Prior authorization / coverage stance

Aetna designates bronchial thermoplasty (BT) as experimental and investigational for the treatment of asthma and other indications because its effectiveness has not been established. As a result, coverage may be denied consistent with this policy designation.

• BT is considered experimental/investigational by Aetna for asthma and other indications.
• Designation may lead to claim denial or requirement for exception review.

Registry/Study participation or specialty‑center justification

Major international guidelines (ERS/ATS, GINA, and others) strongly recommend that BT be performed only in the context of an Institutional Review Board–approved independent registry or clinical study. Authorization decisions should recognize guideline guidance favoring registry/study participation.

• Guidelines recommend use only within IRB‑approved registries or clinical studies.
• Clinicians and centers should document enrollment or justify participation in a specialty-center study or registry.

Specialist center and patient‑selection documentation recommended

The procedure should be performed only in specialist centers by clinicians trained in BT and experienced in managing severe asthma, with multidisciplinary governance and on‑site access to intensive care. Documentation of patient selection and specialist evaluation is recommended for any authorization or utilization review.

• Multi‑disciplinary team in specialist center with on‑site intensive care required.
• Clinician must have training/experience in BT and severe asthma management.
• Document rationale for selecting the patient for BT, including specialist referral.

Prior authorization: specialist evaluation and evidence of maximal inhaled therapy

Prior to consideration of BT, patients should have specialist evaluation confirming severe persistent asthma that remains uncontrolled despite optimized medical therapy (for example, high‑dose inhaled corticosteroid plus long‑acting beta‑agonist and other appropriate controller therapy). For some phenotypes, BT is considered after failure of optimized pharmacologic therapy (including trials of biologics where indicated) and before initiation of maintenance oral corticosteroids in selected pathways.

• Confirm adult patient (≥18 years) with severe persistent asthma not controlled with optimized inhaled therapy.
• Document trials of high‑dose ICS + LABA (and other controllers/biologics when appropriate) and ongoing symptoms/exacerbations.
• State whether BT is being considered as alternative after biologic therapy failure for relevant phenotypes.

Experimental/Investigational denial risk

BT carries denial risk because Aetna classifies it as experimental/investigational. Even in cases where guideline contexts suggest limited use, authorization is not guaranteed.

• Aetna’s experimental/investigational designation is an explicit ground for non‑coverage.
• Guideline endorsement for registry‑based use does not override payer non‑coverage determinations.

Contraindications / Denial Triggers

Contraindications and common denial triggers that should be documented and assessed include active respiratory infection, asthma exacerbation at time of planned treatment, coagulopathy, recent changes to corticosteroid regimen (within 14 days), presence of pacemaker or implantable electronic device, known sensitivities to lidocaine, atropine, or benzodiazepines, and other exclusions used in clinical trials (e.g., frequent chest infections, bronchiectasis, low baseline FEV1 in some studies).

• Active respiratory infection or current asthma exacerbation — exclude.
• Coagulopathy or recent anticoagulation — exclude.
• Pacemaker, implantable cardioverter defibrillator, or other implantable electronic devices — contraindicated.
• Known sensitivities to lidocaine, atropine, or benzodiazepines — contraindicated.
• Recent corticosteroid regimen changes within 14 days prior to planned treatment — contraindicated.

Guidelines recommend BT only in the context of IRB‑approved registry/clinical study

Guidelines emphasize caution in patient selection and recommend BT only in adults and only within IRB‑approved registries or clinical studies to accumulate long‑term safety and effectiveness data. This guideline‑recommended context may influence authorization decisions and payers may require registry/study participation or strong specialty‑center justification.

• Recommendation: perform BT in adults only in context of IRB‑approved registry or clinical study.
• Caution recommended for patients with chronic sinus disease, frequent chest infections, or low FEV1 included in guideline exclusions.
• Authorization requests should address guideline recommendations and provide supporting documentation.

Procedure should only be done in specialist centers

Procedure should only be performed by trained clinicians in specialist centers with multidisciplinary oversight and on‑site intensive care access. Appropriate training and experience should be documented.

• Specialist center with multidisciplinary team and ICU access required.
• Document clinician training and experience with BT.
• Centers should have governance, consent, and audit processes in place.

Authorization and step‑therapy administrative notes

While guidelines and some registries support registry‑based use, there are no explicit Aetna prior authorization or step‑therapy requirements specified in this policy text. Providers should include complete documentation to facilitate authorization review.

• No explicit prior authorization criteria or step‑therapy sequence are specified in the policy text.
• No step‑therapy requirements are specified here; authorization decisions will be handled per payer process and experimental/investigational designation.
• Providers should supply full clinical documentation to support any authorization requests.

Procedure documentation & coding

Include detailed procedural and coding documentation with any claim or authorization request. Relevant CPT codes include 31660 (bronchoscopy with bronchial thermoplasty, 1 lobe) and 31661 (2 or more lobes). Provide bronchoscopy details, number of lobes treated, dates of each session, anesthesia/sedation, and any intra‑ or post‑procedural complications.

• Report CPT 31660 (1 lobe) or 31661 (2+ lobes) as applicable.
• Include bronchoscopy details (procedure dates, number of sessions — typically three, lobes treated).
• Document anesthesia/sedation, conscious sedation vs general anesthesia, and peri‑procedural events.

Suggested Clinical Documentation

Suggested clinical documentation to accompany requests or registry entry includes baseline spirometry (FEV1, FVC), bronchodilator responsiveness, AQLQ and ACT scores, medication history (including doses of ICS, LABA, OCS, biologics), history of exacerbations/hospitalizations/ED visits in prior 12 months, comorbidities, and rationale for BT selection.

• Baseline FEV1, FVC, and bronchodilator reversibility.
• AQLQ and ACT scores at baseline.
• Medication history and doses (high‑dose ICS, LABA, other controllers, biologics, maintenance OCS).
• History of severe exacerbations, ED visits, and hospitalizations in prior 12 months.
• Rationale for choosing BT (failed optimized therapy, phenotype considerations, specialist assessment).

Histologic and clinical follow‑up data collection

When available, histologic and immunohistochemical follow‑up data (airway smooth muscle mass, collagen deposition) and clinical outcomes should be collected and submitted to registries or included in follow‑up reports to support ongoing evaluation of BT safety and effectiveness.

• Collect histologic data where clinically obtained (airway biopsy results showing ASM changes) and summarize findings.
• Collect and report clinical follow‑up: exacerbation rates, hospitalizations, ED visits, spirometry, medication changes, AQLQ/ACT.

Clinicians should enter details of all patients into registries

Clinicians should enter details of all patients undergoing BT into established registries (for example, the UK Severe Asthma Registry or other IRB‑approved registries) when feasible, and document consent, patient selection criteria, and outcomes to support surveillance and future authorization considerations.

• Registry entry: baseline characteristics, consent, ACT/AQLQ, medications, FEV1/FVC, 12‑month baseline exacerbation/utilization data.
• Document long‑term outcomes and any adverse events in registry submissions.

Administrative notes and policy links

This portion of the policy includes administrative notes and links for review history, effective date, and additional information. Providers should consult the policy history and additional information sections for updates and payer‑specific administrative procedures.

• Effective date: 2008‑02‑08; Next review noted in policy header.
• Administrative links and clinical policy bulletin notes available for providers.