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LCD - BILEVEL Device (BIPAP) With and Without Backup Rate

Order Requirements

  1. Patient's Name
  2. Detailed description of item(s) being ordered such as description of device, heated humidifier, type of mask (nasal, full face, oral), headgear, filters and/or tubing.
  3. Pressure settings       
  4. Qty to be dispensed
  5. Frequency of use or duration
  6. Ordering Physician’s NPI
  7. Ordering physician’s legible signature (personally written or electronically signed by the physician, stamps are not accepted by insurance).
  8. Ordering physician’s legible signature date (personally written or electronically signed by the physician, stamps are not accepted by insurance).
  9. Start date of the order – if different than the Physician's signature date.

Coverage Criteria Detail

Four covered clinical groups:
  1. GROUP I: Restrictive Thoracic Disorders
  2. GROUP II: Severe Chronic Obstructive Pulmonary Disease (COPD)
  3. GROUP III: Central Sleep Apnea (CSA) or Complex sleep apnea (COMP SA)
  4. GROUP IV: Hypoventilation Syndrome

NOTE: Obstructive Sleep Apnea [OSA] is not a qualifying diagnosis for a BILevel Device with Backup Rate (BIPAP ST)

Initial Coverage (1st 3 months of therapy)

GROUP I: Restrictive Thoracic Disorders

  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) AND,
  2. One of the following:
  3. a. An arterial blood gas PaCO2, done while awake and breathing the beneficiary’s prescribed FIO2, is ≥ 45 mm Hg OR,

    b. Sleep oximetry demonstrates O2 saturation ≤ 88% for more than 5 minutes nocturnal (minimum recording time of 2 hours), while breathing prescribed FIO2 (whichever is higher), OR,

    c. For a neuromuscular disease (ONLY)
    i. Maximal inspiratory pressure is
    ii. Forced vital capacity is

  4. COPD does not contribute significantly to patient’s pulmonary function.

GROUP II: Severe COPD

BiPAP Without Backup (E0470)

  1. An ABG PaCO2, done while awake and breathing beneficiary’s prescribed FIO2, is ≥ 52 mm Hg; AND,
  2. Sleep oximetry demonstrates O2 saturation ≤ 88% for at least 5 minutes nocturnal (minimum recording time of 2 hours), done while breathing O2 at 2 LPM or the beneficiary’s prescribed FIO2 (whichever is higher); AND
  3. Prior to initiating therapy, (OSA) and treatment with a CPAP has been considered and ruled out

BiPAP with backup (E0471) - Covered for COPD in following two situations

Situation I – 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.

A. ABG PaCO2, while awake and breathing the beneficiary’s prescribed FIO2, shows that the beneficiary’s PaCO2 worsens ≥7 mm HG compared to the original result from criterion #1 (above).

B. A facility-based PSG demonstrates O2 saturation ≤88% for at least 5 minutes nocturnal (minimum recording time of 2 hours) while using an E0470 device that is not caused by obstructive upper airway events – i.e., AHI

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:

A. ABG PaCO2 done while awake and breathing the beneficiary’s prescribed FIO2, still remains ≥ 52 mm Hg AND,

B. Sleep oximetry, while breathing with the E0470 device, demonstrates O2 saturation ≤ 88% for at least 5 minutes nocturnal (minimum recording time of 2 hours), while breathing O2 at 2 LPM or the beneficiary’s prescribed FIO2 (whichever is higher).

GROUP III: Central Sleep Apnea or Complex Sleep Apnea
Prior to initiating therapy, a polysomnogram must be performed documenting both A and B

A. The diagnosis of central sleep apnea (CSA) or complex sleep apnea (CompSA); AND,

B. Significant improvement of the sleep-associated hypoventilation with the use of a Bilevel Device With or Without Backup on the settings that will be prescribed for initial use at home, while breathing the beneficiary’s prescribed FIO2.

Central sleep apnea is defined as
1. An apnea-hypopnea index [AHI] greater than or equal to 5, AND,
2. Central apneas/hypopneas greater than 50% of the total apneas/hypopneas, AND,
3. Central apneas or hypopneas ≥ 5 times per hour, AND,
4. Symptoms of either excessive sleepiness or disrupted sleep.

GROUP IV: Hypoventilation Syndrome
Bilevel Without Backup (E0470) device is covered if criteria 1, 2, and either 3 or 4 are met.

An E0470 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.

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%.)

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).

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.)

Continued coverage beyond 3 months
Must be re-evaluated by treating practitioner no sooner than 61st day after initial therapy.

  • Documenting that patient is compliant with the device. Compliance is using the machine for at least 4 hours per a 24-hour period.
  • Documentation that the patient is benefiting from the use of therapy.
  • Documentation must be legibly signed and dated by the treating physician.

ACCESSORIES

The following table represents the usual maximum amount of accessories expected to be reasonable and necessary:

A4604TUBING WITH INTEGRATED HEATING ELEMENT FOR USE WITH PAP DEVICE1 per 3 mos
A7027COMBINATION ORAL/NASAL MASK, USED WITH CPAP , EACH1 per 3 mos
A7028ORAL CUSHION FOR COMBINATION ORAL/NASAL MASK, REPLACEMENT ONLY, EACH2 per 1 mo
A7029NASAL PILLOWS FOR COMBINATION ORAL/NASAL MASK, REPLACEMENT ONLY, PAIR2 per 1 mo
A7030FULL FACE MASK USED WITH PAP DEVICE, EACH1 per 3 mo
A7031FACE MASK INTERFACE, REPLACEMENT FOR FULL FACE MASK, EACH1 per 1 mo
A7032CUSHION FOR USE ON NASAL MASK INTERFACE, REPLACEMENT ONLY, EACH2 per 1 mo
A7033PILLOW FOR USE ON NASAL CANNULA TYPE INTERFACE, REPLACEMENT ONLY, PAIR2 per 1 mo
A7034NASAL INTERFACE (MASK OR CANNULA TYPE) USED WITH PAP DEVICE, WITH OR WITHOUT HEAD STRAP1 per 3 mos
A7035HEADGEAR USED WITH PAP DEVICE1 per 6 mos
A7036CHINSTRAP USED WITH PAP DEVICEper 6 mos
A7037TUBING USED WITH PAP DEVICE1 per 3 mos
A7038FILTER, DISPOSABLE, USED WITH POSITIVE AIRWAY PRESSURE DEVICE2 per 1 mo
A7039FILTER, NON DISPOSABLE, USED WITH POSITIVE AIRWAY PRESSURE DEVICE1 per 6 mos
A7046WATER CHAMBER FOR HUMIDIFIER, USED WITH PAP DEVICE, REPLACEMENT, EACH1 per 6 mos

Replacement

This section applies to Bilevel Without Backup (E0470) and Bilevel With Backup (E0471) devices initially provided for the scenarios addressed in this policy and reimbursed while the beneficiary was in Medicare fee-for-service (FFS).

If a Bilevel Device With or Without Backup is replaced during the 5 year reasonable useful lifetime (RUL) because of loss, theft, or irreparable damage due to a specific incident, there is no requirement for a new clinical evaluation or testing.

If a Bilevel Device With or Without Backup is replaced following the 5 year RUL, there must be a face-to-face evaluation by their treating physician that documents that the beneficiary continues to use and benefit from the device. There is no requirement for new testing. A new prescription is required.

Patients Entering Medicare

For beneficiaries who received a Bilevel Device With or Without Backup for the conditions described in scenarios I - IV addressed by this policy prior to enrollment in fee-for-service (FFS) Medicare and are seeking Medicare reimbursement for a rental, either to continue using the existing device or for a replacement device, coverage transition is not automatic. These claims are considered to be new, initial rentals for Medicare, Therefore for scenarios I - IV all current coverage and documentation requirements set out in this policy must be met with the exceptions noted below.

  1. Qualification Testing – Use of testing performed prior to Medicare eligibility is allowed. There must be documentation that the beneficiary had the testing required by the applicable scenario i.e., oximetry, sleep testing, spirometry, etc., prior to FFS Medicare enrollment, that meets the current coverage criteria in effect at the time that the beneficiary seeks Medicare coverage of a replacement device and/or accessories; AND,

  2. Clinical Evaluation – Following enrollment in FFS Medicare, the beneficiary must have a face-to-face evaluation by their treating physician who documents in the beneficiary’s medical record that:
    a. The beneficiary has the qualifying medical condition for the applicable scenario; AND,
    b. The testing performed, date of the testing used for qualification and results; AND,
    c. The beneficiary continues to use the device; AND,
    d. The beneficiary is benefiting from the treatment.

  • If either criteria 1 or 2 above are not met, the claim will be denied as not reasonable and necessary.