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.

An auto-titrating positive airway pressure (APAP) device or a continuous positive airway pressure (CPAP) device may be considered medically necessary for the treatment of obstructive sleep apnea (OSA) in adults and covered as durable medical equipment when the following criteria are met:

APAP

• Auto-titrating positive airway pressure (APAP) during a 2-week trial to initiate and titrate CPAP in adult patients with a confirmed diagnosis of OSA.

CPAP

• Patients have confirmed diagnosis of OSA (confirmed via a positive facility-based polysomnogram (PSG) or with a positive home/portable sleep test); and
• Apnea/hypopnea index (AHI) as follows:
  • greater than or equal to 15 events per hour of sleep in an asymptomatic patient; or
  • greater than 5 events per hour of sleep in a symptomatic patient (e.g., sleepiness, fatigue and inattention); or
  • signs of disturbed sleep (e.g., snoring, restless sleep, and respiratory pauses).

BiPAP without back-up rate
Bi-level positive airway pressure without back-up rate (BiPAP) may be considered medically necessary for the treatment of OSA in adults and covered as durable medical equipment when the following criteria are met:

• Patients have confirmed diagnosis of OSA (confirmed via a positive facility-based polysomnogram (PSG) or with a positive home/portable sleep test); and
• AHI greater than or equal to 15 events per hour of sleep in an asymptomatic patient, or
  • 5 events per hour of sleep in a symptomatic patient (e.g., sleepiness, fatigue and inattention), or
  • signs of disturbed sleep (e.g., snoring, restless sleep, and respiratory pauses) and ONE (1) of the following:  
    • Patients have failed a prior trial of CPAP. If the patient is uncomfortable or intolerant of high pressures on CPAP; the patient may be tried on BiPAP. If there are continued obstructive respiratory events at 15 cm H2O of CPAP during the titration study, the patient may be switched to BiPAP; or
    • For whom BiPAP is found to be more effective in the sleep lab.

BiPAP with back-up rate
A bi-level positive airway pressure device with back-up rate is considered not medically necessary with the primary diagnosis of OSA, in adults.

Intra-Oral Appliances
Intraoral appliances (tongue-retaining devices or mandibular advancing/positioning devices) may be considered medically necessary in adult patients with OSA when ALL of the following criteria are met:

• AHI ≥ 15 events per hour of sleep in an asymptomatic patient or > 5 events per hour of sleep in a symptomatic patient (e.g., sleepiness, fatigue and inattention) or signs of disturbed sleep (e.g., snoring, restless sleep, and respiratory pauses); and
• A trial with CPAP has failed or is contraindicated; and
• The device is prescribed by a treating physician; and
• The device is custom-fitted by qualified dental personnel; and
• There is absence of temporomandibular dysfunction or periodontal disease.

If the above coverage criteria are not met, for devices used for the treatment of OSA, the device will be considered not medically necessary and therefore not covered.

There are many different types of appliances that basically fit into one of two categories, tongue retaining appliances, and mandibular repositioning appliances. Payment may be made for one appliance. Additional appliances should be denied as not medically necessary. However, replacement of an oral appliance may be considered medically necessary when the item has reached the end of its five year reasonable use lifetime, or when wear and tear renders the item non-functionaing and not repairable, and the item is no longer under warranty. It will be necessary for the provider to submit medical records and/or additional documentation to determine coverage in this situation.

Over-the-counter (OTC) or prefabricated intra-oral appliances to treat OSA are not considered to be appropriate therapy for OSA in any clinical situation and therefore are not covered. 

Note: CPAP has been shown to have greater effectiveness than oral appliances in general. This difference in efficacy is more pronounced for patients with severe OSA, as oral appliances have been shown to be less efficacious in patients with severe OSA than they are in patients with mild-moderate OSA. Therefore, it is particularly important that patients with severe OSA should have an initial trial of CPAP and that all reasonable attempts are made to continue treatment with CPAP, prior to the decision to switch to an oral appliance.

Nasal Expiratory Positive Airway Pressure (EPAP)
Nasal expiratory positive airway pressure devices (e.g., Provent™, Theravent™) are considered experimental/investigational, and therefore, not covered. The safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature. 

Oral Pressure Therapy (OPT)
Oral pressure therapy (OPT) devices (e.g., Winx® Sleep Therapy System) are considered experimental/investigational, and therefore, not covered. The safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

Payment for the rental of a PAP device
Payment will be made for the rental of a PAP device for the first three (3) months (rental period) from the original start date of therapy, when the above clinical criteria are met. Device expenses incurred during the first three (3) months of rental will be applied to the purchase price. Payment will be made for the purchase of the device when both of the following criteria are met:

• Documented compliance with objective findings (i.e., compliance chip, telemonitoring, computer software) of device usage for three (3) consecutive months; and
• The patient is experiencing success in treatment.

Throughout the PAP device rental period, the DME supplier must check that the member is compliant with use of the device. If the device isn’t being used as prescribed, the DME supplier should contact the patient’s physician and discuss removal of the device. If the physician agrees that removal of the machine is warranted, the supplier must remove the machine and discontinue billing for the rental. However, if the member is found to be using the PAP device as directed and is achieving the desired results, the DME supplier must contact the patient’s physician near the end of the rental period and ask the doctor to prescribe the purchase of the device. Non-compliance, with the prescribed PAP therapy will render the PAP device as a non-covered service.

Compliance monitoring equipment for CPAPs, APAPs, or BiPAPs (e.g., smart card, compliance chip, telemonitoring, computer software) is considered an integral component of the function of the device and is not eligible for separate reimbursement.

Continued use beyond the first three months of therapy
The medical records must also document objective findings of compliance information, (i.e. compliance chip, telemonitoring, computer software), confirming that the member has been adhering to PAP therapy and is benefiting from its use. Adherence to therapy is defined as use of PAP ≥ 4 hours per night on 70% of nights during a consecutive thirty (30) day period anytime during the first three (3) months of initial usage.

Replacement of PAP Devices
Replacements of PAP devices for members with an existing diagnosis of OSA do not need a compliance chip if documentation of previous compliance, (i.e., compliance chip, telemonitoring, computer software), has been confirmed in the medical record.

Accessories

Liners
Liners are not interfaces for use with a PAP mask. Liners are products placed between the patient’s skin and the PAP mask interface and are made of cloth, silicone or other materials. These are not considered “interfaces” as defined in this policy.

Liners must not be billed as replacement interface for a PAP mask or as a replacement cushion for use on nasal mask interface.

A liner used in conjunction with a PAP mask is considered a comfort and convenience item and is considered a non-covered item or service. 

There is no additional payment for liners used with a PAP mask.

Accessories used with a positive airway pressure (PAP) device are covered when the criteria for the device are met. If the criteria are not met, the accessories will be denied as not medically necessary.

A replacement cushion/pillow is not billable when supplying an ongoing replacement of the frame with cushion/pillow. Billing for each individual component is considered unbundling of these supplies. The allowance of a replacement mask interface every month is considered an exception and documentation should support the medical necessity.

Note: See Table A, entitled “Usual Maximum Amount of Accessories Expected To Be Medically Necessary” on the attachment, for the usual maximum amount of accessories considered to be medically necessary. A replacement device is not covered if due to misuse or abuse and is considered a non-covered service. 

Quantities of supplies greater than those described in the policy as the usual maximum amounts will be denied as not medically necessary. Regardless of utilization, a supplier must not dispense more than a three (3)-month quantity at a time.

Either a heated humidifier or a non-heated humidifier is eligible for use with a covered PAP device when prescribed by the treating physician to meet the needs of the individual patient.

Please refer to the following Medical Policy Bulletins for additional information:

• E-34,  Respiratory Assist Devices
• E-38, Continuous Rental of Life Sustaining Durable Medical Equipment (DME)
• Z-8,  Sleep Disorder Services for Adults
• Z-64, Diagnosis and Treatment of Obstructive Sleep Apnea in Children

Experimental/Investigational (E/I) services are not covered regardless of place of service.

A device used for the treatment of obstructive sleep apnea in adults is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Quantity level limits or quantity of supplies that exceed the frequency guidelines listed on the policy will be denied as non-covered. A network provider cannot bill the member for the non-covered service.

A network provider cannot bill the member for the non-covered service.

• Link to Provider Resource Center for the Medical Policy Update

07/2015, Criteria Revised for Devices Used in the Treatment of Obstructive Sleep Apnea in Adults
05/2016, Criteria Revised for the Use of PAP Devices

• Link to Diagnosis Codes

• Link to Table Attachment(s)

• Link to References