In this policy, the term PAP (positive airway pressure) device will refer to both a single-level continuous positive airway pressure device (E0601) and a bi-level respiratory assist device without back-up rate (E0470) when it is used in the treatment of obstructive sleep apnea (OSA).

Used in the treatment of OSA, CPAP (E0601) is covered as durable medical equipment when ALL of the following criteria are met:

1. Sleep Study Results (attended or unattended):
   
   1. Apnea-Hypopnea Index (AHI) equal to or greater than 5 (also called the Respiratory Disturbance Index or RDI)
      
   
   
2. Results of CPAP Trial [at optimum CPAP pressure (i.e., titration study)]:
   
   1. Apnea-Hypopnea Index less than 5, or for patients with AHI greater than 20, reduction in AHI is greater than 75%
   2. No oxygen desaturation less than 85%
   3. Abolition of arrhythmia(s)(e.g., Type II second degree heart block or pause greater than 3 seconds or ventricular tachycardia at a rate greater than 140/minute lasting greater than 15 complexes)

The claim must also certify that the documentation supporting a diagnosis of OSA is available. The medical records must document (via compliance chip information or other compliance monitoring mechanism) 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.

New purchases or replacements of CPAP machines for members with an existing diagnosis of OSA do not need a compliance chip.

When all the above criteria are met, payment will be made for the rental of a CPAP device for the first three months from the original start date of therapy. After members have been using a CPAP device for three months, are found to be maintaining 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 CPAP 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 CPAP machine 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.

If a claim 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.

For auto-titrating single-level CPAP devices, use code E0601.

The use of CPAP in the treatment of congestive heart failure (CHF) patients with OSA who do not meet the above criteria will be given individual consideration. Refer all claims for medical review.

NOTE:

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

See Medical Policy Bulletin Z-8 for information on attended or unattended sleep studies.

See Medical Policy Bulletin E-34, Respiratory Assist Devices, for coverage, coding, and documentation requirements for the use of E0470 and E0471 for diagnoses other than OSA.

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.

The following represents the usual maximum amount of accessories expected to be medically necessary:

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.

For the purpose of this policy, arterial blood gas, sleep oximetry, and polysomnographic studies may not be performed by a DME supplier. A DME supplier is not considered a qualified provider or supplier of these tests for purposes of this policy's coverage and payment guidelines. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests.

Services that do not meet the medical necessity criteria on this policy will be considered not medically necessary. A participating, preferred, or network 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 should be maintained in the provider's records.

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

NOTE:

Total payments for a rental item may not exceed its allowable purchase price, except for those items identified as life sustaining DME. For information on continuous rental of life sustaining DME, see Medical Policy Bulletin E-38, Continuous Rental of Life Sustaining Durable Medical Equipment (DME).

NOTE:

The BiPap/ST Ventilatory Support System (code E0472) should not be confused with the BiPap Airway Management System (codes E0470 and E0471). The guidelines in this policy are not applicable to code E0472. See Medical Policy Bulletin E-1, Screening List for Durable Medical Equipment (DME), for guidelines on code E0472.

Description

A single-level continuous positive airway pressure (CPAP) device (E0601) delivers a constant level of positive air pressure (within a single respiratory cycle) by way of tubing and a noninvasive interface (such as a nasal, oral, or facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs.

A bi-level respiratory assist device without backup rate (E0470) allows independent setting of inspiratory and expiratory pressures to deliver positive airway pressure within a single respiratory cycle by way of tubing and a noninvasive interface (such as a nasal, oral, or facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs.

A bi-level respiratory assist device with backup rate (E0471) allows independent setting of inspiratory and expiratory pressures to deliver positive airway pressure within a single respiratory cycle by way of tubing and a noninvasive interface (such as a nasal or oral facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs. In addition, E0471 devices have a timed backup feature to deliver this air pressure whenever sufficient spontaneous inspiratory efforts fail to occur. 

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.

DME MAC Jurisdiction A L11528

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

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