Bi-Level Positive Airway Pressure (BiPAP) Device Qualifying Criteria
For a BiPAP to be covered, the treating physician must fully document in the patient’s medical record symptoms characteristic of sleep-associated hypoventilation, such as daytime hypersomnolence, excessive fatigue, morning headache, cognitive dysfunction, dyspnea, etc.
A BiPAP used to administer positive airway pressure therapy is covered for those patients with clinical disorder groups characterized as (I) restrictive thoracic disorders (i.e., progressive neuromuscular diseases or severe thoracic cage abnormalities), (II) severe chronic obstructive pulmonary disease (COPD), (III) central sleep apnea (CSA), or (IV) obstructive sleep apnea (OSA) and who also meet the following criteria:
- Restrictive Thoracic Disorders:
- There is documentation in the patient’s medical record of a progressive neuromuscular disease (for example, amyotrophic lateral sclerosis) or a severe thoracic cage abnormality (for example, post-thoracoplasty for TB), and
- 1) An arterial blood gas PaCO2 , done while awake and breathing the patient’s usual FIO2 is greater than or equal to 45 mm Hg, or
2) Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for at least five continuous minutes, done while breathing the patient’s usual FIO2, or,
3) For a progressive neuromuscular disease (only), maximal inspiratory pressure is less than 60 cm H20 or forced vital capacity is less than 50% predicted, and
- Chronic obstructive pulmonary disease does not contribute significantly to the patient’s pulmonary limitation.
- Severe COPD:
- 1) An arterial blood gas PaCO2, done while awake and breathing the patient’s usual FIO2, is greater than or equal to 52 mm Hg, and
2) Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for at least five continuous minutes, done while breathing oxygen at 2 LPM or the patient’s usual FIO2 (whichever is higher), and
- Prior to initiating therapy, OSA (and treatment with CPAP) has been considered and ruled out.
- Central Sleep Apnea or Complex Sleep Apnea:
Prior to initiating therapy, a complete facility-based, attended PSG must be performed documenting the following:
- The diagnosis of central sleep apnea (CSA) or complex sleep apnea, and
- The ruling out of CPAP as effective therapy if either CSA or OSA is a component of the initially observed sleep-associated hypoventilation, and
- 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 patient’s usual FIO2.
- Obstructive Sleep Apnea (OSA):
Criteria (A) and (B) are both met:
- A complete facility-based, attended polysomnogram, has established the diagnosis of obstructive sleep apnea according to the following criteria:
- The apnea-hypopnea index (AHI) is greater than or equal to 15 events per hour, or
- The AHI is from 5 to 14 events per hour with documented symptoms of:
- Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia, or
- Hypertension, ischemic heart disease, or history of stroke, and
b. A single level device (CPAP Device) has been tried and proven ineffective.
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