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New Oral Appliance Coverage Determination Released

In late November, the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) released a new local coverage determination for oral appliances. The policy, effective for claims with dates of service on or after January 3, 2011, states that a custom fabricated mandibular advancement oral appliance (E0486) used to treat obstructive sleep apnea is covered if certain criteria are met.

“The policy is a great step forward for both patients and providers. Choices in treatment are a must and treatment can now be personalized,” said Steve Moore, VP of sales and marketing for Airway Management Inc. “To say that everyone should have CPAP is like saying that everyone should wear the same type of shoes. Given the growing awareness that many people are not compliant with CPAP therapy, a second treatment option should increase the number of people who are successfully treated for obstructive sleep apnea.”

According to the policy:

A custom fabricated mandibular advancement oral appliance (E0486) used to treat obstructive sleep apnea (OSA) is covered if criteria A – E are met.

A. The patient has a face-to-face clinical evaluation by the treating physician prior to the sleep test to assess the patient for obstructive sleep apnea testing.

B. The patient has a Medicare-covered sleep test that meets either of the following criteria (1 or 2):

1. The apnea-hypopnea index (AHI) or Respiratory Disturbance Index (RDI) is greater

than or equal to 15 events per hour with a minimum of 30 events; or

2. The AHI or RDI is greater than or equal to 5 and less than or equal to 14 events per

hour with a minimum of 10 events and documentation of:

a. Excessive daytime sleepiness, impaired cognition, mood disorders, or

insomnia; or

b. Hypertension, ischemic heart disease, or history of stroke.

C. If the AHI >30 or the RDI >30 and meets either of the following (1 or 2):

1. The patient is not able to tolerate a positive airway pressure (PAP) device or

2. The treating physician determines that the use of a PAP device is contraindicated.

D. The device is ordered by the treating physician following review of the report of the sleep

test. (The physician who provides the order for the oral appliance could be different from the

one who performed the clinical evaluation in criterion A.)

E. The device is provided and billed for by a licensed dentist (DDS or DMD).

If all of these criteria (A-E) are not met, the custom fabricated oral appliance (E0486) will be denied as not reasonable and necessary.

“Patients can now have a custom appliance as first line treatment without the requirement to “fail” PAP therapy first,” Moore said. “If the patient has an AHI/RDI >30 events/hour, the treating physician must state that the patient is intolerant to PAP or that PAP therapy is contraindicated.”

Moore also pointed out that “strict requirements for devices must be met and only custom appliances that advance the mandible into a treatment position will qualify for payment. Custom appliances must be adjustable by the patient and advance the mandible in 1 mm increments,” Moore said. “Noncustom (boil and bite) appliances and tongue retaining devices are deemed medically unnecessary.”

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