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Medical Policy Bulletin
| Title: | Noninvasive Respiratory Assist Devices (RADs): Continuous Positive Airway Pressure (CPAP) Devices and Bi-Level Devices |
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The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.
When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.
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 Intent |
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The intent of this policy is to communicate the medical necessity criteria for noninvasive respiratory assist devices (RADs): continuous positive airway pressure (CPAP) devices and bi-level devices.
For information on policies related to this topic, refer to the Cross References section in this policy.
| Description |
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A noninvasive respiratory assist device (RAD), such as a single-level continuous positive airway pressure (CPAP) device or a bi-level positive airway pressure device delivers noninvasive positive pressure respiratory assistance (NPPRA). NPPRA is the administration of positive air pressure (PAP) using a nasal and/or oral mask interface that creates a seal and minimizes the need for accessing the airway invasively (eg, via tracheostomy). NPPRA is sometimes used to treat conditions that may involve sleep-associated hypoventilation. It should be distinguished from invasive ventilation administered via a securely intubated airway or tracheostomy, which could lead to the imminent demise of an individual if it is interrupted.
A polysomnogram is often used to evaluate the need for a RAD. Polysomnography is the continuous and simultaneous monitoring and recording of various physiologic and pathophysiologic parameters of sleep for six or more hours; a physician provides a review, interpretation, and report afterwards. It must include sleep staging with a one-to-four lead electroencephalogram, an electrooculogram, and a submental electromyogram. It must also include airflow, respiratory effort, and oxygen saturation by oximetry.
A CPAP RAD delivers continuous single levels of pressure during both inspiration and expiration. The device's purpose is to prevent the collapse of the oropharyngeal walls and the obstruction of airflow that occurs during sleep apnea. (Apnea is defined as the cessation of airflow for at least 10 seconds.)
A bi-level RAD also delivers continuous pressure by allowing the pressure to be adjusted separately during inspiration and expiration. The device cycles between a predetermined inspiratory PAP phase and a preset expiratory PAP phase. The backup rate feature on some of these machines ensures that individuals will receive a set minimum number of breaths per minute if they should stop breathing spontaneously.
Bi-level RADs can be divided further into two categories: those without a backup rate feature and those with a backup rate feature:
- A bi-level RAD without a backup rate feature, such as the Bi-PAP® Pro 2 with BiFlex® (Respironics Inc., Murrysville, PA), delivers adjustable, variable levels of PAP via tubing and a noninvasive interface (ie, a nasal, oral, or facial mask) to assist spontaneous respiratory efforts and supplement the volume of air inspired into the lungs.
- A bi-level RAD with a backup rate feature, such as the Bi-PAP® Synchrony® Spontaneous/Timed Mode (S/T) Ventilatory Support System (Respironics, Inc.) or the VPAP III ST and VPAP III STA (ResMed Corp, Poway, CA), delivers adjustable, variable levels of PAP within a single respiratory cycle via tubing and a noninvasive interface (ie, nasal, oral, or facial mask) to assist spontaneous respiratory efforts and supplement the volume of air inspired into the lungs. In addition, it has a timed backup feature to deliver PAP whenever sufficient spontaneous inspiratory efforts fail. The built-in sensor recognizes respiratory changes and automatically adjusts to variable sensitivity thresholds for an optimum breathing response.
DEFINITIONS OF TERMS USED IN THIS POLICY
Apnea is defined as the cessation of airflow for at least 10 seconds.
Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds associated with at least a 30 percent reduction in thoracoabdominal movement or airflow as compared to baseline and with at least a 4 percent decrease in oxygen saturation.
The apnea-hypopnea index (AHI) is defined as the average number of episodes of apnea and hypopnea per hour of sleep without the use of a positive airway pressure device.
The respiratory disturbance index (RDI) is defined as the average number of apneas plus hypopneas per hour of recording without the use of a positive airway pressure device.
If the AHI or RDI is calculated based on less than two hours of sleep or recording time, the total number of recorded events used to calculate the AHI must be at least the number of events that would have been required in a two-hour period (ie, must reach greater than or equal to 30 events without symptoms or greater than or equal to 10 events with symptoms).
Central sleep apnea (CSA) is defined by meeting all of the following criteria:
- An AHI greater than 5
- Central apneas or hypopneas greater than 50 percent of the total apneas/hypopneas
- Central apneas or hypopneas greater than or equal to five times per hour
- Symptoms of either excessive sleepiness or disrupted sleep
Complex sleep apnea (CompSA) is a form of central sleep apnea specifically identified by the persistence or emergence of central apneas or hypopneas upon exposure to a CPAP RAD or a bi-level RAD without a backup rate feature when obstructive events have disappeared. These individuals have predominately obstructive or mixed apneas during the diagnostic sleep study occurring at greater than or equal to five times per hour.
| Policy |
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TREATMENT OF OBSTRUCTIVE SLEEP APNEA (OSA)
A single-level continuous positive airway pressure (CPAP) respiratory assist device (RAD) (Healthcare Common Procedure Coding System [HCPCS] code E0601) is considered medically necessary and, therefore, covered for the treatment of OSA when all of the following criteria are met:
- The individual has a face-to-face clinical evaluation prior to a sleep test to assess the individual for OSA. The clinical evaluation must include, at a minimum, all of the following:
- Sleep history and symptoms including, but not limited to, snoring, daytime sleepiness, observed apneas, choking or gasping during sleep, or morning headaches
- Validated sleep hygiene inventory such as the Epworth Sleepiness Scale (refer to Guidelines for the scale)
- Physical examination that documents body mass index (BMI), neck circumference, and a focused cardiopulmonary and upper airway system evaluation
- The diagnosis of OSA has been established by a covered sleep test (see the Adult Sleep Disorder Testing policy for covered sleep tests) that meets one of the following criteria:
- The apnea-hypopnea index (AHI) or respiratory disturbance index (RDI) is greater than or equal to 15 events per hour with a minimum of 30 events
- The AHI or RDI is 5 to 14 events per hour with a minimum of 10 events and documentation of at least one of the following:
- Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia
- Hypertension, ischemic heart disease, or history of stroke
- The individual and/or their caregiver has received instruction from the supplier of the CPAP RAD and accessories in the proper use and care of the equipment
A bi-level RAD without a backup rate feature (HCPCS code E0470) is considered medically necessary and, therefore, covered when the diagnosis of OSA has been established and documented by a covered sleep test, and the individual meets the above criteria for a CPAP RAD (HCPCS code E0601) and the following criterion:
- A CPAP RAD (HCPCS code E0601) has been tried and proven ineffective, based on a therapeutic trial conducted in either a facility or home setting.
The coverage of a single-level CPAP RAD (HCPCS code E0601) is initially limited to a three-month period for individuals diagnosed with OSA as described above. A single-level CPAP RAD is subsequently covered for individuals diagnosed with OSA whose OSA improves as a result of a single-level CPAP RAD during this three-month period. If a single-level CPAP RAD is tried and found ineffective during the initial three-month home trial, substitution of a bi-level RAD without a backup rate feature (HCPCS code E0470) does not require a new initial face-to face clinical evaluation or new sleep test, and substitution of a bi-level RAD without a backup rate feature (HCPCS code E0470) does not change the length of the trial unless there is less than 30 days remaining in the trial period. If more than 30 days remain in the trial period, the clinical re-evaluation would still occur between the 31st and 91st day following the initiation of a single-level CPAP RAD (HCPCS code E0601) and objective documentation of adherence on the bi-level RAD without a backup rate feature (HCPCS code E0470) would need to occur prior to the 91st day following initiation of the single-level CPAP RAD (HCPCS code E0601.) If less than 30 days remain in the trial period, the clinical re-evaluation and objective documentation of adherence must occur before the 120th day following the initiation of the single-level CPAP RAD (HCPCS code E0601.)
If a single-level CPAP RAD (HCPCS code E0601) has been used for more than three months and the individual is switched to a bi-level RAD without a backup rate feature (HCPCS code E0470), a new initial face-to-face clinical evaluation is required, but a new sleep test is not required. A new three-month trial would begin for use of the bi-level RAD without a backup rate feature.
Continued coverage of a single-level CPAP RAD (HCPCS code E0601) or a bi-level RAD without a backup rate feature (HCPCS code E0470) beyond the first three months of therapy requires that, no sooner than the 31st day but not later than the 91st day after initiating therapy, the treating professional provider must conduct a clinical re-evaluation and document that the individual is benefiting from the therapy. Clinical benefit is demonstrated by both of the following:
- Face-to-face clinical re-evaluation by the treating health care provider with documentation that the symptoms of OSA have improved.
- Objective evidence of adherence to the use of a single-level CPAP RAD (HCPCS code E0601) or a bi-level RAD without a backup rate feature (HCPCS code E0470), reviewed by the treating professional provider. Adherence to therapy is defined as the use of the device at least four hours per night on 70 percent of the nights during a consecutive thirty-day period anytime during the first three months of initial use.
If the above criteria are not met, continued coverage of the single-level CPAP RAD (HCPCS code E0601) or bi-level RAD without backup rate feature (HCPCS code E0470) and related accessories are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support its use in the treatment of illness or injury.
A bi-level RAD with a backup rate feature (HCPCS codes E0471 and E0472) and related accessories for the primary diagnosis of OSA are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support its use in the treatment of illness or injury.
TREATMENT OF CENTRAL SLEEP APNEA (CSA) OR COMPLEX SLEEP APNEA (CompSA)
A bi-level RAD without a backup rate feature (HCPCS code E0470) or a bi-level RAD with a backup rate feature (HCPCS codes E0471 and E0472) is considered medically necessary and, therefore, covered when the diagnosis of central sleep apnea (CSA) or complex sleep apnea (CompSA) has been established and documented by an attended polysomnography (PSG) at an accredited site of service and meets the following criterion:
- Significant improvement of sleep-associated hypoventilation with the use of a bi-level RAD with or without a backup rate feature on the settings that will be prescribed for the initial home use while an individual is breathing their prescribed FIO2
TREATMENT OF RESTRICTIVE THORACIC DISORDERS
A bi-level RAD without a backup rate feature (HCPCS code E0470) or a bi-level RAD with a backup rate feature (HCPCS codes E0471 and E0472) is considered medically necessary and, therefore, covered when all of the following criteria are met:
- There is documentation in the individual's medical record of neuromuscular disease (eg, amyotrophic lateral sclerosis) or a severe thoracic cage abnormality (eg, post-thoracoplasty for tuberculosis), and one or more of the following criteria are met:
- An arterial blood gas PaCO2 is greater than or equal to 45 mm Hg while the individual is awake and breathing their prescribed FIO2
- Sleep oximetry demonstrates that oxygen saturation is less than or equal to 88 percent for at least five continuous minutes of nocturnal recording time (minimum recording time of 2 hours), done while the individual is breathing their prescribed FIO2
- For neuromuscular disease (only), maximal inspiratory pressure is less than 60 cm H2O, or forced vital capacity is less than 50 percent predicted
- Chronic obstructive pulmonary disease does not contribute significantly to the individual's pulmonary limitation
TREATMENT OF SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
A bi-level RAD without a backup rate feature (HCPCS code E0470) is considered medically necessary and, therefore, covered for the treatment of severe COPD when all of the following criteria are met:
- An arterial blood gas PaCO2 is greater than or equal to 52 mm Hg while the individual is awake and breathing their prescribed FIO2
- Sleep oximetry demonstrates that oxygen saturation is less than or equal to 88 percent for at least five minutes of nocturnal recording time (minimum recording time of 2 hours), done while the individual is breathing oxygen at 2 liters per minute (LPM) or their prescribed FIO2, whichever is higher
- Prior to the initiation of therapy, OSA and treatment with a CPAP RAD has been considered and ruled out
If compliant use of a bi-level RAD without a backup rate feature (HCPCS code E0470) does not provide the individual with sufficient improvement, a bi-level RAD with a backup rate feature (HCPCS codes E0471 and E0472) is considered medically necessary and, therefore, covered for individuals with COPD when all of the following criteria are met:
- An arterial blood gas PaCO2, done while the individual is awake and breathing their prescribed FIO2 , demonstrates that the individual's PaCO2 has worsened at least 7 mm HG when compared to the original arterial blood gas result which qualified the individual for the bi-level RAD without a backup rate feature.
- A facility-based polysomnogram (PSG) demonstrates oxygen saturation is less than or equal to 88 percent for at least five minutes of nocturnal recording time (minimum recording time of 2 hours), while the individual is using a bi-level RAD without a backup rate feature (HCPCS code E0470), that is not caused by obstructive upper airway events (ie, AHI less than 5).
If two months of compliant use of a bi-level RAD without a backup rate feature (HCPCS code E0470) does not provide the individual with sufficient improvement, a bi-level RAD with a backup rate feature (HCPCS codes E0471 and E0472) is considered medically necessary and, therefore, covered for individuals with COPD when all of the following criteria are met:
- An arterial blood gas PaCO2, repeated no sooner than two months after the initiation of compliant use of a bi-level RAD without a backup rate feature (HCPCS code E0470) and done while the individual is awake and breathing their prescribed FIO2, still remains greater than or equal to 52 mm Hg.
- A sleep oximetry, repeated no sooner than two months after the initiation of compliant use of a bi-level RAD without a backup rate feature (HCPCS code E0470) and while the individual is breathing with this device, demonstrates oxygen saturation is less than or equal to 88 percent for at least five minutes of nocturnal recording time (minimum recording time of 2 hours), done while the individual is breathing oxygen at 2 LPM or their prescribed FIO2, whichever is higher.
- A signed and dated statement from the treating professional provider, completed no sooner than two months after the initiation of a bi-level RAD without a backup rate feature (HCPCS code E0470), declares that the individual has been compliantly using the bi-level RAD without a backup rate feature (HCPCS code E0470) for an average of four hours per 24-hour period but is not benefiting from its use.
TREATMENT OF HYPOVENTILATION SYNDROME
A bi-level RAD without a backup rate feature (HCPCS code E0470) is considered medically necessary and, therefore, covered to treat an individual who has hypoventilation syndrome when all of the following criteria are met:
- An initial arterial blood gas PaCO2 is greater than or equal to 45 mm Hg while the individual is awake and breathing their prescribed FIO2
- Spirometry demonstrates an FEV1/FVC 70 percent or greater and FEV1 50 percent or greater of predicted, and one of the following criteria:
- An arterial blood gas PaCO2 done during sleep or immediately upon awakening, done while the individual is breathing their prescribed FIO2, demonstrates the individual's PaCO2 has worsened at least 7 mn HG when compared to the original arterial blood gas
- A facility-based PSG demonstrates oxygen saturation is less than or equal to 88 percent for at least five minutes of nocturnal recording time (minimum recording time of 2 hours) that is not caused by obstructive upper airway events (ie, AHI less than 5).
A bi-level RAD with a backup rate feature (HCPCS code E0471 or E0472) is considered medically necessary and, therefore, covered to treat an individual who has hypoventilation syndrome when all of the following criteria are met:
- A covered bi-level RAD without a backup rate feature (HCPCS code E0470) is being used
- Spirometry demonstrates an FEV1/FVC 70 percent or greater and FEV1 50 percent or greater of predicted and one of the following criteria:
- An arterial blood gas PaCO2 done while the individual is awake and breathing their prescribed FIO2 demonstrates the individual's PaCO2 has worsened at least 7 mn HG when compared to the arterial blood gas result performed to qualify the individual for the bi-level RAD without a backup rate feature (HCPCS code E0470)
- A facility-based PSG demonstrates oxygen saturation is less than or equal to 88 percent for at least five minutes of nocturnal recording time (minimum recording time of 2 hours) that is not caused by obstructive upper airway events (ie, AHI less than 5).
CONTINUED COVERAGE OF A BI-LEVEL RAD WITHOUT A BACKUP RATE FEATURE (HCPCS CODE E0470) OR A BI-LEVEL RAD WITH A BACKUP RATE FEATURE (HCPCS CODE E0471 OR E0472) BEYOND THE FIRST THREE MONTHS OF THERAPY FOR TREATMENT OF CENTRAL SLEEP APNEA (CSA) OR COMPLEX SLEEP APNEA (CompSA), TREATMENT OF RESTRICTIVE THORACIC DISORDERS, TREATMENT OF SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), OR TREATMENT OF HYPOVENTILATION SYNDROME
Continued coverage of a bi-level RAD without a backup rate feature (HCPCS code E0470) or a bi-level RAD with a backup rate feature (HCPCS code E0471) beyond the first three months of therapy requires that, no sooner than the 61st day after initiating therapy, the treating professional provider must conduct a clinical re-evaluation and document the progress of relevant symptoms and the individual's usage of the device up to that time.
OTHER USES
All other uses of single-level CPAP and bi-level RADs and associated accessories that do not meet any of the above criteria are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the treatment of illness or injury.
PEDIATRICS
Requests for the pediatric use of single-level CPAP and bi-level RADs are considered on an individual basis and require, at minimum, a complete evaluation by and recommendation from a specialist such as a pediatric pulmonologist or cardiothoracic surgeon.
ACCESSORIES (SEPARATELY REIMBURSED FROM THE DEVICE)
Heated or nonheated humidifiers for any rented or purchased RADs are eligible for separate reimbursement. Either a nonheated humidifier (HCPCS code E0561) or a heated humidifier (HCPCS code E0562) is covered and paid separately when ordered by the treating professional provider for use with a covered single-level CPAP RAD (HCPCS code E0601), bi-level RAD without a backup rate feature (HCPCS code E0470), or bi-level RAD with a backup rate feature (HCPCS codes E0471 and E0472).
The following are the maximum annual limitations for each HCPCS accessory code that has limits:
- A4604: Tubing with integrated heating element for use with a positive airway pressure device: 4 per calendar year
- A7027: Combination oral/nasal mask, used with continuous positive airway pressure device, each: 4 per calendar year
- A7028: Oral cushion for combination oral/nasal mask, replacement only, each: 24 per calendar year
- A7029: Nasal pillow for combination oral/nasal mask, replacement only, pair: 24 per calendar year
- A7030: Full face mask used with a positive airway pressure device, each: 4 per calendar year
- A7031: Face mask interface, replacement for full face mask, each: 12 per calendar year
- A7032: Replacement cushion for use on a nasal application device mask interface, replacement only, each: 24 per calendar year
- A7033: Pillow for use on a nasal cannula type interface, replacement only, pair: 24 per calendar year
- A7034: Nasal interface (mask or cannula type) used with a positive airway pressure device, with or without head strap: 4 per calendar year
- A7035: Headgear used with a positive airway pressure device: 2 per calendar year
- A7036: Chin strap used with a positive airway pressure device: 2 per calendar year
- A7037: Tubing used with a positive airway pressure device: 4 per calendar year
- A7038: Filter, disposable, used with a positive airway pressure device: 24 per calendar year
- A7039: Filter, nondisposable, used with a positive airway pressure device: 2 per calendar year
- A7044: Oral interface used with a positive airway pressure device, each: 4 per calendar year
- A7046: Water chamber for humidifier, used with positive airway pressure device, replacement, each: 2 per calendar year
Single-level CPAP and bi-level RADs and associated accessories that do not meet medical necessity criteria are considered not medically necessary and, therefore, not covered.
REQUIRED DOCUMENTATION
The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must reflect the medical necessity of the care and services provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.
An order for each item billed must be signed and dated by the professional provider who is treating the member and kept on file by the supplier. Medical record documentation must include a shipment confirmation or member's receipt of supplies and equipment. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
For a noninvasive RAD to be reimbursable, the treating professional provider must fully document the symptoms that characterize an individual's sleep-associated hypoventilation (ie, daytime hypersomnolence, excessive fatigue, morning headache, cognitive dysfunction) in the individual's medical record.
A signed and dated statement completed by the treating professional provider declaring that the individual is compliantly (an average of 4 hours per 24 hour period) using a bi-level RAD without a backup rate feature (HCPCS code E0470) or a bi-level RAD with a backup rate feature (HCPCS code E0471) and that the individual is benefiting from its use must be obtained by the supplier of the device for continued coverage of the device beyond three months.
Documentation of adherence to PAP therapy shall be accomplished through direct download or visual inspection of usage data with documentation provided in a written report format to be reviewed by the treating physician and included in the individual's medical record and available to the Company upon request.
For individuals changing from a covered single-level CPAP RAD (HCPCS code E0601) to bi-level RAD without a backup rate feature (HCPCS code E0470) due to ineffective therapy while on E0601 (either during a facility-based titration or in the home setting), the treating physician must document all of the following:
- The individual tried but was unsuccessful with attempts to use the single-level CPAP RAD (HCPCS code E0601) device
- Multiple interface options have been tried and the current interface is most comfortable to the individual
- The work of exhalation with the current pressure settings of the single-level CPAP RAD (HCPCS code E0601) prevents the individual from tolerating the therapy
- Lower pressure settings of the single-level CPAP RAD (HCPCS code E0601) fail to adequately control the symptoms of OSA or reduce the AHI/RDI to acceptable levels.
| Guidelines |
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Sleep studies are to be performed in a site-of-service (ie, sleep lab/center, free-standing, office-based, or hospital-affiliated) that is accredited by either the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and/or the American Academy of Sleep Medicine (AASM).
The treating professional provider who orders and monitors the use of respiratory assist devices (RADs) must be qualified or trained in noninvasive respiratory assistance.
EPWORTH SLEEPINESS SCALE
The Epworth Sleepiness Scale measures how likely an individual is to doze off or fall asleep in the following situations, in contrast to feeling just tired, using the following scale to choose the most appropriate number for each situation:
0 = would never doze or sleep
1 = slight chance of dozing or sleeping
2 = moderate chance of dozing or sleeping
3 = high chance of dozing or sleeping
Situation | Chance of Dozing or Sleeping |
| Sitting and reading | ____ |
| Watching TV | ____ |
| Sitting inactive in a public place | ____ |
| Being a passenger in a motor vehicle for an hour or more | ____ |
| Lying down in the afternoon | ____ |
| Sitting and talking to someone | ____ |
| Sitting quietly after lunch (no alcohol) | ____ |
| Stopped for a few minutes in traffic while driving | ____ |
Total score (add the scores up)
(This is your Epworth score.) | ____ |
0-9 – Average score, normal population
Source: Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep.1991;14(6):540-545. This copyrighted material is used with permission granted by the Associated Professional Sleep Societies—November 2008. Unauthorized copying, printing or distribution of this material is strictly prohibited.
BENEFIT APPLICATION
Subject to the terms and conditions of the applicable benefit contract, noninvasive respiratory assist devices (RADs): continuous positive airway pressure (CPAP) devices and bi-level devices are covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.
MEDICARE
This policy is consistent with Medicare's coverage criteria. The Company's payment methodology may differ from Medicare.
RENTAL OF DEVICE
As determined by the Company and based on its contracts with DME suppliers and other vendors, noninvasive RADs may be:
- Rented until the rental cost of the device meets or exceeds the purchase price
- Always rented on a continuous basis
US FOOD AND DRUG ADMINISTRATION (FDA) STATUS
The FDA has approved several types of single level continuous positive airway pressure (CPAP) and bi-level positive airway pressure (PAP) RADs under the 510(k) process.
| References |
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American Academy of Family Physicians (AAFP). American Family Physician. CPAP for sleep apnea. [AAFP Web site]. 02/01/04. Available at: http://www.aafp.org/afp/20040201/572ph.html. Accessed January 29, 2010.
Kushida CA, Chediak A, Berry RB, et al. Positive Airway Pressure Titration Task Force of the American Academy of Sleep Medicine. Clinical guidelines for the manual titration of positive airway pressure in patients with obstructive sleep apnea. J Clin Sleep Med. 2008 Apr 15;4(2):157-71.
National Heritage Insurance Company (NHIC). Local Coverage Determination (LCD). L11504: Respiratory assist devices. [NHIC Web site]. Original: 10/01/99. (Revised: 02/01/10). Available at: http://www.medicarenhic.com/dme/medical_review/mr_lcds/mr_lcd_current/L11504_2010-02-01_PA_2009-09.pdf. Accessed March 11, 2010.
National Heritage Insurance Company (NHIC). Local Coverage Determination (LCD). L11528: Positive airway pressure (PAP) devices for the treatment of obstructive sleep apnea. [NHIC Web site]. Original: 10/01/93. (Revised: 04/01/10). Available at:http://www.medicarenhic.com/dme/medical_review/mr_lcds/mr_lcd_current/L11528_2010-04-01_PA_2010-04.pdf Accessed March 15, 2010.
Shah PS, Ohlsson A, Shah JP: Continuous negative extrathoracic pressure or continuous positive airway pressure for acute hypoxemic respiratory failure in children. The Cochrane Database of Systematic Reviews. 2008;1:CD003699. |
| Coding Table |
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Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.
The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.
In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company. |
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| Code System | Code Number(s) and Narrative(s) |
| CPT | N/A |
| ICD Procedure | N/A |
| ICD Diagnosis | DIAGNOSIS CODES THAT MAY BE REPORTED WHEN REQUESTING A SINGLE-LEVEL CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) OR BI-LEVEL NONINVASIVE RESPIRATORY ASSIST DEVICE (RAD) INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING
OBSTRUCTIVE SLEEP APNEA (OSA) AND CENTRAL SLEEP APNEA (CSA)
327.21: Primary central sleep apnea
327.23: Obstructive sleep apnea (adult) (pediatric)
327.27: Central sleep apnea in conditions classified elsewhere
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
491.20: Obstructive chronic bronchitis, without exacerbation
491.21: Obstructive chronic bronchitis, with (acute) exacerbation
491.22: Obstructive chronic bronchitis with acute bronchitis
493.20: Chronic obstructive asthma, unspecified
493.21: Chronic obstructive asthma with status asthmaticus
493.22: Chronic obstructive asthma with (acute) exacerbation
496: Chronic airway obstruction, not elsewhere classified
SEVERE THORACIC CAGE ABNORMALITY
738.3: Acquired deformity of chest and rib
754.89: Other specified nonteratogenic anomalies
NEUROMUSCULAR DISEASES
335.10: Unspecified spinal muscular atrophy
335.11: Kugelberg-Welander disease
335.19: Other spinal muscular atrophy
335.20: Amyotrophic lateral sclerosis
335.21: Progressive muscular atrophy
335.22: Progressive bulbar palsy
335.23: Pseudobulbar palsy
335.24: Primary lateral sclerosis
335.29: Other motor neuron diseases
335.8: Other anterior horn diseases
335.9: Unspecified anterior horn cell disease
HYPOVENTILATION SYNDROME
327.24 Idiopathic sleep related nonobstructive alveolar hypoventilation
327.25 Congenital central alveolar hypoventilation syndrome
327.26 Sleep related hypoventilation/hypoxemia in conditions classifiable elsewhere
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| HCPCS Level II | CPAP DEVICE
E0601: Continuous airway pressure (CPAP) device
BI-LEVEL RESPIRATORY ASSIST DEVICE WITHOUT A BACKUP RATE FEATURE
E0470: Respiratory assist device, bi-level pressure capability, without backup rate feature, used with noninvasive interface, eg, nasal or facial mask (intermittent assist device with continuous positive airway pressure device)
BI-LEVEL RESPIRATORY DEVICE WITH A BACKUP RATE FEATURE
E0471: Respiratory assist device, bi-level pressure capability, with back-up rate feature, used with noninvasive interface, eg, nasal or facial mask (intermittent assist device with continuous positive airway pressure device)
E0472: Respiratory assist device, bi-level pressure capability, with backup rate feature, used with invasive interface, eg, tracheostomy tube (intermittent assist device with continuous positive airway pressure device)
ACCESSORIES
A4604: Tubing with integrated heating element for use with positive airway pressure device
A7027: Combination oral/nasal mask, used with continuous positive airway pressure device, each
A7028: Oral cushion for combination oral/nasal mask, replacement only, each
A7029: Nasal pillow for combination oral/nasal mask, replacement only, pair
A7030: Full face mask used with positive airway pressure device, each
A7031: Face mask interface, replacement for full face mask, each
A7032: Cushion for use on nasal mask interface, replacement only, each
A7033: Pillow for use on nasal cannula type interface, replacement only, pair
A7034: Nasal interface (mask or cannula type) used with positive airway pressure device, with or without head strap
A7035: Headgear used with positive airway pressure device
A7036: Chinstrap used with positive airway pressure device
A7037: Tubing used with positive airway pressure device
A7038: Filter, disposable, used with positive airway pressure device
A7039: Filter, nondisposable, used with positive airway pressure device
A7044: Oral interface used with positive airway pressure device, each
A7045: Exhalation port with or without swivel used with accessories for positive airway devices, replacement only
A7046: Water chamber for humidifier, used with positive airway pressure device, replacement, each
E0561: Humidifier, nonheated, used with positive airway pressure device
E0562: Humidifier, heated, used with positive airway pressure device |
| Revenue Codes | N/A |
| Cross References |
| Cross Reference Policies |
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| Version Effective Date: 07/13/2010 | |
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The Policy Bulletins on this web site were developed to assist AmeriHealth and its subsidiaries ("AmeriHealth") in administering the provisions of the respective benefit programs, and do not constitute a contract. If you are an AmeriHealth member, please refer to your specific benefit program for the terms, conditions, limitations and exclusions of your coverage. AmeriHealth does not provide health care services, medical advice or treatment, or guarantee the outcome or results of any medical services/treatments. The facility and professional providers are responsible for providing medical advice and treatment. Facility and professional providers are independent contractors and are not employees or agents of AmeriHealth. If you have a specific medical condition, please consult with your doctor. AmeriHealth reserves the right at any time to change or update its Policy Bulletins. ©2010 AmeriHealth, Inc. All Rights Reserved. Current Procedural Terminology ©2010 American Medical Association. All Rights Reserved. |
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