Respiratory Assist Devices CPAP-BiPAP - Health Plan of Nevada

RESPIRATORY ASSIST DEVICES, CONTINUOUS
POSITIVE AIRWAY PRESSURE (CPAP),
BI-POSITIVE ASSIST PRESSURE (BI-PAP)
Protocol: DME001
Effective Date: November 15, 2010
Table of Contents
Page
COMMERCIAL COVERAGE RATIONALE......................................................................................... 1
MEDICARE & MEDICAID COVERAGE RATIONALE...................................................................... 3
BACKGROUND ...................................................................................................................................... 5
APPLICABLE CODES............................................................................................................................ 6
REFERENCES ......................................................................................................................................... 6
PROTOCOL HISTORY/REVISION INFORMATION .......................................................................... 9
INSTRUCTIONS FOR USE
This protocol provides assistance in interpreting UnitedHealthcare benefit plans. When deciding
coverage, the enrollee specific document must be referenced. The terms of an enrollee's document
(e.g., Certificate of Coverage (COC) or Evidence of Coverage (EOC)) may differ greatly. In the event
of a conflict, the enrollee's specific benefit document supersedes this protocol. All reviewers must first
identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage
prior to use of this Protocol. Other Protocols, Policies and Coverage Determination Guidelines may
apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Protocols, Policies and
Guidelines as necessary. This protocol is provided for informational purposes. It does not constitute
medical advice.
COMMERCIAL COVERAGE RATIONALE
Note: Requires Medical Director Approval if Less Than 15 Apnea-Hypopnea Index (AHI)
Events
A respiratory assist device (E0470, E0471) used to administer noninvasive positive pressure
response assistance (NPPRA) therapy is medically necessary for those individuals with clinical
disorder groups characterized as:
A. Restrictive Thoracic Disorders
1. There is documentation in the individual’s medical record of a progressive
neuromuscular disease (for example, amyotrophic lateral sclerosis (ALS), or a severe
thoracic cage abnormality (for e.g., post-thoracoplasty for Tuberculosis (TB) , and
a. A partial pressure of carbon dioxide (PaCO2) arterial blood gas, was done
while the individual was awake and breathing the individual’s usual FIO2 is
greater-than-or-equal-to 45 mm Hg, or
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. Sleep oximetry demonstrates oxygen saturation less-than-or-equal-to 88% for
at least five continuous minutes, done while breathing the individual’s usual
FIO2, or
c. Maximal inspiratory pressure for progressive neuromuscular disease is, less
than 60 cm H20 or forced vital capacity is less than 50% predicted, and
1. Chronic obstructive pulmonary disease (COPD) does not contribute
significantly to the individual’s pulmonary limitation.
2. If the above criteria are met, either an E0470 or E0471 device will be
covered for individuals within this group of conditions for the first three
months of NPPRA therapy.
B. Severe COPD
1. An arterial blood gas PaCO2, was done while individual was awake and breathing
the individual’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 liter per minute or
the individual’s usual FIO2, whichever is higher; and
3. Obstructive Sleep Apnea (OSA) (and treatment with CPAP) has been considered
and ruled out prior to initiating therapy.
4. If all of the above criteria for individuals with COPD are met, an E0470 device
will be covered for the first three months of NPPRA therapy.
5. An E0471 device will not be covered for an individual with COPD during the first
two months, because therapy with an E0470 device with proper adjustments of the
device’s setting and individual accommodation to its use will usually result in
sufficient improvement without the need of a back-up rate.
C. Central Sleep Apnea (CSA) or Complex Sleep Apnea (CompSA) (apnea not due to airway
obstruction)
1. Prior to initiating therapy, a complete facility-based, attended polysonigraph
(PSG) must be performed documenting the following:
a. The diagnosis of CSA or CompSA (see definitions in Appendices section);
b. The ruling out of CPAP as effective therapy if either CSA or OSA is a
component of the initially observed sleep-associated hypoventilation; and
c. 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 individual’s usual FIO2.
2. If all above criteria are met, either an E0470 or E0471 device (based upon the
judgment of the treating physician) will be covered for individuals with
documented CSA or CompSA for the first three months of NPPRA therapy.
Obstructive Sleep Apnea (OSA)
1. A complete facility-based, attended polysomnogram, has established the diagnosis
of obstructive sleep apnea according to the following criteria:
a. The Apnea-Hypopnea Index (AHI) is greater-than-or-equal-to15 events per
hour; or
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. The AHI is greater-than-or-equal-to 5 to less-than-or-equal-to14 events per
hour with documented symptoms of:
i. Excessive daytime sleepiness, or
ii. Impaired cognition, mood disorders, insomnia, or
iii. Hypertension, or
iv. Ischemic heart disease, or
v. History of stroke, or
vi. Greater than 20 episodes of oxygen desaturation less than 85%
during a full night sleep study or any one episode of oxygen
desaturation less than 70%.
c. If the above criteria are met, an E0470 device will be covered for the first 60
days of NPPRA therapy.
Note: The Apnea-Hypopnea Index (AHI) is equal to the average number of episodes of apnea and hypopnea per
hour and must be based on a minimum of 2 hours of sleep recorded by polysomnography using actual recorded
hours of sleep (i.e., the AHI may not be extrapolated or projected). For the purposes of this protocol, Apnea is
defined as a cessation of airflow for at least 10 seconds. Hypopnea is defined as an abnormal respiratory event
lasting at least 10 seconds with at least a 30% reduction in thoracoabdominal movement or airflow as compared to
baseline, and with at least a 4% oxygen desaturation.
1. For All Product Lines – either a non-heated (E0561) or a heated (E0562) humidifier is
covered when ordered by the treating physician for use with a covered E0601 device.
2. CPAP must be prescribed and ordered by the treating physician (MD/DO).
3. Polysomnography must be performed in a facility-based sleep study laboratory, and not in
the home or in a mobile facility.
4. CPAP-BIPAP is authorized for 60 days to determine individual tolerance to the equipment.
5. Continued coverage of an E0601 device beyond the 60 days requires the supplier ascertain
from either the member or the treating physician that the member is to use the CPAP
device.
6. All CPAP-BIPAP devices and accessories must be ordered through the contracted DME
vendor
7. Refer to Protocol PUL004, Polysomnography & Portable Monitoring for evaluation of
Sleep Related Breathing Disorders .
CPAP-BiPAP devices are not medically necessary when the above criteria have not been met.
An E0471 device is not medically necessary if the primary diagnosis is Obstructive Sleep Apnea
(OSA).
MEDICARE & MEDICAID COVERAGE RATIONALE
Medicare has a National Coverage Determination for Continuous Positive Airway Pressure (C-PAP)
Therapy for Obstructive Sleep Apnea (OSA).
The National Coverage Determination is as follows:
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Treatment of sleep apnea is covered when criteria are met. Examples include, but are not limited to:
Continuous Positive Airway Pressure (CPAP)
The use of CPAP is covered as medically necessary when used in adult patients with diagnosis of
OSA under the following situations:
1. The use of CPAP is covered under Medicare when used in adult patients with OSA. Coverage
of CPAP is initially limited to a 12-week period to identify beneficiaries diagnosed with OSA
as subsequently described who benefit from CPAP. CPAP is subsequently covered only for
those beneficiaries diagnosed with OSA who benefit from CPAP during this 12-week period.
2. The provider of CPAP must conduct education of the beneficiary prior to the use of the CPAP
device to ensure that the beneficiary has been educated in the proper use of the device. A
caregiver, for example a family member, may be compensatory, if consistently available in the
beneficiary's home and willing and able to safely operate the CPAP device.
3. A confirmed diagnosis of OSA for the coverage of CPAP must include a clinical evaluation
and a positive:
a. attended polysomnography (PSG) performed in a sleep laboratory, or
b. unattended home sleep test (HST) with a Type II home sleep monitoring device, or
c. unattended HST with a Type III home sleep monitoring device, or
d. unattended HST with a Type IV home sleep monitoring device that measures at least 3
channels.
4. The use of CPAP devices must be ordered and prescribed by the licensed treating physician to
be used in adult patients with moderate to severe OSA. An initial 12-week period of CPAP is
covered in adult patients with OSA if either of the following criterion using the AHI or RDI
are met:
a. AHI or RDI greater than or equal to 15 events per hour, or
b. AHI or RDI greater than or equal to 5 events and less than or equal to 14 events per
hour with documented symptoms of excessive daytime sleepiness, impaired cognition,
mood disorders or insomnia, or documented hypertension, ischemic heart disease, or
history of stroke.
Notes: The AHI is equal to the average number of episodes of apnea and hypopnea per hour and must
be based on a minimum of 2 hours of sleep recorded by polysomnography using actual recorded hours
of sleep (i.e., the AHI may not be extrapolated or projected).
If the AHI or RDI is calculated based on less than two hours of continuous recorded sleep, the total
number of recorded events to calculate the AHI or RDI during sleep testing is at least the number of
events that would have been required in a two hour period.
Coverage with Evidence Development (CED)
CPAP based on clinical diagnosis alone or using a diagnostic procedure other than PSG or Type II,
Type III, or a Type IV HST measuring at least three channels is covered only when provided in the
context of a clinical study when that study meets the following standards:
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A clinical study seeking Medicare payment for CPAP provided to the beneficiary pursuant to Coverage
with Evidence Development (CED) must address one or more of the following questions:
1. In Medicare aged subjects with clinically identified risk factors for OSA, how does the
diagnostic accuracy of a clinical trial of CPAP compare with PSG and Type II, III & IV HST in
identifying subjects with OSA who will respond to CPAP?
2. In Medicare aged subjects with clinically identified risk factors for OSA who have not
undergone confirmatory testing with PSG or Type II, III & IV HST, does CPAP cause
clinically meaningful harm?
Note: Studies must meet other Medicare Clinical Trial Study criteria.
There is a Local Coverage Determination for Nevada for Positive Airway Pressure (PAP) Devices for
the Treatment of Obstructive Sleep Apnea.
A bi-level respiratory assist device without back-up rate is covered as medically necessary for
those patients with OSA who meet the criteria for C-PAP, in addition to the following:
1. A C-PAP device has been tried and proven ineffective based on a therapeutic trial conducted in
either a facility or in a home setting.
Ineffective is defined as documented failure to meet therapeutic goals using an E0601 during the
titration portion of a facility-based study or during home use despite optimal therapy (i.e., proper mask
selection and fitting and appropriate pressure settings).
A bi-level positive airway pressure device with back-up rate (E0471) is not medically necessary if
the primary diagnosis is OSA;
For Medicare and Medicaid Determinations Related to States Outside of Nevada:
Please review Local Coverage Determinations that apply to other states outside of Nevada.
http://www.cms.hhs.gov/mcd/search
Important Note: Please also review local carrier Web sites in addition to the Medicare Coverage
database on the Centers for Medicare and Medicaid Services’ Website.
BACKGROUND
A Continuous Positive Airway Pressure (CPAP) device delivers a constant level of positive air
pressure, within a single respiratory cycle (an inspiration followed by an expiration) by way of tubing
and a noninvasive interface (such as nasal or face mask, nasal cannula or oral interface) to assist
spontaneous respiratory efforts and supplement the volume of inspired air into the lungs. CPAP- Bipositive
Airway Pressure (BIPAP) devices are considered Durable Medical Equipment (DME) and as
such must meet the definition requirements. Consideration for approval will be based on the stated
indications and individual compliance with recommended conservative medical treatment plans. Refer
to plan benefits for DME coverage.
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APPLICABLE CODES
CPT ® Code
Description
94660
Continuous positive airway pressure ventilation (CPAP), initiation and
management
94799 Unlisted pulmonary service or procedure
CPT ® is a registered trademark of the American Medical Association
HCPCS Codes
E0470
E0471
E0601
E0561
E0562
Respiratory assist device, bi-level pressure capability, without backup rate
feature, used with noninvasive interface, e. g., nasal or facial mask
(intermittent assist device with continuous positive airway pressure device)
Respiratory assist device, bi-level pressure capability, with backup rate
feature, used with noninvasive interface, e. g., nasal or facial mask
(intermittent assist device with continuous positive airway pressure device)
Single level continuous positive airway pressure device
Humidifier, non-heated, used with positive airway pressure device
Humidifier, heated, used with positive airway pressure device
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PROTOCOL HISTORY/REVISION INFORMATION
Date
09/23/2010
07/24/2009
Action/Description
Corporate Medical Affairs Committee
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