CurrentKaiser PermanentePolicy N/A

Clinical Review Criteria — Bronchial Thermoplasty for Treatment of Severe Bronchial Asthma

Clinical review criteria governing medical necessity and coverage determinations for bronchial thermoplasty (Alair system) for adults with severe persistent asthma within Kaiser Permanente Washington; affects providers requesting authorization and utilization management staff.

Policy Summary

PayerKaiser Permanente

PolicyBronchial Thermoplasty for Treatment of Severe Bronchial Asthma (Clinical Review Criteria)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the last 6 months of clinical notes from the requesting provider and/or specialist (pulmonary/allergy) to support medical necessity for prior authorization review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

FDA-cleared (Apr 2010)Regulatory status

3Treatment sessions

Adults 18+Age group

31660,31661Not medically necessary codes

MCG A-0634Non-Medicare guidance

Policy Summary

PayerKaiser Permanente

PolicyBronchial Thermoplasty for Treatment of Severe Bronchial Asthma (Clinical Review Criteria)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the last 6 months of clinical notes from the requesting provider and/or specialist (pulmonary/allergy) to support medical necessity for prior authorization review.

SourceLink

On This Page

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Coverage determination

Covered when ALL of the following statements apply:

Overall coverage stance: For Non-Medicare members, Kaiser Permanente uses the MCG guideline (A-0634) for medical necessity determinations; bronchial thermoplasty is not covered per MCG. CPT codes 31660 and 31661 are listed as considered not medically necessary. For Medicare members, in the absence of an active NCD/LCD Kaiser Permanente applies its own Clinical Review Criteria (use the Non-Medicare criteria for review).

Non-Medicare: follow MCG A-0634 (service not covered). Medicare: Kaiser Clinical Review Criteria applied due to absence of NCD/LCD.

Supporting clinical context: Bronchial thermoplasty (BT) is a device-based bronchoscopic procedure (Alair system) intended for adults with severe persistent asthma; randomized trials (AIR, AIR2, RISA) evaluated BT in adults with moderate to severe or symptomatic severe asthma despite high-dose inhaled corticosteroids and long-acting beta-agonists, with varying trial designs and manufacturer support noted.

Clinical evidence summarized for context; does not alter coverage stance.

Patients should not be considered for bronchial thermoplasty if any of the following clinical conditions are present immediately prior to the procedure: acute or active respiratory infection, known coagulopathy, or an asthma exacerbation. Additionally, patients with a changing dose of systemic corticosteroids for asthma (either increasing or decreasing) within 14 days before the planned procedure should be excluded from consideration.

Bronchial thermoplasty procedures billed with CPT codes 31660 and 31661 are listed as Considered Not Medically Necessary in this policy.

Prior Authorization, Documentation, and Provider Guidance

Prior Authorization

Prior Authorization Required

Prior authorization review is required. Kaiser Permanente uses Kaiser Permanente Clinical Review Criteria (Bronchial Thermoplasty for Treatment of Severe Bronchial Asthma) for Medicare medical necessity determinations and MCG (A-0634) for Non‑Medicare members. Verify preauthorization requirements by plan using the Pre-authorization Code Check.

Affected codes may require prior authorization — use Pre-authorization Code Check to confirm by plan type

Denial Risk

Non‑Medicare Coverage Stance / Denial Risk

For non‑Medicare members, Kaiser Permanente has elected to follow MCG (A-0634). Per MCG guidance, bronchial thermoplasty is not covered for non‑Medicare members; lack of MCG coverage may result in denial of the service. Providers may request a copy of the specific MCG criteria used for an individual member by contacting Kaiser Permanente Clinical Review staff at 1-800-289-1363 or via the provider portal MCG Guideline Index.

Non‑Medicare stance: Service not covered per MCG (A-0634)
To request the specific MCG criteria used for a member, call 1-800-289-1363 or access MCG via the provider portal

Billing Rule

Not Medically Necessary CPT Codes

The following CPT codes are considered Not Medically Necessary for bronchial thermoplasty and may result in claim denial if billed:

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
Note: Code lists may not be exhaustive. Verify current code requirements and authorization via the Pre-authorization Code Check.

Documentation Required

Required Clinical Documentation

Required clinical documentation must be submitted to support medical necessity.

Submit the last 6 months of clinical notes from the requesting provider and/or specialist (pulmonology/allergy).
Provide any additional clinical information used to support the request per the applicable clinical review criteria (Kaiser Permanente Clinical Review Criteria for Medicare or MCG A-0634 for Non‑Medicare).

Step Therapy

Step Therapy / Medication Step‑down

Step‑therapy / medication step‑down: there is no explicit step‑therapy requirement documented for bronchial thermoplasty and the cited trials did not assess bronchial thermoplasty as a means to step down or reduce maintenance asthma medications. Medication step‑down decisions should follow national guideline recommendations and the applicable clinical review criteria.

Trials (AIR, AIR2, RISA) did not study BT for step‑down of maintenance asthma medications; BT should not be assumed to allow medication reduction.
No formal step therapy pathway for BT is specified in the criteria.

Clinical Background

Bronchial thermoplasty (BT) is a device-based bronchoscopic procedure that delivers controlled radiofrequency thermal energy to airway walls with the goal of reducing airway smooth muscle mass and the bronchoconstrictor response in patients with severe persistent asthma. The procedure is performed using the Alair Bronchial Thermoplasty System, which was cleared by the U.S. Food and Drug Administration in April 2010 for adults age 18 years and older whose asthma is not controlled with inhaled corticosteroids and long-acting beta agonists. Treatment is typically administered over three outpatient bronchoscopic sessions, treating airways approximately 3–10 mm in diameter, and involves approximately 60–100 energy activations per patient depending on anatomy and patient size.

Definitions and Device Information

Bronchial Thermoplasty (BT)

DefinitionBronchial Thermoplasty (BT) is a device-based bronchoscopic procedure that applies controlled, low‑power temperature‑controlled radiofrequency (RF) energy to airway walls to reduce airway smooth muscle mass and bronchoconstrictor response.

Treatment targetAll visible and reachable airways 3–10 mm in diameter distal to the main stem bronchi are treated using contiguous RF activations.

Procedure setting and sedationPerformed under conscious sedation in an outpatient setting; procedure duration is typically 30–45 minutes per session.

Treatment courseAdministered in three outpatient bronchoscopic sessions approximately 3 weeks apart, treating different lung regions each session (one lower lobe, second lower lobe, then both upper lobes).

Delivery methodAn RF catheter with an expandable electrode array is passed through a flexible bronchoscope; each 10‑second activation delivers RF energy over ~5 mm, with repositioning to treat adjacent airway segments per a mapped plan.

Alair Bronchial Thermoplasty System

Device componentsThe Alair Bronchial Thermoplasty System comprises the Alair RF catheter with an expandable electrode array on the tip and the Alair RF controller that supplies temperature‑controlled RF energy.

Mechanism of actionThe controller delivers low‑power, temperature‑controlled RF thermal energy via the catheter to heat airway walls and selectively reduce excess airway smooth muscle.

Deployment and operationThe catheter is deployed through a compatible flexible bronchoscope under direct vision; the electrode array is expanded to contact the airway wall and activations are triggered by a footswitch for ~10 seconds per activation.

Anatomic reach and activation detailsDesigned to treat airways down to 3 mm in diameter; a single activation delivers RF energy over approximately 5 mm, with typically 60–100 activations per patient depending on airway size and anatomy.

FDA/regulatory contextThe Alair System (Asthmatx) is described in the document as the first device designed to use RF to selectively reduce airway smooth muscle; (regulatory clearance details in policy stats: FDA‑cleared April 2010).

OpenPayer

Clinical Review Criteria — Bronchial Thermoplasty for Treatment of Severe Bronchial Asthma

Coverage Determination and Clinical Criteria

Billing and Code Status

Prior Authorization, Documentation, and Provider Guidance

Clinical Background

Definitions and Device Information

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.