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DESCRIPTIONBronchial thermoplasty is a potential treatment option for patients with severe persistent asthma. It consists of radiofrequency energy delivered to the distal airways with the aim of decreasing smooth muscle mass believed to be associated with airway inflammation.
Asthma, a chronic lung disease, affects approximately 8% of adults and 9.3% of children in the United States and, in 2012, accounted for approximately 440,000 hospitalizations and 3,400 deaths. Asthma symptoms include episodic shortness of breath that is generally associated with other symptoms such as wheezing, coughing and chest tightness. Objective clinical features include bronchial hyper-responsiveness and airway inflammation, and reversible airflow obstruction (at least 12% improvement in forced expiratory volume in 1 second [FEV-1] post-bronchodilator, with a minimum of 200 mL improvement). However, there is substantial heterogeneity in the inflammatory features of patients who are diagnosed with asthma and this biological diversity is responsible, at least in part, for the variable response to treatment in the asthma population.
Management of asthma consists of environmental control, patient education, management of comorbidities and regular follow-up for all affected patients, as well as a stepped approach to medication treatment. Guidelines from the National Heart, Lung and Blood Institute (NHLBI) define 6 pharmacologic steps: step 1 for intermittent asthma, and steps 2-6 for persistent asthma. The preferred daily medications: step 1: short-acting beta-agonists as needed; step 2: low-dose inhaled corticosteroids (ICS); step 3: ICS and long-acting beta-agonists (LABA) or medium-dose ICS; step 4: medium dose ICS and LABA; step 5: high-dose ICS and LABA; and, step 6: high-dose ICS and LABA, and oral corticosteroids.
Despite this multidimensional approach, many patients continue to experience considerable morbidity. In addition to ongoing efforts to optimally implement standard approaches to asthma treatment, new therapies are being developed. One recently developed therapy is bronchial thermoplasty, the controlled delivery of radiofrequency energy to heat tissues in the distal airways. Bronchial thermoplasty is based on the premise that patients with asthma have an increased amount of smooth muscle in the airway and that contraction of this smooth muscle is a major cause of airway constriction. The thermal energy delivered via bronchial thermoplasty aims to reduce the amount of smooth muscle and thereby decrease muscle-mediated bronchoconstriction with the ultimate goal of reducing asthma-related morbidity. Bronchial thermoplasty is intended as a supplemental treatment for patients with severe persistent asthma (i.e., steps 5 and 6 in the stepwise approach to care).
Bronchial thermoplasty procedures are preformed on an outpatient basis, and each session lasts approximately one hour. During the procedure, a standard flexible bronchoscope is placed through the patient’s mouth or nose into the most distal targeted airway and a catheter is inserted into the working channel of the bronchoscope. After placement, the electrode array in the top of the catheter is expanded, and radiofrequency energy is delivered from a proprietary controller and used to heat tissue to 65 degrees Centigrade over a 5 mm area. The positioning of the catheter and application of thermal energy is repeated several times in contiguous areas along the accessible length of the airway. At the end of the treatment session, the catheter and bronchoscope are removed. A course of treatment consists of 3 separate procedures in different regions of the lung scheduled about 3 weeks apart.
In April 2010, the Alair® Bronchial Thermoplasty System (Asthmatx, Inc., Sunnyvale, CA, now part of Boston Scientific) was approved by the FDA through the premarket approval (PMA) process for use in adults with severe and persistent asthma whose symptoms are not adequately controlled with inhaled corticosteroids and long-acting beta agonists. Use of the treatment is contraindicated in patients with implantable devices and those with sensitivities to lidocaine, atropine or benzodiazepines. It should also not be used while patients are experiencing an asthma exacerbation, active respiratory infection, bleeding disorder, or within 2 weeks of making changes in their corticosteroid regimen. The same area of the lung should not be treated more than once with bronchial thermoplasty.
POLICYBronchial thermoplasty for the treatment of asthma is considered investigational.
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 HISTORY07/22/2010: Approved by Medical Policy Advisory Committee
10/14/2010: Annual ICD-9 code update: Added new ICD-9 procedure code 32.26.
08/03/2011: Policy reviewed; no changes.
09/25/2012: Policy reviewed; no changes.
05/06/2013: Added CPT codes 31660 and 31661 to the Code Reference section. Also corrected typo in ICD-9 procedure code section: 32.26 was changed to 32.27.
11/06/2013: Policy reviewed; no changes.
09/16/2014: Policy reviewed; description updated. Policy statement unchanged.
08/21/2015: Code Reference section updated for ICD-10.
10/28/2015: Policy reviewed. Policy statement unchanged. Investigative definition updated in policy guidelines.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.127
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.