National Medical Policy

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1 National Medical Policy Subject: Policy Number: Airway Clearance Devices NMP214 Effective Date*: March 2005 Updated: August 2017 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State s Medicaid manual(s), publication(s), citation(s), and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies guidelines first For Medicaid Plans: Please refer to the appropriate Medicaid Manuals for coverage guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link X National Coverage Determination (NCD) Intrapulmonary Percussive Ventilator (IPV) (240.5): National Coverage Manual Citation X Local Coverage Determination (LCD)* High Frequency Chest Wall Oscillation Devices: X Article (Local)* High Frequency Chest Wall Oscillation Devices: X Other MLN Matters Number: MM8304 Revised Related Change Request CR May 31, The Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program: Traveling Beneficiary: Education/Medicare-Learning-Network- MLN/MLNMattersArticles/Downloads/MM8304.pd Airway Clearance Systems Aug 17 1

2 f None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Health Net, Inc. considers any of the following airway clearance devices medically necessary durable medical equipment (DME) to assist in mobilizing secretions of the respiratory tract: Mechanical Percussors Health Net, Inc. considers mechanical percussors medically necessary for any of the following when the patient or operator of the powered percussor has received appropriate training by a physician or therapist: Cystic fibrosis Chronic bronchitis Bronchiectasis Asthma Immotile cilia syndrome FLUTTER Health Net, Inc. considers small hand-held positive expiratory pressure devices, such as the FLUTTER mucous clearance device and the Acapella device, medically necessary as an adjunct to airway clearance in patients when other methods have proven inadequate or ineffective in mobilizing pulmonary secretions, who can demonstrate effective use of the device and who have any of the following: Cystic fibrosis Bronchiectasis and conditions that produce increased sputum or secretions Alpha-1-antitrypsin deficiency Positive Expiratory Pressure Health Net, Inc. considers positive expiratory pressure (PEP) masks medically necessary for any of the following: Cystic fibrosis Chronic obstructive pulmonary disease (COPD) Airway Clearance Systems Aug 17 2

3 Vest Airway Clearance System Health Net, Inc. considers high-frequency chest compression systems (The Vest Airway Clearance System, formerly known as the ThAIRapy Bronchial Drainage System, ABI Vest) medically necessary as an alternative to chest physiotherapy in patients age 2 years or older or 20-inch chest size, whichever comes first for any of the following: Cystic fibrosis in whom home chest physiotherapy (CPT) has been found to be ineffective to adequately mobilize retained secretions or cannot be provided; or Lung transplant recipients within the first six months postoperatively who are unable to tolerate standard chest physiotherapy; or Bronchiectasis, characterized by daily productive cough for at least 6 continuous, months or, frequent (i.e. more than 2/year) exacerbations requiring antibiotic therapy, and confirmed by high resolution, spiral, or standard CT scan and well-documented failure of standard treatments to adequately mobilize retained secretions; or Neuromuscular disease (i.e., Post-polio, Acid maltase deficiency, Anterior horn cell diseases, Multiple sclerosis, Quadriplegia, Hereditary muscular dystrophy, myotonic disorders, other myopathies or paralysis of the diaphragm) for patients with well-documented failure of routine chest physiotherapy to adequately mobilize retained secretions as evidenced by recurrent pneumonia Medical records documentation to support medical necessity must include all of the following: Excessive sputum production combined with the member s inability to clear the sputum without assistance A well-documented failure of standard treatments to mobilize secretions Frequent exacerbations requiring antibiotic therapy more than two times per year Diagnosis confirmed by high resolution or spiral computed tomography (CT) Documentation of need for at least daily chest physiotherapy (CPT) by provider with specialty in pulmonary disease Significant worsening of pulmonary function* Specific documentation why this therapy is superior to other most cost-effective therapy methods, including at least one of the following: The patient s family or other resources cannot adequately perform the required chest physiotherapy (CPT); or Allows independent living for university of college attendarnce for the member; or Provides health stabilization in single adults or emancipated individuals without able partners to assist with CPT * A significant worsening of pulmonary function exists when at least two of the following are met: Forced expiratory capacity (FEC) of less than 80% predicted Airway Clearance Systems Aug 17 3

4 Forced vital capacity (FVC) of less than 50% predicted Small airway score (FEP 25-75%) decrease in one year of 25% or more Pattern of annual or more often hospitalizations from acute pulmonary exacerbations Demonstration of reduction of pulmonary function while on steroids for a year Note: Rental of a high frequency chest compression system for three months is required before purchase of the equipment will be considered. Patient compliance and tolerance will determine medical necessity for purchase of the system. Note: Intolerance to the device or failure to comply with usage meter checks is a basis for the use of alternative methods of airway clearance. Insufflator-Exsufflator Device Health Net, Inc. considers a mechanical insufflator-exsufflator device, such as the CoughAssist, medically necessary in a small subset of patients with neuromuscular disease (e.g., amyotrophic lateral sclerosis, high spinal cord injury with quadriplegia) associated with a significant impairment of chest wall and/or diaphragmatic movement when there is an inability to adequately clear secretions in the airways using standard mechanisms (e.g., chest percussion, postural drainage, etc.). There should be evidence of significantly low forced expiratory flow of less than 80% predicted and vital capacity not associated with obstructive disease. Note: It is not medically necessary for a patient to use both a high frequency chest wall compression, (HFCWC) device and a mechanical in-exsufflation device. Contraindications Contraindications for high-frequency chest compression systems (The Vest Airway Clearance System, formerly known as the ThAIRapy Bronchial Drainage System, ABI Vest): Unstable head injury Unstable neck injury Active Hemorrhage with hemodynamic instability Subcutaneous emphysema Recent epidural spinal infusion/anesthesia Recent skin grafts or flaps on the thorax Osteoporosis Burns, open wounds and/or skin infections of the thorax Recently placed transvenous pacemaker or subcutaneous pacemaker Suspected pulmonary tuberculosis Lung contusion Bronchospasm Complaint of chest wall pain Osteomyelitis of ribs History of pneumothorax, hemoptysis, or cardiac arrest in the past 30 days. Note: Intrapulmonary percussive ventilation (IPV) systems, e.g., Percussionaire device, and IPPB devices as an alternative to chest physiotherapy are not medically necessary because there are inadequate scientifically controlled studies in the medical literature to validate their effectiveness. There is insufficient evidence supporting their effectiveness in the home setting. Airway Clearance Systems Aug 17 4

5 Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets. ICD-9 Codes Cystic fibrosis with pulmonary manifestations Amyotrophic lateral sclerosis 340 Multiple sclerosis Congenital hereditary muscular dystrophy Hereditary progressive muscular dystrophy Myotonic disorders Acute bronchiolitis due to respiratory syncytial virus (RSV) Acute bronchiolitis due to other infectious organisms Influenza with other respiratory manifestations Simple chronic bronchitis Mucopurulent chronic bronchitis Obstructive chronic bronchitis, without exacerbation Obstructive chronic bronchitis, with (acute) exacerbation Other chronic bronchitis Bronchiectasis without acute exacerbation Bronchiectasis with acute exacerbation Bronchitis and pneumonitis due to fumes and vapors Chronic respiratory conditions due to fumes and vapors Other specified alveolar and parietoalveolar pneumonopathies Pulmonary collapse Congenital bronchiectasis Complications of transplanted lung V46.0 Dependence on aspirator V46.1 Dependence on respirator (ventilator) V46.8 Dependence on other enabling machines ICD-10 Codes E84.0- E84.9 Cystic fibrosis G G12.9 Motor neuron disease G35 Multiple sclerosis G71.0- G71.9 Primary disorder of muscles J1Ø.1 Influenza due to other identified influenza virus with other respiratory manifestations J11.1 Influenza due to unidentified influenza virus with other respiratory manifestations J21.0- J12.9 Acute bronchiolitis Airway Clearance Systems Aug 17 5

6 J41.0- J41.8 Simple and mucopurulent chronic bronchitis J42 Unspecified chronic bronchitis J47.0- J47.9 Bronchiectasis J68.0- J68.9 Respiratory conditions due to inhalation of chemicals, gases, fumes and vapors J J84.09 Alveolar and parieto-alveolar conditions Q33.0- Q33.9 Congenital malformations of lung T86.81Ø Lung transplant rejection T Lung transplant failure T Unspecified complication of lung transplant Z99.0- Z99.12 Dependence on respirator CPT Codes Manipulation chest wall, e.g., cupping, percussing, and vibration to facilitate lung function; initial demonstration and /or evaluation Manipulation chest wall, e.g., cupping, percussing, and vibration to facilitate lung function; subsequent demonstration. HCPCS Codes 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 E0480 Percussor, electric or pneumatic, home model E0482 Cough stimulating device, alternating positive and negative airway pressure E0483 High frequency chest wall oscillation air-pulse generator system, (includes hoses and vest), each E0484 Oscillatory positive expiratory pressure device, non-electric, any type, each S8185 Flutter device Scientific Rationale Update August 2016 Lee et al. (2015) completed randomised controlled parallel and cross-over trials that compared an airway clearance technique (ACT) versus no treatment, sham ACT or directed coughing in participants with bronchiectasis. The authors used standard methodological procedures as expected by The Cochrane Collaboration. Seven studies involving 105 participants met the inclusion criteria of this review, six of which were cross-over in design. Six studies included adults with stable bronchiectasis; the other study examined clinically stable children with bronchiectasis. Three studies provided single treatment sessions, two lasted 15 to 21 days and two were longer-term studies. Interventions varied; some control groups received a sham intervention and others were inactive. The methodological quality of these studies was variable, with most studies failing to use concealed allocation for group assignment and with absence of blinding of participants and personnel for outcome measure assessment. Heterogeneity between studies precluded inclusion Airway Clearance Systems Aug 17 6

7 of these data in the meta-analysis; the review is therefore narrative. One study including 20 adults that compared an airway oscillatory device versus no treatment found no significant difference in the number of exacerbations at 12 weeks (lowquality evidence). Data were not available for assessment of the impact of ACTs on time to exacerbation, duration or incidence of hospitalisation or total number of hospitalized days. The same study reported clinically significant improvements in HRQoL on both disease-specific and cough-related measures. The median difference in the change in total St George's Respiratory Questionnaire (SGRQ) score over three months in this study was 7.5 units (P value = (Wilcoxon)). Treatment consisting of high-frequency chest wall oscillation (HFCWO) or a mix of ACTs prescribed for 15 days significantly improved HRQoL when compared with no treatment (low-quality evidence). Two studies reported mean increases in sputum expectoration with airway oscillatory devices in the short term of 8.4 ml (95% confidence interval (CI) 3.4 to 13.4 ml) and in the long term of 3 ml (P value = 0.02). HFCWO improved forced expiratory volume in one second (FEV1) by 156 ml and forced vital capacity (FVC) by ml when applied for 15 days, but other types of ACTs showed no effect on dynamic lung volumes. Two studies reported a reduction in pulmonary hyperinflation among adults with non-positive expiratory pressure (PEP) ACTs (difference in functional residual capacity (FRC) of 19%, P value < 0.05; difference in total lung capacity (TLC) of 703 ml, P value = 0.02) and with airway oscillatory devices (difference in FRC of 30%, P value < 0.05) compared with no ACTs. Low-quality evidence suggests that ACTs (HFCWO, airway oscillatory devices or a mix of ACTs) reduce symptoms of breathlessness and cough and improve ease of sputum expectoration compared with no treatment (P value < 0.05). ACTs had no effect on gas exchange, and no studies reported effects of antibiotic usage. Among studies exploring airway oscillating devices, investigators reported no adverse events. The authors feel that ACTs appear to be safe for individuals (adults and children) with stable bronchiectasis and may account for improvements in sputum expectoration, selected measures of lung function, symptoms and HRQoL. The role of these techniques in acute exacerbation of bronchiectasis is unknown. In view of the chronic nature of bronchiectasis, additional data are needed to establish the short-term and long-term clinical value of ACTs for patient-important outcomes and for long-term clinical parameters that impact disease progression in individuals with stable bronchiectasis, allowing further guidance on prescription of specific ACTs for people with bronchiectasis. Scientific Rationale Update August 2015 Intrapulmonary percussive ventilation (IPV), also known as the Percussionaire Corporation IPV Ventilator, is an example of a passive airway clearance technique or device that uses vibration and moisture from aerosolized saline or medications to loosen mucous so it can be more easily coughed out of the lungs. It is used by individuals with cystic fibrosis, neuromuscular diseases affecting the muscles used for breathing, and by those with chronic lung disease. Instead of a therapist clapping or slapping the patient's chest wall, the IPV delivers mini-bursts, more than 200 per minute, of respiratory gasses to the lungs via a mouthpiece. Its intended purpose is to mobilize endobronchial secretions and diffuse patchy atelectasis. The patient controls variables such as inspiratory time, peak pressure and delivery rates. The American Association for Respiratory Care (AARC) is a non profit organization and is the only professional organization supporting Respiratory Care in the United States. The AARC began in 1943, as the Inhalation Technician Association and has evolved rapidly and repeatedly since. In 2013, the AARC has developed clinical guidelines on the effectiveness of nonpharmacologic airway clearance therapies in Airway Clearance Systems Aug 17 7

8 hospitalized patients. They note that Some studies suggest that intrapulmonary percussive ventilation (IPV) may decrease stay in the ICU for non-intubated patients with COPD, but insufficient high-level evidence exists to support a recommendation for this therapy. AARC also notes that IPV cannot be recommended, due to insufficient evidence. However, AARC also states that positive expiratory pressure (PEP), and high frequency chest wall compression (HFCWC), cannot be recommended for the same reason. At this time, Health Net does consider PEP and HFCWC medically necessary with specific criteria. There are two Clinical Trials on IPV that pertain to this policy, and that have been completed but no study results are posted. There is a Clinical Trial on The Effects of IPV Assessed with Functional Imaging that is currently recruiting participants. The ClinicalTrials.gov Identifier is NCT , and it was last updated May 27, In this study, the investigators are trying to determine the long term effects of an IPV treatment evaluated with classical outcome parameters, (i.e.,fev1, Raw). They want to find out if this technique is comparable with other standard treatment. The primary completion date is December There is another Clinical Trial on A Comparison Study of Two Respiratory Physical Therapy Methods and Standard Medical Treatment for Treating COPD Patients during Acute Exacerbation which is not currently recruiting participants. The ClinicalTrials.gov Identifier is NCT , and it was last updated in May One of the main goals of the respiratory physical therapy is to help people who are suffering from accumulating of secretions in their airways and lungs, and to investigate if respiratory physical therapy treatment in addition to standard medical care during the acute phase, can improve the respiratory and medical condition and reduce hospitalization stay. Three groups of COPD patients will be compared during acute exacerbation; two groups will get one out of two respiratory physical therapy techniques: manually or Intrapulmonary Percussive Ventilator (IPV) in addition to standard medical care and the third group will get standard medical care alone. The estimated completion date is December Peer reviewed studies do not demonstrate any advantage of IPV over that achieved with good pulmonary care in the hospital environment and there is a paucity of studies in the home setting. Since there is minimal data to support the effectiveness of the device in the home setting, it is considered not medically necessary at this time. Scientific Rational Update August 2013 At this time, there is insufficient peer reviewed published literature to evaluate the safety and efficacy of intrapulmonary percussive ventilation. Its effect on health outcomes or patient management in patients with cystic fibrosis is undefined. There is a Clinical Trial on Effects of IPV Assessed With Functional Imaging which is currently recruiting participants. The ClinicalTrials.gov Identifier is NCT and it was last updated on June 27, The investigators are trying to find what the long term effects of an IPV treatment would be evaluated with classical outcome parameters, (i.e., FEV1, Raw). The authors are also questioning if the possible effect noticeable on this technique is comparable with the classical outcome parameters? The estimated primary completion date is December Airway Clearance Systems Aug 17 8

9 Scientific Rationale Update - September 2011 Additional contraindications to high-frequency chest compression systems include a history of pneumothorax, hemoptysis, or cardiac arrest in the past 30 days. These were added to the current list of contraindications. Scientific Rationale Update- April 2009 Bronchiectasis is a syndrome of chronic cough and daily viscid sputum production associated with airway dilatation and bronchial wall thickening. Multiple conditions are associated with the development of bronchiectasis, but all require an infectious insult plus impairment of drainage, airway obstruction, and/or a defect in host defense. There are numerous etiologies that can induce or contribute to the pathophysiologic processes that result in bronchiectasis, including primary infection, bronchial obstruction, foreign body aspiration), cystic fibrosis, Young's syndrome, primary ciliary dyskinesa, allergic bronchopulmonary aspergillosis (ABPA ), immunodeficiency states, and autoimmune diseases. The high frequency chest wall compressor (HFCWC), a vest worn over the thorax that is connected to an air compressor, delivers mechanical percussions at rates and pressures that can be varied by the patient to target different caliber airways, also sets to patient comfort. Examples of high frequency chest wall oscillation systems include the Vest airway clearance system (Advanced Respiratory) and Medpulse SmartVest (ElectroMed Co). There is no published comparison study available that has demonstrated superiority of one device over another. A Cochrane review reported by Morrison and Agnew (2009) found no clear evidence that oscillation was a more or less effective intervention overall than other forms of physiotherapy. They recommended that more adequately-powered long-term randomised controlled trials are needed. The authors identified two hundred and sixty-five studies; thirty studies (total of 708 participants) that compared oscillating devices with any other form of physiotherapy in people with Cystic Fibrosis (CF). Single treatment interventions (therapy technique used only once in the comparison) were excluded. Studies varied in duration from up to one week to one year in duration. Nineteen of the studies were cross-over in design. Data were not published in sufficient detail in most of these studies to perform meta-analysis. Forced expiratory volume in one second (FEV (1) was the most frequently measured outcome. Results did not show significant difference in effect between oscillating devices and other methods of airway clearance on FEV (1) or other lung function parameters. Where there has been a small but significant change in secondary outcome variables such as sputum volume or weight this has not been wholly in favour of oscillating devices. Participant satisfaction was reported in eleven studies, but this was not specifically in favor of an oscillating device as some participants preferred breathing techniques or techniques used prior to the study interventions. The results for the remaining outcome measures were not examined or reported in sufficient detail to provide any high level evidence. Lange et al (2006) reported the results of a randomized controlled trial of HFCWC in a group of 46 patients with ineffective airway clearance due to ALS. Patients who received HFCWC therapy in addition to usual care reported less breathlessness, compared with usual care alone. These patients also experienced increased nighttime coughing, which the authors suggested may have been due to increased mobilization of secretions. Airway Clearance Systems Aug 17 9

10 Although the evidence regarding the efficacy of HFCWC vest therapy in patients with non CF-related disorders of clearance is very limited, when conventional PDT and other devices have failed or are contraindicated, high-frequency chest wall compression may be indicated. Scientific Rationale Initial Respiratory health depends on consistent clearance of airway secretions. Normal airway clearance is accomplished by two important mechanisms: the mucociliary clearance (MCC) system and the ability to cough. Impaired MCC is linked to poor lung function in a broad range of diseases and disabilities. When mucus secretion and mucus clearance are not in balance, excessive, often sticky, airway mucus may accumulate in the airways and cause serious problems. At-risk individuals are prone to recurrent episodes of respiratory inflammation, infection and, eventually, irreversible lung damage, and even death. Improvement of MCC is a vital treatment goal - one that can be accomplished with an individualized plan of chest physiotherapy. The aims are to reduce airway obstruction by improving the clearance of secretions, to reduce the severity of the infection by clearing infected material and to maintain optimal respiratory function and exercise tolerance. There are individuals whose MCC and cough are not in balance due to their specific disease or condition, such as: cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), primary ciliary dyskinesia (PCD). These are often identified as impaired airway clearance conditions. These individuals require external assistance for their airway clearance needs through some sort of airway clearance therapy to avoid retention of mucus in their lungs. Without effective airway clearance, such patients risk gaining stagnate mucus in their lungs creating a site prone to infection. Repeated infections typically lead to frequent hospitalizations and progressive pulmonary deterioration, which can result in death. Passive interventions include nebulized bronchodilating medication, postural drainage combined with chest percussion and/or vibration, and diaphragmatic (or "quad") coughing maneuvers. Active interventions consist of autogenic drainage or breathing and coughing techniques such as forced expiratory technique ("huff" coughing), active cycle breathing (deep breathing or breath stacking), and pursed lip breathing (creates positive expiratory pressure). Usually, several of these mechanisms are utilized in an effective pulmonary toilet program. Pulmonary complications are major causes of morbidity and mortality for patients with compromised airway clearance mechanisms. This is particularly true in patients with cystic fibrosis (CF), an autosomal recessive disease characterized by a chronic progressive course with acute exacerbations. Neuromuscular diseases (NMDs) are characterized by progressive atrophy and weakness of skeletal muscle, skeletalspinal deformities, limb contractures, and restrictive lung disease leading to poor respiratory function. Among inherited NMDs, the most prevalent include muscular dystrophies (Duchenne, Becker, facioscapulohumeral, limb girdle), the myotonias, and the spinal muscular atrophies. Acquired NMDs include amyotrophic lateral sclerosis, multiple sclerosis, Guillain Barré Syndrome, and poliomyelitis. The principal cause of the morbidity and mortality associated with these diseases is the production of excessively thick and tenacious tracheobronchial mucus, which leads to airway obstruction and secondary infection. CF patients require routine maintenance chest physiotherapy to clear their airways (i.e., manual percussion and postural drainage) every day to assist in the removal of mucous secretions from the lung. These treatments may be administered one to three times a day for 20 to 30 minutes per session by a physical therapist or another trained adult in the home, typically a Airway Clearance Systems Aug 17 10

11 parent if the patient is a child. Conditions such as high spinal cord injuries, neuromuscular deficits, or severe fatigue associated with intrinsic lung disease can diminish the effectiveness of a cough, or eliminate the ability to cough altogether. Other conditions such as bronchiectasis and pneumonia can affect the ability of the lungs to manage secretions and influence the viscosity and amount of sputum produced. Several devices have been developed as an adjunct or alternative to one or more of the mechanisms described above when the individual is unable to clear pulmonary secretions effectively. The Vest Airway Clearance System (formerly known as the ABI Vest or the ThAIRapy Bronchial Drainage System) and the Percussionaire device are oscillatory devices designed to provide self-administered airway clearance. The Vest 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 secretions. There are no studies with final health outcomes that demonstrate that the ThAIRapy Vest System is equivalent or superior to other techniques designed to improve pulmonary clearance in patients with cystic fibrosis. However, in some situations, other methods of therapy, such as chest PT by a family member, are not available. The published literature includes a number of small, randomized studies that compared different mucus clearance techniques, typically in crossover studies that do not include final health outcomes regarding long-term stabilization or improvement of lung function or a decrease in pulmonary exacerbations resulting in hospitalization. Pulmonary function and weight of expectorated sputum are typically analyzed immediately after treatment. The reliability and validity of sputum weight as a proxy for health outcome is still unresolved. The sparse data that are available do not suggest that any one alternative, including the various oscillatory devices, autogenic drainage, or positive expiratory pressure, is superior to another. Kluft and colleagues (1996) at Children s Hospital, Washington, DC, looked at 29 CF patients and compared traditional chest physiotherapy (CPT) with the Vest system. Each patient received two days of each form of therapy over a four-day period. Expectorated secretions were collected during and after treatment. The results indicated significantly more pulmonary secretions were expectorated during treatment with the Vest system as compared with CPT. Mechanical percussors are typically electrical devices used in lieu of a caretaker's hands for chest percussion and/or vibration. This method of CPT creates an internal percussion effect on the lungs as they are held in a state of partial inspiration. The FLUTTER mucous clearance device and Acapella device are small handheld devices that provide positive expiratory pressure (PEP.) Exhaling through the device creates oscillations, or "flutter" in pressures in the airway resulting in loosening of mucous. Other PEP devices are used with a small volume nebulizer, and function in conjunction with medication delivery. Mechanical Insufflator-Exsufflator (CoughAssist) is a portable electric device which utilizes a blower and a valve to alternately apply a positive and then a negative pressure to a patient's airway in order to assist the patient in clearing retained bronchopulmonary secretions. Air is delivered to and from the patient via a breathing circuit incorporating a flexible tube, a bacterial filter and either a facemask, a mouthpiece, or an adapter to a tracheostomy or endotracheal tube. Airway Clearance Systems Aug 17 11

12 The published data suggest that mechanical insufflation-exsufflation (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. While controlled trials would ideally further delineate who is most likely to benefit from MI-E, particularly those who would benefit from having 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. The non-investigational status for the MI-E device is based on these considerations. Intrapulmonary percussive ventilation (IPV) is an aerosol machine that delivers high frequency, low-volume, positive-pressure jets of air to the airways by a pneumatic flow interrupter at a rate of cycles/minute via a mouthpiece. The patient is able to control variables such as inspiratory time, peak pressure, and delivery rates. Aerosolized medications can be delivered under pressure and with oscillations that vibrate the chest. The patient controls variables such as inspiratory time, peak pressure and delivery rates. The clinical data regarding the Percussionaire device are sparse. Two small short-term studies have found IPV as effective as standard aerosol and chest physiotherapy in preserving lung function and no advantage of IPV over that achieved with good pulmonary care in the hospital environment. There are no studies in the home setting. Intermittent positive pressure breathing (IPPB) devices use pressure to passively fill the lungs when a breath is initiated. An incorporated manometer and mechanical valves serve to terminate the flow of inspired air when a predetermined pressure is reached on inhalation. IPPB breathing circuits are designed to nebulize inhaled medication. Most IPPB devices are powered by compressed air and are not suitable for home use. Review History March 22, 2005 April 26, 2005 February 2007 October 2008 April 2009 April 2011 September 2011 August 2012 August 2013 August 2014 August 2015 August 2016 August 2017 Medical Advisory Council Initial Approval Medical Advisory Council Final Approval Update No revisions Removed statement regarding endorsement of vest system by AARC from scientific rationale Added High frequency chest wall oscillation devices (vest airway clearance system) as medically necessary for bronchiectasis and neuromuscular disease when specific criteria is met. Update no revisions Update. Added Revised Medicare Table with link to LCD. Added history of pneumothorax, hemoptysis, or cardiac arrest in the past 30 days under contraindications. Update no revisions Update no revisions. Codes updated. Update no revisions. Update no revisions. Codes updated. Update no revisions. Codes updated. Update no revisions. Airway Clearance Systems Aug 17 12

13 This policy is based on the following evidence-based guidelines: 1. No authors listed. AARC (American Association for Respiratory Care) clinical practice guidelines. Postural drainage therapy. Respir Care. 1991;36(12): No authors listed. AARC (American Association for Respiratory Care) clinical practice guidelines. Directed cough. Respir Care. 1993;38(5): No authors listed. AARC (American Association for Respiratory Care) clinical practice guidelines. Suctioning of the Patient in the Home. Respir Care 1999;44(1): The Veterans Health Administration Clinical Practice Guideline for the Management of Persons with Chronic Obstructive Pulmonary Disease (COPD) or Asthma. 5. Hayes Medical Technology Directory. High-Frequency Chest Wall Compression for Cystic Fibrosis. May 3, Updated May 20, Update May Updated April 16, Hayes Medical Technology Directory. High-Frequency Chest Wall Compression for Diseases Other than Cystic Fibrosis. June Updated Sept Updated September 2, Updated September 20, Updated March 31, Updated March 15, Hayes. Search & Summary. Intrapulmonary Percussive Ventilation (IPV) for Treatment of Cystic Fibrosis in Children and Adolescents. May 20, Archived June Stickland SL, Rubin BK, Drescher GS, et al. AARC Clinical Practice Guideline: Effectiveness of Nonpharmacologic Airway Clearance Therapies in Hospitalized Patients. Respiratory Care. December Volume 58, No. 12. References Update August Lee AL, Burge AT, Holland AE. Et al. Airway clearance techniques for bronchiectasis. Cochrane Database Syst Rev Nov 23. References Update August Clinicaltrials.gov. The Effects of IPV Assessed with Functional Imaging. ClinicalTrials.gov Identifier: NCT May 27, Clinicaltrials.gov. A Comparison Study of Two Respiratory Physical Therapy Methods and Standard Medical Treatment for Treating COPD Patients during Acute Exacerbation. ClinicalTrials.gov Identifier: NCT May Finder JD. Atelectasis in children. UpToDate. September Gokdemir Y, Karadag-Saygi E, Erdem E, et al. Comparison of conventional pulmonary rehabilitation and high-frequency chest wall oscillation in primary ciliary dyskinesia. Pediatr Pulmonol. 2014;49(6): Huang WC, Wu PC, Chen CJ, et al. High-frequency chest wall oscillation in prolonged mechanical ventilation patients: a randomized controlled trial. Clin Respir J Sep 4. doi: /crj [Epub ahead of print]. 6. Morrisson L, Agnew J. Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev Jul 20;7:CD doi: / CD pub3. 7. Nolan P, Gourabathini H, Tran C, et al. High frequency chest wall oscillation for atelectasis in infants and toddlers: A case series report. Chest Oct 1;146. References Update August 2014 Airway Clearance Systems Aug 17 13

14 1. Fitzgerald K, Dugre J, Pagala S,et al. High-frequency chest wall compression therapy in neurologically impaired children. Respir Care Jan;59(1): Lee AL, Burge A, Holland AE. Airway clearance techniques for bronchiectasis. Cochrane Database Syst Rev May 31;5:CD References Update August Clinicaltrials.gov. Effects of IPV Assessed With Functional Imaging. ClinicalTrials.gov Identifier:NCT June Available at: 2. Clinkscale D, Spihlman K, Watts P, et al. A randomized trial of conventional chest physical therapy versus high frequency chest wall compressions in intubated and non-intubated adults. Respir Care Feb;57(2): Cochrane Database Syst Rev Dec 12;12:CD doi: / CD pub3.Active cycle of breathing technique for cystic fibrosis. 4. 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 Feb 13. References Update August Atkeson AD, RoyChoudhury A, Harrington-Moroney G, et al. Patient-ventilator asynchrony with nocturnal noninvasive ventilation in ALS. Neurology 2011; 77: Janssens JP, Borel JC, Pépin JL, et al. Nocturnal monitoring of home noninvasive ventilation: the contribution of simple tools such as pulse oximetry, capnography, built-in ventilator software and autonomic markers of sleep fragmentation. Thorax 2011; 66: Hill NS, Kramer NR. Practical aspects of nocturnal noninvasive ventilation in neuromuscular and chest wall disease. UpToDate. February 23, Hill NS, Kramer NR. Types of noninvasive nocturnal ventilatory support in neuromuscular and chest wall disease. UpToDate. May 14, Tsolaki V, Pastaka C, Kostikas K, et al. Noninvasive ventilation in chronic respiratory failure: effects on quality of life. Respiration 2011; 81:402. References Update September Crescimanno G, Marrone O. High frequency chest wall oscillation plus mechanical in-exsufflation in Duchenne muscular dystrophy with respiratory complications related to pandemic Influenza A/H1N1. Rev Port Pneumol. 2010;16(6): Nowobilski R, Włoch T, Płaszewski M, et al. Efficacy of physical therapy methods in airway clearance in patients with chronic obstructive pulmonary disease: a critical review. Pol Arch Med Wewn. 2010;120(11): Stafler P, Carr SB. Non-cystic fibrosis bronchiectasis: its diagnosis and management. Arch Dis Child Educ Pract Ed. 2010;95(3): Texas Tech University Health Sciences Center. Use of High Frequency Chest Compression in Pediatric Status Asthmaticus. National Library of Medicine (NLM) Identifier: NCT Updated December 29, ClinicalTrials.gov Available at: 5. Yuan N, Kane P, Shelton K, et al. Safety, tolerability, and efficacy of highfrequency chest wall oscillation in pediatric patients with cerebral palsy and neuromuscular diseases: an exploratory randomized controlled trial. J Child Neurol. 2010;25(7): Airway Clearance Systems Aug 17 14

15 References Update April Kempainen RR, Milla C, Dunitz J, et al. Comparison of settings used for highfrequency chest-wall compression in cystic fibrosis. Respir Care Jun;55(6): Robinson KA, McKoy N, Saldanha I, Odelola OA. Active cycle of breathing technique for cystic fibrosis. Cochrane Database Syst Rev Nov 10;(11):CD Wang QX, Zhang XY, Li Q. Effects of a flutter mucus-clearance device on pulmonary function test results in healthy people 85 years and older in China. Respir Care Nov;55(11): References Update April McCool FD, Rosen MJ. Nonpharmacologic airway clearance therapies: ACCP evidence-based clinical practice guidelines. Chest 2006 Jan; 129(1 Suppl): 250S-9S. 2. Centers for Medicare & Medicaid Services. LCD for High Frequency Chest Wall Oscillation Devices (L12739). Noridian Administrative Services. 3. Centers for Medicare & Medicaid Services. LCD for High Frequency Chest Wall Oscillation Devices 4. Morrison L, Agnew J. Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev Jan 21;(1) 5. Hristara-Papadopoulou A, Tsanakas J, Diomou G, Papadopoulou O. Current devices of respiratory physiotherapy. Hippokratia Oct; 12(4): Lange DJ, Lechtzin N, Davey C et al. High-frequency chest wall oscillation in ALS: an exploratory randomized, controlled trial. Neurology Sep 26;67(6): References 1. Main E, Prasad A, Schans C. Conventional chest physiotherapy compared to other airway clearance techniques for cystic fibrosis. Cochrane Database Syst Rev Jan 25;(1):CD Yoo Y, Koh YY. Current treatment for primary ciliary dyskinesia conditions. Expert Opin Pharmacother Feb;5(2): Elkins MR, Jones A, Schans C. Positive expiratory pressure physiotherapy for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. 2004;(1):CD Boucher RC. New concepts of the pathogenesis of cystic fibrosis lung disease. Eur Respir J Jan;23(1): Doring G, Hoiby N; Consensus Study Group. Early intervention and prevention of lung disease in cystic fibrosis: A European consensus. J Cyst Fibros. 2004;3(2): Phillips GE, Pike SE, Jaffe A, Bush A. Comparison of active cycle of breathing and high-frequency oscillation jacket in children with cystic fibrosis. Pediatr Pulmonol. 2004;37(1): Button BM, Heine RG, Catto-Smith AG, et al. Chest physiotherapy in infants with cystic fibrosis: To tip or not? A five-year study. Pediatr Pulmonol. 2003;35(3): Jones AP, Rowe BH. Bronchopulmonary hygiene physical therapy for chronic obstructive pulmonary disease and bronchiectasis (Cochrane Review). In: The Cochrane Library, Issue 1, Oxford, UK: Update Software. 9. Goss CH. Airway clearance in cystic fibrosis. Respir Care. 2003;48(1): Airway Clearance Systems Aug 17 15

16 10. van der Schans C, Prasad A, Main E. Chest physiotherapy compared to no chest physiotherapy for cystic fibrosis (Cochrane Review). In: The Cochrane Library, Issue 3, Oxford, UK: Update Software. 11. Main E, Prasad A, van der Schans C. Conventional chest physiotherapy compared to other forms of chest physiotherapy for cystic fibrosis (Protocol for a Cochrane Review). In: The Cochrane Library, Issue 3, Oxford, UK: Update Software. 12. Dosman CF, Zuberbuhler PC, Tabak JI, Jones RL. Effects of positive endexpiratory pressure on oscillated volume during high frequency chest compression in children with cystic fibrosis. Can Respir J. 2003;10(2): Silverman E, Ebright L, Kwiatkowski M, Cullina J. Current management of bronchiectasis: Review and 3 case studies. Heart Lung. 2003;32(1): 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): Volsko TA, DiFiore J, Chatburn RL. Performance comparison of two oscillating positive expiratory pressure devices: Acapella versus Flutter. Respir Care. 2003;48(2): Toussaint M, De Win H, Steens M, Soudon P. Effect of intrapulmonary percussive ventilation on mucus clearance in duchenne muscular dystrophy patients: A preliminary report. Respir Care. 2003;48(10): Miyata T. Novel approach to respiratory pharmacology--pharmacological basis of cough, sputum and airway clearance. Yakugaku Zasshi Dec;123(12): Donaldson SH, Boucher RC. Update on pathogenesis of cystic fibrosis lung disease. Curr Opin Pulm Med Nov;9(6): Hess DR. The evidence for secretion clearance techniques. Respir Care. 2002;46(11): Plioplys AV, Lewis S, Kasnicka I. Pulmonary vest therapy in pediatric long-term care. J Am Med Dir Assoc. 2002;3(5): Braverman JM. Increasing the quantity of lungs for transplantation using highfrequency chest wall oscillation: A proposal. Prog Transplant. 2002;12(4): Davidson KL. Airway clearance strategies for the pediatric patient. Respir Care. 2002;47(7): Fink JB, Mahlmeister MJ. High-frequency oscillation of the airway and chest wall. Respir Care. 2002;47(7): Deakins K, Chatburn RL. A comparison of intrapulmonary percussive ventilation and conventional chest physiotherapy for the treatment of atelectasis in the pediatric patient. Respir Care. 2002;47(10): Fink JB, Mahlmeister MJ. High-frequency oscillation of the airway and chest wall. Respir Care. 2002;47(7): Thompson CS, Harrison S, Ashley J, et al. Randomised crossover study of the Flutter device and the active cycle of breathing technique in non-cystic fibrosis bronchiectasis. Thorax. 2002;57(5): Wolkove N, Kamel H, Rotaple M, Baltzan MA Jr. Use of a mucus clearance device enhances the bronchodilator response in patients with stable COPD. Chest. 2002;121(3): Oermann CM, Sockrider MM, Giles D, et al. Comparison of high-frequency chest wall oscillation and oscillating positive expiratory pressure in the home management of cystic fibrosis: A pilot study. Pediatr Pulmonol. 2001;32(5): Airway Clearance Systems Aug 17 16

17 29. Scholz SE, Sticher J, Haufler G, et al. Combination of external chest wall oscillation with continuous positive airway pressure. Br J Anaesth. 2001;87(3): McIlwaine PM, Wong LT, Peacock D, Davidson AG. 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): Bellone A, Lascioli R, Raschi S, et al. Chest physical therapy in patients with acute exacerbation of chronic bronchitis: Effectiveness of three methods. Arch Phys Med Rehabil. 2000;81(5): Bach JR, Niranjan V, Weaver B. Spinal muscular atrophy type 1. Noninvasive respiratory management approach. Chest. 2000;117(4): Kang SW, Bach JR. Maximum insufflation capacity: vital capacity and cough flows in neuromuscular disease. Am J Phys Med Rehab. 2000;79(3): Bach JR, Kang SW. Disorders of ventilation: weakness, stiffness, and mobilization [editorial]. Chest. 2000;117(2): Houtmeyers E, Gosselink R, Gayan-Ramirez G, et al. Regulation of mucociliary clearance in health and disease. Eur Respir J. 1999;13(5): Pryor JA. Physiotherapy for airway clearance in adults. Eur Respir J. 1999;14(6): Gondor M, Nixon PA, Mutich R, et al. Comparison of flutter device and chest physical therapy in the treatment of cystic fibrosis pulmonary exacerbation. Pediatr Pulmonol. 1999;28(4): Padman R, Geuouque DM, Engelhardt MT. Effects of the flutter device on pulmonary function studies among pediatric cystic fibrosis patients. Del Med J. 1999;71(1): Langenderfer B. Alternatives to percussion and postural drainage. A review of mucus clearance therapies: percussion and postural drainage, autogenic drainage, positive expiratory pressure, flutter valve, intrapulmonary percussive ventilation, and high-frequency chest compression with the ThAIRapy Vest. J Cardiopulm Rehabil. 1998;18(4): Scherer TA, Barandun J, Martinez E, et al. Effect of high-frequency oral airway and chest wall oscillation and conventional chest physical therapy on expectoration in patients with stable cystic fibrosis. Chest. 1998;113(4): Homnick DN, Anderson K, Marks JH. Comparison of the flutter device to standard chest physiotherapy in hospitalized patients with cystic fibrosis: A pilot study. Chest. 1998:114(4): Burioka N, Sugimoto Y, Suyama H, et al. Clinical efficacy of the FLUTTER device for airway mucus clearance in patients with diffuse panbronchiolitis. Respirology. 1998;3(3): App EM, Kieselmann R, Reinhardt D, et al. Sputum rheology changes in cystic fibrosis lung disease following two different types of physiotherapy: Flutter vs autogenic drainage. Chest. 1998:114(1): Newhouse PA, White F, Marks JH, et al. The intrapulmonary percussive ventilator and flutter device compared to standard chest physiotherapy in patients with cystic fibrosis. Clin Pediatr (Phila). 1998;37(7): Van Winden CM, Visser A, Hop W, et al. Effects of flutter and PEP mask physiotherapy on symptoms and lung function in children with cystic fibrosis. Eur Respir J. 1998;12(1): Hanayama K, Ishikawa Y, Bach JR. Amyotrophic lateral sclerosis. Successful treatment of mucous plugging by mechanical insufflation-exsufflation. Am J Phys Med Rehabil. 1997;76(4): Airway Clearance Systems Aug 17 17