Oral appliances are used to reposition oral and pharyngeal tissues in an effort to create and maintain a patient's airway during sleep.

For any item to be covered, it must:

1. be eligible for a defined Medicare benefit category;
2. be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member; and,
3. meet all other applicable statutory and regulatory requirements.

For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage.

For an item to be covered, a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary.

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

1. 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.
   
   
2. The patient has a covered sleep test that meets one of the following criteria (1 - 3):
   
   
   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:
      
      1. Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or,
      2. Hypertension, ischemic heart disease, or history of stroke, or
         
         
   3. If the AHI> 30 or the RDI> 30 and meets either of the following(a or b):
      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.
         
         
3. 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.)
   
   
4. The device is provided and billed for by a licensed dentist (DDS or DMD).

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

Custom fabricated appliances that achieve their effect through positioning of the tongue (E1399) will be denied as not medically necessary. There is insufficient evidence to show that these items are effective therapy for OSA.

A prefabricated oral appliance (E0485) will be denied as not medically necessary. There is insufficient evidence to show that these items are effective therapy for OSA.

Custom fabricated mandibular advancement devices that do not meet the requirements in the Coding Guidelines section of this policy (E1399) will be denied as not medically necessary.

Services that do not meet the medical necessity criteria on this policy will be considered not medically necessary. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Definitions

As used in this policy, physician refers to a licensed MD, DO, nurse practitioner, clinical nurse specialist, or physician's assistant working within their scope of practice. The term physician does not include a dentist (DDS or DMD).

Apnea is defined as the cessation of airflow for at least 10 seconds.

Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds associated with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4% decrease in oxygen saturation.

The apnea-hypopnea index (AHI) is defined as the average number of episodes of apnea and hypopnea per hour of sleep without the use of a positive airway pressure device. For purposes of this policy, respiratory effort related arousals (RERAs) are not included in the calculation of the AHI. Sleep time can only be measured in a Type I (facility-based polysomnogram) or Type II sleep study (see descriptions below).

The respiratory disturbance index (RDI) is defined as the average number of apneas plus hypopneas per hour of recording without the use of a positive airway pressure device. For purposes of this policy, respiratory effort related arousals (RERAs) are not included in the calculation of the RDI. The RDI is reported in Type III, Type IV, and Other home sleep studies.

If the AHI or RDI is calculated based on less than 2 hours of sleep or recording time, the total number of recorded events used to calculate the AHI or RDI (respectively) must be at least the number of events that would have been required in a 2-hour period (i.e., must reach ≥30 events without symptoms or ≥10 events with symptoms).

Sleep Tests

Coverage of an oral appliance for the treatment of OSA is limited to claims where the diagnosis of OSA is based upon a covered sleep test (Type I, II, III, IV, Other). A covered sleep test must be either a polysomnogram performed in a facility-based laboratory (Type I study) or a home sleep test (HST) (Types II, III, IV, Other). The test must be ordered by the member's treating physician and conducted by an entity that qualifies as a Medicare provider of sleep tests and is in compliance with all applicable state regulatory requirements.

A Type I sleep test is the continuous and simultaneous monitoring and recording of various physiological and pathophysiological parameters of sleep with physician review, interpretation, and report. It is facility-based and must include sleep staging, which is defined to include a 1-4 lead electroencephalogram (EEG), and electro-oculogram (EOG), submental electromyogram (EMG) and electrocardiogram (ECG). It must also include at least the following additional parameters of sleep: airflow, respiratory effort, and oxygen saturation by oximetry. It may be performed as either a whole night study for diagnosis only or as a split night study to diagnose and initially evaluate treatment.

An HST is performed unattended in the member's home using a portable monitoring device. A portable monitoring device for conducting an HST must meet one of the following criteria:

1. Type II device – Monitors and records a minimum of seven (7) channels: EEG, EOG, EMG, ECG/heart rate, airflow, respiratory movement/effort and oxygen saturation; or,
   
   
2. Type III device – Monitors and records a minimum of four (4) channels: respiratory movement/effort, airflow, ECG/heart rate and oxygen saturation; or,
   
   
3. Type IV device - Monitors and records a minimum of three (3) channels, one of which is airflow; or,
   
   
4. Other - Devices that monitor and record a minimum of three (3) channels that include actigraphy, oximetry and peripheral arterial tone and for which there is substantive clinical evidence in the published peer-reviewed medical literature that demonstrates that the results accurately and reliably correspond to an AHI or RDI as defined above. This determination will be made on a device-by-device basis (WatchPAT [Itamar Medical] is currently the only approved device in this category).

All members who undergo an HST must, prior to having the test, receive instruction on how to properly apply a portable sleep monitoring device. This instruction must be provided by the entity conducting the HST and may not be performed by a DME supplier. Patient instruction may be accomplished by either:

1. Face-to-face demonstration of the portable sleep monitoring device's application and use; or
   
   
2. Video or telephonic instruction, with 24-hour availability of qualified personnel to answer questions or troubleshoot issues with the device.

All sleep tests must be interpreted by a physician who holds either:

1. Current certification in Sleep Medicine by the American Board of Sleep Medicine (ABSM); or,
   
   
2. Current subspecialty certification in Sleep Medicine by a member board of the American Board of Medical Specialties (ABMS); or,
   
   
3. Completed residency or fellowship training in a program approved by an ABMS member board and has completed all the requirements for subspecialty certification in sleep medicine except the examination itself and only until the time of reporting of the first examination for which the physician is eligible; or,
   
   
4. Active staff membership of a sleep center or laboratory accredited by the American Academy of Sleep Medicine (AASM) or The Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations – JCAHO).

No aspect of an HST, including but not limited to delivery and/or pickup of the device, may be performed by a DME supplier. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests.

Reasons for Non-coverage

Oral occlusal appliances used to treat temporomandibular joint (TMJ) disorders of the jaw are considered dental-related items and are non-covered.

Oral appliances used to treat other dental conditions are non-covered.

Oral appliances used to treat snoring without a diagnosis of OSA are non-covered.

All follow-up care, including fitting, adjustments, modifications, professional services (not all-inclusive) required during the first 90 days after provision of the oral appliance are considered to be included in the payment for device. Claims for these will be denied as not separately payable.

After the initial 90-day period, adjustments, modifications and follow-up visits are not eligible for coverage under the DME benefit.

Repairs are covered for items that meet the coverage criteria. To repair means to fix or mend and to put the item back in good condition after damage or wear. Repairs are covered when necessary to make the item serviceable. If the expense for repairs exceeds the estimated expense of purchasing another item, no payment can be made for the amount of the excess.

Oral appliances are eligible for replacement at the end of their 5-year reasonable useful lifetime (RUL). These items may be replaced prior to the end of the 5-year RUL in cases of loss, theft, or irreparable damage. Irreparable damage refers to a specific accident or to a natural disaster (e.g., fire, flood). Replacement due to wear-and-tear as the result of everyday use will be denied as statutorily non-covered prior to the expiration of the 5-year RUL.

Documentation Requirements

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected procedure code. Items submitted with an EY modifier will be denied as not medically necessary.

The diagnosis code that justifies the need for these items must be included on the claim.

Suppliers must add a KX modifier to a code only if all of the criteria in the "Indications and Limitations of Coverage" section of this policy have been met. If the requirements for the KX modifier are not met, the KX modifier must not be used.

If all of the coverage criteria have not been met, the GA or GZ modifier must be added to a claim line for the oral appliance. When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Pre-Service Denial Notice or the GZ modifier if they have not obtained a valid Pre-Service Denial Notice. Services submitted with a GA modifier will be denied as not medically necessary and are billable to the member. Services submitted with a GZ modifier will be denied as not medically necessary and are not billable to the member.

Claim lines billed without a GA, GZ, or KX modifier will be rejected as missing information.

Physicians shall document the face-to-face clinical evaluation in a detailed narrative note in their charts in the format that they use for other entries. The report would commonly document pertinent information about the following elements, but may include other details. Each element would not have to be addressed in every evaluation.

History

• Signs and symptoms of sleep disordered breathing including snoring, daytime sleepiness, observed apneas, choking or gasping during sleep, morning headaches;
  
  
• Duration of symptoms
  
  
• Validated sleep hygiene inventory such as the Epworth Sleepiness Scale (see Attachment)

Physical Exam

• Focused cardiopulmonary and upper airway system evaluation
  
  
• Neck circumference
  
  
• Body mass index (BMI)

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Mandibular advancement devices reposition the mandible in a forward position.

Tongue positioning devices reposition the tongue through the use of a vacuum-bulb or other mechanism such as bars, prongs or extensions (not all-inclusive) in a depressed and/or more anterior position.

A prefabricated oral appliance (E0485) is one, which is manufactured in quantity without a specific patient in mind. A prefabricated oral appliance may be trimmed, bent, molded (with or without heat), or otherwise modified for use by a specific patient (i.e., custom fitted). Any appliance that does not meet the definition of a custom fabricated oral appliance is considered prefabricated. E0485 is used for all prefabricated oral appliances used for the treatment of OSA including, but not limited to, mandibular advancement devices, tongue positioning appliances, etc.

A custom fabricated oral appliance (E0486) is one which is individually and uniquely made for an individual patient. It involves taking an impression of the patient's teeth and making a positive model of plaster or equivalent material. Basic materials are cut, bent, and molded over the positive model. It requires more than trimming, bending, or making other modifications to a substantially prefabricated item. A custom fabricated oral appliance may include a prefabricated
component (e.g., the joint mechanism).

Code E0486 may only be used for custom fabricated mandibular advancement devices. To be coded as E0486, custom fabricated mandibular advancement devices must:

1. Have a mechanism that is hinged or jointed at the sides, front or palate, and
   
   
2. Have a mechanism that allows the mandible to be advanced, and
   
   
3. Be able to protrude the mandible beyond the front teeth at maximum protrusion, and
   
   
4. Be adjustable by the member in increments of one millimeter or less, and
   
   
5. Retain their adjustment setting when removed.

Custom fabricated mandibular advancement devices that do not incorporate all of the criteria (1-5) above must not be coded as E0486 and must be coded as E1399.

Custom fabricated tongue positioning appliances are coded E1399.

Oral appliances used to treat snoring without a diagnosis of OSA established with a sleep test as described in this policy are coded A9270. The provider cannot bill the member for the denied service.

Suppliers should contact the Pricing, Data Analysis, and Coding (PDAC) contractor for guidance on the correct coding of these items. https://www.dmepdac.com/

Provider News

04/2011, Medicare Advantage covers oral appliances for obstructive sleep apnea, patients must meet specific criteria

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the patient’s medical records will reflect the need for the care provided. The patient’s medical records include the physician’s office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

Covered Diagnosis Codes

For procedure code E0486