CurrentRegencePolicy 184

Bronchial Valves

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Coverage of bronchial valve placement, removal, replacement, and revision for severe emphysema, including medical necessity requirements for providers.

Policy Summary

PayerRegence

PolicyBronchial Valves

Policy CodePolicy 184

Change TypeNo material change

Effective DateJuly 1, 2026

Last ReviewMay 1, 2026

Next Review DateMarch 1, 2027

Key ActionSubmit clinical records and test results supporting all medical necessity criteria for review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

40+Minimum age

<35Maximum BMI

100–500 mWalking distance

15%–45%FEV1 range

≥175%Residual volume

Investigational

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CurrentRegencePolicy 184

Bronchial Valves

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Sign up for regence Policy 184 alerts

Get alerted when Policy 184 changes without checking for updates manually.

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Coverage of bronchial valve placement, removal, replacement, and revision for severe emphysema, including medical necessity requirements for providers.

Policy Summary

PayerRegence

PolicyBronchial Valves

Policy CodePolicy 184

Change TypeNo material change

Effective DateJuly 1, 2026

Last ReviewMay 1, 2026

Next Review DateMarch 1, 2027

Key ActionSubmit clinical records and test results supporting all medical necessity criteria for review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

40+Minimum age

<35Maximum BMI

100–500 mWalking distance

15%–45%FEV1 range

≥175%Residual volume

Investigational

Medical Necessity and Coverage Criteria

Initial therapy for severe emphysema

Bronchial valve treatment for severe emphysema may be considered medically necessary when ALL of the following are met.

Initial bronchial valve placement for severe emphysema

FDA approval and patient characteristics: The valve is FDA-approved, specifically the Zephyr Endobronchial Valve System or Spiration Valve System; the individual is age 40 years or older; and BMI is less than 35 kg/m².Age ≥40 years; BMI <35 kg/m²
Preprocedure clinical requirements: The individual completed pulmonary rehabilitation before valve placement; does not smoke cigarettes or has documented abstinence from cigarette smoking for at least four consecutive months before and throughout evaluation; and has little or no collateral ventilation as determined by Chartis or SeleCT.Smoking abstinence ≥4 consecutive months when applicable
Pulmonary function and exercise requirements: TLC is greater than 100% predicted, 6MWD is at least 100 m and less than 500 m, and RV is at least 175% predicted.TLC >100% predicted; 6MWD ≥100 m and <500 m; RV ≥175% predicted
Prior surgery exclusion criteria: The individual has not had a prior lung transplant, lung volume reduction surgery, ipsilateral bullectomy, or lobectomy.None of the listed prior procedures
HRCT requirements: HRCT obtained within 90 days of screening shows no large bullae encompassing more than 30% of either lung, target-lobe emphysema destruction of at least 40%, and at least a 10% disease-severity difference between the targeted lobe and the ipsilateral lobe in heterogeneous emphysema.HRCT within 90 days; bullae ≤30%; target-lobe destruction ≥40%; severity difference ≥10%
Gas exchange and medication stability: Post-bronchodilator FEV1 is 15% to 45% predicted; PaCO2 is less than 60 mmHg and PaO2 is greater than 45 mmHg on room air; and the individual is stable on less than 20 mg daily prednisone or equivalent.FEV1 15%-45% predicted; PaCO2 <60 mmHg; PaO2 >45 mmHg; prednisone <20 mg/day
Cardiovascular safety requirements: Within 90 days of screening, echocardiogram, right heart catheterization, and/or electrocardiogram documents no uncontrolled pulmonary hypertension, LVEF less than 45%, evidence or history of cor pulmonale, congestive heart failure, or resting bradycardia less than 50 beats/min.Pulmonary artery systolic pressure ≤45 mm Hg; LVEF ≥45%; heart rate ≥50 beats/min

Removal, replacement, or revision

Removal, replacement, or revision may be considered medically necessary.

Removal, replacement, or revision of bronchial valve: The valve is an FDA-approved Zephyr Endobronchial Valve System or Spiration Valve System and was previously placed for treatment of emphysema.FDA-approved system previously placed for emphysema

Investigational indications

Bronchial valve use is investigational for all other indications.

Investigational uses

Emphysema with unmet criteria: The requirements of Criterion I are not met.
Air-leak treatment: Bronchial valve is used to treat an air leak.

Advanced emphysema placement

FDA-approved endobronchial valve placement may be considered medically necessary when policy criteria are met.

Medically necessary bronchial valve treatment: Treatment is for advanced emphysema and uses an FDA-approved endobronchial valve.Policy criteria must be met

The specific clinical criteria are stated in the severe-emphysema criteria above.

Revision, replacement, or removal

After valve placement, revision, replacement, or removal may be considered medically necessary when clinically appropriate.

Post-placement valve management: Revision or replacement may be needed for proper device functioning, or removal may be appropriate when the individual's condition has changed.Existing FDA-approved endobronchial valve

Investigational or noncovered placement

Bronchial valve placement is investigational for indications other than severe emphysema when policy criteria are met.

Investigational or noncovered placement: Placement is for treatment of air leaks or for emphysema when policy criteria are not met.Any indication other than qualifying severe emphysema

These uses are considered investigational.

For initial bronchial valve placement, the individual must have no prior lung transplant, lung volume reduction surgery, ipsilateral bullectomy, or lobectomy.

HRCT obtained within 90 days of screening must show no large bullae encompassing more than 30% of either lung.

The cardiovascular evaluation, completed within 90 days of screening by echocardiogram, right heart catheterization, and/or electrocardiogram, must show no contraindication, including uncontrolled pulmonary hypertension with systolic pulmonary artery pressure greater than 45 mm Hg, LVEF less than 45%, evidence or history of cor pulmonale, congestive heart failure, or resting bradycardia below 50 beats per minute.

Bronchial valve placement is investigational for indications other than severe emphysema when all policy criteria are met. This includes treatment of air leaks and treatment of emphysema when the required policy criteria are not met.

Coding and Clinical Thresholds

FDA Product Codemixed

NJK	FDA product code for endobronchial valve systems

CPT CodesCPT

31647	Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with balloon occlusion, when performed, assessment of air leak, airway sizing, and insertion of bronchial valve(s), initial lobe
31649	Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with removal of bronchial valve(s), initial lobe

Age

Minimum age≥40 years

Body mass index

Maximum BMI<35 kg/m²

Total lung capacity

Required TLC>100% predicted

Six-minute walking distance

Required 6MWD

Documentation and Review Requirements

Prior Authorization

Submit clinical documentation for review

Clinical documentation supporting the medical necessity criteria is required for review. Submit the records and test results specified in the Required Documentation section.

Documentation Required

Document that all criteria are met

Submit medical records, including history and physical examination or chart notes, documenting that all requirements in Criterion I are met.

Documentation Required

Provide a recent high-resolution CT

Submit high-resolution CT results obtained within 90 days of screening. The results must document the required imaging subcriteria, including the absence of large bullae and the required target-lobe emphysema findings.

Clinical Background

Bronchial valves are synthetic, one-way devices placed bronchoscopically in the ventilatory airways to control airflow. In severe emphysema, they are intended to reduce the volume of a diseased lobe or produce atelectasis, which may improve hyperinflation and functional lung capacity. Because collateral ventilation can prevent the intended lobar volume reduction, assessment with systems such as Chartis, SeleCT, or CT fissure analysis may be used to identify appropriate candidates.

Terms and Clinical Concepts

Bronchial valves

DefinitionSynthetic devices deployed with bronchoscopy into ventilatory airways of the lung to control airflow.

Collateral ventilation

DefinitionAirflow through pathways that bypass the normal bronchial airways; its presence may prevent lobar volume reduction or atelectasis after valve placement.

Chartis system

DefinitionBronchoscopic assessment system using a balloon-tipped catheter and console to evaluate expiratory airflow, pressure, and resistance after airway occlusion.

CT-fissure analysis

Policy Summary

PayerRegence

PolicyBronchial Valves

Policy CodePolicy 184

Change TypeNo material change

Effective DateJuly 1, 2026

Last ReviewMay 1, 2026

Next Review DateMarch 1, 2027

Key ActionSubmit clinical records and test results supporting all medical necessity criteria for review.

SourceLink

On This Page

Residual volume

Minimum RV≥175% predicted

Emphysema destruction in target lobe

Target-lobe destruction≥40% emphysema destruction

Heterogeneous emphysema severity difference

Minimum severity difference≥10% between the targeted lobe and the ipsilateral lobe

Post-bronchodilator FEV1

Required FEV115%-45% predicted

PaCO2

Maximum PaCO2<60 mmHg on room air

PaO2

Minimum PaO2>45 mmHg on room air

Prednisone dose

Maximum daily dose<20 mg daily prednisone or equivalent

Pulmonary artery systolic pressure

Pressure thresholdPulmonary artery systolic pressure ≤45 mm Hg; uncontrolled pulmonary hypertension is defined as >45 mm Hg

Left ventricular ejection fraction

Minimum LVEF≥45%

Resting heart rate

Minimum resting heart rate≥50 beats/min

HRCT timing

Required timingHRCT obtained within 90 days of screening

Large bullae

ExclusionLarge bullae must be absent; no bullae may encompass >30% of either lung

FEV1 improvement minimal important difference

Minimal important difference>100 mL improvement in FEV1

Residual-volume reduction minimal important difference

Minimal important difference>430 mL reduction in residual volume

Six-minute walk test improvement minimal important difference

Minimal important difference>26 m improvement on the six-minute walk test

Severe emphysema study eligibility

Study eligibility thresholdFEV1 ≤45% predicted

Target-lobe volume reduction minimal clinically important difference

Minimal clinically important difference>563 mL target-lobe volume reduction

Documentation Required

Document cardiovascular safety

Submit echocardiogram, right heart catheterization, and/or electrocardiogram results documenting that the cardiovascular contraindication subcriteria are met. The evaluation must be completed within 90 days of screening.

Documentation Required

Identify the valve system

Document the type of bronchial valve system to be used, such as the FDA-approved Zephyr Endobronchial Valve System or Spiration Valve System.

Denial Risk

Avoid investigational indications

Bronchial valve use is investigational for all other indications, including treatment of air leaks and treatment of emphysema when Criterion I is not met.

Do not submit air-leak treatment as a covered indication.
Confirm that all severe-emphysema medical necessity criteria are met before requesting coverage.

Denial Risk

Verify every medical necessity criterion

Coverage may be denied when the individual does not meet any required medical necessity condition. Required conditions include age, BMI, pulmonary rehabilitation, smoking status, collateral ventilation, pulmonary function, imaging, exercise capacity, prior surgery, blood gas, prednisone stability, and cardiovascular safety requirements.

Denial Risk

Prevent documentation-related delays or denial

Missing clinical records or required test results may affect the review and decision outcome. Submit the medical records, high-resolution CT results, cardiovascular test results, and valve-system information required for review.

Denial Risk

Confirm the indication is covered

Bronchial valve placement is considered investigational for indications other than severe emphysema when policy criteria are met, including treatment of air leaks or treatment of emphysema when policy criteria are not met.

DefinitionCT-based analysis used to assess fissure completeness and support assessment of collateral ventilation.

i-BODE index

DefinitionComposite disease-severity measure consisting of the incremental shuttle walk test, body mass index, FEV1, and Medical Research Council dyspnea score; scored from 0 to 10, with higher scores indicating greater severity.

Alpha-1 antitrypsin deficiency

DefinitionRare hereditary cause of chronic obstructive pulmonary disease and emphysema associated with deficient alpha-1 antitrypsin levels.