Bronchial Valves

POLICY NUMBER

A.7.01.128

DESCRIPTION

Bronchial valves are synthetic devices deployed with bronchoscopy into ventilatory airways of the lung to control airflow. They have been investigated for use in individuals who have prolonged bronchopleural air leaks and in individuals with lobar hyperinflation from severe or advanced emphysema.

Pulmonary Air Leaks

Proper lung functioning is dependent on the separation between the air-containing parts of the lung and the small vacuum-containing space around the lung called the pleural space. When air leaks into the pleural space, the lung is unable to inflate, resulting in hypoventilation and hypoxemia; this condition is known as a pneumothorax. A pneumothorax can result from trauma, high airway pressures induced during mechanical ventilation, lung surgery, and rupture of lung blebs or bullae, which may be congenital or a result from chronic obstructive pulmonary disease (COPD).

Emphysema

Emphysema, a form of COPD, is a progressive, debilitating disease characterized by irreversible destruction of alveolar tissue. This destruction results in reduced elastic recoil, progressive hyperinflation, and gas trapping with patients experiencing chronic dyspnea, limited exercise tolerance, and poor health related quality of life. In emphysematous COPD, diseased portions of the lung ventilate poorly, cause air trapping, and hyperinflate, compressing relatively normal lung tissue. The patterns and degree of emphysema heterogeneity (i.e., the extent and distribution of air space enlargements) can be measured using computed tomography (CT) density as an indicator for tissue destruction. The most diseased portions of lung can then potentially be targeted for lung volume reduction procedures. In homogeneous emphysema, there is minor or no regional difference in disease within or between lobes of the lung.

In the United States, prevalence of COPD varies widely by state, with the estimated prevalence in 2021 ranging from <4.5% in California, the District of Columbia, Hawaii, and Utah to >9% in Kentucky, Mississippi, Tennessee, and West Virginia. In 2018, chronic lower respiratory disease, primarily COPD, was the fourth leading cause of death in the United States. COPD mortality has decreased among Americans overall, but this decline has not been observed in all sociodemographic groups. An analysis of COPD mortality between 2004 and 2018 found that African American women were the only sociodemographic group to have had an increase in COPD mortality, with an annual percent change (APC) of 1.3% (95% confidence interval [CI], 0.9% to 1.6%), compared to a decrease in men (APC -1.2%; 95% CI -1.5% to -0.9%), and no change for women overall.

The Global Initiative for Chronic Obstructive Lung Disease, or GOLD, system is commonly used to categorize patients with emphysema according to severity. Stages of airflow limitation are based on the forced expiratory volume in 1 second (FEV1), or the amount of air a person can force out in 1 second after taking a deep breath. Patients with an FEV1 of less than 50% of their predicted value are considered to have severe airflow limitation. Patients are also grouped in the GOLD system using the ABE assessment tool according to categories of risk of having an exacerbation. These groups are based on the number and type of exacerbations per year and self-reported symptoms such as breathlessness. Of note, group E was previously divided into 2 separate groups, but was merged in 2023 to highlight the clinical significance of exacerbations.

Classification of Disease Severity

FEV1: forced expiratory volume in 1 second; GOLD: Global Initiative for Chronic Obstructive Lung Disease.

Bronchial Valves

Bronchial valves are synthetic devices deployed with bronchoscopy into ventilatory airways of the lung to control airflow. During inhalation, the valve is closed, preventing air flow into the diseased area of the lung. The valve opens during exhalation to allow air to escape from the diseased area of the lung. They have been investigated for use in patients who have prolonged bronchopleural air leaks and in patients with lobar hyperinflation from severe or advanced emphysema.

When used to treat persistent air leaks from the lung into the pleural space, the bronchial valve theoretically permits less air flow across the diseased portion of the lung during inhalation, aiding in air leak closure. The valve may be placed, and subsequently removed, by bronchoscopy.

The use of bronchial valves to treat emphysema is based on the improvement observed in patients who have undergone lung volume reduction surgery. Lung volume reduction surgery involves excision of peripheral emphysematous lung tissue, generally from the upper lobes. The precise mechanism of clinical improvement for patients undergoing lung volume reduction has not been firmly established. However, it is believed that elastic recoil and diaphragmatic function are improved by reducing the volume of the diseased lung. Currently, and at the time the clinical trials were designed, very few lung volume reduction procedures were performed. The procedure is designed to relieve dyspnea and improve functional lung capacity and quality of life; it is not curative. Medical management remains the most common treatment for a majority of patients with severe emphysema.

In early trials of bronchial valves for treatment of emphysema, absence of collateral ventilation (pathways that bypass the normal bronchial airways) was associated with better outcomes, presumably because patients with collateral ventilation did not develop lobar atelectasis (collapse). In subsequent trials, patients were selected for absence of collateral ventilation, and it is current practice for patients to be assessed for the presence of collateral ventilation prior to undergoing the procedure. Collateral ventilation is measured by the Chartis System, which requires bronchoscopy, or as a surrogate, CT scanning to assess the completeness of fissures. After 45 days post-procedure, residual volume can provide information on whether lung volume reduction has been achieved successfully.

In October 2008, the Spiration® IBV Valve System (Spiration) was approved by the U.S. Food and Drug Administration (FDA) through the humanitarian device exemption process for use in controlling prolonged air leaks of the lung or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy, or lung volume reduction surgery. An air leak present on postoperative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during the normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. Use of the intrabronchial Valve System is limited to 6 weeks per prolonged air leak.

Two bronchial valve systems are FDA approved for treatment of patients with severe emphysema. In June 2018, the FDA granted the Zephyr Valve system breakthrough device status with expedited approval for the bronchoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation. In December 2018, the FDA approved the Spiration Valve System for adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation.

Bronchial Valve Systems Approved by the FDA

FDA: Food and Drug Administration, HDE: human device exemption; PMA: premarket approval application.

Also, see the related medical policy, Lung Volume Reduction Surgery for Severe Emphysema .

POLICY

Bronchial valves are considered investigationalin all situations including, but not limited to:

• Treatment of prolonged air leaks, and

• Treatment for individuals with chronic obstructive pulmonary disease or emphysema.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

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.

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

03/31/2011: Approved by Medical Policy Advisory Committee.

03/27/2012: Policy reviewed; no changes.

12/21/2012: Added the following new 2013 CPT codes to the Code Reference section: 31647, 31648, 31649 and 31651.

03/17/2014: Policy reviewed; no changes to policy statement. Removed deleted CPT codes 0250T, 0251T, and 0252T from the Code Reference section.

04/06/2015: Policy description updated. For clarification, combined investigational policy statements and added "in situations including, but not limited to." Policy guidelines updated to revise definition of investigative.

08/21/2015: Code Reference section updated for ICD-10.

05/31/2016: Policy number A.7.01.128 added.

07/15/2016: Policy description updated. For clarification, policy statement updated to state that endobronchial valves are considered investigational in "all" situations.

07/18/2017: Policy title, description, and statement updated to change "Endobronchial Valves" to "Bronchial Valves."

07/20/2018: Policy description updated. Policy statement unchanged.

07/16/2019: Policy description updated regarding devices. Policy statement unchanged.

07/15/2020: Policy description updated regarding emphysema and bronchial valves. Policy statement unchanged.

08/27/2021: Policy description updated. Policy statement unchanged.

07/14/2022: Policy description updated regarding prevalence of COPD. Policy statement updated to change "patients" to "individuals."

08/02/2023: Policy description updated. Policy statement unchanged.

07/23/2024: Policy description updated with minor changes. Policy statement unchanged.

08/25/2025: Policy description updated regarding new data for COPD prevalence and classification of disease severity. Policy statement unchanged.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.128 

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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