Medical Policy: 01.01.01 
Original Effective Date: February 1995 
Reviewed: May 2016 
Revised: May 2016 


Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.


Description:

Cystic fibrosis, chronic bronchitis, bronchiectasis, immotile cilia syndrome, neuromuscular disease with progressive respiratory muscle weakness, asthma and some acute respiratory tract infections are some of the conditions that can lead to abnormal airway clearance or increase sputum production.  

 

Chest physiotherapy is a treatment that attempts to compensate for abnormal airway clearance by removing mucopurulent secretions.  However, the standard of care remains manual clapping, vibration and compression, together with postural drainage and assisted coughing.

 

A conventional manual chest percussion and postural drainage program to remove accumulated secretions requires a caregiver's assistance and may cause children and adults to be less compliant with a treatment regimen.  Many alternative oscillatory devices are designed to provide self-administered airway clearance and have been investigated as an alternative to percussion and postural drainage.

 

High frequency oscillatory chest compression devices (e.g., the Frequencer, the SmartVest, the MedPulse Respiratory Vest System, the Vest Airway Clearance System, the ABI Vest, Respin11 Bronchial Clearance System, and the InCourage Vest/System) are passive oscillatory devices designed to provide airway clearance without the active participation of the patient. 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 cause the vest to inflate and deflate against the thorax, creating high-frequency chest wall oscillation and mobilization of pulmonary secretions.

 

Mechanical percussor (e.g., Fluid Flo and Frequencer, including acoustical percussor Vibralung) The purpose of percussion is to apply kinetic energy to the chest wall and lung at regular intervals.  Percussion is also referred to as cupping, clapping, and tapotement.  It can be accomplished by rhythmically striking the thorax with a cupped hand or a mechanical device applied directly over the lung segment(s) being drained.  According to the guidelines developed by American Association for Respiratory Care (AARC) on postural drainage therapy, no convincing evidence demonstrates the superiority of one method over the other.

 

Vibratory/oscillatory positive expiratory pressure (PEP) devices (FLUTTER®, Acapella®) With PEP devices. in which the patient exhales multiple times through a device. The FLUTTER device is a small pipe-shaped, easily 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 device is similar in concept but uses a counterweighted plug and magnet to create air flow oscillation.


Intrapulmonary percussive ventilator (e.g., the Percussionaire and the TXP® Universal VENTILATOR Percussionator®) This device combines internal thoracic percussion through rapid minibursts of inhaled air and continuous therapeutic aerosol delivered through a nebulizer. An aerosol machine that delivers a series of pressurized gas minibursts at rates of 100 to 225 cycles/min to the respiratory tract.  Aerosolized medications can be delivered under pressure and with oscillations that vibrate the chest.

 

Mechanical insufflation – exsufflation device (CoughAssist, known as In-Exsufflator, Cofflator, cough machine) is designed to inflate the lung with positive pressure and assist cough with negative pressure. Report by the American College of Chest Physicians stated that "[t]he inability of patients with respiratory muscle weakness to achieve high lung volumes is likely to contribute to cough ineffectiveness.  Increasing the inhaled volume prior to cough by air-stacking positive pressure breaths or by glossopharyngeal breathing increases cough expiratory flows by 80 % in these patients.  Cough efficiency may be further enhanced by the application of negative pressure to the airway for a period of 1 to 3 s.  Using this technique of mechanical insufflation-exsufflation, peak cough expiratory flows can be increased by more than four-fold."


Prior Approval:

 

Not applicable


Policy:

One of the following devices may be considered medically necessary for the one of the following scenarios:

  • when standard chest physiotherapy has failed; OR
    • Failure includes repeat respiratory infections or decreased breathing capacity when chest physiotherapy has been consistently performed as prescribed
  • standard chest physiotherapy (CPT) is unavailable or not tolerated.

    • There must be documentation of inability to use other airway clearance therapies including manual chest physical therapy due to one or more of the following:

      • There are two or more individuals with cystic fibrosis, chronic bronchiectasis or chronic neuromuscular disorder in the family requiring chest physical therapy; or

      • 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

High frequency oscillatory chest wall compression devices for airway clearance in patients with:

  • Cystic Fibrosis
  • Chronic Diffuse Bronchiectasis (Chronic diffuse brochiectasis is defined by: daily productive cough for at least 6 continuous months, or more than 2 times a year exacerbations requiring antibiotic therapy, and confirmed by high resolution or spiral chest computed tomography scan.)
  • Duchenne Muscular Dystrophy, Amyotrophic Lateral Sclerosis (ALS) or Spinal Muscular Atrophy (SMA)-as part of the bronchial hygiene protocol ONLY when the member is ventilatory dependant and doesn’t tolerate manual chest physiotherapy.  

High-frequency chest wall compression devices are considered not medically necessary as an alternative to chest physical therapy in patients with cystic fibrosis, neurodegenerative diseases, or chronic bronchiectasis in any other clinical situation. There is a lack of clinical data to show that these devices provide any additional health benefit compared to conventional chest physical therapy in these situations.

 

High-frequency chest wall compression devices are considered not medically necessary for acute episodes of bronchiectasis.

 

There is insufficient evidence for the use of high frequency chest wall compression  therapy in those with other conditions. The evidence is limited and insufficient to support definitive conclusions. There has not been adequate evidence to prove superiority over manual therapy. There are limited studies evaluating oscillatory devices for the treatment of COPD, acute exacerbations, and other respiratory conditions; the available evidence did not tend to find that these devices were more effective than conventional treatment.  Therefore, use of high frequency chest wall compression for all other conditions is considered not medically necessary.


Mechanical percussors for airway clearance in patients with:

  • for cystic fibrosis
  • chronic bronchitis
  • chronic bronchiectasis

The use of Vibralung the auditory percussor, which is considered an upgrade, is only medically necessary for cystic fibrosis, chronic bronchitis, chronic bronchiectasis) in the clinical scenario where a mechanical percussor can not be used (i.e burns, chest trauma).

 

Vibratory/oscillatory positive expiratory pressure device for airway clearance in patients with:

  • cystic fibrosis
  • chronic bronchitis
  • chronicbronchiectasis

Positive expiratory pressure (PEP) mask for airway clearance in patients with:

  • cystic fibrosis
  • chronic bronchitis

Mechanical insufflation-exsufflation devices for airway clearance in patients with:

  • Progressive neurodegenerative/neuromuscular disease, including Duchenne’s Muscular Dystrophy, Spinal Muscular Atrophy and Amyotrophic Lateral Sclerosis or spinal cord injury and impaired ability to cough, who require ventilatory assistance.

 

The use of intrapulmonary percussion ventilation (also known as the Percussionaire Corporation IPV Ventilator) in the home setting has not been proven safe or more effective than manual CPT. The safety of home use has been questioned in the home setting. The use of IPV ventilation in the home setting is considered investigational.

 

Other applications of airway clearance devices, including, but not limited to their use with other lung diseases and other neuromuscular disorders is considered investigational.

 

The upgrading of a covered device to a newer model due to preference or convenience is considered not medically necessary.



Procedure Codes and Billing Guidelines:

  • To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
  • 94669  Mechanical chest wall oscillation to facilitate lung function, per session
  • E0480  Percussor device, electric or pneumatic, home model
  • E0481  Intrapulmonary percussive ventilation system and related accessories
  • E0482  Cough stimulating device, alternating positive and negative airway pressure (mechanical insufflation-exsufflation)
  • E0483  High frequency chest wall oscillation air-pulse generator system (includes hoses and vest), each
  • E0484  Oscillatory positive pressure device, non-electric, any type, each

Selected References:

  • The Medical Policy Reference Manual (MPRM) developed by the Blue Cross Blue Shield Association Health Management Systems, based on Technology Evaluation Center (TEC) criteria.
  • KatkinJp. Cystic Fibrosis.  Rakel, ed, Conn's Current Therapy 199, 51st edition.
    W.B. Saunders Co. 58:1999
  • Derdak S. et. Al. High-frequency oscillatory ventilation for acute respiratory distress syndrome in adults. Am J Respir Crit Care Med 2002;166:801-808.
  • Bellone A et. Al. Chest physical therapy in patients with acute exacerbation of chronic bronchitis: effectiveness of three methods. Arch Phys Med Rehabil 2000;81:558-560.
  • Jones AP, Rowe BH.   Bronchopulmonary hygiene physical therapy for chronic obstructive pulmonary disease and bronchiectasis (Chochrane Review) In: the Chochrane Library, Issue 4.2002. Oxford: Update Software.
  • Silverman E, et al. Current management of bronchiectasis: review and 3 case studies.  Heart Lung. 2003 Jan-Feb;32(1):59-64.
  • McCool, FD, Rosen, MJ. Nonpharmacologic airway clearance therapies: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):250S-259S.
  • Marks J. Airway clearance devices in cystic fibrosis. Paediatric Respiratory Reviews 2007; 8 17-23.
  • Myers TR, Positive Expiratory Pressure and Oscillatory Positive Expiratory Pressure Therapies. Respiratory Care 10/2007, 52(10) 1308-1327.
  • ECRIExternal Site Mechanical Insufflation-Exsufflation for Respiratory Insufficiency. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2011 March 21. (ECRI Hotline Response).
  • ECRIExternal Site High Frequency Chest Compression for Cystic Fibrosis and Other Pulmonary Conditions. Plymouth Meeting (PA): ECRI Health Technology Information Service 2011 March 21. (ECRI Hotline Response).
  • Pryor JA, Tannenbaum E, Scott SF, et al. Beyond postural drainage and percussion: Airway clearance in people with cystic fibrosis. J Cyst Fibros. 2010 May;9(3):187-92.
  • ECRIExternal Site High-frequency chest compression for airway clearance. Plymough Meeting (PA): ECRI Health Technology Information Service; April 2012. [Hotline Response].
  • Mahajan AK, Diette GB, Hatipoglu U, et al. High frequency chest wall oscillation for asthma and chronic obstructive pulmonary disease exacerbations: a randomized sham-controlled clinical trial. Respir Res. 2011 Sep 10;12:120.
  • Osadnik CR, McDonald CF, Jones AP, Holland AE. Airway clearance techniques for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012 Mar 14;3:CD008328. 
  • McCool F, Rosen MJ. Nonpharmacologic airway clearance therapies: accp evidence-based clinical practice guidelines. Chest. 2006; 129 250S-259S.
  • Global Initiative for the diagnosis, management, and prevention of chronic obstructive pulmonary diseaseExternal Site Updated 2013.
  • Benditt J, Boitano L. Pulmonary issues in patients with chronic neuromuscular disease. Am J Respir Crit Care Med 187 Apr 2013(10): 1046-1055.
  • 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
  • Newhouse PA, White F, Marks JH, et al. The intrapulmonary percussive ventilator and flutter device compared to standard chest physiotherapy in patients with cystic fibrosis. Clin Pediatr. 1998; 37(7):427-432.
  • Centers for Medicare and Medicaid Services. National Coverage Determination for Intrapulmonary Percussive Ventilator. NCD #240.5. Effective date: July 14, 1997.
  • McCool FD, Rosen MJ. Nonpharmacologic airway clearance therapies: ACCP evidence-based clinical practice guidelines. Chest. 2006;129(1 suppl):250S-259S.
  • 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. Aug 2013;68(8):746-751. PMID 23407019
  • Morrison L, Agnew J. Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. 2014;7:CD006842. PMID 25038719
  • American Association for Respiratory Care (AARC). AARC Clinical Practice Guideline. Postural drainage therapy. Respir Care. 1991;36(12):1418-1426. Also available on the Respiratory Care Web siteExternal Site 
  • Lee AL, Burge AT, Holland AE. Airway clearance techniques for bronchiectasis. Cochrane Database of Systematic Reviews 2015, Issue 11. Art. No.: CD008351. DOI: 10.1002/14651858.CD008351.pub3.

Policy History:

  • May 2016 - Annual Review, Policy Revised
  • June 2015 - Annual Review, Policy Revised
  • July 2014 - Annual Review, Policy Revised
  • September 2013 - Annual Review, Policy Revised
  • October 2012 - Annual Review, Policy Renewed
  • November 2011 - Annual Review, Policy Revised
  • October 2010 - Annual Review, Policy Renewed

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.