Bronchial Valves
Customize your policy alerts
Sign up for blue cross blue shield - louisiana Policy MA-227 alerts
Get alerted when Policy MA-227 changes without checking for updates manually.
Monitor payer policy activity
Policy governing coverage of bronchial (endobronchial/intrabronchial) valves for treatment of prolonged air leaks and for bronchoscopic lung volume reduction in adults with severe emphysema; applies to products administered or underwritten by the Health Plan.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial therapy — Emphysema (endobronchial valve placement)
Covered when ALL of the following are met
Emphysema indication
- Clinical: Medical history and physical exam consistent with emphysema; highly symptomatic despite optimal medical therapy and maximal pulmonary rehabilitation; nonsmoking >=4 months; BMI <35 kg/m2; able to tolerate procedural sedation
- Pulmonary function: FEV1 >=15% and <=45% predicted; TLC >=100% predicted; RV >=175% predicted; 6MWD >=100 m and <500 m after supervised pulmonary rehabilitation
- Imaging and collateral ventilation: High-resolution CT demonstrating hyperinflation/emphysema and intact lobar fissures (>=90% completeness) in target regions; if fissure <90% completeness on quantitative CT, absence of collateral ventilation must be confirmed with Chartis system during bronchoscopy
Initial therapy — Prolonged bronchopleural air leak
Covered when ALL of the following are met
Use of the Intrabronchial Valve System is limited to 6 weeks per prolonged air leak
Covered when evidence and selection criteria met
Evidence summary and guideline-aligned coverage considerations
Do not flatten trial limitations or adverse event risk; consider guideline-recommended multidisciplinary evaluation and optimization prior to intervention.
Based on review of the available evidence, the Health Plan considers the use of bronchial valves in all situations not explicitly described as covered to be investigational and not covered. This includes any indication or patient presentation that does not meet the specific criteria listed under the policy's covered indications.
Established contraindications include: cigarette smoking within the prior 4 months; comorbid cardiac illness that would increase surgical mortality (for example, significant coronary heart disease or heart failure with left ventricular ejection fraction <40%); BMI ≥35 kg/m2; inability to complete a 6–10 week pulmonary rehabilitation program; prior ipsilateral cardiothoracic surgery (including lung transplant, LVRS, or lobectomy); end-stage pulmonary disease as defined by severe resting hypoxemia (PaO2 <45 mmHg), hypercapnia (PaCO2 >60 mmHg), FEV1 <15% predicted, or 6-minute walk distance <100 m; large bullae >30% of either lung; and active pulmonary infection.
For patients with pulmonary air leaks, the available evidence (systematic reviews, case series, and observational studies related to the Humanitarian Device Exemption for the Spiration IBV Valve) is limited and heterogeneous. There are no comparative data with alternatives, and the evidence is considered inadequate and insufficient to determine an improvement in net health outcome. Because of these evidence gaps, a noncoverage or investigational determination may be made for air-leak indications depending on a full review of clinical context and policy criteria.
Federal and State law, and applicable contract language (including definitions and any specific contract provisions or exclusions), take precedence over this Medical Policy. These legal and contractual provisions must be considered first when determining eligibility for coverage.
Use of bronchial valves for indications or patient scenarios other than the specific covered indications outlined in this policy is considered investigational (not medically necessary) and is not covered by the Health Plan.
The evidence for bronchial valves to treat pulmonary air leaks and for some emphysema subpopulations is limited. Systematic reviews, small series, and uncontrolled cohort studies provide heterogeneous data, and randomized trials have limitations. Overall, the body of evidence is considered insufficient to determine an improvement in net health outcome for these uses, particularly in the absence of comparative data and in light of procedure-related harms described in trials.
Coding
| OAZ | FDA product code for Intrabronchial Valve System (Spiration IBV Valve) for prolonged air leaks |
| NJK | FDA product code referenced for Spiration valve system for emphysema |
| No codes | No HCPCS codes listed |
| All related diagnoses | Policy references all related ICD-10 diagnoses |
| No codes |
| All related diagnoses |
Provider Actions & Authorization
Prior authorization required — verify benefits and medical necessity
Confirm member benefits and obtain prior authorization before scheduling or performing bronchial valve procedures to verify contract coverage and that the patient meets medical necessity criteria (including pulmonary function, imaging, and rehabilitation status).
- Benefits must be available in the member's contract/certificate.
- Prior authorization is used to confirm medical necessity criteria are met (pulmonary function, imaging, rehab status, etc.).
Prior authorization for bronchoscopic valve procedures — include selection documentation
Obtain prior authorization for bronchoscopic valve placement and include documentation supporting patient selection (multidisciplinary assessment, prior pulmonary rehabilitation, imaging and physiologic testing). Anticipate use of CPT codes 31647, 31648, 31649, and 31651 to identify these services.
Prior authorization required for listed codes
Obtain prior authorization for all listed procedure codes before delivering services; do not perform these services without authorization.
- NOTICE: All codes listed on the Medical Policy require prior authorization.
Therapy optimization required before valve consideration
Document that the patient has had optimized medical therapy and maximal pulmonary rehabilitation prior to consideration of endobronchial valve therapy for emphysema.
- Medical history and exam consistent with emphysema and highly symptomatic despite optimal medical therapy and maximal pulmonary rehabilitation.
- Evidence of completion of supervised pulmonary rehabilitation prior to consideration.
Optimize noninvasive therapy before intervention
Consider bronchoscopic interventions only for patients refractory to optimized medical care and after pulmonary rehabilitation, consistent with guideline recommendations for selected patients. Ensure noninvasive optimization has been attempted before valve therapy.
- GOLD and NICE recommend considering bronchoscopic lung volume reduction only in selected patients refractory to optimized care and after pulmonary rehabilitation.
- Refer to multidisciplinary evaluation when appropriate.
Transition and authorization note
(See adjacent documentation requirements)
Required clinical documentation for emphysema indication
Provide all required clinical documentation to support emphysema indication when requesting authorization: history and physical consistent with emphysema, evidence of symptomatic disease despite optimal medical therapy, nonsmoking ≥4 months, BMI <35 kg/m2, pulmonary function tests (FEV1, TLC, RV), 6MWD after supervised pulmonary rehabilitation, high-resolution CT showing hyperinflation/emphysema and fissure completeness, and ability to tolerate procedural sedation.
- FEV1 ≥15% and ≤45% predicted; TLC ≥100% predicted; RV ≥175% predicted.
- 6MWD ≥100 m and <500 m after supervised pulmonary rehabilitation; nonsmoking ≥4 months; BMI <35 kg/m2.
- CT demonstrating intact lobar fissures ≥90% completeness or Chartis confirmation of absent collateral ventilation if fissure <90%.
Documentation required for prolonged air leak indication
For prolonged bronchopleural air leak authorization, provide documentation demonstrating a postoperative air leak not improving ≥5 days after chest tube insertion (or meeting the HDE definition) and note that Intrabronchial Valve System use is limited to 6 weeks per prolonged air leak.
- An air leak present on postoperative day 7 is considered prolonged unless only during forced exhalation or cough; consider treatment on day 5 if continuous, present during normal inhalation, or present on normal expiration with subcutaneous emphysema or respiratory compromise.
- Use of the Intrabronchial Valve System is limited to 6 weeks per prolonged air leak.
Recommended documentation — multidisciplinary assessment for emphysema candidates
Include recommended documentation of multidisciplinary team assessment for emphysema candidates per NICE guidance: evidence of multidisciplinary evaluation, prior pulmonary rehabilitation, assessment of collateral ventilation, and CT imaging demonstrating emphysema and hyperinflation.
- NICE recommends patient selection by a multidisciplinary team including chest physician, radiologist, thoracic surgeon, and respiratory nurse.
- Document prior pulmonary rehabilitation and assessment of collateral ventilation (Chartis or quantitative CT fissure analysis).
Authorization transition — accept prior authorizations for 90-day transfer period
If a member moves from another health plan, provide documentation of the prior authorization from the previous plan to request that Blue Advantage honor the authorization for the same service during a 90-day transition period; the prior authorization must be provided by the member or provider and the service must be covered under the Blue Advantage benefit.
- Blue Advantage may honor a prior authorization from the previous health plan for a 90-day transition period if documentation is provided.
- The services must otherwise be covered under the Blue Advantage plan.
Benefit and medical necessity — confirm contract coverage and criteria
Confirm that benefits are available in the member's contract/certificate and that all medical necessity criteria in the policy are met before seeking coverage. Lack of contract benefits or failure to meet medical necessity will preclude coverage.
- Coverage requires both available benefits and fulfillment of the policy's medical necessity criteria and guidelines.
Prior authorization required — all listed codes
All codes listed in this policy require prior authorization; obtain authorization prior to providing services to ensure appropriate utilization and alignment with clinical guidelines.
- NOTICE: All codes listed on the Medical Policy require prior authorization.
Background
Bronchial valves are one-way endobronchial devices placed bronchoscopically into airways supplying diseased lung regions. They permit air and secretions to exit the target region on exhalation while limiting inspiratory airflow into that region, promoting regional volume reduction and collapse. Valves are used for closure of prolonged bronchopleural air leaks and for bronchoscopic lung volume reduction in selected patients with severe emphysema and little or no collateral ventilation, with candidate selection informed by CT assessment of fissure completeness or physiologic assessment (e.g., the Chartis system).
Definitions
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.