DESCRIPTION
Certain respiratory abnormalities, conditions or diseases may cause excessive production of tracheobronchial mucus, resulting in inadequate clearing of respiratory secretions, inflammation and secondary infection. Approximately 50% of individuals with this type of irreversible airway damage have cystic fibrosis.
Chest physiotherapy (CPT) or percussion and postural drainage (P/PD) is the most commonly used and effective secretion clearance technique. There are several types of devices and breathing methods intended to promote the clearance of respiratory secretions and are used passively or actively by the individual. The devices may be designed as a vest, flutter valve, or as a percussive ventilator. The devices may be referred to as oscillatory devices, high-frequency chest compression devices or mucus clearance devices.
The bronchial drainage vest system (e.g., the Vest Airway Clearance SystemŪ, formerly known as the ThAIRapy VestŪ or the ABI VestŪ) is a portable device that provides external thoracic percussion. It consists of a non-stretching inflatable vest linked to an air pulse generator by two flexible hoses. The generator rapidly inflates and deflates the vest, gently compressing and releasing the chest wall to create airflow within the lungs. This process moves mucous toward the larger airways where it can be cleared by coughing. This airway clearance therapy is commonly referred to as high frequency chest wall oscillation. It is not position dependent for mucus clearance.
The intrapulmonary percussive ventilator (IPV) provides internal thoracic percussion by self-administered chest physiotherapy for airway clearance. It is a form of oscillating positive expiratory pressure device. IPV combines internal thoracic percussion through rapid mini-bursts of inhaled air through a mouthpiece and continuous therapeutic aerosol delivered through a nebulizer. Upon expiration, the individual coughs to assist in eliminating secretions. The purpose of the treatment is for therapeutic mobilization of retained endobronchial secretions and resolution of diffuse patchy atelectasis.
Patients with cystic fibrosis also use oscillatory positive expiratory pressure devices (i.e. FLUTTERŪ and Acapella devices). It is a small pipe-shaped, 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 type device is similar in concept but uses a counterweighted plug and magnet to create air flow oscillation.
POLICY
The bronchial drainage vest system for the treatment of cystic fibrosis and bronchiectasis is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Hand held oscillatory positive expiratory pressure devices for the treatment of cystic fibrosis and bronchiectasis are considered medically necessary if the medical appropriateness criteria are met (See Medical Appropriateness below.)
Intrapulmonary percussive ventilation, as an alternative to chest physiotherapy, is considered not medically necessary.
The bronchial drainage vest system for the treatment of other conditions/diseases is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
See also: Mechanical In-Exsufflator (Cough Machine)
MEDICAL APPROPRIATENESS
The bronchial drainage vest system is considered medically appropriate if ALL of the following are met:
ABSENCE of ALL of the following absolute contraindications, as defined by the American Association of Respiratory Care (AARC) for external manipulation of the thorax:
Bronchospasms
Complaint of chest wall pain
Unstable head and/or neck injury
Subcutaneous emphysema
Recent epidural spinal infusion or spinal anesthesia
Recent skin grafts, or flaps, on the thorax
Burns, open wounds, and skin infections of the thorax
Recently placed transvenous pacemaker or subcutaneous pacemaker
Osteomyelitis of the ribs
Active hemorrhage with hemodynamic instability
Suspected pulmonary tuberculosis
Lung contusion
ANY ONE of the following conditions:
Cystic fibrosis with ALL of the following:
Individual is 2 years old or greater
Documentation that less intensive treatments have been tried and failed (chest physical therapy and/or the electric home model percussor)
Documentation that there is no competent caregiver
Bronchiectasis with ALL of the following criteria are met:
Individual is 2 years old or greater
Documentation of daily productive cough for at least six continuous months
Frequent (i.e., more than 2/year) exacerbations requiring antibiotic therapy
Confirmed diagnosis by high resolution, spiral, or standard CT scan
Documentation of failure of standard treatments to adequately mobilize retained secretions
The hand held oscillatory positive expiratory pressure devices for the treatment of cystic fibrosis and bronchiectasis are considered medically appropriate if ALL of the following are met:
ANY ONE of the following:
Bronchiectasis and/ or cystic fibrosis is the documented diagnosis requiring mucus elimination
The individual has tried and failed the usual conventional therapy including but not limited to chest physical therapy
The device is being used as an alternative to conventional chest physical therapy
IMPORTANT REMINDER
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, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Requests for the bronchial drainage system vest should be referred to the Case Management Department for review. For review purposes, consider how often chest physiotherapy has been ordered [e.g., if the order is for chest physiotherapy more than 2 times per day, and the caregiver is at work 8 hours a day, the bronchial drainage system vest may be medically appropriate]. Documentation that less intensive treatments have been tried and failed may be further evidenced by repeated courses of home antibiotic infusion therapy due to problematic secretions, and/or recurrent hospitalizations for respiratory exacerbations.
The Vest Airway Clearance SystemŪ now includes a lifetime warranty covering: parts, labor, vest refits, and accessories. Individuals will be responsible only for shipping and handling charges incurred more than two years after initial shipment of the vest system. There is insufficient data to show the efficacy of the use of the bronchial drainage system vest for other diseases/conditions.
The intrapulmonary percussive ventilator device is investigated as an alternative (not adjunct) to conventional chest physical therapy. There is no clinical data to show that intrapulmonary percussive ventilation (IPV) provides any additional health benefit compared to conventional chest physical therapy; the use of these devices primarily represents a convenience to the individual. It is on this basis that these devices are considered not medically necessary.
The literature does not verify the efficacy and safety of percussive/oscillating devices in neuromuscular diseases compared to the health outcomes of conventional chest percussion treatment.
SOURCES
American Association for Respiratory Care (AARC). (1991). AARC clinical practice guideline. Postural drainage therapy. Retrieved August 19, 2011 from http://www.aarc.org/resources/protocol_resources/documents/broncho_hygiene_algorithm.pdf.
American Lung Association. (2011). Understanding bronchiectasis. Retrieved August 19, 2011 from http://www.lungusa.org/lung-disease/bonchiectasis/understanding-bronchiectasis.html?print=t.
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2011). Oscillatory devices for the treatment of cystic fibrosis and other respiratory disorders (1.01.15). Retrieved August 19, 2011 from BlueWeb. (13 articles and/ or guidelines reviewed)
BlueCross BlueShield of Tennessee network physicians. August 2005.
Chatburn, R. (2007). High-frequency assisted airway clearance. Respiratory Care, 52 (9), 1224-1237.
Complete Guide to Medicare Coverage Issues [Computer software]. (2011, April). Intrapulmonary percussive ventilator (IPV) (NCD 240.5, p. 2-206). Ingenix.
Cystic Fibrosis Foundation. (2010, April). Airway clearance techniques. Retrieved August 19, 2011 from: http://www.cff.org/treatments/Therapies/Respiratory/AirwayClearance/.
ECRI Institute. Health Technology Information Service. Evidence Reports. (2000, October).High-frequency chest compression for cystic fibrosis. Retrieved August 19, 2011 from ECRI Institute. (34 articles and/or guidelines reviewed)
Flume, P. A., Robinson, K. A., OSullivan, B. P., Finder, J. D., Vender, R. L., Willey-Courand, et al. (2009). Cystic fibrosis pulmonary guidelines: Airway clearance therapies. Respiratory Care, 54 (4), 522-537.
Hristara-Papadopoulou, A., Tsanakas, J., Diomou, G., & Papadopoulou, O. (2008). Current devices of respiratory physiotherapy. Hippokratia, 12 (4), 211-220.
Kempainen, R., Milla, C., Dunitz, J., Savik, K., Hazelwood, A., Williams, C., et al. (2010). Comparison of settings used for high-frequency chest-wall compression in cystic fibrosis. Respiratory Care, 55 (6), 695-701. (Level 3 Evidence - Industry sponsored)
Kempainen, R., Williams, C., Hazelwood, A., Rubin, B., & Milla, C. (2007).Comparison of high-frequency chest wall oscillation with differing waveforms for airway clearance in cystic fibrosis. Chest, 132 (4), 1227-1232. (Level 3 Evidence - Independent study)
Kennedy, J., & Martin, A. (2009). Chronic respiratory failure and neuromuscular disease. Pediatric Clinics of North America, 56 (1), 261-273.
Kim, D., & Lazarus, A. (2008). Management of bronchiectasis. Disease a Month, 54 (8), 540-546.
Lange, D. J., Lechtzin, N., Davey, C., David, W., Heiman-Patterson, T., Gelinas, D., et al. (2006). High-frequency chest wall oscillation in ALS: An exploratory, randomized, controlled trial. Neurology, 67 (6), 991-997. (Level 2 Evidence - Industry sponsored)
Marks, J. (2008). Pulmonary care of children and adolescents with developmental disabilities. Pediatric Clinic of North America, 55 (6), 1299-1314.
McCool, F., & Rosen, M. (2006). Nonpharmacologic airway clearance therapies: ACCP evidence-based clinical practice guidelines. Chest, 129 (1 Suppl), 250S-259S.
Pisi, G., & Chetta, A. (2009). Airway clearance therapy in cystic fibrosis patients. Acta Biomed, 80 (2), 102-106.
Schechter, M. (2007). Airway clearance applications in infants and children. Respiratory Care, 52 (10), 1382-1390.
Sontag, M. K., Quittner, A. L., Modi, A. C., Koenig, J. M., Giles, D., Oermann, C. M., et al. (2010). Lessons learned from a randomized trial of airway secretion clearance techniques in cystic fibrosis. Pediatric Pulmonology, 45 (3), 291-300. (Level 2 Evidence - Industry sponsored)
U. S. Food and Drug Administration. (2005, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K063645. Retrieved August 19, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf5/K053248.pdf.
U. S. Food and Drug Administration. (2007, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K063645. Retrieved August 19, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf6/K063645.pdf.
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/cdrh_docs/pdf9/K091557.pdf.
Winifred S. Hayes. Medical Technology Directory. (2008, September; last update search August 2010). High-frequency chest wall compression for diseases other than cystic fibrosis. Retrieved August 19, 2011 from www.Hayesinc.com/subscribers. (42 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 10/25/2001
MOST RECENT REVIEW DATE: 9/22/2011
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.