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For an E0470 or an E0471 RAD to be covered, the treating practitioner must fully document in the beneficiary’s medical record symptoms characteristic of sleep-associated hypoventilation, such as daytime hypersomnolence, excessive fatigue, morning headache, cognitive dysfunction, dyspnea.

A RAD (E0470, E0471) is covered for those beneficiaries with one of the following clinical disorders: restrictive thoracic disorders (i.e., neuromuscular diseases or severe thoracic cage abnormalities), severe chronic obstructive pulmonary disease (COPD), CSA or CompSA, or hypoventilation syndrome, as described in the following section.

Restrictive Thoracic Disorders

An E0470 or E0471 device is covered when criteria A – C are met.

A. There is documentation in the beneficiary’s medical record of a neuromuscular disease (for example, amyotrophic lateral sclerosis) or a severe thoracic cage abnormality (for example, post-thoracoplasty for TB).

B. One of the following:

• An arterial blood gas PaCO2, done while awake and breathing the beneficiary’s prescribed FIO2 is greater than or equal to 45 mm Hg, or
• Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for greater than or equal to 5 minutes of nocturnal recording time (minimum recording time of 2 hours), done while breathing the beneficiary’s prescribed recommended FIO2, or
• For a neuromuscular disease (only), either 1 or 2,

1. Maximal inspiratory pressure is less than 60 cm H20, or
2. Forced vital capacity is less than 50% predicted

C. Chronic obstructive pulmonary disease does not contribute significantly to the beneficiary’s pulmonary limitation.

Severe COPD

An E0470 device is covered if criteria A - C are met.

A. An arterial blood gas PaCO2, done while awake and breathing the beneficiary’s prescribed FIO2, is greater than or equal to 52 mm Hg.

B. Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for greater than or equal to a cumulative 5 minutes of nocturnal recording time (minimum recording time of 2 hours), done while breathing oxygen at 2 LPM or the beneficiary’s prescribed FIO2 (whichever is higher).

C. Prior to initiating therapy, sleep apnea and treatment with a continuous positive airway pressure device (CPAP) has been considered and ruled out. (Note: Formal sleep testing is not required if there is sufficient information in the medical record to demonstrate that the beneficiary does not suffer from some form of sleep apnea (Obstructive Sleep Apnea (OSA), CSA and/or CompSA) as the predominant cause of awake hypercapnia or nocturnal arterial oxygen desaturation).

An E0471 device will be covered for a beneficiary with COPD in either of the two situations below, depending on the testing performed to demonstrate the need.

Situation 1. For severe COPD beneficiaries who qualified for an E0470 device, an E0471 started any time after a period of initial use of an E0470 device is covered if both criteria A and B are met.

A. An arterial blood gas PaCO2, done while awake and breathing the beneficiary’s prescribed FIO2, shows that the beneficiary’s PaCO2 worsens greater than or equal to 7 mm Hg compared to the original result from criterion A, (above).

B. A facility-based PSG demonstrates oxygen saturation less than or equal to 88% for greater than or equal to a cumulative 5 minutes of nocturnal recording time (minimum recording time of 2 hours) while using an E0470 device that is not caused by obstructive upper airway events – i.e., AHI less than 5. (Refer to the Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea LCD for information about E0470 coverage for obstructive sleep apnea).

Situation 2. For severe COPD beneficiaries who qualified for an E0470 device, an E0471 device will be covered if, at a time no sooner than 61 days after initial issue of the E0470 device, both of the following criteria A and B are met:

A. An arterial blood gas PaCO2 is done while awake and breathing the beneficiary’s prescribed FIO2, still remains greater than or equal to 52 mm Hg.

B. Sleep oximetry while breathing with the E0470 device, demonstrates oxygen saturation less than or equal to 88% for greater than or equal to a cumulative 5 minutes of nocturnal recording time (minimum recording time of 2 hours), done while breathing oxygen at 2 LPM or the beneficiary’s prescribed FIO2 [whichever is higher].

Central Sleep Apnea or Complex Sleep Apnea

An E0470 or E0471 device is covered when, prior to initiating therapy, a complete facility-based, attended PSG is performed documenting the following (A and B):

A. The diagnosis of CSA or CompSA; and

B. Significant improvement of the sleep-associated hypoventilation with the use of an E0470 or E0471 device on the settings that will be prescribed for initial use at home, while breathing the beneficiary’s prescribed FIO2.

Hypoventilation Syndrome 

An E0471 device is covered for a beneficiary with hypoventilation syndrome if both criteria A, B, and either criterion C or D are met:

A. A covered E0470 device is being used.

B. Spirometry shows an FEV1/FVC greater than or equal to 70%. (Refer to SEVERE COPD (above) for information about device coverage for beneficiaries with FEV1/FVC less than 70%).

C. An arterial blood gas PaCO2, done while awake, and breathing the beneficiary’s prescribed FIO2, shows that the beneficiary’s PaCO2 worsens greater than or equal to 7 mm Hg compared to the arterial blood gas (ABG) result performed to qualify the beneficiary for the E0470 device (criterion A under E0470).

D. A facility-based PSG or HST demonstrates oxygen saturation less than or equal 88% for greater than or equal to 5 minutes of nocturnal recording time (minimum recording time of 2 hours) that is not caused by obstructive upper airway events – i.e., AHI less than 5 while using an E0470 device. 

REPLACEMENT

This section applies to E0470 and E0471 devices initially provided for the scenarios addressed in this policy and reimbursed while the beneficiary was in Medicare fee-for-service (FFS).

If an E0470 or E0471 device is replaced during the 5 year reasonable useful lifetime (RUL) because of loss, theft, or irreparable damage due to a specific incident, there is no requirement for a new clinical evaluation or testing.

If an E0470 or E0471 device is replaced following the 5 year RUL, there must be an in-person evaluation by their treating practitioner that documents that the beneficiary continues to use and benefit from the device. There is no requirement for new testing. A new prescription is required.

Link to Medicare Criteria Website