The company’s CARE oral devices for sleep apnea are now eligible for Medicare reimbursement, broadening accessible treatment alternatives for beneficiaries.

Summary: Vivos Therapeutics Inc announced that its CARE oral appliances for sleep apnea treatment have received the necessary approvals for Medicare reimbursement. This decision enables Medicare beneficiaries to access these devices, which offer a potential resolution of obstructive sleep apnea (OSA) within about 12 months without ongoing intervention, unlike the traditionally used CPAP machines. With Medicare covering allowable charges, the treatment can reach more patients with reduced out-of-pocket expenses. This aligns with commercial billing practices and opens up Vivos’ therapy to the millions suffering from OSA, a condition linked to serious comorbidities if untreated.

Key Takeaways: 

  • Vivos Therapeutics’ CARE oral medical devices for sleep apnea treatment have received full regulatory approval for Medicare reimbursement, making them accessible to Medicare beneficiaries.
  • The CARE devices offer an alternative to CPAP machines, potentially resolving obstructive sleep apnea (OSA) within approximately 12 months without the need for further intervention in most cases.
  • The approval aligns Medicare billing practices with those of commercial insurers for the Vivos devices, significantly expanding access to an effective treatment for OSA, a condition associated with numerous health risks if left untreated.

Vivos Therapeutics Inc, a developer of oral appliance therapy for sleep apnea, announced receipt of all required regulatory approvals to enable Medicare reimbursement for its CARE oral medical devices. 

Effective immediately, millions of Medicare beneficiaries now have coverage and reimbursement for allowable charges billable to Medicare.

“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. 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,” says Kirk Huntsman, Vivos chairman and chief executive officer, in a release. “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.” 

Now, the devices, which have been proven effective for all levels of OSA severity, can be accessible to more people with less out-of-pocket cost. According to CMS, as of December 2023, 66.9 million people were enrolled in Medicare. 

Vivos provider and medical billing expert Chris Farrugia, DDS, DABSB, says in a release, “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.”

Research has shown that, when left 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. The Vivos Method is estimated to be indicated and potentially effective (within the scope of the FDA-cleared uses) in approximately 80% of cases of OSA where patients are compliant with clinical treatments.

“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. This should also drive increased patient count and utilization of our Vivos Devices and Method,” says Huntsman in a release.

Photo caption: Vivos’ mRNA oral appliance

Photo credit: Vivos Therapeutics