Obstructive Sleep Apnea (OSA)

HCPCS Code E0486

Oral Appliances: First-Line Therapy for OSA During COVID-19 Pandemic 

An Oral Appliance (OA) can Easily be Disinfected to Kill COVID-19 Viruses by Patients and Does Not Share Any of the Aerosol Liabilities Associated with CPAP Devices

The flexTAP® is an FDA-Cleared premium, lab-made custom oral appliance for treating obstructive sleep apnea (OSA) and billable under HCPCS code E0486. Offering the most efficient lab services with a 5-day in-lab lead time, ensuring quickest production and delivery.

Most Innovative Custom Oral Appliance

The flexTAP® is a customized oral appliance that has been designed to provide maximum comfort and ease of use. What makes it unique is that it is the first TAP without any metal parts. The appliance features a patented Vertex Technology that sets it apart from other similar products available in the market. The post angulation in the hardware's design is the key to FlexTAP®'s success. Moreover, FlexTAP® is equipped with a self-adjuster that makes at-home adjustments easy. The newest version of FlexTAP® comes with a blue ThermAcryl® liner, which is thinner, more durable, and easy to adjust using warm water.


To further improve comfort and treatment outcomes, FlexTAP® includes a standard nasal breathing component, which is called the FlexTAP® Mouth Shield. This makes it the first custom oral appliance to include a nasal breathing component.


Metal Free, No Bite Registration Needed, and 3 Year Warranty


Top Reasons for Choosing the Oral Appliance:

1. Patient Preference: 81% of patients preferred the FlexTAP® over CPAP machines for comfort and ease of use.


2. Quick Turnaround: Offers a 5-day in-lab lead time, ensuring rapid production and delivery.


3. Extended Warranty: Comes with a 3-year warranty, providing confidence and assurance in its durability and effectiveness.


Key Features:

- PDAC Approval: Classified under HCPCS code E0486, it meets insurance coverage and reimbursement requirements.


- Metal-Free Composition: This ensures comfort and safety with a 14 mm range of patient adjustability, accommodating various jaw positions.


- Comprehensive Support Tools: Each case includes a Mouth Shield nasal breathing trainer and an AM Aligner®, enhancing treatment effectiveness and patient comfort.


- Simplified Fitting Process: No bite registration is required, facilitating an easier and more efficient fitting experience for the provider and the patient.


The FlexTAP® is an innovative, patient-friendly solution for managing snoring and obstructive sleep apnea. It combines ease of use with effective treatment outcomes.


Reimbursable by Medical Insurance Companies

NEW flexTAP® (HCPCS E0486)

ALERT

Oral Appliances: First-Line Therapy for OSA during the COVID-19 Pandemic

https://www.aadsm.org/docs/COVID_Position_Statement.pdf


It is the position of the American Academy of Dental Sleep Medicine (AADSM) that oral appliance therapy (OAT) should be prescribed as first-line therapy for the treatment of obstructive sleep apnea (OSA) during the COVID-19 pandemic. This recommendation is being made based on the following information:


The American Academy of Sleep Medicine (AASM) has indicated that PAP therapy potentially exposes individuals, especially those in proximity to the patient, to increased risk of transmission of COVID-19.


• A number of studies have found evidence that COVID-19 can remain suspended in the air in aerosol particles.


• It is unknown whether it is possible for patients to be re-infected from re-using PAP tubing, filters, and/or masks.


• There have been reported shortages of distilled water and other supplies necessary for optimal use of PAP machines.


• Oral appliances do not generate aerosols and can be easily disinfected by patients to kill the COVID-19 virus.


According to the AADSM and AASM clinical practice guidelines, oral appliances should be prescribed for adult patients who prefer alternate therapy to PAP. During this pandemic, it is reasonable to assume that patients would prefer a therapy that both treats their OSA and does not increase the risk of COVID-19 transmission.


Oral appliance therapy is an effective treatment for OSA without increased risks for transmitting COVID-19. Patients who prefer OAT may be more likely to adhere to treatment if they are confident that their therapy is not putting those in their household at an increased risk for COVID-19 exposure.

Journal of Dental Sleep Medicine Vol 7, Nov 3, 2020

OSA is as High as 80% in Patients with Hypertension, Heart Failure, Coronary Artery Disease, Pulmonary Hypertension, Atrial Fibrillation, and Stroke

https://www.ahajournals.org/doi/10.1161/CIR.0000000000000988

Snoring and Sleep Apnea

The most common type is Obstructive Sleep Apnea (OSA) which occurs when the muscles in the back of the throat fail to keep the airway open, despite efforts to breathe. The breathing pauses repeatedly occur during sleep and last at least ten (10) seconds at a time for a minute or longer. In recent years, there is mounting data where obesity and obstructive sleep apnea sit at the epicenter and its control can lead to improvement and prevention of diabetes and cardiovascular complications. Symptoms related to sleep or screening for sleep apnea have been overlooked by cardiac, diabetic, pulmonary, and general medicine clinics despite recommendations for screening by several societies.

OSA was Found in Over 70% of Type 2 Diabetics in a Meta-Analysis, Therefore Clinicians Should Consider Treatments for Patients.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3449487

Data has been in the scientific literature for several years, indicating the associations of OSA with almost any disease like glaucoma, end-stage renal disease, chronic obstructive pulmonary disease, polycystic ovarian syndrome, metabolic syndrome, cardiovascular disease, stroke, depression, obesity, and DM. OSA has also been identified in non-obese patients and children with enlarged tonsils and adenoids. Moreover, the treatment has led to improvements in the underlying condition. Early diagnosis and treatment of OSA will help in preventing the increased morbidity and mortality associated with those conditions. Studies have shown that improvement in ejection fraction, carotid intimal thickening and benefits in coronary artery disease, maintenance of sinus rhythm from A-Fib after cardioversion, and improvement in insulin resistance while untreated OSA is associated with an increased risk of death. 

Early Diagnosis and Treatment of OSA can Significantly Reduce Morbidity and Mortality Risks

OSA, COVID, and CPAP Recall

Breathing is mandatory to sustain life and we often take it for granted until we start having trouble breathing. The novel coronavirus SARS-CoV-2 is a highly transmissible virus that causes respiratory illness in humans that can lead to death. It emerged in late 2019 and has caused a pandemic of acute respiratory disease, named ‘coronavirus disease 2019’ (COVID-19). Obstructive Sleep Apnea (OSA) involves compromised breathing during sleep and is most often managed with Positive Airway Pressure (PAP) and uses pressurized air to maintain airway patency during sleep. PAP has been considered the “First Line” therapy for OSA since it was first introduced in the early 1980s. Dentistry has used an alternative to PAP for the management of OSA, with an Oral Appliance (OA), which maintains airway patency during sleep by holding the jaw in a forward position. Studies demonstrate that only 30-40% of patients wear their PAP all night, versus approximately 90% for Oral Appliances (OA). Measurements of therapeutic benefit are similar for both devices, believed to be due to this much higher compliance rate. 

Patients on CPAP Devices Should be Prescribed an Oral Appliance (OA) to Patients Who Snore or Have Been Diagnosed with OSA or COVID-19.

PAP has been implicated with spreading COVID-19 within the Washington state nursing home in February 2020 which became ground zero in North America during this Pandemic. The First Responders that responded to the Life Care nursing facility in Kirkland Seattle in late February used nebulizers and PAP machines to treat patients. “It’s best practice for us for people with respiratory illnesses,” said Jim Whitney, medical services administrator for the Redmond Fire Department. “We had no idea that we potentially had COVID patients there… We essentially aerosolized it,” said one responder after the fact, “We made it worse”. It was only later that King County public health officials advised Redmond Fire and other first responders in the region not to use PAP for patients suspected of having COVID-19 illness. Whitney said responders were using machines with specialized filters, which can reduce the amount of virus released. But King County public health authorities recommend that first responders avoid using PAP altogether. Redmond Fire has now discontinued the use of PAP for COVID-19 patients. 

An Oral Appliance (OA) can Easily be Disinfected to Kill COVID-19 Viruses by Patients and Does Not Share Any of the Aerosol Liabilities Associated with PAP Devices

The American Academy of Sleep Medicine currently recommends that if a PAP user becomes positive for COVID-19, they should speak to their physician about assessing the risks and benefits of continuing to use the PAP device at home. Persons at risk for infection from continued PAP usage include all cohabitants of the same household. In these cases, an Oral Appliance (OA) could be considered an effective alternative to PAP. For these reasons, on November 3, 2020, an official position statement by the American Academy of Dental Sleep Medicine (AADSM) stated the following: Oral Appliance Therapy Should be Prescribed as a First-Line Therapy for OSA during the COVID-19 Pandemic (the official AADSM statement is listed below).

More Contagious Variants of COVID-19 will Continue to Emerge, and Simpler Alternatives Like Oral Appliances (OA) Should be First-Line Therapy 


On June 2021, Phillips's Respironics recalled millions of CPAPS, Bilevel PAPs, and Ventilators which sent shock waves throughout sleep medicine and has resulted in sleep lab administrators and sleep clinicians searching for alternative sleep apnea therapies for their patients. Even the very best fitting PAP devices leak, this is simply a limitation of the technology and acknowledged as acceptable by ResMed, the inventor of PAP. Now that we know about the liability associated with PAP, we should never forget it - prescribe only oral appliances.


Credit to John Viviano can be reached at John@DrViviano.com, Office: 905 212 7732, Cell: 416 500 2901 

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