Commercial

Medical Policy

Notification

Noninvasive Respiratory Assist Devices (RADs): Continuous Positive Airway Pressure (CPAP) Devices, Auto-Adjusting Positive Airway Pressure (APAP) and Bi-Level Devices

Notification Issue Date:

This version of the policy will become effective 01/02/2023. This policy's formatting and organization has been updated for clarity.

Medically Necessary criteria have been added to this policy for auto-adjusting positive airway pressure (APAP) devices
Face-to-face requirement language has been added for the following HCPCS codes:

A7030 Full face mask used with positive airway pressure device, each
A7031 Face mask interface, replacement for full face mask, each

Title:

Noninvasive Respiratory Assist Devices (RADs): Continuous Positive Airway Pressure (CPAP) Devices, Auto-Adjusting Positive Airway Pressure (APAP) and Bi-Level Devices

Policy #:

05.00.30p

Policy

This policy only applies to members for whom Independence Administrators serves as the claims administrator and whose group has not enrolled in the UM vendor program. For those groups who have been given the option to enroll in the UM vendor program, this policy is no longer applicable upon their renewal effective date. Individual member benefits must be verified before/prior to providing services.

MEDICALLY NECESSARY

INITIATION AND TITRATION OF CPAP OR APAP
An auto-adjusting positive airway pressure (APAP) respiratory assist device (RAD) to initiate and titrate continuous positive airway pressure (CPAP) may be considered medically necessary and, therefore, covered during a 2-week trial for individuals with obstructive sleep apnea (OSA) who do not have significant comorbidities (i.e., congestive heart failure [CHF)], chronic obstructive pulmonary disease [COPD], central sleep apnea syndromes [CSA]/complex sleep apnea [CompSA], or hypoventilation syndromes) and who meet the below criteria for CPAP or APAP.

TREATMENT OF OBSTRUCTIVE SLEEP APNEA (OSA)
SINGLE-LEVEL CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP)
A single-level CPAP RAD for the treatment of OSA is considered medically necessary and, therefore, covered when all of the following criteria are met:

A diagnosis of OSA has been established by an appropriate sleep test 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
Morbid obesity or metabolic syndrome

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.

AUTO-ADJUSTING POSITIVE AIRWAY PRESSURE (APAP)

An APAP RAD is considered medically necessary and, therefore, covered for the treatment of OSA in individuals without significant comorbidities (i.e., CHF, COPD, CSA/CompSA, or hypoventilation syndromes) when all of the following criteria are met:

A diagnosis of OSA has been established by an appropriate sleep test that meets one of the following criteria:

An apnea-hypopnea index (AHI), respiratory disturbance index (RDI), or respiratory event index (REI) of at least 15 events per hour
An AHI, RDI, or REI of at least five events per hour and documentation of at least one of the following:

Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia
Hypertension, cardiovascular heart disease, or stroke
Morbid obesity or metabolic syndrome

BI-LEVEL POSITIVE AIRWAY PRESSURE
A bi-level RAD without a backup rate feature 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 and the following criterion:

A CPAP RAD or an APAP RAD has been tried and proven ineffective, based on a therapeutic trial in either a facility or a home setting.

INITIAL USE FOR CPAP RAD, APAP RAD, AND BI-LEVEL RAD

The coverage of a single-level CPAP RAD or an APAP RAD is initially limited to a 3-month period for individuals diagnosed with OSA as described above.

A single-level CPAP RAD or an APAP RAD is subsequently covered for individuals diagnosed with OSA whose OSA improves as a result of a single-level CPAP RAD or an APAP RAD during this 3-month period.

If a single-level CPAP RAD or an APAP RAD is tried and found ineffective during the initial 3-month home trial, substitution of a bi-level RAD without a backup rate feature does not require a new initial clinical evaluation or new sleep test, and substitution of a bi-level RAD without a backup rate feature does not change the length of the trial unless there are fewer 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 or an APAP RAD, and objective documentation of adherence on the bi-level RAD without a backup rate feature would need to occur prior to the 91st day following initiation of the single-level CPAP RAD or an APAP RAD.

If fewer 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 or an APAP RAD.

CONTINUED COVERAGE FOR CPAP RAD, APAP RAD, AND BI-LEVEL RAD
If a single-level CPAP RAD or an APAP RAD has been used for more than 3 months and the individual is switched to a bi-level RAD without a backup rate feature, a new initial clinical evaluation between the 31st and 91st day following the initiation of the bi-level RAD without a backup rate feature is required, but a new sleep test is not required. A new 3-month trial would begin for use of the bi-level RAD without a backup rate feature.

Continued coverage of a single-level CPAP RAD, an APAP RAD or a bi-level RAD without a backup rate feature beyond the first 3 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:

Documentation by the treating professional provider that the symptoms of OSA have improved.
Objective evidence of adherence to the use of a single-level CPAP RAD, APAP RAD, or a bi-level RAD without a backup rate feature, reviewed by the treating professional provider. Adherence to therapy is defined as the use of the device at least 4 hours per night on 70% of the nights during a consecutive 30-day period any time during the first 3 months of initial use.

TREATMENT OF CENTRAL SLEEP APNEA (CSA) OR COMPLEX SLEEP APNEA (CompSA)
A bi-level RAD without a backup rate feature or a bi-level RAD with a backup rate feature 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 or a bi-level RAD with a backup rate feature 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 (e.g., amyotrophic lateral sclerosis) or a severe thoracic cage abnormality (e.g., 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% for at least 5 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% predicted.
COPD 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 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% for at least 5 minutes of cumulative 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. (Note: Formal sleep testing is not required if there is sufficient information in the medical record to demonstrate that the individual does not suffer from some form of sleep apnea (OSA, CSA/and or CompSA) as the predominant cause of awake hypercapnia or nocturnal arterial oxygen desaturation).

If compliant use of a bi-level RAD without a backup rate feature does not provide the individual with sufficient improvement, a bi-level RAD with a backup rate feature 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% for at least 5 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 that is not caused by obstructive upper airway events (i.e., AHI <5).

If 2 months of compliant use of a bi-level RAD without a backup rate feature does not provide the individual with sufficient improvement, a bi-level RAD with a backup rate feature 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 2 months after the initiation of compliant use of a bi-level RAD without a backup rate feature 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 2 months after the initiation of compliant use of a bi-level RAD without a backup rate feature and while the individual is breathing with this device, demonstrates oxygen saturation is less than or equal to 88% for at least 5 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 2 months after the initiation of a bi-level RAD without a backup rate feature, declares that the individual has been compliantly using the bi-level RAD without a backup rate feature for an average of 4 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 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% or greater and one of the following criteria: (For less than an FEV1/FVC of 70%, please see Severe COPD criteria above)
- 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 mm Hg when compared to the original arterial blood gas.
- A facility-based PSG demonstrates oxygen saturation is less than or equal to 88% for at least 5 minutes of nocturnal recording time (minimum recording time of 2 hours) that is not caused by obstructive upper airway events (i.e., AHI <5).

A bi-level RAD with a backup rate feature 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 is being used.
Spirometry demonstrates an FEV1/FVC 70% and one of the following criteria: (For less than an FEV1/FVC of 70%, please see Severe COPD criteria above)
- 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 mm Hg when compared to the arterial blood gas result performed to qualify the individual for the bi-level RAD without a backup rate feature.
- A facility-based PSG demonstrates oxygen saturation is less than or equal to 88% for at least 5 minutes of nocturnal recording time (minimum recording time of 2 hours) that is not caused by obstructive upper airway events (i.e., AHI <5 while using an E0470 device).

CONTINUED COVERAGE OF A BI-LEVEL RAD WITHOUT A BACKUP RATE FEATURE OR A BI-LEVEL RAD WITH A BACKUP RATE FEATURE
Continued coverage of a bi-level RAD without a backup rate feature or a bi-level RAD with a backup rate feature beyond the first 3 months of therapy for the treatment of Restrictive Thoracic Disorders, severe COPD, or Hypoventilation Syndrome, 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.

PEDIATRICS

Requests for the pediatric use of single-level CPAP, an APAP RAD, and bi-level RADs are considered on an individual basis and require, at minimum, a complete evaluation by, and a recommendation from, a specialist such as a pediatric pulmonologist or cardiothoracic surgeon.

ACCESSORIES (REIMBURSED SEPARATELY FROM THE DEVICE)

Heated or nonheated humidifiers for any rented or purchased RADs are eligible for separate reimbursement. Either a nonheated humidifier or a heated humidifier is covered and paid separately when ordered by the treating professional provider for use with a covered single-level CPAP RAD, an APAP RAD, a bi-level RAD without a backup rate feature, or a bi-level RAD with a backup rate feature.

The following codes represent the maximum annual limitations for each HCPCS accessory code that has limits:

HCPCS Accessory	Frequency Limit (per calendar year)
A4604: Tubing with integrated heating element for use with a positive airway pressure device	4
A7027: Combination oral/nasal mask, used with continuous positive airway pressure device, each	4
A7028: Oral cushion for combination oral/nasal mask, replacement only, each	24
A7029: Nasal pillow for combination oral/nasal mask, replacement only, pair	24
A7030: Full face mask used with a positive airway pressure device, each	4
A7031: Face mask interface, replacement for full face mask, each	12
A7032: Replacement cushion for use on a nasal application device mask interface, replacement only, each	24
A7033: Pillow for use on a nasal cannula type interface, replacement only, pair	24
A7034: Nasal interface (mask or cannula type) used with a positive airway pressure device, with or without head strap	4
A7035: Headgear used with a positive airway pressure device	2
A7036: Chin strap used with a positive airway pressure device	2
A7037: Tubing used with a positive airway pressure device	4
A7038: Filter, disposable, used with a positive airway pressure device	24
A7039: Filter, nondisposable, used with a positive airway pressure device	2
A7044: Oral interface used with a positive airway pressure device, each	4
A7046: Water chamber for humidifier, used with positive airway pressure device, replacement, each	2

ACCESSORIES (NOT REIMBURSED SEPARATELY FROM THE DEVICE)

Compliance monitoring equipment for single-level CPAP RADs, APAP RADs, or bi-level RADs (e.g., smart card) are considered an integral component of the function of the device and are not eligible for separate reimbursement.

NOT MEDICALLY NECESSARY

The following indications for single-level CPAP, APAP, and bi-level RADs and associated accessories 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:

Single-level CPAP, APAP, and bi-level RADs and associated accessories that do not meet the above medical necessity criteria
A bi-level RAD with a backup rate feature and related accessories for the primary diagnosis of OSA
For all other uses of single-level CPAP, APAP, and bi-level RADs and associated accessories

NOT COVERED

There is no additional payment for liners, which are made of cloth, silicone, or other materials and placed between the skin and positive airway pressure (PAP) mask interface used with a PAP mask, because they are considered a comfort/convenience item. Liners are not interfaces for use with a PAP mask.

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 be maintained on file to 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.

STANDARD WRITTEN ORDER REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete standard written order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective standard written order at the time of an audit or after an audit for submission as an original standard written order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY REQUIREMENTS
Medical record documentation must include a contemporaneously prepared delivery confirmation or member's receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The durable medical equipment (DME) supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual's medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.

For a noninvasive RAD to be reimbursable, the treating professional provider must fully document the symptoms that characterize an individual's sleep-associated hypoventilation (i.e., 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 in compliance with their use of a bi-level RAD (an average of 4 hours per 24-hour period) without a backup rate feature or a bi-level RAD with a backup rate feature, 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 3 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 or an APAP RAD to a bi-level RAD without a backup rate feature 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 or an APAP RAD 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 prevents the individual from tolerating the therapy.
Lower pressure settings of the single-level CPAP RAD fail to adequately control the symptoms of OSA or reduce the AHI/RDI to acceptable levels.

Guidelines

The American Academy of Sleep Medicine (AASM) recommends that individuals being treated with fixed continuous positive airway pressure (CPAP) on the basis of auto-adjusting positive airway pressure (APAP) titration or being treated with APAP must have close clinical follow-up in the first few weeks following initiation of PAP to determine treatment effectiveness and safety.

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

Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep.1991;14(6):540-5.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, noninvasive respiratory RADs, CPAP devices, auto-adjusting 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.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The FDA has approved several types of single-level CPAP, APAP RADs, and bi-level PAP RADs for obstructive sleep apnea and/or respiratory insufficiency caused by central and/or mixed apneas and periodic breathing.

Description

A noninvasive respiratory assist device (RAD), such as a single-level continuous positive airway pressure (CPAP), auto-adjusting positive airway pressure (APAP) RAD or a bi-level positive airway pressure (PAP) device delivers noninvasive positive pressure respiratory assistance (NPPRA). NPPRA is the administration of PAP using a nasal and/or oral mask interface that creates a seal and minimizes the need for accessing the airway invasively (e.g., 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 an RAD. Polysomnography is the continuous and simultaneous monitoring and recording of various physiologic and pathophysiologic parameters of sleep. A physician provides a review, interpretation, and report afterwards. It must include sleep staging with a four or more 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 purpose of the device 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.)

An APAP RAD automatically adjusts the level of air pressure for each breath taken based on the level of resistance. Because individuals sometimes complain of discomfort while wearing a CPAP device, the APAP devices can increase compliance by making it easier for the individual to wear the device. An APAP RAD may be used for CPAP titration in individuals without significant comorbidities (i.e., congestive heart failure, chronic obstructive pulmonary disease, central sleep apnea syndromes, or hypoventilation syndromes) to determine a fixed treatment pressure for individuals with moderate to severe obstructive sleep apnea who will be treated with a standard CPAP device. It may also be used as primary treatment for moderate to severe obstructive sleep apnea in individuals without significant comorbidities instead of a standard CPAP.

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.

Bi-level RADs can be divided further into two categories: those without a backup rate feature and those with a backup rate feature. 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.

A bi-level RAD without a backup rate feature, such as the Bi-PAP® Pro with BiFlex® (Respironics Inc., Murrysville, PA), delivers adjustable, variable levels of PAP via tubing and a noninvasive interface (i.e., 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® S/T (Respironics, Inc.) or the VPAP ST and VPAP III ST-A (ResMed Corp, San Diego, CA), delivers adjustable, variable levels of PAP within a single respiratory cycle via tubing and a noninvasive interface (i.e., 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% reduction in thoracoabdominal movement or airflow as compared to baseline and with at least a 4% 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 PAP device. For purposes of this policy, respiratory effort–related arousals (RERAs) are not included in the calculation of AHI. Sleep time can only be measured in a type I or type II sleep study.

The respiratory disturbance index (RDI) is defined as the average number of apneas plus hypopneas per hour of recording without the use of a PAP device. For purposes of this policy, respiratory effort–related arousals (RERAs) are not included in the calculation of RDI. The RDI is reported in type III and type IV sleep studies.

If the AHI or RDI is calculated based on less than 2 hours of sleep or recording time, the total number of recorded events used to calculate the AHI or RDI, respectively, must be at least the number of events that would have been required in a 2-hour period (i.e., must reach ≥30 events without symptoms or ≥10 events with symptoms).

Central apnea–central hypopnea index (CAHI) is used for the diagnosis of CSA and is defined as the average number of episodes of central apnea and central hyponea per hour of sleep without the use of a PAP device. For complex sleep apnea (CompSA), the CAHI is determined during the use of PAP device after obstructive events have disappeared.

Central sleep apnea (CSA) is defined by meeting all of the following criteria:

An AHI greater than or equal to 5
Central apneas or hypopneas greater than 50% of the total apneas/hypopneas (moved down)
CAHI is greater than or equal to five episodes per hour.
The presence of at least one of the following:
- Sleepiness
- Difficulty initiating or maintaining sleep, frequent awakenings, or nonrestorative sleep
- Awakening short of breath
- Snoring
- Witnessed apneas
There is no evidence of daytime or nocturnal hypoventilation.

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 per hour. With use of a CPAP or bi-level RAD without backup, individuals show a pattern of apneas and hypopneas that meet the definition of CSA above.

Obstructive sleep apnea (OSA) is a diagnosis established when sleep testing results meet one of the following criteria:

The AHI or RDI is greater than or equal to 15 events per hour with a minimum of 30 events
The AHI or RDI is greater than or equal to 5 and less than or equal to 14 events per hour with a minimum of 10 events and documentation of one of the following:
- Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia
- Hypertension, ischemic heart disease, or history of stroke

References

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American Academy of Family Physicians (AAFP). American Family Physician. CPAP for sleep apnea. [AAFP Web site]. 02/01/2004. Available at: https://www.aafp.org/pubs/afp/issues/2004/0201/p572.html#:~:text=Continuous positive airway pressure (CPAP) is the most,and reduces snoring and apnea (see Picture 2). Accessed May 4, 2023.

American Academy of Pediatrics. Clinical practice guideline: Diagnosis and Management of Childhood Obstructive Sleep Apnea Syndrome. Pediatrics. 2012;130(3):576-84.

Aurora RN, Chowdhuri S, Ramar K, et al. The treatment of central sleep apnea syndromes in adults: practice parameters with an evidence-based literature review and meta-analyses. Sleep. 2012;35(1):17-40.

Balk EM, Moorthy D, Obadan NO, et al. Diagnosis and Treatment of Obstructive Sleep Apnea in Adults. Comparative Effectiveness Review No. 32 (Prepared by Tufts Evidence-based Practice Center under Contract No. 290-2007-100551) AHRQ Publication No. 11-EHC052-EF. Rockville MD: Agency for Healthcare Research and Quality Jul 2011.

Berry RB, Parish JM, Hartse KM. The use of auto-titrating continuous positive airway pressure for treatment of adult obstructive sleep apnea. An American Academy of Sleep Medicine review. Sleep 2002;25(2):148-73.

Berry RB, Kryger MH, Massie CA. A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial. Sleep. 2011;34(4):479-85.

Epstein LJ, Kristo D, Strollo PJ Jr, et al. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009;15;5(3):263-76.

Giles TL, Lasserson TJ, Smith BH, et al. Continuous positive airways pressure for obstructive sleep apnoea in adults. Cochrane Database Syst Rev. 2006; 3:CD001106.

Hussain SF, Love L, Burt H, et al. A randomized trial of auto-titrating CPAP and fixed CPAP in the treatment of obstructive sleep apnea-hypopnea. Respir Med. 2004;98(4):330-333.

Johns MW. A new method for measuring daytime sleepiness: The Epworth Sleepiness Scale. Sleep.1991;14(6):540-545.

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. 200815;4(2):157-71.

Kushida CA, Chediak A, Berry RB, et al. Clinical Guidelines for the Manual Titration of Positive Airway Pressure in Patients with Obstructive Sleep Apnea. Positive Airway Pressure Titration Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2008;4(2):157-71.

Kushida CA, Littner M, Hirshkowitz M, et al. Practice parameters for the use of continuous and bilevel positive airway pressure devices to treat adult patients with sleep-related breathing disorders. Sleep. 2006;29(3):375-80.

Kryger MH, Berry RB, Massie CA. Long-term use of a nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA). J Clin Sleep Med. 2011;7(5):449-453B.

Lisan QQ, Van Sloten TT, Marques Vidal, et al. Association of positive airway pressure prescription with mortality in patients with obesity and severe obstructive sleep apnea: the sleep heart health study. JAMA Otolaryngol Head Neck Surg. 2019;145(6):509-15.

Littner M, Hirshkowitz M, Davila D, et al. Practice parameters for the use of auto-titrating continuous positive airway pressure devices for titrating pressures and treating adult patients with obstructive sleep apnea syndrome. An American Academy of Sleep Medicine report. Sleep. 2002;25(2):143-7.

Marcus CL, Brooks LJ, Draper KA, et al. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012;130(3):576-84.

Marrone O, Resta O, Salvaggio A, et al. Preference for fixed or automatic CPAP in patients with obstructive sleep apnea syndrome. Sleep Med. 2004;5(3):247-51.

Morgenthaler TI, Aurora N, Brown T, et al. Practice parameters for the use of auto-titrating continuous positive airway pressure devices for titrating pressures and treating adult patients with obstructive sleep apnea syndrome: An update for 2007. An American Academy of Sleep Medicine report. Sleep. 2008;31(1):141-7.

Mulgrew AT, Fox N, Ayas NT. et al. Diagnosis and initial management of obstructive sleep apnea without polysomnography: a randomized validation study. Ann Intern Med. 2007;146(3):157-66.

Noridian. Local Coverage Determination (LCD).Respiratory Assist Devices (L33800): [Noridian Web site]. Effective 10/01/2015. Revised 08/08/2021. Available at:
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33800. Accessed May 4, 2023.

Noridian. Local Coverage Determination (LCD).Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L33718): [Noridian Web site]. Effective 10/01/2015. Revised 09/27/2021. Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33718&ContrId=389. Accessed May 4, 2023.

Noridian Healthcare Solutions. Local Coverage Article.A52467: Positive airway pressure (PAP) devices for the treatment of obstructive sleep apnea. [Noridian Healthcare Solutions Web site]. 01/01/2020. Revised 08/08/2021. Available at: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52467&ver=52. Accessed May 4, 2023.

Noridian Healthcare Solutions. Local Coverage Article.A52517: Respiratory assist devices. [Noridian Healthcare Solutions Web site]. 01/01/2020. Revised 08/08/2021. Available at:https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52517. Accessed May 4, 2023.

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Senn O, Brack T, Russi EW, et al. A continuous positive airway pressure trial as a novel approach to the diagnosis of the obstructive sleep apnea syndrome. Chest. 2006;129(1):67-75.

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Coding

CPT Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

E66.2 Morbid (severe) obesity with alveolar hypoventilation

G12.1 Other inherited spinal muscular atrophy

G12.20 Motor neuron disease, unspecified

G12.21 Amyotrophic lateral sclerosis

G12.22 Progressive bulbar palsy

G12.23 Primary lateral sclerosis

G12.24 Familial motor neuron disease

G12.25 Progressive spinal muscle atrophy

G12.29 Other motor neuron disease

G12.8 Other spinal muscular atrophies and related syndromes

G12.9 Spinal muscular atrophy, unspecified

G47.31 Primary central sleep apnea

G47.33 Obstructive sleep apnea (adult) (pediatric)

G47.34 Idiopathic sleep related nonobstructive alveolar hypoventilation

G47.35 Congenital central alveolar hypoventilation syndrome

G47.36 Sleep related hypoventilation in conditions classified elsewhere

G47.37 Central sleep apnea in conditions classified elsewhere

J44.0 Chronic obstructive pulmonary disease with (acute) lower respiratory infection

J44.1 Chronic obstructive pulmonary disease with (acute) exacerbation

J44.89 Other specified chronic obstructive pulmonary disease

J44.9 Chronic obstructive pulmonary disease, unspecified

M95.4 Acquired deformity of chest and rib

Q67.8 Other congenital deformities of chest

HCPCS Level II Code Number(s)

MEDICALLY NECESSARY

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 pillows 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

E0470 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)

E0471 Respiratory assist device, bi-level pressure capability, with back-up rate feature, used with noninvasive interface, e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure device)

E0561 Humidifier, nonheated, used with positive airway pressure device

E0562 Humidifier, heated, used with positive airway pressure device

E0601 Continuous airway pressure (CPAP) device

NOT COVERED

THE FOLLOWING CODE IS USED TO REPRESENT PAP MASK LINERS:

A9999 Miscellaneous DME supply or accessory, not otherwise specified

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 05.00.30p:

10/01/2023

This policy has been identified for the ICD-10 CM code update, effective 10/01/2023.

The following ICD-10 code has been added to the policy:

J44.89: Other specified chronic obstructive pulmonary disease

Revisions From 05.00.30o:

07/31/2023

The version of the policy will become effective 07/31/2023.

Face-to-Face Requirement language and documentation requirements have been removed.

Revisions From 05.00.30n:

01/02/2023

This version of the policy will become effective 01/02/2023. This policy's formatting and organization has been updated for clarity.

Medically Necessary criteria have been added to this policy for auto-adjusting positive airway pressure (APAP) devices

Face-to-face requirement language has been added for the following HCPCS codes:

A7030 Full face mask used with positive airway pressure device, each

A7031 Face mask interface, replacement for full face mask, each

Revisions From 05.00.30m:

07/28/2021

The policy has been reviewed and reissued to communicate the Company’s continuing position on noninvasive respiratory assist devices (RADs): continuous positive airway pressure (CPAP) devices and bi-level devices.

06/03/2020

12/18/2019	This policy has been reissued in accordance with the Company's annual review process.
10/01/2019	This policy has been identified for the ICD-10 CM code update, effective 10/01/2019. The following ICD-10 narrative has been revised in this policy: Changed from: J44.0 Chronic obstructive pulmonary disease with acute lower respiratory infection Changed to: J44.0 Chronic obstructive pulmonary disease with (acute) lower respiratory infection

Revisions From 05.00.30l:

10/08/2018

This version of the policy will become effective 10/08/2018.

The following criteria have been deleted from the this policy for a single-level continuous positive airway pressure (CPAP) respiratory assist device (RAD) in the treatment of obstructive sleep apnea (OSA):

The individual has a face-to-face clinical evaluation prior to a sleep test to assess 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

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date:

10/1/2023

Version Issued Date:

9/29/2023

Version Reissued Date: