BiLevel Devices/Respiratory Assist Devices
- For a respiratory assist device to be covered, the treating physician or healthcare provider must fully document in your medical record symptoms characteristic of sleep-associated hypoventilation, such as daytime hyper-somnolence, excessive fatigue, morning headaches, cognitive dysfunction, dyspnea, etc.
- A respiratory assist device is covered if you have a clinical disorder characterized as • (I) restrictive thoracic disorders (i.e., progressive neuromuscular diseases or severe thoracic cage abnormalities),
- (II) severe chronic obstructive pulmonary disease (COPD), or
- (III) central sleep apnea (CSA) or Complex Sleep Apnea (CompSA),
- (IV) hypoventilation syndrome
- If you are diagnosed with Obstructive Sleep Apnea, see the coverage criteria for Positive Airway Pressure Devices below.
- Various tests may need to be performed to establish one of the above clinical disorders.
- Three months after starting your therapy you must return to your doctor or healthcare provider for a follow-up to confirm the machine is benefitting you and that you are regularly using the device. • This must be documented in your doctor or healthcare provider’s notes from that office visit. Your physician or healthcare provider will be required to respond in writing to questions regarding your continued use along with how well the machine is treating your condition.
- If you are not using your machine for an average of four hours per night per 24 hour period at the time you meet with your doctor or healthcare provider, then you may be held responsible (via an Advance Beneficiary Notice) to pay for the rental until you meet this requirement.
- BiLevel Devices are considered to be capped rental items, and that means they cannot be purchased outright. You will own the equipment after Medicare makes 13 payments toward the purchase of the equipment.
- Depending on which product is ordered, your supplier may not be able to deliver this equipment to you without a compliant written order or certificate of medical necessity from your doctor or healthcare provider. If the equipment is subject to these special rules, your supplier cannot get the documentation at a later date because if they do, Medicare can never make payment for those products to you or your supplier when a compliant order is not secured before delivery. So please be patient with your supplier while they collect the required documentation from your physician or healthcare provider.
** Some or all of the products in this category may be subject to competitive bidding depending on where you live. Ask your supplier for details.