Print

Date Printed: October 23, 2017: 07:28 AM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-E0000-21

Original Effective Date: 02/15/01

Reviewed: 08/24/17

Revised: 09/15/17

Subject: Positive Airway Pressure Devices

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Obstructive sleep apnea (OSA) syndrome is associated with sleep-related breathing disorders such as snoring, upper airway resistance syndrome, and obesity-hypoventilation syndrome and is believed to affect approximately 2 – 4% of the US adult population. OSA syndrome is most common in middle-aged, obese, male smokers. Untreated, OSA can result in daytime somnolence, cognitive impairment, systemic hypertension, pulmonary hypertension, myocardial infarction, cardiac arrhythmias, and increased risk of accidents.

Diagnosis of OSA typically includes sleep study testing (see MCG Sleep Testing, 01-95828-01) performed during the patient’s habitual sleep hours and ideally includes all stages and positions of sleep.

Treatment of OSA is primarily based on all of the following:

Sleep studies are scored according to how many times per hour a patient stops breathing (apnea), or almost stops breathing (hypopnea). The final score is called a Respiratory Disturbance Index (RDI), or Apnea-Hypopnea Index (AHI). Any score over 5 may mean that the patient has sleep apnea.

RDI = # of apnea episodes + # of hypopnea episodes
Total number of hours of sleep

Continuous Positive Airway Pressure (CPAP), the first line treatment of OSA, is a non-invasive means of delivering low levels of air pressure through a nasal mask and flow generator system, through the nostrils, to prevent collapse of the oropharyngeal walls during sleep. CPAP acts as a pneumatic splint of the upper airway and is considered the treatment of choice for OSA. In order to assure adequate treatment results, an optimal CPAP pressure is determined by conducting a titration study where the pressure is gradually increased until the sleep-related breathing events are eliminated in all stages and positions of sleep.

C-Flex (also known as pressure-relief CPAP) is a flexible positive airway pressure device (Respironics, Murrysville, PA), which is characterized by a pressure reduction at the beginning of expiration and return to a therapeutic pressure before inhalation. Flexible positive airway pressure devices are intended to improve patient satisfaction and adherence over standard CPAP.

CPAP with expiratory pressure relief (EPR) is an enhancement to CPAP, used to improve patient comfort and adherence over standard CPAP.

Bi-level positive airway pressure creates higher inspiratory and lower expiratory pressures and is primarily used in patients with concomitant hypoventilation syndromes, central sleep apnea or treatment-emergent central sleep apnea.

Bi-Flex is a type of or enhancement to a bi-level device, which "softens" airflow at inhalation and exhalation, making breathing more natural and comfortable for patients.

Adaptive servoventilation (ASV) is a type of bi-level device that has a backup rate feature. This type of positive airway pressure device automatically adjusts its settings according to the individual’s breathing effort. Brand examples of ASV devices are VPAP Adapt and ResMed.

Bi-level PAP S/T (spontaneous timed) is a bi-level respiratory assist device which delivers alternating levels of positive airway pressure rather than the continuous pressure provided by a CPAP device. These devices have two pressure settings, a higher pressure for inhalation and a lower pressure for exhalation. However, some individual’s require a backup timed response where a breath will be initiated if a breath is not taken within the set timed parameter.

Auto-titrating CPAP (APAP) has the ability to provide variable expiratory pressures based upon the patient’s physiologic response to treatment (i.e.: flow, pressure, airway resistance). APAP devices can also provide a non-variable continuous positive airway pressure (CPAP). APAP is an effective treatment for OSA when a facility based titration has not been performed; to address possible pressure changes that may occur throughout the night due to body position or sleep stage; or to assist with patient comfort.

Nasal expiratory positive airway pressure (EPAP) devices (e.g., Provent® Professional Sleep Apnea Therapy) are nasal patches with microvents (valves) that are inserted into each nostril and worn during sleep. They are then disposed of and replaced with another pair each night. This appliance may also be referred to as a nasal dilator or a nasal valve device.

Oral pressure therapy (OPT) (e.g., ApniCure’s Winx™ Sleep Therapy System) used for the treatment of OSA provides light negative pressure to the oral cavity by using a flexible mouthpiece connected to a bedside console that delivers negative pressure. This device is proposed to increase the size of the retropalatal airway (i.e., region behind the palate) by pulling the soft palate forward and stabilizing the base of the tongue.

POSITION STATEMENT:

CPAP (including APAP, C-flex or CPAP with ERP)

CPAP devices meet the definition of medical necessity for the first three months of therapy when:

− AHI or RDI of 5 or more but less than 15 in adult members with symptomatic OSA (excessive daytime sleepiness, impaired cognitive ability, mood disorders, insomnia, hypertension, ischemic heart disease, or stroke) OR

− AHI or RDI of 15 or more in adult members with symptomatic or asymptomatic OSA. (CPAP is contraindicated in asymptomatic members without cardiovascular disease who demonstrate mild OSA on diagnostic NPSG.)

NOTE: In pediatric members, AHI or RDI greater than or equal to 1.5 is considered abnormal, and AHI or RDI of 15 or more is considered severe OSA.

Bi-level Positive Airway Pressure (including Bi-Flex)

Bi-level positive airway pressure with a backup rate feature (E0471) meets the definition of medical necessity for the first three months of therapy for members with clinical disorder groups characterized as one of the following (see specific criteria for each specific disorder):

  1. Restrictive thoracic disorders (i.e., progressive neuromuscular diseases or thoracic cage abnormalities)
  2. Severe chronic obstructive pulmonary disease (COPD)
  3. Central sleep apnea (CSA) or treatment-emergent central sleep apnea.

Restrictive Thoracic Disorders:

All of the following criteria must be met:

  1. There is documentation in the member’s medical record of a progressive neuromuscular disease (for example, amyotrophic lateral sclerosis) or thoracic cage abnormality (for example, post-thoracoplasty for TB),
  2. One of the following:

a. An arterial blood gas PaCO2, done while awake and breathing the member’s usual FIO2 is greater than or equal to 45 mm Hg;

b. Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for at least five continuous minutes, done while breathing the member’s usual FIO2;

c. For a progressive neuromuscular disease (only), maximal inspiratory pressure is less than 60 cm H20 or forced vital capacity (FVC) is less than 50% predicted;

  1. There is documentation that chronic obstructive pulmonary disease does not contribute significantly to the member’s pulmonary limitation.

Severe COPD:

All of the following criteria must be met:

  1. An arterial blood gas PaCO2, done while awake and breathing the member’s usual FIO2, is greater than or equal to 52 mm Hg;
  2. Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for at least five continuous minutes, done while breathing oxygen at 2 LPM or the member’s usual FIO2 (whichever is higher);
  3. Prior to initiating therapy, Obstructive Sleep Apnea (OSA) and treatment with a continuous positive airway pressure device (CPAP) has been considered and ruled out.

Central Sleep Apnea or Treatment-Emergent Central Sleep Apnea:

Prior to initiating therapy, a complete facility-based, attended polysomnogram must be performed documenting ALL of the following:

  1. The diagnosis of central sleep apnea (CSA) or treatment-emergent central sleep apnea;
  2. The ruling out of CPAP as effective therapy if either CSA or OSA is a component of the initially observed sleep-associated hypoventilation;
  3. Significant improvement of the sleep-associated hypoventilation with the use of a bi-level therapy or APAP on the settings that will be prescribed for initial use at home, while breathing the member’s usual FIO2.

Central sleep apnea (CSA) or treatment-emergent central sleep apnea is defined as:

Treatment-emergent central sleep apnea is a form of central sleep apnea specifically identified by the persistence or emergence of central apneas and/or hypopneas upon exposure to CPAP, bi-level therapy, or APAP, when obstructive events have disappeared. These members have predominately obstructive or mixed apneas during the diagnostic sleep study occurring at greater than or equal to 5 times per hour. With use of a CPAP, bi-level therapy, or APAP, they show a pattern of central apneas and/or central hypopneas that meets the definition of CSA described above.

If a CPAP device is tried and found ineffective during the initial 3-month home trial, substitution of bi-level therapy or APAP does not require a new clinical evaluation OR a new sleep test if the above criteria is met.

If a CPAP device has been used for more than 3 months and is switched to bi-level therapy or APAP, a new initial face-to-face clinical evaluation is required and the criteria above must be met, but a new sleep test is not required. A new 3-month trial would begin for use of bi-level therapy or APAP.

NOTE: If the above criteria are not met, continued coverage of a PAP device and related accessories will be denied as does not meet the definition of medical necessity.

A member who fails (including member non-adherence) the initial 3-month PAP trial is eligible to re-qualify for a PAP device but must have BOTH:

  1. Face-to-face clinical re-evaluation by the treating physician to determine the etiology of the failure to respond to PAP therapy; AND
  2. Repeat sleep test in a facility-based setting (Type 1 study).

Bi-level therapy without a backup rate feature (E0470) meets the definition of medical necessity for the treatment of obstructive sleep apnea when CPAP has been tried and proven ineffective or is not tolerated.

Bi-level therapy with a backup rate feature (E0471) is considered experimental or investigational for the treatment of obstructive sleep apnea as the published clinical evidence does not support proven value for this indication.

Bi-level therapy S/T with a backup rate feature is considered experimental or investigational when used as a life-support ventilator, as there is insufficient scientific peer-reviewed literature to support the application of Bi-level therapy S/T other than to augment the ventilation of a spontaneously breathing member.

Nasal expiratory positive airway pressure (EPAP) devices (e.g., Provent® Professional Sleep Apnea Therapy) and oral pressure therapy devices (e.g., ApniCure’s Winx™ Sleep Therapy System) are considered experimental or investigational as there is insufficient clinical evidence published in the peer-reviewed literature to support the safety, efficacy, and long-term outcomes of the use of these types of devices in the treatment of OSA.

CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS (90 days) OF THERAPY

Continued coverage of a PAP device (E0470 or E0601) beyond the first three months of therapy requires that, no sooner than the 31st day but no later than the 91st day after initiating therapy, there must be documented objective evidence that the member is adhering to PAP therapy.

(Objective evidence of adherence to use of the PAP device, is defined as: Use of PAP ≥4 hours per night on 70% of nights during a consecutive thirty (30) day period anytime during the first three (3) months of initial usage.)

If the above criteria are not met, continued coverage of a PAP device and related accessories will be denied as not meeting the definition of medical necessity.

Accessories:

Accessories used with a PAP device are covered when the coverage criteria for the PAP device are met.

If the coverage criteria are not met, the accessories will be denied as not meeting the definition of medical necessity.

Replacement

Mask replacement may be warranted due to the following supported by documentation:

• Proper mask fit to ensure comfort and adequate control of symptoms of OSA (especially during the first 3 months to 1 year)

• Malfunction of mask

• Verification of warranty expiration.

A replacement PAP/Bi-level device meets the definition of medical necessity to treat obstructive sleep apnea or essential sleep apnea with a prescription from a qualified health professional due to reasonable wear and tear to the device which renders the item:

• nonfunctioning and not repairable, AND

• the item is no longer under warranty.

Travel PAP Therapy

Duplicate equipment is considered a convenience (e.g., travel PAP) and does not meet the definition of medical necessity.

The following table represents the usual maximum amount of accessories expected to be medically necessary:

Table:

A4604

4 in 12 months

A7027

4 in 12 months

A7028

24 in 12 months

A7029

24 in 12 months

A7030

4 in 12 months

A7031

12 in 12 months

A7032

24 in 12 months

A7033

24 in 12 months

A7034

4 in 12 months

A7035

2 in 12 months

A7036

2 in 12 months

A7037

4 in 12 months

A7038

24 in 12 months

A7039

2 in 12 months

A7046

2 in 12 months

Quantities of supplies greater than those described above, as the usual maximum amounts, will be subject to medical review of documentation supporting medical necessity, justifying a larger quantity in the individual case. The following information may be required documentation to support medical necessity, such as: attending physician history and physical, attending physician visit notes, other pertinent information such as nursing home records, home health agency records, and records from other healthcare professionals.

LOINC Codes:

DOCUMENTATION TABLE

LOINC CODES

LOINC TIME FRAME MODIFIER CODE

LOINC TIME FRAME MODIFIER CODES NARRATIVE

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician visit note

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Clinical notes and chart section (i.e., nursing home records, home health agency records, and other health care professional

28650-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Either a non-heated (E0561) or heated (E0562) humidifier is covered when ordered by the treating physician for use with a covered PAP device.

BILLING/CODING INFORMATION:

The following codes may be used to describe positive airway pressure devices and accessories:

HCPCS Coding:

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 of 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

A7047

Oral interface used with respiratory suction pump, each (investigational)

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 backup rate feature, used with noninvasive interface, e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure device) [describes adaptive servo ventilation]

E0472

Respiratory assist device, bi-level pressure capability, with backup rate feature, used with invasive interface, e.g., tracheostomy tube (intermittent assist device with continuous positive airway pressure device)

E0561

Humidifier, non-heated, used with positive airway pressure device

E0562

Humidifier, heated, used with positive airway pressure device

E0601

CPAP (continuous positive airway pressure) device (also used for reporting APAP)

S8186

Swivel adapter

* NOTE: Bi-level therapy devices with a backup rate feature (E0471) are considered experimental or investigational when billed with any of the below listed ICD-10 diagnosis codes for obstructive sleep apnea.

NOTE: There is no specific HCPCS code for reporting C-Flex, CPAP with ERP, or Bi-Flex devices.

NOTE: Oral pressure therapy devices (e.g., Winx Sleep Therapy System) are considered experimental or investigational, but may sometimes be reported using E0600 (respiratory suction pump, home model, portable or stationary, electric) and A7002 (tubing, used with suction pump, each).

Refer to section entitled POSITION STATEMENT for coverage criteria.

ICD-10 Diagnoses Codes That Support Medical Necessity:

G47.30

Sleep apnea, unspecified

G47.33

Obstructive sleep apnea (adult) (pediatric)

G47.39

Other sleep apnea

R40.0

Somnolence

REIMBURSEMENT INFORMATION

Equipment and Accessories:

Documentation Required:

LOINC Codes:

DOCUMENTATION TABLE

LOINC CODES

LOINC TIME FRAME MODIFIER CODE

LOINC TIME FRAME MODIFIER CODES NARRATIVE

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

Physician initial assessment

18736-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician progress note

18741-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician hospital discharge summary

11490-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Provider orders

46209-3

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician consulting initial assessment

18763-3

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician consulting progress notes

28569-2

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Clinical notes and chart section (i.e., nursing home records, home health agency records, and other health care professional

28650-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Pulmonary studies

27896-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician visit notes

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Neuromuscular electro-physiology studies

27897-8

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Blood gas tests

18767-4

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

There is no specific HCPCS code for reporting C-flex, CPAP with ERP, or Bi-Flex devices. Therefore, these devices are typically reported as a standard CPAP or Bi-level device. These devices or enhancements would not be considered separately reimbursable from standard devices. Literature does not support an increased efficacy of these devices over standard CPAP and Bi-level therapy.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (240.4) located at cms.gov.

The following Durable Medical Equipment Regional Carrier (DMERC) Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L33718) and Respiratory Assist Devices (L33800) located at cgsmedicare.com.

DEFINITIONS:

Apnea: temporary cessation of breathing and, therefore, of the body's intake of oxygen and release of carbon dioxide; cessation of airflow for 10 seconds or more.

Apnea index (AI): the number of apneic episodes per hour of sleep.

Apnea-hypopnea index (AHI): The number of episodes of reduced or absent respiratory effort per hour; the total apneas plus hypopneas during total time asleep, divided by the number of hours asleep.

Bi-level PAP S/T (spontaneous/timed): a ventilatory support system.

Central sleep apnea: Absence of breathing during sleep that occurs when the respiratory center of the brainstem does not send normal periodic signals to the muscles of respiration. Observation of the patient reveals no respiratory effort, that is, no movement of the chest, and no breath sounds.

Data card: A small card resembling a credit card that stores information from CPAP, Bi-level therapy or AUTOPAP (APAP) machines. This data card is then placed into a data card reader, downloaded to a computer, and read with optional software. Depending on the model of the machine, the data card will hold compliance data, total hours that the machine has been used, and efficiency data (e.g., Smart Card).

Excessive daytime sleepiness: Score greater than or equal to 10 on the Epworth Sleepiness Scale.

Hypopnea: an abnormal respiratory event lasting 10 seconds or more with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4% oxygen desaturation.

Obstructive sleep apnea (OSA): Absent or dysfunctional breathing that occurs when the upper airway is intermittently blocked during sleep. Observation of the patient reveals vigorous but ineffective respiratory efforts, often with loud snoring or snorting.

Respiratory disturbance index (RDI): The average number of episodes of apnea, hypopnea, and respiratory event-related arousal per hour of sleep.

Sleep apnea: The cessation of breathing during sleep. To be so classified, the apnea lasts for at least 10 sec and occurs 30 or more times during a 7-hr period of sleep. This strict definition may not apply to older persons in whom periods of sleep apnea are increased. The disorder is classified according to the mechanism involved. In obstructive apnea, respiratory effort is present but ineffective because of obstruction to the upper airway. Central sleep apnea is marked by absence of respiratory muscle activity. Mixed apnea begins with absence of respiratory effort followed by upper airway obstruction. Patients with obstructive sleep apnea are usually middle-aged, obese men with a history of excessive daytime sleepiness and night breathing marked by loud snorting, snoring, and gasping sounds. Patients with central sleep apnea may exhibit excessive daytime sleepiness, but the snorting and gasping sounds during sleep are absent.

Somnolence: sleepiness; drowsiness.

Treatment-Emergent Central Sleep Apnea: A form of central sleep apnea specifically identified by the persistence or emergence of central apneas and/or hypopneas upon exposure to CPAP, bi-level therapy, or APAP, when obstructive events have disappeared.

Type I sleep study devices – polysomnography : capable of recording all of the physiologic parameters and signals defined for polysomnography. The recording is furnished in a sleep laboratory facility in which a technologist is physically present to supervise the recording during sleep time and has the ability to intervene if needed. Minimal requirements include recording of EEG, EOG, chin EMG, anterior tibialis EMG, ECG, airflow, respiratory effort and oxygen saturation. Body position must be documented or objectively measured. A sleep technologist must be in constant attendance during the sleep study.

Type II sleep study devices: for sleep studies performed unattended in or out of a sleep lab facility or attended in a sleep lab facility. Type II devices are portable devices that may measure the same channels as Type I testing, except that a heart-rate monitor can replace the ECG. These devices have a minimum of 7 channels (e.g., EEG, EOG, EMG, ECG-heart rate, airflow, respiratory effort, and oxygen saturation and monitors sleep staging). A sleep technologist is not in constant attendance in Type II studies.

Type III sleep study devices: for sleep studies performed unattended in or out of a sleep lab facility or attended in a sleep lab facility. Type III devices monitor and record a minimum of 4 channels and must record ventilation or airflow, heart rate or ECG, and oxygen saturation. A sleep technologist is not in constant attendance in Type III studies.

Type IV sleep study devices: measures three or more channels. Type IV devices must include airflow as one of the required 3 channels. Other measurements may include oximetry and heart rate. A sleep technologist is not in constant attendance when Type IV devices are used.

RELATED GUIDELINES:

Medical & Surgical Management of Obstructive Sleep Apnea (OSA), Snoring, and Other Conditions of the Soft Palate and Nasal Passages (e.g., LAUP, UPPP, Somnoplasty, Coblation), 02-40000-16
Oxygen, 09-E0400

Sleep Testing, 01-95828-01

OTHER:

None applicable.

REFERENCES:

  1. Agency for Health Care Policy and Research – Evidence Report/Technology Assessment Systematic Review of the Literature Regarding the Diagnosis of Sleep Apnea. January 01, 1999.
  2. Agency for Healthcare Research and Quality. Comparative Effectiveness Review - Diagnosis and Treatment of Obstructive Sleep Apnea in Adults (08/08/11).
  3. Allam JS, Olson EJ, Gay PC, Morgenthaler TI. Efficacy of Adaptive Servoventilation in Treatment of Complex and Central Sleep Apnea Syndromes. Chest 2007; 132;1839-1846.
  4. Aloia MS, Stanchina M, Arnedt JT, Malhotra A, Millman RP. Treatment adherence and outcomes in flexible vs. standard continuous positive airway pressure therapy. Chest. 2005 Jun; 127(6): 2085-93.
  5. American Academy of Sleep Medicine. Clinical Guideline for the Evaluation, Management, and Long-term Care of Obstructive Sleep Apnea in Adults. Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med, Vol. 5, No. 3, 2009.
  6. American Academy of Sleep Medicine. Clinical Guidelines for the Manual Titration of Positive Airway Pressure in Patients with Obstructive Sleep Apnea. Positive Airway Pressure Titration Task Force of the AASM. J Clin Sleep Med, Vol. 4, No.2, 2008.
  7. Balk EM, Moorthy D, Obadan NO, Patel K, Ip S, Chung M, Bannuru RR, Kitsios GD, Sen S, Iovin RC, Gaylor JM, D’Ambrosio C, Lau J. Diagnosis and Treatment of Obstructive Sleep Apnea in Adults. Comparative Effectiveness Review No. 32. (Prepared by Tufts Evidence-based Practice Center under Contract No. 290-2007-10055-1). AHRQ Publication No. 11-EHC052-EF. July 2011.
  8. 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 Apr 1;34(4):479-85.
  9. Blue Cross Blue Shield Association Medical Policy 2.01.18 – Diagnosis and Medical Management of Obstructive Sleep Apnea, 06/17.
  10. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (240.4), accessed at cms.gov.
  11. CGS Administrators, LLC; DME MAC, Local Coverage Determination (LCD): Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L33718), accessed at cgsmedicare.com.
  12. CGS Administrators, LLC; DME MAC, Local Coverage Determination (LCD): Respiratory Assist Devices (L33800), accessed at cgsmedicare.com.
  13. Chai CL, Pathinathan A, Smith B. Continuous positive airway pressure delivery interfaces for obstructive sleep apnea. Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.: CD005308. DOI: 10.1002/14651858. CD005308.pub2.
  14. Colrain IM; Brooks S; Black J. A pilot evaluation of a nasal expiratory resistance device for the treatment of obstructive sleep apnea. J Clin Sleep Med 2008; 4(5):426-433.
  15. Epstein LJ; Kristo D; Strollo PJ; Friedman N; Malhotra A; Patil SP; Ramar K; Rogers R; Schwab RJ; Weaver EM; Weinstein MD. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med 2009;5(3):263-276.
  16. 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 Oct 15;7(5):449-53B.
  17. Kushida CA, 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 of Clin Sleep Med 2008; 4:157-171.
  18. Kushida CA; Chediak A; Berry RB; Brown LK; Gozal D; Iber C; Parthasarathy S; Quan SF; Rowley JA; Positive Airway Pressure Titration Task Force of the American Academy of Sleep Medicine. Clinical guidelines for the manual titration of positive airway pressure in patients with obstructive sleep apnea. J Clin Sleep Med 2008; 4(2): 157-171.
  19. Kushida CA; Littner MR; 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): 375-380.
  20. Leidag M, Hader C, Keller T, Meyer Y, Rasche K. Mask leakage in continuous positive airway pressure and C-Flex. J Physiol Pharmacol. 2008 Dec; 59 Suppl 6:401-6.
  21. Littner Michael, Hirshkowitz Maxwell, 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 Standards of Practice Committee of the American Academy of Sleep Medicine. SLEEP, Vol. 25, No. 2, 2002.
  22. Loube, DI, et al. Consensus Statement. Indications for Positive Airway Pressure Treatment of Adult Obstructive Sleep Apnea Patients. Chest 1999; 115:863-866.
  23. Marshall NS, Neill AM, Campbell AJ. Randomised trial of compliance with flexible (C-Flex) and standard continuous positive airway pressure for severe obstructive sleep apnea. Sleep Breath. 2008 Nov; 12(4): 393-6. Epub 2008 May 31.
  24. Morgenthaler TI, Aurora RN, Brown T et al. Practice parameters for the use of autotitrating 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.
  25. National Guideline Clearinghouse. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: a report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with Obstructive Sleep Apnea. (07/21/08).
  26. National Guideline Clearinghouse (NGC 003087). Management of obstructive sleep apnoea/hypopnoea syndrome in adults. A national clinical guideline. (2003; reaffirmed 2012).
  27. National Institute for Health and Care Excellence (NICE). Continuous positive airway pressure for the treatment of obstructive sleep apnoea/hypopnoea syndrome (2008).
  28. Nilius G, Happel A, Domanski U, Ruhle KH. Pressure-relief continuous positive airway pressure vs. constant continuous positive airway pressure: a comparison of efficacy and compliance. Chest. 2006 Oct; 130(4): 1018-24.
  29. Patel AV, Hwang D, Masdeu MJ, Chen GM, Rapoport DM, Ayappa I. Predictors of response to a nasal expiratory resistor device and its potential mechanisms of action for treatment of obstructive sleep apnea. J Clin Sleep Med. 2011 Feb 15;7(1):13-22.
  30. Pépin JL, Muir JF, Gentina T, Dauvilliers Y, Tamisier R, Sapene M, Escourrou P, Fleury B, Philip-Joet F, Philip P, d'Ortho MP. Pressure Reduction During Exhalation in Sleep Apnea Patients Treated by CPAP. Chest. 2009 Jun 30. [Epub ahead of print].
  31. Pepperell JCT, Maskell NA, Jones DR, Langford-Wiley, VA, Crosthwaite N, Strading JR, Davies RJO. A Randomized Controlled Trial of Adaptive Ventilation for Cheyne-Stokes Breathing in Heart Failure. Am J Respir Crit Care Med, Vol. 168, pp 1109-1114, 2003.
  32. Philippe C, Stoica-Herman M, Drouot X, Raffestin B, Escourrou P, Hittinger L, Michel P-L, Fouault S, d’Ortho M-P. Compliance with and effectiveness of adaptive servoventilation versus continuous positive airway pressure in the treatment of Cheyne-Stokes respiration in heart failure over a six month period. Heart 2006; 92:337-342.
  33. Rosenthal L, Massie CA, Dolan DC, Loomas B, Kram J, Hart RW. A multicenter, prospective study of a novel nasal EPAP device in the treatment of obstructive sleep apnea: efficacy and 30-day adherence. J Clin Sleep Med. 2009 Dec 15;5(6):532-7.
  34. Vital FMR, Saconato H, Ladeira MT, Sen A, Hawkes CA, Soares B, Burns KE. A., Atallah ÁN. Non-invasive positive pressure ventilation (CPAP or bi-level NPPV) for cardiogenic pulmonary edema. Cochrane Database of Systematic Reviews 2008, Issue 3. Art. No.: CD005351. DOI: 10.1002/14651858. CD005351.pub2.
  35. Wenzel M, Kerl J, Dellweg D, Barchfeld T, Wenzel G, Köhler D. Pneumologie. 2007 Nov; 61(11): 692-5. Epub 2007 Jul 27.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 08/24/17.

GUIDELINE UPDATE INFORMATION:

02/15/01

Medical Coverage Guideline Reformatted.

01/01/02

HCPCS coding update.

02/28/02

Reviewed; reimbursement information added regarding supplies and accessories.

06/15/02

Revised AHI (i.e., RDI) requirement for patients with asymptomatic OSA; added Medicare & More program exception for reimbursement of accessories.

10/01/02

Local codes removed.

01/01/03

HCPCS coding update.

05/15/03

Reviewed; reimbursement limitation removed for accessories and supplies reported with positive airway pressure devices.

10/15/03

HCPCS code added (S8186).

01/01/04

Annual HCPCS coding update.

04/15/04

Scheduled review; added limitations for accessories, added cross-reference to the Oxygen MCG for oxygen used with CPAP; revised timeframe for physician follow-up to 90 days; revised coverage criteria to reflect AHI values of 5 – 14 and 15 or more.

06/15/04

Revised BiPAP coverage criteria; remove criteria regarding patient compliance.

01/15/05

Annual HCPCS coding update (A7045 added).

05/15/05

Scheduled review; add coverage criteria for APAP (DPAP); add A7046.

01/01/06

Annual HCPCS coding update: revise A7032 and A7033.

05/15/06

Scheduled review (consensus review); no change in coverage statement; references updated.

08/15/06

Revisions consisting of changes in coverage criteria for BiPAP and APAP/DPAP; added non-coverage statement and definition for BiPAP S/T.

07/01/07

HCPCS 3rd quarter coding update: added K0553, K0554, and K0555.

08/15/07

Reviewed; guideline reformatted; references updated.

01/01/08

Annual HCPCS coding update: added A7027, A7028, and A7029; removed K0553, K0554, and K0555.

02/15/08

Revised to expand ICD-9 diagnosis list for obstructive sleep apnea.

09/15/08

Scheduled review; added position statement regarding Smartcards; added limitation for A7027 and revised limitation for A7037; added Program Exception for Medicare Advantage products regarding Bi-PAP S/T and home sleep testing; updated references.

05/15/09

Revised to include coverage criteria for initial trial period for use of PAP devices and continuation beyond the initial trial period; added criteria for specific diagnoses/conditions; added criteria for determining compliance; added documentation requirements; reformatting revisions.

08/15/09

Revised position statement regarding data cards (e.g., Smart Card) for PAP devices; added position statement for C-Flex devices; updated references.

04/15/10

Scheduled review with revisions. MCG title changed. Added criteria regarding adaptive nasal ventilation (i.e., BiPAP with backup rate feature). Updated references.

08/15/10

Revision to Position Statement to include indicators for pediatric patients.

10/15/10

Revision; formatting changes; related ICD-10 codes added.

04/15/11

Scheduled review with revisions to address C-Flex, CPAP with ERP, and Bi-flex devices; references updated; formatting changes.

07/01/11

Revision; formatting changes.

11/15/11

Revision to add position statement regarding nasal expiratory positive airway pressure devices (EPAP).

11/15/12

Annual review; position statement unchanged; continuation of coverage criteria revised; references updated.

03/15/13

Reimbursement section revised; position statement unchanged.

12/15/13

Annual review; position statement unchanged; Program Exceptions section updated; references updated.

01/01/14

Annual HCPCS coding update: added A7047; updated Description section and Position Statement; formatting changes.

05/15/14

Revisions regarding APAP description; formatting changes.

05/15/15

Revision; position statements, description, and references updated; formatting changes.

11/01/15

Revision: ICD-9 Codes deleted.

08/15/16

Revision; position statement section and references updated; formatting changes.

10/01/16

Revision; formatting changes.

02/15/17

Revision; Update to position statement.

09/15/17

Review; Replacement and travel PAP position statements updated; references updated.

Date Printed: October 23, 2017: 07:28 AM