RAD - E0470 & E0471

Face to Face (F2F)

• Treating physician must have in person exam with client within 6 months prior to WOPD

• Exam must document that the client was evaluated/treated for a condition that supports the item

• Date of F2F must be on or before the WOPD and no more than 6 months prior to WOPD

• Dispensing order template must be entered to support WOPD received prior to delivery

For purposes of this policy the following definitions are used:FI02 - is the fractional concentration of oxygen delivered to the beneficiary for inspiration. The beneficiary’s prescribed FIO2 refers to the oxygen concentration the beneficiary normally breathes when not undergoing testing to qualify for coverage of a Respiratory Assist Device (RAD). That is, if the beneficiary does not normally use supplemental oxygen, their prescribed FIO2 is that found in room air.

FEV1 - is the forced expired volume in 1 second.FVC - is the forced vital capacity.Central sleep apnea (CSA) is defined by all of the following:1. An apnea-hypopnea index (AHI) greater than or equal

to 5; and2. The sum total of central apneas plus central hypopneas

is greater than 50% of the total apneas and hypopneas; AND

3. A central apnea-central hypopnea index (CAHI) is greater than or equal to 5 per hour; AND

4. The presence of at least one of the following:• Sleepiness• Difficulty initiating or maintaining sleep,

frequent awakenings, or non-restorative sleep• Awakening short of breath• Snoring• Witnessed apneas

5. There is no evidence of daytime or nocturnal hypoventilation.

Complex sleep apnea (CompSA) is a form of central apnea specifically identified by all of the following:

1. With use of a positive airway pressure device without a backup rate (E0601 or E0470), the polysomnogram (PSG) shows a pattern of apneas and hypopneas that demonstrates the persistence or emergence of central apneas or central hypopneas upon exposure to CPAP (E0601) or a bi-level device without backup rate (E0470) device when titrated to the point where obstructive events have been effectively treated (obstructive AHI less than 5 per hour).

2. After resolution of the obstructive events, the sum total of central apneas plus central hypopneas is greater than 50% of the total apneas and hypopneas; and

3. After resolution of the obstructive events, a central apnea-central hypopnea index (CAHI) greater than or equal to 5 per hour.

Respiratory Assist Devices (RAD)E0470 & E0471

Home Care Medical

Apnea - is defined as the cessation of airflow for at least 10 seconds.

Hypopnea - is defined as an abnormal respiratory event lasting at least 10 seconds associated with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at !east a 4% decrease in oxygen saturation.

Apnea-hypopnea index (AHI)- is defined as the average number of episodes of apnea and hypopnea per hour of sleep without the use of a positive airway pressure device.

For diagnosis of CSA, the central apnea-central hypopnea index (CAHI) is defined as the average number of episodes of central apnea and central hypopnea per hour of sleep without the use of a positive airway pressure device. For CompSA, the CAHI is determined during the use of a positive airway pressure device after obstructive events have disappeared.

If the AHI or CAHI is calculated based on less than 2 hours of continuous recorded sleep, the total number of recorded events used to calculate the AHI or CAHI must be at least the number of events that would have been required in a 2-hour period (i.e., greater than or equal to 10 events).

Medical RecordsFor initial coverage (first 3 months of treatment), medical records must document: Symptoms characteristic of at least one sleep associated hypoventilation

• Daytime hypersomnolence• Excessive fatigue• Morning headache• Cognitive dysfunction• Dyspnea AND

Client has (1) of the following disorders and meets all coverage criteria for that disorder.

Restrictive Thoracic DisorderMedical Records must document

• Progressive neuromuscular disease (i.e. amyotrophic lateral sclerosis) or severe thoracic cage abnormality (i.e. post thoracoplast for TB) AND

• Arterial blood gad PaCO2, done while awake and breathing the usual FIO2, is > 45mm Hg; OR

• Sleep oximetry demonstrates oxygen saturation < 88% for > 5 minutes of nocturnal recording time (min recording time of 2 hours), done while breathing the client’s prescribed recommended FIO2 OR

• For neuromuscular disease only, maximal inspiratory pressure is < 60 cm H20 or forced vital capacity is < 50% predicted; AND

Chronic Obstructive Pulmonary Disease (COPD) does not contribute significantly to the client’s pulmonary limitation.

Severe COPD - E0470Medical Records must document

• Arterial blood gas PaC02 is > 52 mm Hg while client is awake and breathing the prescribed FI02; AND

• Sleep oximetry study 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 client’s usual FI02 {whichever is higher); AND

• Prior to initiating therapy, OSA and treatment with a CPAP has been considered and ruled out.

Severe COPD - E0471Situation (1): an E0471 started any time after a period of initial use of E0470 is covered if:

• An arterial blood gas PaC02, done while awake and breathing the client’s prescribed F102, shows the client worsens > 7 mm Hg compared to the 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).

Situation (2): an E0471 will be covered no sooner than 61 days after initial issue of E0470 if:

• An arterial blood gas PaC02 is done while awake and breathing the client’s prescribed FI02, still remains 52 mm Hg; AND

• Sleep oximetry while breathing with E0470 demon-strates oxygen saturation < 88% for > 5 cumulative minutes of nocturnal recording time (min. recording time of 2 hours), done while breathing oxygen at 2 LPM or the client’s prescribed FI02 (whichever is higher).

Central Sleep or Complex Sleep ApneaPrior 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 FI02.

Hypoventilation SyndromeE0470 is covered if the medical records support:

• An initial arterial blood gas PaC02, done while awake and breathing the client’s prescribed FI02, is > 45 mm Hg; AND

• Spirometry shows and FEVl/FVC > 70% and an FEVl > 50% of predicted; AND

• An arterial blood gas PaC02, done during sleep or immediately upon awakening, and while breathing the client’s prescribed FI02, shows the client’s PaC02 worsened > 7 mm Hg compared to the original result; OR

• A facility based PSG or home sleep test (HST) demonstrates oxygen saturation < 88% for > 5 minutes of nocturnal recording (min. recording time of 2 hours) that is caused by obstructive upper airway events (AHi <5).

E0471 is covered if the medical record support:• A covered E0470 is being used; AND• Spirometry shows an FEVl/FVC > 70% and an FEVl >

50% predicted; AND• An arterial blood gas PaC02, done while awake and

breathing the client’s prescribed F102, shows the client’s PaC02 worsens > 7 mm Hg compared to the ABG result performed to qualify the client for the E0470 device; OR

• A facility based PSG or HST demonstrates oxygen saturation < 88% for > 5 minutes of nocturnal recording time (min. recording of 2 hours) that is not caused by obstructive upper airway events (AHi < 5 while using E0470).

Continued Coverage - beyond the first 3 months of treatment of E0470 or E0471Medical records document the beneficiary was re-evaluated on or after the 61st day of use

• Progress of relevant symptoms; AND• Client usage of the device (average of 4 hours per

24 hour period)

Documentation in HCM records:• Signed and dated physician statement completed

no sooner than the 61 days after initiating use of the device stating:

• Client is consistently using the device an average of 4 hours per 24 hour period; AND

• Client is benefitting from its use

Ventilators with Noninvasive Interfaces (NIV - E0466)Medical Record documentation on the following conditions:

• Neuromuscular disease• Thoracic restrictive disease• Chronic respiratory failure consequent to COPD; AND

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

• Medical record should rule out why BiPAP does not meet client’s need with good, clear and thorough documentation that the medical necessity for the NIV

• Documentation is key, and physician needs to “paint the picture” with course of treatment/need for NIV.

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Respiratory Assist Devices (RAD) E0470 & E0471 | February 2016