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MP 1.01.15

Oscillatory Devices for the Treatment of Cystic Fibrosis and Other Respiratory Disorders


Medical Policy    
Section
Durable Medical Equipment 
Original Policy Date
11/1/97
Last Review Status/Date
Reviewed with literature search/2:2014
Issue
2:2014
  Return to Medical Policy Index

Disclaimer

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.


Description

Oscillatory devices are used as alternatives to the standard daily percussion and postural drainage 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).

Background

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.

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. 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.


Policy

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 sections) (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.


Policy Guidelines

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.


Benefit Application
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).


Rationale

This policy was originally created in 1997 and was updated regularly with searches of the MEDLINE database. The most recent literature search was performed from December 18, 2012, to December 20, 2013. Following is a summary of the literature to date:

Cystic Fibrosis

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. The Cochrane review was published in 2009.(1) Investigators identified 30 RCTs with a total of 708 patients that compared oscillatory devices with another recognized airway clearance technique. Eleven studies used a parallel design and 19 were crossover studies. Ten of the included studies were published as abstracts only. Most, 16, were conducted in the United States. Sample sizes of individual studies ranged from 5 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, 5 using intrapulmonary percussive ventilation, and 2 using Cornet. No studies were identified that compared Acapella with another treatment. Study duration ranged from 1 week to 1 year; 21 of the studies were of less than 3 months’ duration and 10 lasted less than 1 week. 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 follow-up. 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.

Since publication of the Cochrane review, additional RCTs have been published. For the most part, these studies tended to be underpowered due to small sample sizes and/or high dropout rates and did not find clear advantages of one oscillatory device over another. Moreover, studies tended to report sputum weight or pulmonary function measures, eg, forced expiratory volume in 1 second (FEV1) as the primary outcome measure rather than functional outcomes such as exacerbation rates.

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 cystic fibrosis; 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. A total of 88 of 107 (82%) 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 FEV1. Limitations of this study were that patients were not blinded, and there was nearly a 20% dropout rate.

Findings from other representative RCTs follow (this includes studies from the Cochrane review, as well as more recent studies):

Sontag et al conducted a multicenter randomized trial with 166 adults and children with cystic fibrosis.(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, %) predicted. The small sample size and high dropout rate greatly limit the conclusions that might be drawn from this study.

Pryor et al evaluated patients aged 16 years and older with cystic fibrosis from a single center in 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 of 75 (87%) patients completed the study, and these were included in the analysis. Mean 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.

McIlwaine et al compared PEP and the Flutter device in 40 children with cystic fibrosis.(5) Participants were randomly assigned to physical therapy with PEP or the Flutter device for 1 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 FVC. This difference did not become apparent until 6 to 9 months into the study, underlining the importance of long-term results.

Varekojis et al 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 cystic fibrosis.(6) Patients used each modality for 2 days in a randomized order over a 6-day period. While wet sputum weights from use of the Percussionaire device were significantly greater than the Vest, 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.

Section Summary

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 cystic fibrosis. There is limited evidence that 1 device is superior to another, although a 2013 RCT found better outcomes with PEP than HFCWO.

Bronchiectasis

In 2013, Lee et al published a Cochrane review on airway clearance techniques for treating bronchiectasis.(7) 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 study, 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).(8) 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. (9) 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.

Section Summary

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 to medical treatment alone. In this study, HFCWO was at least as good as chest physical therapy, and as superior to chest physical therapy on some outcome measures.

Chronic Obstructive Pulmonary Disorder

At least 2 systematic reviews of studies on airway clearance techniques in patients with chronic obstructive pulmonary disorder (COPD) have been published.(10,11) 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 whom used oscillatory devices (Flutter or Cornet), and one 2007 study on high-frequency chest wall oscillation.(10) 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.(11)

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 in the United Kingdom published a randomized crossover study that included patients with moderate to severe COPD and mucus hypersecretion.(12) Patients received HFCWO or conventional treatment, in random order, for 4 weeks, with a 2-week wash-out 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 the 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.(13) Patients were randomized to receive 5 days of treatment with medical therapy plus HCFWO using the Vest Airway Clearance System (n=25) or medical therapy-only (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.

Section Summary

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 Through Physician Specialty Societies and Academic Medical Centers

In response to requests, input was received from 2 academic medical centers while this policy was under review in December 2008. 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.The reviewers indicated that the available studies demonstrate that these devices are comparable with chest physical therapy for both cystic fibrosis and bronchiectasis. The clinical input was not supportive of using oscillatory devices for treatment of COPD.

Summary

Oscillatory devices are designed to move mucus and clear airways. In patients with cystic fibrosis, 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 cystic fibrosis 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 cystic fibrosis 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 recommend (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.(14)

In April 2009, the Cystic Fibrosis Foundation published guidelines on airway clearance therapies based on a systematic review of evidence.(15) They recommend airway clearance therapies for all patients with cystic fibrosis 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.

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.

References:

  1. Morrison L, Agnew J. Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev 2009; (1):CD006842.
  2. 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 2013; 68(8):746-51.
  3. 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.
  4. 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):187-92.
  5. McIlwaine PM, Wong LT, Peacock D et al. Long-term comparative trial of positive expiratory pressure versus oscillating positive expiratory pressure (Flutter) physiotherapy in the treatment of cystic fibrosis. J Pediatr 2001; 138(6):845-50.
  6. Varekojis SM, Douce FH, Flucke RL 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. Respir Care 2003; 48(1):24-8.
  7. Lee AL, Burge A, Holland AE. Airway clearance techniques for bronchiectasis. Cochrane Database Syst Rev 2013; 5:CD008351.
  8. Murray MP, Pentland JL, Hill AT. A randomised crossover trial of chest physiotherapy in non-cystic fibrosis bronchiectasis. Eur Respir J 2009; 34(5):1086-92.
  9. 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.
  10. 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.
  11. Osadnik CR, McDonald CF, Jones AP et al. Airway clearance techniques for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2012; 3:CD008328.
  12. 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; 6:693-9.
  13. 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 2013; 27(8):710-8.
  14. McCool FD, Rosen MJ. Nonpharmacologic airway clearance therapies: ACCP evidence-based clinical practice guidelines. Chest 2006; 129(1 suppl):250S-59S.
  15. Flume PA, Robinson KA, O’Sullivan BP et al. Cystic fibrosis pulmonary guidelines: airway clearance therapies. Respirat Care 2009; 54(4):522-37.

 

Codes

Number

Description

CPT  No Code 
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
  S8185  Flutter device 
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 

 


Index

Acapella Device
Cystic Fibrosis, Oscillatory Devices
FLUTTER Device
High Frequency Chest Compression
Intrapulmonary Percussive Ventilation (IPV)
IPV (Intrapulmonary Percussive Ventilation)
Oscillatory Devices for Cystic Fibrosis
Percussionaire
ThAIRapy Vest


Policy History
Date Action Reason
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”.