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DESCRIPTIONEndobronchial valves are synthetic devices that are deployed with bronchoscopy into ventilatory airways of the lung for the purpose of controlling airflow. They have been investigated for use in patients who have prolonged broncho-pleural air leaks, as well as an alternative to lung volume reduction surgery (LVRS) in patients with lobar hyperinflation from severe emphysema.
Proper lung functioning is dependent upon a 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 a variety of processes including trauma, high airway pressures induced during mechanical ventilation, lung surgery, and rupture of lung blebs or bullae which may be congenital or a result of chronic obstructive pulmonary disease (COPD).
Although an air leak from the lung into the pleural space may seal spontaneously, it often requires intervention. Techniques currently employed to attempt air leak closure include the following:
An endobronchial valve is a device that permits one-way air movement. During inhalation the valve is closed preventing air flow to the diseased area of the lung. The valve opens during exhalation to allow air to escape from the diseased area of the lung. When used to treat persistent air leak from the lung into the pleural space, the endobronchial 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.
Endobronchial valves have also been investigated for use in severe emphysematous COPD. In emphysematous COPD peripheral lung tissue may form bullae. These diseased portions of the lung ventilate poorly, cause air trapping, and hyperinflate, compressing relatively normal lung tissue. They also may rupture, causing a pneumothorax. Use of an endobronchial valve is thought to prevent hyperinflation of these bullae.
Consideration for the use of endobronchial valves in COPD is based on the improvement observed in patients who have undergone lung volume reduction surgery (LVRS). LVRS involves excision of
In October 2008, the “IBV® Valve System” (Spiration, Inc, Redmond, WA) was approved by the FDA under the Humanitarian Device Exemption 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 (LVRS). 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 normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. IBV Valve System use is limited to 6 weeks per prolonged air leak.
In December 2008, the “Zephyr Endobronchial Valve” (formerly Emphasys, now Pulmonx, Redwood City, CA) was considered by the Anesthesiology and Respiratory Therapy Device Panel for use as a permanent implant intended to improve forced air expiratory volume in one second (FEV1) and 6-minute walk test distance in patients with severe, heterogeneous emphysema who have received optimal medical management. The panel declined to recommend the device for FDA approval.
Also, see the related medical policy, Lung Volume Reduction Surgery for Severe Emphysema.
POLICYEndobronchial valves are considered investigational as a treatment of prolonged air leaks.
Endobronchial valves are considered investigational as a treatment for patients with COPD or emphysema.
POLICY EXCEPTIONSFederal 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 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.
POLICY HISTORY03/31/2011: 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.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.128
This may not be a comprehensive list of procedure codes applicable to this policy.