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FAQ: REMSleep's Medicare PDAC Coding Approval for DeltaWave Product Portfolio
TL;DR
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.
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REMSleep Holdings, Inc. has received Healthcare Common Procedure Coding System (HCPCS) approvals from the PDAC contractor for the entire DeltaWave product portfolio, allowing durable medical equipment providers to bill Medicare and private insurance payors for all configurations of the DeltaWave system.
This approval represents the final regulatory requirement needed for REMSleep's full commercial launch, combining with expanded FDA 510(k) clearance to enable nationwide distribution across multiple healthcare settings.
Thomas Wood, CEO and founder of REMSleep, and Jeff Marshall, REMSleep's operations manager, are key figures. DME providers, sleep laboratories, and patients are affected as the approval enables billing and distribution to serve diverse patient populations.
Key milestones include expanded FDA 510(k) clearance on January 7, 2026, and complete PDAC coding approval for all DeltaWave configurations on January 21, 2026, following a soft launch in Q4 2025 and infrastructure buildout in December 2025.
The system will be distributed nationwide across home care, institutional, and sleep laboratory settings, including DME providers, sleep laboratories for diagnostic titration, and hospital respiratory departments and long-term care facilities.
The expansion was informed by 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 needed to better serve patient populations.
The three-channel strategy includes: 1) DME/HME rescue mask positioning targeting CPAP patients who fail their initial mask, 2) sleep laboratory partnerships for diagnostic titration, and 3) institutional sales to hospital respiratory departments and long-term care facilities for BiPAP and ventilation support.
DME providers now have all necessary components for billing Medicare and private insurers, while patients gain access to a complete solution with various configurations tailored to different needs across multiple care environments.
Feedback revealed 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, which informed the portfolio expansion.
Curated from NewMediaWire
