The U.S. Food and Drug Administration (FDA)-approved bronchial valve placement devices, Zephyr® or Spiration® Valve System, will be covered effective April 1, 2022. Coverage applies to Independence Commercial and Medicare Advantage members for the treatment of severe emphysema when ALL of the following criteria are met:
- Dyspneic symptoms are poorly controlled or activities of daily living are markedly restricted despite maximal medical management
- Individual has completed a pulmonary rehabilitation program prior to valve placement
- 40 to 75 years of age
- Body mass index (BMI) is less than 35kg/m2
- Stable with ≤20mg prednisone (or equivalent) daily
- Forced expiratory volume (FEV1) between 15% and 45% of predicted value at initial evaluation
- Six-minute walking distance (6MWD) ≥100m and <500m
- There is little to no interlobar collateral ventilation as determined using the Chartis® (Zephyr) or SeleCT® (Spiration) systems
- Abstinence from cigarette smoking for 4 consecutive months prior to initial evaluation, and throughout the evaluation for the procedure.
Humanitarian device exemption
The FDA-approved IBV
® Valve System is covered in individuals for the treatment of prolonged air leaks following lobectomy, segmentectomy, or lung volume reduction surgery.
For detailed information, please read Commercial medical policy
#11.16.09: Bronchial Valves and Medicare Advantage medical policy
#MA11.020: Bronchial Valves.