Medical Policy

 

Subject: Oscillatory Devices for Airway Clearance including High Frequency Chest Compression and Intrapulmonary Percussive Ventilation
Document #: DME.00012 Publish Date:    02/28/2018
Status: Reviewed Last Review Date:    01/25/2018

Description/Scope

This document addresses the use of oscillatory devices 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. Two types of oscillatory devices are addressed in this document: 1) High Frequency Chest Compression systems, (such as the VestAirway Clearance System and the Medpulse® Respiratory Vest System), and 2) Intrapulmonary Percussive Ventilation (IPV® ) devices, (such as the Percussionaire® Corporation IPV Ventilator device).

Note: Other types of mucous clearance systems, that are neither high frequency chest compression devices nor intrapulmonary percussive ventilation devices, are not addressed within this document, (for example, the Flutter® Mucous Clearance System, the Acapella® Vibratory PEP Therapy System, etc.). See Definitions section for further information.

Position Statement

I.  High Frequency Chest Compression Devices

Medically Necessary:

Initial use of a high frequency chest compression device (see index for examples) is considered medically necessary when ALL of the following are met:

  1. The device is cleared by the U.S. Food and Drug Administration; and
  2. There is documented need for airway clearance; and
  3. The individual has one of the following diagnoses:
    1. Cystic fibrosis; or
    2. Chronic bronchiectasis; or
    3. Chronic neuromuscular disorder affecting the ability to cough or clear respiratory secretions with prior history of pneumonia or other significant worsening of pulmonary function; and
  4. There is documentation of i) failure of or ii) inability to use other airway clearance therapies including manual chest physical therapy due to one or more of the following:
    1. There are 2 or more individuals with cystic fibrosis, chronic bronchiectasis, or chronic neuromuscular disorder (meeting criteria above) in the family; or
    2. The caregiver is unable (physically or mentally) to perform chest physical therapy at the required frequency; or
    3. There is no available parental or partner resource to perform chest physical therapy; and
  5. There is documentation of an initial trial during which the affected individual and the family (when applicable) have demonstrated compliance with the high frequency chest compression device (see the following statement for details).

Continued use of a high frequency chest compression device is considered medically necessary when ongoing use, (that is, compliance with use) is documented at 6 month to 12 month intervals. (Note: For high frequency chest compression devices with usage meters, documentation should reflect use, in general, at least 67% of the prescribed time).

Not Medically Necessary:

High frequency chest compression devices, including but not limited to, the Vest Airway Clearance System are 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  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.

High frequency chest compression 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 high frequency chest compression are considered investigational and not medically necessary , including, but not limited to, chronic obstructive pulmonary disease. .

II.  Intrapulmonary Percussive Ventilation Devices

Investigational and Not Medically Necessary:

Intrapulmonary percussive ventilation devices, also known as the Percussionaire   Corporation IPV Ventilator, 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 U.S. Food and Drug Administration (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), the SmartVest Airway Clearance System (Electromed, Inc., New Prague, MN), the inCourage System (RespirTech, 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, the ACCP determined that the evidence supporting the use of oscillatory devices, (that is, intrapulmonary percussive ventilation [IPV], HFCC 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 13 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 Percussionaire 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. Multiple IPV devices have been cleared by the FDA for similar indications including the mobilization of endobronchial secretions. 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, (for example, Flutter valve, and/or HFCC device, and/or standard CPT and P/PD). Also, outcome measurements differed amongst the studies, 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 an HFCC 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, an HFCC 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 (HFCC)

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. The currently approved indications are:

To promote airway clearance or improve bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician's choice of treatment. The indications typically follow the Clinical Practice Guideline published by the American Association for Respiratory Care (AARC) in 1991. In addition, the device is also indicated for the purpose of collecting mucus for diagnostic evaluation. 

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 system 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 H2 O, 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 CF), 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 it may be 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.

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.)

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® : 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, each
E0483 High frequency chest wall oscillation air-pulse generator system, (includes hoses and vest), each
   
ICD-10 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-10 Diagnosis  
  All diagnoses
   
References

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Government Agency, Medical Society, and Other Authoritative Publications:

  1. Centers for Medicare and Medicaid Services. National Coverage Determination for Intrapulmonary Percussive Ventilator. NCD #240.5. Effective date: July 14, 1997. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=229&ncdver=1&DocID=240.5&ncd_id=240.5&ncd_version=1&basket=ncd%25253A240%25252E5%25253A1%25253AIntrapulmonary+Percussive+Ventilator+%252528IPV%252529&bc=gAAAAAgAAAAA&. Accessed on November 10 2016.
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  3. Flume PA, Robinson KA, O'Sullivan BP, et al. Cystic Fibrosis Foundation. Cystic fibrosis pulmonary guidelines: airway clearance therapies. Respir Care. 2009; 54(4):522-537.
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  7. Morrison L, Agnew J. Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. 2014;(7):CD006842.
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Websites for Additional Information
  1. Cystic Fibrosis Information from the Cleveland Clinic web site. Available at:  http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/pulmonary/cystic-fibrosis/#bib91.   Accessed on November 10, 2016.
  2. Genetic Disease Foundation. Information about Cystic Fibrosis. Available at:  http://www.geneticdiseasefoundation.org/genetic-diseases/cystic-fibrosis/?_kk=cystic%20fibrosis%20genetic&_kt=e752161d-9a3e-45c9-9dea-5a3284a40700&gclid=CNiapfGWhMoCFQiKaQodb1EIwQ. Accessed on November 10, 2016.
Index

ABI Vest Cystic Fibrosis High Frequency Chest Compression (HFCC)
Frequencer
Impulsator®
inCourage System
Intrapulmonary Percussive Ventilation (IPV)
Medpulse Respiratory Vest System
Oscillatory Devices
Percussionaire Device
SmartVest Airway Clearance System
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
Reviewed 01/25/2018 Medical Policy & Technology Assessment Committee (MPTAC) review.  The document header wording updated from “Current Effective Date” to “Publish Date.”
Revised 02/02/2017 MPTAC review. Updated formatting in Position Statement section. Updated References section.
Reviewed 02/04/2016 MPTAC review.  References were updated.  Removed ICD-9 codes from Coding section.
Reviewed 02/05/2015 MPTAC review. Updated Reference and Index sections.
Reviewed 02/13/2014 MPTAC review. Updated Reference and Index sections.
Reviewed 02/14/2013 MPTAC review. The Rationale, Background, and References were updated.
Reviewed 02/16/2012 MPTAC review. References were updated.
Revised 02/17/2011 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. 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. 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. The Rationale and References sections were updated.
Reviewed 03/23/2006 MPTAC review. 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