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For any item to be covered by Medicare, it must: 1) be eligible for
a defined Medicare Benefit Category, 2) be reasonable and necessary for the
diagnosis or treatment of illness or injury or to improve the functioning
of a malformed body member, and 3) meet all other applicable Medicare
statutory and regulatory requirements. For the items addressed in this
medical policy, the criteria for "reasonable and necessary" is
defined by the following indications and limitations of coverage and/or
medical necessity.
For an item to be covered by Medicare, a written signed and dated order
must be received by the supplier before a claim is submitted. If the
supplier bills for an item addressed in this policy without first receiving
the completed order, the item will be denied as not medically necessary.
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 (RAD). 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 non-invasive positive pressure respiratory
assistance (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 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 an 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 FOR THE FIRST THREE
MONTHS OF THERAPY:
For an E0470 or an E0471 RAD 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 RAD (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:
- Restrictive
Thoracic Disorders:
- 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
- 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 H20 or
forced vital capacity is less than 50% predicted, and
- Chronic
obstructive pulmonary disease does not contribute significantly to
the patient’s pulmonary limitation.
If all of the above criteria are met, either an E0470 or an 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
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.
- Severe COPD:
- 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
- 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.)
If all of the above criteria are not met, E0470 and related
accessories will be denied as not medically necessary.
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 E0471 is billed and the criteria for an E0470
device are met, it will be paid as the least costly medically appropriate
alternative, E0470. If E0471 is billed and the criteria for an E0470 device
are not met, it will be denied as not medically necessary.
- Central Sleep
Apnea or Complex Sleep Apnea:
Prior to initiating therapy, a complete facility-based, attended PSG
must be performed documenting the following:
- The diagnosis
of central sleep apnea (CSA) or complex sleep apnea (CompSA) (see definitions in Appendices section)
and
- The ruling
out of CPAP as effective therapy if either CSA or OSA is a component
of the initially observed sleep-associated hypoventilation, and
- 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 of the above criteria are met, either an E0470 or an E0471 device
(based upon the judgment of the treating physician) will be covered for
patients with documented CSA or CompSA 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.
- Obstructive
Sleep Apnea (OSA):
Criteria (A) and (B) are both met:
- A complete
facility-based, attended polysomnogram, has
established the diagnosis of obstructive sleep apnea according to the
following criteria:
- The apnea-hypopnea index (AHI) is greater than or equal to
15 events per hour, or
- The AHI is
from 5 to 14 events per hour with documented symptoms of:
- Excessive
daytime sleepiness, impaired cognition, mood disorders, or
insomnia, or
- Hypertension,
ischemic heart disease, or history of stroke, and
- A single
level device (E0601, Continuous Positive Airway Pressure (CPAP)
Device) has been tried and proven ineffective.
If the above criteria 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). If E0470 is billed and these criteria are not
met but the coverage criteria in the Continuous Positive Airway Pressure
System (CPAP) LCD are met, payment will be based on the allowance for the
least costly medically appropriate alternative, E0601.
An E0471 device is not medically necessary if the primary diagnosis is OSA.
If E0471 is billed and the criteria for an E0470 device are met, it will be
paid as the least costly medically appropriate alternative, E0470. If E0471
is billed and the criteria for an E0470 device are not met, but the
coverage criteria in the Continuous Positive Airway Pressure System (CPAP)
LCD are met, payment will be based on the allowance for the least costly
medically appropriate alternative, E0601.
CONTINUED COVERAGE CRITERIA FOR E0470 AND E0471 DEVICES BEYOND THE FIRST
THREE MONTHS OF THERAPY:
Patients covered for the first 3 months of an E0470 or an 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.
There must be documentation in the patient’s medical record about the
progress of relevant symptoms and patient usage of the device up to that
time. Failure of the patient to be consistently using the E0470 or E0471
device for an average of 4 hours per 24 hour period by the time of the
re-evaluation (on or after 61 days after initiation of therapy) would
represent non-compliant utilization for the intended purposes and
expectations of benefit of this therapy. This would constitute reason for
Medicare to deny continued coverage as not medically necessary.
The following items of documentation must be obtained by the supplier of
the device for continued coverage beyond three months:
- a signed and
dated statement completed by the treating physician no sooner than 61
days after initiating use of the device, declaring that the patient is
compliantly using the device (an average of 4 hours per 24 hour
period) and that the patient is benefiting from its use, and
- a Medicare
beneficiary statement completed by the patient no sooner than 61 days
after initiating use of the device (see below).
If the above criteria are not met, continued coverage of an E0470 or an
E0471 device and related accessories will be denied as not medically
necessary.
For Group II patients (COPD) who qualified for an E0470 device, if at a
time no sooner than 61 days after initial issue and compliant use of an
E0470 device, the treating physician believes the patient requires an E0471
device, the E0471 device will be covered if the following criteria are met:
- An arterial
blood gas PaCO2, repeated no sooner than 61 days after initiation of
compliant use of the E0470, done while awake and breathing the
patient’s usual FIO2, still remains greater than or equal to 52 mm Hg,
and
- A sleep oximetry, repeated no sooner than 61 days after
initiation of compliant use of a E0470 device, and while breathing
with the E0470 device, 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
- A signed and
dated statement from the treating physician, completed no sooner than
61 days after initiation of the E0470 device, declaring that the
patient has been compliantly using the E0470 device (an average of 4
hours per 24 hour period) but that the patient is NOT benefiting from
its use, and
- A Medicare
beneficiary statement completed by the patient, no sooner than 61 days
after initiation of the E0470 device.
If the above criteria for an E0471 are not met, but the criteria for an
E0470 are met, the device will be paid as the least costly medical
alternative, E0470. If E0471 is billed and the criteria for an E0470 device
are not met, it will be denied as not medically necessary.
MEDICARE BENEFICIARY STATEMENT:
For continued coverage of an E0470 or an E0471 device, the supplier must
obtain a signed and dated statement from the beneficiary documenting that
the device is currently being used for 4 or more hours per 24 hour period,
that it has been used for at least 2 months at the time of the statement’s
completion, that the beneficiary plans to continue using the device in the
future, and that the person completing the statement was not the supplier.
A suggested form for collecting this information is attached. (Whatever
form is used must contain all of the questions contained on the attached
suggested form.) All of the questions on any Medicare beneficiary statement
must be answered by the beneficiary, or a family member or caregiver, but
may not be completed by the supplier. The completed statement documenting
that the criteria for continued coverage have been met must be obtained by
the supplier in order for the fourth and succeeding months’ claims to be
eligible for coverage
If the above criteria are not met, continued coverage of an E0470 or an
E0471 device and related accessories will be denied as not medically
necessary.
ACCESSORIES:
The following table represents the usual maximum amount of accessories
expected to be medically necessary:
A4604 – 1 per 3 months
A7027 - 1 per 3 months
A7028 - 2 per 1 month
A7029 - 2 per 1 month
A7030 – 1 per 3 months
A7031 – 1 per 1 month
A7032 - 2 per 1 month
A7033 – 2 per 1 month
A7034 - 1 per 3 months
A7035 - 1 per 6 months
A7036 - 1 per 6 months
A7037 - 1 per 3 month
A7038 - 2 per 1 month
A7039 - 1 per 6 months
A7046 – 1 per 6 months
Billing for quantities of supplies greater than those described in the
policy as the usual maximum amounts, in the absence of documentation
clearly explaining the medical necessity of the excess quantities, will be
denied as not medically necessary.
Either a non-heated (E0561) or heated (E0562) humidifier is covered and
paid separately when ordered by the treating physician for use with a
covered E0470 or E0471 RAD.
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