Description

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 for Emphysema

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.

For information regarding pulmonary rehabilitation, please refer to Pulmonary Rehabilitation Medical Coverage Policy.

Coverage Determination

Humana members may be eligible for endobronchial valve placement for the treatment of severe emphysema when the following criteria are met:

• Device is FDA approved (eg, Spiration Valve System, Zephyr Endobronchial Valve); AND
• 18 years of age or older; AND
• Absence of contraindications; AND
• 6-minute walk distance greater than 100 meters at initial evaluation; AND
• Body mass index (BMI) greater than 15 kg/m2 and less than 35 kg/m2; AND
• Diffusion capacity for carbon monoxide (DLCO) greater than 20% predicted value at initial evaluation; AND
• Forced expiratory volume (FEV1) greater than or equal to 15% and less than or equal to 45% of predicted value at initial evaluation; AND

Endobronchial Valves for Emphysema Effective Date: 08/24/2023
Revision Date: 08/24/2023
Review Date: 08/24/2023
Policy Number: HUM-0569-005
Page: 3 of 7

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• High resolution computed tomography (HRCT) obtained within the last 90 days demonstrates at least one of the following:
  1. Emphysema heterogeneity score greater than 15%; OR
  2. Large bullae encompassing less than 30% of either lung; OR
  3. Parenchymal destruction score of less than 75% in all three right lobes or both left lobes; AND
• Individual must be nicotine-free for at least 4 consecutive months prior to the date of the anticipated surgery; AND
• Individual who has been a nicotine user prior to the anticipated surgery must provide documentation of nicotine cessation, as evidenced by negative lab test report for cotinine, to have been performed within 30 days of the planned surgical procedure; AND
• Little or no collateral ventilation (CV-) as determined using the Chartis (Zephyr) or SeleCT (Spiration) systems; AND
• PaCO2 less than 55 mm Hg on room air at initial evaluation; AND
• PaO2 greater than 45 mm Hg on room air at initial evaluation; AND
• Recent completion (within 6 months of initial evaluation) of a supervised pulmonary rehabilitation program; AND
• Residual volume (RV) greater than 150% predicted at initial evaluation; AND
• Stable with 20 milligrams or less of prednisone daily; AND
• Total lung capacity (TLC) greater than or equal to 100% predicted at initial evaluation

Endobronchial Valves for Emphysema Effective Date: 08/24/2023
Revision Date: 08/24/2023
Review Date: 08/24/2023
Policy Number: HUM-0569-005
Page: 4 of 7

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Coverage Limitations

Humana members may NOT be eligible under the Plan for endobronchial valve placement for any indications other than those listed above OR if any of the following contraindications are present:

• COPD exacerbation or respiratory infection (eg, pneumonia) requiring hospitalization within last 90 days; OR
• Evidence of active pulmonary infection; OR
• Homogeneous emphysema (for Spiration valves only); OR
• Individual who is unable to tolerate bronchoscopic procedures; OR
• Known allergy to Nitinol (nickel-titanium) or its constituent metals (nickel or titanium) or known allergy to silicone; OR
• Presence of alpha-1 anti-trypsin deficiency; OR
• Prior lung transplant, LVRS, bullectomy or lobectomy; OR
• Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure greater than 50 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram (completed within the last 90 days)

This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Background

Additional information about COPD may be found from the following websites:

• American Lung Association
• National Library of Medicine

Medical Alternatives

Lung transplantation • Lung volume reduction surgery

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Humana may offer a disease management program for this condition.

Endobronchial Valves for Emphysema Effective Date: 08/24/2023
Revision Date: 08/24/2023
Review Date: 08/24/2023
Policy Number: HUM-0569-005
Page: 5 of 7

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

The member may call the number on his/her identification card to ask about our programs to help manage his/her care.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.