High Frequency Chest Wall Oscillating Devices (HFCWO) (Airway Clearance Systems)

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High Frequency Chest Wall Oscillating Devices (HFCWO) (Airway Clearance Systems) Date of Origin: 05/2015 Last Review Date: 07/26/2017 Effective Date: 07/26/2017 Dates Reviewed: 07/2016 Developed By: Medical Necessity Criteria Committee I. Description Chest wall oscillation is when devices are used for clearing excess mucus from lung airways (bronchi and bronchioles). It is principally used in the treatment of cystic fibrosis, but is gaining use in the treatment of other diseases, such as bronchiectasis, COPD, cerebral palsy and muscular dystrophy, in which excessive mucus can block airways due to excessive production or impaired clearance. This "passive system" is not dependent on the effort of the patient. It uses a compressor to inflate and deflate the vest rhythmically at timed intervals and thus imposes high frequency chest wall oscillations (HFCWO) that are transferred to the lungs. These oscillations thin thixotropic airway mucus, facilitating its removal by coughing. Delivery of air to the vest can be controlled manually. II. Criteria: CWQI HCS-0024 A. High frequency chest wall oscillating devices (HFCWO) are considered medically necessary for All of the following: a. The treating physician (MD, DO or DPM), physician assistant (PA), nurse practitioner (NP) or clinical nurse specialist (CNS) must have face-to-face examination with the patient within the six (6) months prior to the date of the request b. The request is NOT for Both an HFCWO and mechanical in-exsufflation device (E0482) and One or more of the following: i. Airway clearance devices are considered are considered medical necessary to assist in mobilizing respiratory tract secretions for 1 or more of the following 1. Airway oscillating devices (i.e., Flutter and Acapella) are considered medically necessary for One of the following: b. Chronic bronchitis c. Bronchiectasi, d. Immotile cilia syndrome (also known as primary ciliary dyskinesia) e. Asthma 2. Mechanical percussors (i.e. Fluid Flo and Frequencer) are considered medically necessary for One of the following: Moda Health Medical Necessity Criteria High Frequency Chest Wall Oscillation Devices (HFCWO) Page 1/5

b. Chronic bronchitis c. Bronchiectasis d. Immotile cilia syndrome (also known as primary ciliary dyskinesia) e. Asthma 3. Positive expiration pressure (PEP) mask is considered medically necessary for One of the following: b. Chronic bronchitis c. Immotile cilia syndrome d. Asthma e. Chronic obstructive pulmonary disease (COPD) ii. High-frequency chest compression systems (i.e. the Frequencer, the SmarVest, the MedPulse Respiratory Vest System, the Vest Airway Clearance System, the ABI Vest, Respin11 Bronchial Clearance system, the InCourage Vest/System) are considered medically necessary in lieu of chest physiotherapy with All of the following: 1. HFCWO is considered medically necessary for 1 or more of the following conditions a. Bronchiectasis and All of the following: i. High resolution, spiral, or standard CT scan documenting bronchiectasis and One or more of the following: 1. History of daily productive cough for at least 6 continuous months 2. History of frequent exacerbations requiring antibiotic therapy (i.e. more than 2 times/year) ii. The patient does NOT have chronic bronchitis and chronic obstructive pulmonary disease in the absence of confirmed diagnosis of bronchiectasis b. Cystic Fibrosis c. Immotile cilia syndrome d. The patient has One of the following neuromuscular diseases: i. Acid maltase deficiency ii. Anterior horn cell diseases, including amyotrophic lateral sclerosis iii. Hereditary muscular dystrophy iv. Multiple sclerosis v. Myotonic disorders vi. Other myopathies vii. Paralysis of the diaphragm viii. Post-polio ix. Quadriplegia regardless of etiology e. Patient has had a lung transplant and All of the following: i. Request is within the first 6 months post-operatively ii. Patient unable to tolerate standard chest physiotherapy 2. There is well-documented failure of standard treatments to adequately mobilize retained secretions. Moda Health Medical Necessity Criteria High Frequency Chest Wall Oscillation Devices (HFCWO) Page 2/5

B. High-frequency chest compression systems are considered experimental and investigational for other indications (e.g., alpha 1-antitrypsin deficiency, childhood atelectasis, cerebral palsy, coma, kyphosis, leukodystrophy, scoliosis, and stiff-person (stiff-man) syndrome; not an all-inclusive list) because their effectiveness for these indications has not been established. C. Intrapulmonary percussive ventilators (i.e. the Impulsator F00012) are considered experimental and investigational for all indications because there is insufficient evidence supporting their effectiveness. D. Mechanical in-exsufflation devices are considered medically necessary for patients with a neuromuscular disease (e.g., amyotrophic lateral sclerosis, high spinal cord injury with quadriplegia) that is causing a significant impairment of chest wall and/or diaphragmatic movement and for whom standard treatments (e.g., chest percussion and postural drainage, etc.) have not been successful in adequately mobilizing retained secretions. III. Information Submitted with the Prior Authorization Request: 1. Chart notes documenting diagnosis and all treatments 2. Pulmonary function test 3. Reports of imaging studies IV. CPT or HCPC codes covered: Codes E0483 A7025 A7026 Description HIGH FREQUENCY CHEST WALL OSCILLATION AIR-PULSE GENERATOR SYSTEM, (INCLUDES HOSES AND VEST), EACH HIGH FREQUENCY CHEST WALL OSCILLATION SYSTEM VEST, REPLACEMENT FOR USE WITH PATIENT OWNED EQUIPMENT, EACH HIGH FREQUENCY CHEST WALL OSCILLATION SYSTEM HOSE, REPLACEMENT FOR USE WITH PATIENT OWNED EQUIPMENT, EACH V. Annual Review History Review Date Revisions Effective Date 05/2015 New criteria adopted from CMS national and/or regional 07/01/2015 guideline 07/2016 Annual Review: Reviewed to match Noridian L33785 for 07/27/2016 HFCWO 07/2017 Annual Review: No Changes 07/26/2017 Moda Health Medical Necessity Criteria High Frequency Chest Wall Oscillation Devices (HFCWO) Page 3/5

VII. References 1. CMS Local Coverage Determination for High Frequency Chest Wall Oscillation Devices L33785; Noridian Healthcare Solutions, LLC; Revision date 10/01/2015; effective date 10/31/2014; 2. Hippokratia 2008 Oct-Dec; 12(4): 211-220; Current devices of Respiratory physiotherapy; http://www.ncbi.nlm.nih.gov/pmc/articles/pmc2580042/ 3. Hayes, Inc. Medical technology Directory. High-Frequency Chest Wall Compression for cystic Fibrosis. Lansdale, PA: Hayes, Inc., May 3, 2012 4. Lange DJ, Lechtzin N, Davey C, David W, Heiman-Patterson T, Gelinas D, Becker B, Mitsumoto H; HFCWO Study Group. High-frequency chest wall oscillation in ALS: an exploratory randomized, controlled trial. Neurology. 2006 Sep 26; 67(6):991-7 5. American Association for Respiratory Care (AARC). AARC clinical practice guidelines. Postural drainage therapy. Respir Care. 1991;36(12):1418-1426 6. Advanced Respiratory. The Vest Airway Clearance System [website]. St. 7. Paul, MN: Advanced Respiratory; 2003. Available at: http://www.abivest.com/. Accessed February 28, 2003. 8. Langenderfer B. Alternatives to percussion and postural drainage. A review of mucus clearance therapies: Percussion and postural drainage, autogenic drainage, positive expiratory pressure, flutter valve, intrapulmonary percussive ventilation, and high-frequency chest compression with the ThAIRapy Vest. J Cardiopulm Rehabil. 1998;18(4):283-289. 9. CMS Local Coverage Article: High Frequency Chest Wall oscillation Devices-Policy Article-Effective October 2014 (A25365); Noridian Healthcare Solutions; Accessed 07/2017 Appendix 1 Applicable ICD-10 diagnosis codes: Codes Description A15.0 Tuberculosis of lung A15.4 Tuberculosis of intrathoracic lymph nodes A15.5 Tuberculosis of larynx, trachea and bronchus A15.6 Tuberculous pleurisy A15.8 Other respiratory tuberculosis A15.9 Respiratory tuberculosis unspecified B91 Sequelae of poliomyelitis G14 Postpolio syndrome E84.9 Cystic fibrosis, unspecified E84.0 Cystic fibrosis with pulmonary manifestations D84.1 Defects in the complement system G35 Multiple sclerosis G95.0 Syringomyelia and syringobulbia G12.8 Other spinal muscular atrophies and related syndromes G12.9 Spinal muscular atrophy, unspecified G82.51 Quadriplegia, C1-C4 complete G82.52 Quadriplegia, C1-C4 incomplete G82.53 Quadriplegia, C5-C7 complete G82.54 Quadriplegia, C5-C7 incomplete Moda Health Medical Necessity Criteria High Frequency Chest Wall Oscillation Devices (HFCWO) Page 4/5

G82.50 Quadriplegia, unspecified G71.2 Congenital myopath G71.0 Muscular dystrophy G71.11 Myotonic muscular dystrophy G71.12 Myotonia congenita G71.13 Myotonic chondrodystrophy G71.14 Drug induced myotonia G71.19 Other specified myotonic disorders G72.2 Myopathy due to other toxic agents G73.7 Myopathy in diseases classified elsewhere G72.89 Other specified myopathies J47.9 Bronchiectasis, uncomplicated J47.1 Bronchiectasis with (acute) exacerbation J98.6 Disorders of diaphragm Q33.9 Congenital bronchiectasis Appendix 1 Centers for Medicare and Medicaid Services (CMS) Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, 50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan. Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD): Jurisdiction(s): 5, 8 NCD/LCD Document (s): Noridian Local Coverage Determination LCD 33785 High Frequency Chest Wall Oscillation Device https://med.noridianmedicare.com/documents/2230703/7218263/high+frequency+chest+wall+oscillation+ Devices/2c8213bc-6773-4dcf-9fa5-80557b80b888 NCD/LCD Document (s): Noridian Local Coverage Determination High Frequency Chest Wall Oscillation Device Policy Article Medicare Part B Administrative Contractor (MAC) Jurisdictions Jurisdiction Applicable State/US Territory Contractor F (2 & 3) AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ Noridian Healthcare Solutions, LLC Moda Health Medical Necessity Criteria High Frequency Chest Wall Oscillation Devices (HFCWO) Page 5/5