A 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.

For any item to be covered, it must:

1. be eligible for a defined Medicare benefit category;
2. be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member; and,
3. meet all other applicable statutory and regulatory requirements.

For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage.

Initial Coverage

A single level continuous positive airway pressure (CPAP) device (E0601) is covered if the patient has a diagnosis of obstructive sleep apnea (OSA) documented by an attended, facility-based polysomnogram and meets either of the following criteria (1 or 2):

1. The apnea-hypopnea index (AHI) is greater than or equal to 15 events per hour, or
2. The AHI is from 5 to 14 events per hour with documented symptoms of:

   1. Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or,
   2. Hypertension, ischemic heart disease, or history of stroke.

If a claim for a CPAP device (E0601) is submitted and the criteria above have not been met, it will be denied as not medically necessary.

For an item to be covered, a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary.

The apnea-hypopnea index (AHI) is defined as the average number of episodes of apnea and hypopnea per hour and must be based on a minimum of 2 hours of sleep without the use of a positive airway pressure device, reported by polysomnography using actual recorded hours of sleep (i.e., the AHI may not be extrapolated or projected).

For the purpose of this policy, polysomnographic studies must be performed in a facility based sleep study laboratory, and not in the home or in a mobile facility. These labs must be qualified providers of Medicare services and comply with all applicable state regulatory requirements.

For the purpose of this policy, polysomnographic studies must not be performed by a DME supplier. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests.

If there is discontinuation of usage of an E0601 device at any time, the supplier is expected to ascertain this, and stop billing for the equipment and related accessories and supplies.

Continued Coverage Beyond the First 3 Months of Therapy
Continued coverage of an E0601 device beyond the first three months of therapy requires that, no sooner than the 61st day after initiating therapy, the supplier ascertain from either the member or the treating physician that the member is continuing to use the CPAP device.

If the above criterion is not met, continued coverage of an E0601 device and related accessories will be denied as not medically necessary.

Accessories
Accessories used with an E0601 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, in the absence of documentation clearly explaining the medical necessity of the excess quantities, will be denied as not medically necessary.

Either a non-heated (E0561) or heated (E0562) humidifier is covered when ordered by the treating physician for use with a covered E0601 device.

All services that do not meet the medical necessity criteria on this policy will be considered not medically necessary.  Effective January 26, 2009, a 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, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Documentation Requirements

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected procedure code.

When billing for quantities of supplies greater than those described in the policy as the usual maximum amounts, documentation supporting the medical necessity for the higher utilization must be available on request.

Proper use of the KX modifier is discussed below. The KX modifier must not be used on claims submitted until the requirements outlined in the documentation section have been met.

Initial Coverage (First 3 Months)
On claims for the first through third months, suppliers must add a KX modifier to codes for equipment (E0601) and accessories only if all of the criteria in the “Indications and Limitations of Coverage” section of this policy ("Initial Coverage") have been met.

Continued Coverage Beyond the First 3 Months of Therapy
On the fourth month’s claim (and any month thereafter), the supplier must add a KX modifier to codes for equipment (E0601) and accessories only if both the "Initial Coverage" criteria and the "Continued Coverage" criteria in the “Indications and Limitations of Coverage” section of this policy have been met.

Suppliers must maintain documentation in their records that these criteria have been met and this must be available upon request.

If the supplier does not obtain information that the member is continuing to use the CPAP device in time for submission of the fourth or succeeding months’ claims, the supplier may still submit the claims, but a KX modifier must not be added. However, if the supplier chooses to hold claims for the fourth and succeeding months until they determine that the member is continuing to use the device, those claims may then be submitted with the KX modifier.

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.

For auto-titrating CPAP devices, use procedure code E0601.

Accessories are separately reimbursable at the time of initial issue and when replaced.

Code A4604 describes tubing used with a heated humidifier which has a heated wire running the length of the tubing. It is designed for use with a positive airway pressure device and a non-invasive interface – i.e., nasal or face mask, nasal cannula, or oral interface.

Code A7032 is used for a replacement nasal mask interface that goes around the nose, but not into the nostrils. The unit of service for this code is “each.”

Code A7033 is used for a replacement nasal cannula-type interface. This interface extends a short distance into the nostrils. The unit of service for this code is “pair.” For some products, there are two physically separate cushions or “pillows” – one for each nostril. Two cushions/ pillows equal one unit of service of code A7033. For other products, the interface is a single piece with two protrusions that extend into the nostrils. One of these interfaces equals one unit of service of code A7033.

Code A7027 (Combination oral/nasal mask, used with continuous positive airway pressure device, each) is a two piece system with separate elements for oral and nasal use.

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the patient’s medical records will reflect the need for the care provided. The patient’s medical records include the physician’s office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

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