CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy | Bronchial Valves

Policy governing medical coverage and criteria for use of endobronchial/bronchial valves (e.g., Zephyr, Spiration) for treatment of severe emphysema with hyperinflation and for prolonged pulmonary air leaks for members of Medicare Advantage Plans and Commercial Products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy | Bronchial Valves

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionPrior authorization is required for Medicare Advantage Plans and recommended for Commercial Products via the online tool for participating providers.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

15%-45%Required FEV1 range

>100 and <500 mRequired 6MWD

40-75Age range

31647Procedure code listed

Spiration IBV HDE; Zephyr FDARegulatory approvals

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

Initial Therapy (Severe Emphysema)

Covered when ALL of the following are met:

Conservative therapy prerequisite: Patient has not responded to adequate medical therapy including pulmonary rehabilitation, oxygen supplementation, and optimal medication management

Chunk 2

Lung function: FEV1 between 15% and 45% predicted15%-45%

Chunk 2

Exercise capacity: 6-minute walk distance (6MWD) >100 and <500 meters>100 and <500 m

Chunk 2

Age 40-75 years40-75 years

Chunk 2

Collateral ventilation assessment: Little to no collateral ventilation as determined using the Chartis System and quantitative lung CT analysis

Chunks 2,11

Smoking abstinence: Abstained from cigarette smoking for 4 consecutive months prior to initial evaluation and throughout evaluation for the procedure4 months

Chunk 2

Exclusion conditions absent: Does not have any of the following: history of bronchiectasis; current or history of liver disease; prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy; heart attack or decompensated congestive heart failure within the last 6 months; unstable/uncontrolled ischemic heart disease or unstable/uncontrolled arrhythmia; allergy to nickel, titanium, or silicone; active pulmonary infection; large bullae encompassing greater than 30% of either lung; severe hypoxemia (e.g., PaO2 <45 mmHg on room air) or severe hypercapnia (e.g., PaCO2 >60 mmHg on room air)

Chunk 2

Prolonged Air Leaks

Position on treatment of prolonged air leaks:

Prolonged air leaks stance: Although the Spiration IBV Valve has an FDA Humanitarian Device Exemption for controlling prolonged air leaks (use limited to 6 weeks), bronchial valves are considered not covered/not medically necessary for treatment of prolonged air leaks by this payer due to insufficient evidence of improvement in net health outcome

Chunks 3,4,15,11

The policy explicitly excludes members with certain clinical histories or conditions from coverage for bronchial valve placement. Specifically, coverage is not provided for individuals with a history of bronchiectasis; current or prior liver disease; prior lung transplant, lung volume reduction surgery (LVRS), bullectomy or lobectomy; a myocardial infarction or decompensated congestive heart failure within the prior 6 months; unstable or uncontrolled ischemic heart disease or arrhythmia; allergy to nickel, titanium, or silicone; active pulmonary infection; large bullae involving >30% of either lung; or severe gas exchange abnormalities such as PaO2 <45 mmHg on room air or PaCO2 >60 mmHg on room air.

For both Medicare Advantage Plans and Commercial Products, bronchial valves are not covered for the treatment of prolonged pulmonary air leaks. The policy states these uses are considered outside covered indications because there is insufficient evidence that valve placement in those scenarios improves net health outcomes.

This policy does not replace member-specific benefit determinations. Eligibility and benefits are governed by the member's subscriber agreement or employer agreement, which supersede the provisions of this medical policy. For member-specific coverage questions, contact the provider call center.

Use of bronchial valves for prolonged air leaks or for other clinical scenarios that do not meet the specified emphysema criteria is considered not medically necessary by this payer because of insufficient evidence demonstrating a net health benefit.

When services are determined to be not medically necessary or otherwise non‑covered, the member may only be billed if they were informed in advance and provided written agreement to proceed at their own expense. This policy itself does not guarantee payment; benefit and eligibility determinations remain based on the member’s contract.

Coding

Covered CPT CodesCPTCovered

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

inv-09: 6-Minute Walk Distance (6MWD) — required range for coverage

Required 6MWD range>100 and <500 meters

Context for use6MWD is part of initial therapy criteria for endobronchial valves in severe emphysema; must be within the specified range to be considered medically necessary

Measurement relevanceUsed to assess exercise capacity and suitability for bronchoscopic lung volume reduction

inv-10: FEV1 — required percent predicted range for coverage

Required FEV1 range15% - 45% predicted

Clinical roleFEV1 is used to define lung function eligibility for endobronchial valve placement for severe emphysema

Severity mappingCorresponds to GOLD severe-to-very severe airflow limitation categories as referenced in disease staging

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Medicare Advantage plans and is recommended for Commercial products. Participating providers should submit authorization requests via the payer's online prior authorization tool. See the Related Policies section for the Prior Authorization of Services, Treatments or Procedures policy.

Applies to: Medicare Advantage (required); Commercial (recommended)
Submit via: BCBSRI online prior authorization portal for participating providers

Note

Payment and Eligibility Notice

This policy does not guarantee payment. Benefits and eligibility are determined by the member's subscriber agreement, member certificate, or employer agreement — those documents supersede this policy. For member-specific benefits, contact the provider call center prior to scheduling or performing services.

Verify member-specific benefits and eligibility with the provider call center before rendering services
Member documents and employer agreements take precedence over this policy

Billing Rule

Member Financial Responsibility When NMN or Non‑Covered

If services are determined to be not medically necessary (NMN) or are otherwise non-covered under the member's benefit plan, the provider may not bill the member unless the member has been informed in advance and has agreed in writing to accept financial responsibility for the services. Refer to your participation agreement(s) for applicable provisions.

Billing the member for NMN or non-covered services is permitted only with prior written member consent
Review participation agreement for additional billing rules

Documentation Required

Required Clinical Documentation

Documentation must support that the clinical criteria are met prior to authorization and at the time of request. Essential documentation includes objective measurements and procedural correspondence.

Pulmonary function testing with FEV1 demonstrating 15%–45%
6-minute walk distance (6MWD) >100 and <500 meters
Evidence of failed/intolerant conservative therapy (pulmonary rehabilitation, oxygen supplementation, optimal medical management)
Assessment of collateral ventilation (Chartis System and quantitative lung CT analysis) and documentation of absence or minimal collateral ventilation
Age documented between 40 and 75 years
Smoking cessation documentation: abstinent from cigarette smoking for 4 consecutive months prior to evaluation
Operative/procedure planning notes and correspondence supporting target lobe selection and procedural indication

Denial Risk

Non‑Coverage Triggers

Bronchial valves are not covered when used in scenarios outside the specified medical criteria (for example, treatment of prolonged air leaks). Services provided outside coverage criteria may be denied.

Non‑coverage examples: treatment of prolonged air leaks
Denial risk if criteria such as FEV1, 6MWD, absence of significant collateral ventilation, or conservative therapy prerequisites are not met

Note

Eligibility and Benefits

Contact the provider call center for questions about eligibility, benefits, or prior authorization status. Member agreements or employer contracts may supersede this policy; always confirm member-specific coverage before scheduling procedures.

Call the BCBSRI provider call center for member-specific benefit verification and prior authorization status
Member subscriber agreements and employer contracts supersede this policy

Definitions

inv-20: Collateral ventilation — definition and clinical relevance (prevents lobar collapse after valve placement)

DefinitionCollateral ventilation are alternate airflow pathways that bypass normal bronchial airways and can prevent lobar collapse after valve placement

Assessment methodsDetermined using the Chartis System and quantitative lung CT fissure analysis (per coverage criteria)

Clinical relevancePresence of collateral ventilation reduces effectiveness of endobronchial valves by preventing target lobe atelectasis and is a key exclusion for valve therapy

inv-21: Prolonged air leak — definition (air leak present on postoperative day 7; day 5 may be considered) and treatment considerations

DefinitionProlonged air leak: an air leak present on postoperative day 7 is considered prolonged

Earlier-treatment considerationAn air leak on postoperative day 5 may be considered for treatment if continuous, present during normal inspiration, or present on normal expiration with subcutaneous emphysema or respiratory compromise

Treatment considerationsSpiration IBV Valve HDE allows use for controlling prolonged air leaks (limited to 6 weeks); valves may be placed and subsequently removed by bronchoscopy

inv-22: Endobronchial valve systems — examples (Zephyr, Spiration, IBV) and intended uses

Examples of systemsZephyr, Spiration (IBV), Intrabronchial Valve (IBV) systems

Intended usesOne-way bronchoscopically placed valves intended to reduce hyperinflation in emphysema and to control or treat prolonged pulmonary air leaks

Regulatory notesSpiration IBV received FDA HDE approval for prolonged air leaks (2008); Zephyr and Spiration have FDA approvals for emphysema indications (2018)

OpenPayer

Medical Coverage Policy | Bronchial Valves

Coverage Criteria

Coding

Provider Actions & Requirements

Background

Definitions