Latest Review Date: November 2022

Category:  Durable Medical Equipment        

POLICY:

Non-invasive Positive Pressure Ventilation Devices may be considered medically necessary for the following disorders when coverage criteria is met:

For Restrictive Thoracic Disorders / Neuromuscular Abnormalities when ALL 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).

For Severe Chronic Obstructive Pulmonary Disease (COPD) when ALL the following are met:

• An arterial blood gas PaCO₂, done while awake and breathing the individual's usual FiO₂, is ≥ 52 mm Hg; OR
• Sleep oximetry demonstrates oxygen saturation ≤ 88% for at least 5 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.

For Hypoventilation Syndrome when ALL the following criteria are met:

• An initial arterial blood gas PaCO₂, done while awake and breathing the patient’s prescribed FiO₂, is ≥ 45 mm Hg; AND
• Spirometry shows an FEV1/FVC ≥ 70% and an FEV1 ≥ 50% of predicted; OR
• An arterial blood gas PaCO₂, done during sleep or immediately upon awakening, and breathing the patient’s prescribed FiO₂, shows a PaCO₂ worsened ≥ 7 mm HG compared to the original result in criterion 1 (above); OR
• An approved facility-based PSG demonstrates oxygen saturation ≤ 88% for ≥ 5 minutes of nocturnal recording time (minimum recording time of 2 hours unless an emergency protocol was activated) that is not caused by obstructive upper airway events – i.e., AHI < 5.

For Non-invasive Positive Pressure Ventilation with back-up when ALL the criteria are met:

• A covered E0470 device is being used; AND
• Spirometry shows an FEV1/FVC ≥ 70% and an FEV1 ≥ 50% of predicted; AND
• An arterial blood gas PaCO₂ done while awake, and breathing the patient's prescribed FiO₂, shows that the beneficiary's PaCO₂ worsens ≥ mm HG compared to the ABG result performed to qualify the patient for the E0470 device; OR
• A facility-based PSG demonstrates oxygen saturation ≤ 88% for ≥ 5 minutes of nocturnal recording time (minimum recording time of 2 hours unless an emergency protocol was activated) that is not caused by obstructive upper airway events – i.e., AHI < 5 while using an E0470 device.

For Central Sleep Apnea (CSA), (i.e., apnea not due to airway obstruction) when, prior to initiating therapy, a complete, (full or split night) approved facility based, attended polysomnography has been performed, and the test results have revealed ALL the following:

• The diagnosis of central sleep apnea (CSA) has been confirmed, defined as an AHI > 5, central apneas/hypopneas consist of 50% or more of the total apneas/hypopneas; 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
• Significant clinical improvement of the patient's sleep-associated hypoventilation has been demonstrated with the use of a Bi-level positive pressure device, adjusted to the settings that will be prescribed for initial home use, while breathing the individual's usual FiO₂.

A non-invasive positive pressure ventilation device with back-up is standard treatment for this diagnosis.

Non-invasive positive pressure respiratory assist devices (BiPAP) which includes a back-up rate may be considered medically necessary for any one of the above disorders when coverage criteria is met AND BiPAP has failed as evidenced by continued hypoxemia or CO₂ retention.

Adaptive –Servoventilation bi-level devices may be considered medically necessary when the following criteria are met:

• The diagnosis of central sleep apnea (CSA) or Complex Sleep Apnea (CompSA) has been confirmed; AND
• Coverage criteria for BIPAP has been met as defined above;  AND
• Patient has failed a BiPAP trial.

Phrenic Nerve Stimulation for central sleep apnea (e.g. Remede) is addressed in MP#730 Phrenic Nerve Stimulation for Central Sleep Apnea.

Compliance Documentation

Compliance documentation should be maintained in the supplier's record.  This documentation should include that the physician certifies the patient is compliant with the treatment and the sleep disorder has improved based on the treatment OR a recorded compliance document indicating proper utilization.  (≥ 4 hours per night on 70% of the nights during a 30 consecutive day period during the initial 90 days of usage.) (Compliance documentation that extended beyond the 90 days will be reviewed on an individual basis (i.e. Accidents, change in physical status, surgery, etc.)

Replacement Devices

Previously covered devices may be considered medically necessary to be replaced when the following criteria are met:

(Repeat sleep study is not required)

• The equipment has suffered irreparable damage (repair cost exceeds purchase price) and has been in the home for 3 years or longer; OR
• The patient's condition has changed and a different piece of equipment is determined to be medically necessary.

Replacement devices are not covered for replacing functioning equipment with a newer more advanced model. 

(Compliance documentation is not required on replacement equipment).

Replacement devices should be filed with modifier “RA” to indicate they are not the initial device but a replacement piece of equipment.

If the patient-owned DME is being repaired, up to one month rental for that piece of durable medical equipment may be considered medically necessary.

Payment is based on the type of replacement device that is provided, but will not exceed the rental allowance for the equipment that is being repaired.

*Obstructive Sleep Apnea treatment is addressed in medical policy #065 Medical Management of Obstructive Sleep Apnea Syndrome.

DESCRIPTION OF PROCEDURE OR SERVICE:

Bi-level respiratory assist device (BIPAP)

A bi-level respiratory assist device delivers alternating levels of positive airway pressure instead of the continuous pressure applied by CPAP. These machines function as a non-invasive ventilator.  There are 2 set pressures, a higher pressure for inhalation and a lower pressure for exhalation, but some require a back-up timed response in which a breath will be initiated if a breath is not taken within the set timed parameters. This feature may be useful in treating central sleep apnea and a number of pulmonary disorders.

The device cycles between a pre-determined inspiratory positive airway pressure (IPAP) phase—the pressure maintained during each inhalation—and a preset expiratory positive airway pressure (EPAP) phase.  Each inspiration can be initiated by the patient or by the machine itself if it's programmed with a backup rate.  The backup rate ensures that the patient will receive a set number of breaths per minute if he should become apneic.  By helping to open up a patient's airways and alveoli, noninvasive positive pressure ventilation can enhance the patient's tidal volume—the amount of air passing in and out of the lungs per respiratory cycle.  The expected improvement in tidal volume can be measured by looking at the difference between IPAP and EPAP.

These devices are in the FDA category of non-continuous ventilator, and as such, are primarily intended to augment patient ventilation.  Bi-level positive airway pressure with back-up rate is not appropriate for obstructive sleep apnea but is appropriate for patients with neuromuscular respiratory insufficiency or restrictive lung disease from thoracic wall deformity and for some patients with central sleep apnea.

Adaptive servo-ventilation (ASV)

Adaptive servo-ventilation (ASV), a bi-level PAP system with a backup rate feature, uses an automatic, minute ventilation-targeted device (VPAP Adapt, ResMed, Poway, CA) that performs breath-to-breath analysis and adjusts its settings accordingly.  Depending on breathing effort, the device will automatically adjust the amount of airflow it delivers in order to maintain a steady minute ventilation.  Most studies on the use of ASV have investigated its use for heart failure patients with central apnea or Cheyne-Stokes respiration.

Central Sleep Apnea

Central sleep apnea is a disorder in which your breathing repeatedly stops and starts during sleep. Central sleep apnea occurs because your brain doesn't send proper signals to the muscles that control your breathing. This condition is different from obstructive sleep apnea, in which you can't breathe normally because of upper airway obstruction. Central sleep apnea is less common than obstructive sleep apnea. Central sleep apnea may occur as a result of other conditions, such as heart failure and stroke. Treatments for central sleep apnea may involve treating existing conditions, using a device to assist breathing or using supplemental oxygen. Central sleep apnea (CSA) is common in heart failure (HF) patients. Traditional treatment of CSA includes continuous positive airway pressure (CPAP), adaptive servo ventilation (ASV), oxygen therapy, and CO2 inhalation. 

Central apnea-hypopnea index (CAHI) - For diagnosis of CSA, the central apnea-central hypopnea index (CAHI) is defined as the average number of episodes of central apnea and central hypopnea per hour of sleep without the use of a positive airway pressure device. For CompSA, the CAHI is determined during the use of a positive airway pressure device after obstructive events have disappeared.  If the CAHI is calculated based on less than 2 hours of continuous recorded sleep, the total number of recorded events used to calculate the CAHI must be at least the number of events that would have been required in a 2-hour period (i.e., greater than or equal to 10 events).

Table 1. Definitions

See Medical Policy #065: Medical Management of Obstructive Sleep Apnea Syndrome, for medical criteria coverage of CPAP devices.

Phrenic Nerve Stimulation for central sleep apnea (e.g. Remede) is addressed in MP#730 Phrenic Nerve Stimulation for Central Sleep Apnea.

KEY POINTS:

Literature review completed through November 2022.

Summary of Evidence:

Patients with neuromuscular dysfunction, chest wall abnormalities, COPD, diaphragmatic dysfunction, and/or disorders of ventilatory control are susceptible to significant deterioration in oxygenation and ventilation during sleep.  Nocturnal hypoventilation may be associated with cor pulmonale, nocturnal arrhythmias, morning headaches, impaired cognitive function, and reduced daytime vigilance.  In addition to adversely impacting on the patient's health, significant deterioration in productivity and quality of life may follow. Nocturnal noninvasive ventilatory assistance has been used to treat a number of disorders in an effort to improve the quality and duration of life in these patients.

A wide variety of restrictive thoracic diseases have been successfully treated with NPPV, including thoracic cage abnormalities (e.g., chest wall deformities, kyphoscoliosis, thoracoplasty, etc.) in addition to both rapidly and slowly progressive neuromuscular disorders (e.g., amyotrophic lateral sclerosis (ALS), neuropathies, myopathies, dystrophies, sequelae of polio, spinal cord injury, etc.).  These conditions result in derangement of hypoventilation, and oxygen therapy alone is not only usually ineffective in relieving symptoms, but may also be dangerous and lead to a marked acceleration of carbon dioxide (CO2) retention. NPPV is generally not indicated for patients who cannot cooperate with NPPV treatment or who need a protected airway to handle excessive secretions.  (Patients who have impaired ability to protect the upper airway or excessive secretions are usually better managed with tracheostomy.)   The availability of a full face mask, however, has made it possible to use NPPV even in patients with significant bulbar weakness.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Practice Guidelines and Position Statements:

American Thoracic Society

Long-Term Noninvasive Ventilation in Chronic Stable Hypercapnic Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Clinical Practice Guideline (2020)

Recommendations:

1) We suggest the use of nocturnal NIV in addition to usual care for patients with chronic stable hypercapnic COPD (conditional recommendation, moderate certainty);

2) We suggest that patients with chronic stable hypercapnic COPD undergo screening for obstructive sleep apnea before initiation of long-term NIV (conditional recommendation, very low certainty);

3) We suggest not initiating long-term NIV during an admission for acute-on-chronic hypercapnic respiratory failure, favoring instead reassessment for NIV at 2–4 weeks after resolution (conditional recommendation, low certainty);

4) We suggest not using an in-laboratory overnight polysomnogram to titrate NIV in patients with chronic stable hypercapnic COPD who are initiating NIV (conditional recommendation, very low certainty); and

5) We suggest NIV with targeted normalization of PaCO2 in patients with hypercapnic COPD on long-term NIV (conditional recommendation, low certainty).

National Institute for Health and Care Excellence Global

In 2019, the United Kingdom's National Institute for Health and Care Excellence (NICE) published a guideline for the diagnosis and management of COPD. NICE recommends that patients with COPD who have chronic hypercapnic respiratory failure despite adequate pharmacologic and oxygen therapy should be referred to a specialist center for consideration of long-term, non-invasive ventilation.

KEY WORDS:

BiPap® ST, Synchrony ® S/T, respiratory assist devices with backup rate feature, noninvasive positive pressure respiratory assistance (NPPRA) , BiPap®,  Adaptive –Servo ventilation bi-level devices, BiPap AUTO SV, VPAP, Variable PAP, VPAP ST, VPAP adapt SV, CSA, Central Sleep Apnea, ASV

APPROVED BY GOVERNING BODIES:

There are numerous FDA approved devices.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

REFERENCES:

1. American Thoracic Society. New Clinical Practice Guidelines on Non-Invasive Ventilation in Chronic Stable Hypercapnic COPD Published by the American Thoracic Society. https://www.atsjournals.org/doi/full/10.1164/rccm.202006-2382ST .August 2020.
2. Amra B, Balouchianzadeh S, Soltaninejad F, et al. Heart rate variability changes by non-invasive ventilation in obesity hypoventilation syndrome. Clin Respir J. 2021;15(7):770-778.
3. Claman DM, Piper A, Sanders MH, et al. Nocturnal non-invasive positive pressure ventilatory assistance-review article. Chest 1996.
4. Collaborative Research Group of Noninvasive Mechanical Ventilation for Chronic Obstructive Pulmonary Disease. Early use of non-invasive positive pressure ventilation for acute exacerbations of chronic obstructive pulmonary disease: A multicentre randomized controlled trial. Chin Med J (Engl). 2005;118(24):2034-2040.
5. Curtis JR, Cook DJ, Sinuff T, et al; Society of Critical Care Medicine Palliative Noninvasive Positive Ventilation Task Force. Noninvasive positive pressure ventilation in critical and palliative care settings: Understanding the goals of therapy. Crit Care Med. 2007;35(3):932-939.
6. Evensen AE. Management of COPD exacerbations. Am Fam Physician. 2010;81(5):607-613.
7. Gomes Neto M, Duarte LFG, Rodrigues ES Jr, et al. Effects of noninvasive ventilation with bilevel positive airway pressure on exercise tolerance and dyspnea in heart failure patients. Hellenic J Cardiol. 2018;59(6):317-320.
8. Guilleminault C, Phillip P, Robinson A. Sleep and neuromuscular disease: bilevel positive airway pressure by nasal mask as a treatment for sleep disordered breathing in patients with neuromuscular disease. J Neurol Neurosurg Psychiatry. 1998; 65:225-232.
9. Hastings PC, Vazir A, Meadows GE, et al. Adaptive servo-ventilation in heart failure patients with sleep apnea: A real world study. Int J Cardiol. 2010;139(1):17-24.
10. Hillberg RE, Johnson DC. Current concepts: Noninvasive ventilation. N Engl J Med. 1997;337(24):1746-1752.
11. Jiang H, Han Y, Xu C, et al. Noninvasive positive pressure ventilation in chronic heart failure. Can Respir J. 2016;2016:3915237.
12. Loube DI, Gay PC, Strohl KP, et al. ACCP consensus statement: indications for positive airway pressure treatment of adult sleep apnea patients. Chest. 1999; 115:863-866.
13. Momomura S, Seino Y, Kihara Y, et al. Adaptive servo-ventilation therapy using an innovative ventilator for patients with chronic heart failure: A real-world, multicenter, retrospective, observational study (SAVIOR-R). Heart Vessels. 2015;30(6):805-817.
14. Morgenthaler TI, Gay PC, Gordon N, Brown LK. Adaptive servoventilation versus noninvasive positive pressure ventilation for central, mixed, and complex sleep apnea syndromes. Sleep. 2007 Apr;30(4):468-75.
15. Morrell MJ, Meadows GE, Hastings P, et al. The effects of adaptive servo ventilation on cerebral vascular reactivity in patients with congestive heart failure and sleep-disordered breathing. Sleep. 2007; 30(5):648-653.
16. National Association for Medical Direction of Respiratory Care. (NAMDRC).  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.  1999; 116(2): 521-534.
17. National Institute for Health and Care Excellence (NICE). Chronic obstructive pulmonary disease in over 16s: diagnosis and management [NG115]. 2019 https://www.nice.org.uk/guidance/ng115 Accessed November 29, 2021.
18. Quon BS, Gan WQ, Sin DD. Contemporary management of acute exacerbations of COPD: A systematic review and metaanalysis. Chest. 2008;133(3):756-766.
19. Ram FSF, Picot J, Lightowler J, Wedzicha JA. Non-invasive positive pressure ventilation for treatment of respiratory failure due to exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2004;(3):CD004014.
20. Tsai CL, Lee WY, Delclos GL, et al. Comparative effectiveness of noninvasive ventilation vs invasive mechanical ventilation in chronic obstructive pulmonary disease patients with acute respiratory failure. J Hosp Med. 2013;8(4):165-172.
21. U.S. Department of Health and Human Services, Center for Medicare and Medicaid Services. Durable medical equipment reference list. Medicare Coverage Issues Manual §60.9. Baltimore, MD: CMS, 2002.
22. Vasquez MM, McClure LA, Sherrill DL, et al. Positive Airway Pressure Therapies and Hospitalization in Chronic Obstructive Pulmonary Disease. Am J Med. Jul 2017; 130(7): 809-818.
23. Wilson ME, Dobler CC, Morrow AS, et al. Association of home noninvasive positive pressure ventilation with clinical outcomes in chronic obstructive pulmonary disease: A systematic review and meta-analysis. JAMA. 2020;323(5):455-465.

POLICY HISTORY:

Medical Policy Group, June 1998

Medical Policy Group, May 2001

Medical Policy Group, August 2004 (2)

Medical Policy Administration Committee, September 2004

Available for comment November 2-December 16, 2004

Medical Policy Group, February 2006 (1)

Medical Policy Group, April 2007 (2)

Medical Policy Administration Committee, April 2007

Available for comment April 20-June 4, 2007

Medical Policy Group, October 2008 (1)

Medical Policy Group, March 2010 (3)

Medical Policy Administration Committee, April 2010

Available for comment March 24-May 7, 2010

Medical Policy Group, June 2010 (3)

Medical Policy Administration Committee, July 2010

Medical Policy Group, July 2010 (3)

Medical Policy Administration Committee, August 2010

Available for comment August 6-September 18, 2010

Medical Policy Group, July 2013 (3): 2013 Update – no updated literature to add; no change in policy statement

Medical Policy Group, July 2013: Effective July 31, 2013, this policy will remain active but will no longer be scheduled for regular literature updates and reviews.

Medical Policy Group, October 2013 (3):  Corrected error in policy statement – no change in content of coverage

Medical Policy Group, April 2014 (5):  Updated Maximums for tubing.

Medical Policy Administration May 2014

Available for comment May 6 through June 19, 2014

Medical Policy Group, April 2016 (6):  Removed policy statement regarding non-invasive pressure ventilation for obstructive sleep apnea and moved to policy #065 Diagnosis and Medical Management of Obstructive Sleep Apnea Syndrome and removed table with supply maximums. Policy name changed for clarification to Non-invasive Positive Pressure Ventilation for Conditions Other Than Obstructive Sleep Apnea; no changes to policy intent.

Medical Policy Group, June 2017 (6): Removed old policy statement from 2014. No change to policy statement.

Medical Policy Group, November 2018 (6): Updates to Description, policy statement, Key Words (Remede, ASV, CSA, Central Sleep Apnea, Phrenic nerve stimulation), Practice Guidelines, Coding (0424T- 0436T,94660) and References.

Medical Policy Group, June 2019 (6): All information regarding phrenic nerve stimulation moved to MP 203 Phrenic Nerve Stimulation for Central Sleep Apnea.

Medical Policy Group, December 2020 (6): Updates to Description, Key Points, Current Coding (A7027/A7028/A7029/A7044/A7045/A7046) removed CPT 94660, Practice Guidelines and References.

Medical Policy Group, January 2022 (6):Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy. Updates to Policy statement, Key Points, Practice Guidelines and References.

Medical Policy Group, November 2022 (6): Updates to Key Points and Practice Guidelines.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.