
Financial Status and Strategic Initiatives
While Helius has revealed a decline in revenue during the second quarter of 2024, the company has secured financial stability projected into 2025 following a successful public offering. Moreover, it is preparing for a submission to the FDA for the authorization of stroke therapy and is searching for opportunities to expand PoNS's use to traumatic brain injuries.
Expanding Accessibility and Future Preparations
Despite experiencing financial hurdles, Helius has strategically focused on enhancing the accessibility of PoNS therapy while establishing partnerships with federal bodies such as Lovell Government Services. An impending Medicare reimbursement expected from a future date could bolster the company's revenue, pointing toward the potential for Helius to solidify and expand its presence in the healthcare space.
Frequently Asked Questions
What is the PoNS device?
The PoNS device is a Portable Neuromodulation Stimulator that is aimed at improving balance and gait in patients with neurological disorders.
Why is Helius Medical Technologies contesting CMS reimbursement rates?
Helius argues that the reimbursement rates set by CMS do not align with the significant research investments made for the PoNS device.
What are the next steps for Helius regarding CMS?
Helius plans to present additional evidence to CMS and is preparing to challenge the preliminary classification of the PoNS Controller.
Is Helius expanding its therapy offerings?
Yes, Helius is pursuing FDA authorization for the use of the PoNS device in stroke treatments and investigating its application for traumatic brain injury patients.
What financial steps has Helius taken recently?
Helius secured a successful public offering which has extended its financial stability into the upcoming years despite experiencing recent revenue declines.
About Investors Hangout
Investors Hangout is a leading online stock forum for financial discussion and learning, offering a wide range of free tools and resources. It draws in traders of all levels, who exchange market knowledge, investigate trading tactics, and keep an eye on industry developments in real time. Featuring financial articles, stock message boards, quotes, charts, company profiles, and live news updates. Through cooperative learning and a wealth of informational resources, it helps users from novices creating their first portfolios to experts honing their techniques. Join Investors Hangout today: https://investorshangout.com/
Disclaimer: The content of this article is solely for general informational purposes only; it does not represent legal, financial, or investment advice. Investors Hangout does not offer financial advice; the author is not a licensed financial advisor. Consult a qualified advisor before making any financial or investment decisions based on this article. The author's interpretation of publicly available data shapes the opinions presented here; as a result, they should not be taken as advice to purchase, sell, or hold any securities mentioned or any other investments. The author does not guarantee the accuracy, completeness, or timeliness of any material, providing it "as is." Information and market conditions may change; past performance is not indicative of future outcomes. If any of the material offered here is inaccurate, please contact us for corrections.
Related Articles
- Transforming Orthodontics: Invisalign Palatal Expander Launch
- Global Shrimp Market Trends and Innovations for 2024-2028
- Tokyo Metro's IPO Pricing Marks Major Milestone for Japan
- Transforming the US Home Furniture Market: Growth Powered by AI
- Transforming Video Management Software: Market Growth & AI Impact
- Hyperspectral Imaging Market Forecast: AI and Night Vision Surge
- Citi Research Adjusts Oil Price Forecasts Amid Conflicts
- CTS Corporation Prepares for Upcoming Earnings Release and Call
- IEHP Team Raises Significant Funds for Breast Cancer Charity
- Changing Fortunes: Why German Automakers Are Falling Behind
Recent Articles
- Evercore's Predictions for TAP, EXPE, and ABNB Ahead of Earnings
- Innovations in Compounding: Jennifer Lines to Inspire at Seminar
- Helius Medical Technologies Updates on PoNS Device Reimbursement
- Bel Fuse Inc. Welcomes Uma Pingali as Global Sales Leader
- Atossa Therapeutics Announces Participation in 2024 Healthcare Summit
- Helen Masters Takes Leadership Role at Smartsheet in APJ Region
- Understanding the Ongoing Class Action Against Iris Energy Limited
- Top Wealth Group Holding Limited Successfully Completes $10.8M Offering
- Bitcoin Cash Surges as Cryptocurrency ETFs Attract Investors
- Seeking Justice: United Parcel Service Investors Class Action
- A Fresh Look at the Upcoming Growth in Alcoholic Beverages Market
- EnLink Midstream Announces Third Quarter Distribution Update
- A Comprehensive Look at the Growing Condiments Market
- Growth Surge in Ophthalmology Devices Market Due to AI Innovations and Demand
- Stephens Initiates Valvoline Coverage with Optimistic Outlook
- Moderna Faces Tough Times with Price Target Reduced to $55
- Market Reactions to Recent Developments in Key Stocks
- Top Wealth Group Secures $10.8 Million Through Share Offering
- GEICO Sets Up Inspection Sites in Florida After Hurricane
- Exploring the Dynamics of Roku's Options Trading Landscape
- Onto Innovation's Upcoming Q3 2024 Financial Results Overview
- Understanding MARA Holdings' Growing Options Market Trends
- Stewart Information Services to Discuss Q3 2024 Results Soon
- Investor Insights: Unpacking the Swan Song for HLT Options
- United Airlines Prepares for Q3 with New Routes and Challenges
- Goldman Sachs Predicts Stock Boost with Trump Victory
- CBL Properties Declares Significant Dividend and Expansion Plans
- DCG ONE Enhances Marketing Services with Cirangle Design Buyout
- Sanjiv Razdan Takes the Helm as CEO of The Joint Corp.
- PTC Therapeutics Advances with New Drug Application for PKU Drug
- Phillips 66 Divests Key Stake as Part of Strategic Restructuring
- Modine Manufacturing's New CIO Sets Strategic Digital Vision
- Winnebago's Strategic Shift: Leadership in Towable RVs
- Coty Inc. Sees Steady Growth Despite Market Challenges Ahead
- Leadership Changes in AI: Microsoft VP Moves to OpenAI
- Brazilian Stock Market Gains Strong Momentum Amid Diverse Sectors
- U.S. Stock Markets Surge: Key Players and Sector Highlights
- Tesla's Humans Behind Optimus Bots at Recent Robotaxi Showcase
- Sabadell Chair Highlights Risks of Banking Consolidation Effects
- The Joint Corp. Welcomes Sanjiv Razdan as New CEO
- Empowering Cybersecurity Training Through Real-World Scenarios
- Legacy Housing's Upcoming Earnings Call and What to Expect
- Shoals Technologies Group Set to Share Q3 Earnings Insights Soon
- Summary of Company Shares and Voting Rights Information
- Exploring Travere Therapeutics' Latest Insights into Kidney Health
- Tragic Tesla Crash Claims Four Lives in Fiery Incident
- Voting Rights and Share Information of the Company
- Travere Therapeutics Announces Key Data at ASN Kidney Week 2024
- Marijuana Stocks Soar: Body and Mind and Global Compliance Lead Gains
- Legacy Housing Corporation Sets Earnings Call for Q3 2024