Non-invasive positive pressure respiratory assist devices which deliver different pressures during inspiration and expiration, also known as bi-level respiratory assist devices (BPAP), are non-invasive devices that utilize a full-face mask or nasal mask to deliver differing levels of positive airway pressure during inspiration and expiration, instead of the single level of pressure applied by continuous positive airway pressure (CPAP) machines.  BPAP devices are in the FDA category of non-continuous ventilator and are intended to augment spontaneous respirations, as part of the treatment plan for certain pulmonary conditions.

This document addresses the medical necessity criteria for the intermittent home use of BPAP devices. This document does not address the use of these devices, as part of the treatment of the acutely ill, hospitalized individual.

For additional information related to the diagnosis and management of obstructive sleep apnea (OSA), please refer to the following:

• MED.00002 Multiple Sleep Latency Testing (MSLT) and other Sleep Testing Services;
• SURG.00074 Nasal Surgery for the Treatment of Obstructive Sleep Apnea (OSA) and Snoring;
• SURG.00129 Oral, Pharyngeal and Maxillofacial Surgical Treatment for Obstructive Sleep Apnea;
• CG-MED-01 Polysomnography and Home Portable Monitors;
• CG-DME-32 Continuous Positive Airway Pressure (CPAP) and Auto-titrating Positive Airway Pressure (APAP) Devices.

Medically Necessary:

BPAP devices are considered medically necessary for any one of the following disorders, (subject to specific criteria for each respective condition – see further information below):

1. Restrictive thoracic disorders, (e.g., progressive neuromuscular diseases or severe thoracic cage abnormalities); or
2. Severe chronic obstructive pulmonary disease (COPD); or
3. Central sleep apnea (CSA); or
4. Obstructive sleep apnea (OSA).

A.  For Restrictive Thoracic Disorders 

Medically Necessary: 

The use of a BPAP device with or without the back-up rate feature for the treatment of restrictive thoracic disorders is considered medically necessary when ALL of the following criteria are met:

• The member has been diagnosed with a progressive neuromuscular disease, (e.g., amyotrophic lateral sclerosis [ALS] or a severe thoracic cage abnormality, [e.g., post-thoracoplasty for TB]); and 
• COPD does not contribute significantly to the individual's pulmonary limitation; and ONE or more of the following criteria are met:
  • An arterial blood gas PaCO₂ level is greater than or equal to 45 mm Hg, done while awake and breathing the individual's usual FIO₂ (fractionated inspired oxygen concentration); or
  • Sleep oximetry demonstrates an oxygen saturation less than or equal to 88% for at least five continuous minutes, done while breathing the individual's usual FIO_2^; or
  • Maximal inspiratory pressure is less than 60 cm H₂O or forced vital capacity is less than 50% of predicted (for those with a progressive neuromuscular disease only). 

Not Medically Necessary:

The use of a BPAP device with or without the back-up rate feature for the treatment of restrictive thoracic disorders is considered not medically necessary if ALL the above medical necessity criteria are not met.

B.  For Severe Chronic Obstructive Pulmonary Disease (COPD) 

Medically Necessary: 

The use of a BPAP device without back-up rate feature for the treatment of severe COPD is considered medically necessary when ALL of the following are met:

• An arterial blood gas PaCO_2^, done while awake and breathing the individual's usual FIO_2^, is greater than or equal to 52 mm Hg; and
• Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for at least five continuous minutes, done while breathing oxygen at 2 L/min. or the individual's usual FIO₂ (whichever is higher); and
• Prior to initiating therapy, OSA and treatment with CPAP has been considered and ruled out.

Not Medically Necessary: 

The use of a BPAP device  without back-up rate feature for the treatment of severe COPD is considered not medically necessary if ALL the above criteria are not met.

The use of a BPAP device with the back-up rate feature is considered not medically necessary during the first two (2) months of therapy for persons with severe COPD (because proper adjustments and user accommodation to the use of a BPAP device without back-up feature will usually produce the desired therapeutic effect).

B.i.  For COPD Requiring Use of a BPAP device with the back-up rate feature

Medically Necessary: 

The subsequent use of a BPAP device with the back-up rate feature, for the treatment of severe COPD for individuals who have already met the medical necessity criteria and have used a BPAP device without the back-up rate feature for the first two months of therapy, is considered medically necessary when ALL of the following criteria are met:

• An arterial PaCO₂ that remains greater than or equal to 52 mm Hg, (repeated not sooner than 61 days post-initiation of initial device use) and done while awake and breathing the individual's usual FIO_2^; and
• A sleep oximetry demonstrating oxygen saturation levels of less than or equal to 88% for at least five continuous minutes and tested while using the BPAP device and breathing oxygen at 2 L/min. or the individual's usual FIO₂, whichever is higher; (this repeat testing is to be done not sooner than 61 days post-initiation of the initial therapy regimen); and
• Clinical documentation from the treating physician to indicate user compliance with the initial device (BPAP without back-up rate feature)and the lack of desired therapeutic effect from use of this device.

 Not Medically Necessary: 

Subsequent use of a BPAP device with the back-up rate feature for the treatment of severe COPD is considered not medically necessary when the above criteria are not met. 

C.  For Central Sleep Apnea, (i.e., apnea not due to airway obstruction) 

Medically Necessary: 

The use of a BPAP device either with or without the back-up rate feature for the treatment of central sleep apnea (CSA) is considered medically necessary when, prior to initiating therapy, a complete, facility-based, attended polysomnography has been performed and the test results have revealed ALL of the following:

• The diagnosis of CSA has been confirmed; and
• The presence of OSA has been excluded, as the predominant cause of the sleep-associated hypoventilation; and
• If OSA is a component of the sleep-associated hypoventilation, CPAP has been ruled out as an effective therapy; and
• Oxygen saturation level is less than or equal to 88% for at least five continuous minutes, done while breathing the individual's usual FIO_2^; and
• Significant clinical improvement of the sleep-associated hypoventilation has been demonstrated with the use of a BPAP device, either with or without the back-up rate feature, adjusted to the settings that will be prescribed for initial home use, while breathing the individual's usual FIO_2^.

Not Medically Necessary: 

The use of a BPAP device either with or without the back-up rate feature for the treatment of CSA is considered not medically necessary if ALL the above criteria are not met.

D.  For Obstructive Sleep Apnea (OSA) 

Medically Necessary: 

A BPAP device without back-up rate feature, is considered medically necessary when used by individuals diagnosed with OSA or upper airway resistance syndrome (UARS) when CPAP has failed as demonstrated by any of the following documented in the medical record:

• Claustrophobia from CPAP; or
• Inability to breathe through the nose; or
• Pain or discomfort from CPAP; or
• User intolerance to CPAP; or
• Individuals at high pressures of CPAP (greater than10 cm H₂0) complaining of pressure discomfort.

Not Medically Necessary:

The use of a BPAP device without back-up rate feature for the treatment of OSA is considered not medically necessary if ALL the above criteria are not met.

The use of a BPAP device with the back-up rate feature is considered not medically necessary for the treatment of OSA.

E.  COMPLIANCE MONITORING AND CONTINUED COVERAGE CRITERIA FOR POSITIVE AIRWAY PRESSURE DEVICES:

Medically Necessary:

Ongoing use of a BPAP device is considered medically necessary when either of the following criteria are met:

• Compliance with treatment is demonstrated by medical records or device log which demonstrates a minimum average use of 4 hours per 24-hour period;  OR
• There is clinical evidence that the individual continues to benefit from use of the BPAP device. 

Not Medically Necessary:

Ongoing use of a BPAP device is considered not medically necessary when neither of the criteria in this section are  met.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

This guideline is based on the recommendations of the Centers for Medicare and Medicaid Services (CMS) for the intermittent home use of non-invasive positive pressure respiratory assist devices, also known as Bi-level respiratory assist devices (BPAP).  In general, these devices have been recommended and demonstrated to be of benefit, when used intermittently in the treatment of conditions associated with ventilatory failure, resulting in hypercarbia (CO₂ retention) and hypoxemia.  This may result from restrictive or obstructive ventilatory impairments associated with: thoracic cage abnormalities, (e.g., severe kyphoscoliosis or post-thoracoplasty), lung disease (e.g., chronic obstructive pulmonary disease), neuromuscular disorders affecting the muscles of respiration, (e.g., amyotrophic lateral sclerosis), or central hypoventilation, (e.g., central sleep apnea).

Often, these devices may be required only during sleep when ventilatory disorders tend to be more prominent or manifest.  Classically, this would be the case in the sleep apnea syndromes, but this is often the case in other types of ventilatory insufficiency also.  In some of the latter conditions, however, respiratory assistance may be required for intermittent daytime support, in addition.  The use of BPAP devices may allow individuals with these latter conditions to avoid, or at least delay, the need for more invasive forms of ventilatory support, such as tracheostomy and mechanical ventilation.

There are multiple variations in BPAP devices, an example of which is VPAP^™ (Variable Positive Airway Pressure), which are basically BPAP devices that deliver differing levels of inspiratory and expiratory pressure, in order to maintain airway patency during sleep.  There are multiple machines currently available that have FDA clearance for use in the treatment of obstructive sleep apnea and respiratory insufficiency caused by central and/or mixed apneas and periodic breathing disorders (FDA, 2005).

Bi-level positive pressure respiratory assist device (BPAP):  These devices deliver two levels of positive airway pressure, both of which are delivered non-invasively, through tubing connected to a full-face or nasal mask or through nasal pillows.  The device cycles between a pre-determined inspiratory positive airway pressure phase and a pre-set expiratory positive airway pressure phase.  The back-up rate feature on some of these machines ensures that the individual will receive a set minimum number of breaths per minute, if he/she should become apneic (stop breathing spontaneously).  The term BiPAP is a registered trademark of Respironics, Inc., but is widely used to describe any bi-level positive airway pressure device currently marketed.

Central sleep apnea (CSA):  This variant of obstructive sleep apnea (OSA) has a different etiology and is caused by decreased respiratory center output in the brain.  This sleep apnea syndrome is not as common as OSA but is associated with similar symptoms.

Chronic obstructive pulmonary disease (COPD):  Any disorder that persistently obstructs bronchial airflow and mainly involves two related diseases -- chronic bronchitis and emphysema.  Both cause chronic obstruction of air flowing through the airways and in and out of the lungs which is generally permanent and progresses (becomes worse) over time.

Obstructive sleep apnea (OSA):  This syndrome is associated with the interruption of breathing during sleep, due to obstructive tissue in the upper airway that collapses into the air passage with respiration.  This may occur several hundred times a night and is thought to cause many symptoms, such as depression, irritability, sexual dysfunction, learning and memory difficulties and the frequent complaint of excessive daytime sleepiness.

Restrictive thoracic disorders:  Refers to a variety of neuromuscular and anatomical anomalies of the chest/rib cage area that may result in hypoventilation, particularly during sleep.  Nocturnal hypoventilation is associated with a host of health hazards and can also significantly impact the quality of life.  The use of non-invasive positive pressure respiratory assist devices has been found helpful in reducing the episodes of nocturnal hypoventilation and the associated complications for a significant number of those who are able to tolerate the therapy. 

Upper airway resistance syndrome (UARS):  This syndrome is a very similar but less severe sleep disorder than OSA and is also characterized by airway resistance to breathing during sleep. However, the parameters used to determine severity in OSA (Apnea-Hypopnea Index [AHI] or Respiratory Disturbance Index [RDI] and oxygen saturation levels) are less severely affected in UARS than in OSA.  The primary symptoms of UARS include daytime sleepiness and excessive fatigue.  Untreated UARS can progress to the diagnosis of OSA.

Peer Reviewed Publications:

1. Berry RB, Parish JM, Hartse KM.  The use of auto-titrating continuous positive airway pressure for treatment of adult obstructive sleep apnea.  Sleep. 2002; 25(2):148-173.
2. Bonekat, HW. Noninvasive ventilation in neuromuscular disease.  Crit Care Clin. October 1998; 14(4):775-797.
3. Criner GJ, et al. Efficacy and compliance with noninvasive positive pressure ventilation in patients with chronic respiratory failure.  Chest. September 1999; 116(3):667-675.
4. Hill NS. Noninvasive mechanical ventilation for post acute care.  Clin Chest Med. 2001; 22(1):35-54.
5. Hill NS. Noninvasive ventilation in chronic obstructive pulmonary disease.  Clin Chest Med. 2000; 21(4):783-797.
6. Hunter MH, King DE. COPD: management of acute exacerbations and chronic stable disease.  Am Fam Physician. 2001; 64(4):603-612.
7. Keenan SP, Mehta S. Noninvasive ventilation for patients presenting with acute respiratory failure: The randomized controlled trials. Respir Care. 2009; 54(1):116-126.
8. Massie CA, McArdle N, Hart RW, et al.  Comparison between automatic and fixed positive airway pressure therapy in the home.  Am J Respir Crit Care Med.  2003; 167(1):20-23.
9. Nussbaumer Y, Block KE, Genser T, Thurnheer R.  Equivalence of auto adjusted and constant continuous positive airway pressure in home treatment of sleep apnea.  Chest. 2006; 129(3):638-643.
10. Padman R, Lawless ST, Kettrick RG. Noninvasive ventilation via bilevel positive airway pressure in pediatric practice.  Crit Care Med. 1998; 26(1):169-173.
11. 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):443-449.
12. Strollo PJ, Jr, Sanders MH, Atwood CW. Positive pressure therapy. Clin Chest Med. 1998; 19(1):55-68.
13. Vanpee D, El Khawand C, Rousseau L, et al. Effects of nasal pressure support on ventilation and inspiratory work in normocapneic and hypercapneic patients with stable COPD. Chest. 2002; 122(1):75-83.

Government Agency, Medical Society, and Other Authoritative Publications:

1. 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. July 2011. Available at:  www.effectivehealthcare.ahrq.gov/reports/final.cfm.  Accessed on October 12, 2011.
2. Bradley WG, et al. Current management of ALS: Comparison of the ALS Care Database and the AAN Practice Parameter.  The American Academy of Neurology. Neurology. 2001; 57(3):500-504.
3. Centers for Medicare and Medicaid Services. National Coverage Determination for Durable Medical Equipment Reference List.  NCD #280.1.  Effective May 5, 2005.  Available at:   http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=190&ncdver=2&DocID=280.1&bc=gAAAAAgAAAAA&. Accessed on October 11, 2011.
4. Centers for Medicare and Medicaid Services. National Coverage Determination: Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea. NCD #240.4. Effective March 13, 2008. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=226&ncdver=3&DocID=240.4&bc=gAAAAAgAAAAA&.  Accessed on October 11, 2011.
5. Centers for Medicare and Medicaid Services (CMS). Federal Register. Vol. 71, No. 18. Final Rule: 42 CFR Part 414. Payment for Respiratory Assist Devices with Bilevel Capability and a Backup Rate. January 27, 2006.  Available at:  http://www.cms.gov/DMEPOSFeeSched/Downloads/CMS1167F.pdf.  Accessed on October 11, 2011.
6. Epstein LJ, Kristo D, Strollo PJ, et al. 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.  Available at: http://www.aasmnet.org/Resources/ClinicalGuidelines/OSA_Adults.pdf.  Accessed on October 11, 2011.
7. Gay P, Weaver T, Loube D, Iber C.  American Academy of Sleep Medicine (AASM).  Positive Airway Pressure Task Force Standards of Practice Committee. Evaluation of positive airway pressure treatment for sleep-related breathing disorders in adults.  Sleep. 2006; 29(3):381-401.  Available at:  http://www.aasmnet.org/Resources/PracticeParameters/Review_PositiveAirwayPressure.pdf.  Accessed on October 11, 2011.
8. Kushida CA, Chediak A, Berry RB, et al. Positive Airway Pressure Titration Task Force of the American Academy of Sleep Medicine. Clinical guidelines for the manual titration of positive airway pressure in patients with obstructive sleep apnea. J Clin Sleep Med. 2008; 4(2):157-171. Available at: http://www.aasmnet.org/Resources/ClinicalGuidelines/040210.pdf.  Accessed on October 11, 2011.
9. Kushida CA, Littner MR, Hirshkowitz M, et al; American Academy of Sleep Medicine. 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.  Available at:  http://www.aasmnet.org/Resources/PracticeParameters/PP_PositiveAirwayPressure.pdf.  Accessed on October 11, 2011.
10. Littner M, Hirshkowitz M, Davila D, et al; Standards of Practice Committee of the American Academy of Sleep Medicine. 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.  Sleep. 2002; 25(2):143-147.
11. Morgenthaler TI, Aurora RN, Brown T, et al. Standards of Practice Committee of the AASM; American Academy of Sleep Medicine. 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):141-147.  Available at: http://www.aasmnet.org/Resources/PracticeParameters/PP_Autotitrating_Update.pdf.  Accessed on October 11, 2011.
12. Morgenthaler TI, Kapen S, Lee-Chiong T, et al; Standards of Practice Committee of the American Academy of Sleep Medicine Practice parameters for the medical therapy of obstructive sleep apnea.  Sleep. 2006; 29(8):1031-1035.  Available at:  http://www.aasmnet.org/Resources/PracticeParameters/PP_MedicalTherapyOSA.pdf.  Accessed on October 11, 2011.
13. National Association for Medical Direction of Respiratory Care.  Consensus Conference.  Clinical Indications for Noninvasive Positive Pressure Ventilation in Chronic Respiratory Failure due to Restrictive Lung Disease, COPD, and Nocturnal Hypoventilation: A Consensus Conference Report.  Chest.  116(2): August 1999.
14. National Heart, Lung and Blood Institute of the United States; National Institutes of Health and the World Health Organization.  New International Guidelines for Chronic Obstructive Pulmonary Disease. Executive Summary.  Available at: http://www.goldcopd.com  Accessed on October 11, 2011.
15. National Institutes of Health (NIH).  National Heart, Lung, and Blood Institute (NHLBI).  Sleep Apnea.  Available at:   http://www.nhlbi.nih.gov/health/dci/Diseases/SleepApnea/SleepApnea_WhatIs.html.  Accessed on October 11, 2011.
16. U.S. Food and Drug Administration (FDA).  VPAP ADAPT 510(k) Summary of Safety and Effectiveness.  No. K051364. Rockville, MD: FDA. August 16, 2005.  Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K051364.pdf. Accessed on October 11, 2011.

BiPAP Machines, Non-Invasive Positive Pressure
Non-Invasive Respiratory Assist Devices, Positive Pressure (BiPAP)
Respiratory Assist Devices, Non-Invasive Positive Pressure
VPAP^™

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.