An auto-titrating positive airway pressure (APAP)(E0601) device or a continuous positive airway pressure (CPAP)(E0601) 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
• 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). 

BiPAP without back-up rate (E0470)
Bi-level positive airway pressure without back-up rate (BiPAP)(E0470):

• Patients have confirmed diagnosis of OSA (confirmed via a positive facility-based polysomnogram (PSG) or with a positive home/portable sleep test); and
• 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 ONE (1) of the following:  
  1. Who 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 BPAP. 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
  2. For whom BiPAP is found to be more effective in the sleep lab.

BiPAP with back-up rate (E0471)
A bi-level positive airway pressure device with back-up rate (E0471) is considered not medically necessary with the primary diagnosis of OSA in adults. A participating, preferred, or network provider cannot bill the member for the denied service.

Intra-Oral Appliances (E0485, E0486 )
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.

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 the appliance is covered in case of loss or irreparable damage or wear when necessary due to a change in the patient's condition. It will be necessary for the provider to submit medical records and/or additional documentation to determine coverage in this situation.

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 (EPAP) devices are considered experimental/investigational. The safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature. A participating, preferred, or network provider can bill the member for the denied service.

Oral Pressure Therapy (OPT)(E0600, A7002, A7047)
Oral pressure therapy (OPT) devices (e.g., Winx® Sleep Therapy System) are considered experimental/investigational. The safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature. A participating, preferred, or network provider can bill the member for the denied service.

Payment for the rental of a Positive Airway Pressure (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. 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 (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 should 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 should 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 should contact the patient’s physician near the end of the rental period and ask the doctor to prescribe the purchase of the device.

Continued use beyond the first three months of therapy
The medical records must also document 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.

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

Accessories

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

A replacement cushion/pillow (A7031) is not billable when supplying an ongoing replacement of the frame with cushion/pillow (A7030). 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.

The following represents the usual maximum amount of accessories expected to be medically necessary. Replacement device is not covered if due to misuse or abuse. 

A4604 1 per 3 months	Tubing with integrated heating element for use with positive airway pressure device
A7027 1 per 3 months	Combination oral/nasal mask, used with continuous positive airway pressure device, each
A7028 2 per 1 month	Oral cushion for combination oral/nasal mask, replacement only, each
A7029 2 per 1 month	Nasal pillows for combination oral/nasal mask, replacement only, pair
A7030 1 per 3 months	Full face mask used with positive airway pressure device, each
A7031 1 per 1 month	Face mask interface, replacement for full face mask, each
A7032 2 per 1 month	Cushion for use on nasal mask interface, replacement only, each
A7033 2 per 1 month	Pillow for use on nasal cannula type interface, replacement only, pair
A7034 1 per 3 months	Nasal interface (mask or cannula type) used with positive airway pressure device, with or without head strap
A7035 1 per 6 months	Headgear used with positive airway pressure device
A7036 1 per 6 months	Chinstrap used with positive airway pressure device
A7037 1 per 3 months	Tubing used with positive airway pressure device
A7038 2 per 1 month	Filter, disposable, used with positive airway pressure device
A7039 1 per 6 months	Filter, non-disposable, used with positive airway pressure device
A7046 1 per 6 months	Water chamber for humidifier, used with positive airway pressure device, replacement, each

Quantities of supplies greater than those described in the policy as the usual maximum amounts will be denied as not medically necessary.

Either a heated humidifier (E0562) or a non-heated humidifier (E0561) is eligible for use with a covered PAP (E0470 or E0601) device when prescribed by the treating physician to meet the needs of the individual patient.

Coverage for durable medical equipment is determined according to individual or group customer benefits.

Services that do not meet the criteria of this policy will not be considered medically necessary. A Pennsylvania participating, preferred or 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.  Out of Network/Non-participating providers and providers located outside of Pennsylvania may be able to bill members if the service is denied.

Place of Service: Outpatient

Devices 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.

Description

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 patients with OSA in adults. Close follow-up for PAP device usage and problems in patients with OSA by appropriately trained health care providers is indicated to establish effective utilization patterns and remediate problems if needed.

According to the American Academy of Sleep Medicine (AASM) obstructive sleep apnea (OSA) in adults is defined as either:

• More than 15 apneas, hypopneas, or respiratory effort related arousals (RERAs) per hour of sleep (i.e., an apnea/hypopnea index (AHI) or respiratory disturbance index (RDI) >15 events/hr.) in an asymptomatic patient; or
• More than 5 apneas, hypopneas, or RERAs per hour of sleep (i.e., an AHI or RDI >5 events per hour) in a patient with symptoms (e.g., sleepiness, fatigue and inattention), or signs of disturbed sleep (e.g., snoring, restless sleep, and respiratory pauses). More than 75% of the apneas or hypopneas must have an obstructive pattern.

The AASM classifies mild, moderate and severe OSA as:

• Mild OSA: AHI of 5-15
  • Involuntary sleepiness during activities that require little attention, such as watching TV or reading
• Moderate OSA: AHI of 15-30
  • Involuntary sleepiness during activities that require some attention, such as meetings or presentations
• Severe OSA: AHI of more than 30
  • Involuntary sleepiness during activities that require more active attention, such as talking or driving

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.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

02/2001, Guidelines clarified for specific Durable Medical Equipment
02/2002, CPAP device coverage guidelines change
12/2008, Coverage guidelines for CPAP accessories
08/2009, Three month rental period now required at start of CPAP therapy
12/2010, Blue Cross Blue Shield covers CPAP and BiPAP devices to treat OSA
04/2011, CPAP compliance guidelines redefined
04/2013, Coverage criteria revised for use of positive airway pressure (PAP) devices in the treatment of obstructive sleep apnea
08/2013, Place of service designation included on additional medical policies
12/2013, Criteria revised for accessories used with a positive airway pressure device
04/2014, Criteria revised for devices used in the treatment of obstructive sleep apnea in adults

DME MAC Jurisdiction A L11528

CMS Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Section 240.4

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