Oscillatory Devices for the Treatment of Cystic Fibrosis and Other Respiratory Disorders
Durable Medical Equipment
|Original Policy Date
|Last Review Status/Date
Reviewed with literature search/2:2015
|Return to Medical Policy Index|
Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.
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 (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 handheld 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.
Other airway clearance techniques require active patient participation. For example, autogenic drainage and active cycle of breathing technique both involve a combination of breathing exercises performed by the patient. PEP therapy requires patients to exhale through a resistor to produce PEPs 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.
In contrast, high-frequency chest wall oscillation (HFCWO) devices (eg, the Vest Airway Clearance System, formerly known as the ABI Vest or the ThAIRapy Bronchial Drainage 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 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 Percussionaire device delivers intrapulmonary percussive ventilation (IPV) and is another type of passive oscillatory device. This device combines internal thoracic percussion through rapid minibursts of inhaled air and continuous therapeutic aerosol delivered through a nebulizer.
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 COPD.
This policy addresses outpatient use of oscillatory devices. Inpatient device use, eg, in the immediate postsurgical period, is not included in the policy.
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. The Flutter® device is currently marketed in the United States by Axcan.
- The ThAIRapy Bronchial Drainage System in 1998. Since that time, updated versions of the device were cleared by 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 Acapella® device (DHD Healthcare) in 1999.
- The RC Cornet™ Mucus Clearing Device (PARI Respiratory Equipment) in 1999.
- The inCourage® System (Respiratory Technologies; Lakeville, MN) in 2005.
- The Vibralung Acoustical Percussor (Westmed Inc., Tucson AZ) in May 2014
FDA product codes: BYI, BYT
Use of an oscillatory PEP device may be considered medically necessary in patients with hypersecretory lung disease (ie, produce excessive mucus) who have difficulty clearing the secretions and recurrent disease exacerbations.
High-frequency chest wall compression devices and IPV devices may be considered medically necessary in patients with cystic fibrosis or chronic diffuse bronchiectasis as determined by specific criteria (see Policy Guidelines section) (including chest computed tomography [CT] scan) when standard chest physical therapy has failed OR standard chest physical therapy is unavailable or not tolerated. In considering the chest wall compression and IPV devices, there should be demonstrated need for airway clearance. There should also be documented failure of standard treatments, ie, the patient has frequent severe exacerbations of respiratory distress involving inability to clear mucus despite standard treatment (chest physical therapy and, if appropriate, use of an oscillatory PEP device) or valid reasons why standard treatment cannot be performed, such as inability of the caregiver to perform it.
High-frequency chest wall compression devices and intrapulmonary percussive ventilation devices are considered not medically necessary as an alternative to chest physical therapy in patients with cystic fibrosis or chronic bronchiectasis in any other clinical situations; there are no clinical data to show that these devices provide any additional health benefit compared with conventional chest physical therapy in situations other than those specified here.
Other applications of high-frequency chest wall compression devices and intrapulmonary percussive ventilation devices, including, but not limited to, their use as an adjunct to chest physical therapy or their use in other lung diseases, such as chronic obstructive pulmonary disease, are considered investigational.
For this policy, chronic diffuse bronchiectasis is defined by daily productive cough for at least 6 continuous months or more than 2 times per year exacerbations requiring antibiotic therapy and confirmed by high-resolution or spiral chest computed tomography scan.
For the chest wall compression devices, a trial period to determine patient and family compliance may beconsidered. Those who appear to benefit most from the compression devices are adolescents and adults due to lifestyle factors in which manual P/PD may essentially not be available.
A trial period may also be helpful because patients’ responses to the various types of devices can be variable; the types of devices should be considered as alternative, and not equivalent, devices.
BlueCard/National Account Issues
Oscillatory devices such as the Flutter® device, the Vest™ Airway Clearance System, and Percussionaire IPV® device have been primarily investigated as an alternative (not adjunct) to conventional chest physical therapy. Since the published clinical data do not suggest that these devices are associated with an increased health benefit, their use primarily represents a convenience to the patient, and it is on this basis that they are considered not medically necessary (unless conventional chest physical therapy has failed or is unavailable).
This policy was originally created in 1997 and was updated regularly with searches of the MEDLINE database. Most recently, the literature was reviewed through December 15, 2014. Following is a summary of the key literature.
A number of randomized controlled trials (RCTs) and a Cochrane systematic review of RCTs have evaluated oscillatory devices for the treating patients with cystic fibrosis (CF). The Cochrane review was updated in 2014.(1) Investigators identified 35 RCTs with a total of 1050 patients that compared oscillatory devices with another recognized airway clearance technique. Fifteen studies used a parallel design and 20 were crossover studies. Ten of the included studies were published as abstracts only. Sixteen were conducted in the United States, and 14 of these were single-center studies. Sample sizes of individual studies ranged from 5 to 166 and half of the studies included children. Outcomes included pulmonary function, sputum weight and volume, hospitalization rate, and quality-of-life measures. Findings of the studies could not be pooled due to the variety of devices used, outcome measures, and lengths of followup. 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 RCTs with long-term follow-up.
Representative recent RCTs follow.
In 2013, Mcllwaine et al published an RCT comparing 2 types of oscillatory devices.(2) The study differed from previous trials in several ways. It had a larger sample size (N=107) and the primary outcome measure was a clinically meaningful outcome, ie, number of pulmonary exacerbations requiring an antibiotic. Moreover, the study was conducted over a relatively long time period (1 year), was multicenter, and was not industry-funded, although industry did donate devices.
The study included individuals older than 6 years of age with clinically stable CF; age ranged from 6 to 47 years. Patients were randomized to perform either positive expiratory pressure (PEP) using a face mask (n=51) or high-frequency chest wall oscillation (HFCWO) using the inCourage system (n=56) for 1 year. After randomization, there was a 2-month washout period (without knowledge of treatment group assignment). Eight patients in each arm dropped out after randomization and before treatment, and another 3 patients dropped out during the intervention phase. Eighty-eight (82%) of 107 randomized patients completed the study. By the end of 1 year, there were 49 exacerbations requiring antibiotics in the PEP group and 96 in the HFCWO group; the difference between groups was statistically significant, favoring PEP (p=0.007). The time to first pulmonary exacerbation was 220 days in the PEP group and 115 days in the HFCWO group (p=0.02). There was not a statistically significant difference in pulmonary measures, including forced expiratory volume in 1 second (FEV1). Limitations of this study were that patients were not blinded, and there was a nearly 20% dropout rate.
In 2010, Sontag et al published a multicenter randomized trial with 166 adults and children with CF.(3) Patients were assigned to receive treatment with percussion and postural drainage (P/PD; n=58), the Flutter device (n=51), or the Vest (n=57). Investigators planned to evaluate participants on a quarterly basis for 3 years. However, dropout rates were high and consequently the trial ended early; 35 (60%), 16
(31%), and 5 (9%) patients withdrew from the postural drainage, Flutter, and Vest groups, respectively. Fifteen patients withdrew in the first 60 days (11 of these on the day of randomization) and the remainder after 60 days. The most common reasons for withdrawal after 60 days were moved or lost to follow-up (n=13), and lack of time (n=7). At study termination, patients had a final assessment; the length of participation ranged from 1.3 to 2.8 years. An intention-to-treat (ITT) analysis found no significant differences between treatment groups in the modeled rate of decline for FEV1 predicted or forced vital capacity (FVC) percent predicted. The small sample size and high dropout rate greatly limit the conclusions that might be drawn from this study.
Pryor et al (2010) evaluated patients aged 16 years and older with CF from a single center from the U.K.(4) The 75 patients were randomly assigned to receive 1 of 5 treatments for 1 year (15 per group): the Cornet device, the Flutter device, PEP, active cycle of breathing technique or autogenic drainage. Sixty-five (87%) of 75 patients completed the study and were included in the analysis. Mean (SD) FEV1 values at
12 months, the primary outcome, were 1.90 (0.89) in the Cornet group (n=14), 2.43 (0.94) in the Flutter group (n=12), 2.02 (1.17) in the PEP group (n=13), 1.94 (0.80) in the active cycle of breathing group (n=13), and 2.64 (1.22) in the autogenic drainage group (n=13). The difference among the 5 groups was not statistically significant for FEV1 or any other lung function variable; however, this study had a small
number of patients per group.
A number of RCTs and systematic reviews have tended to find that oscillatory devices are at least as effective as chest physical therapy for treatment of CF. There is limited evidence that 1 device is superior to another, although a 2013 RCT found better outcomes with PEP than HFCWO.
In 2013, Lee et al published a Cochrane review on airway clearance techniques for treating bronchiectasis.(5) Five small RCTs comparing airway clearance techniques with sham or an alternative treatment were identified. Sample sizes ranged from 8 to 20 patients, and the 5 studies included a total of 51 patients. Three of the 5 trials used the Flutter device and all were unblinded. The investigators did not pool study findings. Only 1 trial, a crossover study with 20 patients, reported primary outcomes of interest to Cochrane investigators: exacerbations and quality of life. This trial, published by Murray et al, did not find a statistically significant difference at 12 weeks in the number of exacerbations; there were 5 exacerbations with the Acapella device and 7 without the Acapella device (p=0.48).(6) There was
significantly better cough-related quality of life after 12 weeks of airway clearance compared with no airway clearance.
Also in 2013, Nicolini et al published an RCT evaluating HFCWO using the Vest Airway Clearance System in patients with bronchiectasis.7 Participants were randomized to 1 of 3 groups: HFCWO (n=10), chest physical therapy (n=10,) or medical therapy without airway clearance (n=10). Patients were treated 5 days a week for 15 days. The primary outcome measures included the Breathlessness, Cough and Sputum Scale (BCSS), the COPD Assessment Test (CAT), and the Modified Medical Research Council (MMRC) Dyspnea Scale. On all of these measures, the HFCWO and chest physical therapy groups showed significantly greater improvement compared with the medical treatment-only group (p=0.001 for each comparison). In addition, improvement on the BCBSS and CAT scales, but not the MMRC scale was significantly better in the HFCWO group compared with the chest physical therapy group.
A 2013 systematic review identified only 5 small RCTs evaluating oscillatory devices for treating bronchiectasis and most of these did not report clinically important outcomes. Another small RCT, not included in the systematic review, found better outcomes with HFCWO or chest physical therapy compared with medical treatment alone. In this study, HFCWO was at least as good as chest physical therapy, and superior to chest physical therapy on some outcome measures.
Chronic Obstructive Pulmonary Disease
At least 2 systematic reviews of studies on airway clearance techniques in patients with chronic obstructive pulmonary disease (COPD) have been published.(8,9) Both reviews addressed a variety of techniques ie, they were not limited to studies on oscillatory devices. The 2011 review by Ides et al identified 6 studies evaluating PEP in COPD patients, 4 of which used oscillatory devices (Flutter or Cornet), and one 2007 study of high-frequency chest wall oscillation.(8) Sample sizes in individual studies ranged from 10 to 50 patients; the study with the largest sample size was published in German. The Ides review did not pool study findings but the authors commented that the evidence on techniques such as oscillating PEP is poor due to a lack of appropriate trials. The 2012 Cochrane review on airway clearance techniques for COPD did not specifically discuss the number of studies or the results of studies on oscillatory devices.(9)
More recent studies that have evaluated HFCWO in patients with COPD tended to find that HFCWO did not result in significant improvement in health outcomes. Chakrovorty et al (2011) in the United Kingdom published a randomized crossover study that included patients with moderate to severe COPD and mucus hypersecretion.10 Patients received HFCWO or conventional treatment, in random order, for 4 weeks, with a 2-week washout period between treatments. Thirty patients enrolled in the study and 22 (73%) completed the trial; 8 patients withdrew due to COPD exacerbations. The primary outcome was quality of life; this was measured with the St. George’s Respiratory Questionnaire (SGRQ). Only 1 of 4 dimensions of the SGRQ (the symptom dimension) improved after HFCWO compared with before treatment, with a decrease in mean score from 72 to 64 (p=0.02). None of the 4 dimensions of the SGRQ improved after conventional treatment. There were no significant differences in secondary outcomes such as FEV1 or FVC after either treatment compared with before treatment. The study was limited by the relatively high dropout rate and lack of ITT analysis.
In 2013, Goktalay et al in Turkey published a study that included 50 patients with stage 3-4 COPD who were hospitalized for COPD exacerbations.(11) Patients were randomized to receive 5 days of treatment with medical therapy plus HFCWO using the Vest Airway Clearance System (n=25) or medical therapyonly (n=25). At day 5, outcomes, including FEV1, scores on the MMRC dyspnea scale and the 6-minute walk test, did not differ significantly between groups. This was a short-term study and included hospitalized patients who may not be similar to COPD patients treated on an outpatient basis.
There are limited studies evaluating oscillatory devices for the treatment of COPD, and the available evidence did not tend to find that these devices were more effective than conventional treatment.
Clinical Input Received 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 December 2008. The reviewers indicated that the available studies demonstrate that these devices are comparable with chest physical therapy for both CF and bronchiectasis. The clinical input was not supportive of using oscillatory devices for treatment of COPD.
Summary of Evidence
Oscillatory devices are designed to move mucus and clear airways. In patients with cystic fibrosis (CF), it is difficult to reach scientific conclusions regarding the relative efficacy of oscillatory therapies compared with standard treatment with daily percussion and postural drainage. However, findings from randomized controlled trials (RCTs), combined with clinical input, suggest that oscillatory devices may be comparable with chest physical therapy 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 chest physical therapy has failed or is unavailable or not tolerated by the patient. A 2013 RCT, conducted with CF patients, found better outcomes with positive expiratory pressure (PEP) than high-frequency chest wall oscillation, but other evidence on the relative efficacy of devices is limited. The Flutter® device, autogenic drainage, and PEP are simple devices or maneuvers that can be learned by most patients. In contrast, intrapulmonary percussive ventilation or high-frequency chest wall compression, eg, with the Vest™ Airway Clearance System are more complex devices.
The use of high-frequency chest wall compression and intrapulmonary percussive ventilation devices in other chronic pulmonary diseases, such as chronic obstructive pulmonary disorder, is considered investigational due to insufficient evidence on the impact of treatment on health outcomes.
Practice Guidelines and Position Statements
The 2006 guidelines from the American College of Chest Physicians recommended (level of evidence; low) that in patients with CF, 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.(12)
In April 2009, the Cystic Fibrosis Foundation published guidelines on airway clearance therapies based on a systematic review of evidence.(13) They recommended 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.
U.S. Preventive Services Task Force Recommendations
Medicare National Coverage
There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.
- Morrison L, Agnew J. Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. 2014;7:CD006842. PMID 25038719
- McIlwaine MP, Alarie N, Davidson GF, et al. Long-term multicentre randomised controlled study of high frequency chest wall oscillation versus positive expiratory pressure mask in cystic fibrosis. Thorax. Aug 2013;68(8):746-751. PMID 23407019
- Sontag MK, Quittner AL, Modi AC, et al. Lessons learned from a randomized trial of airway secretion clearance techniques in cystic fibrosis. Pediatr Pulmonol. 2010;45(3):291-300.
- Pryor JA, Tannenbaum E, Scott SF, et al. Beyond postural drainage and percussion: Airway clearance in people with cystic fibrosis. J Cyst Fibros. 2010;9(3):187-192.
- Lee AL, Burge A, Holland AE. Airway clearance techniques for bronchiectasis. Cochrane Database Syst Rev. 2013;5:CD008351. PMID 23728674
- Murray MP, Pentland JL, Hill AT. A randomised crossover trial of chest physiotherapy in non-cystic fibrosis bronchiectasis. Eur Respir J. Nov 2009;34(5):1086-1092. PMID 19541717
- Nicolini A, Cardini F, Landucci N, et al. Effectiveness of treatment with high-frequency chest wall oscillation in patients with bronchiectasis. BMC Pulm Med. 2013;13:21. PMID 23556995
- Ides K, Vissers D, De BL, et al. Airway clearance in COPD: need for a breath of fresh air? A systematic review. Copd. 2011;8(3):196-205.
- Osadnik CR, McDonald CF, Jones AP, et al. Airway clearance techniques for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012;3:CD008328. PMID 22419331
- Chakravorty I, Chahal K, Austin G. A pilot study of the impact of high-frequency chest wall oscillation in chronic obstructive pulmonary disease patients with mucus hypersecretion. Int J Chron Obstruct Pulmon Dis. 2011;6:693-699. PMID 22259246
- Goktalay T, Akdemir SE, Alpaydin AO, et al. Does high-frequency chest wall oscillation therapy have any impact on the infective exacerbations of chronic obstructive pulmonary disease? A randomized controlled single-blind study. Clin Rehabil. Aug 2013;27(8):710-718. PMID 23503735
- McCool FD, Rosen MJ. Nonpharmacologic airway clearance therapies: ACCP evidence-based clinical practice guidelines. Chest. 2006;129(1 suppl):250S-259S.
- Flume PA, Robinson KA, O’Sullivan BP, et al. Cystic fibrosis pulmonary guidelines: airway clearance therapies. Respirat Care. 2009;54(4):522-537.
|ICD-9 Procedure||93.18||Breathing exercise|
|ICD-9 Diagnosis||277.00-277.09||Cystic Fibrosis NOS|
|494.0, 494.1||Bronchiectasis without and with acute exacerbations, respectively|
|HCPCS||E0483||High frequency chest wall oscillation air-pulse generator system (includes hoses and vest), each|
|A7025||High frequency chest wall oscillation system vest, replacement for use with patient-owned equipment, each|
|A7026||High frequency chest wall oscillation system hose, replacement for use with patient-owned equipment, each|
|E0481||Intrapulmonary percussive ventilation system and related accessories|
|E0484||Oscillatory positive expiratory pressure device, non-electric, any type|
|ICD-10-CM (effective 10/1/15)||E84.0-E84.9||Cystic fibrosis code range|
|J47.1-J47.9||Broncheictasis code range|
|ICD-10-PCS (effective 10/1/15)||ICD-10-PCS codes are only used for inpatient services. There are no ICD-10-PCS codes for devices and there is no is no specific ICD-10-PCS code for this therapy.|
|F07C6ZZ||Physical rehabilitation and diagnostic audiology, rehabilitation, motor treatment, respiratory system- whole body, therapeutic exercise|
|Type of Service||Pulmonary|
|Place of Service||Home|
Cystic Fibrosis, Oscillatory Devices
High Frequency Chest Compression
Intrapulmonary Percussive Ventilation (IPV)
IPV (Intrapulmonary Percussive Ventilation)
Oscillatory Devices for Cystic Fibrosis
|11/01/97||Add to DME Section||New policy|
|07/12/02||Replace policy||Policy reviewed and updated, no change in policy statement|
|10/09/03||Replace policy||Literature review updated, expanded policy title, Medicare policy and new HCPCS codes added; policy statement unchanged|
|04/16/04||Replace policy||Policy updated with literature review. Acapella device added (similar to Flutter device); no change in policy statement|
|4/1/05||Replace policy||Policy updated with literature review; no changes in policy statement.|
|10/10/06||Replace policy||Policy updated with literature review through August 2006; policy statement unchanged. References 14-16 added and reference 17 is renumbered.|
|12/11/08||Replace policy||Policy updated with literature review; reference numbers 17 – 21 added. Clinical input reviewed. Policy statements changed to indicate high-frequency chest wall compression devices may be medically necessary in cystic fibrosis and chronic bronchiectasis when specific criteria are met and that flutter valves and Acapella device may be considered medically necessary in some cases of hypersecretory chronic lung diseases. Chest wall compression devices remain investigational for other conditions such as COPD.|
|02/11/10||Replace policy||Policy updated with literature review; Policy statements changed to indicate intrapulmonary percussive devices may be medically necessary in cystic fibrosis and chronic bronchiectasis when specific criteria are met. (Same as criteria for high-frequency chest wall compression devices). Rational re-written; reference numbers 1 and 11 added, others renumbered/removed.|
|2/10/11||Replace policy||Policy updated with literature review. References 7 and 8 added. No changes to policy statements.|
|2/09/12||Replace policy||Policy updated with literature review. References 12, 13 and 14 added. No changes to policy statements.|
|02/14/13||Replace Policy||Policy updated with literature review through December 18, 2012. References 13 and 14 added; other references renumbered or removed.|
|2/13/14||Replace policy||Policy updated with literature review through December 20, 2013. In first 2 medically necessary statements, Flutter or Flutter and Acapella changed to oscillatory positive expiratory pressure device. References 2, 7, 8, 9, and 13 added; other references renumbered or removed. In second policy statement, “standard chest physiotherapy treatment” changed to “standard treatment”.|
|2/12/15||Replace policy||Policy updated with literature review through December 15, 2014. Reference 1 added. Policy statements unchanged.|