CurrentAetnaPolicy 0160

Lung Denervation Therapy and Lung Volume Reduction Surgery

Medical necessity and coverage criteria for lung denervation therapy, lung volume reduction surgery (LVRS), bullectomy, and FDA‑approved endobronchial valves for members with emphysema or related conditions; governs Aetna benefit determinations for covered members.

Policy Summary

PayerAetna

PolicyLung Denervation Therapy and Lung Volume Reduction Surgery

Policy CodePolicy 0160

Change TypeNo material change

Effective DateMay 19, 1997

Next Review DateFeb 8, 2024

Key ActionObtain prior authorization documenting patient selection criteria, imaging and pulmonary function results, and evidence of optimized medical therapy before requesting coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≤45%FEV1 threshold

≥150%RV threshold

>140 m6MWD threshold

1,218NETT patients cited

TLDListed investigational

03/16/2023

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.

Medical Necessity and Coverage Criteria

Lung Volume Reduction Surgery (LVRS) — Medical necessity

Covered when ALL of the following selection criteria are met

General candidate requirements: Member has severe emphysema with disabling dyspnea; history and physical examination consistent with emphysema; has not smoked for 4 or more months; if cardiac ejection fraction <45%, no history of congestive heart failure or myocardial infarction within 6 months of consideration for surgery

Based on National Emphysema Treatment Trial

Pre-operative work-up findings (ALL required): CT scan evidence of bilateral emphysema; FEV1 (maximum of pre- and post-bronchodilator values) ≤ 45% predicted (if aged ≥70 years, FEV1 ≥ 15% predicted); plasma cotinine ≤ 13.7 ng/ml (if not using nicotine) or carboxyhemoglobin ≤ 2.5% (if using nicotine); post-bronchodilator TLC ≥ 100% predicted; RV ≥ 150% predicted; resting PaCO2 ≤ 60 mm Hg on room air; resting PaO2 ≥ 45 mm Hg; six-minute walk test > 140 metersSee each parameter

All items required on pre-operative work-up

Contraindications and exclusion criteria for LVRS

LVRS should NOT be performed if any of the following contraindications or exclusions are present

High-risk physiologic contraindications: Post-bronchodilator FEV1 ≤ 20% predicted with either DLCO ≤ 20% predicted or homogeneous emphysema on CT

High risk for death after LVRS

Emphysema distribution and workload risk: Predominantly non‑upper‑lobe emphysema AND a high maximal workload (defined here as >40th percentile: >25 W for women or >40 W for men on specified cycle ergometry protocol)

These patients have higher mortality and little functional improvement

Other exclusion conditions (any one excludes): Alpha‑1 antitrypsin deficiency; clinically significant bronchiectasis; systemic disease or neoplasia expected to limit survival; giant bulla (>1/3 lung volume in involved lung); history of recurrent infections with clinically significant sputum production; oxygen requirement >6 L/min at rest to maintain SpO2 ≥90%; pleural or interstitial disease precluding surgery; prior lobectomy; prior LVRS (laser or excision); pulmonary hypertension (mean PAP ≥35 mm Hg or peak systolic PAP ≥45 mm Hg); pulmonary nodule requiring surgery; resting bradycardia <50 bpm, frequent multifocal PVCs, complex ventricular arrhythmia or sustained SVT; uncontrolled hypertension (SBP >200 or DBP >110); unplanned weight loss >10% within 3 monthsSee individual items

Presence of any one item excludes candidacy

FDA‑approved endobronchial valve — Medical necessity

Covered when ALL of the following are met

Valve candidacy: Adult patient with hyperinflation associated with severe emphysema in regions that have little to no collateral ventilation; treatment with an FDA‑approved endobronchial valve (eg, Zephyr or Spiration) per device indication

Device indication and patient selection per FDA labeling and trial-based selection

Bullectomy — Medical necessity

Covered when ALL of the following are met

Bullectomy candidacy: Dyspneic patients with giant bullous emphysema who have a single large bulla producing significant respiratory compromise and FEV1 < 50% predicted; video‑assisted thoracoscopic (VATS) blebectomy/bullectomy is considered medically necessary for prevention of recurrent pneumothorax

Single large bulla producing significant compromise; other indications considered investigational

Selection criteria associated with trial-based benefit

BLVR (including EBV) may produce benefit in selected patients; trials used specific selection criteria

Trial‑based selection: Key randomized trials required: heterogeneous emphysema distribution with an identified target lobe; intact inter‑lobar fissures or physiologic absence of collateral ventilation; significant gas trapping (TLC > 100% predicted and RV > 150% predicted); MMRC dyspnea score ≥ 3; 6‑minute walk distance < 450 m; optimized medical therapy and non‑smoking statussee node text

Derived from Zoumot 2015, GOLD statement, and trial protocols

Efficacy and safety findings

Evidence summary of outcomes by technique

Nitinol coils: Randomized trial showed higher proportion achieving ≥54 m improvement in 6MWD at 6 months (36% coils vs 18% usual care); modest FEV1 gains and QOL changes reported; high short‑term costs and uncertain durability (incremental cost‑effectiveness ratio ~$782,598 per QALY)6‑month outcomes reported

Deslee et al 2016

Endobronchial valves (EBV): Meta‑analysis of 3 RCTs (565 patients) demonstrated increases in FEV1% and improvements in SGRQ and dyspnea; prospective trial selecting patients with intact fissures and heterogeneity showed significant FEV1 and volume reduction benefits but higher rates of pneumothorax and other thoracic SAEsFEV1 and SGRQ WMDs reported

Liu 2015; Zoumot 2015; device trials

Biologic sealants and other BLVR techniques: AeriSeal and other biologic approaches showed variable FEV1 and QOL improvements in limited RCTs but with increased adverse events; airway bypass stents did not demonstrate significant benefit in larger trials

Device-based BLVR medical necessity

Covered when ALL of the following are met

Selection and baseline requirements: Patient has severe emphysema with significant hyperinflation refractory to optimized medical therapy including pulmonary rehabilitation; multidisciplinary team selection documented (eg, chest physician, radiologist, thoracic surgeon, respiratory nurse)

NICE and guideline recommendations for multidisciplinary selection

Anatomic/physiologic suitability: Target lobe identified with appropriate emphysema distribution per device indication and assessment demonstrating absent or acceptable collateral ventilation when required for the chosen device (eg, fissure integrity or physiologic testing)

Device success depends on collateral ventilation status

Device‑specific contraindications excluded: No active lung infection; no allergy to device materials (eg, nitinol, nickel, titanium, silicone per device labeling); patient is not an active smoker; patient can tolerate bronchoscopy; prior major lung procedures and comorbidities considered per device labeling

Contraindications per FDA labeling (Zephyr, Spiration) and trial protocols

Bronchoscopic Thermal Vapor Ablation (BTVA) criteria

Covered when ALL of the following are met for BTVA

BTVA candidate criteria: Upper‑lobe predominant emphysema; prior pulmonary rehabilitation; age approximately 40–75 years in selected studies; FEV1 generally in the ~15%–45% predicted range (study‑dependent); heterogeneity index ≥ 1.2 and target segment selection aided by software; other physiologic thresholds (eg, RV and DLCO) considered per study protocols

Study entry criteria from single‑arm and RCT reports

Monitoring and setting: Procedure performed in settings with capability for deep sedation or general anesthesia and close post‑procedure monitoring for inflammatory reactions and complications

NICE recommends use in research context until more data available

TLD investigational / trial inclusion criteria (evidence summary)

TLD has been studied under trial‑specific inclusion criteria; evidence supports safety signals but efficacy requires larger trials. Trial criteria included the following ALL requirements:

TLD trial inclusion: Patients met all of: FEV1/FVC < 0.7; post‑bronchodilator FEV1 30% to 60% predicted; symptomatic disease (mMRC ≥2 or CAT ≥10); exacerbation history as specified in pivotal trials (eg, ≥2 moderate or ≥1 severe exacerbation in prior year for AIRFLOW‑3)FEV1 30%–60% predicted; CAT ≥10; mMRC ≥2

These reflect enrollment criteria from AIRFLOW trials and related studies

Use of PGA patch with bullectomy (evidence summary)

PGA patch use during bullectomy was associated with improvements on several surgical endpoints in meta-analysis when compared with non‑PGA bullectomy:

PGA patch benefits (meta‑analysis): Meta‑analysis (8 studies, 1,095 patients) reported lower rates of post‑operative recurrence and prolonged air leaks, and shorter time to chest tube removal with PGA patch compared with non‑PGA bullectomystatistical significance reported in meta‑analysis

Authors cautioned limitations of included studies and need for higher‑quality RCTs

Experimental and investigational procedures — Not covered

The following procedures are considered experimental and investigational (effectiveness not established)

Listed experimental/investigational procedures: Thoracoscopic laser bullectomy for diffuse emphysema; thoracoscopic bullectomy via trans‑areolar approach for spontaneous pneumothorax; bronchoscopic thermal vapor ablation (BTVA); other bronchoscopic lung volume reduction procedures including biologic lung volume reduction (BLVR/Aeris); airway bypass stents; targeted lung denervation (dNerva Lung Denervation System); and other bronchoscopic interventions not FDA‑approved for emphysema

These approaches are considered experimental/investigational per policy

Targeted lung denervation (the dNerva Lung Denervation System) and the other bronchoscopic lung volume reduction techniques listed in this policy (including bronchoscopic thermal vapor ablation and other BLVR approaches) are classified as experimental and investigational because their effectiveness for the treatment of COPD/emphysema has not been established in the peer‑reviewed literature. These procedures are not considered standard coverage outside of research settings or clearly defined trial protocols.

The Umbrella Implantable IntraBronchial Valve (IBV) system has received FDA clearance via a Humanitarian Device Exemption (HDE) specifically for controlling prolonged air leaks following lung resection. Its use for treatment of emphysema has not been FDA‑approved, remains under investigation in the U.S., and therefore is considered investigational for emphysema indications.

Device labeling and guidance identify several exclusion factors that should preclude device-based bronchoscopic therapies: active lung infection, allergy to device materials (for example, nitinol, nickel, titanium, or silicone in valve devices), active smoking, and inability to tolerate the bronchoscopic procedure. These contraindications must be excluded when documenting candidacy for bronchoscopic lung volume reduction.

Systematic reviews and expert commentaries note that the current evidence base for targeted lung denervation (TLD) is limited. Available randomized data are small and subject to design limitations, and reviewers have concluded the level of evidence is too low to incorporate TLD into therapeutic COPD guidelines. As a result, TLD remains an investigational option outside of clinical trials.

Medicare guidance historically states that lung volume reduction surgery (reduction pneumoplasty) for emphysema and COPD is not generally covered (Medicare Coverage Issues Manual §35‑93), reflecting long‑standing payer caution about broad coverage for LVRS outside specific selection criteria.

Lung volume reduction surgery (LVRS), bullectomy, and bronchoscopic procedures performed for indications other than those explicitly listed as medically necessary in this policy are considered experimental and investigational and therefore not medically necessary for those unlisted indications.

Bronchoscopic lung volume reduction (BLVR) techniques remain in the experimental phase in the U.S.; the evidence does not currently support routine coverage for general use. Patient selection, technique, and longer‑term outcomes are still being defined, and routine coverage is not supported outside of clinical trials or well‑defined selection criteria.

The National Institute for Health and Care Excellence (NICE) indicates that bronchoscopic thermal vapor ablation (BTVA) has inadequate evidence in quantity and quality and recommends that BTVA should only be used in the context of research. Routine use outside research settings is not supported by that guidance.

Available evidence across novel bronchoscopic and denervation procedures is limited by small sample sizes, short follow‑up windows, and study designs with crossover or lack of sham controls. These limitations reduce confidence in durability of benefit and in the net balance of benefits and harms for outcomes such as lung function, exacerbation rates, and quality of life.

Codes and Clinical Thresholds

Covered CPT Codes (when selection criteria met)CPTCovered

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
31648	with removal of bronchial valve(s), initial lobe
31649	with removal of bronchial valve(s), each additional lobe (list separately in addition to code for primary procedure)
31651	with balloon occlusion, when performed, 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])
32141	Thoracotomy major; with excision-plication of bullae, with or without any pleural procedure
32491	Removal of lung, other than total pneumonectomy; excision-plication of emphysematous lung(s) (bullous or non-bullous) for lung volume reduction, sternal split or transthoracic approach, with or without any pleural procedure
32655	Thoracoscopy, surgical; with excision-plication of bullae, including any pleural procedure [Video-assisted thoracoscopic (VATS) blebectomy/bullectomy]
32672	Thoracoscopy, surgical; with resection-plication for emphysematous lung (bullous or non-bullous) for lung volume reduction (LVRS), unilateral includes any pleural procedure, when performed

CPT Codes listed (experimental/investigational in policy)CPTExperimental

0781T	Bronchoscopy, rigid or flexible, with insertion of esophageal protection device and circumferential radiofrequency destruction of the pulmonary nerves, including fluoroscopic guidance when performed; bilateral mainstem bronchi [Targeted lung denervation]
0782T	Unilateral mainstem bronchus [Targeted lung denervation]

Related CPT CodesCPT

88740

Hemoglobin, quantitative, transcutaneous, per day; carboxyhemoglobin

Covered HCPCS Codes for perioperative servicesHCPCSCovered

G0302	Preoperative pulmonary surgery services for preparation for LVRS, complete course of services, to include a minimum of 16 days of services
G0303	Preoperative pulmonary surgery services for preparation for LVRS, 10 to 15 days of services
G0304	Preoperative pulmonary surgery services for preparation for LVRS, 1 to 9 days of services
G0305	Post discharge pulmonary surgery services after LVRS, minimum of 6 days of services

ICD-10 Codes (covered and not covered groups mixed as listed)ICD-10

J43.0 - J43.9	Emphysema [except due to alpha-1-antitrypsin deficiency]
J93.81 - J93.9	Other pneumothorax and air leak
E88.01	Alpha-1-antitrypsin deficiency
I27.0 - I27.2	Other pulmonary heart diseases
I47.1	Supraventricular tachycardia
J44.0 - J44.9	Chronic obstructive pulmonary disease
J93.11	Primary spontaneous pneumothorax
R00.1	Bradycardia, unspecified

Regulatory status / device codesmixed

HDE (Humanitarian Device Exemption)

Regulatory status noted for IBV valve system approval for prolonged air leaks

Regulatory-approved devicesmixed

FDA devices

Zephyr Endobronchial Valve (approved June 29, 2018); Spiration Valve System (approved Dec 3, 2018)

No explicit codes in this excerptmixed

No codes listed

FEV1 threshold — clinical key value

FEV1 thresholdFEV1 ≤ 45% of predicted on pre- or post-bronchodilator testing (if age ≥70 years, FEV1 ≥ 15% predicted required)

ContextPart of LVRS pre-operative work-up selection criteria based on NETT

MeasurementUse the maximum of pre- and post-bronchodilator FEV1 values as specified

TLC threshold — clinical key value

TLC thresholdPost-bronchodilator total lung capacity (TLC) ≥ 100% of predicted

Authorization, Documentation, and Operational Guidance

Prior Authorization

Prior authorization: confirm candidate selection

Confirm prior authorization by ensuring candidate selection criteria are met before approving bronchoscopic or surgical lung volume reduction procedures. Documentation should confirm heterogeneous emphysema (or other listed imaging patterns), intact or assessed fissure integrity / absence of collateral ventilation when relevant, severity thresholds (e.g., FEV1 and hyperinflation indices), and that noninvasive optimization has been attempted.

Confirm heterogeneous emphysema on CT when indicated
Document fissure integrity or physiologic assessment of collateral ventilation
Confirm FEV1 and hyperinflation thresholds per selection criteria
Verify smoking cessation and cotinine/CO testing where required

Prior Authorization

Authorization requirements for BLVR devices

For bronchoscopic lung volume reduction (BLVR) device authorization, require documentation of symptomatic severe emphysema despite optimized medical therapy, CT characterization of target lobe(s) (heterogeneity, fissure integrity or collateral ventilation assessment), prior pulmonary rehabilitation, and multidisciplinary team evaluation. Also document device-specific contraindications (e.g., active infection, allergy to device materials, ongoing smoking) and prior therapies (prior LVRS, lobectomy) that affect candidacy.

Background and Context

Lung volume reduction surgery (LVRS) encompasses surgical excision of emphysematous lung tissue or resection of large bullae intended to improve pulmonary mechanics, gas exchange, and symptoms in selected patients with advanced emphysema. Bilateral procedures generally produce greater spirometric and exercise improvements than unilateral approaches, but benefit depends strongly on patient selection and emphysema distribution, as demonstrated in major trials.

Definitions and Terminology

LVRS — definition

DefinitionLung volume reduction surgery (LVRS): surgical excision of emphysematous lung tissue or bullae to improve pulmonary function and symptoms in advanced emphysema

TechniquesIncludes excision of large bullae by thoracotomy or thoracoscopy and resection of diffusely emphysematous lung tissue (stapled reduction, laser, etc.)

PurposeAimed at reducing hyperinflation and improving exercise capacity and quality of life in selected patients

Endobronchial valve — definition

DefinitionEndobronchial valve: a one-way bronchoscopic valve placed to prevent inspiratory airflow into a lobe and permit trapped gas to escape, designed to induce lobar atelectasis and reduce hyperinflation

MechanismOccludes inspiratory flow to hyperinflated regions while allowing trapped gas to escape, potentially reducing hyperinflation

Policy Revision History

2023-03-16policy_reviewLatest

Policy last reviewed on 03/16/2023 and confirmed current; next scheduled review set for 02/08/2024.

1997-05-19policy_effective

Policy effective date established as 05/19/1997.

2024-02-08next_review_scheduled

Policy Summary

PayerAetna

PolicyLung Denervation Therapy and Lung Volume Reduction Surgery

Policy CodePolicy 0160

Change TypeNo material change

Effective DateMay 19, 1997

Next Review DateFeb 8, 2024

Key ActionObtain prior authorization documenting patient selection criteria, imaging and pulmonary function results, and evidence of optimized medical therapy before requesting coverage.

SourceLink

On This Page

variable; evidence quality low‑to‑moderate

Systematic reviews and trial data

ContextRequired on LVRS pre-operative work-up

SignificanceIndicates hyperinflation consistent with LVRS candidacy

RV threshold — clinical key value

RV thresholdResidual volume (RV) ≥ 150% of predicted (post-bronchodilator)

ContextRequired on LVRS pre-operative work-up to document gas trapping

RelationUsed with TLC to assess hyperinflation/gas trapping

PaCO2 threshold — clinical key value

PaCO2 thresholdResting partial pressure of carbon dioxide (PaCO2) ≤ 60 mm Hg on room air

ContextRequired on LVRS pre-operative arterial blood gas assessment

PurposeEnsures acceptable ventilatory status before surgery

PaO2 threshold — clinical key value

PaO2 thresholdResting partial pressure of oxygen (PaO2) ≥ 45 mm Hg on room air

ContextRequired on LVRS pre-operative arterial blood gas assessment

PurposeDemonstrates baseline oxygenation adequate for consideration of LVRS

Six-minute walk test threshold — clinical key value

Six-minute walk test thresholdSix-minute walk distance (6MWD) > 140 meters

ContextRequired on LVRS pre-operative work-up to document exercise capacity

UsePart of NETT-based selection criteria for LVRS candidacy

Smoking abstinence verification — cotinine or carboxyhemoglobin thresholds

Cotinine thresholdPlasma cotinine ≤ 13.7 ng/ml if member is not using nicotine products

Carboxyhemoglobin thresholdCarboxyhemoglobin ≤ 2.5% if member is using nicotine products

PurposeObjective verification of smoking abstinence prior to LVRS

Gas trapping and hyperinflation thresholds — TLC >100% and RV >150% predicted

Gas trapping thresholdsTotal lung capacity (TLC) > 100% predicted; residual volume (RV) > 150% predicted

ContextUsed in trial-based selection and NETT-derived LVRS criteria to define hyperinflation/gas trapping

AssessmentTypically documented by post-bronchodilator pulmonary function testing and CT characterization

Dyspnea and exercise thresholds — MMRC ≥3; 6MWD <450 m

Dyspnea thresholdModified Medical Research Council (mMRC) dyspnea score ≥ 3

Exercise threshold6-minute walk distance (6MWD) < 450 meters (trial selection parameter)

ContextUsed in EBV trial (Zoumot et al.) selection and other trial-based candidate criteria

FEV1 subgroup mentioned by GOLD — FEV1 15%–45% predicted

GOLD FEV1 subgroupFEV1 15%–45% predicted identified by GOLD as a subgroup in which BLVR showed modest improvements

ContextReferenced in GOLD guideline analysis of BLVR outcomes

ImplicationHelps identify patients more likely to derive modest benefit from BLVR

BTVA selection thresholds — FEV1 20–45% predicted; RV >175% predicted; DLCO ≥20% predicted; upper-lobe predominant emphysema

FEV1 range for BTVAFEV1 20%–45% predicted

Additional BTVA thresholdsRV > 175% predicted; DLCO ≥ 20% predicted; upper-lobe predominant emphysema

ContextSelection criteria described for bronchoscopic thermal vapor ablation candidates

FEV1 inclusion range — 30% to 60% predicted (trial range)

Trial inclusion FEV1 rangeFEV1 30% to 60% predicted (used in TLD pivotal/trial enrollment and other trial designs)

ContextReflects common inclusion range in TLD and other device trials (e.g., AIRFLOW studies)

UseMay inform trial-based eligibility and potential future coverage criteria

Document optimized pharmacotherapy and completed pulmonary rehabilitation
CT evidence of target lobe suitability (intact fissure or physiologic testing)
Multidisciplinary team selection (pulmonologist, thoracic surgeon, radiologist, respiratory nurse)
Device contraindications (active infection, allergy, active smoker)

Prior Authorization

Potential prior authorization criteria for TLD

Potential prior authorization criteria for Targeted Lung Denervation (TLD) should mirror pivotal-trial enrollment parameters while acknowledging evolving evidence: symptomatic COPD despite optimal therapy, airflow obstruction thresholds, and exacerbation history. Use trial-based thresholds to guide candidate selection and documentation when considering coverage.

Consider FEV1 30%–60% predicted (post-bronchodilator) and FEV1/FVC < 0.7 as enrollment-aligned thresholds
Document symptom burden (CAT ≥10 or mMRC ≥2)
Document exacerbation history (e.g., ≥2 moderate or ≥1 severe in prior 12 months)
Require documentation of optimal pharmacotherapy prior to TLD consideration

Prior Authorization

Prior authorization governed by Clinical Policy Bulletin

Prior authorization requirements and review procedures for lung volume reduction and denervation interventions are governed by this Aetna Clinical Policy Bulletin. Providers should follow the CPB for submission, required documentation, and for scheduling of medical necessity reviews and periodic policy updates.

Submit requests through Aetna prior authorization channels per the Clinical Policy Bulletin
Refer to CPB effective and next-review dates for policy currency

Prior Authorization

No separate, universal prior authorization rule is specified in these excerpts beyond the Clinical Policy Bulletin — however, individual devices/procedures (BLVR, TLD, LVRS, bullectomy) commonly require prior review and supporting documentation as described in this section.

Follow device- and procedure-specific prior authorization processes when present
Absence of an explicit standalone PA requirement in this excerpt does not preclude plan-level authorization rules

Denial Risk

Experimental procedures may be denied

Procedures that are labeled experimental or investigational in this policy (for indications not specifically listed as medically necessary) may be denied authorization. LVRS, bullectomy, and other interventions are considered investigational for indications outside the enumerated selection criteria.

LVRS considered experimental/investigational for indications not listed in the Medical Necessity section
Bullectomy experimental/investigational for indications beyond those specified

Denial Risk

Investigational status may lead to noncoverage

Because several procedures or indications remain investigational, lack of established effectiveness may lead to noncoverage. Ensure submitted documentation demonstrates that the indication aligns with the policy’s listed medically necessary criteria.

Denial risk if indication is outside listed medically necessary indications
Provide trials/evidence and patient-specific rationale when seeking approval for less-established uses

Note

Not applicable in this excerpt

Not applicable — no additional action specified in this excerpt.

Note

No step therapy requirements are specified

No specific step-therapy or explicit denial-trigger matrix is provided in the excerpt. Providers should not assume absence of authorization or denial triggers at the plan level; follow CPB and payer prior authorization workflows.

No step therapy requirements specified in these document chunks
Confirm with payer if local benefit or plan-level rules impose additional criteria

Documentation Required

Required pre-operative documentation for LVRS

Required pre-operative documentation for LVRS must demonstrate the selection criteria from the National Emphysema Treatment Trial and policy: CT evidence of bilateral emphysema, specified pulmonary function thresholds (FEV1, TLC, RV), smoking cessation verification (cotinine or CO), arterial blood gases, and six-minute walk test results.

CT scan showing bilateral emphysema
FEV1 ≤45% predicted (with older-age adjustments) and TLC ≥100% predicted, RV ≥150% predicted
Plasma cotinine ≤13.7 ng/mL or carboxyhemoglobin ≤2.5% as applicable
PaCO2 ≤60 mm Hg and PaO2 ≥45 mm Hg on room air
Six-minute walk distance >140 meters (per policy thresholds)

Documentation Required

Required pre-procedure documentation

Required pre-procedure documentation for bronchoscopic or surgical interventions should include multidisciplinary team selection notes, evidence of pulmonary rehabilitation and optimization, imaging demonstrating target anatomy, physiologic testing for collateral ventilation when relevant, and informed consent discussing risks (e.g., pneumothorax, infection).

Multidisciplinary team evaluation documented (pulmonologist, thoracic surgeon, radiologist, respiratory nurse)
Evidence of completed pulmonary rehabilitation and optimized medical therapy
CT characterization of emphysema distribution and fissure integrity or collateral ventilation testing
Device contraindications and informed consent documentation

Documentation Required

Surgical documentation (thoracoscopic bullectomy)

For thoracoscopic bullectomy (including VATS approaches), operative and perioperative documentation should include detailed operative report, approach used (e.g., VATS, trans-areolar), intraoperative findings, complications, chest drain management, length of stay, and follow-up outcomes to support medical necessity and claims processing.

Operative report with technique and findings
Hospital course and post-operative drainage/chest-tube details
Complications and follow-up visit documentation

Documentation Required

Clinical documentation (TLD)

Clinical documentation to support consideration of TLD should include baseline pulmonary function (FEV1/FVC, FEV1), symptom scores (CAT, mMRC), exacerbation history, prior optimized pharmacotherapy, and rationale for TLD referencing available trial evidence (AIRFLOW series).

Baseline spirometry with post-bronchodilator FEV1 and FEV1/FVC
Symptom scores (CAT ≥10 or mMRC ≥2)
Exacerbation history and prior-year hospitalizations for COPD
Documentation of optimal pharmacotherapy and rationale for TLD trial candidacy

Note

Supporting trial citations

Cite supporting randomized trials and pivotal studies in authorization requests when relevant: EMBEDDED evidence includes EMPROVE, REACH, REVOLENS, AIRFLOW-2, and AIRFLOW-3 design/publications, as well as landmark LVRS literature (e.g., National Emphysema Treatment Trial).

EMPROVE (Spiration Valve) and REACH trials for valve systems
REVOLENS and coil trials for nitinol coil evidence
AIRFLOW-2 and AIRFLOW-3 for TLD evidence
National Emphysema Treatment Trial and LVRS literature

Note

No documentation requirements are specified in these chunks

No additional documentation requirements are specified in these chunks beyond the pre-operative and device-specific items listed above. Providers should include all applicable clinical, imaging, and multidisciplinary team documentation when submitting prior authorization requests.

If no documentation requirement is listed here, follow CPB and payer instructions for required attachments
Include operative, imaging, pulmonary rehab, and medication optimization records as applicable

Documentation Required

Optimization before BLVR

Prior to bronchoscopic interventions, ensure noninvasive optimization (pulmonary rehabilitation, inhaled pharmacotherapy, oxygen therapy as indicated) has been attempted and documented. Optimization is a key step in candidate selection and device success.

Document pulmonary rehabilitation completion and response
Confirm optimized inhaled bronchodilator/ICS therapy per guidelines
Document supplemental oxygen use and stability if applicable

Note

Treatment sequencing considerations

Treatment sequencing should reflect imaging pattern, collateral ventilation status, and local expertise: choose bronchoscopic (valves, coils) versus surgical LVRS based on heterogeneity, fissure integrity/physiologic collateral ventilation testing, patient risk profile, and available multidisciplinary expertise.

Use CT and collateral ventilation assessment to guide bronchoscopic vs surgical approach
Consider local center proficiency and patient comorbidities in sequencing decisions
Document patient preference and multidisciplinary team rationale

UseUsed bronchoscopically as a less invasive alternative to LVRS in selected patients

Endobronchial valve (EBV) — definition

EBV (Zephyr) definitionZephyr Endobronchial Valve: a one-way silicone duckbill valve attached to a self-expanding nitinol stent retainer designed to produce lobar atelectasis

Indication statusEvaluated in trials (e.g., VENT) for heterogeneous emphysema; later received FDA approval for selected patients

CharacteristicsRemovable design allowing potential reversibility of bronchoscopic treatment

Implantable intrabronchial valve (IBV) — definition

IBV definitionImplantable intrabronchial valve (IBV): a polyurethane-membrane umbrella-shaped nitinol frame valve designed to limit distal airflow while permitting proximal clearance

Regulatory noteIBV approved under Humanitarian Device Exemption (HDE) for prolonged air leaks; investigational for emphysema indication

Design featureIncludes a proximal center rod permitting repositioning or removal

Biologic lung volume reduction (BLVR) / AeriSeal — definition

BLVR / AeriSeal definitionBiologic lung volume reduction (BLVR)/AeriSeal: bronchoscopic instillation of agents (eg, fibrin-based hydrogel) after surfactant/epithelium disruption to collapse and scar over-inflated lung regions

Procedure settingPerformed under general anesthesia in hospital with overnight stay; investigational with ongoing phase III study

GoalInduce collapse and scarring of targeted lung tissue to reduce lung volume over weeks

Endobronchial coils — definition

Endobronchial coils definitionEndobronchial coils: nitinol coils placed into parenchyma to compress diseased tissue and restore elastic recoil, aiming to reduce lung volume without reliance on collateral ventilation

MechanismCoils compress emphysematous tissue to reduce hyperinflation and improve mechanics

EvidenceStudied in pilot and randomized trials showing variable efficacy and increased adverse events profile

Airway bypass stents — definition

Airway bypass stents definitionAirway bypass stents: creation of extra-anatomic airway–parenchyma communications using stents to facilitate emptying of emphysematous regions

Target populationTargeted at patients with homogeneous emphysema and long expiratory times

EvidenceLarge trials did not show significant benefit in FEV1 or SGRQ

Collateral ventilation (CV) — definition

Collateral ventilation (CV) definitionCollateral ventilation: inter-lobar collateral airflow that may prevent lobar atelectasis after valve placement; absence of CV is associated with superior outcomes

AssessmentAssessed by fissure integrity on HRCT or physiologic endoscopic testing

RelevanceKey predictor of success for endobronchial valve therapy

Bronchoscopic thermal vapor ablation (BTVA) — definition

BTVA definitionBronchoscopic thermal vapor ablation (BTVA): delivery of heated water vapor to targeted emphysematous segments to induce inflammation and irreversible tissue/volume reduction

Procedure featuresTarget segment selection aided by software; performed under deep sedation or general anesthesia with close post-procedure monitoring

IndicationConsidered for upper-lobe–predominant emphysema; data limited and often performed in trials or registries

Targeted Lung Denervation (TLD) — definition

TLD definitionTargeted Lung Denervation (TLD): bronchoscopic circumferential radiofrequency ablation of parasympathetic nerves along the main bronchi using a dNerva catheter to reduce cholinergic-mediated airway effects

MechanismAims to decrease airway resistance, mucus hypersecretion and reflex airway hyper-responsiveness by disrupting parasympathetic input

Evidence statusStudied in randomized sham-controlled trials with promising safety signals but remains investigational pending pivotal trials (eg, AIRFLOW-3)

Polyglycolic acid (PGA) patch — definition

PGA patch definitionPolyglycolic acid (PGA) patch: a surgical patch applied to the lung at bullectomy sites intended to reduce post-operative air leaks and recurrence of pneumothorax

EvidenceMeta-analysis (8 studies, 1,095 patients) showed reduced recurrence and prolonged air leaks with PGA patch use

UseApplied during bullectomy to decrease postoperative complications

Targeted lung denervation (TLD) — alternate/expanded definition

TLD alternate definitionTargeted lung denervation (alternate): bronchoscopic radiofrequency ablation of peri-bronchial vagal nerve trunks to reduce cholinergic stimulation of airway smooth muscle and submucosal glands

ContextDescribed in exploratory reports including non-COPD indications (eg, severe asthma) with limited data

ImplicationAlternate descriptions reflect evolving applications and require further evidence for broader indications

Next policy review scheduled for 02/08/2024.

2020evidence_update

AIRFLOW-3 pivotal trial for targeted lung denervation (planned enrollment 400) described in background evidence summaries, indicating ongoing evaluation of TLD effectiveness.