Bronchial (Endobronchial) Valves — Coverage and Medical Necessity
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This policy governs coverage and medical necessity criteria for bronchial (endobronchial) valves for treatment of severe emphysema with hyperinflation and addresses use for prolonged air leaks; it applies to Medicare Advantage and Commercial products of the payer.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Endobronchial valves for severe emphysema (medical necessity)
Covered when ALL of the following are met:
Primary eligibility
- Physiologic measures: FEV1 between 15% and 45%FEV1 15%-45%
Supported by trial eligibility and policy criteria
- Functional capacity: 6-minute walk distance (6MWD) >100 and <500 m6MWD >100 and <500 m
Policy uses >100 and <500 m; pivotal trials used <450 m
- Age between 40 and 75 years40-75 years
- Collateral ventilation: Little to no collateral ventilation as determined using the Chartis System and quantitative lung CT analysis
Collateral ventilation assessment required for selection
- Smoking status: Abstained from cigarette smoking for 4 consecutive months prior to initial evaluation and throughout the evaluation for the procedure4 months abstinence
Exclusion list per policy
Initial therapy for severe emphysema
Covered when ALL of the following are met:
Consistent with eligibility used in pivotal RCTs (LIBERATE, TRANSFORM, IMPACT)
Trial inclusion criteria
Used in pivotal randomized trials
Required for selection in RCTs and practice
Pulmonary air leaks
Not sufficiently supported / investigational when used for:
Evidence insufficient to demonstrate improved net health outcome
Bronchial valves are not covered / not medically necessary for uses outside the specified emphysema coverage criteria. This includes treatment of prolonged bronchopleural air leaks and other scenarios that do not meet the policy’s specified eligibility requirements, because there is insufficient evidence demonstrating an improvement in net health outcome for those indications.
Available evidence for use of bronchial valves to treat pulmonary air leaks consists of systematic reviews, case series, and a prospective cohort related to a Humanitarian Device Exemption; there are no comparative data with alternatives. Because of the limited and noncomparative nature of the evidence, the impact on overall survival, symptoms, function, quality of life, and treatment‑related morbidity is uncertain, and the evidence is insufficient to demonstrate improved net health outcome for pulmonary air leaks.
Use of bronchial valves for prolonged air leaks or for clinical scenarios that do not meet the policy’s emphysema coverage criteria is considered not covered / not medically necessary. Providers should anticipate denials for these indications unless documentation demonstrates the patient meets the specific medical necessity criteria described elsewhere in this policy.
Because the literature on bronchial valves for pulmonary air leaks lacks randomized or other comparative studies and is limited to observational series and registry/cohort reports, use of valves in this context is considered investigational / of insufficient evidence to support routine coverage and may be deemed not medically necessary.
Coding and Key Clinical Thresholds
| 31647 | Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with balloon occlusion, when performed, assessment of air leak, airway sizing, and insertion of bronchial valve(s), initial lobe |
Prior Authorization, Documentation, and Billing Guidance
Prior authorization required
Prior authorization must be obtained for Medicare Advantage members; for Commercial products prior authorization is recommended and should be submitted via the payer's online tool for participating providers.
Prior authorization documentation and policy reference
Prior authorization may be required per the payer's Prior Authorization of Services, Treatments or Procedures policy; submit supporting clinical documentation as described in the policy (including eligibility criteria and clinical measures).
- Follow the payer's Prior Authorization of Services, Treatments or Procedures policy when requesting authorization
- Include the clinical documentation elements outlined in the policy
Conservative therapy prerequisite
Document that the patient has not responded to adequate medical therapy before valve placement, including trials of pulmonary rehabilitation, oxygen supplementation, and optimal medication management.
- Record evidence of completed pulmonary rehabilitation
- Document ongoing oxygen therapy if applicable
- Detail prior medication optimization and lack of adequate response
Confirm optimal medical management before device
Ensure the medical record shows the patient received optimal medical management — including maximum pulmonary rehabilitation — prior to considering bronchial valve placement.
- Document completion and intensity of pulmonary rehabilitation
- Note other elements of optimal medical management tried prior to referral
Prior authorization submission method
Submit prior authorization for Medicare Advantage and consider prior authorization for Commercial members via the payer's online tool for participating providers.
- Use the online prior authorization tool identified by the payer
- Attach required clinical documentation described in the policy
Required clinical documentation
Provide clinical documentation that the patient has severe emphysema with hyperinflation, has trialed optimal medical management including maximal pulmonary rehabilitation, has FEV1 within the eligible range, limited to no collateral ventilation, and appropriate 6MWD.
- FEV1 between 15% and 45%
- 6-minute walk distance as specified by the applicable criteria (policy lists >100 and <500 m; pivotal RCTs used <450 m)
- Assessment of collateral ventilation by Chartis or quantitative CT fissure analysis
- Documentation of smoking abstinence (4 consecutive months prior to evaluation and during evaluation)
Procedure documentation and CPT coding
When billing, include procedure details consistent with CPT 31647: bronchoscopy with balloon occlusion when performed, assessment of air leak, airway sizing, and insertion of bronchial valve(s) for the initial lobe.
- Report CPT code 31647 for the initial lobe procedure
- Document procedural steps: balloon occlusion (if performed), air leak assessment, airway sizing, and valve insertion
Non-covered indications (prolonged air leaks)
Do not bill or expect coverage for bronchial valve procedures performed for prolonged air leaks or other scenarios that do not meet the emphysema criteria; such uses are considered not covered or not medically necessary.
- Procedures for treatment of prolonged air leaks are not covered per the policy
- Ensure indication matches the covered severe emphysema criteria before proceeding
Adverse events and documentation risk
Be aware that adverse events (pneumothorax, infection, or need for valve removal) and insufficient or missing documentation of device appropriateness or monitoring plans can lead to claim denials or noncoverage.
- Document monitoring plans and awareness of post-procedure risks (pneumothorax, infection, potential valve removal)
- Include registry submission or follow-up data when available to support outcomes
Background and Clinical Context
Bronchial valves are endobronchial devices placed bronchoscopically to block inspiratory airflow into targeted diseased lung regions while permitting egress during exhalation. They have been evaluated both as a method of bronchoscopic lung volume reduction for selected patients with severe emphysema and hyperinflation (particularly when there is little to no collateral ventilation) and as a technique to seal prolonged pulmonary air leaks. Randomized controlled trials and regulatory approvals support use in carefully selected emphysema patients, whereas evidence for treating air leaks is limited and noncomparative, raising concerns about adverse events such as pneumothorax, infection, and need for valve removal.
Definitions and Devices
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