Lung Denervation Therapy and Lung Volume Reduction Surgery
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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.
No material clinical or coverage changes in this revision.
Medical Necessity and Coverage Criteria
Lung Volume Reduction Surgery (LVRS) — Medical necessity
Covered when ALL of the following selection criteria are met
Based on National Emphysema Treatment Trial
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 for death after LVRS
These patients have higher mortality and little functional improvement
Presence of any one item excludes candidacy
FDA‑approved endobronchial valve — Medical necessity
Covered when ALL of the following are met
Device indication and patient selection per FDA labeling and trial-based selection
Bullectomy — Medical necessity
Covered when ALL of the following are met
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
Derived from Zoumot 2015, GOLD statement, and trial protocols
Efficacy and safety findings
Evidence summary of outcomes by technique
Deslee et al 2016
Liu 2015; Zoumot 2015; device trials
Systematic reviews and trial data
Device-based BLVR medical necessity
Covered when ALL of the following are met
NICE and guideline recommendations for multidisciplinary selection
Device success depends on collateral ventilation status
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
Study entry criteria from single‑arm and RCT reports
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:
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:
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)
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
| 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 |
| 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] |
| 88740 | Hemoglobin, quantitative, transcutaneous, per day; carboxyhemoglobin |
| 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 |
| 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 |
| HDE (Humanitarian Device Exemption) | Regulatory status noted for IBV valve system approval for prolonged air leaks |
| FDA devices | Zephyr Endobronchial Valve (approved June 29, 2018); Spiration Valve System (approved Dec 3, 2018) |
| No codes listed |
Authorization, Documentation, and Operational Guidance
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
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.
- 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)
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 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
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
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
Not applicable in this excerpt
Not applicable — no additional action specified in this excerpt.
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
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)
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
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
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
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
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
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
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
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
Policy Revision History
Policy last reviewed on 03/16/2023 and confirmed current; next scheduled review set for 02/08/2024.
Policy effective date established as 05/19/1997.
Next policy review scheduled for 02/08/2024.
AIRFLOW-3 pivotal trial for targeted lung denervation (planned enrollment 400) described in background evidence summaries, indicating ongoing evaluation of TLD effectiveness.
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