Bronchial Valves (Endobronchial Valve Therapy) Coverage Criteria
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Policy governing coverage and prior authorization for endobronchial bronchial valves (e.g., Zephyr Valve System) for treatment of severe emphysema with hyperinflation and guidance on noncoverage for other uses such as prolonged air leaks; applies to Medicare Advantage and Commercial products of the payer.
No material clinical or coverage changes in this revision.
Coverage Criteria
Coverage for severe emphysema with hyperinflation (Medicare Advantage and Commercial)
Covered when ALL of the following are met:
Reference to trial inclusion criteria and GOLD staging
Trials often used <450 m as eligibility
Chartis requires bronchoscopy; CT used as surrogate
Severe hypoxemia: PaO2 <45 mmHg on room air; Severe hypercapnia: PaCO2 >60 mmHg on room air
Initial Therapy - Severe Emphysema
Covered when ALL of the following are met
Derived from pivotal RCT inclusion criteria and policy rationale; providers should consider risks such as pneumothorax and infection
Indication - Prolonged Postoperative Air Leak (Spiration IBV)
Covered when ALL of the following are met
Use of the Intrabronchial Valve System is limited to 6 weeks for prolonged air leak per FDA HDE indication
Bronchial valves are not covered / not medically necessary when used for indications other than treatment of severe emphysema with hyperinflation that meet the policy's selection criteria. Specifically, use of bronchial valves for management of prolonged bronchopleural air leaks and other non‑specified scenarios is considered not covered because the evidence is insufficient to demonstrate an improvement in net health outcome.
Bronchoscopic valve placement is contraindicated or not appropriate in patients who are suboptimal candidates for anesthesia or who have contraindications to bronchoscopy. The evidence and expert guidance emphasize careful patient selection and the use of specific exclusion criteria to identify suboptimal candidates prior to considering endobronchial valve therapy.
Placement of bronchial valves for prolonged postoperative or bronchopleural air leaks is generally described as not covered / not medically necessary outside of the limited Spiration IBV regulatory indication; the policy cites insufficient evidence for routine treatment of prolonged air leaks and notes that the Spiration IBV indication is time‑limited. Where used under the specific IBV indication, valve duration is limited (see device‑specific guidance).
Placement of endobronchial valves in patients who do not meet the policy's documented selection criteria is not covered / not medically necessary. The policy highlights that trials and guidelines define explicit selection and exclusion criteria and that patients with anatomy or clinical features making benefit unlikely (for example, significant collateral ventilation or other anatomic limitations) should not undergo valve placement.
Coding
| 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 |
Provider Actions & Documentation
Prior authorization required (Medicare Advantage); recommended for Commercial
Prior authorization is required for Medicare Advantage plans and recommended for Commercial products; submit authorization requests via the payer's online tool for participating providers.
Prior authorization and medically necessary coding (CPT 31647)
Prior authorization is referenced via the related Prior Authorization policy; CPT 31647 may be considered medically necessary when the medical criteria in this policy are met.
- CPT 31647: "Bronchoscopy, rigid or flexible... insertion of bronchial valve(s), initial lobe"
Document prior failure of adequate medical therapy
Documented failure to respond to adequate medical therapy is required before considering endobronchial valves; this includes pulmonary rehabilitation, oxygen supplementation, and optimal medication management.
- Must have undergone pulmonary rehabilitation
- Must have tried oxygen supplementation if indicated
- Must have optimized medication management
Expect pre-procedure optimization including maximal pulmonary rehabilitation
Patients are expected to have undergone optimal medical management, including maximal pulmonary rehabilitation, prior to bronchial valve placement.
- Maximal pulmonary rehabilitation should have been attempted as part of optimization
Submit prior authorization and documentation via online tool
Prior authorization is required for Medicare Advantage and recommended for Commercial products; use the payer's online tool for submitting requests and associated documentation.
Provide required clinical documentation to support medical criteria
Documentation must support the diagnosis of severe emphysema with hyperinflation and show evidence of prior optimal medical management, objective measures (FEV1 15%–45%, 6MWD thresholds), and assessment of collateral ventilation (e.g., Chartis or quantitative CT).
- FEV1 between 15% and 45% predicted
- 6-minute walk distance within policy-specified range (refer to policy thresholds)
- Evidence of little to no collateral ventilation (Chartis or CT)
- Records of pulmonary rehabilitation and smoking abstinence
Noncovered indications — prolonged air leaks and other scenarios outside criteria
Bronchial valves are not covered or are not medically necessary for indications outside the specified criteria, including for the treatment of prolonged air leaks where evidence is insufficient.
- Requests for valve placement for prolonged air leaks may be denied as not covered for Medicare Advantage and Commercial products
Coverage is documentation-dependent — missing evidence may trigger denial for CPT 31647
Lack of documentation showing that the medical criteria are met (e.g., absence of evidence for prior medical therapy, FEV1/6MWD thresholds, or collateral ventilation assessment) may result in denial of coverage for CPT 31647.
- Denial risk if FEV1, 6MWD, smoking abstinence, or collateral ventilation assessment are not documented
- Denial risk if evidence of adequate trial of maximal medical management is missing
Background
Bronchial valves are synthetic, bronchoscopically deployed one‑way valves that are closed on inhalation to limit air entry to diseased lung regions and open on exhalation to allow air to escape. Their mechanism aims to isolate and collapse (reduce volume of) targeted hyperinflated lobes or to occlude airways feeding persistent air leaks, thereby improving respiratory mechanics or controlling postoperative air leaks. The Zephyr valve received FDA approval in 2018 for treatment of severe emphysema with hyperinflation, and device selection and success depend on assessment of interlobar collateral ventilation (eg, Chartis or CT fissure analysis).
Definitions
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