Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Noninvasive Respiratory Assist Devices (RADs): Continuous Positive Airway Pressure (CPAP) Devices and Bi-Level Devices (Independence Administrators)

Policy #:05.00.30l

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


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.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

AUTO-ADJUSTING CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) FOR INITIATION AND TITRATION OF CPAP

An auto-adjusting continuous positive airway pressure (CPAP) respiratory assist device (RAD) (Healthcare Common Procedure Coding System [HCPCS] code E0601) may be considered medically necessary and, therefore, covered during a 2-week trial to initiate and titrate CPAP for individuals with obstructive sleep apnea (OSA) who do not have significant comorbidities (i.e., congestive heart failure, chronic obstructive pulmonary disease, central sleep apnea syndromes, or hypoventilation syndromes) and who meet the below criteria for CPAP.

TREATMENT OF OBSTRUCTIVE SLEEP APNEA (OSA)

A single-level continuous positive airway pressure (CPAP) respiratory assist device (RAD) (HCPCS code E0601) is considered medically necessary and, therefore, covered for the treatment of OSA 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.

An auto-adjusting CPAP RAD (Healthcare Common Procedure Coding System [HCPCS] code E0601) is considered medically necessary and, therefore, covered for the treatment of OSA in individuals without significant comorbidities (i.e., congestive heart failure, chronic obstructive pulmonary disease, central sleep apnea syndromes, or hypoventilation syndromes) when the individual meets the above criteria for a CPAP RAD device.

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 or an auto-adjusting (CPAP) respiratory assist device (RAD) (HCPCS code E0601) has been tried and proven ineffective, based on a therapeutic trial in either a facility or a home setting.

The coverage of a single-level CPAP RAD or an auto-adjusting CPAP RAD (HCPCS code E0601) is initially limited to a 3-month period for individuals diagnosed with OSA as described above. A single-level CPAP RAD or an auto-adjusting CPAP RAD is subsequently covered for individuals diagnosed with OSA whose OSA improves as a result of a single-level CPAP RAD or an auto-adjusting CPAP RAD during this 3-month period. If a single-level CPAP RAD or an auto-adjusting CPAP RAD is tried and found ineffective during the initial 3-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 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 auto-adjusting 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 or an auto-adjusting CPAP RAD (HCPCS code E0601). 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 auto-adjusting CPAP RAD (HCPCS code E0601).

If a single-level CPAP RAD or an auto-adjusting CPAP RAD (HCPCS code E0601) has been used for more than 3 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 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 auto-adjusting CPAP RAD (HCPCS code E0601) or a bi-level RAD without a backup rate feature (HCPCS code E0470) 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:
  • 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), auto-adjusting 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 4 hours per night on 70 percent of the nights during a consecutive 30-day period any time during the first 3 months of initial use.

If the above criteria are not met, continued coverage of the single-level CPAP RAD (HCPCS code E0601), an auto-adjusting 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 their use in the treatment of illness or injury.

A bi-level RAD with a backup rate feature (HCPCS codes E0471 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 their 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 code E0471) 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 code E0471) 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 mmHg 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 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 mmHg 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 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 predominent cause of awake hypercapnia or nocturnal arterial oxygen desaturation).

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 code E0471) 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 mmHg 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 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 (HCPCS code E0470) that is not caused by obstructive upper airway events (.i.e, AHI less than 5).

If 2 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 code E0471) 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 (HCPCS code E0470) and done while the individual is awake and breathing their prescribed FIO2, still remains greater than or equal to 52 mmHg.
  • 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 (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 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 (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 mmHg while the individual is awake and breathing their prescribed FIO2.
  • Spirometry demonstrates an FEV1/FVC 70 percent 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 mmHg when compared to the original arterial blood gas; OR
    • A facility-based PSG demonstrates oxygen saturation is less than or equal to 88 percent 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 less than 5).

A bi-level RAD with a backup rate feature (HCPCS code E0471) 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 percentand 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 mmHg 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); OR
    • A facility-based PSG demonstrates oxygen saturation is less than or equal to 88 percent for at least 5 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 while using an E0470 device).

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 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 3 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, auto-adjusting CPAP RAD (HCPCS code E0601), 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, an auto-adjusting CPAP RAD (HCPCS code E0601), 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 (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), an auto-adjusting CPAP RAD (HCPCS code E0601), 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).

The following codes represent 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

ACCESSORIES (NOT REIMBURSED SEPARATELY FROM THE DEVICE)

Compliance monitoring equipment for single-level CPAP RADs, auto-adjusting CPAP 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 COVERED

Single-level CPAP, auto-adjusting CPAP, and bi-level RADs and associated accessories that do not meet medical necessity criteria are considered not medically necessary and, therefore, not covered.

There is no additional payment for liners, which are made of cloth, silicone, or other materials and placed between the skin and 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.

FACE-TO-FACE REQUIREMENTS

As a condition for payment, a professional provider must have a face-to-face examination with the individual for whom the item is ordered that meets all of the following requirements:
  • The treating professional provider must have an in-person examination with the individual within the six (6) months prior to the date of the written order prior to delivery.
  • This examination must document that the individual was evaluated and/or treated for a condition that supports the need for the item(s) of DME ordered.

A new face-to-face examination is required each time a new prescription for one of the specified items is ordered. A new prescription is required:
  • For all claims for purchases or initial rentals
  • When there is a change in the prescription for the accessory, supply, drug, etc.
  • If periodic prescription renewal required per medical policy
  • When an item is replaced
  • When there is a change in the supplier
  • When required by state law

In this policy the specified items are:

Code
Narrative
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)
E0601
Continuous airway pressure (CPAP) device

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. This policy is consistent with Medicare's documentation requirements, including the following required documentation:

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete 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 order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
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.

Documentation of a face-to-face encounter between the treating professional provider and the individual meeting the above requirements, including an assessment of the individual’s clinical condition supporting the need for the prescribed DME item(s) must be provided to, and kept on file by, the DME supplier.

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 (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 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 auto-adjusting CPAP RAD (HCPCS code E0601) to a 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 or an auto-adjusting 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

The American Academy of Sleep Medicine (AASM) recommends that individuals being treated with fixed CPAP on the basis of auto-adjusting CPAP titration or being treated with auto-adjusting CPAP 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

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, 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 continuous positive airway pressure (CPAP), auto-adjusting CPAP RADs, and bi-level positive airway pressure (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) 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 (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 auto-adjusting CPAP 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 auto-adjusting CPAP devices can increase compliance by making it easier for the individual to wear the device. An auto-adjusting CPAP 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 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. 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 positive airway pressure 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 greater than or equal to 30 events without symptoms or greater than or equal to 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 positive airway pressure device. For complex sleep apnea (CompSA), the CAHI is determined during the use of positive airway pressure device after obstructive events have disappeared.

Central sleep apnea (CSA) is defined by meeting all of the following criteria:
  • An AHI greater than 5 or equal to 5
  • Central apneas or hypopneas greater than 50 percent of the total apneas/hypopneas (moved down)
  • Central apnea--central hypopnea index (CAHI)s 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 non-restorative 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 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; or
  • 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:
    • Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or,
    • Hypertension, ischemic heart disease, or history of stroke

References


Ahmed I, Thorpy M. Clinical features, diagnosis and treatment of narcolepsy. Clin Chest Med. 2010;31(2):371-81.

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 July 3, 2018.

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.

Centers for Medicare and Medicaid Services (CMS). Coverage Decision Memorandum for Sleep Testing for Obstructive Sleep Apnea (OSA) 100-3, Change request 6534. 2009. Available at: http://www.cms.gov/transmittals/downloads/R103NCD.pdf. Accessed July 3, 2018.

Centers for Medicare and Medicaid Services (CMS). National coverage determination for continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA); 240.4. Available at: http://www.cms.hhs.gov/manuals/downloads/ncd103c1_Part4.pdf. Accessed July 3, 2018.

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):330-3.

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):449-53B.

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 01/01/2017. Available at:
https://med.noridianmedicare.com/web/jadme/policies/lcd/active. Accessed July 3, 2018.

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 01/01/2017. Available at: https://med.noridianmedicare.com/web/jadme/policies/lcd/active.
Accessed July 3, 2018.

National Institute for Health and Clinical Excellence. NICE technology appraisal guidance 139. Continuous positive airway pressure for the treatment of obstructive sleep apnoea/hypopnoea syndrome. Available online at: http://www.nice.org.uk/nicemedia/pdf/TA139Guidance.pdf. Accessed July 3, 2018.

Reeves-Hoche MK, Hudgel DW, Meck R, et al. Continuous versus bilevel positive airway pressure for obstructive sleep apnea. Am J Respir Crit Care Med. 1995;151(2 Pt 1):443-9.

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.

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.

Skomro RP, Gjevre J, Reid J, et al. Outcomes of home-based diagnosis and treatment of obstructive sleep apnea. Chest. 2010;138(2):257-63.

Somers VK, White DP, Amin R, et al. Sleep apnea and cardiovascular disease: an American Heart Association/american College Of Cardiology Foundation Scientific Statement from the American Heart Association Council for High Blood Pressure Research Professional Education Committee, Council on Clinical Cardiology, Stroke Council, and Council On Cardiovascular Nursing. In collaboration with the National Heart, Lung, and Blood Institute National Center on Sleep Disorders Research (National Institutes of Health). Circulation. 2008;118(10):1080-111.

Stammnitz A, Jerrentrup A, Penzel T, et al. Automatic CPAP titration with different self-setting devices in patients with obstructive sleep apnea. Eur Respir J. 2004;24(2):273-8.





Coding

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.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


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

J44.9 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

Coding and Billing Requirements


Cross References


Policy History

Revisions to 05.00.30l
10/08/2018This 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: 10/08/2018
Version Issued Date: 10/08/2018
Version Reissued Date: N/A

Connect with Us        


© 2017 Independence Blue Cross.
Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.