Bronchial Valves
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Policy governing use of FDA‑approved bronchial (endobronchial/intrabronchial) valves for adults with emphysema-related hyperinflation and for prolonged air leaks; applies to Capital BlueCross products subject to benefit variations.
No material clinical or coverage changes in this revision.
Coverage Criteria
Coverage for emphysema-related hyperinflation
Covered when ALL of the following are met
Devices: Zephyr® and Spiration® Valve Systems for emphysema; selection requires assessment of collateral ventilation (Chartis or CT).
Societal guidance and the policy recommend multidisciplinary selection and assessment for absence of collateral ventilation prior to the procedure.
Coverage for prolonged postoperative air leaks (HDE IBV®)
Covered when ALL of the following are met
An air leak present on postoperative day 7 is considered prolonged; consider treatment on day 5 if continuous, present during normal inspiration, or present on normal expiration with subcutaneous emphysema or respiratory compromise. HDE use is limited to facilities with IRB oversight and valve use is limited to 6 weeks.
Covered with evidence-differentiated stance: Air leaks vs Emphysema
Policy stance summarized from document
No randomized controlled data; limitations include small series, heterogeneous patients, and lack of comparative groups.
Confidence tempered by study limitations (lack of blinding, wide confidence intervals).
Bronchial valves approved by the U.S. Food and Drug Administration for management of prolonged postoperative air leaks are addressed separately from valves approved for emphysema. This policy specifies that valves with FDA approval for air‑leak indications are considered not medically necessary when billed for emphysema treatment. For emphysema‑related hyperinflation, treatment with FDA‑approved valves (Zephyr® or Spiration®) is medically necessary when all coverage criteria are met, including assessment for absence of collateral ventilation and prior optimization of medical management.
The evidence for bronchial valve use to manage pulmonary air leaks consists mainly of case series and observational data, including prospective cohort data related to the Spiration IBV® HDE. The largest multicenter series (Travaline et al.) treated 40 patients: 47.5% (19/40) achieved complete resolution of the air leak and most had reductions in leak magnitude; however, these studies lacked control groups and other reports are small and heterogeneous. Because there are no comparative trials and available studies have important limitations, the evidence is judged insufficient to determine improvement in net health outcomes for air‑leak management with bronchial valves.
Any use of bronchial valves that is not explicitly described in this policy—including indications other than FDA‑approved emphysema treatment or the limited HDE pathway for prolonged postoperative air leaks—is considered investigational / not medically necessary due to insufficient evidence. Providers should confirm that the planned use matches one of the covered indications and document the applicable FDA approval or HDE oversight when submitting for coverage.
Historically, bronchial valves for air leaks were previously listed as not medically necessary in earlier policy updates. The current policy acknowledges that prior positions changed over time and now summarizes the evidence for air‑leak indications as limited; although HDE data (Spiration IBV®) and case series report favorable results in uncontrolled cohorts, the overall evidence remains inadequate to support general coverage outside of the HDE pathway with IRB oversight.
Coding and Billing
| FDA product code OAZ | Spiration IBV Valve System HDE air leaks |
| FDA product code NJK | Spiration Valve System for emphysema |
| P180007 | Spiration Valve System (premarket identifier) |
| P180002 | Zephyr Endobronchial Valve System (premarket identifier) |
| H060002 | IBV Valve System HDE (Humanitarian Device Exemption) |
| J43.0 | Unilateral pulmonary emphysema |
| J43.1 | Panlobular emphysema |
| J43.2 | Centrilobular emphysema |
| J43.8 | Other emphysema |
| J43.9 | Emphysema, unspecified |
| J93.82 | Other air leak |
Provider Actions and Requirements
Prior authorization and benefit variations may apply
This policy applies only to certain Capital BlueCross programs and products and may be subject to product-specific benefit variations; coverage and prior authorization requirements vary by product.
- Policy applicability limited to specific programs/products administered by Capital BlueCross.
Check member's plan for preauthorization
Preauthorization may be required depending on the member's specific health benefit plan; providers and members should consult the member's plan or contact Capital Blue Cross for benefit and preauthorization information.
- Verify member's benefit design and preauthorization requirements with Capital BlueCross prior to scheduling.
Preprocedure optimization and rehabilitation required
Patients considered for bronchoscopic lung volume reduction should have optimized medical management and completed pulmonary rehabilitation prior to valve consideration; multidisciplinary selection is recommended.
- Confirm failure or refractoriness to optimized medical care before proceeding.
- Document participation in pulmonary rehabilitation as recommended by guidance.
Facility/oversight and approval requirements
Ensure facility and treatment processes meet policy expectations (e.g., IRB oversight for HDE use) and obtain any required approvals before proceeding.
- For HDE IBV® use, ensure Institutional Review Board (IRB) oversight at the facility.
- Confirm device regulatory status and any product-specific requirements prior to use.
Required supporting documentation
Document the device regulatory status and, when applicable, IRB oversight for HDE use; include assessment of collateral ventilation and other clinical information supporting medical necessity.
- Document that an FDA‑approved device is being used for the indicated population or that HDE criteria are met for IBV®.
- If using an HDE device (IBV®), record IRB oversight and compliance with HDE conditions.
- Include assessment for collateral ventilation (Chartis or CT fissure analysis) in the medical record.
Coding and documentation must support medical necessity
Identification of a code in the coding section does not by itself denote coverage; clinical documentation must support medical necessity per the member's benefit plan.
- Ensure documentation clearly supports the medical necessity for the selected billing codes.
Air‑leak indication considered not medically necessary
Use of bronchial valves for air leaks when valves are FDA‑approved for air‑leak indications is considered not medically necessary under this policy and may lead to claim denial when billed for that indication.
- Do not bill bronchial valve procedures for air‑leak indications expecting coverage unless the specific HDE criteria (IBV®) under IRB oversight apply.
Member's benefit plan governs coverage and payment
Coverage is determined by the member's health benefit plan; the existence of this medical policy does not guarantee that the service is a covered benefit or payment.
- Confirm coverage, exclusions, limits, and preauthorization requirements with the member's specific plan before performing services.
Background
Emphysema is a subtype of COPD characterized by irreversible alveolar destruction leading to hyperinflation, air trapping, dyspnea, and reduced exercise capacity. Bronchial (endobronchial/intrabronchial) valves are one‑way devices placed bronchoscopically to block inspiratory airflow to targeted diseased lung regions, promoting lobar volume reduction and potentially improving respiratory mechanics. Appropriate patient selection—specifically demonstration of little or no collateral ventilation by Chartis or CT fissure analysis—and prior optimization of medical therapy and pulmonary rehabilitation are central to achieving the benefits seen in randomized trials.
Definitions
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