Item Covered Denied CMN SOP Item Information
• Respiratory Assist Device (RAD)




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Covered by Medicare for the following conditions:

Restrictive Thoracic Disorder

  1. Documentation of a progressive neuromuscular disease or a severe thoracic cage abnormality, and
  2. An ABG ≥ 45mm HG while awake on the patient's usual FIO2 or a sleep oximetry ≤ 88% for at least 5 continuous minutes on the patient's usual FIO2 or progressive neuromuscular disease, with maximal inspiratory pressure < 60 cm H2O or forced vital capacity < 50% predicted, and
  3. COPD does not contribute significantly to the patient's pulmonary limitation.

Severe COPD

  1. An ABG ≥ 55mm Hg while awake and breathing the patient's usual FIO2 and a sleep oximetry < 88% for at least five continuous minutes at 2LPM or on the patient's usual FIO2 (whichever is higher), and
  2. Prior to initializing therapy, OSA and treatment with a CPAP have been considered and ruled out.

If a respiratory assist device, bi-level capability, with backup rate feature, used with noninvasive interface, e.g., nasal or a facial mask; or respiratory assist device, bi-level pressure capability, with backup rate feature, used with invasive interface, e.g., tracheostomy tube, is required after the first 2 months of therapy:

  1. A repeat ABG no sooner than 61 days after initiation of therapy, and
  2. A repeat sleep oximetry no sooner than 61 days of initiation of therapy, and
  3. Completed beneficiary and physician certification letters signed no sooner than 61 days after initiation of therapy.

A DME supplier is NOT considered a qualified provider of testing referenced.

Central Sleep Apnea

  1. The diagnosis of central sleep apnea, and
  2. The exclusion of obstructive sleep apnea (OSA) as the predominant cause of sleep associated hypoventilation, and
  3. Ruling out of CPAP as effective therapy if OSA is a component of sleep associated hypoventilation, and
  4. Oxygen SAT is ≥ 88% for at least 5 continuous minutes breathing the patient's usual FIO2, and
  5. Significant improvement of sleep associated hypoventilation of the setting prescribed for use in the home on the patient's usual FIO2.

Obstructive Sleep Apnea

  1. A complete facility-based, attended polysomnogram (a DME supplier is NOT considered a qualified provider of this test) has established the diagnosis of obstructive sleep apnea according to the following guidelines:
    1. The apnea-hypopnea index (AHI) is ≥ 15 events per hour, or
    2. The AHI is from 5-14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition mood disorders, or insomnia, or
    3. The AHI is from 5-14 events per hour with hypertension, ischemic heart disease, or history of stroke, and,
  2. A single-level device (CPAP) has been tried and proved ineffective.

The physician must re-evaluate the patient's condition no sooner than 60 days after initiation of treatment to ensure compliance and demonstrate improvement. A statement from the physician and patient must be obtained no sooner than 60 days after initiation of treatment. These statements must be filed in the patient's chart.

Supplies can only be billed separately for respiratory assist device, bi-level pressure capability, without backup rate feature, used with noninvasive interface (e.g., nasal or facial mask) - K0532.