REMSleep Holdings, Inc. has received Healthcare Common Procedure Coding System approvals from the Pricing, Data Analysis, and Coding contractor for its complete DeltaWave product portfolio, enabling durable medical equipment providers to bill Medicare and private insurance payors for all configurations of the sleep therapy system. This development represents the final regulatory requirement for the company's full commercial launch following expanded FDA 510(k) clearance granted on January 7.
The PDAC coding approvals are significant because they remove reimbursement barriers that previously limited market access. With both expanded FDA clearance and full reimbursement coding now established, REMSleep can begin nationwide distribution across multiple healthcare settings. This matters to patients, providers, and the sleep therapy industry because it expands access to a medical device that addresses specific needs within the positive airway pressure therapy market.
"This marks a critical milestone for our DME partners who now have everything they need the expanded FDA clearance, HCPCS codes for all configurations, and a fully stocked inventory," said Thomas Wood, CEO and founder of REMSleep. The company's product portfolio expansion was informed by feedback from early adoption partners during a Q4 2025 soft launch, with providers identifying specific component combinations and sizing variations required to better serve diverse patient populations.
Sleep laboratories requested pillow-only options for diagnostic titration, while some providers preferred complete systems and others needed separate components tailored to their patient demographics. This feedback shaped the final product offering that now has full reimbursement approval. The implications extend beyond REMSleep's commercial prospects to potentially impact how sleep therapy equipment is developed and marketed, with increased attention to provider input and patient-specific configurations.
Since December 2025, REMSleep has achieved several operational milestones including infrastructure buildout, sales force training, and early market validation with zero product returns and repeat orders. The company is now activating a three-channel commercial strategy targeting durable medical equipment providers serving CPAP patients who fail their initial mask, sleep laboratory partnerships for diagnostic titration, and institutional sales to hospital respiratory departments and long-term care facilities.
"We are now fully equipped to execute our strategy across multiple channels," said Jeff Marshall, REMSleep's operations manager. With all regulatory approvals in place, the company is positioned to address what it identifies as a significant market segment the 20-30% of CPAP patients who experience mask failure with initial therapy. The availability of insurance reimbursement for all DeltaWave configurations through Medicare and private payors could influence prescribing patterns and equipment selection in sleep medicine practices.
The broader impact of this development includes potential changes to how sleep therapy equipment is integrated across care settings, from initial diagnosis in sleep laboratories to long-term management in home and institutional environments. By securing coding approvals for the complete product portfolio, REMSleep has addressed a key challenge in medical device commercialization ensuring providers can obtain reimbursement for the specific configurations their patients require. This could serve as a model for other medical device companies navigating the complex intersection of regulatory clearance and reimbursement pathways.
