CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Oral Appliances and Novel Devices for Obstructive Sleep Apnea — Coverage Criteria

Defines coverage and billing guidance for intraoral oral appliances for treatment of mild-to-moderate obstructive sleep apnea and states coverage stance on several novel OSA devices (EPAP, oral pressure therapy, tongue stimulation, positional trainers) for Medicare Advantage and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyOral Appliances and Novel Devices for Obstructive Sleep Apnea — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAug 1, 2022

Next Review DateN/A

Key ActionPrior authorization is not required; bill intraoral appliances under the member's durable medical equipment service and follow coding guidelines (E0485, E0486).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not requiredPrior authorization policy

E0485,E0486Covered HCPCS codes

Not coveredNovel devices status

3 visitsGlobal fee follow-ups

55+

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Coverage Criteria

Covered: Intraoral appliances (custom/prefab)

Covered when the following conditions apply for Medicare Advantage Plans and Commercial Products:

Intraoral appliance coverage: Intraoral appliances for treatment of documented mild to moderate obstructive sleep apnea are covered when rendered by doctors trained in oral sleep appliances and billed under the member's durable medical equipment service.documented mild to moderate OSA

Appliance fitting and the appliance are provided by a dentist/orthodontist experienced in making these devices; over-the-counter appliances, devices for snoring without OSA, and appliances for TMJ/bruxism are not covered.

Devices and services considered not covered for Medicare Advantage Plans and considered not medically necessary for Commercial Products include: devices for treatment of snoring that is not associated with obstructive sleep apnea; over-the-counter oral appliances for OSA; palate and mandible expansion devices; nasal expiratory positive airway pressure (EPAP) devices; oral pressure therapy devices; sleep positioning trainers with vibration; daytime electrical stimulation of the tongue; and the following HCPCS codes: K1001, K1028, K1029, and A7047.

This medical policy is provided for informational purposes and is not a guarantee of payment. Benefits and eligibility are determined by the member's subscriber agreement, member certificate, and/or employer agreement, which supersede this policy. For member-specific benefits or eligibility, contact the provider call center.

The use of listed novel technologies — including palate/mandible expansion, nasal EPAP, oral pressure therapy, daytime tongue stimulation, and sleep positioning trainers with vibration — is considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products due to insufficient evidence demonstrating improved net health outcomes.

Services determined to be not medically necessary (or medically necessary services that are non-covered benefits) are not covered and may not be billed to the member unless the member was informed and provided prior written agreement to self-pay. Claims for devices identified as not covered are subject to denial for Medicare Advantage Plans and will be considered not medically necessary for Commercial Products.

Coding and Billing Codes

Covered HCPCS codes for oral devicesHCPCSCovered

E0485	Oral device/appliance used to reduce upper airway collapsibility, adjustable or non-adjustable, prefabricated, includes fitting and adjustment
E0486	Oral device/appliance used to reduce upper airway collapsibility, adjustable or non-adjustable, custom fabricated, includes fitting and adjustment

Not covered HCPCS codesHCPCSNot Covered

K1001	Electronic positional obstructive sleep apnea treatment, with sensor, includes all components and accessories, any type
K1028	Power source and control electronics unit for oral device/appliance for neuromuscular electrical stimulation of the tongue muscle for the reduction of snoring and obstructive sleep apnea, controlled by phone application
K1029	Oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, used in conjunction with the power source and control electronics unit, controlled by phone application, 90day supply

Codes applicable to oral pressure therapy interfaces (not covered)HCPCSNot Covered

A7047

Oral interface used with respiratory suction pump, each

Unlisted codesHCPCS

unlisted DME

Claims for services or therapies without assigned CPT/HCPCS codes should be filed with the unlisted DME code

Referenced CPT code in literatureCPT

CPT 95807-52

daytime, abbreviated cardio-respiratory sleep study (as cited in a referenced trial)

Referenced External Coverage Determinationsmixed

L33611	CMS Local Coverage Determination for Oral Appliances for Obstructive Sleep Apnea
A52512	CMS Local Coverage Determination Policy Article for Oral Appliances for Obstructive Sleep Apnea

Provider Actions and Billing Guidance

Prior Authorization

Prior authorization review is not required.

Documentation Required

Follow Referenced LCDs and Payer Authorization

Follow the referenced CMS Local Coverage Determination (LCD L33611) and associated policy article (A52512). Providers are responsible for adhering to the coverage, documentation, and billing requirements in those LCDs and for obtaining any payer authorizations when required by product-specific rules.

Providers must follow CMS LCD L33611 and Policy Article A52512 where applicable.
Obtain payer authorization when required by the member's specific product/benefit plan.

Note

Definitions and Novel Treatments

Definition: Oral appliances (MADs, TRDs) and DME classification

Device typesMandibular advancing/positioning devices (mandibular advancement devices, MADs) and tongue-retaining/retaining devices (TRDs); available as prefabricated ('off-the-shelf') or custom-fabricated appliances.

PurposeReduce upper airway collapsibility to treat mild-to-moderate obstructive sleep apnea (OSA).

Clinical fitting and follow-upShould be fitted by personnel trained and experienced in oral health management with follow-up examinations, device adjustments, and follow-up polysomnography to ensure therapeutic benefit.

Medicare classificationOral appliances are categorized by Medicare as durable medical equipment (DME), not dental devices.

Global fee componentsFitting, initial evaluation, impressions, fabrication, initial fitting/education, and follow-up visits are considered part of the device global fee (see coding for HCPCS).

Background

Obstructive sleep apnea (OSA) is characterized by repetitive upper airway collapse during sleep leading to hypoxemia, arousals, and daytime sleepiness and can have cardiovascular and pulmonary consequences. Management options include weight loss, positional measures, positive airway pressure (eg, CPAP/BiPAP/APAP), and oral appliances. Oral appliances — mandibular advancing/positioning devices or tongue-retaining devices — may be custom fabricated or prefabricated and are categorized as durable medical equipment when used for documented mild to moderate OSA. For Medicare Advantage Plans and Commercial Products, intraoral appliances for documented mild to moderate OSA are covered when provided by clinicians trained in oral sleep appliances and billed under the member's DME service; appliance fitting and specified associated services are inclusive in the device global fee.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyOral Appliances and Novel Devices for Obstructive Sleep Apnea — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAug 1, 2022

Next Review DateN/A

Key ActionPrior authorization is not required; bill intraoral appliances under the member's durable medical equipment service and follow coding guidelines (E0485, E0486).

SourceLink

On This Page

First-line Therapy Context

CPAP is supported by evidence as the preferred first-line therapy for obstructive sleep apnea; oral appliances are an alternative for patients with documented mild-to-moderate OSA who are intolerant of or refuse CPAP, or when clinically indicated per the referenced LCDs.

CPAP is the first-line therapy over oral appliances.
Oral appliances are an option for documented mild to moderate OSA or when CPAP is not tolerated.

Billing Rule

Billing and Documentation for Oral Appliance Services

The global fee for an oral appliance includes the initial evaluation, dental impressions, fabrication of the appliance, initial fitting with patient education, and up to three follow-up visits. A cephalometric X-ray set (with and without the appliance) may be billed separately as diagnostic testing. Members are responsible for applicable DME copayments, coinsurance, and deductibles. Non-covered or services deemed not medically necessary may not be billed to the member unless the member was informed and agreed in writing in advance.

Global fee includes: initial evaluation; oral/dental impressions; fabrication; initial fitting, education, and teaching; three follow-up visits once patient has begun to use the device.
Cephalometric X-rays (with and without appliance) billable separately as diagnostic testing.
Member financial responsibility: applicable DME copays, coinsurance, and deductibles.
Non-covered or not medically necessary services may not be billed to the member without prior written agreement.

Denial Risk

Not Covered Devices

The following devices and services are considered not covered or not medically necessary due to insufficient evidence: nasal expiratory positive airway pressure and oral pressure therapy devices, daytime electrical stimulation of the tongue, palate and mandible expansion devices, sleep positional trainers with vibration, and over-the-counter oral appliances and devices for snoring not associated with sleep apnea. The specific non-covered HCPCS/K codes include K1001, K1028, K1029, and A7047; unlisted DME codes may be used where no specific HCPCS exists.

Not covered / not medically necessary: EPAP/OPT devices, neuromuscular tongue stimulation devices, palate/mandible expansion, positional trainers, OTC oral appliances for snoring.
Non-covered HCPCS/K codes: K1001, K1028, K1029, A7047.

Note

Benefits and Eligibility

For benefit and eligibility questions, contact the provider call center to obtain member-specific determinations. This policy is informational and not a guarantee of payment; member subscriber agreements and employer contracts govern coverage.

Contact provider call center for member-specific benefits and eligibility.

Novel or alternative OSA treatments referenced

EPAP (PROVENT)Single-use nasal expiratory positive airway pressure valves inserted into the nostrils (PROVENT).

Oral Pressure Therapy (Winx/OPT)Systems that deliver light negative pressure to the oral cavity via a mouthpiece and bedside console to pull the soft palate forward (Winx/OPT).

Positional trainer (NightBalance)Wearable device providing vibration when supine to prompt position changes for positional OSA (NightBalance).

Palate/mandible expansion (DNA/mRNA)Daytime-Nighttime Appliance (DNA) and mandibular Repositioning Nighttime Appliance (mRNA) — customized devices proposing gradual upper/lower jaw expansion to treat OSA.

Daytime tongue stimulation (eXciteOSA)Device that delivers daytime electrical stimulation of the tongue to increase muscle tone aiming to reduce snoring and mild OSA (eXciteOSA).

Clinical practice guidelines and key systematic reviews cited

AASM practice parameters and guidelinesPractice parameters and clinical practice guidelines for oral appliances and PAP devices (e.g., Kushida et al.; Morgenthaler et al.).

Systematic reviews and meta-analysesSystematic reviews/meta-analyses evaluating PAP therapy and cardiovascular outcomes and comparing CPAP with oral appliances (e.g., Yu et al.).

Positional therapy trials and reviewsRandomized trials and follow-up studies comparing Sleep Position Trainer with oral appliance therapy and positional trainer effectiveness (de Ruiter et al., Berry et al.).

AASM and specialty society clinical practice guidelinesClinical practice guidelines for diagnosis and management of OSA (e.g., AASM diagnostic guideline, Epstein et al.; AAP pediatric guidance).