Coverage Policy Manual
Policy #: 1998031
Category: DME
Initiated: February 1998
Last Review: June 2023
  Airway Clearance Devices
Description:
Oscillatory devices are used as alternatives to the standard daily percussion and postural drainage (P/PD) method of airway clearance for patients with cystic fibrosis. There are several types of devices including high-frequency chest compression with an inflatable vest and oscillating positive expiratory pressure devices, such as the FLUTTER and Acapella devices. Oscillatory devices are also proposed for other respiratory conditions such as diffuse bronchiectasis and chronic obstructive pulmonary disorder (COPD), and respiratory conditions associated with neuromuscular disorders.
 
Oscillatory devices are designed to move mucus and clear airways; the oscillatory component can be intra- or extra-thoracic. Some of the devices require the active participation of the patient. These include oscillating positive expiratory pressure 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.
 
Mechanical insufflation-exsufflation devices are non-invasive devices designed to simulating a natural cough and clear secretions from the airway. This is achieved by gradually applying positive air pressure (insufflation) to inflate the lungs and then quickly reversing the flow of air by shifting to negative air pressure (exsufflation). The high expiratory flow helps to mobilize secretions out of the airway.
 
Other airway clearance techniques require active patient participation. For example, autogenic drainage and an active cycle breathing both involve a combination of breathing exercises performed by the patient. Positive expiratory pressure therapy requires patients to exhale through a resistor to produce positive expiratory pressures during a prolonged period of exhalation. It is hypothesized that the positive pressure supports the small airway such that the expiratory airflow can better mobilize secretions.
 
High-frequency chest wall oscillation devices (e.g. the Vest™Airway Clearance System) are passive oscillatory devices designed to provide airway clearance without the active participation of the patient. The Vest™ Airway Clearance System provides high-frequency chest compression using an inflatable vest and an airpulse generator. Large-bore tubing connects the vest to the air-pulse generator. The air-pulse generator creates pressure pulses that inflate and deflate the vest against the thorax, creating high frequency chest wall oscillation and mobilization of pulmonary secretions.
  
All of these techniques can be used as alternatives to daily percussion and postural drainage, also known as chest physical therapy or chest physiotherapy, in patients with cystic fibrosis. Daily percussion and postural drainage 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. Oscillatory devices can also potentially be used by patients with other respiratory disorders to promote bronchial secretion drainage and clearance, such as diffuse bronchiectasis and chronic obstructive pulmonary disorder (COPD). Additionally, they could benefit individuals with neuromuscular disease who have impaired cough clearance
 
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:
 
    • Flutter® Mucus Clearance Device in 1994. The Flutter® device is currently marketed in the United States by Axcan Scandipharm.
    • VestAirway Clearance System (Hill-Rom) in 1998
    • The Acapella® device (DHD Healthcare) in 1999.
    • The RC Cornetä Mucus Clearing Device (PARI Respiratory Equipment) in 1999.
    • The inCourage® System (RespirTech) in 2005.
    • Smartvest Airway Clearance System (Electromed) in 2013
    • The AerobiKA oscillating PEP device (Trudell Medical) in 2013.
    • The Vibralung Acoustical Percussor (Westmed) in May 2014.
    • The V estAirway C learance S ystem (Hill-Rom) in 2015
    • The Monarch™ Airway Clearance System (Hill-Rom) in 2017
    • Pulsehaler™ (Respinova) in 2021
 
FDA product codes: BYI, BYT
 
Policy/
Coverage:
Effective August 1, 2023
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
A. Oscillatory Positive Expiratory Pressure (PEP) Devices
 
Use of an oscillatory positive expiratory pressure device meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in individuals with hypersecretory lung disease (i.e., produce excessive mucus), including but not limited to cystic fibrosis and chronic diffuse bronchiectasis, who have difficulty clearing the secretions and recurrent disease exacerbations.
 
 
B. High-frequency Chest Wall Oscillation (HFCWO) and Intrapulmonary Percussive Ventilation (IPV) Devices
 
Initial Review (3-month trial)
 
An initial 3-month trial of a high-frequency chest wall compression device or intrapulmonary percussive ventilation device meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for individuals who meet the FDA labeled indications for the device and the following criteria are met:
 
    • Individual has a diagnosis of:
      • cystic fibrosis confirmed by genetic testing OR  
      • chronic diffuse bronchiectasis defined by a daily productive cough for at least 6 continuous months or exacerbations more than 2 times per year requiring antibiotic therapy and confirmed by high-resolution or spiral chest computed tomography scan
 
AND
 
    • There is documented failure of standard treatments (Chest Physical Therapy or Oscillatory Positive Pressure Device when appropriate) to adequately mobilize retained secretions OR
    • There are valid reasons why standard treatment cannot be performed (inability of caregiver to perform it or standard treatment not tolerated).
 
Continuation (Beyond 3-month trial)
 
Continuation of high-frequency chest wall compression device and or intrapulmonary percussive ventilation device beyond the 3-month trial meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness when documentation is received demonstrating:
 
    • Individual’s tolerance of the device; AND
    • Efficacy of device (Individual’s response to therapy).
 
C. Mechanical In-Exsufflation Devices (Cough Assist Devices)
Mechanical in-exsufflation devices (E0482) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness when ALL of the following criteria are met:  
 
    • Individual has a neuromuscular disease (e.g., amyotrophic lateral sclerosis, congenital myopathies, inclusion body myositis, muscular dystrophy, myasthenia gravis, poliomyelitis, progressive bulbar palsy, spinal muscular atrophy) or high spinal cord injury; and
    • This condition is causing a significant impairment of chest wall and/or diaphragmatic movement; and
    • Standard treatments (e.g., chest percussion and postural drainage, etc.) have not been successful in adequately mobilizing retained secretions
  
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
A. Oscillatory Positive Expiratory Pressure (PEP) Devices
 
Use of an oscillatory positive expiratory pressure device for any indication not described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, use of an oscillatory positive expiratory pressure device for any indication not described above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
 
B. High-frequency Chest Wall Oscillation (HFCWO) and Intrapulmonary Percussive Ventilation (IPV) Devices
 
All other uses of high-frequency chest wall compression devices and intrapulmonary percussive ventilation devices do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. This includes, but is not limited to, the following:
 
    • use in individuals with cystic fibrosis or chronic diffuse bronchiectasis other than as specified above
    • use as an adjunct to chest physical therapy
    • use in other lung diseases such as chronic obstructive pulmonary disease or respiratory conditions associated with neuromuscular disorders
 
For members with contracts without primary coverage criteria, all other uses of high-frequency chest wall compression devices and intrapulmonary percussive ventilation devices are considered investigational. This includes, but is not limited to, the following:
 
    • use in individuals with cystic fibrosis or chronic diffuse bronchiectasis other than as specified above
    • use as an adjunct to chest physical therapy
    • use in other lung diseases such as chronic obstructive pulmonary disease or respiratory conditions associated with neuromuscular disorders
 
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
C. Mechanical In-Exsufflation Devices (Cough Assist Devices)
Mechanical in-exsufflation devices (E0482) for any other circumstance other than stated above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.  
 
For members with contracts without primary coverage criteria, use of a Mechanical in-exsufflation devices for any indication not described above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective January 1, 2023 to July 31, 2023
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
A. Oscillatory Positive Expiratory Pressure (PEP) Devices
 
Use of an oscillatory positive expiratory pressure device meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in individuals with hypersecretory lung disease (i.e., produce excessive mucus), including but not limited to cystic fibrosis and chronic diffuse bronchiectasis, who have difficulty clearing the secretions and recurrent disease exacerbations.
 
 
B. High-frequency Chest Wall Oscillation (HFCWO) and Intrapulmonary Percussive Ventilation (IPV) Devices
 
Initial Review (3-month trial)
 
An initial 3-month trial of a high-frequency chest wall compression device or intrapulmonary percussive ventilation device meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for individuals who meet the FDA labeled indications for the device and the following criteria are met:
 
    • Individual has a diagnosis of:
      • cystic fibrosis confirmed by genetic testing OR  
      • chronic diffuse bronchiectasis defined by a daily productive cough for at least 6 continuous months or exacerbations more than 2 times per year requiring antibiotic therapy and confirmed by high-resolution or spiral chest computed tomography scan
 
AND
 
    • There is documented failure of standard treatments (Chest Physical Therapy or Oscillatory Positive Pressure Device when appropriate) to adequately mobilize retained secretions OR
    • There are valid reasons why standard treatment cannot be performed (inability of caregiver to perform it or standard treatment not tolerated).
 
Continuation (Beyond 3-month trial)
 
Continuation of high-frequency chest wall compression device and or intrapulmonary percussive ventilation device beyond the 3-month trial meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness when documentation is received demonstrating:
 
    • Individual’s tolerance of the device; AND
    • Efficacy of device (Individual’s response to therapy).
 
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
A. Oscillatory Positive Expiratory Pressure (PEP) Devices
 
Use of an oscillatory positive expiratory pressure device for any indication not described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, use of an oscillatory positive expiratory pressure device for any indication not described above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
 
B. High-frequency Chest Wall Oscillation (HFCWO) and Intrapulmonary Percussive Ventilation (IPV) Devices
 
All other uses of high-frequency chest wall compression devices and intrapulmonary percussive ventilation devices do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. This includes, but is not limited to, the following:
 
    • use in individuals with cystic fibrosis or chronic diffuse bronchiectasis other than as specified above
    • use as an adjunct to chest physical therapy
    • use in other lung diseases such as chronic obstructive pulmonary disease or respiratory conditions associated with neuromuscular disorders
 
For members with contracts without primary coverage criteria, all other uses of high-frequency chest wall compression devices and intrapulmonary percussive ventilation devices are considered investigational. This includes, but is not limited to, the following:
 
    • use in individuals with cystic fibrosis or chronic diffuse bronchiectasis other than as specified above
    • use as an adjunct to chest physical therapy
    • use in other lung diseases such as chronic obstructive pulmonary disease or respiratory conditions associated with neuromuscular disorders
 
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective prior to January 1, 2023
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
High-frequency chest wall compression devices (e.g., the Vest™ Airway Clearance System), intrapulmonary percussive ventilation devices (e.g., Percussionaire device) and oscillating positive expiratory pressure devices (e.g., FLUTTER® and Acapella) meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for members who have cystic fibrosis when standard chest physiotherapy has failed, is unavailable or not tolerated.
 
Oscillating Positive Expiratory Pressure devices (e.g. Flutter and Acapella) meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the treatment of patients with non-cystic fibrosis bronchiectasis or hypersecretory lung disease (i.e., produce excess mucus) who have difficulty clearing secretions and recurrent disease exacerbations.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
The use of high-frequency chest wall compression devices (e.g., the Vest™ Airway Clearance System), intrapulmonary percussive ventilation devices (e.g., Percussion aire device) and oscillating positive expiratory pressure devices (e.g., FLUTTER® and Acapella) in patients with cystic fibrosis for any other reason does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For contracts without primary coverage criteria,  high-frequency chest wall compression devices (e.g., the Vest™ Airway Clearance System), intrapulmonary percussive ventilation devices (e.g., Percussion aire device) and oscillating positive expiratory pressure devices (e.g., FLUTTER® and Acapella) in patients with cystic fibrosis for any other reason is considered investigational.  Investigational services are exclusions in the member benefit certificate of coverage.
 
The use of these devices in any other circumstance does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.  For contracts without primary coverage criteria, the use of these devices in any other circumstance is considered investigational.  Investigational services are exclusions in the member benefit certificate of coverage.
 
Effective February 2010 – July 2017
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
High-frequency chest wall compression devices (e.g., the Vest™ Airway Clearance System), intrapulmonary percussive ventilation devices (e.g., Percussionaire device) and oscillating positive expiratory pressure devices (e.g., FLUTTER® and Acapella) meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for members age 17years or older who have cystic fibrosis when standard chest physiotherapy has failed, is unavailable or not tolerated.
 
Oscillating Positive Expiratory Pressure devices (e.g. Flutter and Acapella) meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the treatment of patients with non-cystic fibrosis bronchiectasis or hypersecretory lung disease (i.e., produce excess mucus) who have difficulty clearing secretions and recurrent disease exacerbations.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
The use of  high-frequency chest wall compression devices (e.g., the Vest™ Airway Clearance System), intrapulmonary percussive ventilation devices (e.g., Percussion aire device) and oscillating positive expiratory pressure devices (e.g., FLUTTER® and Acapella) in patients with cystic fibrosis for any other reason does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For contracts without primary coverage criteria,  high-frequency chest wall compression devices (e.g., the Vest™ Airway Clearance System), intrapulmonary percussive ventilation devices (e.g., Percussion aire device) and oscillating positive expiratory pressure devices (e.g., FLUTTER® and Acapella) in patients with cystic fibrosis for any other reason is considered investigational.  Investigational services are exclusions in the member benefit certificate of coverage.
 
The use of these devices in any other circumstance does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.  For contracts without primary coverage criteria, the use of these devices in any other circumstance is considered investigational.  Investigational services are exclusions in the member benefit certificate of coverage.
 
Effective November 2007 through January 2010
Oscillatory devices for chest physical therapy meet primary coverage criteria for effectiveness and are covered for members age 17 years or older who have cystic fibrosis dependent on member certificate language.   The use of the device in  in any other circumstance does not meet Primary Coverage Criteria and is not covered.  Studies have not shown superiority of the device compared to traditional chest physiotherapy.
 
For contracts without Primary Coverage Criteria, the use of an oscillatory device for any reason other than cystic fibrosis patients 17 years of age or older is considered investigational and not covered.  Investigational services are a contract exclusion.
 
Effective November 2001 through October 2007
Oscillatory devices for chest physical therapy are not covered based on benefit contract exclusion.
 
Effective June 2000 through October 2001
Oscillatory devices are considered not medically necessary as an alternative to chest physical therapy in patients with cystic fibrosis; Randomized trials have shown no increased benefit from oscillatory devices as compared to conventional chest physical therapy.
 
Other applications of oscillatory devices, including, but not limited to, their use as an adjunct to chest physical therapy or their use in diseases other than cystic fibrosis are not covered based on contract exclusion.
 
Rationale:
This policy was originally created in 1998. It has been updated regularly with searches of the MEDLINE and PubMed databases. For a copy of the complete rationale prior to June 2022, please email: codespecificinquiry@arkbluecross.com. The most recent literature update was performed through April 19, 2021. Following is a summary of the key literature:
 
Cystic Fibrosis
Systemic Reviews
A number of RCTs and a Cochrane systematic review of RCTs have evaluated oscillatory devices for treating patients with CF. The Cochrane review addressed a variety of oscillatory devices, was last updated by Morrison and Milroy (Morrison, 2020). The dates of the review are from inception to July 2019. It consisted of 39 trials with a total of 1114 participants with cystic fibrosis. It consisted of RCT and controlled studies with a duration between 2 days to 2.8 years. Outcomes included pulmonary function, sputum weight and volume, hospitalization rate, and QOL measures. Meta-analysis was limited due to the variety of devices, outcome measures, and lengths of follow-up used. Reviewers concluded that there was a lack of evidence supporting the superiority of oscillatory devices versus any other form of physical therapy or that 1 device was superior over another, and that there is a need for adequately powered RCTs with long-term follow-up.
 
Randomized Controlled Trials
Mcllwaine et al published an RCT comparing high-frequency chest wall oscillation (HFCWO) with PEP mask therapy (McIlwaine, 2013). The trial consisted to 107 children with cystic fibrosis over the age of 6. It took place at 12 sites in Canada between 2008-2012. The primary outcome measure was the number of pulmonary exacerbations requiring an antibiotic. At the end of 1 year, patients in the PEP arm had a statistically significant lower incidence of pulmonary exacerbations requiring antibiotics compared with HFCWO group. The time to first pulmonary exacerbation was 220 days in the PEP group and 115 days in the HFCWO group (p=.02). There were no statistically significant differences in pulmonary measures, including the forced expiratory volume in 1 second (FEV1).
 
Sontag et al published a multicenter RCT that compared postural drainage, the Flutter device, and HFCWO (Sontag, 2010). The trial consisted of 166 patients (children and adult) with cystic fibrosis. It took place at 20 sites in the United States between 1999-2002. At study termination, patients had a final assessment; the length of participation ranged from 1.3 to 2.8 years. An intention-to-treat analysis found no significant differences between treatment groups in the modeled rate of decline for percent predicted FEV1 or forced vital capacity (FVC). The small sample size and high dropout rate limited the conclusions drawn from this trial.
 
Pryor et al evaluated 75 patients age 16 years and older with CF from a single center in the U.K. (Pryor, 2010). This RCT consisted of 75 patients with cystic fibrosis 16 years of age and older. Sixty-five (87%) of 75 patients completed the trial and were included in the analysis. Although the study was described as a noninferiority trial, it was not statistically analyzed as such. Instead, no statistically significant differences among the regimens in the primary outcome measure of FEV1 were construed as evidence for noninferiority.
 
Radtke et al evaluated 15 adult patients with cystic fibrosis using the Flutter with moderate intensity interval cycling exercise to measure pulmonary diffusing capacity (Radtke, 2018). The outcomes of interest included pulmonary function, sputum viscosity and volume, hospitalization rate and QOL measures. The results yielded no differences in absolute changes in pulmonary diffusion capacity.
 
A number of RCTs evaluating oscillatory devices have reported mixed findings and limitations (eg, small sample sizes, large dropout rates). A systematic review identified 39 RCTs comparing oscillatory devices with another recognized airway clearance techniques; some were published only as abstracts. The study findings were not pooled due to heterogeneity in designs and outcome measures. The systematic review concluded that results from additional RCTs with adequate power and long-term follow-up would permit conclusions on the effect of oscillatory devices on outcomes for CF.
 
Bronchiectasis
Systematic Reviews
Lee et al published a Cochrane review of airway clearance techniques for treating bronchiectasis (Lee, 2015). It consisted of 7 RCTS between 1966-2015. Participants consisted of adults and children diagnosed with bronchiectasis based on plain-film chest radiography, bronchography, high-resolution computed tomography or physician diagnosis. Of the 7 RCTs, 6 were crossover trials. Five trials used a PEP device, 1 used HFCWO, and 1 used postural drainage. Reviewers did not pool study findings due to heterogeneity among studies. Primary outcomes of interest were pulmonary exacerbations, hospitalizations for bronchiectasis, and QOL.
 
Randomized Controlled Trials
Murray et al reported on a crossover study with 20 patients radiologically diagnosed with bronchiectasis. The number of exacerbations did not differ statistically at 12 weeks (Murray, 2009). Cough-related QOL was significantly better after 12 weeks of any airway clearance technique compared with no airway clearance. Cochrane reviewers noted that the study was not blinded, and that patient-reported QOL measures may have been subject to bias.
 
Herrero-Cortina et al reported on a crossover RCT with 31 patients radiologically diagnosed with bronchiectasis (Herrero-Cortina, 2016). The interventions were temporary PEP, autogenic drainage, and slow expiration with the glottis opened in the lateral position. There were no significant differences among treatments in the mean sputum clearance during the 24-hour period after each intervention, cough severity (measured using the total Leicester Cough Questionnaire score), or in lung function measures (eg, FEV1).
 
A 2015 systematic review identified 7 small RCTs assessing several types of oscillatory devices; only 1 reported the clinically important outcomes exacerbations or hospitalizations. Three reported on QOL, and trial findings were mixed. A 2016 crossover RCT did not find a significant benefit of temporary PEP compared with other airway clearance techniques.
 
Chronic Obstructive Pulmonary Disease
Systematic Reviews
Systematic reviews have evaluated studies of airway clearance techniques in patients with COPD (Ides, 2011; Osadnik, 2012; Alghamdi, 2020). Two early reviews addressed various techniques (ie, they were not limited to studies on oscillatory devices) while the most recent review was specific to oscillatory devices. The review by Ides et all consisted of 26 trials between 1980-2008. There were a total of 659 patients with COPD. The review by Osadinik et al took place from inception to 2009 (PEDro) or 2011 (CAGR). It consisted of 28 trials with 907 participants with investigator defined COPD, emphysema or chronic bronchitis. Studies included in the systematic reviews were mostly small. and reviewers noted that quality of evidence was generally poor. The meta-analysis conducted by Alghamdi et al found oscillatory PEP to reduce exacerbations (odds ratio 0.37, 95% confidence interval [CI] 0.19-0.72) and improved 6 minute walk distance (mean difference, 49.8 m, 95% CI 14.2 to 85.5 m), but the authors noted the need for higher-quality studies (Alghamdi, 2020). This study consisted of 8 trials from inception to March 2020. It consisted of 381 patients with COPD.
 
Randomized Controlled Trials
Chakrovorty et al reported results of a crossover RCT among patients with moderate-to-severe COPD and mucus hypersecretion (Chakravorty, 2011). Participants included 38 individuals with at least 1 COPD exacerbation with FEV1 <0.8, FEV1/FVC <0.7, and a daily wet sputum volume of >25 ml.  The active group wore the SmartVest Airway Clearance System while the comparator group did not. Patients received HFCWO or conventional treatment in random order, for 4 weeks, with a 2-week washout period between treatments. The primary outcome was QOL as measured using the St. George's Respiratory Questionnaire (SGRQ). Only 1 of 4 dimensions of the SGRQ (the symptom dimension) improved after HFCWO compared with baseline, with a decrease in mean score from 72 to 64 (p=.02). None of the 4 SGRQ dimensions improved after conventional treatment. There were no significant pre- to posttreatment differences in secondary outcomes (eg, FEV1, FVC).
 
Svenningsen et al reported on results of an unblinded, industry-funded, randomized crossover study (Svenningsen, 2016). Participants included 32 individuals with COPD self-identified as sputum-producers or non-sputum-producers. The active group wore the oscillatory PEP (AerobiKA device) while the comparator group did not. Each intervention period lasted 21 to 28 days. In the nonsputum producers, scores differed significantly only on the Patient Evaluation Questionnaire total score. In patients who were sputum-producers at baseline, pre- versus post-PEP scores differed significantly for FVC, 6-minute walk distance, SGRQ total score, and the Patient Evaluation Questionnaire ease of bringing up sputum and patient global assessment subscales. It is unclear if the interventions were clinically meaningful. The crossover studies had similar limitations including no between-group comparisons (ie, outcomes after oscillatory device use vs the control intervention), lack of intention-to-treat analysis, and short-term follow-up (immediate posttreatment period).
 
Goktalay et al reported on the results of a parallel-group RCT (Goktalay, 2013). Participants included 50 patients with stage 3 or 4 COPD hospitalized for COPD exacerbation. Patients were randomized to 5 days of treatment with medical therapy plus HFCWO (n=25) or medical therapy only (n=25). At day 5, outcomes including FEV1, modified Medical Research Council dyspnea scale scores, and the 6-minute walk distance, did not differ significantly between groups. This short-term trial included hospitalized patients who might differ from COPD patients treated on an outpatient basis.
 
Only a few controlled studies have evaluated oscillatory devices for the treatment of COPD, and they tended to use intention-to-treat analysis and between-group comparisons. The published studies reported mixed findings and did not support the use of oscillatory devices in COPD patients.
 
Respiratory Conditions Related to Neuromuscular Disorders
Systematic Reviews
A Cochrane review by Winfield et al evaluated the nonpharmacologic management of respiratory morbidity in children with severe global developmental delay treated with airway clearance techniques (Winfield, 2014). The review consisted of 15 trials in children up to 18 years of age. Reviewers included RCTs and nonrandomized comparative studies. They identified 3 studies on HFCWO (1 RCT, 2 pre-post) and one on PEP (pre-post), with sample sizes from 15 and 28 patients. As a result of heterogeneity, a meta-analysis was not conducted.
 
Randomized Controlled Trials
Yuan et al reported results of a parallel-arm RCT (Yuan, 2010). Participants included 28 individuals with cerebral palsy or neuromuscular disease attending a pediatric pulmonary clinic. The active group received HCFWO and the comparator group had standard chest physical therapy. Both groups were instructed to perform the assigned treatment for 12 minutes, 3 times a day for the study period (mean, 5 months). There were no statistically significant differences between groups on primary outcomes. No therapy-related adverse events were reported in either group.
 
Lange et al reported on results of a parallel-arm RCT in adults with amyotrophic lateral sclerosis (Lange, 2006). Participants included 46 adults with amyotrophic lateral sclerosis in 6 sites in the United States. The active group received HCFWO and the comparator group had no treatment. Patients were randomized to 12 weeks of HCFWO or usual care. There were no statistically significant between-group differences in pulmonary measures (FVC predicted, capnography, oxygen saturation, or peak expiratory flow). There was also no significant difference in the amyotrophic lateral sclerosis Functional Rating Scale respiratory subscale score (worsening) at 12 weeks. Of symptoms assessed as secondary outcomes, there was significantly less breathlessness and night cough in the HCFWO group than in the usual care group, and groups did not differ significantly on other symptoms, including the noise of breathing, suction frequency, suction amount, day cough, and nocturnal symptoms.
 
Two RCTs and a systematic review have evaluated oscillatory devices for treatment of respiratory conditions in neuromuscular disorders. One RCT was not powered to detect statistical significance. The other, conducted in amyotrophic lateral sclerosis patients, did not find statistically significant improvement after HCFWO compared with usual care for the primary outcomes (pulmonary function measures) or most secondary outcomes.
 
SUPPLEMENTAL INFORMATION
Clinical Input From Physician Specialty Societies and Academic Medical Centers
While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.
 
In response to requests, input was received from 2 academic medical centers while this policy was under review in 2008. Input indicated the available studies demonstrated that these oscillatory devices are comparable with chest physical therapy for cystic fibrosis and bronchiectasis. The most commonly mentioned clinical criteria were patients who failed or were intolerant of other methods of mucus clearance and patients who lacked caregivers to provide chest physical therapy. Input did not support the use of oscillatory devices for treatment of chronic obstructive pulmonary disease.
 
American College of Chest Physicians
In 2006, the guidelines from the American College of Chest Physicians recommended (level of evidence: low) that, in patients with cystic fibrosis, devices designed to oscillate gas in the airway, either directly or by compressing the chest wall, can be considered as an alternative to chest physical therapy (McCool, 2006).
 
Cystic Fibrosis Foundation
In 2009, the Cystic Fibrosis Foundation published guidelines on airway clearance therapies based on a systematic review of evidence (Flume, 2009). The Foundation recommended airway clearance therapies for all patients with cystic fibrosis but stated that no therapy had been demonstrated to be superior to others (level of evidence: fair; net benefit: moderate; grade of recommendation: B).
 
Medicare National Coverage
There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.
 
Ongoing and Unpublished Clinical Trials
  • NCT03013452 Oscillating PEP vs Autogenic Drainage in People With Bronchiectasis (oPEP-vs-AD) has a planned enrollment of 50 participants. It has a scheduled completion date of June 2020
  • NCT04271969 Clinical Effectiveness Of High Frequency Chest Wall Oscillation (HFCWO) In A Bronchiectasis Population has a planned enrollment of 100 participants. It has a planned completion date of June 2022
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Alghamdi et al compared the Acapella device to usual care in patients with stable COPD (N=122) (Alghamdi, 2023). The primary outcome was the change from baseline in LCQ score. Results demonstrated significant improvement in LCQ scores with the use of Acapella compared to usual care.
 
August 2023 Update
A literature search was performed using the MEDLINE database through July 2023.  
 
Bach (2023) published a review of the effectiveness of mechanical insufflation-exsufflation for stimulating cough flows to clear airway secretions and reported positive results in patients with neuromuscular disease.
 
Auger et al (2017) published a systematic review of literature to analyze the benefit/risk ratio of the use of mechanical insufflation-exsufflation (MI-E) devices for airway clearance in patients with neuromuscular diseases. Twelve studies met the inclusion criteria (4 randomized controlled trials, 3 comparative studies, and 5 observational studies). The quality of the selected studies was overall poor.However, the author noted that there are an absence of alternatives for non-invasive devices for airway clearance.
 
Rose et al (2017) published a Cochrane review of cough augmentation techniques for extubation or weaning from mechanical ventilation. The researchers identified two trials (1 of which was a randomized controlled trial) and one cohort study. The studies reported higher extubation rate in the mechanical insufflation-exsufflation (MI-E) group.  Cough augmentation techniques when used in mechanically ventilated critically-ill people appear to result in few adverse events. However, overall quality of evidence on the efficacy of cough augmentation techniques for critically-ill people is very low.
CPT/HCPCS:
A7020Interface for cough stimulating device, includes all components, replacement only
A7025High frequency chest wall oscillation system vest, replacement for use with patient owned equipment, each
A7026High frequency chest wall oscillation system hose, replacement for use with patient owned equipment, each
E0481Intrapulmonary percussive ventilation system and related accessories
E0482Cough stimulating device, alternating positive and negative airway pressure
E0483High frequency chest wall oscillation system, with full anterior and/or posterior thoracic region receiving simultaneous external oscillation, includes all accessories and supplies, each
E0484Oscillatory positive expiratory pressure device, non electric, any type, each
S8185Flutter device
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