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RESPIRATORY
OXYGEN
Indications and Limitations of Coverage and/or Medical Necessity
Documentation Requirements
RESPIRATORY ASSIST DEVICE (RAD) -- BIPAP
Indications and Limitations of Coverage and/or Medical Necessity
Documentation Requirements
CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM (CPAP)
Indications and Limitations of Coverage and/or Medical Necessity
Documentation Requirements
NEBULIZERS
Indications and Limitations of Coverage and/or Medical Necessity



OXYGEN

Indications and Limitations of Coverage and/or Medical Necessity

Home oxygen therapy is covered only if all of the following conditions are met:

1. The treating physician has determined that the patient has a severe lung disease or hypoxia-related symptoms that might be expected to improve with oxygen therapy, and

2. The patient's blood gas study meets the criteria stated below, and

3. The qualifying blood gas study was performed by a physician or by a qualified provider or supplier of laboratory services, and

4. The qualifying blood gas study was obtained under the following conditions:

  • If the qualifying blood gas study is performed during an inpatient hospital stay, the reported test must be the one obtained closest to, but no earlier than 2 days prior to the hospital discharge date, or
  • If the qualifying blood gas study is not performed during an inpatient hospital stay, the reported test must be performed while the patient is in a chronic stable state -- i.e., not during a period of acute illness or an exacerbation of their underlying disease, and

5. Alternative treatment measures have been tried or considered and deemed clinically ineffective.

Group I criteria:

1. An arterial PO2 at or below 55 mm Hg, or an arterial oxygen saturation at or below 88 percent taken at rest (awake).

Initial coverage for patients meeting Group I criteria is limited to 12 months or the physician-specified length of need, whichever is shorter.

Group II criteria include the presence of (a) an arterial PO2 of 56-59 mm Hg or an arterial blood oxygen saturation of 89 percent at rest (awake).

Initial coverage for patients meeting Group II criteria is limited to 3 months or the physician specified length of need, whichever is shorter.

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Documentation Requirements

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available to the DMERC upon request.

A Certificate of Medical Necessity (CMN) which has been completed, signed, and dated by the treating physician must be kept on file by the supplier and made available to the DMERC on request.

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RESPIRATORY ASSIST DEVICE (RAD) -- BIPAP

Indications and Limitations of Coverage and/or Medical Necessity

GENERAL:

  • The "treating physician" must be one who is qualified by virtue of experience and training in non-invasive respiratory assistance, to order and monitor the use of respiratory assist devices. Physicians who treat patients for other medical conditions may or may not be so qualified, and if not, though they may be the treating physician of the beneficiary for other conditions, they are not considered the "treating physician" for the administration of NPPRA therapy.
  • For the purpose of this policy, polysomnographic 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 polysmnographic 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 E0470 AND E0471 DEVICES -- BIPAP

  • 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:

A) There is documentation in the patient's medical record of a progressive neuromuscular disease (for example, amyotrophic lateral sclerosis) or a severe thoracic cage abnormality (for example, post-thoracoplasty for TB), and

B)

1) An arterial blood gas PaCo2, done while awake and breathing the patient's usual FIO2 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 FIO2, or,

3) For a progressive neuromuscular disease (only), maximal inspiratory pressure is less than 60 cm H2O or forced vital capacity is less than 50% predicted, and

C) Chronic obstructive pulmonary disease does not contribute significantly to the patient's pulmonary limitation.

If all above criteria are met, either an E0470 or E0471 device (based upon the judgment of the treating physician) will be covered for patients within this group of conditions for the fist 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.

II) Severe COPD:

A)

1) An arterial blood gas PaCO2 done while awake and breathing the patient's usual FIO2 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 LPM or the patient's usual FIO2 (whichever is higher), and

B) Prior to initiating therapy, OSA (and treatment with CPAP) has been considered and ruled out.

If all of the above criteria for patients with COPD are met, an E0470 device will be covered for the first three months of NPPRA therapy (see below for continued coverage after the initial three months). An E0471 device will not be covered for a patient with COPD during the first two months, because therapy with an 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 an E0471 device for COPD after 2 month's use of an 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 an E0470 device are met, since 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 polysmnogram must be performed documenting the following:

A) The diagnosis of central sleep apnea (CSA), and

B) The exclusion of obstructive sleep apnea (OSA) as the predominant cause of sleep-associated hypoventilation, and

C) The ruling out of CPAP as effective therapy if OSA is a component of the sleep-associated hypoventilation, and

D) Oxygen saturation less than or equal to 88% for at least five continuous minutes, done while breathing the patient's usual FIO2, and

E) 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 patient's usual FIO2.

If all above criteria are met, either and E0470 or E0471 device (based upon the judgment of the treating physician) will be covered for 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:

(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 14 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

(B) A single level device (E0601, Continuous Positive Airway Pressure Device, CPAP) has been tried and proven ineffective.

CONTINUED COVERAGE FOR E0470 AND R0471 DEVICES BEYOND FIRST THREE MONTHS OF THERAPY:

Patients covered for the first 3 months of an 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. Medicare will not continue coverage for the 4th and succeeding months of NPPRA therapy until this re-evaluation has been completed.

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Documentation Requirements

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available to the DMERC upon request.

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CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM (CPAP)

Indications and Limitations of Coverage and/or Medical Necessity

INITIAL COVERAGE:

A single level continuous positive airway pressure (CPAP) device (E0601) is covered if the patient has a diagnosis of obstructive sleep apnea (OSA) documented by an attended, facility-based polysomnogram and meets either of the following criteria (1 or 2):

1) The AHI is greater than or equal to 15 events per hour, or

2) The AHI is from 5 to 14 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.

If a continuous positive airway pressure device (E0601) is provided and the criteria above have not been met, it will be denied as not medically necessary.

For the purpose of this policy, polysomnographic studies must be performed in a facility based sleep study laboratory, and not in the home or in a mobile facility. These labs must be qualified providers of Medicare services and comply with all applicable state regulatory requirements.

CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY:

Continued coverage of an E0601 device beyond the first three months of therapy requires that, no sooner than the 61st day after initiating therapy, the supplier ascertain from either the beneficiary or the treating physician that the beneficiary is continuing to use the CPAP device.

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Documentation Requirements

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available to the DMERC upon request.

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NEBULIZERS

Indications and Limitations of Coverage and/or Medical Necessity

A small volume nebulizer (A7003, A7004, A7005) and related compressor (E0570, E0571) are covered when:

a) It is medically necessary to administer beta-adrenergics, anticholinergics, corticosteroids, and cromolyn for the management of obstructive pulmonary disease (ICD-9 diagnosis codes 491.0 - 505), or

b) It is medically necessary to administer gentamicin, tobramycin, amikacin, or dornase alfa to a patient with cystic fibrosis (ICD-9 diagnosis code 277.00) or

c) It is medically necessary to administer pentamidine to patients with HIV (ICD-9 diagnosis code 042), pneumocystosis (ICD-9 diagnosis code 136.3), and complications of organ transplants (ICD-9 diagnosis codes 996.80-996.89), or

d) It is medically necessary to administer mucolytics (other than dornase alpha) for persistent thick or tenacious pulmonary secretions (ICD-9 diagnosis codes 480.0-505, and 786.4).

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