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Endobronchial 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 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 diseased lung. The procedure is designed to relieve dyspnea and improve functional lung capacity and quality of life; it is not curative. Endobronchial valves have been investigated as a non-surgical alternative to LVRS.
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. As of December 2014, the Zephyr Endobronchial Valve has not been cleared by FDA.
Also, see the related medical policy, Lung Volume Reduction Surgery for Severe Emphysema.
Endobronchial valves are considered investigational in situations including, but not limited to:
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 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.
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.
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.
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.