Oscillatory Devices for the Treatment of Cystic Fibrosis and Other Respiratory Conditions

POLICY NUMBER

A.1.01.15

DESCRIPTION

Oscillatory devices are alternatives to the standard daily percussion and postural drainage 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. Respiratory therapists and other providers may also use oscillatory devices for other respiratory conditions such as diffuse bronchiectasis, chronic obstructive pulmonary disease, and respiratory conditions associated with neuromuscular disorders.

Oscillatory devices are designed to move mucus and clear airways; the oscillatory component can be intra- or extrathoracic. Some devices require the active participation of patients. They 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 handheld 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, the 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 also require active patient participation. For example, autogenic drainage and an 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.

High-frequency chest wall oscillation devices (e.g. the Vest Airway Clearance System) are passive oscillatory devices designed to provide airway clearance without active patient participation. 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 inflate and deflate the vest against the thorax, creating high-frequency chest wall oscillation and mobilization of pulmonary secretions.

All of these techniques may be alternatives to daily percussion and postural drainage in patients with cystic fibrosis, also known as chest physical therapy. Daily percussion and postural drainage need to be administered by a physical therapist or another trained adult in the home, often a parent if the patient is a child. The necessity for regular therapy can be particularly burdensome for adolescents or adults who 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 disease. Additionally, they could benefit patients with neuromuscular disease who have impaired cough clearance.

This policy addresses the outpatient use of oscillatory devices. This policy does not address inpatient device use (eg, in the immediate postsurgical period).

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:

Select Oscillatory Devices Cleared by the Food and Drug Administration

PEP: positive expiratory pressure.

Other indications for Respiratory Devices are discussed in a separate policy.

POLICY

High-frequency chest wall compression devices and intrapulmonary percussive ventilation devices may be considered medically necessary in individuals 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 individuals with hypersecretory lung disease (i.e., produce excessive mucus) who have difficulty clearing the secretions and recurrent disease exacerbations.

Other applications of high-frequency chest wall compression devices and intrapulmonary percussive ventilation devices, including, but not limited to, their use in individuals with cystic fibrosis or chronic diffuse bronchiectasis other than as specified above, their use as an adjunct to chest physical therapy, and their use in other lung diseases, such as chronic obstructive pulmonary disease or respiratory conditions associated with neuromuscular disorders are considered investigational.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

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 compressionand intrapulmonary percussive ventilation 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 positive expiratory pressure 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 individual and family compliance may be considered. Those who appear to benefit most from the compression devices are adolescents and adults for whom, due to lifestyle factors, manual percussion and postural drainage may not be available.

For this policy, chronic diffuse bronchiectasis is defined by a daily productive cough for at least 6 continuous months or exacerbations more than 2 times per year requiring antibiotic therapy and confirmed by high-resolution or spiral chest computed tomography scan.

A trial period may also be helpful because individuals' responses to different types of devices can vary; the types of devices should be considered as alternative, 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 Mental Health Disorders, 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 medical necessity, “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 HISTORY

9/24/2009: 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 A.1.01.15 added.

07/25/2016: Code Reference section updated to make the following correction: ICD-10 diagnosis code J49.9 should be J47.9.

08/24/2016: Policy title updated to change "Disorders" to "Conditions." Policy description updated regarding devices. Added "respiratory conditions associated with neuromuscular disorders" to the investigational policy statement.

07/12/2017: Policy description updated. Removed not medically necessary policy statement. Investigational statement updated to add "patients with cystic fibrosis or chronic diffuse bronchiectasis other than as specified above."

06/26/2018: Policy description updated regarding devices. Policy statements unchanged.

12/27/2018: Code Reference section updated to revise code description for HCPCS code E0483, effective 01/01/2019.

07/01/2019: Policy reviewed; no changes.

11/17/2020: Policy description updated regarding devices. Policy statements unchanged.

08/25/2021: Policy description updated regarding devices. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

07/11/2022: Policy description updated regarding devices. Policy statements and Policy Guidelines updated to change "patients" to "individuals."

09/30/2022: Code Reference section updated to revise description for HCPCS code E0483, effective 10/01/2022.

07/18/2023: Policy reviewed; no changes.

10/01/2024: Code Reference section updated to add new HCPCS codes A7021 and E0469.

11/08/2024: Policy reviewed; no changes.

09/19/2025: Policy description updated regarding devices. Policy statements unchanged.

SOURCE(S)

1. Blue Cross & Blue Shield Association policy # 1.01.15

2. Hayes Medical Technology Directory

CODE REFERENCE

This 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.

Covered Codes

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