Cpap/Bipap without back up rate documentation needs (ACA, Face to Face visit is required)

The following qualification criteria need to be documented in the patients’ medical record notes to qualify for the prescribed equipment.  Note: face to face and justification notes are valid for six months.

Cpap: 1-2 and 3 or 4 need to be sufficiently documented to support the need for the prescribed equipment

  1. Document the patient’s face to face clinical evaluation prior to the sleep test to assess the patient for obstructive sleep apnea. AND
  2. Document the patient’s sleep test and the date it was performed. AND
  3. Document the patient’s apnea-hypopnea index (AHI) or respiratory disturbance index (RDI) greater than or equal to 15 events per hour with a minimum of 30 events. AND/OR
  4. Document the patient’s AHI or RDI greater than or equal to 5 and less than or equal to 14 events per hour with a minimum of 10 events and at least one of the following.
    1. Excessive daytime sleepiness, Impaired cognition, Mood disorders or Insomnia
    2. Hypertension, ischemic heart disease or history of stroke

Note: Respiratory effort related arousals (RERAs) fewer than 3% are not able to be included.

Bipap without a backup rate – document the above information and the following.

  1. Document that cpap has been tried and was proven ineffective based on therapeutic trials conducted during the initial facility based titration or home trial.
    1. Explain the trial method
    2. Explain why cpap was proven ineffective

Note: If a cpap has been used for 3 months and the patient is switched to a Bipap a new initial face to face clinical evaluation is required. A new sleep test is not required.

 ASV/AVAPS

Bipap (E0470) or Respiratory assist device (E0471) to be covered, the treating physician 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, etc.

A RAD (E0470, E0471) 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

Bipap (E0470) or Respiratory assist device (E0471) 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).  AND

B. 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 AND

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

 Severe COPD

Bipap (E0470) device is covered if criteria A – C are met.

A. An arterial blood gas PaCO2, done while awake and breathing the beneficiary’s prescribed FIO2, is greater than or equal to 52 mm Hg. AND

B. 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). AND

C. 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).

Central Sleep Apnea or Complex Sleep Apnea

Bipap (E0470) or Respiratory assist device (E0471) device is covered: when, prior to initiating therapy, a complete facility-based, attended PSG is performed documenting the following (A and B):

A. The diagnosis of CSA or CompSA;  AND

B. 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.

Hypoventilation Syndrome

Bipap device is covered if both criteria A and B and either criterion C or D are met.

A. 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. AND

B. 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%.)  AND

C. 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).  AND/OR

D. 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.)

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

A. A covered E0470 device is being used.  AND

B. 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%).  AND

C. 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).  AND/OR

D. 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.)

Supplemental oxygen

  • OSA must be sufficiently treated (patient is in a chronic stable state).
    • Titration was conducted over a 2 hour minimum
    • Optimal pap settings have been determined and the patient is using it at that setting.
    • The AHI/RDI was reduced to or equal to an average of10 events per hour or if the initial AHI/RDI was under 10 further reduction was demonstrated.
    • Nocturnal oximetry conducted during the PSG was 88% or below for 5 minutes total (does not need to be continuous).
  • Diagnosis: See LCD (Local coverage determination) at CGSMedicare.com for any additional qualifying information questions, diagnosis codes and descriptions

Medicare approved detailed equipment descriptions for Cpap/Bipap/Respiratory assist device

Cpap – Continuous airway pressure device, (HCPC-E0601)
Bipap – Respiratory assist device, bi-level pressure capability, without back up rate, HCPC-E0470)
ASV/AVAPS- Respiratory assist device (RAD), bi-level capability, with back-up rate, (HCPC-E0471)

 Patient notes/justification – Must be documented using your normal dictation process. Letter of medical necessity, notes wrote on letter head or prescriptions are not valid.

Prescription/order requirements– Must contain Patient’s name, date of the order and Start date, detailed equipment description (See above), Physician’s NPI (national provider number), signature of the ordering physician and a signature date.

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