CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy Bronchial Thermoplasty

Defines Blue Cross Blue Shield of Rhode Island coverage stance for bronchial thermoplasty as a treatment for asthma for Medicare Advantage and Commercial products, including coding guidance and clinical background. Notes that benefits may vary by contract.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Bronchial Thermoplasty

Policy CodePolicy N/A

Change TypeClarified coverage stance

Effective DateFeb 3, 2015

Next Review Date

Key ActionRefer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for limitations when services are not medically necessary.

SourceLink

POLICY UPDATE CHANGES

Policy states bronchial thermoplasty is not covered for Medicare Advantage and not medically necessary for Commercial Products due to insufficient evidence of net health outcome improvement.

2CPT codes listed

1Sham-controlled RCTs cited

10Years safety data reported

Coverage Summary

Bronchial thermoplasty is an interventional procedure that delivers radiofrequency energy to distal airways with the goal of reducing airway smooth muscle mass and thereby decreasing muscle-mediated bronchoconstriction. A typical full course of treatment consists of three, one-hour outpatient sessions given about three weeks apart, treating accessible airways 3–10 mm in diameter (excluding the right middle lobe).

The evidence base includes three randomized controlled trials and observational studies, with the AIR2 trial the only double-blind, sham-controlled RCT. Trial results are mixed—AIR2 did not show superiority for the investigator-designated primary outcome (mean change in AQLQ) but did show a higher proportion of patients achieving a ≥0.5 point AQLQ improvement; the sham group had a high response rate.

Coverage summary

scope_summaryDefines Blue Cross Blue Shield of Rhode Island coverage stance for bronchial thermoplasty as a treatment for asthma for Medicare Advantage and Commercial products, including coding guidance and clinical background. Notes that benefits may vary by contract.

coverage_stanceNot covered for Medicare Advantage; Not medically necessary for Commercial Products (insufficient evidence to demonstrate improvement in net health outcome).

subjectBronchial Thermoplasty for Asthma

statusCURRENT

effective date02/03/2015

Coverage Determination

Coverage Determination for Bronchial Thermoplasty

Coverage statements as provided for Medicare Advantage Plans and Commercial Products:

ALL of the following

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.

Not Covered / Not Medically Necessary — Rationale

The AIR2 trial is the largest of the RCTs and the only double-blind, sham-controlled study; over one year it did not meet superiority for the prespecified primary endpoint (mean change in AQLQ) though it showed benefit on the proportion achieving a ≥0.5 point AQLQ improvement. The trial also had a high sham response rate, suggesting placebo effects for subjective outcomes.

Safety data from the randomized trials and longer-term follow-up raise concerns: higher rates of procedural adverse events and hospitalizations during the treatment period were reported, and AIR2 follow-up identified more new cases of bronchiectasis in treated patients. Registry data from the United Kingdom reported that about 20% of bronchial thermoplasty procedures were associated with a safety event (procedural complications, emergency respiratory readmissions, ED visits, or overnight stays).

Because there is only a single short-term sham-controlled RCT with a high placebo response, limited long-term sham-controlled efficacy data, and concerning safety signals from trials and registries, the evidence is insufficient to determine that bronchial thermoplasty provides a net health outcome benefit.

Definitions

Bronchial thermoplastyControlled delivery of radiofrequency energy to heat tissues in the distal airways to reduce smooth muscle mass and decrease bronchoconstriction.

Not medically necessary / Not coveredPer this policy, the technology is not covered because evidence is insufficient to demonstrate improvement in net health outcome.

Provider Actions & Billing Impact

Documentation Required

Refer to benefit booklet / subscriber agreement

Benefits may vary between groups/contracts; providers should refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for limitations when services are not medically necessary.

Denial Risk

Service likely not payable without exception

Bronchial thermoplasty is not covered for Medicare Advantage members and is not medically necessary for Commercial members per this policy; claims for these CPT codes are subject to denial unless contract-specific language overrides.

31660
31661
Claims may be denied unless contract language overrides

Background & Evidence

Bronchial thermoplasty involves controlled delivery of radiofrequency energy to heat tissues in the distal airways to reduce smooth muscle mass. The procedure is intended as a supplemental option for patients with severe persistent asthma (generally those at steps 5–6 of guideline-based therapy).

A typical treatment course is three outpatient sessions, each about one hour and spaced approximately three weeks apart; all accessible airways 3–10 mm in diameter are treated once (right middle lobe excluded), with lower lobes treated first followed by upper lobes.

Evidence item	Summary
AIR2 trial	Only double-blind, sham-controlled RCT (AIR2). Not superior to sham on primary mean change in AQLQ over 1 year but superior on proportion achieving ≥0.5 point improvement; high sham response rate suggesting placebo effect; limited long-term sham-controlled efficacy data.
Safety signal	Trials and follow-up report relatively high rates of procedural adverse events including hospitalizations during treatment period; AIR2 follow-up up to 10 years reported higher rates of new bronchiectasis in treated patients.
Registry data (UK)	United Kingdom registry data showed about 20% of bronchial thermoplasty procedures were associated with a safety event (procedural complications, emergency respiratory readmissions, ED visits, and/or postprocedure overnight stays) with uncertain benefit.