CurrentBlue Cross Blue Shield - IowaPolicy 02.01.45

Bronchial Thermoplasty

Policy governs coverage determination for bronchial thermoplasty procedures for treatment of asthma, summarizing evidence, regulatory status, and Wellmark's medical policy position. This part (1 of 2) includes description, evidence review, RCT summaries, rationale, and the explicit policy statement that bronchial thermoplasty is investigational for all indications.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyBronchial Thermoplasty

Policy CodePolicy 02.01.45

Change TypeRevised (Feb 2023); literature update through July 2025

Effective DateJul 1, 2011

Next Review Date

Key ActionDo not authorize claims for bronchial thermoplasty; document that the procedure is considered investigational and recommend registry or clinical study context with baseline and follow-up outcome documentation.

POLICY UPDATE CHANGES

Policy revised February 2023; review date August 2025 with literature update through July 2025.

1Primary Coverage Position (Investigational for all indications)

3Randomized Controlled Trials cited

10Years of long-term follow-up reported (up to)

42.7%PAS2 5-year severe exacerbation rate (reduced to)

Procedures followed by overnight stay (Burn 2017)

11%Procedural complications per procedures (Burn 2017)

Coverage Summary & Determination

This policy addresses coverage for bronchial thermoplasty (BT) as a procedure for asthma management. Bronchial thermoplasty delivers radiofrequency energy to distal airways to reduce airway smooth muscle and is intended as a supplemental treatment for adults with severe persistent asthma (steps 5–6). The Alair® Bronchial Thermoplasty System received U.S. FDA premarket approval in April 2010. A typical full course of treatment consists of three, one-hour outpatient sessions approximately 3 weeks apart, treating accessible airways 3–10 mm in diameter (excluding the right middle lobe). Per the policy statement, bronchial thermoplasty is considered investigational and not covered for all indications (i.e., evidence is insufficient to demonstrate improvement in net health outcomes).

Coverage Determination

Policy statement:

Coverage Determination: Bronchial thermoplasty is considered investigational for all indications, including but not limited to the treatment of asthma because the evidence is insufficient to determine the technology results in an improvement in the net health outcomes.

Policy metadata (compact)

Policy number02.01.45

Effective dateJuly 2011

Last reviewAugust 2025

StatusCURRENT

Primary Coverage PositionInvestigational for all indications

Evidence Summary & Clinical Outcomes

Evidence summary / clinical outcomes

Findings from randomized controlled trials, post-approval studies and registries summarized (no explicit policy eligibility criteria in this part):

AIR2 specifics: AIR2 (sham-controlled) did not meet the primary integrated AQLQ superiority endpoint but showed a higher proportion achieving ≥0.5 AQLQ improvement and reductions in severe exacerbations and ED visits; treatment-phase respiratory AEs and hospitalizations were increased.
Other RCTs: Non-sham RCTs (RISA, AIR) showed some improvements versus medical management but were limited by lack of blinding, small sizes, and higher adverse events during the treatment period.
Leroux 2024: Leroux et al (2024) randomized 30 severe asthma patients and reported a 27% reduction in severe exacerbations over 15 months and a 32% reduction in daily OCS use in the BT group.

Billing, Documentation & Operational Guidance

Denial Risk

Coverage exclusion

Claims for bronchial thermoplasty (BT) are considered investigational and are not covered for any indication, including treatment of asthma. Submission of claims for BT for asthma or other diagnoses will likely result in denial consistent with the policy statement that BT is investigational for all indications.

Documentation Required

Prior approval

Prior approval is not applicable for bronchial thermoplasty per this policy.

Coding Reference

Covered CPT (procedure codes reported for BT-related services)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.

HCPCSHCPCS

No code(s)

No specific HCPCS codes listed for device/procedure in this section.

Place/Type of Servicemixed

Place of Service	Outpatient; Inpatient (both listed as possible).
Type of Service	Surgical

Codingmixed

No codes listed

There are no specific HCPCS device codes listed in this section for the Alair system. The CPT codes provided (e.g., 31660 and 31661) are procedure codes reported for bronchial thermoplasty–related bronchoscopy services. Bronchial thermoplasty procedures are generally performed on an outpatient basis but inpatient stays or overnight observation are possible depending on clinical circumstances and institutional practice.

Background & Definitions

Bronchial thermoplasty is performed to reduce airway smooth muscle mass with the goal of decreasing muscle-mediated bronchoconstriction in patients with severe persistent asthma. The Alair® Bronchial Thermoplasty System received FDA premarket approval in April 2010 for adults with severe persistent asthma not adequately controlled with low-dose inhaled corticosteroids and long-acting β-agonists. A typical treatment course is three one-hour procedures approximately 3 weeks apart, treating accessible distal airways 3–10 mm in diameter once per area and excluding the right middle lobe.

Term	Definition
Bronchial thermoplasty (BT)	Controlled delivery of radiofrequency energy via bronchoscope to heat airway tissue to ~65°C over 5-mm areas to reduce airway smooth muscle; typically performed as 3 one-hour outpatient procedures about 3 weeks apart treating airways 3–10 mm in diameter (except the right middle lobe).
AQLQ MCID	Minimal clinically important difference in the Asthma Quality of Life Questionnaire (AQLQ) is ≥0.5 points.
AQLQ	Asthma Quality of Life Questionnaire; score range 1–7 with higher scores indicating better quality of life; minimal important difference ≥0.5.
ACQ	Asthma Control Questionnaire, an instrument used to assess asthma symptom control and outcomes in studies of bronchial thermoplasty.
PAS2	Post-U.S. FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma, an open-label, nonrandomized post-approval study reporting multi-year outcomes (including reductions in severe exacerbations and medication use).
BTGR	Bronchial Thermoplasty Global Registry, a prospective, multicenter registry reporting real-world outcomes (e.g., reductions in severe exacerbations, ED visits, hospitalizations, and improvements in AQLQ/ACQ) with limitations due to lack of comparator and attrition.
UKSAR	U.K. Severe Asthma Registry, a national registry collecting safety and efficacy data on bronchial thermoplasty in participating U.K. centers, reporting procedural complication rates and changes in AQLQ and healthcare utilization.

Revision History

February 2023revision

Policy revised February 2023; review date August 2025 with literature update through July 2025. Revision history lines present but document indicates no material clinical policy changes in this part.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyBronchial Thermoplasty

Policy CodePolicy 02.01.45

Change TypeRevised (Feb 2023); literature update through July 2025

Effective DateJul 1, 2011

Next Review Date

On This Page

Post-approval studies: Post-approval PAS2 reported reductions in severe exacerbations, ED visits, and hospitalizations at 3 and 5 years compared with baseline; spirometry largely unchanged; maintenance medication use reduced.

Registries: Registry data (UKSAR, BTGR) showed reductions in severe exacerbations, ED visits, hospitalizations, and improvements in AQLQ/ACQ in nonrandomized cohorts but were limited by lack of comparator arms and attrition; procedural complications and postprocedure overnight stays were reported.

Guidelines and position statements: Guideline and position statements vary: ACCP supportive of BT as option for adults with severe asthma; GINA allows consideration as add-on in adults uncontrolled despite optimized therapy and recommends registry/clinical study context; NAEPP conditionally recommends against BT in adults but permits use within trial/registry; NICE supports use with governance and audit.

The evidence includes three randomized controlled trials (notably the sham-controlled AIR2 trial), additional RCTs (AIR and RISA), systematic reviews and HTAs (Hayes, AHRQ), long-term follow-up studies, and registry/postapproval data. The AIR2 sham-controlled RCT found the primary integrated AQLQ change did not reach the predefined superiority threshold versus sham, though a greater proportion of BT patients achieved the AQLQ MCID; it also showed reductions in some secondary outcomes but increased treatment-phase respiratory adverse events and hospitalizations. Other RCTs (AIR, RISA) reported some improvements versus medical management but were limited by lack of blinding and small size. Systematic reviews and HTAs (Hayes HTA 2022 with 2025 review; AHRQ 2017) concluded modest or uncertain benefits and highlighted concerns about harms and patient selection. Long-term safety data (including 10+ year follow-up pooled analyses) report sustained symptom scores but signal for new bronchiectasis in some treated patients. Postapproval and registry outcomes (PAS2, BTGR, UKSAR) reported reductions in severe exacerbations, ED visits, hospitalizations, and maintenance medication use over 3–5 years, but these studies lack randomized comparators and are limited by attrition and potential selection bias; the small 2024 Leroux RCT and PAS2 results reported notable reductions in severe exacerbations and oral corticosteroid use in treatment groups.

Selected quantitative outcomes

Randomized Controlled Trials cited3 RCTs (AIR, AIR2, RISA) + Leroux 2024 added

Years of long-term follow-up (up to)10 years (long-term safety/efficacy reported)

PAS2 5-year severe exacerbation rate42.7% at 5 years (reduced from 77.8% pre-treatment)

Procedures followed by overnight stay (Burn 2017)46.1% of procedures followed by overnight stay

Procedural complications per procedures (Burn 2017)11% of procedures reported procedural complications

Leroux 2024 severe exacerbation reduction27% reduction over 15 months (0.73-fold; p=.039)

Documentation Required

Registry or clinical governance documentation recommended

Guidance and the policy note that BT should be administered only in the context of a systematic registry or clinical study, with appropriate clinical governance, consent, and audit per guideline recommendations (e.g., GINA, NAEPP, NICE). Documentation of enrollment or participation in a registry or clinical study and governance arrangements is recommended.

Documentation Required

Pre-procedure baseline and follow-up outcome documentation

Document baseline and follow-up outcomes to assess effectiveness and safety, including: baseline severe exacerbation rate (12 months prior), emergency department visits, hospitalizations, maintenance medication use (ICS dose, OCS use), validated symptom/QOL scores (AQLQ and/or ACQ), and longitudinal follow-up outcomes for 1–5 years post-procedure.

Baseline severe exacerbation frequency (12 months before BT)
ED visit and hospitalization history related to asthma
Maintenance medication use (daily ICS dose, oral corticosteroid maintenance)
Validated PROs: AQLQ and/or ACQ scores (report baseline and change; note MCID ≥0.5 for AQLQ/ACQ)
Follow-up outcomes annually up to 1–5 years (exacerbations, ED visits, hospitalizations, medication changes, AQLQ/ACQ)