Endobronchial valves for treatment of severe emphysema
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Clinical medical policy governing medical necessity determinations for placement of endobronchial valves (Zephyr®) to treat severe emphysema for Network Health Plan members (Commercial and Medicare). Affects Utilization Management coordinators and providers requesting coverage for EBV procedures.
The upper age limit was removed; policy now allows endobronchial valve coverage for anyone aged 40 and above.
Annual review completed and references and CPT/HCPCS codes were reviewed/updated.
Coverage Criteria for Endobronchial Valves
Initial coverage criteria
Covered when ALL of the following are met
Upper age limit removed; previously 40-75
Selection should align with guideline-supported indications (e.g., GOLD, NICE)
Policy references the Zephyr Endobronchial Valve System as the device used for treatment
UMC-RN to follow policy guidance; documentation should support diagnosis and selection versus alternatives (e.g., LVRS)
Coverage determinations under this policy are subject to the terms of the member's benefit plan and applicable law. Contractual plan language and state or federal laws take precedence over this medical policy. Network Health coverage documents (for example, Certificates of Coverage, Evidence of Coverage, and Summary Plan Descriptions) define the specific contractual terms that apply to a given member and will be considered first when determining eligibility and benefits.
Procedures that do not meet the selection criteria set forth in this policy, or for which appropriate clinical documentation is not provided to support medical necessity, are considered not medically necessary and may be denied. Prior authorization and utilization management determinations will rely on the documented evidence of severe emphysema and patient selection consistent with guideline-supported indications and device information; absence of such documentation increases the risk of denial.
Billing and Coding
| No codes listed |
Provider Actions and Authorization
Prior authorization required
Prior authorization is required and is managed by Utilization Management; determinations of medical necessity for endobronchial valve placement must follow this policy and supporting clinical evidence and be obtained by the provider before the procedure is scheduled.
Consider LVRS and guideline-supported alternatives
Evaluate patients for guideline-supported alternatives and surgical candidacy prior to EBV placement; specifically consider lung volume reduction surgery (LVRS) candidacy and major guideline recommendations when selecting therapy.
- Consider LVRS versus bronchoscopic lung volume reduction as part of patient selection.
- Use guideline recommendations (GOLD, NICE) to inform alternative treatments and candidacy.
Provide clinical documentation supporting EBV
Clinical documentation submitted with the authorization request must support a diagnosis of severe emphysema and patient selection consistent with cited clinical guidance and the FDA Summary of Safety and Effectiveness Data for the Zephyr valve.
- Clinical evidence of severe emphysema and rationale that EBV is preferred over LVRS for this patient.
- Relevant guideline support (e.g., GOLD, NICE) or literature cited in the medical record to justify selection.
- Reference to FDA SSED for the Zephyr endobronchial valve system as device-specific support.
Denial risk if criteria or documentation are unmet
Requests that do not meet the policy's medical necessity criteria or lack required documentation may be denied by Utilization Management.
- Lack of documentation demonstrating severe emphysema or failure to document consideration of alternatives increases risk of denial.
- Failure to obtain prior authorization as required may result in denial of coverage.
Background
Endobronchial valves (e.g., Zephyr®) are bronchoscopically implanted, one-way valves intended to produce lung volume reduction in patients with severe emphysema as a less invasive alternative to lung volume reduction surgery (LVRS). The valve permits air and secretions to exit the targeted emphysematous lung segments but prevents air entry, thereby reducing hyperinflation and improving respiratory mechanics. Major guidelines (GOLD, NICE) support the use of endobronchial valves for appropriately selected patients, and the Zephyr system has received FDA clearance.
Definitions
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