Medical Policy

 

Subject: Intrapulmonary Percussive Ventilation Devices for Airway Clearance
Document #: DME.00012 Publish Date:    05/01/2018
Status: Revised Last Review Date:    01/25/2018

Description/Scope

This document addresses the use of intrapulmonary percussive ventilation devices (IPV) (such as the Percussionaire® Corporation IPV devices, Sandpoint, ID) as an alternative to conventional chest physical therapy to promote the clearance of respiratory secretions in individuals with impaired ability to cough or otherwise expel them on their own.

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.).

Note: For information regarding high frequency chest compression devices, please refer to:

Position Statement

Investigational and Not Medically Necessary:

Intrapulmonary percussive ventilation devices, also known as the Percussionaire Corporation IPV Ventilator, are considered investigational and not medically necessary for all indications as an airway clearance treatment for respiratory disorders associated with retained secretions and/or atelectasis including, but not limited to: cystic fibrosis, bronchiectasis, chronic obstructive pulmonary disease and neuromuscular conditions associated with retained airway secretions or atelectasis.

Rationale

Chest physiotherapy (CPT), which is also known as percussion and postural drainage (P/PD), is traditionally seen as the standard of care of secretion clearance methods for individuals with excessive or retained lung secretions. Currently, there are a variety of mucus clearance devices that have been investigated as alternatives to P/PD.

Intrapulmonary Percussive Ventilation (IPV) devices, such as the Percussionaire and the TXP® Universal VENTILATOR Percussionator® (Percussionaire Corporation, Sandpoint, ID), have been investigated as an alternative to standard CPT and P/PD with or without manual vibration, with most studies having been in subjects with a diagnosis of cystic fibrosis (CF). Multiple IPV devices have been cleared by the FDA for similar indications including the mobilization of endobronchial secretions. However, there is limited published data by which to establish the effectiveness of IPV as a beneficial modality for airway clearance. In the available studies, the numbers of subjects have been small (4 to 24), the study populations different, the treatment settings different (in-hospital versus outpatient), and IPV has been compared to different alternative airway clearance modalities, (for example, Flutter valve, and/or high frequency chest compression [HFCC] device, and/or standard CPT and P/PD). Also, outcome measurements differed amongst the studies, including factors such as sputum volume, sputum viscosity, pulmonary function data or radiographic changes, depending on the study design and study population. There is minimal data directly comparing the performance of an HFCC device with that of IPV.

Within the American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice Guidelines on Nonpharmacologic Airway Clearance Therapies, the ACCP determined that the evidence supporting the use of oscillatory devices, including IPV, in the treatment of individuals with CF was low, and the reported benefits were conflicting. For the treatment of neuromuscular disease, they rated the evidence as low with an intermediate benefit and gave these devices a weak recommendation (McCool, 2006).

The Cystic Fibrosis Foundation commissioned a systematic review to examine the evidence surrounding the use of airway clearance therapies (ACTs) for treating CF. Seven unique reviews and 13 additional controlled trials were deemed eligible for inclusion. Recommendations for use of the ACTs were made, balancing the quality of evidence and the potential harms and benefits. The committee determined that:

Although there is a paucity of controlled trials that assess the long-term effects of ACTs, the evidence quality overall for their use in CF is fair and the benefit is moderate… There are no ACTs demonstrated to be superior to others, so the prescription of ACTs should be individualized (Flume, 2009). 

The limited data that is available suggests that IPV does not produce a superior outcome compared to standard CPT and P/PD, an HFCC device, or a Flutter valve device. Therefore, based on the lack of scientific data demonstrating its effectiveness and equivalence or superiority to established treatments, IPV is considered investigational and not medically necessary as an airway clearance modality.

Background/Overview

Intrapulmonary Percussive Ventilation (IPV) is a pneumatic, oscillating pressure breathing device system which is said to loosen mucus by internally percussing the airways using high frequency, high flow, and low pressure bursts of gas delivered via a mouthpiece, mask or endotracheal tube. The individual uses a thumb control to trigger 15 to 25 high frequency pulses of gas during inspiration and releases the control to allow for passive exhalation. Airway pressures oscillate between 5 and 35 cms H2O, and the walls of the airways vibrate synchronously with these oscillations. A Venturi type system (known as a “Phasitron”), powered by compressed gas, generates the oscillations at a rate of 100 to 300 cycles per minute. Pressures, inspiratory time, and delivery rates are adjustable. Additionally, aerosolized bronchodilators and mucolytics can be delivered by entrainment through the Phasitron device.

The clinical utility of the device is purportedly to loosen retained secretions by means of these airway oscillations, and it has been investigated in the treatment of individuals suffering from secretion retention (particularly that associated with CF), as well as atelectasis. The system can be used either in the hospital or home setting. The scientific data, currently available, are inadequate to permit conclusions regarding the relative efficacy of IPV devices.

Definitions

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. This is the principal cause of morbidity and mortality associated with CF.

Intrapulmonary Percussive Ventilation (IPV): A treatment designed to promote mobilization of retained endobronchial secretions and resolution of diffuse patchy atelectasis (areas of partial lung collapse/dysfunction). IPV delivers a series of pressurized mini-bursts of inhaled air and continuous therapeutic aerosol through a nebulizer. IPV users breathe through a mouthpiece and then cough to clear the loosened secretions.

Coding

The following codes for treatments and procedures applicable to this document 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 for service to determine coverage or non-coverage of these services as it applies to an individual member. 

When services are Investigational and Not Medically Necessary:

HCPCS

 

E0481

Intrapulmonary percussive ventilation system and related accessories

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Birnkrant DJ, Pope JF, Lewarski J, et al. Persistent pulmonary consolidation treated with intrapulmonary percussive ventilation: a preliminary report. Pediatr Pulmonol. 1996; 21(4):246-249.
  2. 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.
  3. Deakins K, Chatburn RL. A comparison of intrapulmonary percussive ventilation and conventional chest physiotherapy for the treatment of atelectasis in the pediatric patient. Respir Care. 2002; 47(10):1162-1167.
  4. Hess DR. The evidence for secretion clearance techniques. Respir Care. 2001; 46(11)1276-1293.
  5. Homnick DN, White F, de Castro C. Comparison of effects of an intrapulmonary percussive ventilator to standard aerosol and chest physiotherapy in treatment of cystic fibrosis. Pediatr Pulmonol. 1995; 20(1):50-55.
  6. Kluft J, Beker L, Castagnino M, et al. A comparison of bronchial drainage treatments in cystic fibrosis. Pediatr Pulmonol. 1996; 22(4):271-274.
  7. Natale JE, Pfeifle J, Homnick DN. Comparison of intrapulmonary percussive ventilation and chest physiotherapy. A pilot study in patients with cystic fibrosis. Chest. 1994; 105(6):1789-1793.
  8. Newhouse PA, White F, Marks JH, Homnick DN. The intrapulmonary percussive ventilator and flutter device compared to standard chest physiotherapy in patients with cystic fibrosis. Clin Pediatr (Phila). 1998; 37(7):427-432.
  9. 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.
  10. Toussaint M, De Win H, Steens M, Soudon P. Effect of intrapulmonary percussive ventilation on mucus clearance in Duchene muscular dystrophy patients: a preliminary report. Respir Care. 2003; 48(10):940-947.
  11. 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.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Centers for Medicare and Medicaid Services. National Coverage Determination for Intrapulmonary Percussive Ventilator. NCD #240.5. Effective date: July 14, 1997. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=229&ncdver=1&bc=AAAAgAAAAAAA&. Accessed on December 18, 2017.
  2. 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.
  3. 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.
  4. Irwin RS, Baumann MH, Bolser DC, et al.; American College of Chest Physicians (ACCP). Diagnosis and management of cough executive summary: ACCP evidence-based clinical practice guidelines. Chest. 2006; 129(1 Suppl):1S-23S.
  5. Lee AL, Burge A, Holland AE. Airway clearance techniques for bronchiectasis. Cochrane Database Syst Rev. 2013;(5):CD008351.
  6. McCool FD, Rosen MJ. Nonpharmacologic airway clearance therapies: ACCP evidence-based clinical practice guidelines. Chest. 2006; 129(1 Suppl):250S-259S.
  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. Osadnik CR, McDonald CF, Jones AP, Holland AE. Airway clearance techniques for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012;(3):CD008328.
  10. 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.
  11. Yankaskas JR, Marshall BC, Sufian B, et al. Cystic fibrosis adult care: consensus conference report. Chest. 2004; 125(1 Suppl):1S-39S.
Websites for Additional Information
  1. Cystic Fibrosis Information from the Cleveland Clinic web site. Available at: http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/pulmonary/cystic-fibrosis/. Accessed on December 18, 2017.
  2. Genetic Disease Foundation. Information about Cystic Fibrosis. Available at: http://www.geneticdiseasefoundation.org/genetic-diseases/cystic-fibrosis/?_kk=cystic%20fibrosis%20genetic&_kt=e752161d-9a3e-45c9-9dea-5a3284a40700&gclid=CNiapfGWhMoCFQiKaQodb1EIwQ. Accessed on December 18, 2017.
Index

Impulsator®
Intrapulmonary Percussive Ventilation (IPV)
Percussionaire Device

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. 

Document History
Status Date Action

Revised

01/25/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. Moved content related to HFCC Devices to new document CG-DME-43 “High Frequency Chest Compression Devices for Airway Clearance.” The document header wording updated from “Current Effective Date” to “Publish Date.” Description/Scope, Definitions, Coding, References, and Websites sections updated.

Revised

02/02/2017

MPTAC review. Updated formatting in Position Statement section. Updated References section.

Reviewed

02/04/2016

MPTAC review.  References were updated.  Removed ICD-9 codes from Coding section.

Reviewed

02/05/2015

MPTAC review. Updated Reference and Index sections.

Reviewed

02/13/2014

MPTAC review. Updated Reference and Index sections.

Reviewed

02/14/2013

MPTAC review. The Rationale, Background, and References were updated.

Reviewed

02/16/2012

MPTAC review. References were updated.

Revised

02/17/2011

MPTAC review. Age criteria of 2 years and older was removed for HFCC devices.  A not medically necessary statement was added regarding device replacement/upgrade.  The title was revised to remove brand names.  The Rationale and References were updated.

Reviewed

02/25/2010

MPTAC review. The Rationale, Background, Definitions and References were updated.

Revised

02/26/2009

MPTAC review. No change to the actual medical necessity criteria but the language of the reporting requirement to demonstrate compliance with device use was clarified. The Coding section was updated. Definitions and References were also updated.

Reviewed

02/21/2008

MPTAC review. The phrase “investigational/not medically necessary” was clarified to read “investigational and not medically necessary.”  This change was approved at the November 29, 2007 MPTAC meeting. References were updated.

Reviewed

03/08/2007

MPTAC review. The Rationale and References sections were updated.

Reviewed

03/23/2006

MPTAC review. References were updated to include the AARC Clinical Practice Guideline: Postural Drainage Therapy. 

Revised

04/28/2005

MPTAC review. Revised document: High Frequency Chest Compression Devices revised based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.  Position statement revised to include Intrapulmonary Percussive Ventilation (IPV); removed HCPCS codes S8200 and S8205 (deleted 01/01/2003)

Updated coding: Added ICD-9 codes 335.10-335.19, 335.20-335.29, 358.0-359.9, 359.0-359.9, 494.0-494.1

Pre-Merger Organizations Last Review Date Document Number Title
Anthem, Inc. 03/20/2003 DME.00012 High Frequency Chest Compression Devices

WellPoint Health Networks, Inc

12/02/2004

2.05.02

High-Frequency Chest Wall Compression