Bronchial Thermoplasty

POLICY NUMBER

A.7.01.127

DESCRIPTION

Bronchial 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

Asthma, a chronic lung disease, affects approximately 8.9% of adults and 6.7% of children in the United States (U.S). As of 2023, 11% of Black children under 18 in the U.S. had asthma, followed by 7.1% of Hispanic children, and 5.6% of White children. In the U.S., the burden of asthma falls disproportionately on Black, Hispanic, and American Indian/Alaska Native individuals; these groups have the highest rates, deaths, and hospitalizations. Compared to White Americans, Black Americans are 1.5 times more likely to have asthma, and Puerto Rican Americans are almost 2 times more likely to have asthma. In 2020 and 2021, asthma exacerbations accounted for nearly 1 million emergency department visits and 3,517 deaths overall, respectively. Black Americans are 5 times more likely than White Americans to visit the emergency department for asthma and 3 times more likely to die from asthma. 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 hyperresponsiveness, airway inflammation, and reversible airflow obstruction (at least 12% improvement in forced expiratory volume in 1-second post-bronchodilator, with a minimum of 200 mL improvement). However, there is substantial heterogeneity in the inflammatory features of patients diagnosed with asthma, and this biologic diversity is responsible, at least in part, for the variable response to treatment in the asthma population.

Management

Management of asthma consists of environmental control, patient education, management of comorbidities, and regular follow-up for affected patients, as well as a stepped approach to medication treatment. Guidelines from the National Heart, Lung and Blood Institute have defined 6 pharmacologic steps: step 1 for intermittent asthma, and steps 2 through 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 implement optimal 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. A typical full course of treatment consists of 3, one hour sessions, given 3 weeks apart under moderate sedation. All accessible airways distal to the main stem bronchus that are 3 to 10 mm in diameter are treated once, except those in the right middle lobe. The lower lobes are treated first followed by the upper lung. Bronchial thermoplasty is intended for consideration as a supplemental treatment for patients with severe persistent asthma (i.e., steps 5 and 6 in the stepwise approach to care).

In April 2010, the Alair® Bronchial Thermoplasty System (Asthmatx, now Boston Scientific) was approved by the U.S. Food and Drug Administration through the premarket approval process for use in adults with severe and persistent asthma whose symptoms are not adequately controlled with low-dose 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.

POLICY

Bronchial thermoplasty for the treatment of asthma is considered investigational.

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

07/22/2010: 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.

05/31/2016: Policy number A.7.01.127 added.

07/05/2016: Policy description updated. Policy statement unchanged.

07/18/2017: Policy description updated. Policy statement unchanged.

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

07/16/2019: Policy reviewed; no changes.

07/15/2020: Policy description updated regarding asthma data for 2018 and treatment for bronchial thermoplasty. Policy statement unchanged.

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

07/14/2022: Policy description updated regarding data for asthma. Policy statement unchanged.

08/02/2023: Policy description updated regarding new asthma data. Policy statement unchanged.

07/23/2024: Policy description updated regarding new data for individuals with asthma. Policy statement unchanged.

08/22/2025: Policy description updated regarding new asthma data. Policy statement unchanged.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.127

CODE REFERENCE

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

Investigational Codes

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