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DESCRIPTIONOscillatory devices are used as alternatives to the standard daily percussion and postural drainage (P/PD) 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. Oscillatory devices are also proposed for other respiratory conditions such as diffuse bronchiectasis and chronic obstructive pulmonary disorder (COPD).
Cystic fibrosis (CF) is an autosomal recessive condition, the pulmonary manifestations of which include the production of excessive tenacious tracheobronchial mucus, leading to airway obstruction and secondary infection, the principal causes of the morbidity and mortality of cystic fibrosis. A variety of mucus clearance techniques have been investigated as methods to increase the amount of expectorated sputum, maintain pulmonary function, and decrease the incidence of acute exacerbations of CF. Daily percussion and postural drainage (P/PD) is the most commonly used secretion clearance technique. A physical therapist or another trained adult in the home, typically a parent, may administer P/PD if the patient is a child. The necessity for regular therapy can be particularly burdensome for adolescents or adults who wish to lead independent lifestyles.
Oscillatory devices are designed to move mucus and clear airways; the oscillatory component can be intra- or extra-thoracic. Some of the devices require the active participation of the patient. These 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 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.
The Percussionaire device delivers intrapulmonary percussive ventilation (IPV). This device combines internal thoracic percussion through rapid minibursts of inhaled air and continuous therapeutic aerosol delivered through a nebulizer. IPV can be self-administered by patients, who breathe through the mouthpiece, then cough to clear the loosened secretions.
All of the above techniques can be used as alternatives to daily percussion and postural drainage (P/PD), also known as chest physical therapy or chest physiotherapy, in patients with cystic fibrosis. P/PD needs to be administered by a physical therapist or another trained adult in the home, typically a parent if the patient is a child. The necessity for regular therapy can be particularly burdensome for adolescents or adults who wish to 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 disorder (COPD).
Other indications for Respiratory Devices are discussed in a separate policy.
POLICYHigh-frequency chest wall compression devices and intrapulmonary percussive ventilation devices may be considered medically necessary in patients with cystic fibrosis or chronic diffuse bronchiectasis (as determined by specific criteria [see Policy Guidelines] including chest computed tomography scan) when standard chest physiotherapy has failed (i.e., the patient has frequent severe exacerbations of respiratory distress involving inability to clear mucus despite P/PD) OR standard chest physiotherapy is unavailable or not tolerated.
Use of the FLUTTER® valve or Acapella device may be considered medically necessary in patients with hypersecretory lung disease (i.e., produce excessive mucus) who have difficulty clearing the secretions and recurrent disease exacerbations.
High-frequency chest wall compression devices and intrapulmonary percussive ventilation devices are considered not medically necessary as an alternative to chest physical therapy in patients with cystic fibrosis or chronic bronchiectasis in any other clinical situations; there are no clinical data to show that these devices provide any additional health benefit compared to conventional chest physical therapy in these situations.
Other applications of high-frequency chest wall compression devices and intrapulmonary percussive ventilation devices, including, but not limited to, their use as an adjunct to chest physical therapy or their use in other lung diseases, such as chronic obstructive pulmonary disease, are considered investigational.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
In considering the chest wall compression devices, there should be demonstrated need for airway clearance. There should also be documented failure of standard treatments (including, if appropriate, use of the FLUTTER® device), or valid reasons why standard chest physiotherapy cannot be performed, such as inability of the caregiver to perform percussion and postural drainage (P/PD). In addition, a trial period to determine patient and family compliance may be considered. Those who appear to benefit most from the compression devices are adolescents and older patients due to lifestyle factors in which manual P/PD may essentially not be available.
For this policy, chronic diffuse bronchiectasis is defined by daily productive cough for at least 6 continuous months or more than 2 times per year exacerbations requiring antibiotic therapy and confirmed by high resolution or spiral chest computed tomography scan.
A trial period may also be helpful because patients’ responses to the various types of devices can be variable; the types of devices should be considered as alternative, and not equivalent, devices.
POLICY HISTORY9/24/2009: Policy Added to address Cystic Fibrosis and Other Respiratory Disorders as a separate policy from the Respiratory Devices policy
4/28/2010: Policy Description section was revised to add other respiratory conditions such as diffuse bronchiectasis and COPD. Policy statements were revised to add "intrapulmonary percussive ventilation devices." Policy Guidelines section was revised to add a trial period may be helpful because patients' responses to the various devices can be variable. The devices should be considered as alternative and not equivalent.
04/20/2011: Policy reviewed; no changes.
03/02/2012: Policy reviewed; no changes.
04/24/2013: Policy reviewed; no changes.
SOURCE(S)Blue Cross & Blue Shield Association policy #1.01.15
Hayes Medical Technology Directory
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.