The Centers for Medicare & Medicaid Services (CMS) has Pricing, Data Analysis and Coding (PDAC)-verified AIOMEGA Biotechnology’s AIO Breathe series of four oral appliances for snoring or mild to moderate obstructive sleep apnea (OSA) in adults.

AIO Breathe (model AIOBR-00), AIO Breathe Comfort (model AIOBRC-001), AIO Breathe MB (model AIOBRMB-002), and AIO Breathe MB Comfort (model AIOBRMBC-003) have been assigned HCPCS code K1027.

K1027 is for oral devices/appliances used to reduce upper airway collapsibility, without fixed mechanical hinges, that are custom-fabricated, and it includes fitting and adjustment.

“I am so excited to finally bring this incredible piece of technology within reach of folks that suffer from sleep apnea,” says sleep physician Raghu Ghuge, MD, founder of AIOMEGA. “CMS PDAC is a serious badge of honor for a device manufacturer that truly holds value-based health care at heart.”

According to Ghuge, the benefits of the AIO Breathe include:

  • Total Antero-Vertical Mandibular-Lingual Repositioning Device (TAVMLRD) that operates through a novel concept of AAVOAT (Adaptive Antero-Vertical Open Airway Therapy). “Its AI-predictive flange design provides breath-to-breath increase in airflow that matches oxygen demand in real time,” Ghuge says.
  • Increases 3-dimensional airway size along the entire length of the human airway in adults. “This means subconscious mouth opening during sleep effortlessly increases momentary anterior advancement of the mandible, proven on cone beam CT scan airway geometry analysis while using an AIO Breathe,” he says.
  • For the dentist, this means one prescription takes care of the patient’s need. “No adjustments needed and no worry about TMJ,” according to Ghuge.
  • For the patient, it means instant effective therapy without the need for recurrent titration.

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