Effective Date: 10/01/2010
Title: Airway Clearance Devices
Revision Date: 01/01/2019
CPT Code(s): A7025, A7026,E0480, E0484, E0482, E0483, S8185, E0481
will apply to all services performed on or after the above revision date which
will become the new effective date.
services referred to in this policy that were performed before the revision
date, contact customer service for the rules that would apply.
of mechanical devices are used to help clear secretions in persons who have
severe lung disease such as cystic fibrosis.
approved, they are covered under the DME benefit.
Intrapulmonary percussive ventilators (IPV) are considered experimental and
investigational as there is insufficient evidence supporting their
following airway clearance devices are considered medically necessary durable
medical equipment (DME) to assist in mobilizing respiratory tract secretions for
members with the following conditions:
oscillating devices (e.g., Flutter and Acapella) are considered medically
necessary for cystic fibrosis (E84.0), bronchitis (J41.0 – J42), bronchiectasis
(Q33.4, J47.0 – J47.9), and asthma (J44.0 – J45.998).
percussors (e.g., Fluid Flo and Frequencer) are considered medically necessary
for cystic fibrosis (E84.0), chronic bronchitis (J41.0 – J42), bronchiectasis
(Q33.4, J47.0 – J47.9), immotile cilia syndrome (J39.8), and asthma (J44.0 –
expiratory pressure (PEP) mask is considered medically necessary for cystic
fibrosis (E84.0), chronic bronchitis (J41.0 – J42), asthma (J44.0 – J45.998),
and chronic obstructive pulmonary disease (J44.9).
High-frequency chest compression systems (the SmartVest, the MedPulse
Respiratory Vest System, the Vest Airway Clearance System, the ABI Vest, and the
InCourage Vest/System) are considered medically necessary in lieu of chest
physiotherapy for the following indications, where there is a documented failure
of standard treatments to adequately mobilize retained secretions, including
Bronchiectasis (Q33.4, J47.0-J47.9), confirmed by CT scan, characterized by
daily productive cough for at least 6 continuous months or by frequent (i.e.,
more than 2 times per year) exacerbations requiring antibiotic therapy; or
fibrosis (E84.0); or
has one of the following neuromuscular disease diagnoses:
maltase deficiency (E74.00)
horn cell diseases (G12.0 – G12.9)
muscular dystrophy (G71.0)
myopathies (G71.3 – G71.9, G72.81 – G72.9)
of the diaphragm (J98.6)
Quadriplegia (G82.50 – G82.54)
transplant recipients, within the first 6 months post-operatively, who are
unable to tolerate standard chest physiotherapy.
High-frequency chest compression systems are considered experimental and
investigational for other indications (e.g., alpha 1-antitrypsin deficiency,
coma, kyphosis, leukodystrophy, and scoliosis).
in-exsufflation devices are considered medically necessary DME for persons 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.
Used In This BI:
chest wall oscillation syst vest, rplcmt for use w/ pt-owned equipmt, ea
chest wall oscillation syst hose, rplcmt for use w/ pt-owned equipmt, ea
electric or pneumatic, home model
percussive ventilation syst & related accessories
stimulating device, alternating positive & negative airway pressure
chest wall oscillation syst, (incl all access & suppl), ea
(code revised 1/1/19)
positive expiratory pressure dvc, nonelec, any type, ea
Intrapulmonary percussive ventilators (IPV) are considered experimental and
investigational as there is insufficient evidence supporting their
Frequency Chest Compression Systems
high-frequency chest wall compression device (The Vest Airway Clearance System,
formerly known as the ThAIRapy Vest, ABI Vest) (Advanced Respiratory, St. Paul,
MN) is an inflatable vest connected to a compressor that provides external
high-frequency chest wall oscillation. The vest is connected via tubing to an
air pulse delivery system. The patient then uses a foot pedal to apply pressure
pulses that cause the vest to inflate and deflate against the thorax creating an
oscillatory or vibratory motion.
High-frequency chest compression devices have been shown to increase sputum
production in CF patients. CF is caused by abnormal chloride ion transport on
the apical surface of epithelial cells in exocrine gland tissues. The abnormally
composition of secretions from affected epithelial surfaces results in increased
viscosity. It has been theorized that high-frequency chest compression devices
are particularly effective in clearing the abnormal secretions of CF because
vibratory shear forces facilitate expectoration by reducing the viscosity of
these secretions, much in the same way that shaking jello causes it to become
fluid. However, high frequency chest compression vests have not been proven to
be more effective than manual chest physiotherapy. It can be used in place of
manual chest physiotherapy for patients with CF where manual chest physiotherapy
High-frequency chest wall compression devices have been promoted for use in
conditions other than cystic fibrosis, including non-CF bronchiectasis.
However, there are no adequate published controlled clinical studies of
high-frequency chest compression devices for conditions other than cystic
fibrosis. Given the unique pathophysiology of cystic fibrosis resulting in the
abnormal composition of CF secretions, evidence of the effectiveness of
high-frequency chest wall compression devices in CF cannot be extrapolated to
other pulmonary conditions. The Vest was cleared by the FDA for a wide variety
of pulmonary conditions based on a 510(k) premarket notification; thus the
manufacturer was not required to submit the type of evidence of effectiveness
that would be required to support a pre-market approval application (PMA).
there are no adequate studies comparing high frequency chest compression to
other, relatively simple and substantially less expensive devices (e.g.,
Flutter, Acapella) that apply high-frequency oscillation to the airway.
clinical evidence is limited, high frequency chest wall oscillation devices have
been used for lung transplant recipients who are unable to tolerate standard
chest physiotherapy in the postoperative period.
The Vest is
only available for purchase (it cannot be rented); the air pulse delivery system
(an air-pulse generator) and flexible hoses are available for rental or
controversy surrounding the use of high-frequency chest physiotherapy devices
for indications other than CF.
It should be
noted that the American College of Chest Physicians` evidence-based clinical
practice guidelines on non-pharmacologic airway clearance therapies (McCool and
Rosen, 2006) recommend oscillatory devices (e.g., Flutter, IPV, and HFCWO) be
considered as an alternative to chest physiotherapy only in CF patients.
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; however, use of a mechanical
percussor can benefit the patient by allowing for independence and greater
The Flutter (Scandipharm,
Birmingham, AL) is a handheld pipe-like device with a plastic mouthpiece on one
end that the patient exhales into. On the other end of the pipe, a stainless
steel ball rests inside a plastic circular cone. When the patient exhales into
the device, the ball rolls and moves up and down, creating an opening and
closing cycle over a conical canal. The cycle repeats itself many times
throughout each exhalation intending to produce oscillations of endobronchial
pressure and expiratory airflow that will vibrate the airway walls and loosen
mucus so that it can be easily expectorated by the patient. The Flutter device
has 510(k) status with the FDA. Although the Flutter device has not been shown
to significantly change respiratory assessment parameters or pulmonary function,
some patients may prefer this method over other therapies.
oscillatory positive airway pressure device, the Acapella (Smiths Medical,
Watford, UK), uses a counterweighted plug and magnet to create air flow
oscillation. Volsko, et al. (2003) noted that the Acapella and Flutter have
similar performance characteristics. The author noted that the Acapella`s
performance is not gravity-dependent (i.e., dependent on device orientation) and
may be easier to use for some patients.
Expiratory Pressure (PEP)
mask/mouthpiece contains a valve that increases resistance to expiratory
airflow. The patient breathes in and out 5 to 20 times through the flow
resistor, creating positive pressure in the airways during exhalation. The
pressure generated can be monitored and adjusted with a manometer. Either low
pressures or high pressures are prescribed. The PEP mask/mouthpiece achieves
the same goal as autogenic drainage (a special breathing technique aimed at
avoiding airway compression by reducing positive expiratory transthoracic
pressure) by expiring against an external airflow obstruction.
on the effectiveness of PEP have been conducted in Europe and they reported
short-term equivalency of PEP to other methods of airway clearance. A published
review of these studies found that PEP had similar effects on sputum clearance
when compared with other methods (postural drainage forced exhalatory
technique). The strongest evidence of the effectiveness of PEP comes from a
1-year randomized controlled clinical trial of PEP vs. conventional
physiotherapy in 40 children with CF. The patients treated with PEP showed
improvements in pulmonary function, whereas pulmonary function actually declined
in patients treated with conventional physiotherapy. The differences between
treatment groups were statistically significant for changes in FVC and FEV1.
numerous PEP Mask/PEP Valves on the market. Examples include: Resistex PEP Mask
(Mercury Medical, Clearwater, FL), TheraPep Valve (DHD Healthcare, Inc.,
Canastota, NY), Acapella (DHD Healthcare, Inc., Wampsville, NY) and PARI PEP
Mask (PARI Respiratory Equipment, Inc., Midlothian, VA).
insufflation-exsufflation (CoughAssist, J.H. Emerson Co., Cambridge, MA) (also
known as In-Exsufflator, Cofflator, cough machine) is designed to inflate the
lung with positive pressure and assist cough with negative pressure; it is
advocated for use in patients with neuromuscular diseases. The published
literature on the effectiveness of mechanical insufflation-exsufflation consists
of review articles, case reports, retrospective analyses, and small,
uncontrolled case series. In addition, published research on mechanical
insufflation-exsufflation has come from a single investigator, raising questions
about the generalization of findings. A Consensus Panel Report by the American
College of Chest Physicians (Irwin, et al., 1998) 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." The Consensus Panel Report, however, concluded that "while a
variety of nonpharmacologic protussive treatment modalities may improve cough
mechanics, clinical studies documenting improvement in patient morbidity and
mortality are lacking."
Intrapulmonary Percussive Ventilator (IPV)
Intrapulmonary Percussive Ventilator (IPV) (Percussionaire Corporation,
Sandpoint, ID) is an aerosol machine that delivers a series of pressurized gas
minibursts at rates of 100-225 cycles per minute to the respiratory tract.
Aerosolized medications can be delivered under pressure and with oscillations
that vibrate the chest. In contrast to PEP and flutter, IPV allows continuous
monitored positive pressure application and percussion throughout the
respiratory cycle. The patient controls variables such as inspiratory time, peak
pressure and delivery rates. The Percussionaire has 510(k) status with the FDA.
There is a
scarcity of scientific data to support the effectiveness of IPV. A small study
(n = 16) by Homnick, et al. (1995) found IPV as effective as standard aerosol
and chest physiotherapy in preserving lung function. A study by Newhouse, et al.
(1998) concluded that larger and longer studies of IPV compared to standard
chest physiotherapy are needed to evaluate its value for independent
administration of chest physiotherapy. Studies do not demonstrate any advantage
of IPV over that achieved with good pulmonary care in the hospital environment
and there are no studies in the home setting.
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Nonpharmacologic airway clearance therapies. ACCP Evidence-Based Clinical
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Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.