![]() | Medical Policy |
| Subject: | Oscillatory Devices for Airway Clearance including High Frequency Chest Compression and Intrapulmonary Percussive Ventilation (IPV) | ||
| Policy #: | DME.00012 | Current Effective Date: | 04/13/2011 |
| Status: | Revised | Last Review Date: | 02/17/2011 |
| Description/Scope |
Oscillatory devices have been utilized as an alternative to conventional chest physical therapy to promote the clearance of respiratory secretions in individuals with impaired ability to cough or otherwise expel them on their own. This document 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).
Note: Other types of mucous clearance systems, that are not either high frequency chest compression devices nor intrapulmonary percussive ventilation devices, are not addressed within this document, (e.g., the FLUTTER® Mucous Clearance System, the Acapella Device, etc.). See Definitions section for further information.
| Position Statement |
A. High Frequency Chest Compression Devices
Medically Necessary:
Initial use of a high frequency chest compression (HFCC) device (see index for examples), is considered medically necessary when ALL of the following are met:
Continued use of a HFCC device is considered medically necessary when ongoing use (i.e., compliance with use) is documented at 6 month to 12 month intervals. (Note: For HFCC devices with usage meters, documentation should reflect use, in general, at least 67% of the prescribed time.)
Not Medically Necessary:
HFCC devices, including, but not limited to, the Vest™ Airway Clearance System are considered not medically necessary when:
HFCC device replacement or upgrade is considered not medically necessary when requested for convenience or to upgrade to newer technology when the current components remain functional.
Investigational and Not Medically Necessary:
All other indications for HFCC are considered investigational and not medically necessary, including, but not limited to, chronic obstructive pulmonary disease (COPD).
B. Intrapulmonary Percussive Ventilation (IPV®) Devices
Investigational and Not Medically Necessary:
Intrapulmonary percussive ventilation devices (IPV), also known as Percussionaire, are considered investigational and not medically necessary for all indications 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.
| Rationale |
Chest physiotherapy (CPT), which is also known as percussion and postural drainage (P/PD), is traditionally seen as the standard of care of secretion clearance methods for individuals 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, which is the standard therapy for mucus clearance in individuals with cystic fibrosis (CF) and other diseases associated with mucus retention. However, because some afflicted individuals may not have an option for CPT, this document outlines criteria for medical necessity in the use of FDA-cleared, high frequency chest compression (HFCC) devices, such as the Vest™ Airway Clearance System, (Hill-Rom, St. Paul, MN; previously manufactured by Advanced Respiratory, Inc., St. Paul, MN) and the Medpulse® Respiratory Vest System (Electromed, Inc., Minnetonka, MN), as an alternative therapy for selected individuals.
Within the American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice Guidelines on Nonpharmacologic Airway Clearance Therapies (originally issued in 1991), the ACCP determined that the evidence supporting the use of oscillatory devices, (i.e., intrapulmonary percussive ventilation, high-frequency chest wall compression and, although outside the scope of this document, the FLUTTER® device), in the treatment of individuals with CF, was low, and the reported benefits were conflicting. 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).
The Cystic Fibrosis Foundation commissioned a systematic review to examine the evidence surrounding the use of airway clearance therapies (ACTs) for treating CF. Seven unique reviews and thirteen additional controlled trials were deemed eligible for inclusion. Recommendations for use of the ACTs were made, balancing the quality of evidence and the potential harms and benefits. The committee determined that, "Although there is a paucity of controlled trials that assess the long-term effects of ACTs, the evidence quality overall for their use in CF is fair and the benefit is moderate…There are no ACTs demonstrated to be superior to others, so the prescription of ACTs should be individualized" (Flume, 2009). The Cystic Fibrosis Foundation recommends that age alone not limit access to HFCC devices, so long as the individual can be properly supervised and tolerates the treatment.
Other applications of HFCC devices, including, but not limited to, their use as an adjunct to CPT or their use in diseases other than CF, chronic bronchiectasis, or chronic neuromuscular disorders, as specified in this document, are considered investigational and 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 Percussionator® and the TXP® Universal VENTILATOR Percussionator® (Percussionaire Corporation, Sandpoint, ID) have been investigated as an alternative to standard CPT and P/PD with or without manual vibration, with most studies having been in subjects with a diagnosis of CF. 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 subjects have been small (4 to 24), the study 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 CPT and P/PD). 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 study 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 CPT and P/PD, 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 and not medically necessary as an airway clearance modality.
| Background/Overview |
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. Chest physical therapy (CPT), which is also referred to as percussion and postural drainage (P/PD), 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 affected individual is a child, may administer CPT. The need 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 in the treatment of CF. Of these techniques, daily P/PD and HFCC devices, such as the Vest™ Airway Clearance System, are passive techniques that do not require the participation of the affected person. 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 who are afflicted with CF 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 which subjects 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, heterogeneity of study subjects, 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 cleared the original Vest™ Airway clearance system in 1998. Several earlier versions included the THAIRapy®Vest System and the ABI Vest®Airway Clearance System, amongst others (Advanced Respiratory, Inc. St. Paul, MN). A similar device, the Medpulse® Respiratory Vest System (Electromed, Inc., Minnetonka, MN) also obtained FDA clearance through the 510(k) approval process (1999), and others have also been cleared by the FDA. In 2007, a similar device, the FREQUENCER™ (DYMEDSO, Inc., Boisbriand, Quebec Canada) obtained FDA clearance as substantially equivalent to the THAIRapy device. It produces sound wave stimulation to oscillate and loosen mucous secretions in the chest.
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 individual 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 individuals 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.
| Definitions |
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, associated 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 (CF): 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 associated with CF.
The Flutter® mucous clearance device (AXCAN Scandipharm, Inc., Birmingham, AL): Another type of oscillatory device which is handheld and resembles a pipe with a plastic mouthpiece on one end that the user exhales into. On the other end of the pipe, a stainless steel ball rests inside a plastic circular cone. When the individual exhales into the device, the ball rolls and moves up and down, creating an opening and closing cycle over a conical canal. The cycle repeats itself many times throughout each exhalation intending to produce oscillations of endobronchial pressure and expiratory airflow that will vibrate the airway walls and loosen mucus so that it can be easily expectorated (coughed up) by the user. The Flutter device has 510(k) status with the FDA, although it has not been shown, in well designed trials, to significantly change respiratory assessment parameters or pulmonary function. Some individuals may prefer this method over other therapies. A similar oscillatory positive airway pressure device is the Acapella™ (Smiths Medical, Watford, UK), which uses a counterweighted plug and magnet to create air flow oscillation. It has been noted that the Acapella device performance is not gravity-dependent and, as such, may be easier to use for some individuals. (Note: The FLUTTER and Acapella devices are not chest compression devices and require active user participation to function properly as positive expiratory pressure oscillatory [PEP] devices.)
The FREQUENCER™: A device that provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. It induces oscillatory sound waves in the chest by means of an electro-acoustical transducer (referred to as the "Power Head") which is placed externally on the user's chest. The Power Head is connected to a frequency generator which is capable of producing frequencies between 20 and 100 Hz. and induces sound waves in the user's chest for the purpose of loosening mucus deposits.
High-frequency chest compression (HFCC): A treatment designed to help improve secretion clearance for individuals 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). These individuals have difficulty clearing lung secretions which leads 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 user's chest.
Intrapulmonary Percussive Ventilation (IPV): A treatment designed to promote mobilization of retained endobronchial secretions and resolution of diffuse patchy atelectasis (areas of partial lung collapse/dysfunction). IPV delivers a series of pressurized mini-bursts of inhaled air and continuous therapeutic aerosol through a nebulizer. IPV users 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): HFCC devices that consist 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 which 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 user. Pressure pulses are controlled by the user and applied during expiration. This device has 510(k) clearance status with the FDA.
| Coding |
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 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 | |
| A7025 | High frequency chest wall oscillation system vest, replacement for use with patient owned equipment |
| E0483 | High frequency chest wall oscillation air-pulse generator system, includes hoses and vest |
| ICD-9 Diagnosis | |
| All diagnoses |
When Services are Not Medically Necessary:
For the procedure codes listed above, when criteria are not met
When Services are Investigational and Not Medically Necessary:
For the procedure codes listed above, when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.
When services are also Investigational and Not Medically Necessary:
| HCPCS | |
| E0481 | Intrapulmonary percussive ventilation system and related accessories |
| ICD-9 Diagnosis | |
| All diagnoses |
| References |
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
| Web Sites for Additional Information |
| Index |
ABI Vest® Cystic Fibrosis High Frequency Chest Compression (HFCC)
FREQUENCER™
Impulsator®
Intrapulmonary Percussive Ventilation (IPV®)
Medpulse® Respiratory Vest System
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.
| Document History |
| Status | Date | Action |
| Revised | 02/17/2011 | Medical Policy & Technology Assessment Committee (MPTAC) review. Age criteria of 2 years and older was removed for HFCC devices. A not medically necessary statement was added regarding device replacement/upgrade. The title was revised to remove brand names. The Rationale and References were updated. |
| Reviewed | 02/25/2010 | MPTAC review. No change to position statements or criteria. The Rationale, Background, Definitions and References were updated. |
| Revised | 02/26/2009 | MPTAC review. No change to the actual medical necessity criteria but the language of the reporting requirement to demonstrate compliance with device use was clarified. The Coding section was updated. Definitions and References were also updated. |
| Reviewed | 02/21/2008 | MPTAC review. No change to criteria. The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting. References were updated. |
| Reviewed | 03/08/2007 | MPTAC review. No changes to criteria. The Rationale and References sections were updated. |
| Reviewed | 03/23/2006 | MPTAC review. No change in criteria. References were updated to include the AARC Clinical Practice Guideline: Postural Drainage Therapy. |
| Revised | 04/28/2005 | MPTAC review. Revised document: High Frequency Chest Compression Devices revised based on Pre-merger Anthem and Pre-merger WellPoint Harmonization. Position statement revised to include Intrapulmonary Percussive Ventilation (IPV); removed HCPCS codes S8200 and S8205 (deleted 01/01/2003) Updated coding: Added ICD-9 codes 335.10-335.19, 335.20-335.29, 358.0-359.9, 359.0-359.9, 494.0-494.1 |
| Pre-Merger Organizations | Last Review Date | Document Number | Title |
| Anthem, Inc. | 03/20/2003 | DME.00012 | High Frequency Chest Compression Devices |
| WellPoint Health Networks, Inc | 12/02/2004 | 2.05.02 | High-Frequency Chest Wall Compression |