Bronchial Thermoplasty Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 02|03|2015 POLICY LAST UPDATED: 08|06|2025 OVERVIEW Bronchial thermoplasty is a potential treatment option for individuals 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. MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION Not applicable POLICY STATEMENT Medicare Advantage Plans Bronchial thermoplasty for the treatment of asthma is not covered as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome. Commercial Products Bronchial thermoplasty for the treatment of asthma is not medically necessary as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome. COVERAGE Benefits may vary between groups/contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement for limitations of benefits/coverage when services are not medically necessary. BACKGROUND Asthma Asthma, a chronic lung disease, affects approximately 8.7% of adults and 6.2% of children in the United States (U.S.). As of 2018, 14.3% of Black children under 18 in the U.S. had asthma, followed by 8% of Hispanic children, 5.6% of White children, and 3.6% of Asian 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 2018 and 2020, asthma exacerbations accounted for nearly 1 million emergency department visits and 3517 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 Medical Coverage Policy | Bronchial Thermoplasty

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

from the National Heart, Lung and Blood Institute have defined six pharmacologic steps: step 1 for intermittent asthma and steps 2 through 6 for persistent asthma. The preferred daily medications: step 1: short-acting b-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. A focused update in 2020 addressed the use of add-on long-acting antimuscarinic agents (LAMA), immunotherapy, and bronchial thermoplasty.

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 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 (ie, steps 5 and 6 in the stepwise approach to care).

For individuals who have asthma refractory to standard treatment who receive bronchial thermoplasty added to medical management, the evidence includes three randomized controlled trials (RCTs) and observational studies. Relevant outcomes are symptoms, quality of life (QOL), hospitalizations, and treatment-related morbidity. Early studies (Research in Severe Asthma [RISA], Asthma Intervention Research [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 trial that is double-blind 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 QOL score but was found to be superior on a related outcome, improvement in the QOL of at least 0.5 points on the Asthma Quality of Life Questionnaire (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 QOL. There are limited 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 10 years have been reported for patients in the AIR2 trial, with a higher rate of new cases of bronchiectasis observed in bronchial thermoplasty-treated patients. Data from a United Kingdom registry showed 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) with uncertain benefit. 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 sufficient 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 determine that the technology results in an improvement in the net health outcome.

CODING Medicare Advantage Plans and Commercial Products The following CPT code(s) are not covered for Medicare Advantage Plans and not medically necessary for Commercial Products: 31660 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial

thermoplasty, 1 lobe

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

31661 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial

thermoplasty, 2 or more lobes

RELATED POLICIES Not applicable

PUBLISHED Provider Update, October 2025 Provider Update, September 2024 Provider Update, August 2023 Provider Update, October 2022 Provider Update, October 2021

REFERENCES

1. Centers for Disease Control & Prevention, National Center for Health Statistics. Asthma. Updated July 2024; https://www.cdc.gov/nchs/fastats/asthma.htm. Accessed April 23, 2025.
2. National Center for Health Statistics. Health, United States, 2019 to 2023. Current asthma in children. https://nchsdata.cdc.gov/DQS/#nchs-home_arthritis-diagnosis/-/total/all-time-periods/1. Accessed April 23, 2025.
3. Asthma and Allergy Foundation of America. Asthma Disparities in America: A Roadmap to Reducing Burden on Racial and Ethnic Minorities. 2020. aafa.org/asthma disparities. Accessed April 29, 2024. Accessed April 23, 2025.
4. National Heart Lung and Blood Institute. Guidelines for the Diagnosis and Management of Asthma (EPR-3). 2012; https://www.nhlbi.nih.gov/health-topics/guidelines-for-diagnosis-management-of- asthma. Accessed April 23, 2025.
5. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2022; https://ginasthma.org/wp-content/uploads/2022/05/GINA-Main-Report-2022-FINAL-22-05-03- WMS.pdf. Accessed April 23, 2025.
6. Pavord ID, Cox G, Thomson NC, et al. Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma. Am J Respir Crit Care Med. Dec 15 2007; 176(12): 1185-91. PMID 17901415
7. Pavord ID, Thomson NC, Niven RM, et al. Safety of bronchial thermoplasty in patients with severe refractory asthma. Ann Allergy Asthma Immunol. Nov 2013; 111(5): 402-7. PMID 24125149
8. Cox G, Thomson NC, Rubin AS, et al. Asthma control during the year after bronchial thermoplasty. N Engl J Med. Mar 29 2007; 356(13): 1327-37. PMID 17392302
9. Thomson NC, Rubin AS, Niven RM, et al. Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial. BMC Pulm Med. Feb 11 2011; 11: 8. PMID 21314924
10. Castro M, Rubin AS, Laviolette M, et al. Effectiveness and safety of bronchial thermoplasty in the treatment of severe asthma: a multicenter, randomized, double-blind, sham-controlled clinical trial. Am J Respir Crit Care Med. Jan 15 2010; 181(2): 116-24. PMID 19815809
11. Castro M, Rubin A, Laviolette M, et al. Persistence of effectiveness of bronchial thermoplasty in patients with severe asthma. Ann Allergy Asthma Immunol. Jul 2011; 107(1): 65-70. PMID 21704887
12. Wechsler ME, Laviolette M, Rubin AS, et al. Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma. J Allergy Clin Immunol. Dec 2013; 132(6): 1295-302. PMID 23998657
13. Chaudhuri R, Rubin A, Sumino K, et al. Safety and effectiveness of bronchial thermoplasty after 10 years in patients with persistent asthma (BT10+): a follow-up of three randomized controlled trials. Lancet Respir Med. May 2021; 9(5): 457-466. PMID 33524320
14. Leroux J, Khayath N, Matau C, et al. Efficacy of bronchial thermoplasty in patients with severe asthma and frequent severe exacerbations: A randomized controlled study ✰. Respir Med Res. Nov 2024; 86:
15. PMID 38875851
16. Chupp G, Laviolette M, Cohn L, et al. Long-term outcomes of bronchial thermoplasty in subjects with severe asthma: a comparison of 3-year follow-up results from two prospective multicentre studies. Eur Respir J. Aug 2017; 50(2). PMID 28860266

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

16. Chupp G, Kline JN, Khatri SB, et al. Bronchial Thermoplasty in Patients With Severe Asthma at 5 Years: The Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma Study. Chest. Mar 2022; 161(3): 614-628. PMID 34774528
17. Burn J, Sims AJ, Keltie K, et al. Procedural and short-term safety of bronchial thermoplasty in clinical practice: evidence from a national registry and Hospital Episode Statistics. J Asthma. Oct 2017; 54(8): 872-879. PMID 27905828
18. Burn J, Sims AJ, Patrick H, et al. Efficacy and safety of bronchial thermoplasty in clinical practice: a prospective, longitudinal, cohort study using evidence from the UK Severe Asthma Registry. BMJ Open. Jun 19 2019; 9(6): e026742. PMID 31221880
19. Torrego A, Herth FJ, Munoz-Fernandez AM, et al. Bronchial Thermoplasty Global Registry (BTGR): 2- year results. BMJ Open. Dec 16 2021; 11(12): e053854. PMID 34916324
20. American College of Chest Physicians (ACCP). Position Statement for Coverage and Payment for Bronchial Thermoplasty. 2014; http://www.chestnet.org/News/CHEST-News/2014/05/Position- Statement-for-Coverage- and-Payment-for-Bronchial-Thermoplasty. Accessed April 23, 2025.
21. Global Initiative for Asthma (GINA). Diagnosis and management of difficult-to-treat & severe asthma [V4.0]. August 2023; https://ginasthma.org/severeasthma/. Accessed April 22, 2025.
22. Cloutier MM, Baptist AP, Blake KV, et al. 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. J Allergy Clin Immunol. Dec 2020; 146(6): 1217-1270. PMID 33280709
23. D'Anci KE, Lynch MP, Leas BF, et al. Effectiveness and Safety of Bronchial Thermoplasty in Management of Asthma. Rockville (MD): Agency for Healthcare Research and Quality (US); 2017 Dec. Report No.: 18-EHC003-EF. PMID: 29659226.

24. National Institute for Health and Care Excellence. Bronchial thermoplasty for severe asthma. Interventional procedures guidance [IPG635]. 2018 https://www.nice.org.uk/guidance/ipg635. Accessed April 23, 2025.

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    This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS