Respiratory Assist Devices CPAP-BiPAP - Health Plan of Nevada
Respiratory Assist Devices CPAP-BiPAP - Health Plan of Nevada
Respiratory Assist Devices CPAP-BiPAP - Health Plan of Nevada
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RESPIRATORY ASSIST DEVICES, CONTINUOUS<br />
POSITIVE AIRWAY PRESSURE (<strong>CPAP</strong>),<br />
BI-POSITIVE ASSIST PRESSURE (BI-PAP)<br />
Protocol: DME001<br />
Effective Date: November 15, 2010<br />
Table <strong>of</strong> Contents<br />
Page<br />
COMMERCIAL COVERAGE RATIONALE......................................................................................... 1<br />
MEDICARE & MEDICAID COVERAGE RATIONALE...................................................................... 3<br />
BACKGROUND ...................................................................................................................................... 5<br />
APPLICABLE CODES............................................................................................................................ 6<br />
REFERENCES ......................................................................................................................................... 6<br />
PROTOCOL HISTORY/REVISION INFORMATION .......................................................................... 9<br />
INSTRUCTIONS FOR USE<br />
This protocol provides assistance in interpreting United<strong>Health</strong>care benefit plans. When deciding<br />
coverage, the enrollee specific document must be referenced. The terms <strong>of</strong> an enrollee's document<br />
(e.g., Certificate <strong>of</strong> Coverage (COC) or Evidence <strong>of</strong> Coverage (EOC)) may differ greatly. In the event<br />
<strong>of</strong> a conflict, the enrollee's specific benefit document supersedes this protocol. All reviewers must first<br />
identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage<br />
prior to use <strong>of</strong> this Protocol. Other Protocols, Policies and Coverage Determination Guidelines may<br />
apply. United<strong>Health</strong>care reserves the right, in its sole discretion, to modify its Protocols, Policies and<br />
Guidelines as necessary. This protocol is provided for informational purposes. It does not constitute<br />
medical advice.<br />
COMMERCIAL COVERAGE RATIONALE<br />
Note: Requires Medical Director Approval if Less Than 15 Apnea-Hypopnea Index (AHI)<br />
Events<br />
A respiratory assist device (E0470, E0471) used to administer noninvasive positive pressure<br />
response assistance (NPPRA) therapy is medically necessary for those individuals with clinical<br />
disorder groups characterized as:<br />
A. Restrictive Thoracic Disorders<br />
1. There is documentation in the individual’s medical record <strong>of</strong> a progressive<br />
neuromuscular disease (for example, amyotrophic lateral sclerosis (ALS), or a severe<br />
thoracic cage abnormality (for e.g., post-thoracoplasty for Tuberculosis (TB) , and<br />
a. A partial pressure <strong>of</strong> carbon dioxide (PaCO2) arterial blood gas, was done<br />
while the individual was awake and breathing the individual’s usual FIO2 is<br />
greater-than-or-equal-to 45 mm Hg, or<br />
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. Sleep oximetry demonstrates oxygen saturation less-than-or-equal-to 88% for<br />
at least five continuous minutes, done while breathing the individual’s usual<br />
FIO2, or<br />
c. Maximal inspiratory pressure for progressive neuromuscular disease is, less<br />
than 60 cm H20 or forced vital capacity is less than 50% predicted, and<br />
1. Chronic obstructive pulmonary disease (COPD) does not contribute<br />
significantly to the individual’s pulmonary limitation.<br />
2. If the above criteria are met, either an E0470 or E0471 device will be<br />
covered for individuals within this group <strong>of</strong> conditions for the first three<br />
months <strong>of</strong> NPPRA therapy.<br />
B. Severe COPD<br />
1. An arterial blood gas PaCO2, was done while individual was awake and breathing<br />
the individual’s usual FIO2, is greater-than-or-equal-to 52 mm Hg; and<br />
2. Sleep oximetry demonstrates oxygen saturation less-than-or-equal-to 88% for at<br />
least five continuous minutes, done while breathing oxygen at 2 liter per minute or<br />
the individual’s usual FIO2, whichever is higher; and<br />
3. Obstructive Sleep Apnea (OSA) (and treatment with <strong>CPAP</strong>) has been considered<br />
and ruled out prior to initiating therapy.<br />
4. If all <strong>of</strong> the above criteria for individuals with COPD are met, an E0470 device<br />
will be covered for the first three months <strong>of</strong> NPPRA therapy.<br />
5. An E0471 device will not be covered for an individual with COPD during the first<br />
two months, because therapy with an E0470 device with proper adjustments <strong>of</strong> the<br />
device’s setting and individual accommodation to its use will usually result in<br />
sufficient improvement without the need <strong>of</strong> a back-up rate.<br />
C. Central Sleep Apnea (CSA) or Complex Sleep Apnea (CompSA) (apnea not due to airway<br />
obstruction)<br />
1. Prior to initiating therapy, a complete facility-based, attended polysonigraph<br />
(PSG) must be performed documenting the following:<br />
a. The diagnosis <strong>of</strong> CSA or CompSA (see definitions in Appendices section);<br />
b. The ruling out <strong>of</strong> <strong>CPAP</strong> as effective therapy if either CSA or OSA is a<br />
component <strong>of</strong> the initially observed sleep-associated hypoventilation; and<br />
c. Significant improvement <strong>of</strong> the sleep-associated hypoventilation with the use<br />
<strong>of</strong> an E0470 or E0471 device on the settings that will be prescribed for initial<br />
use at home, while breathing the individual’s usual FIO2.<br />
2. If all above criteria are met, either an E0470 or E0471 device (based upon the<br />
judgment <strong>of</strong> the treating physician) will be covered for individuals with<br />
documented CSA or CompSA for the first three months <strong>of</strong> NPPRA therapy.<br />
Obstructive Sleep Apnea (OSA)<br />
1. A complete facility-based, attended polysomnogram, has established the diagnosis<br />
<strong>of</strong> obstructive sleep apnea according to the following criteria:<br />
a. The Apnea-Hypopnea Index (AHI) is greater-than-or-equal-to15 events per<br />
hour; or<br />
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. The AHI is greater-than-or-equal-to 5 to less-than-or-equal-to14 events per<br />
hour with documented symptoms <strong>of</strong>:<br />
i. Excessive daytime sleepiness, or<br />
ii. Impaired cognition, mood disorders, insomnia, or<br />
iii. Hypertension, or<br />
iv. Ischemic heart disease, or<br />
v. History <strong>of</strong> stroke, or<br />
vi. Greater than 20 episodes <strong>of</strong> oxygen desaturation less than 85%<br />
during a full night sleep study or any one episode <strong>of</strong> oxygen<br />
desaturation less than 70%.<br />
c. If the above criteria are met, an E0470 device will be covered for the first 60<br />
days <strong>of</strong> NPPRA therapy.<br />
Note: The Apnea-Hypopnea Index (AHI) is equal to the average number <strong>of</strong> episodes <strong>of</strong> apnea and hypopnea per<br />
hour and must be based on a minimum <strong>of</strong> 2 hours <strong>of</strong> sleep recorded by polysomnography using actual recorded<br />
hours <strong>of</strong> sleep (i.e., the AHI may not be extrapolated or projected). For the purposes <strong>of</strong> this protocol, Apnea is<br />
defined as a cessation <strong>of</strong> airflow for at least 10 seconds. Hypopnea is defined as an abnormal respiratory event<br />
lasting at least 10 seconds with at least a 30% reduction in thoracoabdominal movement or airflow as compared to<br />
baseline, and with at least a 4% oxygen desaturation.<br />
1. For All Product Lines – either a non-heated (E0561) or a heated (E0562) humidifier is<br />
covered when ordered by the treating physician for use with a covered E0601 device.<br />
2. <strong>CPAP</strong> must be prescribed and ordered by the treating physician (MD/DO).<br />
3. Polysomnography must be performed in a facility-based sleep study laboratory, and not in<br />
the home or in a mobile facility.<br />
4. <strong>CPAP</strong>-BIPAP is authorized for 60 days to determine individual tolerance to the equipment.<br />
5. Continued coverage <strong>of</strong> an E0601 device beyond the 60 days requires the supplier ascertain<br />
from either the member or the treating physician that the member is to use the <strong>CPAP</strong><br />
device.<br />
6. All <strong>CPAP</strong>-BIPAP devices and accessories must be ordered through the contracted DME<br />
vendor<br />
7. Refer to Protocol PUL004, Polysomnography & Portable Monitoring for evaluation <strong>of</strong><br />
Sleep Related Breathing Disorders .<br />
<strong>CPAP</strong>-<strong>BiPAP</strong> devices are not medically necessary when the above criteria have not been met.<br />
An E0471 device is not medically necessary if the primary diagnosis is Obstructive Sleep Apnea<br />
(OSA).<br />
MEDICARE & MEDICAID COVERAGE RATIONALE<br />
Medicare has a National Coverage Determination for Continuous Positive Airway Pressure (C-PAP)<br />
Therapy for Obstructive Sleep Apnea (OSA).<br />
The National Coverage Determination is as follows:<br />
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Treatment <strong>of</strong> sleep apnea is covered when criteria are met. Examples include, but are not limited to:<br />
Continuous Positive Airway Pressure (<strong>CPAP</strong>)<br />
The use <strong>of</strong> <strong>CPAP</strong> is covered as medically necessary when used in adult patients with diagnosis <strong>of</strong><br />
OSA under the following situations:<br />
1. The use <strong>of</strong> <strong>CPAP</strong> is covered under Medicare when used in adult patients with OSA. Coverage<br />
<strong>of</strong> <strong>CPAP</strong> is initially limited to a 12-week period to identify beneficiaries diagnosed with OSA<br />
as subsequently described who benefit from <strong>CPAP</strong>. <strong>CPAP</strong> is subsequently covered only for<br />
those beneficiaries diagnosed with OSA who benefit from <strong>CPAP</strong> during this 12-week period.<br />
2. The provider <strong>of</strong> <strong>CPAP</strong> must conduct education <strong>of</strong> the beneficiary prior to the use <strong>of</strong> the <strong>CPAP</strong><br />
device to ensure that the beneficiary has been educated in the proper use <strong>of</strong> the device. A<br />
caregiver, for example a family member, may be compensatory, if consistently available in the<br />
beneficiary's home and willing and able to safely operate the <strong>CPAP</strong> device.<br />
3. A confirmed diagnosis <strong>of</strong> OSA for the coverage <strong>of</strong> <strong>CPAP</strong> must include a clinical evaluation<br />
and a positive:<br />
a. attended polysomnography (PSG) performed in a sleep laboratory, or<br />
b. unattended home sleep test (HST) with a Type II home sleep monitoring device, or<br />
c. unattended HST with a Type III home sleep monitoring device, or<br />
d. unattended HST with a Type IV home sleep monitoring device that measures at least 3<br />
channels.<br />
4. The use <strong>of</strong> <strong>CPAP</strong> devices must be ordered and prescribed by the licensed treating physician to<br />
be used in adult patients with moderate to severe OSA. An initial 12-week period <strong>of</strong> <strong>CPAP</strong> is<br />
covered in adult patients with OSA if either <strong>of</strong> the following criterion using the AHI or RDI<br />
are met:<br />
a. AHI or RDI greater than or equal to 15 events per hour, or<br />
b. AHI or RDI greater than or equal to 5 events and less than or equal to 14 events per<br />
hour with documented symptoms <strong>of</strong> excessive daytime sleepiness, impaired cognition,<br />
mood disorders or insomnia, or documented hypertension, ischemic heart disease, or<br />
history <strong>of</strong> stroke.<br />
Notes: The AHI is equal to the average number <strong>of</strong> episodes <strong>of</strong> apnea and hypopnea per hour and must<br />
be based on a minimum <strong>of</strong> 2 hours <strong>of</strong> sleep recorded by polysomnography using actual recorded hours<br />
<strong>of</strong> sleep (i.e., the AHI may not be extrapolated or projected).<br />
If the AHI or RDI is calculated based on less than two hours <strong>of</strong> continuous recorded sleep, the total<br />
number <strong>of</strong> recorded events to calculate the AHI or RDI during sleep testing is at least the number <strong>of</strong><br />
events that would have been required in a two hour period.<br />
Coverage with Evidence Development (CED)<br />
<strong>CPAP</strong> based on clinical diagnosis alone or using a diagnostic procedure other than PSG or Type II,<br />
Type III, or a Type IV HST measuring at least three channels is covered only when provided in the<br />
context <strong>of</strong> a clinical study when that study meets the following standards:<br />
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A clinical study seeking Medicare payment for <strong>CPAP</strong> provided to the beneficiary pursuant to Coverage<br />
with Evidence Development (CED) must address one or more <strong>of</strong> the following questions:<br />
1. In Medicare aged subjects with clinically identified risk factors for OSA, how does the<br />
diagnostic accuracy <strong>of</strong> a clinical trial <strong>of</strong> <strong>CPAP</strong> compare with PSG and Type II, III & IV HST in<br />
identifying subjects with OSA who will respond to <strong>CPAP</strong>?<br />
2. In Medicare aged subjects with clinically identified risk factors for OSA who have not<br />
undergone confirmatory testing with PSG or Type II, III & IV HST, does <strong>CPAP</strong> cause<br />
clinically meaningful harm?<br />
Note: Studies must meet other Medicare Clinical Trial Study criteria.<br />
There is a Local Coverage Determination for <strong>Nevada</strong> for Positive Airway Pressure (PAP) <strong>Devices</strong> for<br />
the Treatment <strong>of</strong> Obstructive Sleep Apnea.<br />
A bi-level respiratory assist device without back-up rate is covered as medically necessary for<br />
those patients with OSA who meet the criteria for C-PAP, in addition to the following:<br />
1. A C-PAP device has been tried and proven ineffective based on a therapeutic trial conducted in<br />
either a facility or in a home setting.<br />
Ineffective is defined as documented failure to meet therapeutic goals using an E0601 during the<br />
titration portion <strong>of</strong> a facility-based study or during home use despite optimal therapy (i.e., proper mask<br />
selection and fitting and appropriate pressure settings).<br />
A bi-level positive airway pressure device with back-up rate (E0471) is not medically necessary if<br />
the primary diagnosis is OSA;<br />
For Medicare and Medicaid Determinations Related to States Outside <strong>of</strong> <strong>Nevada</strong>:<br />
Please review Local Coverage Determinations that apply to other states outside <strong>of</strong> <strong>Nevada</strong>.<br />
http://www.cms.hhs.gov/mcd/search<br />
Important Note: Please also review local carrier Web sites in addition to the Medicare Coverage<br />
database on the Centers for Medicare and Medicaid Services’ Website.<br />
BACKGROUND<br />
A Continuous Positive Airway Pressure (<strong>CPAP</strong>) device delivers a constant level <strong>of</strong> positive air<br />
pressure, within a single respiratory cycle (an inspiration followed by an expiration) by way <strong>of</strong> tubing<br />
and a noninvasive interface (such as nasal or face mask, nasal cannula or oral interface) to assist<br />
spontaneous respiratory efforts and supplement the volume <strong>of</strong> inspired air into the lungs. <strong>CPAP</strong>- Bipositive<br />
Airway Pressure (BIPAP) devices are considered Durable Medical Equipment (DME) and as<br />
such must meet the definition requirements. Consideration for approval will be based on the stated<br />
indications and individual compliance with recommended conservative medical treatment plans. Refer<br />
to plan benefits for DME coverage.<br />
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APPLICABLE CODES<br />
CPT ® Code<br />
Description<br />
94660<br />
Continuous positive airway pressure ventilation (<strong>CPAP</strong>), initiation and<br />
management<br />
94799 Unlisted pulmonary service or procedure<br />
CPT ® is a registered trademark <strong>of</strong> the American Medical Association<br />
HCPCS Codes<br />
E0470<br />
E0471<br />
E0601<br />
E0561<br />
E0562<br />
<strong>Respiratory</strong> assist device, bi-level pressure capability, without backup rate<br />
feature, used with noninvasive interface, e. g., nasal or facial mask<br />
(intermittent assist device with continuous positive airway pressure device)<br />
<strong>Respiratory</strong> assist device, bi-level pressure capability, with backup rate<br />
feature, used with noninvasive interface, e. g., nasal or facial mask<br />
(intermittent assist device with continuous positive airway pressure device)<br />
Single level continuous positive airway pressure device<br />
Humidifier, non-heated, used with positive airway pressure device<br />
Humidifier, heated, used with positive airway pressure device<br />
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Ballester E, Badia JR, Hernandes L, et al. Evidence <strong>of</strong> the effectiveness <strong>of</strong> continuous positive airway<br />
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Barbe R, Mayoralas LR, Duran J, et al. Treatment with continuous positive airway pressure is not<br />
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Calverley PM. Nasal <strong>CPAP</strong> in cardiac failure: case not proven". Sleep 1996 Dec;19 (10 Suppl):S236-9.<br />
Centers for Medicare & Medicaid Services (CMS) NCD for Continuous Positive Airway Pressure (C-<br />
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August 2010.<br />
Centers for Medicare & Medicaid Services (CMS). DME MAC Noridian Administrative Services<br />
(19003) LCD for Positive Airway Pressure (PAP) <strong>Devices</strong> for the Treatment <strong>of</strong> Obstructive Sleep<br />
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Dimsale JE, Loredo JS, Pr<strong>of</strong>ant J. Effecti <strong>of</strong> continuous positive airway pressure. Hypertension<br />
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Engleman HM, Kingshott RN, Wraith PK, et al. Randomized placebo-controlled crossover trial <strong>of</strong><br />
continuous positive airway pressure for mild sleep apnea/hypopnea syndrome. Am J Respir Crit Care<br />
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Engleman HM, Martin SE, Deary IJ, Douglas NJ. Effect <strong>of</strong> <strong>CPAP</strong> therapy on daytime function in<br />
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Faccenda JF, Mackay TW, Boon NA, Douglas NJ. Randomized placebo-controlled trial <strong>of</strong> continuous<br />
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Fox GA, Lam CJ, Darragh WB, Neal AM, Inman KJ, Rutledge FS, Sibbald WJ. Circulatory sequelae<br />
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Henke KG, Grady JJ, Kuna ST. Effect <strong>of</strong> nasal continuous positive airway pressure on<br />
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Scharf SM. Effects <strong>of</strong> continuous positive airway pressure on cardiac output in experiment heart<br />
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PROTOCOL HISTORY/REVISION INFORMATION<br />
Date<br />
09/23/2010<br />
07/24/2009<br />
Action/Description<br />
Corporate Medical Affairs Committee<br />
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