RESPIRATORY ASSISTIVE DEVICES (RAD)

Coverage Guidelines

INITIAL COVERAGE CRITERIA FOR E0470 AND E0471 DEVICES FOR THE FIRST THREE MONTHS OF THERAPY:

​

For a 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 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

A RAD 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 i or ii,

  • Maximal inspiratory pressure is less than 60 cm H20, or

  • Forced vital capacity is less than 50% predicted

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

​

If all of the above criteria are met a RAD device will be covered for the first three months of therapy.

** If all of the above criteria are not met, then RAD and related accessories will be denied as not reasonable and necessary.