For the purpose of this policy, polysomnagraphic studies must be performed in a sleep study laboratory, and not in the home or in a mobile facility, It must comply with all applicable state regulatory requirements.

- For the purpose of this policy, arterial blood gas, sleep oximetry and polysomnographic studies may not be performed by a DME supplier. A DME supplier is not considered a qualified provider or supplier of these tests for purposes of this policy's coverage and payment guidelines, This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests.

- If there is discontinuation of usage of a E0470 or E0471 device at any time, the supplier is expected to ascertain this, and stop billing for the equipment and related accessories and supplies.

INITIAL COVERAGE CRITERIA FOR a FOR E0470 And E0471 DEVICES (First Three Months):

- For a E0470 or E0471 respiratory assist device to be covered, the treating physician must fully document in the patient's medical record symptoms characteristic of sleep-associated hypoventilation, such as daytime hypersomnolence, excessive fatigue, morning headache, cognitive dysfunction, dyspnea, etc.

- A respiratory assist device (E0470, E0471) used to administer NPPRA therapy is covered for those patients with clinical disorder groups characterized as (I) restrictive thoracic disorders (i.e., progressive neuromuscular diseases or severe thoracic cage abnormalities), (II) severe chronic obstructive pulmonary disease (COPD), (III) central sleep apnea (CSA), or (IV) obstructive sleep apnea (OSA) (E0470 only) and who also meet the following criteria:

I) Restrictive Thoracic Disorders:

1. There is documentation in the patient's medical record of a progressive neuromuscular disease (far example, amyotrophic lateral sclerosis) or a severe thoracic cage abnormality (far example, post¬thoracoplasty for T8), and
2. 1.) An arterial blood gas PaCO2 , done while awake and breathing the patient's usual FIQ2 is greater than or equal to 45 mm Hg, or
   2.)Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for at least five continuous minutes, done while breathing the patient's usual FTD2, or,
   3.) For a progressive neuromuscular disease (only), maximal inspiratory pressure is less than 60 cm H20 or forced vital capacity is less than 50% predicted, and
3. Chronic obstructive pulmonary disease does not contribute significantly to the patient's pulmonary limitation.

If all above criteria are met, either a E0470 or E0471 device (based upon the judgment of the treating physician) will be covered for patients within this group of conditions for the first three months of NPPPA therapy (see below for continued coverage after the initial three months). If all of the above criteria are not met, then E0470 or E0471 and related accessories will be denied as not medically necessary.

II) Severe COPD:

1. 1) An arterial blood gas PaCD2, done while awake and breathing the patient's usual FI02, is greater than or equal to 52 mm Hg, and
   2) Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for at least five continuous minutes, done while breathing oxygen at 2 1_PM or the patient's usual FI02 (whichever is higher), and
2. Prior to initiating therapy, OSA (and treatment with CPAP) has been considered and ruled out.
   If all of the above crit

ria for patients with COPD are met, a E0470 device will be covered for the first three months of NPPRA therapy (see below for continued coverage after the initial three months). A E0471 device will not be covered for a patient with COPD during the first two months, because therapy with a E0470 device with proper adjustments of the device's settings and patient accommodation to its use will usually result in sufficient improvement without the need of a back-up rate. (See below for coverage of a E0471 device for COPD after 2 month's use of a E0470 device.)

If all of the above criteria are not met, E0470 and related accessories will be denied as not medically necessary. If E0471 is billed, even if the criteria for a E0470 device are met, since the E0471 is in a different payment category than E0470 and a least costly medically appropriate alternative payment cannot be made, it will be denied as not medically necessary.

III) Central Sleep Apnea, i.e., apnea not due to airway obstruction:

Prior to initiating therapy, a complete facility-based, attended polysomnogram must be performed documenting the following:

1. The diagnosis of central sleep apnea (CSA), and
2. The exclusion of obstructive sleep apnea (OSA) as the predominant cause of sleep-associated hypoventilation, and
3. The ruling out of CPAP as effective therapy if OSA is a component of the sleep-associated hypoventilation, and
4. Oxygen saturation less than or equal to 88°to for at least five continuous minutes, done while breathing the patient's usual F102, and
5. Significant improvement of the sleep-associated hypoventilation with the use of a E0470 or E0471 device on the settings that will be prescribed for initial use at home, white breathing the patient's usual FI02.

If all above criteria are met, either a E0470 or E0471 device (based upon the judgment of the treating physician) will be covered far patients with documented CSA conditions for the first three months of NPPRA therapy (see below for continued coverage after the initial three months). If all of the above criteria are not met, then E0470 or E0471 and related accessories will be denied as not medically necessary.

IV) Obstructive Sleep Apnea (OSA):

Criteria (A) and (B) are both met:

1. A) A complete facility-based, attended polysomnogram, has established the diagnosis of obstructive sleep apnea according to the following criteria:
   1) The apnea-hypopnea index (AHI) is greater than or equal to 15 events per hour, or
   2) The AHI is from 5 to 7,4 events per hour with documented symptoms of:
   a) Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia, or
   b) Hypertension, ischemic heart disease, or history of stroke, and
2. A single level device (E0601, Continuous Positive Airway Pressure Device, CPAP) has been tried and proven ineffective.

If the above criteria are met, a E0470 device will be covered for the first three months of NPPRA therapy (see below for continued coverage after the initial three months). If E0470 is billed and these criteria are not met but the coverage criteria in the DMERC policy for Continuous Positive Airway Pressure System (CPAP) are met, payment will be based on the allowance for the least costly medically appropriate alternative, E0601.

A E0471 device is not medically necessary if the primary diagnosis is OSA. If E0471 is billed, since the E0471 is in a different payment category than E0470 and E0601 and a least costly medically appropriate alternative payment cannot be made, it will be denied as not medically necessary.

CONTINUED COVERAGE FOR E0470 and E0471 DEVICES BEYOND FIRST THREE MONTHS OF THERAPY:

Patients covered for the first 3 months of a E0470 or E0471 device must be re-evaluated to establish the medical necessity of continued coverage by Medicare beyond the first three months. While the patient may certainly need to be evaluated at earlier intervals after this therapy is initiated, the re-evaluation upon which Medicare will base a decision to continue coverage beyond this time must occur no sooner than 61 days after initiating therapy by the treating physician.