Oscillatory devices have been utilized as an alternative to conventional chest physical therapy to promote the clearance of respiratory secretions in patients with impaired ability to cough or otherwise expel them on their own. This policy addresses two types of oscillatory devices: 1) High Frequency Chest Compression systems, (such as the Vest™ Airway Clearance System and the Medpulse® Respiratory Vest System), and 2) Intrapulmonary Percussive Ventilation (IPV®) devices  (such as the Percussionator® device).

A.  High Frequency Chest Compression Devices

Medically Necessary:

FDA-approved high frequency chest compression (HFCC) devices, including, but not limited to, the Vest™ Airway Clearance System (also known as the ABI Vest®, ThAIRapy Vest®, or the ThAIRapy Bronchial Drainage System®) and the Medpulse® Respiratory Vest System are considered medically necessary only when ALL of the following are met:

1. The patient must have documented need of airway clearance; AND
2. The patient must have any one of the following diagnoses:
   • Cystic fibrosis (CF), or
   • Chronic bronchiectasis, or
   • Chronic neuromuscular disorder and prior history of pneumonia or other significant worsening of pulmonary function;
     AND
3. Documentation of failure of other methods, or inability to use other airway clearance therapies including chest physical therapy, (i.e., two or more children with cystic fibrosis in the family; inability of the caregiver [physical or mental] to perform chest physical therapy at the required frequency; or no available parental or partner resource to perform chest physical therapy; AND  
4. Age of at least 2 years; AND
5. Patient/family compliance with the device as evidenced by an initial trial period.

In order to achieve the desired therapeutic effect with HFCC devices, patient compliance is essential.  This can be monitored by:

• A report at 1-2 month intervals regarding comfort, tolerance and willingness to use, or 
• A report at 6 months and one year via monthly usage meter checks documenting use at least 67% of the prescribed time. 

Intolerance to the device or failure to comply with usage meter checks is a basis for the use of alternative methods of airway clearance.

Not Medically Necessary:

HFCC devices , including, but not limited to, the Vest™ Airway Clearance System is considered not medically necessary when:

1. The above criteria have not been met; or
2. Contraindications exist for external manipulation of the thorax, as outlined by the American Association of Respiratory Care (AARC) and contained in their clinical practice guidelines for Postural Drainage Therapy, which include, but may not be limited to: unstable head or neck injury; active hemorrhage with hemodynamic instability; subcutaneous emphysema; recent epidural, spinal fusion or spinal anesthesia; recent skin grafts or flaps on the thorax; burns, open wounds, and skin infections of the thorax; recently placed transvenous pacemaker or subcutaneous pacemaker; suspected pulmonary tuberculosis; lung contusion; bronchospasm; osteomyelitis of the ribs; osteoporosis; coagulopathy; and complaint of significant chest wall pain.

Investigational/Not Medically Necessary:

All other indications for HFCC are considered investigational/not medically necessary, including, but not limited to, chronic obstructive pulmonary disease (COPD).

B.  Intrapulmonary Percussive Ventilation (IPV®) Devices 

Investigational/Not Medically Necessary:

Intrapulmonary percussive ventilation devices (IPV), also known as Percussionaire, are considered investigational/not medically necessary as an airway clearance treatment for respiratory disorders associated with retained secretions and/or atelectasis including, but not limited to: cystic fibrosis, bronchiectasis, chronic obstructive pulmonary disease and neuromuscular conditions associated with retained airway secretions or atelectasis. 

High Frequency Chest Compression with the Vest^TM Airway Clearance System (Hill-Rom, St. Paul, MN; previously manufactured by Advanced Respiratory, Inc., St. Paul, MN) or the Medpulse® Respiratory Vest System (Electromed, Inc., Minnetonka, MN)

Chest physiotherapy (CPT), using percussion and postural drainage (P/PD), is traditionally seen as the standard of care of secretion clearance methods for patients with excessive or retained lung secretions.  Currently, there are a variety of mucus clearance devices that have been investigated as alternatives to P/PD.  Studies related to these devices have not provided adequate data to permit scientific conclusions regarding the relative efficacy of alternative oscillatory therapies compared to CPT, the standard therapy for mucus clearance in patients with cystic fibrosis and other diseases.  However, because some patients may not have an option for CPT, this policy outlines criteria for medical necessity in the use of FDA-approved HFCC devices, such as the Vest™ Airway clearance system, as an alternative therapy for selected patients.

In the Nonpharmacologic Airway Clearance Therapies: ACCP Evidence-Based Clinical Practice Guidelines, the American College of Chest Physicians (ACCP) stated that the evidence supporting the use of oscillatory devices, (i.e., Flutter, intrapulmonary percussive ventilation and high-frequency chest wall oscillation), in the treatment of patients with CF, was low, and the reported benefits were conflicting. Their recommendation was inconclusive. For the treatment of neuromuscular disease, they rated the evidence as low with an intermediate benefit and gave these devices a weak recommendation (McCool, 2006).

Other applications of HFCC devices, including, but not limited to, their use as an adjunct to chest physical therapy or their use in diseases other than cystic fibrosis, chronic bronchiectasis, or chronic neuromuscular disorders, as specified in the policy, are considered investigational/not medically necessary, since the scientific evidence does not permit the conclusion that the technology improves the net health outcome.

Intrapulmonary Percussive Ventilation (IPV®) Devices, such as the Precussionator®, the TXP® Universal VENTILATOR Percussionator® (Percussionaire Corporation, Sandpoint, ID)

Intrapulmonary Percussive Ventilation (IPV) has been investigated as an alternative to standard chest physical therapy and postural drainage with or without manual vibration, with most studies having been in patients with a diagnosis of cystic fibrosis. However, there is limited published data by which to establish the effectiveness of IPV as a beneficial modality for airway clearance.  In the available studies, the numbers of patients have been small (4 to 24), the patient populations different, the treatment settings different (in-hospital versus out-patient), and IPV has been compared to different alternative airway clearance modalities, (e.g., flutter valve, and/or chest wall compression device, and/or standard chest PT and drainage).  Also, outcome measurements differed amongst the studies, variously including factors such as sputum volume, sputum viscosity, pulmonary function data or radiographic changes, depending on the study design and patient population. There is minimal data directly comparing the performance of a chest wall compression device with that of IPV.

The limited data that is available, however, suggests that IPV does not produce a superior outcome compared to standard chest PT and drainage, a chest wall compression device or use of a flutter valve device. Therefore, based on the lack of scientific data demonstrating its effectiveness and equivalence or superiority to established treatments, IPV is considered investigational/not medically necessary as an airway clearance modality.

High Frequency Chest Compression Devices

Disease conditions such as: cystic fibrosis (CF), chronic bronchitis, bronchiectasis, and immotile cilia syndrome can lead to abnormal airway clearance which is a source of increased sputum production, often purulent or tenacious.  The underlying pathology of the decline in mucociliary clearance varies with the given disease.  CPT is the standard treatment program that attempts to compensate for abnormal airway clearance. By improving the clearance of lung secretions, which may often be tenacious, complications of infection, atelectasis, and hyperinflation are reduced, and the decline in respiratory function is slowed in these types of diseases. Depending on the severity of the disease and any presence of infection, CPT sessions can be from 1-3 times per day for 20-30 minutes.  A physical therapist or another trained adult in the home, typically a parent if the patient is a child, may administer CPT. Necessity for regular therapy can be particularly burdensome for adolescents or adults who wish to lead independent lifestyles.  CPT is time consuming and requires the assistance of a skilled caregiver.

Different types of airway clearance techniques and devices have been developed in an attempt to address the problem of convenience and compliance with CPT. Airway clearance techniques or systems have been most often associated and studied with the treatment of CF. Of these techniques, daily percussion and postural drainage (P/PD) and HFCC devices, such as the Vest™ Airway Clearance System are passive techniques, not requiring the participation of the patient.  Although there have been a range of studies on these alternatives, there remains a lack of scientific evidence to support any secretion clearance technique over another.  Thus, the standard of care for airway clearance is CPT.

HFCC devices have shown improved lung function and sputum clearance in many CF patients with few adverse effects. However, the therapy has not been shown to be superior to conventional CPT in short-term studies, and its impact on long-term prognosis is unknown.  In addition, it is not clear from the clinical studies that patients would derive the most benefit from this therapy or at what time during the course of the disease HFCC should be initiated. Interpretations of the data derived from the clinical trials of HFCC for CF are complicated by issues in study design, small sample sizes, inadequate length of follow-up, patient heterogeneity, and lack of control for confounding variables such as concurrent treatment, disease severity, respiratory functions variability, and age.  Moreover, there remain questions of the validity and reliability of outcomes measures, such as sputum weight and respiratory function indexes for the determination of therapeutic efficacy.

The FDA approved the original Vest™ Airway clearance system in 1998.  Several earlier versions included the THAIRapy® Vest System and the ABI Vest® Airway Clearance System, among others (Advanced Respiratory, Inc.).  A similar device, the Medpulse® Respiratory Vest System (Electromed, Inc.) also obtained FDA approval through the 510(k) approval process (1999), and others have since been FDA approved also.

Intrapulmonary Percussive Ventilation (IPV)

Intrapulmonary Percussive Ventilation (IPV) is a pneumatic, oscillating pressure breathing device which is said to loosen mucus by internally percussing the airways using high frequency, high flow, low pressure bursts of gas delivered via a mouthpiece, mask or endotracheal tube. The patient uses a thumb control to trigger 15 to 25 high frequency pulses of gas during inspiration, and releases the control to allow for passive exhalation. Airway pressures oscillate between 5 and 35 cms H2O, and the walls of the airways vibrate synchronously with these oscillations. A Venturi type system (known as a “phasitron”) powered by compressed gas generates the oscillations at a rate of 100 to 300 cycles per minute. Pressures, inspiratory time and delivery rates are adjustable. Additionally, aerosolized bronchodilators and mucolytics can be delivered by entrainment through the phasitron device.

The clinical utility of the device is purportedly to loosen retained secretions by means of these airway oscillations, and it has been investigated in the treatment of patients suffering from secretion retention (particularly that associated with cystic fibrosis) as well as atelectasis.  The system can be used either in the hospital or home setting. The scientific data, currently available, are inadequate to permit conclusions regarding the relative efficacy of IPV devices.

Bronchiectasis: a disorder of major bronchi and bronchioles characterized by abnormal airway dilatation and destruction of walls with resulting inflammation, edema, ulceration, and distortion.  When large, unusual spaces are formed inside the airways of the lungs, mucus secretions can collect in these spaces and be difficult to clear.  This can often lead to more infections and further lung damage. Most commonly from infection or recurrent inflammation, bronchiectasis can also be acquired from a tumor, inhaling a foreign object, or a congenital condition.

Bronchitis: an inflammation of the upper airways, with cough and mucus; it can be caused by infections (infectious bronchitis) or inflammation  (smoker’s cough); chronic bronchitis means that over the last 2 or more years, a person has been coughing up some mucus every day, for at least 3 months out of the year.

Chest physiotherapy (CPT):  (also known as chest physical therapy): CPT traditionally has meant the use of postural drainage, percussion, and vibration (PDPV) for airway clearance; which may also be referred to as percussion and postural drainage (P/PD); CPT is considered the standard of care of secretion clearance methods; this technique is time consuming, requires a skilled care provider and may be associated with discomfort, gastroesophageal reflux, and hypoxemia; the purpose of CPT is to improve mucociliary clearance and pulmonary function in order to reduce the risk of infection and lung damage.

Cystic Fibrosis:  an autosomal recessive condition, the pulmonary manifestations of which include the production of excessive tenacious tracheobronchial mucus, leading to airway obstruction and secondary infection; this is the principal cause of morbidity and mortality of CF.

High-frequency chest compression (HFCC):  a treatment designed to help improve secretion clearance for patients suffering from excessive or retained lung secretions; currently, several conventional therapies, such as percussion on the thorax and postural drainage (P/PD), are used to produce this effect, particularly in cystic fibrosis (CF) patients; these patients have difficulty clearing lung secretions that lead to difficulty in breathing, infection, hypoxemia, and bronchiectasis.

High-frequency chest wall oscillation (HFCWO):  the mechanized technology employed by HFCC; HFCWO involves air pulses generated at various frequencies that are transmitted through a vest and compress the patient’s chest.

Intrapulmonary Percussive Ventilation (IPV):  a treatment designed to promote mobilization of retained endobronchial secretions and resolution of diffuse patchy atelectasis; IPV delivers a series of pressurized mini-bursts of inhaled air and continuous therapeutic aerosol through a nebulizer; IPV patients breathe through a mouthpiece, and then cough to clear the loosened secretions.

Vest™ Airway Clearance System:  (also known as the ABI Vest®, ThAIRapy Vest®, or the ThAIRapy Bronchial Drainage System® from Hill-Rom, Inc., previously manufactured by Advanced Respiratory, St. Paul, MN) consists of an air generator and an inflatable vest that covers the thorax and provides high frequency chest wall oscillation; large-bore tubing connects the vest to the air-pulse generator;  the air-pulse generator creates pressure pulses that cause the vest to inflate and deflate against the thorax, creating high-frequency chest wall oscillation and mobilization of pulmonary secretions; the device is designed for self-therapy and consists of a large volume variable frequency air pulse delivery system and a nonstretchable inflatable vest worn by the patient; pressure pulses are controlled by the patient and applied during expiration; this device has 510(k) approval status with the FDA.

The following codes for treatments and procedures applicable to this policy 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 for service to determine coverage or non-coverage of these services as it applies to an individual member. 

When services may be Medically Necessary when criteria are met:

HCPCS

ICD-9 Diagnosis

Services are Not Medically Necessary:

For the codes listed above, when criteria are not met

When services are Investigational/Not Medically Necessary:

For the codes listed above, for all other diagnoses not listed; or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.

When services are also Investigational/Not Medically Necessary:

HCPCS

ICD-9 Diagnosis

Peer Reviewed Publications:

1. Anbar RD, Powell KN, Iannuzzi DM. Short-term effect of ThAIRapy Vest® on pulmonary function of cystic fibrosis patients.  Am J Respir Crit Care Med 1998; 157(Suppl 3): A130.
2. Arens R, Gozal D, et al. Comparison of high-frequency chest compression and conventional chest physiotherapy in hospitalized patients with cystic fibrosis. Am J Respir Crit Care Med. 1994; 150:1154-7.
3. Birnkrant DJ, Pope JF, et al. Persistent pulmonary consolidation treated with intrapulmonary percussive ventilation: a preliminary report. Pediatr Pulmonol. 1996; Apr;21(4):246-9.
4. Braggion C, Cappelletti LM, et al. Short-term effects of three chest physiotherapy regimens in patients hospitalized for pulmonary exacerbation's of cystic fibrosis: a cross-over randomized study. Pediatric Pulmonol. 1995; 19: 16-22.
5. Castile R, Tice J, et al. Comparison of three sputum clearance methods in in-patients with cystic fibrosis.  Pediatr Pulmonol. 1998; Suppl 17:329, A443.
6. Deakins K, Chatburn RL. A comparison of intrapulmonary percussive ventilation and conventional chest physiotherapy for the treatment of atelectasis in the pediatric patient. Respir Care. 2002; Oct;47(10):1162-7.
7. Gondor M, Nixon PA, Mutich R, et al. Comparison of Flutter device and chest physical therapy in the treatment of cystic fibrosis pulmonary exacerbation. Pediatr Pulmonol 1999 Oct; 28(4):255-60.
8. Hardy KA, Anderson BD. Noninvasive clearance of airway secretions. Respir. Care Clin N. A. 1996; 2 (2):323-345.
9. Hess, DR, The evidence for secretion clearance techniques.  Respiratory care, 2001; 46(11)1276-93.
10. Homnick DN, Anderson K, Marks JH. Comparison of the flutter device to standard chest physiotherapy in hospitalized patients with cystic fibrosis. A pilot study. Chest 1998; 114(4):993-997.
11. Homnick DN, White F, de Castro C. Comparison of effects of an intrapulmonary percussive ventilator to standard aerosol and chest physiotherapy in treatment of cystic fibrosis. Pediatr Pulmonol. 1995; 20(1):50-5.
12. Kluft J, Beker L, et al. A comparison of bronchial drainage treatments in cystic fibrosis. Pediatr Pulmonol 1996; 22: 271-274.
13. Langenderfer B. Alternatives to percussion and postural drainage: a review of mucus clearance therapies: percussion and postural drainage, autogenic drainage, positive expiratory pressure, flutter valve, intrapulmonary percussive ventilation, and high-frequency chest compression with the ThAIRapy Vest. J. Cardiopulm Rehabil 1998;18(4):283-289.
14. Marks JH, Hare KL, et al. Pulmonary function and sputum production in patients with cystic fibrosis. Chest. 2004; 125:1507-1511. 
15. McIlwaine PM, Wong LT, Peacock D, et al. Long-term comparative trial of positive expiratory pressure versus oscillating positive expiratory pressure (flutter) physiotherapy in the treatment of cystic fibrosis. J Pediatr 2001; 138(6):845-50.
16. Natale JE, Pfeifle J, Homnick DN. Comparison of intrapulmonary percussive ventilation and chest physiotherapy. A pilot study in patients with cystic fibrosis. Chest. 1994; 105(6):1789-93. 
17. Newhouse PA, White F, Marks JH, et al. The intrapulmonary percussive ventilator and flutter device compared to standard chest physiotherapy in patients with cystic fibrosis. Clin Pediatr. 1998; 37(7):427-32.
18. Oermann CM, Sockrider MM, Giles D, et al. Comparison of high-frequency chest wall oscillation and oscillating positive expiratory pressure in the home management of cystic fibrosis: A pilot study.  Pediatr Pulmonol. 2001; 32(5):372-77.
19. Oermann CM, Swank PR, Sockrider MM, Validation of an instrument measuring patient satisfaction with chest physiotherapy techniques in cystic fibrosis. Chest. 2000; 118:92-97.
20. Padman R, Geouque DM, Engelhardt MT. Effects of the flutter device on pulmonary function studies among pediatric cystic fibrosis patients. Del Med J. 1999 Jan; 71(1):13-8.
21. Perry RJ, Man GC, Jones RL. Effects of positive end-expiratory pressure on oscillated flow rate during high-frequency chest compression. Chest. 1998; 113(4):1028-1033.
22. Scherer TA, Barandun J, Martinez E, et al. Effect of high-frequency oral airway and chest wall oscillation and conventional chest physical therapy on expectoration in patients with stable cystic fibrosis.  Chest. 1998; 113 (4):1019-1027.
23. Stites SW, Perry GV, Peddicord T, et al.  Effect of high frequency chest wall oscillationon the centraland peripheral distribution of aerosolized diethylene triamine penta-acetic acid as compared to standard chest physiotherapy in cystic fibrosis.  Chest. 2006; 129(3):712-17.
24. Thompson CS, Harrison S, Ashley J, et al. Randomized crossover study of the Flutter device and the active cycle of breathing technique in non-cystic fibrosis bronchiectasis. Thorax. 2002; 57(5):446-448.
25. Toussaint M, De Win H, et al. Effect of intrapulmonary percussive ventilation on mucus clearance in Duchenne muscular dystrophy patients: a preliminary report. Respir Care. 2003; 48(10):940-947.
26. Varekojis SM, Douce FH, et al. A comparison of the therapeutic effectiveness of and preference for postural drainage and percussion, intrapulmonary percussive ventilation, and high-frequency chest wall compression in hospitalized cystic fibrosis patients. Respir Care. 2003; 48(1):24-28.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Association for Respiratory Care (AARC). Clinical Practice Guideline: Use of positive airway pressure adjuncts to bronchial hygiene therapy. Respir Care. 1993; 38:516-521.
2. American Association for Respiratory Care (AARC). Clinical Practice Guideline: Postural Drainage Therapy. Respir Care. 1991; 36:1418-26.  Available at: http://www.aarc.org.  Accessed on January 26, 2007.
3. Hayes Inc. Hayes Medical Technology Directory.  High-Frequency Chest Wall Compression for Cystic Fibrosis.   Lansdale, PA:  Hayes, Inc; June 22, 2004.  Search updated June 20, 2006.
4. Hayes Inc. Hayes Medical Technology Directory.  High-Frequency Chest Wall Compression for Diseases other than Cystic Fibrosis.  Lansdale, PA:  Hayes, Inc; April 14, 2005.  Search updated April 10, 2006. 
5. National Government Services (Adminstar) Medicare Policy. Local Coverage Determination for High Revised Frequency Chest Wall Oscillation Devices (L12806).  Revised 04/01/2005.  Available at: http://www.adminastar.com/  Accessed on January 25, 2007.
6. National Government Services (Adminstar) Medicare Policy.  Intrapulmonary Percussive Ventilation Systems (L11543).  Revised 07/01/2005.  Available at: http://www.adminastar.com/  Accessed on January 25, 2007.
7. McCool FD, Rosen MJ. Nonpharmacologic airway clearance therapies:  ACCP evidence-based clinical practice guidelines.  Chest. 2006; 129(1 Suppl):250S-259S.
8. National Institute for Clinical Excellence (NICE). Chronic obstructive pulmonary disease (COPD). Full Guideline, Second Consultation. London, UK: NICE; October 2003. Available at: http://www.nice.org.uk/page.aspx?o=92319. Accessed on January 25, 2007.

1. Cystic Fibrosis Foundation.  An introduction to airway clearance techniques (consumer fact sheet). Bethesda, MD: Cystic Fibrosis Foundation (CFF).  2004.  Available at:  http://www.cff.org. Accessed on January 25, 2007. 
2. Yankaskas JR, Marshall BC, Sufian B, et al.  Cystic fibrosis adult care consensus conference report.  Chest. 2004; 125(1 Suppl):1S-39S.  Available at:  http://www.chestjournal.org/cgi/content/full/125/1_suppl/1S.  Accessed on January 25, 2007.

ABI Vest®

Cystic Fibrosis

High Frequency Chest Compression (HFCC)

Impulsator®

Intrapulmonary Percussive Ventilation (IPV®)

Oscillatory Devices

Percussionaire Device

ThAIRapy Bronchial Drainage System®

ThAIRapy Vest®

Vest™ Airway Clearance System

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.

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

©CPT Only - American Medical Association