Non-invasive positive pressure respiratory assist devices, also known as Bi-level respiratory assist devices (BiPAP^®), are non-invasive devices that utilize a full-face mask or nasal mask to deliver alternating levels of positive airway pressure, instead of the continuous pressure applied by continuous positive airway pressure (CPAP) machines. BiPAP devices are in the FDA category of non-continuous ventilator and are intended to augment spontaneous patient respirations, as part of the treatment plan for certain pulmonary conditions.

This guideline addresses the medical necessity criteria for the intermittent home use of non-invasive positive pressure respiratory assist devices (BiPAP^®). This guideline does not address the use of these devices, as part of the treatment of the acutely ill, hospitalized patient.

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

• MED.00054 Treatment for Obstructive Sleep Apnea in Adults;
• MED.00002 Diagnosis of Sleep Disorders;
• SURG.00074 Nasal Surgery for the Treatment of Obstructive Sleep Apnea (OSA) (including Radiofrequency Ablation of Nasal Turbinates for Nasal Obstruction with or without OSA);
• Clinical UM Guideline CG-MED-01 Polysomnography Studies in Adults and Children;
• Clinical UM Guideline CG-DME-32 Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea in Adults and Children, and Related Devices for the Treatment of Obstructive Sleep Apnea in Adults

Medically Necessary:

Non-invasive positive pressure respiratory assist devices (BiPAP) are considered medically necessary for any one of the following disorders, (subject to specific criteria for each respective condition – see further information below):

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

For Restrictive Thoracic Disorders

Medically Necessary:

The use of a non-invasive positive pressure respiratory assist device (BiPAP) 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 ≥45 mm Hg, done while awake and breathing the patient's usual FIO₂ (fractionated inspired oxygen concentration); or
  • Sleep oximetry demonstrates an oxygen saturation ≤88% for at least five continuous minutes, done while breathing the patient's usual FIO₂; or
  • Maximal inspiratory pressure is < 60 cm H2O or forced vital capacity is < 50% of predicted (for patients with a progressive neuromuscular disease only). 

Note: When the above medical necessity criteria for patients with the indication of a restrictive thoracic disorder are met, a non-invasive positive pressure bi-level respiratory assist device, either with or without the back-up rate feature, will be considered medically necessary.

Not Medically Necessary:

The use of a non-invasive positive pressure respiratory assist device (Bi-level either 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.

For Severe Chronic Obstructive Pulmonary Disease (COPD) 

Medically Necessary: 

The use of non-invasive positive pressure respiratory assist devices (BiPAP) for the treatment of severe COPD is considered medically necessary when ALL of the following are met:

• An arterial blood gas PaCO₂, done while awake and breathing the individual's usual FIO₂, is ≥52 mm Hg; and
• Sleep oximetry demonstrates oxygen saturation ≤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, obstructive sleep apnea and treatment with CPAP has been considered and ruled out.

Note: When the above medical necessity criteria for patients with the indication of severe COPD are met, a non-invasive positive pressure Bi-level respiratory assist device, without back-up rate feature, will be considered medically necessary.

Not Medically Necessary: 

The use of a non-invasive positive pressure respiratory assist device (Bi-level 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 non-invasive positive pressure respiratory assist device (Bi-level 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 patient accommodation to the use of a Bi-level without back-up feature will produce the desired therapeutic effect).

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

Medically Necessary: 

The use of a non-invasive positive pressure respiratory assist device (BiPAP) for the treatment of central sleep apnea 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 central sleep apnea (CSA) has been confirmed; and
• The presence of obstructive sleep apnea (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 ≤88% for at least five continuous minutes, done while breathing the patient's usual FIO₂; and
• Significant clinical improvement of the patient's sleep-associated hypoventilation has been demonstrated with the use of a Bi-level positive pressure 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 FIO₂.

Note: When the above medical necessity criteria for patients with the indication of CSA are met, a non-invasive positive pressure bi-level device, either with or without the back-up rate feature, will be considered medically necessary.

Not Medically Necessary: 

The use of a non-invasive positive pressure respiratory assist device (Bi-level with/without the back-up rate feature) for the treatment of CSA is considered not medically necessary if ALL the above criteria are not met.

For Obstructive Sleep Apnea (OSA) 

Medically Necessary: 

The use of a non-invasive Bi-level positive pressure respiratory assist device (BiPAP) for the treatment of OSA is considered medically necessary when ALL of the following criteria are met:

• Prior to initiating therapy, a complete, facility-based, attended polysomnography has been performed and the test results have confirmed the diagnosis of OSA; and
• CPAP has been tried and proven ineffective; and
• The medical necessity criteria for the use of Bi-level non-invasive positive pressure respiratory assist devices (BiPAP) for the treatment of OSA, contained within CG-DME-32 have been met.  (Please refer to Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea in Adults and Children, and Related Devices for the Treatment of Obstructive Sleep Apnea in Adults.) 

Note: When the above medical necessity criteria for patients with the indication of OSA are met, a non-invasive positive pressure bi-level device, without back-up rate feature, will be considered medically necessary. 

Not Medically Necessary: 

The use of a non-invasive positive pressure respiratory assist device (Bi-level 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 non-invasive positive pressure respiratory assist device (Bi-level with the back-up rate feature) is considered not medically necessary for the treatment of OSA.

For COPD Patients Requiring Use of the Bi-level device with the back-up rate feature

Medically Necessary: 

The subsequent use of a Bi-level device with the back-up rate feature, for the treatment of severe COPD for patients who have already met the medical necessity criteria and have used a Bi-level 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 ≥52 mm Hg, (repeated not sooner than 61 days post-initiation of initial device use) and done while awake and breathing the patient's usual FIO₂; and
• A sleep oximetry demonstrating oxygen saturation levels of ≤88% for at least five continuous minutes and tested while using the Bi-level 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 patient compliance with the initial device (Bi-level without back-up rate feature) and the lack of desired therapeutic effect from use of this device.

Not Medically Necessary: 

Subsequent use of a Bi-level 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.

Duration:  Initial approval for use of these devices is generally for three (3) months.

Extended Use:  For extended use of these devices, (both for Bi-level with/without the back-up rate feature), beyond the first three months of initial therapy, clinical re-evaluation is generally necessary, to establish medical necessity with documentation about the therapeutic effects of therapy, as well as information about patient compliance/tolerance of the therapy.  Generally, consistent patient home use of these devices for an average of four (4) hours per every 24-hour period would represent patient compliance with the therapy plan, subject to individual case consideration.

Diagnostic Testing: 

• Arterial blood gas testing;
• Pulse oximetry/nocturnal oximetry;
• Spirometry;
• Maximum inspiratory pressure testing;
• Polysomnography.

Please refer to the following documents for information related to the medical necessity criteria for polysomnography and additional types of diagnostic testing and treatment options for the diagnosis of obstructive sleep apnea (OSA):

• MED.00054 Treatment for Obstructive Sleep Apnea in Adults;
• MED.00002 Diagnosis of Sleep Disorders;
• SURG.00074 Nasal Surgery for the Treatment of Obstructive Sleep Apnea (OSA) (including Radiofrequency Ablation of Nasal Turbinates for Nasal Obstruction with or without OSA);
• Clinical UM Guideline CG-MED-01 Polysomnography Studies in Adults and Children;
• Clinical UM Guideline CG-DME-32 Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea in Adults and Children, and Related Devices for the Treatment of Obstructive Sleep Apnea in Adults                                                            

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 Medicare for the intermittent home use of non-invasive positive pressure respiratory assist devices.  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 non-invasive devices may allow patients 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 bilevel positive pressure airway devices, an example of which is VPAP^™ (Variable Positive Airway Pressure), which are basically BiPAP devices that deliver differing levels of inspiratory and expiratory pressure, in order to maintain airway patency during sleep.  There are multiple VPAP machines currently available that have FDA approval 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 (BiPAP^®):  these devices deliver two levels of positive airway pressure, both of which reach the patient 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 patient will receive a set minimum number of breaths per minute, if he 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 sleep apnea 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; COPD 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; the obstruction is generally permanent and progresses (becomes worse) over time

Obstructive sleep apnea (OSA):  this syndrome refers to 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:  this refers to a variety of neuromuscular and anatomical anomalies of the chest/rib cage area that may result in hypoventilation, particularly while the patient sleeps at night; nocturnal hypoventilation is associated with a host of health hazards and can also significantly impact the quality of life for these patients; 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 patients who are able to tolerate the therapy 

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 ventilation in chronic obstructive pulmonary disease.  Clinics in Chest Med. 2000; 21(4).
5. Hill NS. Noninvasive mechanical ventilation for past acute care.  Clinics in Chest Med. 2001; 22(1).
6. Hunter MH, King DE. COPD: Management of Acute Exacerbations and Chronic Stable Disease.  Am Fam Phy. 2001; 64(4).
7. Massie C, McArdle N, Hart R, et al.  Comparison between automatic and fixed positive airway pressure therapy in the home.  Am Respir Crit Care Med.  2003; 167:20-23.
8. 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.
9. Padman R, et al. Noninvasive ventilation via bilevel positive airway pressure in pediatric practice.  Crit Care Med. January 1998; 126(1):169-173.
10. 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.
11. Strollo PJ, et al. Positive Pressure Therapy. Clinics in Chest Med. March 1998; 19(1):55-68.
12. Vanpee D, et al. Effects of nasal pressure support on ventilation and inspiratory work in normocapneic and hypercapneic patients with stable COPD. Chest. 2002; 122(1).

Government Agency, Medical Society, and Other Authoritative Publications:

1. Bradley WG, et al. Current management of ALS: Comparison of the ALS Care Database and the AAN Practice Parameter.  The American Academy of Neurology. Neurol. August 2001; 57(3):500-504.
2. 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.hhs.gov/mcd/viewncd.asp?ncd_id=280.1&ncd_version=2&basket=ncd%3A280%2E1%3A2%3ADurable+Medical+Equipment+Reference+List.  Accessed on July 4, 2008.
3. Centers for Medicare and Medicaid Services. National Coverage Determination: Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea. NCD #240.4. Effective April 4, 2005. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on July 4, 2008.
4. Centers for Medicare and Medicaid Services. Medicare National Coverage Determination Manual (CMS). Publication #100-3.  Chapter 1, §280.1; L11482 Respiratory Assist Devices; updated: January 1, 2005.
5. Centers for Medicare and Medicaid Services (CMS).  Decision Memorandum. Noninvasive Positive Pressure RADs for COPD. #CAG-00052N. Effective date: May 14, 2001.
6. Centers for Medicare and Medicaid Services (CMS). Proposed Decision Memo for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (CAG-00093R).  Sept. 28, 2004.
7. 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.
8. 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.
9. Institute for Clinical Systems Improvement (ICSI).  Health Care Guideline: Diagnosis and Treatment of Obstructive Sleep Apnea.  Bloomington, MN: ISCI; Sixth Edition, June 2008.  Available at: http://www.icsi.org/guidelines_and_more/guidelines__order_sets___protocols/respiratory/sleep_apnea/sleep_apnea__diagnosis_and_treatment_of_obstructive_3.html.  Accessed on July 6, 2008.
10. 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.  American Academy of Sleep Medicine Report. Sleep. 2006; 29(3):375-380.
11. 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.  Sleep. 2002; 25(2):143-147.
12. Merck Manual of Diagnosis and Therapy. 17^th Ed. Merck Research Laboratories. Division of Merck & Co., Inc. Whitehouse Station, NJ. 1999:1687.
13. Morgenthaler TI, Kapen S, Lee-Chiong T, et al. Practice parameters for the medical therapy of obstructive sleep apnea.  Standards of Practice Committee of the American Academy of Sleep Medicine. Sleep. 2006; 29(8):1031-1035.
14. 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.
15. 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 July 8, 2007.
16. National Institutes of Health (NIH).  National Heart, Lung, and Blood Institute (NHLBI).  Sleep Apnea.  Available at:  http://www.nhlbi.nih.gov.  Accessed on July 4, 2008.
17. 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.fda.gov/cdrh/pdf5/K051364.pdf.  Accessed on July 4, 2008.

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.