RAD covered for beneficiaries with:

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– Restrictive Thoracic Disorders

– Severe COPD, or

– Central Sleep Apnea (CSA) or Complex Sleep Apnea (Comp SA)

– Hypoventilation Syndrome

 

What PAP/RAD Device Do I Need?

(Positive Airway Pressure / Respiratory Assist Device)

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CPAP(E0601)/ BiPap

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These devices provide positive airway pressure for patients suffering from Obstructive Sleep Apnea.

Requirements:

• A face-to-face clinical evaluation by the treating physician prior to the sleep study test to assess the         patient for obstructive sleep apnea

• A Medicare-covered sleep test that meets either of the following criteria:

      The apnea-hypopnea index (AHI) (on facility-based polysomnograms) or respiratory disturbance index           (RDI) (on home sleep tests) is greater than or equal to 15 events with a minimum of 30 events; or
      The AHI or RDI is greater than or equal to five and less than or equal to 14 events per hour with a                    minimum of ten events and documentation of:

• Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or

• Hypertension, ischemic heart disease, or history of stroke
  The patient and/or their caregiver have received instruction from the supplier of the PAP device and accessories in the proper use and care of the equipment

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Bi-Level without Backup Rate (E0470)

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Restrictive Thoracic Disorder (ALS) -

•  Abg with PaCO2 of 45 or higher , done while on oxygen and awake

•  Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for greater than 5 minutes cumulative while on O2

• Maximal inspiratory pressure is less than 60cmH20 or Forced Vital Capacity is less than 50% predicted and the medical record supports that COPD does not contribute significantly to the beneficiary's pulmonary limitation.

Severe COPD -

• Abg PaCO2 52mmHg or higher while on oxygen while awake

• Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for greater than 5 minutes cumulative while on O2 and the medical record shows that, prior to initiating therapy, OSA and treatment with CPAP has been considered and ruled out. 

Hypoventilation Syndrome
      An initial arterial blood gas PaCO2, done while awake and breathing the beneficiary’s prescribed FIO2,

      is ≥ 45 mm Hg; and Spirometry shows an FEV1/FVC ≥ 70% and an FEV1 ≥ 50% of predicted; and

      An arterial blood gas PaCO2, done during sleep or immediately upon awakening, and while breathing           the beneficiary’s prescribed FIO2, shows the beneficiary’s PaCO2 worsened ≥ 7mm Hg compared to the       original result; or A facility based PSG or home sleep testing (HST) demonstrates oxygen saturation ≤             88% for ≥ 5 minutes of nocturnal recording (minimum recording time of 2 hours) that is not caused by             obstructive upper airway events (AHI < 5).

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AVAPS with BiPap S/T (Respiratory Assist Device {RAD}) (E0471)

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Provides noninvasive ventilatory support to treat patients with sleep apnea (OSA) and respiratory insufficiency.

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Severe COPD 

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Situation one: An E0471 started any time after a period of initial use of E0470 is covered if:

• An arterial blood gas PaCO2, done while awake and breathing the beneficiary’s prescribed FIO2,       shows the beneficiary’s PaCO2 worsens ≥ 7mm Hg compared to original result above; and  

        A facility based polysomnogram (PSG) demonstrates oxygen saturation ≤ 88% for ≥ 5 cumulative                   minutes of nocturnal recording time (minimum recording time of 2 hours) while using an E0470 that is             not caused by obstructive upper airway events (AHI < 5).

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Situation two: An E0471 will be covered no sooner than 61 days after initial issue of the E0470 if:
        An arterial blood gas PaCO2 is done while awake and breathing the beneficiary’s prescribed FIO2, still

        remains ≥ 52 mm Hg; and Sleep oximetry while breathing with the E0470 demonstrates oxygen                       saturation ≤ 88% for ≥ 5 cumulative 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).

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Central Sleep or Complex Sleep Apnea

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        Prior to initiating therapy, a complete facility-based, attended PSG was performed documenting:                     Diagnosis of either central (CSA) or complex sleep apnea (CompSA); and

        Significant improvement of the sleep-associated hypoventilation with use of an E0470 or E0471 on the           settings the physician prescribed for initial use at home while breathing the usual FIO2.

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Hypoventilation Syndrome

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        A covered E0470 is being used; and Spirometry shows an FEV1/FVC ≥ 70% and an FEV1 ≥ 50% of                 predicted; and An arterial blood gas PaCO2, done while awake and breathing the beneficiary’s                       prescribed FIO2, shows the beneficiary’s PaCO2 worsens ≥ 7 mm Hg compared to the ABG result                 performed to qualify the patient for the E0470 device; or A facility based PSG or HST demonstrates                 oxygen saturation ≤ 88% for ≥ 5 minutes of nocturnal recording time (minimum recording time of 2 hours) that is not caused by obstructive upper airway events (AHI < 5 while using an E0470).

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AVAPS-AE with Trilogy Noninvasive Ventilator (E0466)

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Qualify conditions include:

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• Neuromuscular disease

• Thoracic restrictive disease

• Chronic respiratory failure consequent to COPD; and

       Condition is life-threatening where interruption of respiratory support would quickly lead to serious harm        or death