Medical Policy: 01.01.01
Original Effective Date: February 1995
Reviewed: May 2016
Revised: May 2016
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 some of the conditions that can lead to abnormal airway clearance or increase sputum production.
Chest physiotherapy is a treatment that attempts to compensate for abnormal airway clearance by removing mucopurulent secretions. However, the standard of care remains manual clapping, vibration and compression, together with postural drainage and assisted coughing.
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. Many alternative oscillatory devices are designed to provide self-administered airway clearance and have been investigated as an alternative to percussion and postural drainage.
(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) 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.
(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.
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 that 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.
(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 s. Using this technique of mechanical insufflation-exsufflation, peak cough expiratory flows can be increased by more than four-fold."
One of the following devices may be considered medically necessary for the one of the following scenarios:
standard chest physiotherapy (CPT) is unavailable or not tolerated.
High frequency oscillatory chest wall compression devices for airway clearance in patients with:
High-frequency chest wall compression devices are considered not medically necessary as an alternative to chest physical therapy in patients with cystic fibrosis, 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 these situations.
High-frequency chest wall compression devices are considered not medically necessary for acute episodes of bronchiectasis.
There is insufficient evidence for the use of high frequency chest wall compression therapy in those with other conditions. The evidence is limited and insufficient to support definitive conclusions. There has not been adequate evidence to prove superiority 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. Therefore, use of high frequency chest wall compression for all other conditions is considered not medically necessary.
Mechanical percussors for airway clearance in patients with:
The use of Vibralung the auditory percussor, which is considered an upgrade, is only 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).
Vibratory/oscillatory positive expiratory pressure device for airway clearance in patients with:
Positive expiratory pressure (PEP) mask for airway clearance in patients with:
Mechanical insufflation-exsufflation devices for airway clearance in patients with:
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. 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 due to preference or convenience is considered not medically necessary.
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.