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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).
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.
Other airway clearance techniques require active patient participation. For example, autogenic drainage and active cycle of breathing technique both involve a combination of breathing exercises performed by the patient. Positive expiratory pressure therapy requires patients to exhale through a resistor to produce positive expiratory pressures during a prolonged period of exhalation. It is hypothesized that the positive pressure supports the small airway such that the expiratory airflow can better mobilize secretions.
In contrast, high-frequency chest wall oscillation (HFCWO) devices (e.g. the Vest Airway Clearance System, formerly the ABI Vest or the ThAIRapy Bronchial Drainage 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.
The Percussionaire device delivers intrapulmonary percussive ventilation (IPV) and is another type of passive oscillatory device. This device combines internal thoracic percussion through rapid minibursts of inhaled air and continuous therapeutic aerosol delivered through a nebulizer.
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).
This policy addresses outpatient use of oscillatory devices. Inpatient device use, eg, in the immediate postsurgical period, is not included in the policy.
Several oscillatory devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process including the following:
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 physical therapy has failed (i.e., the patient has frequent severe exacerbations of respiratory distress involving inability to clear mucus despite P/PD) OR standard chest physical therapy is unavailable or not tolerated.
Use of an oscillatory positive expiratory pressure 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 than those specified here.
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.
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 and IPV devices, there should be demonstrated need for airway clearance. There should also be documented failure of standard treatments, ie, the patient has frequent severe exacerbations of respiratory distress involving inability to clear mucus despite standard treatment (chest physical therapy and, if appropriate, use of an oscillatory PEP device) or valid reasons why standard treatment cannot be performed, such as inability of the caregiver to perform it. For the chest wall compression devices, 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 adults 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.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
10/30/2014: Policy reviewed; description updated. First medically necessary policy statement revised to change "physiotherapy" to "physical therapy." Second medically necessary policy statement revised to change "FLUTTER® valve or Acapella device" to "oscillatory positive expiratory pressure device." Policy guidelines updated regarding chest wall compression and IPV devices.
03/06/2015: Policy reviewed; description updated regarding devices. Policy statement unchanged.
08/26/2015: Medical policy revised to add ICD-10 codes. Removed ICD-9 procedure code 93.18 from the Code Reference section. Added ICD-9 diagnosis code 748.61.
04/26/2016: Policy Guidelines updated to add medically necessary and investigative definitions.
06/07/2016: Policy number added.
07/25/2016: Code Reference section updated to make the following correction: ICD-10 diagnosis code J49.9 should be J47.9.
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.