Description:

Bi-Level Positive Airway Pressure devices deliver independent inspiratory and expiratory pressure levels. These devices promote alveolar ventilation in patients with severe COPD, Restrictive Thoracic Lung Disease, Neuromuscular Disease and Obstructive Sleep Apnea. These devices are available with or without backup respiratory rates.

Medicare's Medical Coverage Criteria:
Indications for therapy:

A . Restrictive Thoracic Disorders:

Progressive neuromuscular disease (i.e. ALS) or a severe thoracic cage abnormality (i.e. post-thoracoplasty for TB, severe kyphoscholiosis) and

  1. PaCO2, performed while awake and breathing the patient’s usual FIO2, is equal to or >45mmHg, or
  2. Sleep oximetry demonstrates SaO2 less than or equal to 88% for at least five continuous minutes, performed while breathing the patient’s usual FIO2 or
  3. For progressive neuromuscular diseases only, maximal IP is <60 cmH2O pressure or FVC is <50% predicted, and
  4. Chronic obstructive pulmonary disease does not contribute significantly to the patient’s pulmonary limitation.

B. Severe COPD:

  1. PaCO2, performed while awake and breathing the patient’s usual FIO2, is greater than or equal to 52mmHg, and
  2. Sleep oximetry demonstrates oxygen saturation of less than or equal to 88% for at least five continuous minutes, done while breathing oxygen at 2LPM or the patient’s usual FIO2 (whichever is higher), and

OSA and treatment with CPAP has been considered and ruled out.

C. Central Sleep Apnea or Complex Sleep Apnea

Prior to initiating therapy, a complete facility-based, attended PSG must be performed documenting the following:

A) The diagnosis of central sleep apnea (CSA) or complex sleep apnea (CompSA) (see definitions in Appendices section) and

B) The ruling out of CPAP as effective therapy if either CSA or OSA is a component of the initially observed sleep-associated hypoventilation, and

C) 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.

If all above criteria are met, either an E0470 or E0471 device (based upon the judgment of the treating physician) will be covered for patients with documented CSA or CompSA for the first three months of NPPRA therapy (see below for continued coverage after the initial three months). If all of the above criteria are not met, then E0470 or E0471 and related accessories will be denied as not medically necessary.

Bi-Level / BiPAP

Bi-LEVEL

CLOSE WINDOW

D. Obstructive sleep apnea

1. Polysomnogram results of:
  • OSA diagnosis
  • AHI is greater than or equal to 15/hour, or
  • AHI of 5 to 14 with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders, insomia, hypertension, ischemic heart disease, or history of stroke AND

2. CPAP has been tried and proven ineffective

Continued Coverage beyond the First Three Months of Therapy

Continued coverage of a CPAP device beyond the first three months of therapy requires that, no sooner than the 61 st day after initiating therapy, the supplier ascertain from either the beneficiary or the treating physician that the beneficiary is continuing to use the CPAP device.

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