Medical Policies - DME


Airway Clearance Devices

Number:DME101.027

Effective Date:10-15-2017

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

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

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

Bronchiectasis; OR

Bronchitis; OR

Cystic Fibrosis; OR

Other conditions that produce retained secretions.

II. Intrapulmonary percussive ventilation (IPV) devices * (See NOTE 1) in patients that have:

A. A diagnosis of ONE of the following conditions:

Cystic Fibrosis; OR

Chronic diffuse bronchiectasis (confirmed by computed tomography scan) characterized by;

o Daily productive cough for at least six continuous months; OR

o More than two times per year exacerbations requiring antibiotic therapy; AND

B. Demonstrated need for airway clearance; AND

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

III. High-frequency chest wall compression devices *(See NOTE 1) in patients that have:

A. A diagnosis of ONE of the following conditions:

Cystic Fibrosis; OR

Chronic diffuse bronchiectasis (confirmed by computed tomography scan) characterized by;

o Daily productive cough for at least six continuous months, OR

o More than two times per year exacerbations requiring antibiotic therapy, OR

ONE of the following neuromuscular diseases:

o Acid maltase deficiency; OR

o Anterior horn cell diseases; OR

o Hereditary muscular dystrophy; OR

o Multiple Sclerosis; OR

o Myotonic disorders; OR

o Paralysis of the diaphragm; OR

o Post-polio; OR

o Quadriplegia; OR

o Other myopathies, AND

B. Demonstrated need for airway clearance; AND

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

NOTE 1: *Documentation requirements for intrapulmonary percussive ventilation and high-frequency chest wall compression devices MUST include:

Demonstrated need for airway clearance; AND

Failure of standard treatments:

1. Frequent severe exacerbations of respiratory distress involving inability to clear mucous despite standard treatment [chest physiotherapy (CPT) or percussion and postural drainage (P/PD), and if appropriate, use of the Flutter device]; OR

2. Valid reasons why standard CPT cannot be performed, such as inability of the caregiver to perform.

Use of high-frequency chest wall compression devices and intrapulmonary percussive ventilation devices as an alternative to chest physical therapy is considered not medically necessary unless CPT is contraindicated, ineffective, not tolerated, or unavailable.

Use of high-frequency chest wall compression devices and intrapulmonary percussive ventilation devices for treating lung diseases other than those listed in the policy, such as chronic obstructive pulmonary disease (COPD), is considered experimental, investigational and /or unproven.

NOTE 2: Please refer to the Regulatory Status section for specific product information.

IV. Mechanical insufflation-exsufflation devices (MI-E) devices may be considered medically necessary in patients with neuromuscular disease (e.g., amyotrophic lateral sclerosis, high spinal cord injury with quadriplegia) who have an impaired ability to cough and who require ventilatory assistance.

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

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

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

NOTE: This policy addresses outpatient use of oscillatory devices. Inpatient device use, e.g., in the immediate postsurgical period, is not included in the policy.

Description:

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

Devices

Airway clearance 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 (e.g., the Vest Airway Clearance System, formerly 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 CF. Daily percussion and postural drainage need 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. In addition, they could benefit patients with neuromuscular disease who have impaired cough clearance.

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

Relative contraindications to MI-E are:

Chronic obstructive pulmonary disease; or

Bullous emphysema; or

Known susceptibility to pneumothorax; or

Exposure to recent barotrauma.

Regulatory Status

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

The Bird IPV® Noncontinuous Ventilator (Percussionaire Corp.) in 1989.

Flutter® Mucus Clearance Device in 1994. The Flutter® device is currently marketed in the United States by Axcan Scandipharm.

The ThAIRapy Bronchial Drainage System in 1998. Since that time, updated versions of the device were cleared by the FDA—most recently a fifth generation device. The device is now known as the Vest™Airway Clearance System, and it is manufactured by Hill-Rom.

The Acapella® device (DHD Healthcare) in 1999.

The RC Cornet™Mucus Clearing Device (PARI Respiratory Equipment) in 1999.

The inCourage® System (RespirTech, Lakeville, MN) in 2005.

The AerobiKA oscillating PEP device (Trudell Medical, London, ON) in 2013.

The Vibralung Acoustical Percussor (Westmed Inc., Tucson AZ) in May 2014.

FDA product codes: BYI, BYT.

Rationale:

This policy was originally created in 1993 and has been updated regularly with searches of the MEDLINE database. 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 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 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.

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, i.e., 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 trial 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 but 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. The trial was also stopped early without enrolling the expected number of patients and, thus, may have been underpowered to detect clinically significant differences between groups.

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 trial.

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.

Section Summary: Cystic Fibrosis

A number of RCTs and a systematic review have been published. RCTs had mixed findings and limitations such as small sample sizes and large dropout rates. The systematic review identified 35 RCTs comparing oscillatory devices with another recognized airway clearance techniques; some were published only as abstracts. Study findings could not be pooled due heterogeneity in design and outcome measures. The systematic review concluded that additional RCTs are needed that are adequately powered and have long-term follow-up.

Bronchiectasis

In 2015, Lee et al. published a Cochrane review on airway clearance techniques for treating bronchiectasis. (5) Seven RCTs comparing airway clearance techniques with sham or an alternative treatment were identified. Sample sizes ranged from 8 to 37 patients. All studies, except 1 (N=37), were crossover trials. Five trials used a PEP device, 1 used HFCWO, and 1 used postural drainage. The investigators did not pool study findings due to heterogeneity among studies. Primary outcomes of interest to the Cochrane reviewers were exacerbations, hospitalizations for bronchiectasis, and quality of life (QOL). Only 1 trial, a crossover study with 20 patients, reported exacerbations. This trial, published by Murray et al. (2009), did not find a statistically significant difference at 12 weeks in the number of exacerbations (there were 5 exacerbations with the oscillating PEP device vs 7 without the oscillating PEP device; p=0.48). (6) Cough-related QOL was significantly better after 12 weeks of any airway clearance technique compared with no airway clearance. Three studies reported QOL outcomes. The Murray trial found significantly better health-related quality of life (HRQOL) with a PEP device compared with control. The study by Svenningsen et al. did not. (7) The third study, by Nicolini et al., used HFCWO and found significantly better HRQOL with the oscillatory device than with control. (8) The Cochrane reviewers noted that the studies were not blinded and that patient-reported QOL measures may have been subject to bias.

Section Summary: Bronchiectasis

A 2015 systematic review identified 7 small RCTs on several types of oscillatory devices; only 1 reported the clinically important outcomes exacerbations or hospitalizations. Only 3 reported on QOL and trial findings were mixed.

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. (9, 10) Both reviews addressed a variety of techniques i.e., they were not limited to studies on oscillatory devices. The 2011 review by Ides et al. (9) 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. 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. (10)

Several randomized studies were published after the systematic reviews discussed above. Two were randomized crossover studies. Chakrovorty et al. (2011) in the United Kingdom published a randomized crossover study that included patients with moderate to severe COPD and mucus hypersecretion. (11) 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 baseline, 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 pre- to posttreatment differences in secondary outcomes (e.g., FEV1, FVC).

In 2016, Svenningsen et al. published an unblinded, industry-funded, randomized crossover study of oscillatory PEP versus usual care in 32 COPD patients ages 40 to 85 years. (12) Each intervention period lasted 21 to 28 days. Five (16%) of 32 patients withdrew from the study; the remaining 27 patients were included in the analysis. Findings were reported separately for the subgroup of sputum-producers (n=14) and nonsputum producers (n=13) at baseline. In the nonsputum producers, there were not significant differences before and after PEP use in most outcomes, including FEV1, FVC, FEV1/FVC, 6-minute walk test (6MWT) distance, SGRQ total score, and Patient Evaluation Questionnaire (PEQ) total score. Scores differed significantly only on the PEQ ease of bringing up sputum subscale. In patients who were sputum- producers at baseline, pre versus post PEP scores differed significantly for FVC, 6MWT distance, SGRQ total score, and the PEQ ease of bring up sputum and patient global assessment subscales. There were no significant differences in FEV1, FEV1/FVC, or PEQ global score. The crossover studies had similar limitations including no between-group comparisons (i.e., outcomes after oscillatory device use vs the control intervention), lack of ITT analysis and short-term follow-up (immediate posttreatment period).

A parallel-group RCT was published in 2013 by Goktalay; it 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 HFCWO using the Vest Airway Clearance System (n=25) or medical therapy-only (n=25). At day 5, outcomes, including FEV1, scores on the Modified Medical Research Council (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 Chronic Obstructive Pulmonary Disease

Only a few controlled studies have evaluated oscillatory devices for the treatment of COPD, and they tended to use ITT analysis and between-group comparisons. Moreover, the published studies had mixed findings and did not clearly support use of oscillatory devices in COPD patients.

Respiratory Conditions Related to Neuromuscular Disorders

A 2014 Cochrane review on nonpharmacologic management of respiratory morbidity in children with severe global developmental delay addressed airway clearance techniques. (14) The review included RCTs and nonrandomized comparative studies. Three studies were identified on HFCWO (1 RCT, 2 pre-post) and 1 on PEP (pre-post). Sample sizes ranged from 15 and 28 patients.

The RCT, published by Yuan et al. (2010), compared HCFWO to standard chest physical therapy in 28 patients with cerebral palsy or neuromuscular disease attending a pediatric pulmonary clinic. (15) Both groups were instructed to perform the assigned treatment for 12 minutes 3 times a day for the study period (mean, 5 months). Twenty-three (82%) of 28 patients completed the study; all 5 dropouts were in the HCFWO group. The authors noted that the trial was exploratory and was not powered to detect statistically significant findings on of the primary outcomes (e.g., incidence and duration of acute respiratory infection requiring inpatient or patient antibiotics, adverse effects of treatment). There were no statistically significant differences between groups on primary outcomes. For example, 4 patients required inpatient intravenous antibiotics in the standard physical therapy group and none in the HCFWO group (p=0.09). In addition, 7 patients required oral antibiotics in the standard physical therapy group and 3 in the HFCWO group (p=NS). No therapy-related adverse events were reported in either group. No subsequent RCTs published after their Cochrane review were identified on oscillatory devices in children with neuromuscular diseases.

In addition to the pediatric studies included in the Cochrane review, 1 RCT, published by Lange et al. (2006) was identified on HFCWO in adults with amyotrophic lateral sclerosis (ALS). (16) The trial included 46 patients with probable or definite ALS with respiratory conditions as evidenced by score on the ALS Functional Rating Scale (ALSFRS) respiratory subscale between 6 and 11 (the subscale range, 0 [complete ventilator support] to 12 [normal]). Patients were randomized to 12 weeks of HCFWO or usual care. The primary end points were measures of pulmonary function after 12 weeks. Data were available for 35 (76%) of 46 patients at 12 weeks. 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 ALSFRS 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 noise of breathing, suction frequency, suction amount, day cough, and nocturnal symptoms.

Section Summary: Respiratory Conditions Related to Neuromuscular Disorders

Two RCTs and a systematic review were identified evaluating oscillatory devices for treatment of respiratory conditions in neuromuscular disorders. One RCT was not powered to detect statistical significance. The other, conducted in ALS patients, did not find statistically significant improvement after HCFWO versus usual care for the primary outcomes (pulmonary function measures) or in most secondary outcomes.

Clinical Input Received through Physician Specialty Societies and Academic Medical Centers

In 2008 Blue Cross Blue Shield Association requested and received clinical input from 2 academic medical centers while their policy was under review. The clinical input indicated that that the available studies demonstrated that these devices are comparable with chest physical therapy for CF 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. The clinical input did not support using oscillatory devices for treatment of COPD.

Summary of Evidence

For individuals who have cystic fibrosis (CF) who receive oscillatory devices, the evidence includes randomized controlled trials (RCTs) and a systematic review. Relevant outcomes are symptoms, quality of life, hospitalizations, and medication use. RCTs had mixed findings and limitations such as small sample sizes and large dropout rates. A systematic review identified 35 RCTs comparing oscillatory devices with another recognized airway clearance techniques; some were published only as abstracts. Study findings could not be pooled due to heterogeneity in study design and outcome measures. The systematic review concluded that additional RCTs are needed that are adequately powered and have long-term follow-up. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have bronchiectasis who receive oscillatory devices, the evidence includes RCTs and a systematic review. Relevant outcomes are symptoms, quality of life, hospitalizations, and medication use. A 2015 systematic review identified 7 small RCTs on several types of oscillatory devices; only 1 RCT reported the clinically important outcomes of exacerbations or hospitalizations. Only 3 RCTs reported on quality of life, and findings were mixed. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have chronic obstructive pulmonary disease (COPD) who receive oscillatory devices, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, quality of life, hospitalizations, and medication use. Only a few controlled studies have evaluated oscillatory devices for the treatment of COPD, and they tend to have small sample sizes, short follow-up periods, and limitations in their analyses (e.g., lack of intention to treat analysis and between-group comparisons). Moreover, the published studies have mixed findings and do not clearly support the use of oscillatory devices in COPD patients. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have respiratory conditions related to neuromuscular disorders who receive oscillatory devices, the evidence includes 2 RCTs and a systematic review. Relevant outcomes are symptoms, quality of life, hospitalizations, and medication use. One of the RCTs was not powered to detect statistical significance. The other RCT, conducted in patients with amyotrophic lateral sclerosis, did not find significant improvement after high-frequency chest wall compression devices versus usual care in primary outcomes, in pulmonary function measures, or in most secondary outcomes. The evidence is insufficient to determine the effects of the technology 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. (17)

In April 2009, the Cystic Fibrosis Foundation (CCF) published guidelines on airway clearance therapies based on a systematic review of evidence. (18) CCF 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). CCF also issued a consensus recommendation that the prescribing of airway clearance therapies should be individualized based on factors such as age and patient preference.

Mechanical Insufflation-Exsufflation

Published data suggest that MI-E can improve the intermediate outcome of peak cough expiratory flow. Data regarding its role in the clinical management of the patient consist of case series. In some studies, patients have served as their own control, with a decreased incidence of hospitalization among patients who switch from tracheostomy to a noninvasive approach, which may include MI-E as one component. In 1998, a Consensus Panel Report by the American College of Chest Physicians stated that "[t]he inability of patients with respiratory muscle weakness to achieve high lung volumes is likely to contribute to cough ineffectiveness. Increasing the inhaled volume prior to cough by air-stacking positive pressure breaths or by glossopharyngeal breathing, increases cough expiratory flows by 80% in these patients. Cough efficiency may be further enhanced by the application of negative pressure to the airway for a period of 1 to 3 s. Using this technique of mechanical insufflation-exsufflation, peak cough expiratory flows can be increased by more than four-fold." (22) While controlled trials would ideally further delineate who is most likely to benefit from MI-E, particularly those who would benefit from having such a device in the home, such trials are logistically difficult. The heterogeneous nature of the patients, even among those with similar diseases, almost mandates a case by case approach for these patients. For example, the clinical utility of MI-E would not only depend on the physiologic parameters of lung function, but also on the tempo of the disease course, the availability of home caregivers, and patient preference and motivation.

Contract:

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

Coding:

CODING:

Disclaimer for coding information on Medical Policies

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

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

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

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

94669

HCPCS Codes

A7020, A7025, A7026, E0481, E0482, E0483, E0484, S8185

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Morrison L, Agnew J. Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. 2014; 7:CD006842. PMID 25038719

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. Aug 2013; 68(8):746-751. PMID 23407019

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. Mar 2010; 45(3):291-300. PMID 20146387

4. Pryor JA, Tannenbaum E, Scott SF, et al. Beyond postural drainage and percussion: Airway clearance in people with cystic fibrosis. J Cyst Fibros. May 2010; 9(3):187-192. PMID 20153269

5. Lee AL, Burge AT, Holland AE. Airway clearance techniques for bronchiectasis. Cochrane Database Syst Rev. 2015; 11:CD008351. PMID 26591003

6. 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

7. Svenningsen S, Paulin G, Wheatley A, et al. Oscillating positive expiratory pressure therapy in chronic obstructive pulmonary disease and bronchiectasis [poster]. Chest. 2013; 144(741A):741.

8. 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

9. Ides K, Vissers D, De Backer L, et al. Airway clearance in COPD: need for a breath of fresh air? A systematic review. COPD. Jun 2011; 8(3):196-205. PMID 21513439

10. 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

11. 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

12. Svenningsen S, Paulin GA, Sheikh K, et al. Oscillating positive expiratory pressure therapy in chronic obstructive pulmonary disease and bronchiectasis. COPD. Feb 2016; 13(1):66-74. PMID 26430763

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. Aug 2013; 27(8):710-718. PMID 23503735

14. Winfield NR, Barker NJ, Turner ER, et al. Non-pharmaceutical management of respiratory morbidity in children with severe global developmental delay. Cochrane Database Syst Rev. 2014; 10:CD010382. PMID 25326792

15. Yuan N, Kane P, Shelton K, et al. Safety, tolerability, and efficacy of high-frequency chest wall oscillation in pediatric patients with cerebral palsy and neuromuscular diseases: an exploratory randomized controlled trial. J Child Neurol. Jul 2010; 25(7):815-821. PMID 20357238

16. Lange DJ, Lechtzin N, Davey C, et al. High-frequency chest wall oscillation in ALS: an exploratory randomized, controlled trial. Neurology. Sep 26 2006; 67(6):991-997. PMID 17000967

17. McCool FD, Rosen MJ. Nonpharmacologic airway clearance therapies: ACCP evidence-based clinical practice guidelines. Chest. Jan 2006; 129(1 Suppl):250S-259S. PMID 16428718

18. Flume PA, Robinson KA, O'Sullivan BP, et al. Cystic fibrosis pulmonary guidelines: airway clearance therapies. Respir Care. Apr 2009;54(4):522-537. PMID 19327189

19. Mechanical Insufflation-Exsufflation as a Expiratory Muscle Aid - Archived. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2010 July) Durable Medical Equipment 1.01.21.

20. Oscillatory Devices for the Treatment of Cystic Fibrosis and Other Respiratory Disorders. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2016 June) Durable Medical Equipment 1.01.15.

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Policy History:

Date Reason
10/15/2017 Reviewed. No changes.
10/1/2016 Document updated with literature review. Product names were removed from the coverage section. Coverage unchanged.
7/1/2015 Reviewed. No changes.
10/15/2014 Document updated with literature review. The following was removed from the coverage statement for mechanical insufflation–exsufflation devices: “(a peak cough expiratory flow of less than 2-3L per second).” In addition, the following clarifying statements were added : High-frequency chest wall compression devices and IPV devices used solely as an alternative to CPT for conditions other than those specified in the medically necessary statements above are considered not medically necessary, was changed to the following: Use of high-frequency chest wall compression devices and intrapulmonary percussive ventilation devices as an alternative to chest physical therapy is considered not medically necessary unless CPT is contraindicated, ineffective, not tolerated, or unavailable. Use of high-frequency chest wall compression devices and intrapulmonary percussive ventilation devices for treating lung diseases other than those listed in the policy, such as chronic obstructive pulmonary disease (COPD), is considered experimental, investigational and /or unproven.
1/1/2011 Document updated with literature review. Two medical documents (DME101.027, Oscillatory Devices for the Treatment of Cystic Fibrosis (CF) and Other Lung Disorders and DME104.042, Mechanical Insufflation-Exsufflation as an Expiratory Muscle Aid) were combined into this medical document, and the title of this medical document was changed to Airway Clearance Devices.
7/15/2010 Document updated with literature review. Coverage has been changed: 1) IPV devices may be considered medically necessary for patients with CF or bronchiectasis when criteria are met. 2) High-frequency chest wall compression devices may be considered medically necessary in neuro-muscular diseases when criteria are met.
2/15/2009 Revised/updated entire document.
10/1/2008 Revised updated entire document. This policy is no longer scheduled for routine literature review and update.
6/1/2007 Revised/updated entire document
12/15/2006 Revised/updated entire document
4/1/2003 CPT/HCPCS code(s) updated
3/1/2003 Revised/updated entire document
1/1/2000 CPT/HCPCS code(s) updated
4/1/1999 Revised/updated entire document
2/1/1997 Revised/updated entire document
5/1/1996 CPT/HCPCS code(s) updated
7/1/1995 Revised/updated entire document
4/1/1993 CPT/HCPCS code(s) updated
1/1/1993 New medical document

Archived Document(s):

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