Respiratory Assist Devices

Affected Providers

Treating practitioners and DME suppliers who bill for respiratory assist devices (RADs).

HCPCS & CPT Codes

Local Coverage Determination (LCD): Respiratory Assist Devices (L33800) has the current HCPCS and CPT codes.

Background

According to the 2024 Medicare Fee-for-Service Supplemental Improper Payment Data, the improper payment rate for RADs is 0%, with a projected improper payment amount of $0.

According to the 2023 Medicare Fee-for-Service Supplemental Improper Payment Data, the improper payment rate for RADs was 9.9% with a projected improper amount of $8.9 million.

We cover RADs under the DME benefit. You must meet policy requirements in LCD L33800 and Article: Respiratory Assist Devices (A52517).

Preventing Denials

Initial Coverage Criteria for E0470 & E0471 Devices for the First 3 Months of Therapy

For us to cover an E0470 or E0471 RAD, the treating practitioner must document in the patient’s medical record symptoms characteristic of sleep-associated hypoventilation, like daytime hypersomnolence, excessive fatigue, morning headache, cognitive dysfunction, or dyspnea.

We cover an RAD (E0470 and E0471) for patients with 1 of these clinical disorders:

• Restrictive thoracic disorder
• Severe chronic obstructive pulmonary disease (COPD)
• Central sleep apnea (CSA) or complex sleep apnea (CompSA)
• Hypoventilation syndrome

Restrictive Thoracic Disorders

We cover an E0470 or E0471 device when the patient meets criteria 1–3:

1. The patient’s medical record documents a neuromuscular disease (for example, amyotrophic lateral sclerosis) or a severe thoracic cage abnormality (for example, post-thoracoplasty for tuberculosis)
2. One of these occurs:
   • An arterial blood gas (ABG) partial pressure of carbon dioxide (PaCO2), greater than or equal to 45 mm Hg, done while awake and breathing the patient’s prescribed fraction of inspired oxygen (FIO2)
   • Sleep oximetry shows oxygen saturation less than or equal to 88% for greater than or equal to 5 minutes of nocturnal recording time (smallest recording time of 2 hours), done while breathing the patient’s prescribed FIO2
   • For a neuromuscular disease (only), either of these occur:
     • Maximal inspiratory pressure is less than 60 cm H2O
     • Forced vital capacity is less than 50% predicted value
3. COPD doesn’t contribute significantly to the patient’s pulmonary limitation

If the patient meets criteria 1–3, we cover either an E0470 or E0471 device (based on the treating practitioner’s judgment) for the first 3 months of therapy.

If the patient doesn’t meet criteria 1–3, we deny coverage of E0470 or E0471 and related accessories as not reasonable and necessary.

Severe COPD

We cover an E0470 device if the patient meets criteria 1–3:

1. An ABG PaCO2, greater than or equal to 52 mm Hg, done while awake and breathing the patient’s prescribed FIO2.
2. Sleep oximetry shows oxygen saturation less than or equal to 88% for greater than or equal to 5 cumulative minutes of nocturnal recording time (smallest recording time of 2 hours), done while breathing oxygen at 2 liters per minute (LPM) or the patient’s prescribed FIO2 (whichever is higher).
3. Before initiating therapy, consider and rule out sleep apnea and treatment with a continuous positive airway pressure device (CPAP). We don’t require formal sleep testing if there’s enough information in the medical record to show that some form of sleep apnea (obstructive sleep apnea (OSA), central sleep apnea (CSA), or complex sleep apnea (CompSA)) isn’t the main cause of the patient’s awake hypercapnia or nocturnal arterial oxygen desaturation.

If a patient with COPD meets all the above criteria, we cover an E0470 device for the first 3 months of therapy.

If a patient with COPD doesn’t meet all the above criteria, we deny E0470 and related accessories as not reasonable and necessary.

We cover an E0471 device for a patient with COPD in either of the 2 following situations, depending on the testing done to show the need.

Situation 1: For a patient with severe COPD who qualified for an E0470 device, we cover an E0471 if it’s started any time after a period of first using an E0470 device and if the patient meets both criteria 1 and 2:

1. An ABG PaCO2, done while the patient is awake and breathing their prescribed FIO2, shows that the patient’s PaCO2 worsens to greater than or equal to 7 mm Hg compared with the original result from criterion 1 in the Severe COPD section.
2. A facility-based polysomnogram (PSG), done while the patient is using an E0470 device, shows oxygen saturation less than or equal to 88% for greater than or equal to a cumulative 5 minutes of nocturnal recording time (minimum recording time of 2 hours) that isn’t caused by obstructive upper airway events —that is, apnea-hypopnea index (AHI) less than 5. (See LCD: Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L33718) for information about E0470 coverage for OSA.)

Situation 2: For a patient with severe COPD who qualified for an E0470 device, we cover an E0471 device if, no sooner than 61 days after first issue of the E0470 device, they meet both criteria 1 and 2:

1. An ABG PaCO2 that stays greater than or equal to 52 mm Hg is done while awake and breathing the patient’s prescribed FIO2
2. Sleep oximetry while breathing with the E0470 device shows oxygen saturation of less than or equal to 88% for greater than or equal to 5 cumulative minutes of nocturnal recording time (minimum recording time of 2 hours), done while the patient is breathing oxygen at 2 LPM or their prescribed FIO2, whichever is higher

If you bill E0471 but the patient doesn’t meet criteria described in either situations 1 or 2, we deny it as not reasonable and necessary.

Central Sleep Apnea or Complex Sleep Apnea

We cover an E0470 or E0471 device when, before initiating therapy, you do a complete facility-based, attended PSG documenting both 1 and 2:

1. The diagnosis of CSA or CompSA
2. Significant improvement of the sleep-associated hypoventilation with an E0470 or E0471 device on the settings that will be prescribed for initial use at home, while breathing the patient’s prescribed FIO2

If the patient meets both criteria 1 and 2, we cover either an E0470 or E0471 device (based on the treating practitioner’s judgment) for a patient with documented CSA or CompSA for the first 3 months of therapy.

If the patient doesn’t meet criteria 1 and 2, we deny E0470 or E0471 and related accessories as not reasonable and necessary.

Hypoventilation Syndrome

We cover an E0470 device if the patient meets both criteria 1 and 2 and either criterion 3 or 4:

1. An initial ABG PaCO2 greater than or equal to 45 mm Hg done while awake and breathing the patient’s prescribed FIO2.
2. Spirometry shows a forced expired volume in 1 second (FEV1)/ FVC greater than or equal to 70%. (See the Severe COPD section for information about device coverage for patients with FEV1/FVC of less than 70%.)
3. An ABG PaCO2, done when the patient is asleep or has just woken up and is breathing their prescribed FIO2, shows that the patient’s PaCO2 worsened greater than or equal to 7 mm Hg compared to the original result in criterion 1.
4. A facility-based PSG or home sleep test (HST) shows 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) that isn’t caused by obstructive upper airway events — that is, AHI less than 5. (See LCD L33718 for information about E0470 coverage for OSA.)

If a patient doesn’t meet these criteria, we deny E0470 and related accessories as not reasonable and necessary.

We cover an E0471 device for a patient with hypoventilation syndrome if they meet both criteria 1 and 2 and either criterion 3 or 4:

1. The patient is using a covered E0470 device.
2. Spirometry shows an FEV1/FVC greater than or equal to 70% (see the Severe COPD section for information about device coverage for patients with FEV1/FVC of less than 70%)
3. An ABG PaCO2, done while the patient is awake and breathing their prescribed FIO2, shows the patient’s PaCO2 worsens to greater than or equal to 7 mm Hg compared to the ABG result done to qualify the patient for the E0470 device (criterion 1 under E0470)
4. A facility-based PSG or HST shows 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) that isn’t caused by obstructive upper airway events — that is, AHI less than 5 while using an E0470 device (see LCD L33718 for information about E0470 coverage for OSA)

If a patient doesn’t meet the above criteria, we deny an E0471 device as not reasonable and necessary.

Continued Coverage Criteria for E0470 & E0471 Devices Beyond the First 3 Months of Therapy

• Re-evaluate patients covered for the first 3 months of using an E0470 or E0471 device to show the medical necessity of Medicare’s continued coverage beyond the first 3 months.
• While you may need to evaluate the patient at earlier intervals after initiating therapy, the re-evaluation (when we decide on continued coverage beyond the first 3 months) must happen no sooner than 61 days after initiating therapy.
• We won’t continue coverage for the fourth and succeeding months of therapy until you complete this re-evaluation.
• Documentation in the patient’s medical record must show the progress of relevant symptoms and the patient’s use of the device up to that time.
• If the patient isn’t consistently using their E0470 or E0471 device for an average of 4 hours per 24-hour period by the time of the re-evaluation (on or after 61 days after you start therapy), we consider it non-compliant use for the intended purposes and expectations of this therapy’s benefit, and that’s a reason for us to deny continued coverage as not reasonable and necessary.
• Submit a signed and dated statement, no sooner than 61 days after the patient starts using the device, stating they’re using the device compliantly (an average of 4 hours per 24-hour period) and benefiting from its use. The device’s supplier must get this statement for continued coverage beyond 3 months.

If you don’t meet these criteria, we deny continued coverage of an E0470 or E0471 device and related accessories as not reasonable and necessary.

For the maximum amount of RAD accessories we expect to be reasonable and necessary, see LCD L33800.

Noninvasive Positive Pressure Ventilation in the Home for the Treatment of Chronic Respiratory Failure Resulting from COPD

We cover a home mechanical ventilator (HMV) used in a volume targeted mode as treatment for a patient with chronic respiratory failure (CRF) resulting from COPD who exhibits certain clinical characteristics. National Coverage Analysis: Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD has more information.

Starting June 9, 2025, we pay claims for RADs with or without a backup rate feature and HMVs, in the home, as treatment for patients with CRF resulting from COPD.

Refill Requirements

For DMEPOS items and supplies provided on a recurring basis, base your billing on prospective, not retrospective use.

Documentation Requirements

To justify payment, you must meet specific requirements when ordering DMEPOS.