Humana Endobronchial Valves for Emphysema - Medicare Advantage Form
Please answer all questions to determine coverage (0 of 5)
Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals.
There are no NCDs and/or LCDs for endobronchial valves for emphysema.
Description
Endobronchial Valves for Emphysema Page: 2 of 3
Emphysema is a long-term, progressive form of chronic obstructive pulmonary disease (COPD) involving damage to the alveoli (tiny air sacs in the lungs) where oxygen and carbon dioxide exchange occurs. The lung tissue eventually loses elasticity and may hyperinflate, resulting in poor gas exchange and difficulty breathing. While emphysema is largely caused by cigarette smoking, nonsmoking individuals may also develop the condition.
Endobronchial valves (EBVs) are a less invasive alternative to lung volume reduction surgery (LVRS) in emphysema, where damaged tissue is surgically removed to make the lungs smaller allowing them to function better. EBVs are used to treat individuals with shortness of breath and hyperventilation associated with severe emphysema in regions of the lung that have evidence of little to no collateral ventilation. During the EBVs placement procedure, a bronchoscope is inserted through the mouth, passing through the larynx and trachea into the bronchial pathways. Once the scope reaches the damaged portion of the lung, a one-way valve is implanted to prevent airflow into the area while allowing trapped air and fluids to escape. Based on the condition of the lungs, multiple valves may be implanted.
Examples of these US Food & Drug Administration (FDA)-approved devices include Spiration Valve System and Zephyr Endobronchial Valve. The SeleCT system, used with the Spiration Valve System, is a quantitative computed tomography (QCT) based screening tool used to determine if an individual is eligible for valve placement. The Chartis System, used with the Zephyr Endobronchial Valve, consists of a console and catheter and provides precise flow and pressure readings to assess for presence of collateral ventilation prior to valve placement.
Coverage Determination
Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.
In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria.
Endobronchial Valves for the Treatment of Severe Emphysema
The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.
Coverage Limitations
US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage