Medicare Advantage

Medical Policy

Title:

Bronchial Valves

Policy #:

MA11.020

Policy

MEDICALLY NECESSARY

Bronchial valve placement with an 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,
Has completed a pulmonary rehabilitation program prior to valve placement,
Age is 40 to 75 years,
Body mass index (BMI) is less than 35kg/m2,
Stable with ≤20mg prednisone (or equivalent) daily,
Forced expiratory volume (FEV1) between 15% and 45% of predicted value at initial evaluation,
6-minute walking distance (6MWD) ≥100m and <500m,
There is little to no interlobar collateral ventilation as determined using the Chartis (Zephyr) or SeleCT (Spiration) systems,
Abstinence 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 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.

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, Evidence of Coverage, 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 Evidence of Coverage, bronchial valves covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met, and the any Company applicable precert/preapproval requirements.

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

Two bronchial valve systems are FDA approved for treatment of patients with severe emphysema. In June 2018, 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, 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, Evidence of Coverage, 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 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 post-procedure, residual volume can provide information on whether lung volume reduction has been achieved successfully.

Two major & different types of valves – endobronchial valve (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 (Spiration) was approved by the U.S. Food and Drug Administration (FDA) through the humanitarian device exemption (HDE) (H060002) process).

SUMMARY OF EVIDENCE

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 felt 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. Dec 01 2019; 200(11): 1354-1362. PMID 31365298.

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. Nov 01 2018; 198(9): 1151-1164. PMID 29787288.

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. Sep 12 2015; 386(9998): 1066-73. PMID 26116485.

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. Jul 2020; 17(7): 829-838. PMID 32223724.

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. Apr 2013; 95(4): 1243-9. PMID 23434254.

Gillespie CT, Sterman DH, Cerfolio RJ, et al. Endobronchial valve treatment for prolonged air leaks of the lung: a case series. Ann Thorac Surg. Jan 2011; 91(1): 270-3. PMID 21172529.

Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2020 Global Strategy for Prevention, Diagnosis, and Management of COPD. https://goldcopd.org/gold-reports/. Accessed May 20, 2021.

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. Jan 2021; 18(1): 68-74. PMID 32881586.

Herth FJ, Noppen M, Valipour A, et al. Efficacy predictors of lung volume reduction with Zephyr valves in a European cohort. Eur Respir J. Jun 2012; 39(6): 1334-42. PMID 22282552.

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. Dec 15 2017; 196(12): 1535-1543. PMID 28885054.

Klooster K, ten Hacken NH, Hartman JE, et al. Endobronchial Valves for Emphysema without Interlobar Collateral Ventilation. N Engl J Med. Dec 10 2015; 373(24): 2325-35. PMID 26650153.

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. NA 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. PMID 30554211.

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 May 20, 2021.

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 May 20, 2021.
Sciurba FC, Ernst A, Herth FJ, et al. A randomized study of endobronchial valves for advanced emphysema. N Engl J Med. Sep 23 2010; 363(13): 1233-44. PMID 20860505.

Travaline JM, McKenna RJ, De Giacomo T, et al. Treatment of persistent pulmonary air leaks using endobronchial valves. Chest. Aug 2009; 136(2): 355-360. PMID 19349382.

U.S. Food & Drug Administration. Spiration Valve System. Summary of Safety and Effectiveness Data. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180007B.pdf. Accessed May 20, 2021.

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. Nov 01 2016; 194(9): 1073-1082. PMID 27580428.

van Agteren JE, Hnin K, Grosser D, et al. Bronchoscopic lung volume reduction procedures for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. Feb 23 2017; 2: CD012158. PMID 28230230.

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. Apr 2019; 7(4): 313-324. PMID 30744937.

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. Oct 2014; 21(4): 288-97. PMID 25321447.

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

Revisions From MA11.020:

07/12/2023	This policy has been reissued in accordance with the Company's annual review process.
04/01/2022	This policy is effective as of 04/01/2022. New medical policy for has been created to communicate Company's coverage position and criteria for Bronchial Valves. New policy number 11.16.09 has been issued for this policy topic. The policy was written to be consistent with current template wording and format. Policy content is based on FDA approvals, seminal trial(s), clinical guidelines, and pertinent peer-reviewed literature.

07/12/2023

This policy has been reissued in accordance with the Company's annual review process.

04/01/2022

This policy is effective as of 04/01/2022.

New medical policy for has been created to communicate Company's coverage position and criteria for Bronchial Valves. New policy number 11.16.09 has been issued for this policy topic. The policy was written to be consistent with current template wording and format.

Policy content is based on FDA approvals, seminal trial(s), clinical guidelines, and pertinent peer-reviewed literature.

Version Effective Date:

4/1/2022

Version Issued Date: