A continuous positive airway pressure (CPAP) device (E0601) or an auto-titrating positive airway pressure device (APAP) device (E0601) may be considered medically necessary and covered as durable medical equipment (DME) for the treatment of OSA when the following criteria is met:

• apnea/hypopnea index (AHI) ≥ 15 as documented by polysomnography (PSG) or home/portable sleep study, or
• AHI ≥ 5 and < 15 as documented by PSG or home/portable sleep study, and accompanied by documented symptoms of OSA (e.g., excessive daytime sleepiness, impaired cognition, mood disorders or insomnia) or when the individual has hypertension, ischemic heart disease or history of stroke

When all the above criteria are met, payment will be made for the rental of a PAP device for the first three months (rental period) from the original start date of therapy. After members have been using a PAP device for three months, are found to be maintaining documented compliance with its use, and are experiencing success in treatment, payment will be made for the purchase of the device (after the expenses incurred for the first three month’s rental have been applied to the purchase price).

Throughout the PAP device rental period, the DME supplier should check that the member is compliant with use of the device at a minimum of weekly intervals. 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.

If a request is received for an E0601 is submitted and all of the criteria above have not been met, it will be denied as not medically necessary.

A respiratory assist device (e.g., BiPap – E0470) is covered for those patients with OSA who meet the criteria above, when CPAP (E0601) has been tried and proven ineffective. Ineffective is defined as documented failure to meet therapeutic goals using an E0601 during the titration portion of a facility-based study or during home use despite optimal therapy (i.e., proper mask selection and fitting and appropriate pressure settings).

If E0470 is billed and CPAP has not been tried and proven ineffective, payment will be based on the allowance for the least costly medically appropriate alternative, E0601.

A bi-level positive airway pressure device with back-up rate (E0471) is not medically necessary if the primary diagnosis is OSA. If E0471 is billed with a diagnosis of OSA, payment will be based on the allowance for the least costly medically appropriate alternative, E0470 or E0601.

PAP for a diagnosis of CHF alone is considered experimental/investigational. A participating, preferred, or network provider can bill the member for this denied service.

The use of CPAP in the treatment of CHF patients with OSA needs to seek medical review for individual consideration.

Additional information can be found in the following policies:

For information on sleep disorder services for adults, see Medical Policy Bulletin Z-8.

For information on the use of CPAP devices in the treatment of OSA in children, see Medical Policy Bulletin E-50.

For information on respiratory assist devices, see Medical Policy Bulletin E-34.

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

The use of positive airway pressure (PAP) devices for the treatment of obstructive sleep apnea is typically an outpatient procedure which is only eligible or 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. 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.

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

DME MAC Jurisdiction A L11528

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

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BCBSA Medical Policy Reference Manual 2.01.18

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