Currentcare_continuumPolicy n05666

Endobronchial Valves for the Treatment of Severe Emphysema

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Defines medical necessity, coverage, limitations, and coding guidance for use of the Zephyr® endobronchial valve system to treat severe emphysema for Network Health lines of business, including Medicare Advantage members.

Policy Summary

Payercare_continuum

PolicyEndobronchial Valves for the Treatment of Severe Emphysema

Policy CodePolicy n05666

Change TypeRemoved upper age limit (material)

Effective DateJan 11, 2020

Last ReviewJun 18, 2026

Next Review DateJun 19, 2027

Key ActionObtain prior authorization and document all medical necessity criteria, including Chartis assessment and pulmonary rehabilitation completion.

SourceLink

POLICY UPDATE CHANGES

Removed the upper age limit.

10criteria listed

>=40min age (yrs)

15%-45%FEV1 range

4 mosmoking abstinence

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Currentcare_continuumPolicy n05666

Endobronchial Valves for the Treatment of Severe Emphysema

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Policy Summary

Payercare_continuum

PolicyEndobronchial Valves for the Treatment of Severe Emphysema

Policy CodePolicy n05666

Change TypeRemoved upper age limit (material)

Effective DateJan 11, 2020

Last ReviewJun 18, 2026

Next Review DateJun 19, 2027

Key ActionObtain prior authorization and document all medical necessity criteria, including Chartis assessment and pulmonary rehabilitation completion.

SourceLink

POLICY UPDATE CHANGES

Removed the upper age limit.

10criteria listed

>=40min age (yrs)

15%-45%FEV1 range

4 mosmoking abstinence

Coverage Criteria

Initial therapy

Covered when ALL of the following are met:

Primary medical necessity criteria

Age 40 or older>=40 years
BMI less than 35 kg/m2<35 kg/m2
COPD stability: No hospitalizations as a result of a COPD exacerbation within the past 12 weeks and managed with less than 20 mg prednisone (or equivalent) daily<12 weeks; <20 mg prednisone
Smoking abstinence: Nonsmoking for four (4) months prior to initial evaluation>=4 months
Rehabilitation: Completed supervised pulmonary rehabilitation less than or equal to six (6) months prior to initial evaluation<=6 months
Vaccination: Received current influenza vaccination and pneumococcal vaccination
Pulmonary function: FEV1 between 15% and 45% of predicted value at initial evaluation15%-45% predicted
Collateral ventilation: Little or no collateral ventilation as determined using the Chartis systemChartis: little or no CV
Device(s) used must be approved by the FDA and used according to FDA labelingFDA-approved device
Contraindications absent: Absence of contraindications listed in the Coverage Limitations section
See Coverage Limitations/Exclusions

Coverage statement: Endobronchial valve placement for the treatment of severe emphysema is a covered benefit when deemed medically necessary per the criteria listed above.

Applies to Medicare Advantage members per policy

Exclusion conditions include any of the following: inability to tolerate bronchoscopic procedures; known allergy to device materials (including nitinol, nickel, titanium, or silicone); myocardial infarction within the prior 90 days or a diagnosis of congestive heart failure; two or more COPD exacerbations or two or more episodes of pneumonia within the previous 90 days; prior lung transplant, lung volume reduction surgery (LVRS), bullectomy, or lobectomy; active smoking; inability to safely discontinue anticoagulants or antiplatelet agents for 7 days; and uncontrolled pulmonary hypertension defined as systolic pulmonary arterial pressure > 45 mm Hg or evidence/history of cor pulmonale on an echocardiogram performed within the last 90 days.

Use of endobronchial valves is considered not medically necessary when any one of the exclusion conditions listed above is present. Providers should verify that none of these contraindications apply before pursuing authorization or scheduling valve placement.

Coding and Clinical Thresholds

Related CPT CodesCPT

31647	Bronchoscopy, rigid or flexible, including fluoroscopic guidance... with balloon occlusion, assessment of air leak, airway sizing, and insertion of bronchial valve(s), initial lobe.
31648	Bronchoscopy... with removal of bronchial valve(s), initial lobe.
31649	Bronchoscopy... with removal of bronchial valve(s), each additional lobe (List separately in addition to code for primary procedure).
31651	Bronchoscopy... assessment of air leak, airway sizing, and insertion of bronchial valve(s), each additional lobe (List separately in addition to code for primary procedure[s]).

inv-05: BMI

BMI thresholdBMI less than 35 kg/m2

Context in criteriaListed as criterion 2 in Initial therapy medical indications

Documentation requirementDocumentation should demonstrate BMI <35 kg/m2 at initial evaluation

inv-06: Smoking abstinence

Required abstinence periodNonsmoking for four (4) months prior to initial evaluation (>= 4 months)

Exclusion noteActive smokers are listed in exclusions and are not eligible

Documentation requirement

Provider Actions & Requirements

Prior Authorization

Prior authorization required — include listed CPT codes

Prior authorization is required for endobronchial valve placement. When requesting review, include the procedure CPT codes 31647, 31648, 31649, and 31651 on the authorization request to identify the bronchoscopy/valve procedures.

Use CPT 31647, 31648, 31649, 31651 on authorization requests.
Prior authorization per Network Health policy is required for coverage review.

Step Therapy

Pulmonary rehabilitation must be completed within 6 months

Confirm the patient completed a supervised pulmonary rehabilitation program within six (6) months prior to initial evaluation and that medical therapy has been optimized before consideration for valve placement.

Document supervised pulmonary rehabilitation completion date (≤6 months prior to evaluation).
Document optimization of medical therapy prior to consideration of endobronchial valves.

Background

Endobronchial valves (EBV) are a bronchoscopic, less-invasive alternative to lung volume reduction surgery designed to block inspiratory airflow into severely emphysematous lung segments while permitting trapped air and secretions to escape, with the goal of reducing hyperinflation and improving respiratory mechanics. Multiple valves may be implanted depending on the target lobe(s), and device use must follow FDA-approved labeling.

Definitions

inv-14: Collateral ventilation (CV)

DefinitionCollateral ventilation (CV) is airflow between lobes that can prevent target lobe collapse

Required assessment methodAssessment must be performed using the Chartis system

Candidacy requirementLittle or no collateral ventilation (no/low CV by Chartis) is required for eligibility

Role in device therapyPresence of significant CV may prevent successful target lobe occlusion and is an exclusion for valve placement

Revision History

2026-06-18annual_reviewLatest

Annual review: grammar, formatting, and references updated; removed the upper age limit (material change).

2025-02-20annual_review

Annual review: references updated; CPT/HCPCS codes reviewed and updated; added NH TPA as a covered line of business.

2024-02-15annual_review

Policy Summary

Payercare_continuum

PolicyEndobronchial Valves for the Treatment of Severe Emphysema

Policy CodePolicy n05666

Change TypeRemoved upper age limit (material)

Effective DateJan 11, 2020

Last ReviewJun 18, 2026

Next Review DateJun 19, 2027

Key ActionObtain prior authorization and document all medical necessity criteria, including Chartis assessment and pulmonary rehabilitation completion.

SourceLink

On This Page

Document smoking cessation date relative to initial evaluation

inv-07: Pulmonary rehabilitation recency

Pulmonary rehabilitation recencyCompleted supervised pulmonary rehabilitation less than or equal to six (6) months prior to initial evaluation (<= 6 months)

Requirement roleMust be completed prior to consideration of valve placement

Documentation requirementDocument completion date of supervised pulmonary rehabilitation

inv-08: Pulmonary arterial pressure

Systolic pulmonary arterial pressure thresholdSystolic PAP less than or equal to 45 mm Hg (<= 45 mm Hg)

Uncontrolled definitionUncontrolled pulmonary hypertension defined as systolic PAP greater than 45 mm Hg (>45 mm Hg) — listed as an exclusion

Assessment timeframeRecent echocardiogram within the last 90 days may document pulmonary hypertension or cor pulmonale

Documentation Required

Required documentation — items reviewers need

Provide documentation that demonstrates each medical necessity criterion is met, so the reviewer can confirm eligibility for coverage.

Age ≥ 40 years and current BMI (<35 kg/m2).
Nonsmoking status for ≥4 months prior to initial evaluation.
Date of completion of supervised pulmonary rehabilitation (≤6 months).
Influenza and pneumococcal vaccination status.
FEV1 percent predicted (15%–45%) at initial evaluation.
Chartis assessment showing little or no collateral ventilation.
Statement that device(s) to be used are FDA‑approved and will follow FDA labeling.
Relevant procedural CPT codes for the bronchoscopy/valve procedures.

Denial Risk

Common triggers for denial (exclusion criteria)

Be aware of conditions that will trigger denial; do not submit authorization if exclusion criteria are present.

Inability to tolerate bronchoscopic procedures.
Active smoking.
Myocardial infarction within 90 days or diagnosis of congestive heart failure.
Two or more COPD exacerbations or pneumonia episodes within the previous 90 days.
Prior lung transplant, LVRS, bullectomy or lobectomy.
Known allergy to device materials (nitinol, nickel, titanium, silicone).
Unable to safely discontinue anticoagulants/antiplatelet agents for 7 days.
Uncontrolled pulmonary hypertension (systolic PAP >45 mm Hg) or evidence/history of cor pulmonale.

Annual review: references updated; CPT/HCPCS codes reviewed and updated.

2023-03-16committee_approval

Minor grammatical and formatting changes and references updated; approved by Medical Policy Committee.

2022-02-17committee_approval

Minor grammatical and formatting updates, disclaimer added, references updated; approved by Medical Policy Committee.

2021-02-17administrative_update

Minor grammatical and formatting updates; CPT codes and disclaimer added; references updated; clarified stability on prednisone and vaccination definitions.

2020-02-19policy_creation

New policy created.