Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Several forms of mechanical devices are used to help clear secretions in persons who have severe lung disease such as cystic fibrosis.

2)    These devices require pre-authorization.

3)    When approved, they are covered under the DME benefit.

4)    Intrapulmonary percussive ventilators (IPV) are considered experimental and investigational as there is insufficient evidence supporting their effectiveness.

1)    The 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: 

a)    Airway 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).

b)    Mechanical 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 – J45.998).

c)    Positive 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).

2)    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 chest physiotherapy:

a)    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

b)    Cystic fibrosis (E84.0); or

c)    The member has one of the following neuromuscular disease diagnoses:

1.    Acid maltase deficiency (E74.00)

2.    Anterior horn cell diseases (G12.0 – G12.9)

3.    Hereditary muscular dystrophy (G71.0)

4.    Multiple sclerosis (G35)

5.    Myotonic disorders (G71.11-G71.19)

6.    Other myopathies (G71.3 – G71.9, G72.81 – G72.9)

7.    Paralysis of the diaphragm (J98.6)

8.    Post-polio (G14)

9.    Quadriplegia (G82.50 – G82.54)

d)    Lung transplant recipients, within the first 6 months post-operatively, who are unable to tolerate standard chest physiotherapy.

e)    High-frequency chest compression systems are considered experimental and investigational for other indications (e.g., alpha 1-antitrypsin deficiency, coma, kyphosis, leukodystrophy, and scoliosis).

3)    Mechanical 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.

Codes Used In This BI:

Intrapulmonary percussive ventilators (IPV) are considered experimental and investigational as there is insufficient evidence supporting their effectiveness.

1.    High Frequency Chest Compression Systems

A 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 is unavailable.

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).

In addition, 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.

Although 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 purchase.

There is 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.

2.    Mechanical Percussors

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; however, use of a mechanical percussor can benefit the patient by allowing for independence and greater compliance.

3.    Flutter and Acapella

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.

A similar 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.

4.    Positive Expiratory Pressure (PEP)

The 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.

Most studies 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.

There are 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).

5.    Mechanical Insufflation-Exsufflation

Mechanical 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." 

6.    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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