Clinical UM Guideline

This document addresses the use of high frequency chest compression devices (HFCC) to promote the clearance of respiratory secretions.

Note: Other types of mucous clearance systems are not addressed within this document (for example, the Flutter^® Mucous Clearance System, the Acapella^® Vibratory PEP Therapy System, etc.). See Definitions section for further information.

Note: For information regarding intrapulmonary percussive ventilation devices, please refer to:

• DME.00012 Intrapulmonary Percussive Ventilation Devices

Medically Necessary:

High frequency chest compression devices (see index for examples) are considered medically necessary when ALL of the following are met:

1. The individual has one of the following conditions:
   1. Cystic fibrosis; or
   2. Chronic bronchiectasis; or
   3. Chronic neuromuscular disorder (for example, but not limited to, muscular dystrophy, spinal muscular atrophy, multiple sclerosis, quadriplegia, and amyotrophic lateral sclerosis) affecting the ability to cough or clear respiratory secretions with prior history of pneumonia or other significant worsening of pulmonary function; and
2. There is documentation that other airway clearance therapies including manual chest physical therapy have failed to provide adequate secretion control; and
3. There is documentation of a trial during which the affected individual and the family (when applicable) demonstrate ability to comply with prescribed usage.

Continued use of a high frequency chest compression device is considered medically necessary when ongoing use, (that is, compliance with use) is documented at 6 month to 12 month intervals. (Note: For high frequency chest compression devices with usage meters, documentation should reflect use, in general, at least 67% of the prescribed time).

Not Medically Necessary:

High frequency chest compression devices are considered not medically necessary when the above criteria have not been met.

High frequency chest compression device replacement or upgrade is considered not medically necessary when requested for convenience or to upgrade to newer technology when the current components remain functional.

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for situations designated in the Clinical Indications section as not medically necessary.

Chest physiotherapy (CPT), also known as percussion and postural drainage (P/PD), is a secretion clearance method for individuals with excessive or retained lung secretions as a result of an underlying illness such as Cystic Fibrosis (CF). This document outlines medical necessity criteria for HFCC devices (see Index for a non-exhaustive list of devices) as an alternative to chest physiotherapy. HFCC devices may be medically necessary when conventional chest physiotherapy has failed or any number of circumstances render chest physiotherapy ineffective or a caregiver is unable or unavailable to provide the needed support. This may occur when there are two or more individuals in the family who require airway clearance therapy, or if the caregiver is unable (physically or mentally) to perform chest physical therapy at the required frequency, or there is no available parental or partner resource to perform chest physical therapy.

Conditions for which chest physiotherapy has been shown to improve clinical outcomes such as pulmonary function and reduced rates of exacerbation or hospitalization include cystic fibrosis, chronic bronchiectasis, and neuromuscular disease.

Cystic Fibrosis

Chest physiotherapy or alternative airway clearance techniques (ACTs) like HFCC are recommended by the Cystic Fibrosis Foundation (CFF) for all individuals with CF for clearance of sputum, augmentation of cough, maintenance of lung function, and improved quality of life. The National Heart, Lung, and Blood Institute describes HFCC devices as therapy vests that use vibrations to loosen mucus as an ACT for individuals with CF. The CFF suggests that a person use the vest for 5 minutes, then cough or huff cough to clear the mucus. This process is then repeated with a complete session lasting for 20-30 minutes. Advantages to HFCC may include that it provides therapy to a large area of the chest, pressure and frequency settings can be individualized to optimize sputum production, and that it may be used in individuals who are not cooperative with other ACTs.

In its CF Airway Clearance Therapies Clinical Care Guidelines (Flume, 2009, reviewed 2021), the CFF performed a systematic review of the literature and compared HFCC with other ACTs. It found that no ACT has been demonstrated to be superior to any other in terms of sputum production or lung function. The choice of ACT should be customized to the individual considering factors such as age, personal preference, and individual history of adverse events.

Chronic Bronchiectasis

There are many pathophysiologic processes that can contribute to the development of chronic bronchiectasis. They include pulmonary infections, bronchial narrowing or obstruction due to a tumor, congenital abnormalities or foreign body aspiration, inborn errors of immunity and immunodeficiencies, impaired mucociliary clearance due to CF or ciliary dysfunction such as primary ciliary dyskinesia, and rheumatic and systemic diseases (for example, systemic lupus erythematosus or Sjögren syndrome).

The American College of Chest Physicians (ACCP) CHEST Expert Panel Report on Treating Cough Due to Non-CF and CF Bronchiectasis With Nonpharmacologic Airway Clearance provided consensus-based suggestions including that individuals with productive cough due to bronchiectasis be taught ACTs, and that all ACTs and the frequency be individualized due to the different types of techniques, disease severity, and amount of secretions (Hill, 2018).

Several studies have shown high-frequency chest wall oscillation (HFCWO) to improve both pulmonary function and quality of life related parameters in individuals with non-CF bronchiectasis (Barto, 2020; Nicolini, 2013).

Neuromuscular Diseases

Many different neuromuscular conditions can be associated with difficulty clearing respiratory secretions. These may include but are not limited to muscular dystrophy, spinal muscular atrophy, multiple sclerosis, quadriplegia, and amyotrophic lateral sclerosis (ALS). A number of studies have evaluated the use of HFCWO therapy in improving respiratory health in these individuals. In 2010, Yuan and colleagues conducted a prospective randomized controlled trial of HFCWO and CPT with pediatric participants who had cerebral palsy (n=9) or neuromuscular diseases including muscular dystrophy (n=14). They found that there was a significant increase in maximum saturation level of oxygen in hemoglobin post therapy in the HFCWO group (p=0.01). They also observed a trend toward fewer hospitalizations for respiratory infections in individuals receiving HFCWO compared to those receiving standard CPT (p=0.09). Lange and colleagues (2006) investigated changes in respiratory function in individuals with ALS after using HFCWO in a 12-week randomized controlled trial. A total of 35 participants were in the trial: 19 used HFCWO and 16 were untreated. At 12 weeks, individuals in the HFCWO group reported a decrease in breathlessness (p=0.048).

Other applications of HFCC devices are considered not medically necessary since the scientific evidence does not permit the conclusion that the technology improves the net health outcome.

Bronchiectasis: A disorder of major bronchi and bronchioles characterized by abnormal airway dilatation and destruction of walls with resulting inflammation, edema, ulceration, and distortion. When large, unusual spaces are formed inside the airways of the lungs, mucus secretions can collect in these spaces and be difficult to clear. This can often lead to more infections and further lung damage, most commonly from infection or recurrent inflammation. Bronchiectasis can also be acquired from a tumor, inhaling a foreign object, or from a congenital condition.

Bronchitis: An inflammation of the upper airways associated with cough and mucus. It can be caused by infections (infectious bronchitis) or inflammation (smoker’s cough). Chronic bronchitis means that over the last 2 or more years, a person has been coughing up some mucus every day for at least 3 months out of the year.

Chest physiotherapy (CPT) (also known as chest physical therapy): The use of postural drainage, percussion, and vibration (PDPV) for airway clearance, which may also be referred to as percussion and postural drainage (P/PD). CPT is considered the standard of care of secretion clearance methods. This technique is time consuming, requires a skilled care provider and may be associated with discomfort, gastroesophageal reflux, and hypoxemia. The purpose of CPT is to improve mucociliary clearance and pulmonary function in order to reduce the risk of infection and lung damage.

Cystic fibrosis (CF): An autosomal recessive condition, the pulmonary manifestations of which include the production of excessive tenacious tracheobronchial mucus, leading to airway obstruction and secondary infection.

High-frequency chest compression (HFCC): A treatment designed to help improve secretion clearance for individuals suffering from excessive or retained lung secretions.

High-frequency chest wall oscillation (HFCWO): The mechanized technology employed by HFCC. HFCWO involves air pulses generated at various frequencies that are transmitted through a vest and compress the user’s chest.

Positive expiratory pressure [PEP] oscillatory devices: Devices that create air flow oscillations that vibrate the airway walls and loosen mucus so that it can be cleared. They do not provide HFCC and are not included in this document. Examples include:

Acapella (Smiths Medical, Watford, UK): A device which uses a counterweighted plug and magnet to create air flow oscillations.

Flutter mucous clearance device (AXCAN Scandipharm, Inc., Birmingham, AL): A handheld oscillatory device which produces oscillations of endobronchial pressure and expiratory airflow.

Peer Reviewed Publications:

1. Anbar RD, Powell KN, Iannuzzi DM. Short-term effect of ThAIRapy Vest^® on pulmonary function of cystic fibrosis patients. Am J Respir Crit Care Med. 1998; 157(Suppl 3):A130.
2. Arens R, Gozal D, Omlin KJ, et al. Comparison of high-frequency chest compression and conventional chest physiotherapy in hospitalized patients with cystic fibrosis. Am J Respir Crit Care Med. 1994; 150(4):1154-1157.
3. Barto TL, Maselli DJ, Daignault S, et al. Real-life experience with high-frequency chest wall oscillation vest therapy in adults with non-cystic fibrosis bronchiectasis. Ther Adv Respir Dis. 2020; 14:1753466620932508.
4. Braggion C, Cappelletti LM, Cornacchia M, et al. Short-term effects of three chest physiotherapy regimens in patients hospitalized for pulmonary exacerbations of cystic fibrosis: a cross-over randomized study. Pediatr Pulmonol. 1995; 19(1):16-22.
5. Chaisson KM, Walsh S, Simmons Z, Vender RL. A clinical pilot study: high frequency chest wall oscillation airway clearance in patients with amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2006; 7(2):107-111.
6. Chuang ML, Chou YL, Lee CY, Huang SF. Instantaneous responses to high-frequency chest wall oscillation in patients with acute pneumonic respiratory failure receiving mechanical ventilation: a randomized controlled study. Medicine (Baltimore). 2017; 96(9):e5912.
7. Clinkscale D, Spihlman K, Watts P, et al. A randomized trial of conventional chest physical therapy versus high frequency chest wall compressions in intubated and non-intubated adults. Respir Care. 2012; 57(2):221-228.
8. Darbee JC, Kanga JF, Ohtake PJ. Physiologic evidence for high-frequency chest wall oscillation and positive expiratory pressure breathing in hospitalized subjects with cystic fibrosis. Phys Ther. 2005; 85(12):1278-1289.
9. Fainardi V, Longo F, Faverzani S, et al. Short-term effects of high-frequency chest compression and positive expiratory pressure in patients with cystic fibrosis. J Clin Med Res. 2011; 3(6):279-284.
10. Giarraffa P, Berger KI, Chaikin AA, et al. Assessing efficacy of high-frequency chest wall oscillation in patients with familial dysautonomia. Chest. 2005; 128(5):3377-3381.
11. Gokdemir Y, Kardag-Saygi E, Erdem E, et al. Comparison of conventional pulmonary rehabilitation and high frequency chest wall oscillation in primary ciliary dyskinesia. Pediatr Pulmonol. 2014; 49(6):611-616.
12. Hess DR. The evidence for secretion clearance techniques. Respir Care. 2001; 46(11)1276-1293.
13. Kovesi T. Long-term respiratory complications of congenital esophageal atresia with and without tracheoesophageal fistula: an update. Dis Esophagus. 2013; 26(4):413-416.
14. Kempainen RR, Williams CB, Hazelwood A, et al. Comparison of high-frequency chest wall oscillation with differing waveforms for airway clearance in cystic fibrosis. Chest. 2007; 132(4):1227-1232.
15. Kempainen RR, Milla C, Dunitz J, et al. Comparison of settings used for high frequency chest-wall compression in cystic fibrosis. Respir. Care. 2010; 55(6):695-701.
16. Kluft J, Beker L, Castagnino M, et al. A comparison of bronchial drainage treatments in cystic fibrosis. Pediatr Pulmonol. 1996; 22(4):271-274.
17. Lange DJ, Lechtzin N, Davey C, et al. High-frequency chest wall oscillation in ALS: an exploratory randomized, controlled trial. Neurology. 2006; 67(6):991-997.
18. Lee YW, Lee J, Warwick WJ. The comparison of three high-frequency chest compression devices. Biomed Instrum Technol. 2008; 42(1):68-75.
19. Leemans G, Belmans D, Van Holsbeke C, Becker B, et al. The effectiveness of a mobile high-frequency chest wall oscillation (HFCWO) device for airway clearance. Pediatr Pulmonol. 2020; 55(8): 1984-1992.
20. Marks JH, Hare KL, Saunders RA, Homnick DN. Pulmonary function and sputum production in patients with cystic fibrosis: a pilot study comparing the Percussive Tech HF device and standard chest physiotherapy. Chest. 2004; 125(4):1507-1511.
21. Nicolini A, Cardini F, Landucci N, et al. Effectiveness of treatment with high-frequency chest wall oscillation in patients with bronchiectasis. BMC Pulm Med. 2013; 13:21.
22. Nicolini A, Grecchi B, Banfi P. Effectiveness of two high-frequency chest wall oscillation techniques in patients with bronchiectasis: a randomized controlled preliminary study. Panminerva Med. 2022; 64(2):235-243.
23. Oermann CM, Sockrider MM, Giles D, et al. Comparison of high-frequency chest wall oscillation and oscillating positive expiratory pressure in the home management of cystic fibrosis: a pilot study. Pediatr Pulmonol. 2001; 32(5):372-377.
24. Oermann CM, Swank PR, Sockrider MM. Validation of an instrument measuring patient satisfaction with chest physiotherapy techniques in cystic fibrosis. Chest. 2000; 118(1):92-97.
25. Osman LP, Roughton M, Hodson ME, Pryor JA. Short-term comparative study of high frequency chest wall oscillation and European airway clearance techniques in patients with cystic fibrosis. Thorax. 2010; 65(3):196-200.
26. Perry RJ, Man GC, Jones RL. Effects of positive end-expiratory pressure on oscillated flow rate during high-frequency chest compression. Chest. 1998; 113(4):1028-1033.
27. Plioplys AV, Lewis S, Kasnicka I. Pulmonary vest therapy in pediatric long-term care. J Am Med Dir Assoc. 2002; 3(5):318-321.
28. Pryor JA, Tannenbaum E, Scott SF, et al. Beyond postural drainage and percussion: airway clearance in people with cystic fibrosis. J Cyst Fibros. 2010; 9(3):187-192.
29. Scherer TA, Barandun J, Martinez E, et al. Effect of high-frequency oral airway and chest wall oscillation and conventional chest physical therapy on expectoration in patients with stable cystic fibrosis. Chest. 1998; 113 (4):1019-1027.
30. Sontag MK, Quittner AL, Modi AC, et al. Lessons learned from a randomized trial of airway secretion clearance techniques in cystic fibrosis. Pediatr Pulmonol. 2010; 45(3):291-300.
31. Stites SW, Perry GV, Peddicord T, et al. Effect of high frequency chest wall oscillation on the central and peripheral distribution of aerosolized diethylene triamine penta-acetic acid as compared to standard chest physiotherapy in cystic fibrosis. Chest. 2006; 129(3):712-717.
32. Varekojis SM, Douce FH, Flucke RL, et al. A comparison of the therapeutic effectiveness of and preference for postural drainage and percussion, intrapulmonary percussive ventilation, and high-frequency chest wall compression in hospitalized cystic fibrosis patients. Respir Care. 2003; 48(1):24-28.
33. Warwick WJ, Wielinski CL, Hansen LG. Comparison of expectorated sputum after manual chest physical therapy and high-frequency chest compression. Biomed Instrum Technol. 2004; 38(6):470-475.
34. Yuan N, Kane P, Shelton K, et al. Safety, tolerability, and efficacy of high-frequency chest wall oscillation in pediatric patients with cerebral palsy and neuromuscular diseases: an exploratory randomized controlled trial. J Child Neurol. 2010; 25(7):815-821.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Finder JD, Birnkrant D, Carl J, et al.; American Thoracic Society. Respiratory care of the patient with Duchenne muscular dystrophy: ATS consensus statement. Am J Respir Crit Care Med. 2004; 170(4):456-465.
2. Flume PA, Robinson KA, O'Sullivan BP, et al. Cystic Fibrosis Foundation. Cystic fibrosis pulmonary guidelines: airway clearance therapies. Respir Care. 2009; 54(4):522-537.
3. Hill AT, Barker AF, Bolser DC, et al. Treating cough due to non-CF and CF bronchiectasis with nonpharmacological airway clearance: CHEST Expert Panel Report. Chest. 2018; 153(4):986-993.
4. Lee AL, Burge A, Holland AE. Airway clearance techniques for bronchiectasis. Cochrane Database Syst Rev. 2013;(5):CD008351.
5. Mckoy NA, Wilson, LM, Saldanha, IJ, et al. Active cycle of breathing technique for cystic fibrosis. Cochrane Database Syst Rev. 2016; 7:CD007862.
6. Miller RG, Jackson CE, Kasarskis EJ, et al. Practice parameter update: the care of the patient with amyotrophic lateral sclerosis: drug, nutritional, and respiratory therapies (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology. 2009; 13;73(15):1218-1226.
7. Morrison L, Agnew J. Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. 2014;(7):CD006842.
8. Morrison L, Innes S. Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. 2017;(5):CD006842.
9. Morrison L, Milroy S. Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. 2020. CD006842.
10. Osadnik CR, McDonald CF, Jones AP, Holland AE. Airway clearance techniques for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012;(3):CD008328.
11. Strickland SL, Rubin BK, Drescher GS, et al. American Association for Respiratory Care (AARC) clinical practice guideline: Effectiveness of nonpharmacologic airway clearance therapies in hospitalized patients. Respir Care. 2013; 58(12):2187-2193.
12. Wilson LM, Morrison L, Robinson KA. Airway clearance techniques for cystic fibrosis: an overview of Cochrane systematic reviews. Cochrane Database Syst Rev. 2019;(1):CD011231.
13. Yankaskas JR, Marshall BC, Sufian B, et al. Cystic fibrosis adult care: consensus conference report. Chest. 2004; 125(1 Suppl):1S-39S.

1. American Association for Respiratory Care. Clinical practice guidelines for postural drainage therapy. 1991. Available at: https://www.aarc.org/wp-content/uploads/2014/08/12.91.1418.pdf. Accessed on August 13, 2024.
2. American Lung Association. Treating and managing cystic fibrosis: airway clearance therapy. Available at: https://www.lung.org/lung-health-diseases/lung-disease-lookup/cystic-fibrosis/treating-and-managing. Accessed on August 13, 2024.
3. Cystic Fibrosis Foundation. CF Airway Clearance Therapies Clinical Care Guidelines. Available at: https://www.cff.org/medical-professionals/cf-airway-clearance-therapies-clinical-care-guidelines. Accessed on August 13, 2024.
4. National Heart, Lung, and Blood Institute. Cystic Fibrosis Treatment. Available at: https://www.nhlbi.nih.gov/health/cystic-fibrosis/treatment. Accessed on August 15, 2024.
5. National Organization for Rare Disorders. Cystic Fibrosis. Available at: https://rarediseases.org/rare-diseases/cystic-fibrosis/. Accessed on August 13, 2024.

ABI Vest Cystic Fibrosis High Frequency Chest Compression (HFCC)
AffloVest^®
Frequencer
inCourage System
Medpulse Respiratory Vest System
Monarch^™ Airway Clearance System
Oscillatory Devices
Respin11^® Bronchial Clearance system
SmartVest Airway Clearance System
ThAIRapy Bronchial Drainage System
ThAIRapy Vest
Vest Airway Clearance System
Vest APX System (PVAPX1)

The use of specific product names is illustrative 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.

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