284 Form

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Medical Policy Bronchial Thermoplasty Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History
• Endnotes Policy Number: 284

BCBSA Reference Number: N/A NCD/LCD: N/A Related Policies
None
Policy1 Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity Medicare HMO BlueSM and Medicare PPO BlueSM Members

Bronchial thermoplasty, performed by a pulmonologist who has completed a bronchial thermoplasty training curriculum, may be considered MEDICALLY NECESSARY for individuals ≥18 years when the following criteria are met:

• Individual has been diagnosed with severe persistent asthma by having any of the following criteria in the absence of controller medications: o Daily symptoms o Nighttime awakenings, every night o Use of rescue medicine multiple times per day o Normal activities are extremely limited o Impaired lung function (less than or equal to 60% predicted) o Frequent exacerbations, AND • Co-morbid conditions contributing to asthma exacerbations have either been ruled out or fully controlled (e.g., allergy symptoms, GERD), AND • Individual is taking chronic oral corticosteroids, OR • Poor asthma control despite being on high-dose ICS and LABA for a minimum of 3 months with two or more asthma exacerbations per year. Asthma exacerbations are defined as follows: o Individual required oral systemic corticosteroid use due to respiratory symptoms, OR o Urgent provider’s office visit due to severe respiratory symptoms, OR o Emergency department visit due to respiratory symptoms, OR o Hospitalization due to respiratory symptoms.

2 Bronchial thermoplasty is contraindicated for individuals with the following conditions: • Presence of a pacemaker, internal defibrillator, or other implantable electronic device • Known sensitivity to medications required to perform bronchoscopy, including lidocaine, atropine and benzodiazepines • Individuals previously treated with bronchial thermoplasty • Active respiratory infection • Asthma exacerbation or changing dose of systemic corticosteroids for asthma (up or down) in the past 14 days • Known coagulopathy.

Bronchial thermoplasty is considered INVESTIGATIONAL when the above criteria are not met.

Prior Authorization Information Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) Prior authorization is required. Commercial PPO
Prior authorization is required. Medicare HMO BlueSM Prior authorization is required. Medicare PPO BlueSM Prior authorization is required.

Requesting Prior Authorization Using Authorization Manager Providers will need to use Authorization Manager to submit initial authorization requests for services. Authorization Manager, available 24/7, is the quickest way to review authorization requirements, request authorizations, submit clinical documentation, check existing case status, and view/print the decision letter. For commercial members, the requests must meet medical policy guidelines.
To ensure the service request is processed accurately and quickly: • Enter the facility’s NPI or provider ID for where services are being performed. • Enter the appropriate surgeon’s NPI or provider ID as the servicing provider, not the billing group.

Authorization Manager Resources Refer to our Authorization Manager page for tips, guides, and video demonstrations. CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list.

The following CPT codes are considered medically necessary when the policy guidelines above are met for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue:

3 CPT Codes CPT codes: Code Description 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 ICD-10 Procedure Codes ICD-10-PCS procedure codes: Code Description 0B538ZZ Destruction of Right Main Bronchus, Via Natural or Artificial Opening 0B548ZZ Destruction of Right Upper Lobe Bronchus, Via Natural or Artificial Opening Endoscopic 0B558ZZ
Destruction of Right Middle Lobe Bronchus, Via Natural or Artificial Opening Endoscopic
0B568ZZ
Destruction of Right Lower Lobe Bronchus, Via Natural or Artificial Opening 0B578ZZ Destruction of Left Main Bronchus, Via Natural or Artificial Opening Endoscopic
0B588ZZ Destruction of Left Upper Lobe Bronchus, Via Natural or Artificial Opening Endoscopic
0B598ZZ Destruction of Lingula Bronchus, Via Natural or Artificial Opening Endoscopic
0B5B8ZZ
Destruction of Left Lower Lobe Bronchus, Via Natural or Artificial Opening Endoscopic

Description Asthma demonstrates specific clinical features that include bronchial hyper-responsiveness, airway inflammation and reversible airflow obstruction that cause symptoms of episodic shortness of breath, wheezing, coughing, and chest tightness. Management of asthma consists of environmental control, patient education, management of co-morbidities, and regular follow-up for all affected individuals, as well as a stepped approach to medication treatment. Despite this multidimensional approach, morbidity remains high, and it is believed to be due to the substantial heterogeneity in the inflammatory features of asthmatic patients, yielding variable responses to evidence based treatment.

Bronchial thermoplasty is a procedure, which delivers radiofrequency energy to heat tissues in the distal airways with the ultimate outcome of reducing the amount of smooth muscle to decrease muscle- mediated bronchoconstriction. It is based on the premise that patients with treatment resistant asthma have an increased amount of smooth muscle in the airway resulting in an enhanced inflammatory response and subsequent airway constriction.

Bronchial thermoplasty procedures are performed on an outpatient basis. A standard flexible bronchoscope is placed into the most distal targeted airway. The process is repeated several times along the accessible length of the airway.

An example of bronchial thermoplasty is the Alair Bronchial Thermoplasty System from Asthmatx, Inc. All bronchial thermoplasty procedures are considered investigational regardless of the commercial name, the manufacturer or FDA approval status.

Summary
Three RCTs on bronchial thermoplasty have been published; only one of these, the AIR2 trial had sites in the United States. In the AIR2 trial, bronchial thermoplasty provided benefit in terms of quality of life and some, but not all, secondary outcomes. It is unclear, however, which patients are most likely to respond to treatment. Data from the AIR2 suggests that those with more severe asthma may experience the greatest improvement.

4 Long-term safety data up to 5 years are available from participants in the AIR trial and do not suggest a high rate of delayed complications following bronchial thermoplasty. However, long-term safety data are not yet available from the two other RCTs, and long-term data on clinical outcomes such as exacerbation rates and quality of life are not available. Other ongoing trials are evaluating predictors of response to treatment. Despite the low volume of published long term data on bronchial thermoplasty, patients with severe persistent asthma who are very poorly controlled despite being on maximum ICS and LABA therapy have few other treatment options. Bronchial thermoplasty may provide improved quality of life by decreasing exacerbation frequency, decreasing the need for systemic corticosteroids and improving asthma symptoms overall. Therefore, bronchial thermoplasty is considered medically necessary.

Policy History Date Action 8/2024 Annual policy review. Policy statements unchanged. 9/2023 Policy clarified to include prior authorization requests using Authorization Manager.
8/2023 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 8/2022 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 6/2022 Prior authorization information clarified for PPO plans. Effective 6/1/2022. 1/2022 Clarified prior authorization information 8/2020 BCBSA National medical policy review. Description, summary and references updated. Policy statements unchanged. 8/2019 BCBSA National medical policy review. Description, summary and references updated. Policy statements unchanged. 7/2018 New references added from BCBSA National medical policy. Background and summary clarified. 7/2017 New references added from BCBSA National medical policy. 10/2016 New medically necessary indications described based on expert opinion. Clarified coding information. Effective 10/1/2016. 12/2015 Added coding language. 8/2015 New references added from BCBSA National medical policy. 9/2014 New references added from BCBSA National medical policy. 7/2014 Clarified coding information. 11/2011-4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates.
No changes to policy statements.
4/2011 Reviewed - Medical Policy Group – Cardiology and Pulmonology. No changes to policy statements. 11/1/2010 Medical Policy #284 effective 11/1/2010 describing ongoing non-coverage.

Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References

1. Centers for Disease Control & Prevention, National Center for Health Statistics. Asthma. Updated January 2023; https://www.cdc.gov/nchs/fastats/asthma.htm. Accessed May 2, 2023.
2. National Center for Health Statistics. Health, United States, 2019: Figure 010. 2021. https://www.cdc.gov/nchs/hus/contents2019.htm. Accessed May 2, 2023.
3. Asthma and Allergy Foundation of America. Asthma Disparities in America: A Roadmap to Reducing Burden on Racial and Ethnic Minorities. 2020. aafa.org/asthmadisparities. Accessed May 2, 2023.

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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 May 2, 2023.
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 May 2, 2023.
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 randomised controlled trials. Lancet Respir Med. May 2021; 9(5): 457-466. PMID 33524320
14. 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
15. 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
16. 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
17. 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
18. 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
19. 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 May 2, 2023.
20. Global Initiative for Asthma (GINA). Diagnosis and management of difficult-to-treat & severe asthma [V4]. May 2022; https://ginasthma.org/severeasthma/. Accessed May 1, 2023.
21. 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
22. 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.
23. 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 May 2, 2023.

6 Endnotes

1 Based on expert opinion, MPG April 2016