DESCRIPTION
Oscillatory devices are intended to promote the clearance of respiratory secretions. These devices include high-frequency chest compression with an inflatable vest, oscillating positive expiratory pressure devices, and intrapulmonary percussive ventilation. These devices have been primarily investigated as an alternative (not adjunct) to the standard daily percussion and postural drainage method of airway clearance for individuals with cystic fibrosis. They have been proposed for use in other respiratory conditions such as chronic obstructive pulmonary disorder (COPD), bronchiectasis, or neuromuscular conditions. The oscillatory component can be intra-or extrathoracic.
The oscillatory positive expiratory pressure devices (e.g., Flutter® and Acapella®) are small pipe-shaped, portable hand-held devices, with a mouthpiece at one end. The Flutter device 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.
High frequency chest wall oscillation devices (e.g., the Vest Airway Clearance System®) are passive oscillatory devices designed to provide airway clearance without active participation. 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 inflate and deflate the vest against the thorax, creating high-frequency chest wall oscillation and mobilization of pulmonary secretions.
The intrapulmonary percussive ventilator (IPV) device, e.g., Impulsator® (Percussionaire) is another type of passive oscillatory device. This device combines internal thoracic percussion through rapid mini-bursts of inhaled air and continuous therapeutic aerosol delivered through a nebulizer.
POLICY
Oscillating devices for the treatment of respiratory conditions are considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
High frequency chest wall oscillation devices and intrapulmonary percussive ventilation devices for other uses or for the treatment of other conditions/diseases including, but not limited to the following are considered investigational:
As an adjunct to chest physical therapy
For use in other lung diseases, including but not limited to chronic obstructive pulmonary disease (COPD)
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Oscillating devices are considered medically appropriate if ALL of the following are met:
Types of devices used are ANY ONE of the following:
Hand-held oscillatory positive expiratory pressure device when ALL of the following are met:
Documented diagnosis of hypersecretory lung disease that requires assisted mucus clearing, for example: bronchiectasis, cystic fibrosis or a neuromuscular disease (e.g., Duchenne Muscular Dystrophy)
Documentation of failure of standard chest physical therapy to clear secretions
Documentation of recurrent disease exacerbations
Device is used as an alternative to conventional chest physical therapy
High-frequency chest wall oscillation devices when ALL of the following are met:
No absolute contraindications for external manipulation of the thorax including ABSENCE of ALL the following:
Head and/or neck injury that has not yet been stabilized
Active hemorrhage with hemodynamic instability
Treatment is indicated for ANY ONE of the following conditions:
Cystic fibrosis when ALL of the following are met:
Documentation of ANY ONE of the following:
Less intensive treatments have been tried and failed (e.g., chest physical therapy and/or the electric home model percussor [E0480])
Inability of caregiver to provide effective chest drainage as prescribed
Bronchiectasis when ALL of the following are met:
Confirmed diagnosis by standard or high resolution CT scan
Documented
failure of standard treatments (e.g., chest physical
therapy) including ANY
ONE of the following:
Frequent severe exacerbations of respiratory distress involving inability to clear mucus
Inability of caregiver to provide effective chest drainage as prescribed
Neuromuscular disease (e.g., Duchenne Muscular Dystrophy) when ALL of the following are met:
Documentation of ineffective clearance of airway mucous
Documentation that less intensive treatments have been tried and failed (e.g., chest physical therapy)
Intrapulmonary percussive ventilation for ANY ONE of the following conditions:
Cystic fibrosis when ALL of the following are met:
Documentation of ANY ONE of the following:
Less intensive treatments have been tried and failed (e.g., chest physical therapy and/or the electric home model percussor [E0480])
Inability of caregiver to provide effective chest drainage as prescribed
Bronchiectasis when ALL of the following are met:
Confirmed diagnosis by standard or high resolution CT scan
Documented failure of standard treatments (e.g., chest physical therapy) including ANY ONE of the following:
Frequent severe exacerbations of respiratory distress involving inability to clear mucus
Inability of caregiver to provide effective chest drainage as prescribed
Neuromuscular diseases (e.g., Duchenne Muscular Dystrophy) when ALL of the following are met:
Documentation of ineffective clearance of airway mucous
Documentation that less intensive treatments have been tried and failed (e.g., chest physical therapy)
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
The use of high-frequency chest wall compression and home use of intrapulmonary percussive ventilation devices in other chronic pulmonary diseases, such as chronic obstructive pulmonary disorder, is considered investigational due to insufficient evidence on the impact of treatment on health outcomes.
SOURCES
American College of Chest Physicians. (2018, April). Treating cough due to Non-CF and CF bronchiectasis with nonpharmacological airway clearance. Retrieved October 26, 2022 from https://www.chestnet.org/guidelines/clinical-pulmonary.
American Lung Association. (2022, November). Bronchiectasis symptoms and diagnosis. Retrieved November 15, 2023 from https://www.lung.org.
American Lung Association. (2022, November). Treating and managing bronchiectasis. Retrieved November 15, 2023 from https://www.lung.org.
BlueCross BlueShield Association. Evidence Positioning System. (7:2023). Oscillatory devices for the treatment of cystic fibrosis and other respiratory disorders (1.01.15). Retrieved November 15, 2023 from www.bcbsaoca.com/eps/. (21 articles and/ or guidelines reviewed)
Centers for Medicare & Medicaid Services. CMS.gov. NCD for intrapulmonary percussive ventilator (IPV) (240.5). Retrieved December 27, 2019 from https://www.cms.gov.
CMS.gov: Centers for Medicare & Medicaid Services. CGS Administrators, LLC. (2022, October). High frequency chest wall oscillation devices (L33785). Retrieved November 15, 2023 from https://www.cms.gov.
Cystic Fibrosis Foundation. (2009). CF airway clearance therapies clinical care guidelines. Retrieved November 12, 2018 from https://www.cff.org/Care/Clinical-Care-Guidelines/Respiratory-Clinical-Care-Guidelines/CF-Airway-Clearance-Therapies-Clinical-Care-Guidelines/.
Lauwers, E., Ides, K., Van Hoorenbeeck, K., & Verhulst, S. (2018). The effect of intrapulmonary percussive ventilation in pediatric patients: a systematic review. Pediatric Pulmonology, 53 (11), 1463-1474. Abstract retrieved November 15, 2018 from PubMed database.
Lee, A. L., Burge, A. T., & Holland, A. E. (2015). Airway clearance techniques for bronchiectasis. Cochrane Database System Review, 2015, (11). (Level 2 evidence)
McIlwaine, M., Button, B., & Dwan, K. (2015). Positive expiratory pressure physiotherapy for airway clearance in people with cystic fibrosis. Cochrane Database System Review, 2015, (6). Abstract retrieved January 3, 2017 from PubMed database.
Morrison, L., & Milroy, S. (2020). Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database System Review, 2020, (4), CD006842. (Level 2 evidence)
Reychler, G., Debier, E., Contal, O, & Audag, N. (2018). Intrapulmonary percussive ventilation as an airway clearance technique in subjects with chronic obstructive airway diseases. Respiratory Care, 63 (5), 620-631. (Level 2 evidence)
U. S. Food and Drug Administration. (2005, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K053248 (ElectroMed SmartVest®). Retrieved August 19, 2011 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2007, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K063645 (Frequencer™) Retrieved August 19, 2011 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2010, January). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K091557. Retrieved August 19, 2011 from http://www.accessdata.fda.gov.
Yuan, N., Kane, P., Shelton, K., Matel, J., Becker, B., & Moss, R. (2010). Safety, tolerability, and efficacy of high-frequency chest wall oscillation in pediatric patients with cerebral palsy and neuromuscular diseases: an exploratory randomized controlled trial. Journal of Child Neurology, 25 (7), 815-821. (Level 3 evidence)
ORIGINAL EFFECTIVE DATE: 10/25/2001
MOST RECENT REVIEW DATE: 1/11/2024
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.