Positive airway pressure (PAP) devices are indicated for use in the treatment of obstructive sleep apnea (OSA). PAP devices may improve quality of life in individuals with OSA in adults. Close follow-up for PAP device usage and problems in individuals with OSA by appropriately trained health care providers is indicated to establish effective utilization patterns and remediate problems if needed.

Auto-titrating Positive Airway Pressure (APAP) or Continuous Positive Airway Pressure (CPAP)

An APAP device or a 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

• APAP during a two (2) week trial to initiate and titrate CPAP in adult individuals with a confirmed diagnosis of OSA.

CPAP

• Individuals 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 individual; or
  • Greater than five (5) events per hour of sleep in a symptomatic individual (e.g., sleepiness, fatigue, and inattention); or
  • Signs of disturbed sleep (e.g., snoring, restless sleep, and respiratory pauses).

APAP or CPAP devices not meeting the criteria as indicated in this policy are considered not medically necessary. 

Bi-level Positive Airway Pressure (BiPAP) without back-up rate

BiPAP without back-up rate may be considered medically necessary for the treatment of OSA in adults and may be considered as durable medical equipment when the following criteria are met:

• Individual has confirmed diagnosis of OSA (confirmed via a positive facility-based 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 individual, or
  • Five (5) events per hour of sleep in a symptomatic individual (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:  
    • Individual has failed a prior trial of CPAP. If the individual is uncomfortable or intolerant of high pressures on CPAP; the individual may be tried on BiPAP. If there are continued obstructive respiratory events at 15 cm H2O of CPAP during the titration study, the individual may be switched to BiPAP; or
    • For whom BiPAP is found to be more effective in the sleep lab.

BIPAP without back-up rate devices not meeting the criteria as indicated in this policy are considered not medically necessary. 

BiPAP with back-up rate

A BiPAP 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 individuals with OSA when ALL of the following criteria are met:

• AHI greater than or equal to 15 events per hour of sleep in an asymptomatic individual or greater than five (5) events per hour of sleep in a symptomatic individual (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.

Intra-oral devices not meeting the criteria as indicated in this policy are considered not medically necessary. 

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 (1) appliance. Additional appliances are considered not medically necessary. However, replacement of an oral appliance may be considered medically necessary when the item has reached the end of its five (5) year reasonable use lifetime, or when wear and tear renders the item non-functioning 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 non-covered. 

Note: CPAP has been shown to have greater effectiveness than oral appliances in general. This difference in efficacy is more pronounced for individuals with severe OSA, as oral appliances have been shown to be less efficacious in individuals with severe OSA than they are in individuals with mild-moderate OSA. Therefore, it is particularly important that individuals 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 EPAP devices (e.g., Provent™, Theravent™) are considered experimental/investigational, and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature. 

Oral Pressure Therapy (OPT) 

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

Daytime Electrical Stimulation Devices

Daytime electrical stimulation (eXciteOSA) of the tongue is considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-review literature. 

Sleep Positioning Trainer

Sleep positioning trainer with vibration is considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-review 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 EITHER of the following criteria is met:

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

Throughout the PAP device rental period, the durable medical equipment (DME) supplier must check that the individual is compliant with use of the device. If the device isn’t being used as prescribed, the DME supplier should contact the individual'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 individual is found to be using the PAP device as directed and is achieving the desired results, the DME supplier must contact the individual'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, tele monitoring, and 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 (3) months of therapy
The medical records must also document objective findings of compliance information, (i.e. compliance chip, tele monitoring, computer software), confirming that the individual has been adhering to PAP therapy and is benefiting from its use. Adherence to therapy is defined as use of PAP greater than or equal to four (4) hours per night on 70% of nights during a consecutive 30-day period anytime during the first three (3) months of initial usage.

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

Cleaning Devices

PAP devices have directions from the manufacturing company included for cleaning. CPAP sanitizer cleaning systems are considered convenience items and therefore non-covered. 

Accessories

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

Liners
Liners are not interfaces for use with a PAP mask. Liners are products placed between the individual'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.

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 below  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. 

** Allowing for a three (3) month supply* Allows for a 10 day delivery before run-out

Quantities of supplies greater than those identified as the usual maximum amounts are considered 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 may be considered medically necessary for use with a covered PAP device when prescribed by the treating physician to meet the needs of the individual.