Medical Policy: 01.01.01
Original Effective Date: February 1995
Reviewed: January 2021
Revised: January 2021
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Cystic fibrosis, chronic bronchitis, bronchiectasis, immotile cilia syndrome, neuromuscular disease with progressive respiratory muscle weakness, asthma and some acute respiratory tract infections are conditions that can lead to abnormal airway clearance or increased sputum production.
Chest physiotherapy is a treatment that attempts to compensate for abnormal airway clearance by removing mucopurulent secretions. However, the standard of care continues to be manual clapping, vibration and compression, together with postural drainage and assisted coughing. Most practitioners prescribe 20 to 30-min CPT sessions 1 to 3 times a day, depending on the severity of disease and the presence of intercurrent infection.
A conventional manual chest percussion and postural drainage program to remove accumulated secretions requires a caregiver's assistance and may cause children and adults to be less compliant with a treatment regimen. Different types of airway clearance devices have been developed for independent use, which require little or no assistance by others. When a competent care giver is not available to administer CPT manually, specific alternative methods may be utilized. Many of these techniques have been developed and studied using CF patients.
Bronchiectasis, a chronic illness characterized by permanent and abnormal dilation of bronchi, presents with symptoms of recurrent cough, purulent sputum (often in excessive amounts), dyspnea, and hemoptysis. Bronchiectasis is common in patients with cystic fibrosis and chronic obstructive pulmonary disease. Non-cystic fibrosis bronchiectasis is most often suspected in patients with a chronic cough and sputum production with respiratory infections that are recurrent, severe, or persistent. Diagnosis of bronchiectasis requires confirmation by CT scan.
Use of airway clearance devices in those with neuromuscular disease has been the subject of multiple studies focusing on coughing/expectorant ability and effect on pulmonary exacerbation. Neuromuscular weakness can lead to compromise of the respiratory system, inadequate muscle tone of the upper airway, and the inability to adequately clear secretions. Consequently, this can lead to hypoventilation, obstruction of the airway, aspiration, retention of secretions, and infection. These complications often occur simultaneously and can ultimately lead to respiratory failure.
(e.g., the Frequencer, the SmartVest, the MedPulse Respiratory Vest System, the Vest Airway Clearance System, the ABI Vest, Respin11 Bronchial Clearance System, and the InCourage Vest/System, the AffloVest, The Monarch™ Airway Clearance System) are passive oscillatory devices designed to provide airway clearance without the active participation of the patient. The Vest Airway Clearance System provides high-frequency chest compression using an inflatable vest and an 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 AffloVest is portable and runs via battery pack without a hose and generator. The Monarch™ Airway Clearance System is a portable version of a high frequency chest wall oscillation device utilizing pulmonary oscillating discs (PODs) containing magnets, over the upper and lower lobes of the lungs. It was recently approved by the FDA for use in those over 15 years of age.
The MetaNeb® System delivers continuous high-frequency oscillation and positive expiratory pressure to facilitate pulmonary mucus clearance and provide lung expansion. The system is indicated for mobilizing lung secretions, lung expansion therapy, and treating and preventing pulmonary atelectasis. The device can be used in patients with chronic obstructive pulmonary disease, postoperative airway management, bronchiectasis, neuromuscular disorders, cystic fibrosis, asthma, emphysema, and chest wall trauma. This system has not been studied in the home setting.
(e.g., Fluid Flo and Frequencer, including acoustical percussor Vibralung) The purpose of percussion is to apply kinetic energy to the chest wall and lung at regular intervals. Percussion is also referred to as cupping, clapping, and tapotement. It can be accomplished by rhythmically striking the thorax with a cupped hand or a mechanical device applied directly over the lung segment(s) being drained. According to the guidelines developed by American Association for Respiratory Care (AARC) on postural drainage therapy, no convincing evidence demonstrates the superiority of one method over the other. The Vibralung is marketed as an alternative to high frequency chest wall compression devices.
With PEP devices, in which the patient exhales multiple times through a device, the FLUTTER device is a small pipe-shaped, easily portable hand-held device, with a mouthpiece at one end. It contains a high-density stainless-steel ball that rests in a plastic circular cone. During exhalation, the steel ball moves up and down, creating oscillations in expiratory pressure and airflow. When the oscillation frequency approximates the resonance frequency of the pulmonary system, vibration of the airways occurs, resulting in loosening of mucus. The Acapella device is similar in concept but uses a counterweighted plug and magnet to create air flow oscillation.
(e.g., the Percussionaire and the TXP® Universal VENTILATOR Percussionator®) This device combines internal thoracic percussion through rapid minibursts of inhaled air and continuous therapeutic aerosol delivered through a nebulizer. An aerosol machine delivers a series of pressurized gas minibursts at rates of 100 to 225 cycles/min to the respiratory tract. Aerosolized medications can be delivered under pressure and with oscillations that vibrate the chest. Studies do not demonstrate any advantage of IPV over that achieved with good pulmonary care in the hospital environment and there are no studies in the home setting.
CoughAssist (known as In-Exsufflator, Cofflator, cough machine) is designed to inflate the lung with positive pressure and assist cough with negative pressure. 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 seconds. Using this technique of mechanical insufflation-exsufflation, peak cough expiratory flows can be increased by more than four-fold."
Simeox technology is reported to mobilize and transport mucus from the distal tracts by disseminating a vibratory pneumatic signal in the bronchial tree during exhalation. At this time the Simeox device is not FDA approved for use in the United States.
An AAN practice parameter states that there is insufficient data to support or refute HFCWC for clearing airway secretions in patients with ALS (2014). AAN recommendations included MI-E to aid in clearing secretions in patients with ALS who have reduced peak cough flow, particularly during an acute chest infection.
AARC clinical practice guidelines on non-pharmacologic airway clearance therapies in hospitalized patients state that, due to insufficient evidence, HFCWC cannot be recommended for adult or pediatric patients with neuromuscular disease (NMD), respiratory muscle weakness or impaired cough (2013).
The decision to use postural drainage therapy requires assessment of potential benefits versus potential risks. Therapy should be provided for no longer than necessary to obtain the desired therapeutic results. Listed contraindications are relative unless marked as absolute (A).
The ACCP indicates that devices designed to oscillate gas in the airway (e.g., Flutter, Intrapulmonary Percussive Ventilation, HFCWC), either directly or by compressing the chest wall, may be considered an alternative to chest PT in patients with CF (level of evidence, low; benefit, conflicting; grade of recommendation, inconclusive) (2006).
In a consensus statement on the respiratory care of patients with Duchenne muscular dystrophy (DMD), the ATS states that effective airway clearance is critical for patients with DMD to prevent atelectasis and pneumonia. Ineffective airway clearance can hasten the onset of respiratory failure and death, whereas early intervention to improve airway clearance can prevent hospitalization and reduce the incidence of pneumonia. HFCWC has been used in patients with neuromuscular weakness but there are no published data on which to base a recommendation. Any airway clearance device predicated upon normal cough is less likely to be effective in patients with DMD without concurrent use of assisted cough. Patients with DMD should be taught strategies to improve airway clearance and how to employ those techniques early and aggressively.
ATS makes the following recommendations:
In the guidance on the management of cystic fibrosis, NICE (2017) stated that high-frequency chest wall oscillation should not be offered as an airway clearance technique for people with cystic fibrosis except in exceptional clinical circumstances because the evidence has shown that high-frequency chest wall oscillation is not as effective as other airway clearance techniques. Airway clearance techniques for these patients should be individualized based on the patients’ ability to clear mucus from their lungs, and all factors that may influence adherence should be considered. The effectiveness of the technique should be assessed frequently and modified as needed.
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:
Airway clearance devices have been primarily investigated as an alternative (not adjunct) to conventional chest physical therapy. Published clinical data does not prove an increased health benefit, their use primarily represents a convenience to the member or the caregiver, this is the rationale for these devices being considered not medically necessary unless conventional chest physical therapy has failed, is not possible, or is unavailable. The following criteria gives more detail on the coverage criteria of individual airway clearance devices.
High frequency oscillatory chest wall compression devices for airway clearance may be medically necessary in members with:
There must be documentation of the inability to use or failure* of manual chest physical therapy due to one or more of the following reasons:
* Failure includes repeat respiratory infections or decreased breathing capacity when there is evidence that chest physiotherapy has been consistently performed as prescribed.
High-frequency chest wall compression devices are considered not medically necessary in those with a contraindication as defined by the American Association of Respiratory Care and includes, but may not be limited to:
High-frequency chest wall compression devices are considered not medically necessary as an alternative to chest physical therapy in patients with cystic fibrosis, immotile ciliary dysfunction/ciliary dyskinesia, neurodegenerative diseases, or chronic bronchiectasis in any other clinical situation.
There is a lack of clinical data to show that these devices provide any additional health benefit compared to conventional chest physical therapy in other situations.
There is insufficient evidence for the use of high frequency chest wall compression therapy in those with other medical conditions. The evidence is limited and insufficient to support definitive conclusions. There has not been adequate evidence to prove superiority of mechanical therapy over manual therapy. There are limited studies evaluating oscillatory devices for the treatment of COPD, acute exacerbations, and other respiratory conditions; the available evidence did not tend to find that these devices were more effective than conventional treatment. The use of high frequency chest wall compression for all other conditions, including but not limited to the following is considered investigational:
Not all individuals with Cerebral Palsy and COPD have issues with excessive secretion production. Additionally, there was no clear long-term benefit of airway clearance devices in regard to future exacerbations.
Mechanical percussors may be considered medically necessary for airway clearance in patients with:
There must be documentation of the inability to use, or *failure of other airway clearance therapies including manual chest physical therapy due to one or more of the following reasons:
*Failure includes repeat respiratory infections or decreased breathing capacity when chest physiotherapy has been consistently performed as prescribed.
The use of Vibralung, called an auditory percussor, (which is considered an upgraded percussor), is only considered medically necessary for cystic fibrosis, chronic bronchitis, chronic bronchiectasis in the clinical scenario where a mechanical percussor can not be used (i.e burns, chest trauma, rib fracture).
Vibratory/oscillatory positive expiratory pressure device for airway clearance is considered medically necessary in patients with:
Positive expiratory pressure (PEP) device (E0484/E1399) for airway clearance is considered medically necessary in patients with:
Mechanical insufflation-exsufflation devices for airway clearance may be considered medically necessary in patients who meet ALL of the following criteria:
The use of intrapulmonary percussion ventilation (also known as the Percussionaire Corporation IPV Ventilator) in the home setting has not been proven safe or more effective than manual CPT. The safety of home use has been questioned in the home setting. No studies have been published that focuses use in the home setting. The use of IPV ventilation in the home setting is considered investigational.
Other applications of airway clearance devices, including, but not limited to their use with other lung diseases and other neuromuscular disorders is considered investigational.
The upgrading of a covered device to a newer model, or more portable model, due to preference or convenience is considered not medically necessary.
Combination high frequency chest oscillation and positive expiratory pressure systems (e.g. MetaNeb) are considered investigational.
Use of the Simeox Airway Clearance Technology (Physio Assist) system is considered investigational.
Bronchiectasis: A disorder of major bronchi and bronchioles characterized by abnormal airway dilatation and destruction of walls with resulting inflammation, edema, ulceration, and distortion. When large, unusual spaces are formed inside the airways of the lungs, mucus secretions can collect in these spaces and be difficult to clear. This can often lead to more infections and further lung damage, most commonly from infection or recurrent inflammation. Bronchiectasis can also be acquired from a tumor, inhaling a foreign object, or from a congenital condition.
Bronchitis: An inflammation of the upper airways associated with cough and mucus. It can be caused by infections (infectious bronchitis) or inflammation (smoker’s cough). Chronic bronchitis means that over the last 2 or more years, a person has been coughing up some mucus every day for at least 3 months out of the year.
Chest physiotherapy (CPT) (also known as chest physical therapy): The use of postural drainage, percussion, and vibration (PDPV) for airway clearance, which may also be referred to as percussion and postural drainage (P/PD). CPT is considered the standard of care of secretion clearance methods. This technique is time consuming, requires a skilled care provider and may be associated with discomfort, gastroesophageal reflux, and hypoxemia. The purpose of CPT is to improve mucociliary clearance and pulmonary function in order to reduce the risk of infection and lung damage.
Cystic fibrosis (CF): An autosomal recessive condition, the pulmonary manifestations of which include the production of excessive tenacious tracheobronchial mucus, leading to airway obstruction and secondary infection. This is the principal cause of morbidity and mortality associated with CF.
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
*CPT® is a registered trademark of the American Medical Association.