mp-087
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Oscillatory Devices for the Treatment of Cystic Fibrosis and Other Respiratory Conditions

Policy Number: MP-087

Latest Review Date: June 2021

Category:  DME  

POLICY:

High frequency chest wall compression devices may be considered medically necessary when in the treatment of the following conditions the patient’s family or other resources cannot adequately perform the required chest physiotherapy:

  • Cystic Fibrosis

  • Neuromuscular diseases (i.e., Duchenne’s muscular dystrophy, Spinal Muscular Atrophy, Amyotrophic Lateral Sclerosis) (Other neuromuscular diseases will require individual review)

  • Neuromotor disorders (i.e., Cerebral Palsy, Multiple Sclerosis, traumatic head or spinal cord injuries) (Other neuromuscular diseases will require individual review)

  • Chronic bronchiectasis

The Intrapulmonary Percussive Ventilation System may be considered medically necessary when in the treatment of the following conditions the patient’s family or other resources cannot adequately perform the required chest physiotherapy: 

  • Cystic fibrosis

  • Neuromuscular diseases (i.e., Duchenne’s Muscular Dystrophy, Spinal Muscular Atrophy, Amyotrophic Lateral Sclerosis) (Other neuromuscular diseases will require individual review)

  • Neuromotor disorders (i.e., Cerebral Palsy, Multiple Sclerosis, traumatic head or spinal cord injuries) (Other neuromuscular diseases will require individual review)

  • Chronic bronchiectasis

Use of an oscillating positive expiratory pressure device (PEP) may be considered medically necessary when in the treatment of the following conditions the patient’s family or other resources cannot adequately perform the required chest physiotherapy:

  • Cystic fibrosis

  • Alpha-1-antitrypsin deficiency

  • Bronchiectasis and conditions that produce increased sputum or secretions

The upgrading of a covered device to a newer model is considered not medically necessary.

DESCRIPTION OF PROCEDURE OR SERVICE:

Oscillatory devices are alternatives to the standard daily percussion and postural drainage method of airway clearance for patients with cystic fibrosis. There are several types of devices including high-frequency chest compression with an inflatable vest and oscillating positive expiratory pressure devices, such as the Flutter and Acapella devices. Respiratory therapists and other providers may also use oscillatory devices  for other respiratory conditions such as diffuse bronchiectasis, chronic obstructive pulmonary disease, and respiratory conditions associated with neuromuscular disorders.

Oscillatory devices are designed to move mucus and clear airways; the oscillatory component can be intra- or extrathoracic. Some devices require the active participation of patients. They include oscillating positive expiratory pressure devices, such as Flutter and Acapella, in which the patient exhales multiple times through a device. The Flutter device is a small pipe-shaped, easily portable handheld 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 device is similar in concept but uses a counterweighted plug and magnet to create air flow oscillation.

Other airway clearance techniques also require active patient participation. For example, autogenic drainage and an active cycle breathing technique both involve a combination of breathing exercises performed by the patient. Positive expiratory pressure therapy requires patients to exhale through a resistor to produce positive expiratory pressures during a prolonged period of exhalation. It is hypothesized that the positive pressure supports the small airway such that the expiratory airflow can better mobilize secretions.

High-frequency chest wall oscillation devices (e.g., the Vest Airway Clearance System) are passive oscillatory devices designed to provide airway clearance without the active patient 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.

All of these techniques may be alternatives to daily percussion and postural drainage in patients with cystic fibrosis, also known as chest physical therapy. Daily percussion and postural drainage need to be administered by a physical therapist or another trained adult in the home, often a parent if the patient is a child. The necessity for regular therapy can be particularly burdensome for adolescents or adults who lead independent lifestyles. Oscillatory devices can also potentially be used by patients with other respiratory disorders to promote bronchial secretion drainage and clearance, such as diffuse bronchiectasis and chronic obstructive pulmonary disease. Additionally, they could benefit patients with neuromuscular disease who have impaired cough clearance.

This policy addresses outpatient use of oscillatory devices. Inpatient device use e.g., in the immediate post-surgical period, is not included in the policy.

KEY POINTS:

The most recent literature review was updated through April 19, 2021.

Summary of Evidence:

For individuals who have cystic fibrosis who receive oscillatory devices, the evidence includes randomized controlled trials (RCTs) and a systematic review. Relevant outcomes are symptoms, quality of life, hospitalizations, and medication use. The RCTs had mixed findings and limitations such as small sample sizes and large dropout rates. A systematic review identified 35 RCTs comparing oscillatory devices with another recognized airway clearance techniques; some were published only as abstracts. The review authors could not pool findings due to heterogeneity in study designs and outcome measures, and they concluded that additional adequately powered RCTs with long-term follow up are needed to make conclusions about oscillatory devices for cystic fibrosis.

For individuals who have bronchiectasis who receive oscillatory devices, the evidence includes RCTs and a systematic review. Relevant outcomes are symptoms, quality of life, hospitalizations, and medication use. A 2015 systematic review identified 7 small RCTs on several types of oscillatory devices; only 1 RCT reported the clinically important outcomes of exacerbations or hospitalizations. Only 3 RCTs reported on quality of life, and findings were mixed.

For individuals who have COPD who receive oscillatory devices, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, quality of life, hospitalizations, and medication use. Only a few controlled studies have evaluated oscillatory devices for the treatment of COPD, and they tend to have small sample sizes, short follow-up periods, and limitations in their analyses (e.g., lack of intention to treat analysis and between-group comparisons). Moreover, the published studies have mixed findings and do not clearly support the use of oscillatory devices in COPD patients. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have respiratory conditions related to neuromuscular disorders who receive oscillatory devices, the evidence includes 2 RCTs and a systematic review. Relevant outcomes are symptoms, quality of life, hospitalizations, and medication use. One of the RCTs was not powered to detect statistical significance. The other RCT, conducted in patients with amyotrophic lateral sclerosis, did not find significant improvement after high-frequency chest wall compression devices versus usual care in primary outcomes, in pulmonary function measures, or in most secondary outcomes.

Practice Guidelines and Position Statements:

American College of Chest Physicians

The 2006 guidelines from the American College of Chest Physicians recommended (level of evidence: low) that, in patients with cystic fibrosis, devices designed to oscillate gas in the airway, either directly or by compressing the chest wall, can be considered as an alternative to chest physical therapy.

Cystic Fibrosis Foundation

In 2009, the Cystic Fibrosis Foundation published guidelines on airway clearance therapies based on a systematic review of evidence. The Foundation recommended airway clearance therapies for all patients with cystic fibrosis, but stated that no therapy had been demonstrated to be superior to others (level of evidence: fair; net benefit: moderate; grade of recommendation: B).

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Cystic fibrosis, neuromuscular disease, chest physiotherapy (CPT), The Vest™ Airway Clearance System, high-frequency chest wall oscillation (HFCWO), ABI vest®, intrapulmonary percussive ventilation, IPV, chest physiotherapy, CPT, oscillating positive expiratory pressure, Flutter device, Percussionaire, Medpulse® Respiratory Vest System, Acapella, inCourage, Vibralung Acoustical Percussor, Monarch airway clearance system

APPROVED BY GOVERNING BODIES:

Several oscillatory devices have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process, including those listed in Table 1:

Table 1.  Oscillatory Devices Cleared by the Food and Drug Administration

Device

Manufacturer

Clearance Date

Flutter Mucus Clearance Device

Axcan Scandipharm (for marketing in the United States)

1994

Vest Airway Clearance System

Hill-Rom

1998

Acapella device

DHD Healthcare

1999

RC Cornetä Mucus Clearing Device

PARI Respiratory Equipment

1999

inCourage® System

RespirTech

2005

AerobiKA oscillating PEP device

Trudell Medical

2013

Vibralung Acoustical Percussor

Westmed

2014

 The Vest Airway Clearance system   Hill-Rom   2015

Monarch Airway Clearance System

Hill-Rom

2017

PEP:  positive expiratory pressure.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: FEP does not consider investigational and will be reviewed for medical necessity

CURRENT CODING :

HCPCS codes: 

A7025 Replacement of vest
A7026 Replacement of hose
E0480  Percussor, electric or pneumatic, home model
E0481 Intrapulmonary percussive ventilation system and related accessories
E0483 High frequency chest wall oscillation system, includes all accessories and supplies, each
E0484 Oscillatory positive expiratory pressure device, non-electric, any type, each
S8185 Flutter device

REFERENCES:

  1. AARC Clinical Practice Guideline.  Postural drainage therapy respiratory care, 1991; 36: 1418-1426.

  2. Alghamdi SM, Barker RE, Alsulayyim ASS, et al. Use of oscillatory positive expiratory pressure (OPEP) devices to augment sputum clearance in COPD: a systematic review and meta-analysis. Thorax. Oct 2020; 75(10): 855-863.
  3. App EM, Kieselmann R, Reinhardt D, et al.  Sputum rheology changes in cystic fibrosis lung disease following two different types of physiotherapy.  Chest 1998; 114: 171-177.

  4. Arens, R., Gozal, D., Omlin, K., et al.  Comparison of high frequency chest compression and conventional chest physiotherapy in hospitalized patients with cystic fibrosis, American Journal of Respiratory Critical Care Medicine, 1994, Vol. 150, pp. 1154-1157.

  5. Becherman, Robert C. and Chiappetha, Anna C.  High-frequency chest-wall oscillation in SMA.   The Journal for Respiratory Care Practitioners, 1995; 8(4): 112-11

  6. Bellone, A., Lascioli, R., Raschi, S., Guzzi, L., and Adone, R.  Chest physical therapy in patients with acute exacerbation of chronic bronchitis:  Effectiveness of three methods, Archives of Physical Medicine and Rehabilitation, May 2000; 81(5): 558-60.

  7. Braverman, Jane M.  Airway clearance needs in Duchenne’s muscular dystrophy:  An overview, Advanced Respiratory, St. Paul, Minnesota.

  8. Braverman, Jane M.  Airway clearance needs in respiratory-compromised medically fragile children:  An overview, Advanced Respiratory, St. Paul, Minnesota.

  9. Chakravorty I, Chahal K, Austin G. A pilot study of the impact of high-frequency chest wall oscillation in chronic obstructive pulmonary disease patients with mucus hypersecretion. Int J Chron Obstruct Pulmon Dis 2011; 6:693-9.

  10. Deakins, Kathleen and Chatburn, Robert L.  A comparison of intrapulmonary percussive ventilation and conventional chest physiotherapy for the treatment of atelectasis in the pediatric patient, Respiratory Care 2002; 47(10): 1162-1167).

  11. Eaton T, Young P, et al.  A randomized evaluation of the acute efficacy, acceptability and tolerability of flutter and active cycle of breathing with and without postural drainage in non-cystic fibrosis bronchiectasis.  Chron Respir Dis 2007; 4(1): 23-30.

  12. Flume PA, Robinson KA, et al.  Cystic fibrosis pulmonary guidelines:  Airway clearance therapies.  Respiratory Care, April 2009; 54(4): 522-537.

  13. Goktalay T, Akdemir SE, Alpaydin AO et al. Does high-frequency chest wall oscillation therapy have any impact on the infective exacerbations of chronic obstructive pulmonary disease? A randomized controlled single-blind study. Clin Rehabil 2013; 27(8):710-8.

  14. Hall, Tom.  Case study:  Muscular Dystrophy and congenital myopathy with respiratory insufficiency and pneumonia, Advanced Respiratory 2001, St. Paul, Minnesota.

  15. Hall, Tom.  Case study:  Spinal muscular atrophy and atelectasis, Advanced Respiratory 2001, St. Paul, Minnesota.

  16. Herrero-Cortina B, Vilaro J, Marti D, et al. Short-term effects of three slow expiratory airway clearance techniques in patients with bronchiectasis: a randomised crossover trial. Physiotherapy. Dec 2016; 102(4):357-364.

  17. Homnick, Douglas N., Anderson, Kirk, and Marks, John H.  Comparison of the flutter device to standard chest physiotherapy in hospitalized patients with cystic fibrosis:  A pilot study, Chest, October 1998; 114(4): 993-997.

  18. Ides K, Vissers D, De Backer L et al. Airway clearance in COPD: need for a breath of fresh air? A systematic review. COPD 2011; 8(3):196-205.

  19. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.

  20. Kempainen RR, Williams CB, et al.  Comparison of high-frequency chest wall oscillation with differing waveforms for airway clearance in cystic fibrosis.  Chest 2007; 132: 1227-1232.

  21. Kluft, J., et al.  A comparison of bronchial drainage treatments in cystic fibrosis.  Pediatric Pulmonology, 1996; 22: 271-274.

  22. Landon, Chris, Goldie, William, and Evans, Jerome.  Airway clearance therapy utilizing high-frequency chest wall oscillation for medically fragile children. Pediatric Diagnostic Center, Ventura, California.  Poster presentation, American Medical Directors Association, San Diego, March 2002.

  23. Lange DJ, Lechtzin N, Davey C, et al. High-frequency chest wall oscillation in ALS: an exploratory randomized, controlled trial. Neurology. Sep 26 2006; 67(6):991-997.

  24. Lee AL, Burge A, Holland AE. Airway clearance techniques for bronchiectasis. Cochrane Database Syst Rev 2013; 5:CD008351.

  25. Lee AL, Burge AT, Holland AE. Airway clearance techniques for bronchiectasis. Cochrane Database Syst Rev. 2015; 11:CD008351.

  26. Marks JH.  Airway clearance devices in cystic fibrosis. Pediatric Respir Rev, March 2007; 8(1): 17-23.

  27. McCool FD and Rosen MJ.  Nonpharmacologic airway clearance therapies. Chest 2006; 129: 250S-259S.

  28. McIlwaine MP, Alarie N, Davidson GF et al. Long-term multicentre randomised controlled study of high frequency chest wall oscillation versus positive expiratory pressure mask in cystic fibrosis. Thorax 2013; 68(8):746-51.

  29. McIlwaine PM, Wong LT, Peacock D et al. Long-term comparative trial of positive expiratory pressure versus oscillating positive expiratory pressure (Flutter) physiotherapy in the treatment of cystic fibrosis. J Pediatr 2001; 138(6):845-50.

  30. Morrison L and Agnew J. Oscillating devices for airway clearance in people with cystic fibrosis.  Cochrane Database Syst Rev, 2014; 7: CD006842.

  31. Morrison L, Milroy S. Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. Apr 30 2020; 4: CD006842.
  32. Murray MP, Pentland JL, Hill AT. A randomised crossover trial of chest physiotherapy in non-cystic fibrosis bronchiectasis. Eur Respir J 2009; 34(5):1086-92.

  33. Newhouse PA, White F, marks JH and Homnick DN. The intrapulmonary percussive ventilator and flutter device compared to standard chest physiotherapy in patients with cystic fibrosis. Clin Pediatr, July 1998; 37(7): 427-432.

  34. 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.

  35. 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, November 2001; 32(5): 372-377.

  36. Osadnik CR, McDonald CF, Jones AP et al. Airway clearance techniques for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2012; 3:CD008328.

  37. Patterson JE, Bradley JM, et al. Airway clearance in bronchiectasis: A randomized crossover trial of active cycle of breathing techniques versus acapella®. Respiration 2005; 72: 239-242.

  38. Patterson JE, Hewitt O, Kent L, et al. Acapella versus ‘usual airway clearance’ during acute exacerbation in bronchiectasis: A randomized crossover trial. Chron Respir Disease 2007; 4(2): 67-74.

  39. Percussionaire Corporation. Intrapulmonary percussive ventilation (IPV), www.percussionaire.com/.

  40. 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):187-92.

  41. 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.

  42. Svenningsen S, Paulin G, Wheatley A, et al. Oscillating positive expiratory pressure therapy in chronic obstructive pulmonary disease and bronchiectasis [poster]. Chest. 2013; 144(741A):741.

  43. Svenningsen S, Paulin GA, Sheikh K, et al. Oscillating positive expiratory pressure therapy in chronic obstructive pulmonary disease and bronchiectasis. COPD. Feb 2016; 13(1):66-74.

  44. Thompson CS, Harrison S, et al. Randomized crossover study of the Flutter device and the active cycle of breathing technique in non-cystic fibrosis bronchiectasis. Thorax 2002; 57: 446-448.

  45. 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, January 2003; 48(1): 20-21.

  46. Winfield NR, Barker NJ, Turner ER, et al. Non-pharmaceutical management of respiratory morbidity in children with severe global developmental delay. Cochrane Database Syst Rev. 2014; 10:CD010382.

  47. 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. Jul 2010; 25(7):815-821.

POLICY HISTORY:

Medical Review Committee, August–September 1991

Medical Policy Group, December 2002 (1)

Medical Policy Administration Committee, January 2003

Available for comment February 6-March 24, 2003

Medical Policy Group, September 2003 (1)

Medical Policy Administration Committee, October 2003

Available for comment November 3-December 17, 2003

Medical Policy Group, August 2005 (3)

Medical Policy Administration Committee, August 2005

Available for comment August 27-October 10, 2005

Medical Policy Group, August 2008 (1)

Medical Policy Group, January 2009 (1)

Medical Policy Administration Committee, February 2009

Available for comment February 6-March 23, 2009

Medical Policy Group, February, 2010 (1)

Medical Policy Group, February 2012 (1): Update to Key Points and References related to MPP update; no change in policy statement

Medical Policy Panel, February 2013

Medical Policy Group, June 2013 (1): Update to Policy with addition of non-coverage statement for upgrading of a covered device to a newer model, placed chronic bronchiectasis under IPV criteria, also removed criteria prior to 2009; updated Descriptions, Key Points, and References

Medical Policy Administration Committee, July 2013

Medical Policy Panel, February 2014

Medical Policy Group, February 2014 (1): Update to Policy with removal of specific device names, no change to coverage statement or intent; update to Key Points, Approved Governing Bodies, Key Words and References

Medical Policy Panel, February 2015

Medical Policy Group, February 2015 (6) Update to Key Points, Key Words, Approved by Governing Bodies and References; no change to policy statement.

Medical Policy Panel, June 2016

Medical Policy Group, June 2016 (6) Update to Policy Title, Description, Key Points, Approved by Governing Bodies and References; no change in policy intent.

Medical Policy Panel, June 2017

Medical Policy Group, June 2017 (6): Update to Key Points, Practice Guidelines, and References: No change to policy statement.   

Medical Policy Group, July 2018 (6): Update to Key Points, Practice Guidelines, Key Words (added Monarch airway clearance system) and Coding (added E0480).

Medical Policy Group, December 2018: 2019 CPT Coding Update. Added revised verbiage for code E0483.

Medical Policy Panel, June 2019

Medical Policy Group, July 2019 (6): Updates to Key Points and Governing Bodies.

Medical Policy Panel, October 2020

Medical Policy Group, October 2020 (6): Updates to Key Points.

Medical Policy Group, March 2021 (6): Clarified policy statement to include “traumatic head or spinal cord injuries”. No change to policy intent.

Medical Policy Panel, June 2021

Medical Policy Group, June 2021 (6): Updates to Description, Key Points, Governing Bodies, Key Words and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.