Vivos Therapeutics (NASDAQ:VVOS) announced that its CARE oral medical devices for obstructive sleep apnea (OSA) have been approved for Medicare reimbursement.
The company said this milestone achievement will allow millions of Medicare beneficiaries coverage and reimbursement for allowable charges billable to Medicare.
“We are very pleased the Centers for Medicare and Medicaid Services (CMS) recognizes and validates the benefits our FDA-cleared devices can have on the lives of patients diagnosed with OSA,” Vivos CEO Kirk Huntsman commented.
“Now these novel and patented devices, which have been proven effective for all levels of OSA severity in adults from mild to severe, can be accessible to more people with less out-of-pocket cost.”
He continued: “We believe this latest regulatory approval represents an inflection point for our devices and will open the door for more OSA patients who have Medicare or commercial medical insurance coverage to receive treatment from Vivos-trained professionals utilizing our proprietary core technology and treatment protocols.”
It is estimated that approximately 54 million adults in the US have OSA. When untreated, OSA can increase the risk of comorbidities, such as high blood pressure, heart failure, stroke, diabetes, dementia, chronic pain and other debilitating, life-threatening diseases.
“Prior to these latest developments, moderate to severe OSA patients on Medicare were relegated almost entirely to a lifetime of some form of CPAP—something most patients find undesirable,” Huntsman said.
“Our CARE oral medical devices, on the other hand, can significantly improve and even resolve OSA in about 12 months, with no further intervention required in most cases.”
Vivos provider and medical billings expert Chris Farrugia added that this coding decision from CMS now aligns with standard commercial billing practices for the device under the code K1027 as an oral device appliance used to reduce upper airway collapsibility, without a fixed mechanical hinge.
“This is a big step in making Vivos’ therapy accessible to Medicare beneficiaries as well as the millions of OSA patients covered by commercial insurers,” Farrugia said.