CPT code 31660, 31661 - Bronchial Thermoplasty

Coding Code Description CPT

31660 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial thermoplasty, 1 lobe

31661 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial thermoplasty, 2 or more lobes


Bronchial Thermoplasty


Introduction

Asthma is a long-term lung condition causing the airways of the lung to become inflamed. Inhaling certain substances such as tobacco smoke, pet dander, and dust mites can set off a chain reaction. One thing that happens during this chain reaction is that muscles around the airways constrict (tighten). This makes the airways narrower, which means less air gets into the lungs. This results in wheezing, tightness in the chest, coughing, and shortness of breath. Bronchial thermoplasty is one proposed treatment for asthma. The idea is that if there was less smooth muscle tissue around the airways, there would also be less airway constriction and fewer asthma attacks. Heat, delivered through an instrument known as a bronchoscope, is used to destroy the smooth muscle tissue. Bronchial thermoplasty is investigational (unproven). There are no long-term studies to show how well this treatment works. Longer studies are needed to see if it’s safe and effective.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.


Service Investigational Bronchial thermoplasty Bronchial thermoplasty for the treatment of asthma is considered investigational.



Evidence Review 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.


Background Asthma

Asthma, a chronic lung disease, affects approximately 8.3% of adults and 8.3% of children in the United States and, in 2017, accounted for approximately 1.7 million emergency department visits and 3615 deaths.1 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 postbronchodilator, 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 all 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.2 The preferred daily medications: step 1: short-acting ?-agonists as-needed;
step 2: low-dose inhaled corticosteroids (ICS); step 3: ICS and long-acting ?-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 optimally standard approaches to asthma treatment, new therapies are being developed. One recently developed therapy is bronchial thermoplasty, the controlled delivery of radiofrequency energy to the 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 their airways 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 musclemediated bronchoconstriction with the ultimate goal of reducing asthma-related morbidity. Bronchial thermoplasty is intended as a supplemental treatment for patients with severe persistent asthma (ie, steps 5 and 6 in the stepwise approach to care).


Bronchial thermoplasty procedures are performed on an outpatient basis, and each session lasts approximately 1 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?C over a 5mm 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.

Summary of Evidence

For individuals who have asthma refractory to standard treatment who receive bronchial thermoplasty added to medical management, the evidence includes 3 RCTs and observational studies. Relevant outcomes are symptoms, quality of life, hospitalizations, and treatment-related morbidity. Early studies (RISA, AIR) investigated safety outcomes, finding similar rates of adverse events and exacerbations between the bronchial thermoplasty and control groups. These trials were limited by their lack of sham control. The AIR2 trial is the largest of the 3 published RCTs, and the only one double-blinded and sham-controlled, with sites in the United States. Over 1 year, bronchial thermoplasty was not found to be superior to sham treatment on the investigator-designated primary efficacy outcome of mean change in the quality of life score but was found to be superior on a related outcome, improvement in the quality of life of at least 0.5 points on the AQLQ. There was a high response rate in the sham group of the AIR2 trial, suggesting a large placebo effect, particularly for subjective outcomes such as quality of life.

There are no long-term sham-controlled efficacy data. Findings on adverse events from the 3 trials have suggested that bronchial thermoplasty is associated with a relatively high rate of adverse events, including hospitalizations during the treatment period, but not in the posttreatment period. Safety data up to 5 years have been reported in the RCTs for patients treated with bronchial thermoplasty but not for control patients. Safety data from a U.K. registry study, published in 2016, found that 20% of bronchial thermoplasty procedures were associated with a safety event (ie, procedural complications, emergency respiratory readmissions, emergency department visits, and/or postprocedure overnight stays). Conclusions cannot be drawn about the effect of bronchial thermoplasty on the net health outcome due to the limited amount of sham controlled data (1 RCT) on short-term efficacy, the uncertain degree of treatment benefit in that single sham-controlled trial, the lack of long-term sham controlled data in the face of a high initial placebo response, and the presence of substantial adverse events. Also, there is a lack of data on patient selection factors for   this procedure and, as a result, it is not possible to determine whether there are patient subgroups that might benefit. The evidence is insufficient to determinethe effects of the technology on health outcomes.