High-Frequence Chest Wall Oscillation System

Policy: 200508 Initial Effective Date: 10/14/2005 SUBJECT: High-Frequency Chest Wall Oscillation System

Annual Review Date: 07/21/2020

Last Revised Date: 07/21/2020

Prior approval is required for HCPCS A7025, A7026, E0481 and E0483.

Definition: High frequency chest wall oscillation represents a mechanical form of chest physiotherapy utilized to enhance mobilization of pulmonary secretions in the presence of inadequate airway clearance. An inflatable vest encompasses the chest and back and is connected to an air-pulse generator. The air generator creates pressure pulses that rapidly inflate and deflate the vest against the thorax, creating high frequency chest wall oscillations. This external chest wall vibration produced by high frequency chest wall oscillation is thought to reduce mucus viscosity and improve clearance of respiratory tract secretions.

Medical Necessity: I. High frequency chest wall oscillation system: The Company considers high frequency chest wall oscillation (HCPCS Codes A7025, A7026 and E0483) medically necessary and eligible for reimbursement providing that all of the following medical criteria are met:

• Documented need for airway clearance and at least one of the following clinical conditions:

1. Cystic fibrosis; or 2. Chronic bronchiectasis; or 3. Chronic neuromuscular disorder;

AND

• Failure of, intolerance to or unable to receive standard methods of chest physiotherapy to clear airway secretions or therapy is not feasible due to at least one of the following:

1. Individual is independent but does not have caregiver(s) to perform chest physiotherapy; or 2. Two or more individuals in the same household require frequent chest physiotherapy and insufficient caregivers are present to provide necessary care.

This document is subject to the disclaimer found at http://www.medmutual.com/provider/MedPolicies/Disclaimer.aspx. If printed, this document is subject to change. Always verify with the most current version of the official document at http://www.medmutual.com/provider/MedPolicies/Disclaimer.aspx.

Continuation of coverage: The Company will provide continued coverage for a high frequency chest wall oscillation system providing that patient compliance, effective utilization and significant benefit from the high frequency chest wall oscillation system have been demonstrated during the three month trial period. Medical record documentation must include frequency and duration of treatments and system meter usage prior to consideration of system purchase.

The Company considers a high frequency chest wall oscillation system (HCPCS Codes A7025, A7026 and E0483) for treatment of all other clinical conditions investigational and not eligible for reimbursement.

Documentation Requirements: The Company reserves the right to request additional documentation as part of its coverage determination process. The Company may deny reimbursement when it has determined that the services performed were not medically necessary, investigational or experimental, not within the scope of benefits afforded to the member and/or a pattern of billing or other practice has been found to be either inappropriate or excessive. Additional documentation supporting medical necessity for the services provided must be made available upon request to the Company. Documentation requested may include patient records, test results and/or credentials of the provider ordering or performing a service. The Company also reserves the right to modify, revise, change, apply and interpret this policy at its sole discretion, and the exercise of this discretion shall be final and binding.

Sources of Information:

• Alma L. Vest Airway Clearance Systems for Cystic Fibrosis: Learn If the Airway Clearance Vests for Cystic Fibrosis Are for You. Updated September 2, 2016. verywell [website]. Available at: https://www.verywellhealth.com/airway- clearance-vests-998326 • Barto, T., Maselli, D. J., Daignault, S., Porter, J., Kraemer, C., & Hansen, G. (2019). Two Years of High frequency Chest Wall Oscillation (HFCWO) Outcomes in a Large Registry of Non-CF Bronchiectasis Patients. In C105. BRONCHIECTASIS: FROM CLINICAL PHENOTYPES TO TREATMENT (pp. A5718-A5718). American Thoracic Society. • Blanch, L., VIllar, J., & López-Aguilar, J. (2009). High-frequency percussive ventilation: an old mode with a great future. Crit Care Med, 37(5), 1810-1811. • Centers for Medicare & Medicaid Services. - High frequency chest wall oscillation devices (L33785). Local coverage determination. CGS Administrators, LLC. Revision effective date January 01, 2020. - Intrapulmonary percussive ventilation system (L33786). Local coverage determination. CGS Administrators, LLC. Revision effective date January 01, 2020. - Intrapulmonary percussive ventilator (IPV) (240.5). National coverage determination. Effective date July 14, 1997. • Chaisson, K. M., Walsh, S., Simmons, Z., & Vender, R. L. (2006). A clinical pilot study: high frequency chest wall oscillation airway clearance in patients with amyotrophic lateral sclerosis. Amyotroph Lateral Scler, 7(2), 107-111. • Haas, C. F., Loik, P. S., & Gay, S. E. (2007). Airway clearance applications in the elderly and in patients with neurologic or neuromuscular compromise. Respir Care, 52(10), 1362-1381. • Hayes, Inc. (2016, December 22). Annual Review (2020, April 24). High-frequency chest wall compression for cystic fibrosis. Lansdale, PA: Author. • Kempainen, R. R., Williams, C. B., Hazelwood, A., Rubin, B. K., & Milla, C. E. (2007). Comparison of high- frequency chest wall oscillation with differing waveforms for airway clearance in cystic fibrosis. Chest, 132(4), 1227- 1232. • Kennedy, J. D., & Martin, A. J. (2009). Chronic respiratory failure and neuromuscular disease. Pediatr Clin North Am, 56(1), 261-273, xii. • Marks, J. H., Hare, K. L., Saunders, R. A., & Homnick, D. N. (2004). Pulmonary function and sputum production in patients with cystic fibrosis: a pilot study comparing the PercussiveTech HF device and standard chest physiotherapy. Chest, 125(4), 1507-1511. • McCool, F. D., & Rosen, M. J. (2006). Nonpharmacologic airway clearance therapies: ACCP evidence-based clinical practice guidelines. Chest, 129(1 Suppl), 250S-259S. • Nava, S., Barbarito, N., Piaggi, G., De Mattia, E., & Cirio, S. (2006). Physiological response to intrapulmonary percussive ventilation in stable COPD patients. Respir Med, 100(9), 1526-1533. • Reardon, C. C., Christiansen, D., Barnett, E. D., & Cabral, H. J. (2005). Intrapulmonary percussive ventilation vs incentive spirometry for children with neuromuscular disease. Arch Pediatr Adolesc Med, 159(6), 526-531.

• Reychler, G., Keyeux, A., Cremers, C., Veriter, C., Rodenstain, D. O., & Liistro, G. (2004). Comparison of lung deposition in two types of nebulization: intrapulmonary percussive ventilation vs jet nebulization. Chest, 125(2), 502- 508. • Reychler, G., Walemacq, P., Rodenstein, D. O., Cumps, J., Leal, T., & Liistro, G. (2006). Comparison of lung deposition of amikacin by intrapulmonary percussive ventilation and jet nebulization by urinary monitoring. J Aerosol Med, 19(2), 199-207. • Ries, A. L., Bauldoff, G. S., Carlin, B. W., Casaburi, R., Emery, C. F., Mahler, D. A., … Herrerias, C. (2007). Pulmonary rehabilitation: joint ACCP/AACVPR evidence-based clinical practice guidelines. Chest, 131(5 Suppl), 4S- 42S. • Toussaint, M., De Win, H., Steens, M., & Soudon, P. (2003). Effect of intrapulmonary percussive ventilation on mucus clearance in duchenne muscular dystrophy patients: a preliminary report. Respir Care, 48(10), 940-947. • Vargas, F., Boyer, A., Bui, H. N., Guenard, H., Gruson, D., & Hilbert, G. (2009). Effect of intrapulmonary percussive ventilation on expiratory flow limitation in chronic obstructive pulmonary disease patients. J Crit Care, 24(2), 212- 219. • Vargas, F., Bui, H. N., Boyer, A., Salmi, L. R., Gbikpi-Benissan, G., Guenard, H., … Hilbert, G. (2005). Intrapulmonary percussive ventilation in acute exacerbations of COPD patients with mild respiratory acidosis: a randomized controlled trial [ISRCTN17802078]. Crit Care, 9(4), R382-R389. • Yankaskas, J. R., Marshall, B. C., Sufian, B., Simon, R. H., & Rodman, D. (2004). Cystic fibrosis adult care: consensus conference report. Chest, 125(1 Suppl), 1S-39S. • Yen Ha, T. K., Bui, T. D., Tran, A. T., Badin, P., Toussaint, M., & Nguyen, A. T. (2007). Atelectatic children treated with intrapulmonary percussive ventilation via a face mask: clinical trial and literature overview. Pediatr Int, 49(4), 502-507.