Curated News
By: NewsRamp Editorial Staff
January 30, 2026
REMSleep Secures Medicare Coding Approval for DeltaWave Sleep Therapy System
TLDR
- REMSleep's HCPCS approval gives DME providers a competitive edge by enabling Medicare and private insurance billing for all DeltaWave configurations, facilitating nationwide distribution.
- REMSleep achieved full commercial readiness through sequential milestones: expanded FDA clearance in January 2026, followed by complete PDAC coding approval for all product configurations.
- The DeltaWave system's expanded availability and insurance coverage will improve sleep therapy outcomes for diverse patient populations across home, institutional, and laboratory settings.
- REMSleep's product portfolio was shaped by customer feedback, resulting in tailored options like pillow-only configurations for sleep lab diagnostic titration needs.
Impact - Why it Matters
This development significantly impacts millions of Americans suffering from sleep apnea and other respiratory conditions who rely on CPAP and BiPAP therapy. With Medicare and private insurance reimbursement now secured for all DeltaWave configurations, patients gain access to a more versatile and potentially more comfortable nasal pillow system without facing prohibitive out-of-pocket costs. For healthcare providers, this eliminates billing uncertainties and expands treatment options, particularly for the 20-30% of CPAP patients who struggle with initial mask failure. The expanded FDA clearance covering multiple care environments means patients can maintain continuity of care from sleep laboratories to home settings, potentially improving therapy adherence and health outcomes. In a market where comfort and compliance are critical challenges, this regulatory breakthrough enables broader adoption of a solution that addresses specific patient needs identified through real-world feedback.
Summary
REMSleep Holdings, Inc. (OTCQB: RMSL), a medical device company, has achieved a critical breakthrough with its DeltaWave™ nasal pillow system by securing Healthcare Common Procedure Coding System (HCPCS) approvals from the Pricing, Data Analysis, and Coding (PDAC) contractor for its entire product portfolio. This milestone, announced via NEWMEDIAWIRE, represents the final regulatory requirement needed for the company's full commercial launch, allowing durable medical equipment (DME) providers to bill Medicare and private insurance payors for all configurations of the FDA-cleared DeltaWave system. CEO Thomas Wood emphasized that this approval, combined with expanded FDA 510(k) clearance granted on January 7, 2026, provides DME partners with everything needed for nationwide distribution across home care, institutional, and sleep laboratory settings.
The expanded DeltaWave product portfolio reflects valuable feedback from early adoption partners during REMSleep's Q4 2025 soft launch, with DME providers and sleep laboratories identifying specific component combinations and sizing variations required to better serve diverse patient populations. Operations manager Jeff Marshall explained that some providers prefer complete systems while others need separate components tailored to patient demographics, and sleep labs requested pillow-only options for diagnostic titration. This customer-driven approach has shaped a comprehensive offering that addresses the varied needs of the sleep therapy market, with the company achieving zero product returns and receiving repeat orders during early market validation.
With all regulatory and reimbursement barriers now cleared, REMSleep is activating a sophisticated three-channel commercial strategy targeting DME providers serving CPAP patients who fail their initial mask, establishing sleep laboratory partnerships for diagnostic titration, and supplying hospital respiratory departments and long-term care facilities for BiPAP and ventilation support. The company has systematically progressed through key operational milestones since December 2025, including infrastructure buildout, sales force training, and now complete PDAC coding approval, positioning itself to execute a full-scale national launch. This development marks a significant advancement in sleep therapy technology, offering healthcare providers and patients a versatile, reimbursable solution backed by comprehensive regulatory approvals and market validation.
Source Statement
This curated news summary relied on content disributed by NewMediaWire. Read the original source here, REMSleep Secures Medicare Coding Approval for DeltaWave Sleep Therapy System
