Commercial

Medical Policy

Title:

Bronchial Valves

Policy #:

11.16.09

Policy

MEDICALLY NECESSARY

Bronchial valve placement with a US Food and Drug Administration (FDA)-approved (i.e., Zephyr® or Spiration® Valve System) device is considered medically necessary and, therefore, covered for the treatment of severe emphysema when ALL of the following criteria are met:

Dyspneic symptoms are poorly controlled or activities of daily living are markedly restricted despite maximal medical management
The indivicual has completed a pulmonary rehabilitation program prior to valve placement
Age 40 to 75 years
Body mass index (BMI) is less than 35 kg/m²
Stable with ≤20 mg prednisone (or equivalent) daily
Forced expiratory volume (FEV₁) between 15% and 45% of predicted value at initial evaluation
6-minute walking distance (6MWD) ≥100 m and <500 m
There is little to no interlobar collateral ventilation as determined using the Chartis (Zephyr) or SeleCT (Spiration) systems
The individual has abstained from cigarette smoking for 4 consecutive months prior to initial evaluation, and throughout the evaluation for the procedure

EXPERIMENTAL/INVESTIGATIONAL

Bronchial valves are considered experimental/investigational and, therefore, not covered in all other situations for the treatment of emphysema, including but not limited to individuals:

who do not meet medical necessity criteria described above
who have previously undergone ipsilateral lung volume reductive surgery or lung/lobar transplant
in whom bronchoscopic procedures are contraindicated
with evidence of active pulmonary infection
with known allergies to Nitinol (nickel-titanium) or its constituent metals (nickel or titanium) or silicone
with large bullae encompassing greater than 30% of either lung
with diffuse homogenous emphysema

HUMANITARIAN DEVICE EXEMPTION (HDE)

IBV® Valve System is covered for the following FDA-approved HDE indications in individuals:

For the treatment of prolonged air leaks following lobectomy, segmentectomy, or lung volume reduction surgery.

The use of IBV® Valve System for any other indication is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of those uses cannot be established by review of the available published peer-reviewed literature.

An HDE may only be used in facilities that have an institutional review board (IRB) to oversee the clinical application of such devices. The IRB must approve the application of the device to ensure that it will be used in accordance with the FDA-approved indication(s). In addition, documentation of IRB approval may be requested by the Company to ensure compliance with the HDE indication(s).

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports.

BILLING REQUIREMENTS

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

Guidelines

BENEFIT APPLICATION

MANDATES

This policy is consistent with applicable state mandates. The laws of the state where the group benefit contract is issued determine the mandated coverage.

Subject to the terms and conditions of the applicable benefit contract, bronchial valves are covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met, and any Company applicable precert/preapproval requirements.

Subject to the terms and conditions of the applicable benefit contract, devices that are used for the US Food and Drug Administration (FDA)-approved humanitarian device exemption (HDE) indications listed in this policy are covered under the medical benefits of the Company's products.

However, services that are identified in this policy as experimental/investigational are not eligible for coverage or reimbursement by the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

In October 2008, the Spiration® IBV Valve System (Spiration) was approved by the FDA through the humanitarian device exemption (H060002) process for use in controlling prolonged air leaks of the lung or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy, or lung volume reduction surgery. An air leak present on postoperative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: (1) continuous, (2) present during the normal inhalation phase of inspiration, or (3) present on normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. Use of the Intrabronchial Valve System is limited to 6 weeks per prolonged air leak. FDA product code: OAZ.

Two bronchial valve systems are FDA-approved for treatment of patients with severe emphysema. In June 2018, the FDA granted the Zephyr Valve system breakthrough device status with expedited approval for the bronchoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation. In December 2018, the FDA approved the Spiration Valve System for adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation. FDA product code: NJK.

BILLING GUIDELINES

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

Description

PULMONARY AIR LEAKS

Proper lung functioning depends on the separation between the air-containing parts of the lung and the small vacuum-containing space around the lung called the pleural space. When air leaks into the pleural space, the lung is unable to inflate, resulting in hypoventilation and hypoxemia; this condition is known as a pneumothorax. A pneumothorax can result from trauma, high airway pressures induced during mechanical ventilation, lung surgery, and rupture of lung blebs or bullae, which may be congenital or a result of chronic obstructive pulmonary disease (COPD).

EMPHYSEMA

Emphysema, a form of COPD, is a progressive, debilitating disease characterized by irreversible destruction of alveolar tissue. This destruction results in reduced elastic recoil, progressive hyperinflation and gas trapping with patients experiencing chronic dyspnea, limited exercise tolerance, and poor health-related quality of life. In emphysematous COPD, diseased portions of the lung ventilate poorly, cause air trapping, and hyperinflate, compressing relatively normal lung tissue. The patterns and degree of emphysema heterogeneity (i.e., the extent and distribution of air space enlargements) can be measured using computed tomography (CT) density as an indicator for tissue destruction. The most diseased portions of lung can then potentially be targeted for lung volume reduction procedures. In homogeneous emphysema, there is minor or no regional difference in disease within or between lobes of the lung.

The Global Initiative for Chronic Obstructive Lung Disease, or GOLD, system is commonly used to categorize patients with emphysema according to severity. Stages of airflow limitation are based on the forced expiratory volume in 1 second (FEV₁; or the amount of air a person can force out in 1 second after taking a deep breath). Patients with an FEV1 of less than 50% of their predicted value are considered to have severe airflow limitation. Individuals are also grouped in the GOLD system according to categories of risk of having an exacerbation. These groups are based on number and type of exacerbations per year and self-reported symptoms such as breathlessness.

BRONCHIAL VALVES

Bronchial valves are synthetic devices deployed with bronchoscopy into ventilatory airways of the lung to control airflow. During inhalation, the valve is closed, preventing air flow into the diseased area of the lung. The valve opens during exhalation to allow air to escape from the diseased area of the lung. They have been investigated for use in individuals who have prolonged bronchopleural air leaks and in individuals with lobar hyperinflation from severe or advanced emphysema.

When used to treat persistent air leaks from the lung into the pleural space, the bronchial valve theoretically permits less air flow across the diseased portion of the lung during inhalation, aiding in air leak closure. The valve may be placed, and subsequently removed, by bronchoscopy.

The use of bronchial valves to treat emphysema is based on the improvement observed in individuals who have undergone lung volume reduction surgery. Lung volume reduction surgery involves excision of peripheral emphysematous lung tissue, generally from the upper lobes. The precise mechanism of clinical improvement for individuals undergoing lung volume reduction has not been firmly established. However, it is believed that elastic recoil and diaphragmatic function are improved by reducing the volume of the diseased lung. Currently, and at the time the clinical trials were designed, very few lung volume reduction procedures were performed. The procedure is designed to relieve dyspnea and improve functional lung capacity and quality of life; it is not curative. Medical management remains the most common treatment for a majority of individuals with severe emphysema.

In early trials of bronchial valves for treatment of emphysema, absence of collateral ventilation (pathways that bypass the normal bronchial airways) was associated with better outcomes, presumably because individuals with collateral ventilation did not develop lobar atelectasis (collapse). In subsequent trials, individuals were selected for absence of collateral ventilation, and it is current practice for individuals to be assessed for the presence of collateral ventilation prior to undergoing the procedure. Collateral ventilation is measured by the Chartis System, which requires bronchoscopy, or as a surrogate, CT scanning to assess the completeness of fissures. After 45 days postprocedure, residual volume can provide information on whether lung volume reduction has been achieved successfully.

Two major and different types of valves—endobronchial valves (Zephyr®, Pulmonx Corp., Redwood City, CA, USA) and intrabronchial valves (IBV, Spiration®, Olympus, Tokyo, Japan)—are available, and they differ in shape but have a similar mechanism of action. The two valve systems differ in the mechanism by which the one way valve is created: the Zephyr a duckbill shape and the Spiration an umbrella shape.The choice between one of the two types is influenced more by the bronchial anatomy rather than by different outcomes after valve placement. Although no comparative trial has been published, the effect of both types of valves seems to be similar. (Additionally, In October 2008, the Spiration® IBV Valve System was approved by the U.S. Food and Drug Administration (FDA) through the humanitarian device exemption (HDE) (H060002) process for use in controlling prolonged air leaks of the lung or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy, or lung volume reduction surgery. In rare instances, certain medical devices intended to be used for humanitarian purposes are evaluated by the FDA through the HDE process. The FDA’s humanitarian use device (HUD) designation permits the use of certain medical devices when there is no comparable device available to treat or diagnose a disease or condition affecting fewer than 4000 individuals annually. Because clinical investigation demonstrating the device's efficacy is not feasible (given the low prevalence of the disease in the population), an HDE grants manufacturers an exemption to the usual premarket approval process and allows marketing of the device only for the FDA-labeled HDE indication(s). Under FDA requirements, an HUD may only be used after institutional review board (IRB) approval has been obtained for the use of the device in accordance with the FDA-labeled indication(s) under the HDE.

PEER-REVIEWED LITERATURE

Dransfield et al. performed a post hoc analysis of patient-reported outcomes (PROs), including multidimensional measures of dyspnea, activity, and quality of life, in the Lung Function Improvement after Bronchoscopic Lung Volume Reduction with Pulmonx Endobronchial Valves used in Treatment of Emphysema (LIBERATE) study in 2020.

A total of 190 individuals with severe heterogeneous emphysema and little to no collateral ventilation in the target lobe were randomly assigned 2:1 to the Zephyr Valve or standard of care (SoC) . Changes in PROs at 12 months in the two groups were compared: dyspnea with the Transitional Dyspnea Index (TDI), focal score; the Chronic Obstructive Pulmonary Disease Assessment Test (CAT; breathlessness on hill/stairs); Borg; the EXAcerbations of Chronic pulmonary disease Tool-PRO, dyspnea domain; activity with the TDI, magnitude of task/effort/functional impairment, CAT (limited activities), and the St. George's Respiratory Questionnaire (SGRQ), activity domain; and psychosocial status with the SGRQ, impacts domain, and CAT (confidence and energy).

At 12 months, individuals using the Zephyr valve achieved statistically significant and clinically meaningful improvements in the SGRQ; CAT; and the TDI, focal score, compared with SoC. The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT)-PRO, dyspnea domain, was significantly improved in the Zephyr valve group.

The outcome of the analysis concluded that individuals with severe hyperinflated emphysema achieving lung volume reductions with Zephyr valves experience improvements in multidimensional scores for breathlessness, activity, and psychosocial parameters out to at least 12 months.

Eberhardt et al. in 2021 reviewed 1-year results from an IMPACT randomized clinical trial of 93 individuals who underwent either bronchoscopic lung volume reduction with Zephyr valves or SoC treatment. Individuals with the Zephyr valve were assessed at 3, 6, and 12 months. Individuals received SoC were assessed at 3 and 6 months, and were then offered crossover to Zephyr valve treatment. At 6 months, there was significantly more response from the Zephyr valve versus the SoC group. The clinical benefits were persistent at 12 months. The percentage of individuals with respiratory serious adverse events was higher in the Zephyr valve group compared with SoC during the first 30 days postprocedure but not statistically different for the Zephyr valve and SoC groups from 31 days to 6 months, and was stable in the Zephyr valve group from 6 to 12 months. There were two deaths in the SoC group in the 31-day to 6-month period and none in the Zephyr valve group out to 12 months. The authors concluded that bronchoscopic lung volume reduction with Zephyr valves in individuals with severe homogeneous emphysema and little to no collateral ventilation provides clinically meaningful change from baseline in lung function, quality of life, exercise capacity, dyspnea, and the BODE index at 6 months with benefits maintained out to 12 months.

The National Institute for Health and Care Excellence (NICE) issued the following recommendations in 2017 on endobronchial valve insertion to reduce lung volume in emphysema:

Current evidence on the safety and efficacy of endobronchial valve insertion to reduce lung volume in emphysema is adequate in quantity and quality to support the use of this procedure provided that standard arrangements are in place for clinical governance, consent and audit.
Individual selection should be done by a multidisciplinary team experienced in managing emphysema, which should typically include a chest physician, a radiologist, a thoracic surgeon and a respiratory nurse.
Individuals selected for treatment should have had pulmonary rehabilitation.
The procedure should only be done to occlude volumes of the lung where there is no collateral ventilation, by clinicians with specific training in doing the procedure.

In 2018 with an update in 2019, NICE guidance on the diagnosis and management of COPD included the following recommendations on lung volume reduction procedures:

Offer a respiratory review to assess whether a lung volume reduction procedure is a possibility for people with COPD when they complete pulmonary rehabilitation and at other subsequent reviews, if all of the following apply:

the individual has severe COPD, with FEV₁ less than 50% and breathlessness that affects their quality of life despite optimal medical treatment
Does not smoke
Can complete a 6‑minute walk distance of at least 140 m (if limited by breathlessness)

At the respiratory review, refer the individual with COPD to a lung volume reduction multidisciplinary team to assess whether lung volume reduction surgery or endobronchial valves are suitable if they have:

hyperinflation, assessed by lung function testing with body plethysmography
emphysema on unenhanced CT chest scan
optimized treatment for other comorbidities

The 2023 Global Initiative for Chronic Obstructive Lung Disease (GOLD) publication makes the following statements on lung volume reduction interventions:

In selected individuals with heterogeneous or homogenous emphysema and significant hyperinflation refractory to optimized medical care, surgical or bronchoscopic modes of lung volume reduction (e.g., endobronchial one-way valves, lung coils or thermal ablation) may be considered.
In select individuals with advanced emphysema refractory to optimized medical care, surgical or bronchoscopic interventional treatments may be beneficial

SUMMARY OF EVIDENCE

For individuals who have pulmonary air leaks who receive bronchial valves, the evidence includes the case series and a prospective cohort observational study related to the HDE for the Spiration IBV Valve device. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, and treatment-related morbidity. Other reports are small series of heterogeneous patients. There are no comparative data with alternatives.

For individuals who have severe or advanced emphysema who receive bronchial valves, the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, and treatment-related morbidity. In individuals with severe emphysema and low collateral ventilation, RCTs provide evidence of clinically meaningful benefit for bronchial valves compared to standard medical management on measures of lung function, exercise tolerance, and quality of life, although confidence in these results is low due to study limitations including a lack of blinding and wide confidence intervals around estimates of effect. Across studies, there was an increased risk of serious procedure-related adverse events compared to usual care, including pneumothorax, occurring in up to 27% of patients. The potential benefits of the procedure are believed to outweigh the demonstrated harms in patients with advanced and medically refractory emphysema, and offer a less- invasive alternative to lung volume reduction surgery.

References

Criner GJ, Delage A, Voelker K, et al. Improving Lung Function in Severe Heterogenous Emphysema with the Spiration Valve System (EMPROVE). A Multicenter, Open-Label Randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2019;200(11):1354-1362.

Criner GJ, Sue R, Wright S, et al. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE). Am J Respir Crit Care Med. 2018;198(9):1151-1164.

Davey C, Zoumot Z, Jordan S, et al. Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi study): a randomised controlled trial. Lancet. 2015;386(9998):1066-1073.

Dransfield MT, Garner JL, Bhatt SP, et al. Effect of Zephyr Endobronchial Valves on Dyspnea, Activity Levels, and Quality of Life at One Year. Results from a Randomized Clinical Trial. Ann Am Thorac Soc. 2020; 17(7):829-838.

Eberhardt R, Slebos DJ, Herth FJ, et al. Endobronchial Valve (Zephyr) Treatment in Homogeneous Emphysema: One-Year Results from the IMPACT Randomized Clinical Trial. Respiration. 2021;100(12):1174-1185.

Firlinger I, Stubenberger E, Muller MR, et al. Endoscopic one-way valve implantation in patients with prolonged air leak and the use of digital air leak monitoring. Ann Thorac Surg. 2013;95(4):1243-1249.

Gillespie CT, Sterman DH, Cerfolio RJ, et al. Endobronchial valve treatment for prolonged air leaks of the lung: a case series. Ann Thorac Surg. 2011;91(1):270-273.

Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2023 Global Strategy for Prevention, Diagnosis, and Management of COPD. https://goldcopd.org/2023-gold-report-2/. Accessed April 22, 2024.

Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2024 Global Strategy for Prevention, Diagnosis, and Management of COPD. https://goldcopd.org/2024-gold-report/. Accessed April 22, 2024.

Hartman JE, Klooster K, Ten Hacken NHT, et al. Patient Satisfaction and Attainment of Patient-Specific Goals after Endobronchial Valve Treatment. Ann Am Thorac Soc. 2021;18(1):68-74.

Herth FJ, Noppen M, Valipour A, et al. Efficacy predictors of lung volume reduction with Zephyr valves in a European cohort. Eur Respir J. 2012;39(6):1334-1342.

Kemp SV, Slebos DJ, Kirk A, et al. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM). Am J Respir Crit Care Med. 2017;196(12): 1535-1543.

Klooster K, ten Hacken NH, Hartman JE, et al. Endobronchial Valves for Emphysema without Interlobar Collateral Ventilation. N Engl J Med. 2015;373(24):2325-2335.

Labarca G, Uribe JP, Pacheco C, et al. Bronchoscopic Lung Volume Reduction with Endobronchial Zephyr Valves for Severe Emphysema: A Systematic Review and Meta-Analysis. Respiration. 2019;98(3):268-278. PMID 31117102.

Li S, Wang G, Wang C, et al. The REACH Trial: A Randomized Controlled Trial Assessing the Safety and Effectiveness of the Spiration(R) Valve System in the Treatment of Severe Emphysema. Respiration. 2019; 97(5):416-427.

National Institute for Health and Care Excellence. Chronic obstructive pulmonary disease in over 16s: Diagnosis and management. Available at: https://www.nice.org.uk/guidance/ng115/chapter/Recommendations#managing-stable-copd. Accessed April 22, 2024.

National Institute for Health and Care Excellence. Endobronchial valve insertion to reduce lung volume in emphysema. Available at: https://www.nice.org.uk/guidance/IPG600/chapter/1-Recommendations. Accessed April 22, 2024.

Sciurba FC, Ernst A, Herth FJ, et al. A randomized study of endobronchial valves for advanced emphysema. N Engl J Med. 2010;363(13):1233-44.

Travaline JM, McKenna RJ, De Giacomo T, et al. Treatment of persistent pulmonary air leaks using endobronchial valves. Chest. 2009;136(2):355-360.

U.S. Food & Drug Administration. Spiration Valve System. Summary of Safety and Effectiveness Data. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180007. Accessed April 22, 2024.

U.S. Food & Drug Administration. Zephyr Endobronchial Valve System. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180002. Accessed April 22, 2024.

Valipour A, Slebos DJ, Herth F, et al. Endobronchial Valve Therapy in Patients with Homogeneous Emphysema. Results from the IMPACT Study. Am J Respir Crit Care Med. 2016;194(9):1073-1082.

van Agteren JE, Hnin K, Grosser D, et al. Bronchoscopic lung volume reduction procedures for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2017;2:CD012158.

van Geffen WH, Slebos DJ, Herth FJ, et al. Surgical and endoscopic interventions that reduce lung volume for emphysema: a systemic review and meta-analysis. Lancet Respir Med. 2019;7(4):313-324.

Wood DE, Nader DA, Springmeyer SC, et al. The IBV Valve trial: a multicenter, randomized, double-blind trial of endobronchial therapy for severe emphysema. J Bronchology Interv Pulmonol. 2014;21(4):288-297.

Coding

CPT Procedure Code Number(s)

31647, 31648, 31649, 31651

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

J43.0 Unilateral pulmonary emphysema [MacLeod's syndrome]

J43.1 Panlobular emphysema

J43.2 Centrilobular emphysema

J43.8 Other emphysema

J43.9 Emphysema, unspecified

J95.811 Postprocedural pneumothorax

J95.812 Postprocedural air leak

HCPCS Level II Code Number(s)

N/A

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Version Effective Date:

4/1/2022

Version Issued Date: