Custom Fabricated Oral Appliances for Obstructive Sleep Apnea (OSA)(Eff. beginning 1.1.24) Form

Obstructive Sleep Apnea (OSA)

Obstructive sleep apnea (OSA), the most common form of sleep apnea, is the collapse of the upper airway leading to the reduction or cessation of airflow during sleep. These episodes may be associated with oxygen desaturation. There are three different forms of sleep apnea, obstructive, central, and mixed.

The Apnea Hypopnea Index (AHI) represents the average number of apneas and hypopneas experienced each hour during sleep and is a diagnostic tool used to determine the presence and severity of obstructive sleep apnea.

Oral Devices for OSA

Oral devices are used to treat obstructive sleep apnea (OSA) by restoring airway competence. The restoration of airway competence is intended to reduce morbidity and mortality by reversing hypoxia, hypercapnia, and acidosis as well as improving quality of life.

Clinical Guideline Coverage Criteria

The Plan uses guidance from the Centers for Medicare and Medicaid Services (CMS) and MassHealth for coverage determinations for its Dual Product Eligible plan members. CMS National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Local Coverage Articles (LCAs) and documentation included in the Medicare manuals and MassHealth Medical Necessity Determinations are the basis for coverage determinations where available.

For Tufts Health One Care plan members the following criteria is used:

• Oral Appliances for Obstructive Sleep Apnea LCD L33611

For Harvard Pilgrim Health Care Commercial Members

The Plan requires the use of the following InterQual® Subsets or SmartSheets to obtain prior authorization for custom fabricated oral appliances:

1. Mandibular Advancement Oral Appliance, Adjustable, Custom Fabricated Mandibular Advancement Oral Appliance

In addition, the Member must be aware of the following:

2. Positive airway pressure (PAP) is superior at improving the AHI and oxyhemoglobin saturation. Oral appliance therapy may not provide optimal improvement in oxygenation.
3. Possible side effects with oral appliance treatment, including complications of TMJ.

For Tufts Health Plan Members:

NOTE: Request for custom fabricated oral appliance must be submitted by a certified sleep specialist.

The Plan may authorize the coverage of an FDA-approved (custom fabricated only) oral appliance/device when ALL the following criteria are met:

1. Recent face-to-face clinical evaluation with a sleep specialist certified by an approved specialty board of the American Board of Medical Specialties (e.g., ABIM); and
2. Recent documentation of a facility based or home approved sleep study; and
3. Clinical documentation submitted by certified sleep specialist does not suggest a change in clinical status (e.g., change in cardiac, pulmonary, neuromuscular condition, substantial weight loss, upper airway surgery) since previous sleep study; and
4. There is evidence of obstructive sleep apnea established by a previous sleep study documenting:
   • An AHI or respiratory disturbance index (RDI) of ≥ 5 and <15 and documentation of one or more of the following: Excessive daytime sleepiness, impaired cognition, mood disorder, insomnia, hypertension, ischemic heart disease or history of stroke. Excessive daytime sleepiness must be assessed using the Epworth Sleepiness Scale. An Epworth score ≥10 is required to confirm excessive daytime sleepiness; or
   • An Apnea Hypopnea Index (AHI) or RDI of ≥15 and ≤ 30 or
   • An Apnea Hypopnea Index (AHI) or (RDI) >30;
5. There is documentation from a sleep specialist certified by an approved specialty board of the American Board of Medical Specialties (e.g., ABIM), that the Member has had a previous trial of positive airway pressure (PAP) that failed or was not tolerated for the following reasons:
   • Significant clinical improvement was not demonstrated with a trial of PAP; or

The device trialed could not be tolerated because of claustrophobia, inability to breathe through nose, pain or increasing levels of discomfort;

• Custom Fabricated Oral Appliances for Obstructive Sleep Apnea (OSA)

6. The following information has been discussed with the Member by certified sleep specialist:
   • Positive airway pressure (PAP) is superior at improving the AHI and oxyhemoglobin saturation. Oral appliance therapy may not provide optimal improvement in oxygenation; and
   • Possible side effects with oral appliance treatment, including complications of TMJ

Authorization of a Replacement of or Repair to Custom Oral Appliance

The Plan may authorize replacement or repair of oral appliance when the following criteria are met:

1. Equipment in use ≥ 5 years; or
2. Replacement is necessary due to loss, theft, or irreparable damage; and
3. Member benefits from and is adherent to use of current/previous

Limitations

The Plan does not cover custom oral appliances when:

1. The Member is less than 18 years of age
2. The requested oral appliance is available over the counter or is not custom-made
3. The Member has a diagnosis of central sleep apnea
4. The oral appliance is being requested for snoring without documentation of OSA
5. The oral appliance is being requested to treat central sleep apnea
6. Facility PAP titration study and unattended auto-titration of PAP (APAP) do not qualify as a trial of PAP
7. Convenience item (e.g., for travel)
8. Nasal dilators are not considered appliances for OSA
9. Distributed/interrupted sleep of spouse/partner

Mandibular Anterior Repositioning Appliances/Devices

Mandibular Anterior Repositioning Devices should only be constructed by a dentist with experience in this type of appliance. Compliance and efficacy will be dependent upon the comfort and fit of this appliance.

The Plan does not cover "Morning Repositioner" as this device is considered investigational. Refer to Noncovered Investigational Services Medical Necessity Guidelines.

Codes