Respiratory Asist Device (RAD) - Non OSA

 
Note:  The following coverage criteria is for Medicare, other insurances may have different criteria and may be less stringent.  In most cases, meeting Medicare criteria will meet all other criteria’s.

• A written signed and dated prescription prior to dispensing is required before a RAD is covered by Medicare.
• The face to face notes must include the conditions for coverage  as described below (these must be completed and signed prior to dispensing the item):

A RAD (E0470, E0471) is covered for those beneficiaries with one of the following clinical disorders:

1. Restrictive thoracic disorders (i.e., neuromuscular diseases or severe thoracic cage abnormalities)
2. Severe chronic obstructive pulmonary disease (COPD)
3. CSA or Comp SA, or hypoventilation syndrome, as described in the following section.
   1. Restrictive Thoracic Disorders
      An E0470 or E0471 device is covered when criteria A – C are met. 
      1. 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).
      2. One of the following:
         1. 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
         2. 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
         3. For a neuromuscular disease (only), either i or ii,
            1. Maximal inspiratory pressure is less than 60 cm H20, or
            2. Forced vital capacity is less than 50% predicted
      3. Chronic obstructive pulmonary disease does not contribute significantly to the beneficiary’s pulmonary limitation.

If all of the above criteria are met, either an E0470 or an E0471 device (based upon the judgment of the treating physician) will be covered for the first three months of therapy.

If all of the above criteria are not met, then E0470 or E0471 and related accessories will be denied as not reasonable and necessary.

2. Severe COPD
   An E0470 device is covered if criteria A - C are met.
   1. An arterial blood gas PaCO2, done while awake and breathing the beneficiary’s prescribed FIO2, is greater than or equal to 52 mm Hg.
   2. Sleep oximetry demonstrates 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), done while breathing oxygen at 2 LPM or the beneficiary’s prescribed FIO2 (whichever is higher).
   3. Prior to initiating therapy, sleep apnea and treatment with a continuous positive airway pressure device (CPAP) has been considered and ruled out. (Note: Formal sleep testing is not required if there is sufficient information in the medical record to demonstrate that the beneficiary does not suffer from some form of sleep apnea (Obstructive Sleep Apnea (OSA), CSA and/or CompSA) as the predominant cause of awake hypercapnia or nocturnal arterial oxygen desaturation).

If all of the above criteria for beneficiaries with COPD are met, an E0470 device will be covered for the first three months of therapy.

If all of the above criteria are not met, E0470 and related accessories will be denied as not reasonable and necessary.

An E0471 device will be covered for a beneficiary with COPD in either of the two situations below, depending on the testing performed to demonstrate the need.

Situation 1. For Group II beneficiaries (COPD) who qualified for an E0470 device, an E0471 started any time after a period of initial use of an E0470 device is covered if both criteria A and B are met.

1. An arterial blood gas PaCO2, done while awake and breathing the beneficiary’s prescribed FIO2, shows that the beneficiary’s PaCO2 worsens greater than or equal to 7 mm HG compared to the original result from criterion A, (above).
2. A facility-based PSG demonstrates 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) while using an E0470 device that is not caused by obstructive upper airway events – i.e., AHI less than 5. (Refer to the Positive Airway Pressure Devices LCD for information about E0470 coverage for obstructive sleep apnea).
4. Situation 2. For Group II beneficiaries (COPD) who qualified for an E0470 device, an E0471 device will be covered if, at a time no sooner than 61 days after initial issue of the E0470 device, both of the following criteria A and B are met:

1. An arterial blood gas PaCO2 is done while awake and breathing the beneficiary’s prescribed FIO2, still remains greater than or equal to 52 mm Hg.
2. Sleep oximetry while breathing with the E0470 device, demonstrates 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), done while breathing oxygen at 2 LPM or the beneficiary’s prescribed FIO2 [whichever is higher].

If E0471 is billed but the criteria described in either situation 1 or 2 are not met, it will be denied as not reasonable and necessary.

3. Central Sleep Apnea or Complex Sleep Apnea
   An E0470 or E0471 device is covered when, prior to initiating therapy, a complete facility-based, attended PSG is performed documenting the following (A and B):

1. The diagnosis of CSA or CompSA; and
2. 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 beneficiary’s prescribed FIO2.

If all of the above criteria are met, either an E0470 or an E0471 device (based upon the judgment of the treating physician) will be covered for beneficiaries with documented CSA or CompSA for the first three months of therapy.

If all of the above criteria are not met, then E0470 or E0471 and related accessories will be denied as not reasonable and necessary.

4. Hypoventilation Syndrome
   An E0470 device is covered if both criteria A and B and either criterion C or D are met.

1. An initial arterial blood gas PaCO2, done while awake and breathing the beneficiary’s prescribed FIO2, is greater than or equal to 45 mm Hg
2. Spirometry shows an FEV1/FVC greater than or equal to 70%. (Refer to SEVERE COPD (above) for information about device coverage for beneficiaries with FEV1/FVC less than 70%.)
3. An arterial blood gas PaCO2, done during sleep or immediately upon awakening, and breathing the beneficiary’s prescribed FIO2, shows the beneficiary's PaCO2 worsened greater than or equal to 7 mm HG compared to the original result in criterion A (above).
4. A facility-based PSG or HST 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) that is not caused by obstructive upper airway events – i.e., AHI less than 5. (Refer to the Positive Airway Pressure Devices LCD for information about E0470 coverage for obstructive sleep apnea).

If the above criteria are not met, E0470 and related accessories will be denied as not reasonable and necessary.

An E0471 device is covered for a beneficiary with hypoventilation syndrome if both criteria A, B, and either criterion C or D are met:

1. A covered E0470 device is being used.
   Spirometry shows an FEV1/FVC greater than or equal to 70%. (Refer to SEVERE COPD (above) for information about device coverage for beneficiaries with FEV1/FVC less than 70%).
2. An arterial blood gas PaCO2, done while awake, and breathing the beneficiary’s prescribed FIO2, shows that the beneficiary’s PaCO2 worsens greater than or equal to 7 mm HG compared to the ABG result performed to qualify the beneficiary for the E0470 device (criterion A under E0470).
3. A facility-based PSG or HST demonstrates oxygen saturation less than or equal 88% for greater than or equal to 5 minutes of nocturnal recording time (minimum recording time of 2 hours) that is not caused by obstructive upper airway events – i.e., AHI less than 5 while using an E0470 device. (Refer to the Positive Airway Pressure Devices LCD for information about E0470 coverage for obstructive sleep apnea.)

If the criteria above are not met, an E0471 device will be denied as not reasonable and necessary.