BlueCross and BlueShield of Montana Medical Policy/Codes
Airway Clearance Devices
Chapter: Durable Medical Equipment
Current Effective Date: July 18, 2013
Original Effective Date: December 01, 1991
Publish Date: April 18, 2013
Revised Dates: December 15, 2004, May 9, 2008, March 1, 2010, September 1, 2011, April 6, 2012; April 17, 2013
Description

Background

Normal clearance of airways rests on three basic components: a patent airway, mucociliary clearance, and an adequate cough.  Patients with spinal cord injuries, or a variety of diseases (e.g., neuromuscular, cystic fibrosis (CF), chronic bronchitis, and bronchiectasis), or chest wall deformities may have impaired cough responses, abnormal airway clearance, or increased sputum production, which may lead to respiratory failure due to the inability to clear the profuse respiratory secretions.  Chest wall deformities may include kyphosis, scoliosis, or lordosis, while neuromuscular diseases include muscular dystrophy, poliomyelitis, spinal muscle atrophy, myasthenia gravis, amyotrophic lateral sclerosis, or cerebral palsy.  The great majority of neuromuscular disease morbidity and mortality is related to respiratory muscle weakness, and the vast majority of episodes of respiratory failure occur during otherwise benign episodes of respiratory tract infections.  Chest infections may result in repeated episodes of pneumonia, repeated hospitalizations, and, finally, in tracheostomy with mechanical ventilation.

Standard airway clearance therapies for diseases such as cystic fibrosis per Flume et al. and the 2009 Clinical Practice Guidelines for Pulmonary Therapies Committee are listed as follows depending upon the severity of the disease:

  • percussion and postural drainage (P/PD),
  • positive expiratory pressure (PEP),
  • active-cycle of breathing technique,
  • oscillatory PEP,
  • high-frequency chest compression and exercise.

Respiratory therapists teach family members to administer these therapies to children and other members who cannot perform it themselves.

Cystic fibrosis is an autosomal recessive genetic disorder that is incurable and fatal.  CF primarily affects the respiratory and gastrointestinal systems, leading to chronic lung disease and impaired digestive function.  Pulmonary manifestations include production of excessive tenacious tracheobronchial mucus that cannot easily be cleared, leading to airway obstruction and secondary infection, which are the principal causes of the morbidity and mortality.  A variety of mucus clearance techniques have been investigated as methods to increase the amount of expectorated sputum, maintain pulmonary function, and decrease the incidence of acute exacerbations of CF.  Daily P/PD is the most commonly used secretion clearance technique.  P/PD needs to be administered by a physical therapist or another trained adult in the home, typically a parent if the patient is a child.  The necessity for regular therapy can be particularly burdensome for adolescents or adults who wish to lead independent lifestyles.

Bronchiectasis is the destruction and widening of the large airways.  A person may be born with bronchiectasis or may develop it later in life.  It is often caused by recurrent inflammation or infection of the airways.  It may be present at birth, but most often begins in childhood as a complication from infection.  CF causes about 50% of all bronchiectasis in the United States today.

Factors that contribute to development of bronchiectasis:

Genetic:

  • Kartagener’s syndrome: defect in the action of the cilia;
  • Cystic fibrosis: abnormal viscous mucous production;
  • Young's syndrome: rare combination of conditions where the functioning of the lungs is usually normal but the mucus is abnormally viscous;

Acquired:

  • Loss of mucociliary clearance system;
  • Loss of mucociliary escalator system (obstruction);
  • Defect in clearance mechanism followed by accumulation of secretions, infection and atelectasis;
  • Chronic infection damages integrity of bronchial wall causing dilatation;
  • Temporary tubular bronchial dilatation occurs in all pneumonias.

Examples of diseases that cause acquired bronchiectasis:

  • Tuberculosis;
  • Acquired immune deficiency disease (AIDS);
  • Pneumonia;
  • Fungal infections.

Bronchiectasis may affect many areas of the lung (diffuse bronchiectasis), or it may appear in only one or two areas (focal bronchiectasis). 

Localized bronchiectasis is encountered under the following clinical circumstances:

  • Following necrotizing pneumonia;
  • Obstructive lesion;
  • Tuberculosis (dry bronchiectasis);
  • Allergic bronchopulmonary aspergillosis.

Diffuse bronchiectasis is encountered in:

  • CF;
  • Immobile Cilia Syndrome (Kartagener's Trial);
  • IgA deficiency;
  • Hypogammaglobulinemia;
  • Childhood infections.

Treatment for bronchiectasis includes controlling the infections, relieving obstructions and eliminating accumulated fluid with P/PD.

Devices

Airway clearance devices are designed to move mucus and clear airways; the oscillatory component can be intra- or extra-thoracic.  These devices can be used as alternatives to daily P/PD, also known as chest physical therapy or chest physiotherapy (CPT), in patients with CF.  Oscillatory devices are also proposed for other respiratory conditions such as diffuse bronchiectasis and COPD.

There are several types of devices:

  • oscillating positive expiratory pressure devices (PEP) (e.g., the Flutter and Acapella devices);
  • intrapulmonary percussive ventilation (IPV) devices (e.g., Percussionaire);
  • high-frequency chest compression devices with an inflatable vest (e.g., The Vest™ Airway Clearance System by Hill-Rom™);
  • mechanical insufflation-exsufflation (MI-E) devices.

Some of the devices require active participation of the patient.  These include oscillating PEP devices, such as Flutter and Acapella in which the patient exhales multiple times through a device.  The Flutter device is a small pipe-shaped, easily portable hand-held device, with a mouthpiece at one end.  It contains a high-density stainless steel ball that rests in a plastic circular cone.  During exhalation, the steel ball moves up and down, creating oscillations in expiratory pressure and airflow.  When the oscillation frequency approximates the resonance frequency of the pulmonary system, vibration of the airways occurs, resulting in loosening of mucus.  The Acapella device is similar in concept but uses a counterweighted plug and magnet to create air flow oscillation. 

In contrast, there are devices that are passive and are designed to provide airway clearance without the active participation of the patient.  High-frequency chest wall compression devices (e.g., The Vest Airway Clearance System, formerly known as The ABI Vest or the ThAIRapy® Bronchial Drainage System) provide high-frequency chest compressions using an inflatable vest and an air-pulse generator.  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 intrapulmonary percussive ventilator (Percussionaire) device combines internal thoracic percussion through rapid mini-bursts of inhaled air and continuous therapeutic aerosol delivered through a nebulizer.  

Another device, the In-Exsufflator® (JH Emerson Co, Cambridge, Mass.), an MI-E device, is designed to deliver alternative cycles of positive and negative pressure.  The positive pressure causes air to enter the lungs, followed by a rapid drop in pressure that causes exsufflation.  Cycling between insufflation and exsufflation can either be performed manually or automatically. Five or more treatments are generally given in one session until no further secretions are expelled, and hemoglobin desaturations related to mucous plugging are resolved.  MI-E has been used in a variety of patient populations as an adjunct to noninvasive ventilation using intermittent positive pressure ventilation (IPPV).  For example, many patients with neuromuscular disease or chest wall deformities with progressive ventilatory failure will use noninvasive IPPV (delivered nasally or orally) either nocturnally or throughout the day, depending on such parameters as vital capacity and oxygenation levels.  However, the limitation of IPPV is management of respiratory secretions, particularly during respiratory tract infections or after anesthesia.  MI-E thus complements the IPPV by promoting airway clearance.  Patients managed at home with noninvasive IPPV may monitor oxygen desaturation levels.  A sudden decrease in oxygen desaturation may prompt the use of MI-E to eliminate the offending mucus plug.  Many advocates of MI-E have stated that even patients requiring 24-hour IPPV can be managed noninvasively for prolonged periods of time without hospitalization using this technique.  Other patients may initiate IPPV at the time of sudden ventilatory failure, often secondary to a respiratory tract infection or anesthesia; in this setting IPPV in conjunction with MI-E may eliminate the need for intubation.  Depending on the underlying disease, some patients who have been previously intubated with tracheostomies may be able to transition to noninvasive IPPV and closure of the tracheostomy.  Intubated patients with tracheostomies typically undergo suctioning for airway clearance.  However, the reach of suctioning is limited to the proximal airways, and the left main bronchus is often missed due to its sharper angle.  Furthermore, suctioning may be inadequate to mobilize more tenacious secretions.  Therefore, in patients with tracheostomies, MI-E has been used as an alternative or complement to suctioning.  In addition, it is suggested that MI-E is more comfortable to the patient than suctioning.

Relative contraindications to MI-E are:

  • Chronic obstructive pulmonary disease; or
  • Bullous emphysema; or
  • Known susceptibility to pneumothorax; or
  • Exposure to recent barotrauma.

Regulatory Status

Several oscillatory devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process, including the following:

  • The Bird IPV Noncontinuous Ventilator (Percussionaire Corp) in 1989.
  • Flutter Mucus Clearance Device in 1994, which is currently marketed in the United States by Axcan.
  • The Acapella device (DHD Healthcare) in 1999.
  • The RC Cornet Mucus Clearing Device (PARI Respiratory Equipment) in 1999.
  • The ABI Vest was approved in 1988. Since that time, updated versions of the device were cleared by the FDA—most recently a fifth generation device. The device is now known as the Vest Airway Clearance System and it is manufactured by Hill-Rom™.
  • The ThAIRapy Bronchial Drainage System in 1998.
  • In-Exsufflator (J. H. Emerson Co., Cambridge, MA in 1992).
Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

BCBSMT recommends referral to case management.

Coverage

BCBSMT may consider the following airway clearance devices medically necessary durable medical equipment (DME) to assist in mobilizing respiratory tract secretions for patients when meeting the criteria as outlined below for each device:

I.  Oscillating positive expiratory pressure devices (PEP) (e.g., The Flutter®, Acapella®) in patients with lung disease that produces excessive mucus, have difficulty clearing secretions, and experience recurrent disease exacerbations, including but not limited to:

  • Bronchiectasis; OR
  • Bronchitis; OR
  • Cystic Fibrosis; OR
  • Other conditions that produce retained secretions. 

II.  Intrapulmonary percussive ventilation (IPV) devices * (e.g., Percussionaire®) in patients that have:

A.  A diagnosis of ONE of the following conditions:

  • Cystic Fibrosis; OR
  • Chronic diffuse bronchiectasis (confirmed by computed tomography scan) characterized by;
    • daily productive cough for at least six continuous months; OR
    • more than two times per year exacerbations requiring antibiotic therapy; AND

B.  Demonstrated need for airway clearance; AND

C.  Standard chest physiotherapy has failed OR standard chest physiotherapy is unavailable or not tolerated.

III.  High-frequency chest wall compression devices * (e.g., The Vest™ Airway Clearance System by Hill-Rom™) in patients that have:

A.  A diagnosis of ONE of the following conditions:

  • Cystic Fibrosis; OR
  • Chronic diffuse bronchiectasis (confirmed by computed tomography scan) characterized by;
    • daily productive cough for at least six continuous months, OR
    • more than two times per year exacerbations requiring antibiotic therapy, OR
  • ONE of the following neuromuscular diseases:
    • Acid maltase deficiency; OR
    • Anterior horn cell diseases; OR
    • Hereditary muscular dystrophy; OR
    • Multiple Sclerosis; OR
    • Myotonic disorders; OR
    • Paralysis of the diaphragm; OR
    • Post-polio; OR
    • Quadriplegia; OR
    • Other myopathies, AND

B.  Demonstrated need for airway clearance; AND

C.  Standard chest physiotherapy has failed OR standard chest physiotherapy is unavailable or not tolerated.

NOTE*Documentation requirements for intrapulmonary percussive ventilation and high-frequency chest wall compression devices MUST include:

  • Demonstrated need for airway clearance; AND
  • Failure of standard treatments;
    1. frequent severe exacerbations of respiratory distress involving inability to clear mucous despite standard treatment [chest physiotherapy (CPT) or percussion and postural drainage (P/PD), and if appropriate, use of the Flutter device], OR
    2. valid reasons why standard CPT cannot be performed, such as inability of the caregiver to perform.

High-frequency chest wall compression devices and IPV devices used solely as an alternative to CPT for conditions other than those specified in the medically necessary statements above are considered not medically necessary.

IV.  Mechanical insufflation-exsufflation devices  (MI-E) devices may be considered medically necessary in patients with neuromuscular disease (e.g., amyotrophic lateral sclerosis, high spinal cord injury with quadriplegia) who have an impaired ability to cough (a peak cough expiratory flow of less than 2-3L per second) and who require ventilatory assistance.

MI-E may be either offered on a temporary basis in patients with noninvasive intermittent positive pressure ventilation (IPPV) who are suffering from a respiratory tract illness, or used on a more chronic basis in an attempt to avoid the option of tracheostomy and suctioning.

In patients with a tracheostomy, MI-E may be offered in lieu of suctioning.

All other uses of airway clearance devices are considered experimental, investigational and unproven.

Rationale

Cystic Fibrosis

Available trials include small numbers of patients, and the outcome variables do not include final health outcomes such as the rates and severity of pulmonary exacerbations.  With the limited data available, The Vest Airway Clearance System has been shown to be as effective, or superior, to other techniques in terms of volume of sputum produced.  However, the reliability and validity of sputum weight as a proxy for health outcome is still unresolved.  The clinical data regarding the Percussionaire device are sparse.  One randomized trial of 16 CF patients reported no difference in spirometric measures or number of hospitalizations, suggesting that the Percussionaire device was equivalent to CPT.

A literature search based on the MedLine database for the period 1997 through June 2006 did not identify any published studies that would change the above conclusions.  The citations identified in the literature search included a number of small, randomized studies that compared different mucus clearance techniques, typically in crossover studies.  Pulmonary function and weight of expectorated sputum are typically analyzed immediately after treatment.  Thus these small short-term studies focus on intermediate outcomes, and do not include any data regarding long-term stabilization or improvement of lung function, nor a decrease in pulmonary exacerbations that resulted in hospitalizations.  The following discussion briefly summarizes those studies using the Vest Airway Clearance System, the Percussionaire device, or the Flutter device in the outpatient or home setting.

Oermann and colleagues conducted a pilot study of 24 patients with CF who were randomly assigned to receive either the Vest Airway Clearance System or the Flutter device for four weeks followed by crossover to the other group.  Spirometry, lung volume, quality of life, and patient satisfaction were measured after each four-week treatment period.  The only significant difference between the two groups was patient satisfaction; 50% of the participants preferred the Vest Airway Clearance System, while 37% preferred the Flutter device.

App and colleagues performed a randomized trial with a crossover design comparing the Flutter device and autogenic drainage in 14 patients with CF.  Patients received therapy with either autogenic drainage or the Flutter device and then crossed over to the alternate treatment. At the beginning and end of each four-week interval, pulmonary function was measured before and after an acute 30-minute therapy.  At the end of the session, the weight and viscoelasticity of the sputum were evaluated.  No significant changes in pulmonary function or sputum volume were noted throughout the study.  Sputum viscoelasticity was lower in those receiving Flutter therapy, potentially allowing it to be cleared more easily by cough and airflow mechanisms.

Newhouse and colleagues reported on the results of a randomized trial with crossover design that compared the results of the Percussionaire device and the Flutter device in eight patients with CF.  Each regimen was administered randomly to each patient on three separate days during three successive weeks.  Post-treatment pulmonary function tests were obtained at one and four hours after each treatment regimen.  The weight of sputum samples collected over four hours after treatment was also recorded.  There was no difference in sputum quantity with any method studied.  Results of pulmonary function tests were inconsistent in this small trial.

In a randomized trial, McIlwaine and colleagues compared PEP and the Flutter device in 40 children with CF.  Participants were randomly assigned to physiotherapy with PEP or the Flutter device for one year.  Clinical status, pulmonary function, and compliance were measured at regular intervals throughout the year.  In the PEP group the pulmonary function remained relatively stable, while in the Flutter group there was a greater mean annual rate of decline in forced vital capacity.  This difference did not become apparent until six to nine months into the study, underlining the importance of long-term results.

Varekojis and colleagues compared high-frequency chest wall compression using the Vest and intrapulmonary percussive ventilation using the Percussionaire device to P/PD in 24 hospitalized patients with CF.  Patients used each modality for two days in a randomized order over a six-day period.  While wet sputum weights from use of the Percussionaire™ device were significantly greater than The Vest Airway Clearance System, there was no significant difference in any of the modalities in dry sputum weights.  In addition, patients found use of each of the devices to be equally acceptable when questioned about comfort, convenience, effectiveness, and ease of use.

Other Respiratory Disorders

There are few studies on use of oscillatory devices for treatment of respiratory diseases other than CF.  Three randomized controlled trials were identified that included patients with bronchiectasis; two of these evaluated the Flutter device.

Thompson et al. evaluated use of the Flutter device compared to active cycle of breathing technique (breathing control, thoracic expansion exercises, and forced expiratory technique) in the home in 17 patients with non-CF bronchiectasis.  When measuring sputum weight, peak expiratory flow rate, breathlessness, bronchodilator spirometric tests, and health-related quality of life, no significant difference in outcomes was noted with use of either treatment modality.  Patient preference favored the Flutter device (11 of 17).

In a randomized controlled trial from New Zealand reporting on 18 patients with chronic bronchiectasis, Eaton found an increase in dry sputum weight for active cycle of breathing technique (ACBT) with postural drainage compared to use of just ACBT or use of the Flutter device.  A third randomized study evaluated the Acapella device. In a small study of 20 patients with acute exacerbation of bronchiectasis during antibiotic therapy, Patterson found no difference in changes in lung function for “usual” airway clearance approach compared to Acapella.

No controlled studies were identified evaluating oscillatory devices for treatment of COPD.

In summary, data are inadequate to permit scientific conclusions regarding the relative efficacy of oscillatory therapies compared to P/PD, considered the standard therapy for mucus clearance in patients with CF.  However, alternative therapies may need to be considered in patients who either lack a caregiver to perform routine P/PD or who are poorly tolerant or noncompliant with P/PD.  The sparse data that are available do not suggest that any one alternative, including the various oscillatory devices, autogenic drainage, or PEP, is superior to another.  The Flutter device, autogenic drainage, and expiratory pressure are simple devices or maneuvers that can be learned by most patients.  In contrast, intrapulmonary positive ventilation or use of the Vest Airway Clearance System device may be a consideration in patients requiring a passive system of mucus clearance.

2008 Update

In a review of airway clearance devices in CF, Marks comments that conventional CPT remains the gold standard of airway clearance methods and may be the best choice for some patients, such as infants and young children.  The review adds that newer methods of airway clearance are available and allow CF patients and their families to choose the techniques that suit them.  The review also notes that most of the newer airway clearance devices have been studied in comparison to standard CPT and most studies show no advantage of one method over another.  He also notes that the evidence to support IPV treatment in patients with CF is limited.  A recent study evaluated a small (n=18) group of patients with CF and noted no difference in single-session sputum production with sine versus triangular waveform chest wall oscillation devices.

The limited data indicate that oscillatory devices appear comparable to CPT for assisting with clearance of copious airway secretions in patients with both CF and chronic bronchiectasis.  Thus, they may be considered alternatives to CPT in those patients who are not able to undergo CPT.  Use of these devices in other chronic pulmonary disease, such as COPD, remains experimental, investigational and unproven due to a lack of information about the impact on outcomes. 

2010 Update

A search of peer-reviewed literature through January 2010 identified the following information.

In 2009, a Cochrane Review evaluating the evidence on oscillating devices for the treatment of CF was published.  Investigators searched the literature through November 2008 for randomized controlled trials comparing oscillatory devices to another recognized airway clearance technique. A total of 30 studies with 708 patients met inclusion criteria.  Eleven studies used a parallel design and 19 were cross-over studies.  Ten of the included studies were published as abstracts only.  The majority, sixteen, were conducted in the United States.  Sample sizes of individual studies ranged from five to 166, with a median of 20 participants.  There were 16 studies using the Flutter device as a comparison, 11 using high-frequency chest wall oscillation, five using intrapulmonary percussive ventilation and two using Cornet.  No studies were identified that compared Acapella to another treatment.  Study duration ranged from one week to one year; 21 of the studies were of less than three months duration and 10 lasted less than one week.  Outcomes included pulmonary function, sputum weight and volume, hospitalization rate and quality of life measures.  Due to the variety of devices used, outcome measures and lengths of follow-up, quantitative meta-analyses of multiple studies could not be performed.  The authors concluded that there is a lack of evidence supporting any one airway clearance technique or device over another and that there is a need for adequately-powered randomized controlled studies with long-term follow-up.  No randomized controlled trials meeting these criteria have been published since the Cochrane review.

High-frequency chest wall compression devices have been shown to increase sputum clearance in CF patients.  It is theorized that the abnormally viscous secretions are cleared due to the vibratory shear forces of the device.  High-frequency chest wall compression devices have been promoted for use in conditions other than CF, including bronchiectasis and neuromuscular diseases. However, there are no adequate published controlled trials of high-frequency chest compression devices for conditions other than CF.  The Vest was cleared by the FDA for a wide variety of pulmonary conditions based on a 510(k) pre-market notification; therefore the manufacturer was not required to submit the type of evidence of effectiveness that would be required to support a pre-market approval application. 

Neuromuscular diseases (NMD) are characterized by weakness of skeletal muscle and progressive atrophy, skeletal and spinal deformities, limb contractures, and restrictive lung disease leading to poor respiratory function.  Recurrent pulmonary infections place them at high risk for lung damage and respiratory failure, the chief cause of death in NMD.  Numerous causes lead to disruption of normal airway clearance resulting in increased secretion production and impaired secretion clearance, including inability to cough effectively to remove secretions. 

The standard of care for patients with ineffective mucus clearance with NMD is CPT.  However, it may be difficult or impossible to do on patients with NMD.  With a high-frequency chest wall compression device, all lobes of the lung are treated at the same time, and treatment is not technique or position dependent.  

The data indicates that high-frequency chest wall devices appear comparable to CPT for assisting with clearance of copious airway secretions in patients with CF.   Thus, they may be considered alternatives to CPT in those patients with neuromuscular diseases who are not able to undergo CPT.  Use of these devices in other chronic pulmonary disease, such as COPD, remains experimental, investigational and unproven due to a lack of information about the impact on outcomes. 

Technology Assessments, Guidelines and Position Statements

The 2006 evidence-based clinical guidelines from the American College of Chest Physicians recommend that devices designed to oscillate gas in the airway, either directly or by compressing the chest wall, can be considered as an alternative to CPT only in patients with CF.

In April 2009, the Cystic Fibrosis Foundation published guidelines on airway clearance therapies based on a systematic review of evidence.  They recommend airway clearance therapies for all patients with CF but state that no therapy has been demonstrated to be superior to others (level of evidence, fair: net benefit, moderate; grade of recommendation, B).  They also issued a consensus recommendation that the prescribing of airway clearance therapies should be individualized based on factors such as age and patient preference.

Summary

In patients with CF, it is difficult to reach scientific conclusions regarding the relative efficacy of oscillatory therapies compared to P/PD, considered the standard therapy for mucus clearance in patients with CF.  However, findings of the Cochrane Review, combined with clinical input, suggest that oscillatory devices may be comparable to CPT for CF patients in some situations.  The available evidence and clinical input also suggest that oscillatory devices may be appropriate for treating diffuse bronchiectasis in similar situations.  Thus, these devices may be considered medically necessary when CPT has failed or is unavailable or not tolerated by the patient.  The sparse data do not suggest that any one oscillatory device is superior to another for CF or bronchiectasis.  The Flutter device, autogenic drainage, and PEP are simple devices or maneuvers that can be learned by most patients.

In contrast, IPV or high-frequency chest wall compression (e.g., The Vest Airway Clearance System) device are more complex devices.  The data indicates that high-frequency chest wall devices appear comparable to CPT for assisting with clearance of copious airway secretions in patients with CF.  Thus, they may be considered alternatives to CPT in those patients with bronchiectasis and NMD who are not able to undergo CPT.  Use of these devices in other chronic pulmonary disease, such as COPD, remains experimental, investigational and unproven due to a lack of information about the impact on outcomes. 

Use of IPV devices appear comparable to CPT for assisting with clearance of copious airway secretions in patients with CF and chronic diffuse bronchiectasis and our position remains medically necessary for these two conditions.  Use of IPV devices in other chronic pulmonary diseases, such as COPD, remains investigational due to lack of information about the impact on outcomes.

An additional search was done of the published literature through November 2010 with respect to mechanical insufflation exsufflation devices.   Published data suggest that MI-E can improve the intermediate outcome of peak cough expiratory flow.  Data regarding its role in the clinical management of the patient consist of case series.  In some studies, patients have served as their own control, with a decreased incidence of hospitalization among patients who switch from tracheostomy to a noninvasive approach, which may include MI-E as one component.  In 1998, a Consensus Panel Report by the American College of Chest Physicians stated that "[t]he inability of patients with respiratory muscle weakness to achieve high lung volumes is likely to contribute to cough ineffectiveness.  Increasing the inhaled volume prior to cough by air-stacking positive pressure breaths or by glossopharyngeal breathing, increases cough expiratory flows by 80% in these patients.  Cough efficiency may be further enhanced by the application of negative pressure to the airway for a period of 1 to 3 s.  Using this technique of mechanical insufflation-exsufflation, peak cough expiratory flows can be increased by more than four-fold."   While controlled trials would ideally further delineate who is most likely to benefit from MI-E, particularly those who would benefit from having such a device in the home, such trials are logistically difficult.  The heterogeneous nature of the patients, even among those with similar diseases, almost mandates a case by case approach for these patients.  For example, the clinical utility of MI-E would not only depend on the physiologic parameters of lung function, but also on the tempo of the disease course, the availability of home caregivers, and patient preference and motivation.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

ICD-9 Codes

011.50-011.56, 93.18, 138, 277.00- 277.09, 277.6, 335.0-335.9, 340, 344.00-344.09, 359.0- 359.1, 359.21-359.29, 359.4, 359.5, 359.6, 359.89, 466.0, 490, 491.1, 491.2, 491.21, 491.22, 491.8, 491.9, 492.0, 492.8, 493.0, 493.00, 493.01, 493.02, 493.1, 493.10, 493.11, 493.12, 493.2, 493.20, 493.21, 493.22, 493.8, 493.81, 493.82, 493.9, 493.90, 493.91, 493.92, 494.0, 494.1, 495.0, 495.1, 495.2, 495.3, 495.4, 495.5, 495.6, 495.7, 495.8, 495.9, 496, 519.4, 748.61, 805.00, 805.01, 805.02, 805.03, 805.04, 805.05, 805.06, 805.07, 805.08, 805.1, 805.10, 805.11, 805.12, 805.13, 805.14, 805.15, 805.16, 805.17, 805.18, 805.2, 805.3, 805.4, 805.5, 805.6, 805.7, 805.8, 805.9, 806.0, 806.00, 806.01, 806.02, 806.03, 806.04, 806.05, 806.06, 806.07, 806.08, 806.09, 806.1, 806.10, 806.11, 806.12, 806.13, 806.14, 806.15, 806.16, 806.17, 806.18, 806.19, 806.2, 806.20, 806.21, 806.22, 806.23, 806.24, 806.25, 806.26, 806.27, 806.28, 806.29, 806.3, 806.30, 806.31, 806.32, 806.33, 806.34, 806.35, 806.36, 806.37, 806.38, 806.39, 907.2, 907.3, 952.0, 952.00, 952.01, 952.02, 952.03, 952.04, 952.05, 952.06, 952.07, 952.08, 952.09, 952.1, 952.10, 952.11, 952.12, 952.13, 952.14, 952.15, 952.16, 952.17. 952.18, 952.19

ICD-10 Codes
E84.0-E84.9, J47.1-J47.9, F07C6ZZ 
Procedural Codes: A7020, A7025, A7026, E0481, E0482, E0483, E0484, S8185
References
  1. Fowler, W.M. Jr. Profiles of Neuromuscular Diseases. Design of the Protocol. AM J Phys Med Rehabil (1995 Sept-Oct) 74 (5 Suppl):S62-9.
  2. App, E.M., Kieselmann, R., et al.  Sputum rheology changes in cystic fibrosis lung disease following two different types of physiotherapy: flutter vs. autogenic drainage.  Chest (1998) 114(1):171-7.
  3. Irwin, R.S., Boulet, L.P., et al. Managing cough as a defense mechanism and as a symptom. A consensus panel report of the American College of Chest Physicians. Chest. (1998) 114(2 Suppl Managing):133S-81S.
  4. Newhouse, P.A., White, F., et al.  The intrapulmonary percussive ventilator and flutter device compared to standard chest physiotherapy in patients with cystic fibrosis.  Clinical Pediatrics (1998) 37(7):427-32.
  5. Schramm, C.M. Current Concepts of Respiratory Complications of Neuromuscular Disease in Children.  Curr Opin Pediatric (2000 June) 12(3):203-7.
  6. Oermann, C.M., Sockrider, M.M., et al.  Comparison of high-frequency chest wall oscillation and oscillating positive expiratory pressure in the home management of cystic fibrosis: a pilot study.  Pediatric Pulmonology (2001) 32(5):372-7.
  7. McIlwaine, P.M., Wong, L.T., et al.  Long-term comparative trial of positive expiratory pressure versus oscillating positive expiratory pressure (flutter) physiotherapy in the treatment of cystic fibrosis.  Journal of Pediatrics (2001) 138(6):845-50.
  8. Thompson, C.S., Harrison, S, 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):446-8.
  9. Varekojis, S.M., Douce, F.H., 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.  Respiratory Care (2003) 48(1):24-8.
  10. McCool, F.D., Rosen, M.J.  Nonpharmacologic airway clearance therapies: ACCP evidence-based clinical practice guidelines.  Chest (2006) 129(1 suppl):250S-9S.
  11. Panitech, H. B. Airway Clearance in Children with Neuromuscular Weakness. Current Opinion in Pediatrics (2006) 18:277-81.
  12. Marks, H.H.  Airway clearance devices in cystic fibrosis.  Paediatric Respiratory Review (2007) 8(1):17-23.
  13. Eaton, T., Young, P., et al.  A randomized evaluation of the acute efficacy, acceptability and tolerability of flutter and active cycle of breathing with and without postural drainage in non-cystic fibrosis bronchiectasis.  Chronic Respiratory Disease (2007) 4(1):23-30.
  14. Homnick, D.N. Mechanical insufflation-exsufflation for airway mucous clearance. Respir Care. (2007) 52(10): 1296-307.
  15. Patterson, J.E., Hewitt, O., et al.  Acapella versus ‘usual airway clearance’ during acute exacerbation in bronchiectasis: a randomized crossover trial.  Chronic Respiratory Disease (2007) 4(2):67-74.
  16. Ambrosino, N., Carpene, N. et al. Chronic respiratory care for neuromuscular diseases in adults.  Eur Respir J. (2009 Aug) 34 (2): 444-51.
  17. American Lung Association.  Bronchiectasis (2009).  Available at www.lungusa.org .  (accessed – 2009 January).
  18. Morrison, L., Agnew, J.  Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev (2009) (1):CD006842.
  19. Flume PA, Robinson KA, O’Sullivan BP et al. Cystic fibrosis pulmonary guidelines: airway clearance therapies. Respirat Care (2009) 54(4):522-37.
  20. LCD for High Frequency Chest Wall Oscillation Devices (L12934).  Medicare Durable Medical Equipment Regional Carrier (DMERC).  (2009 October) http://www.palmettogba.com.
  21. Oscillatory Devices for the Treatment of Cystic Fibrosis and Other Respiratory Disorders.  Chicago, Illinois:  Blue Cross Blue Shield Association Medical Policy Reference Manual (2010 February) Durable Medical Equipment 1.01.15.
History
September 2011 Policy updated with literature review. References 7 and 8 added. No changes to policy statements.
April 2012 Policy updated with literature review. References 12, 13 and 14 added. No changes to policy statements. Name change from In-Home Bronchial Drainage Systems for the Treatment of Cystic Fibrosis and Other Respiratory Disorders to Oscillatory Devices for the Treatment of Cystic Fibrosis and Other Respiratory Disorders
April 2013 Policy title changed from "Oscillatory Devices for the Treatment of Cystic Fibrosis and Other Respiratory Disorders" to "Airway Clearance Devices".  Medically Necessary statement added regarding mechanical insufflation-exsufflation devices.  Added codes A7020 and E0482.
BCBSMT Home
®Registered marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. ®LIVE SMART. LIVE HEALTHY. is a registered mark of BCBSMT, an independent licensee of the Blue Cross and Blue Shield Association, serving the residents and businesses of Montana.
CPT codes, descriptions and material only are copyrighted by the American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS Restrictions Apply to Government Use. CPT only © American Medical Association.
Airway Clearance Devices