Latest Review Date: July 2024

Category: Surgery                                                                  

POLICY:

Bronchial valves as a treatment of prolonged air leaks are considered investigational.

Bronchial valves as a treatment for patients with COPD or emphysema are considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Bronchial valves are synthetic devices deployed with bronchoscopy into ventilatory airways of the lung to control airflow. 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.

Pulmonary Air Leaks

Proper lung functioning is dependent upon a 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 a variety of processes including 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.

In the United States, prevalence of COPD varies widely by state, with the estimated prevalence in 2019 ranging from <4.5% in California, Colorado, Hawaii, Massachusetts, Minnesota, and Utah to >9% in Alabama, Arkansas, Kentucky, and West Virginia. In 2018, chronic lower respiratory disease, primarily COPD, was the fourth leading cause of death in the United States. COPD mortality has decreased among Americans overall but this decline has not been observed in all sociodemographic groups. An analysis of COPD mortality between 2004 and 2018 found that African American women were the only sociodemographic group to have had an increase in COPD mortality, with an annual percent change (APC) of 1.3% (95% confidence interval [CI], 0.9% to 1.6%), compared to a decrease in men (APC -1.2%; 95% CI -1.5% to -0.9%), and no change for women overall.

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. Patients 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.

Table 1. Classification of Disease Severity

Stages of Airflow Limitation	Severity Grouping
GOLD 1 (mild): FEV1 ≥80% predicted GOLD 2 (moderate): 50% ≤ FEV1 <80% predicted GOLD 3 (severe): 30% ≤ FEV1 <50% predicted GOLD 4 (very severe): FEV1 <30% predicted	Group A: low risk 0 to 1 exacerbation per year, not requiring hospitalization, fewer symptoms Group B: low risk 0 to 1 exacerbation per year, not requiring hospitalization, more symptoms Group C: high risk ≥2 exacerbations per year, or 1 or more requiring hospitalization, fewer symptoms Group D: high risk ≥2 exacerbations per year, or 1 or more requiring hospitalization, more symptoms

FEV1: forced expiratory volume in 1 second; GOLD: Global Initiative for Chronic Obstructive Lung Disease.

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 patients who have prolonged bronchopleural air leaks and in patients 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 patients 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 patients 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 patients 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 patients with collateral ventilation did not develop lobar atelectasis (collapse). In subsequent trials, patients were selected for absence of collateral ventilation, and it is current practice for patients 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.

KEY POINTS:

This evidence review has been updated regularly with search of the PubMed database. Most recently, the literature was reviewed through April 26, 2024.

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 Humanitarian Device Exemption 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. This evidence is inadequate to determine the impact of this technology on the net health outcome. The evidence is insufficient to determine that the technology results in an improvement in net health outcome.

For individuals who have severe or advanced emphysema with little or no collateral ventilation between target and ipsilateral lobe who receive bronchial valves, the evidence includes multiple randomized controlled trials (RCTs) comparing bronchial valves to usual care at 6 or 12 months, 1 RCT comparing bronchial valves to lung volume reduction surgery (LVRS) through 12 months, systematic reviews, and a single center prospective cohort study with patient-reported outcomes. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, and treatment-related morbidity. In patients 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. However, 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. Results at 24 months have been published from one RCT (EMPROVE), with evaluable data from 114 of 172 participants (66.3%). Between the 12-month visit and 24-month visit, 10 participants died (8 intervention and 2 control). Change from baseline in FEV1 remained significantly improved in the treatment group compared to control group through 24 months, but the FEV1 responder rate (15% or greater improvement from baseline) at 24 months did not differ between groups (19.7% treatment vs 13.3% control; P =.57).  Acute exacerbations of COPD at the 24-month follow-up occurred in 13.7% (14 of 102) and 15.6% (7 of 45) of individuals in the treatment and control groups, respectively (P =.80). Significant improvements were maintained through 24 months on some, but not all, measures of quality of life. A RCT (CELEB) that compared bronchial valves to LVRS in 80 individuals found no statistically significant difference between treatment groups on the primary outcome (change from baseline to 12 months on the iBODE instrument, -0.27 (-0.62 to 1.17); P =.54). Notably, the magnitude of change from baseline for both groups on the i-BODE was below the 1.5-point difference considered by the study investigators to be sufficiently clinically important. The trial was limited by lack of participant blinding, high loss to follow-up, choice of a composite primary outcome, and evidence of selective outcome reporting. The trial's results do not support a conclusion that bronchial valves are associated with less procedure-related morbidity than LVRS. More participants in the bronchial valve group required additional procedures post-intervention, including 4 (8.5%) who went on to LVRS. In a prospective cohort study of patient-reported outcomes 1 year following treatment, 74.8% were satisfied with the treatment, 52.6% were satisfied with the reduction in their symptoms after treatment, and 91.4% said they would recommend the treatment to other patients. Confidence in these findings is limited by the study's uncontrolled design and high loss to follow-up (29.9%). The potential benefits of the procedure do not outweigh the demonstrated harms. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

Global Initiative for Chronic Obstructive Lung Disease (GOLD)

The 2023 GOLD publication makes the following statements on lung volume reduction interventions:

• "In selected patients 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 patients with advanced emphysema refractory to optimized medical care, surgical or bronchoscopic interventional treatments may be beneficial."

National Institute for Health and Care Excellence (NICE)

In December 2017, NICE issued the following recommendations 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.

Patient 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.

Patients 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.

NICE guidance on the diagnosis and management of COPD (2018, updated 2019) 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:

• they have severe COPD, with FEV1 less than 50% and breathlessness that affects their quality of life despite optimal medical treatment
• they do not smoke
• they can complete a 6‑minute walk distance of at least 140 m (if limited by breathlessness).

At the respiratory review, refer the person 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 and
• emphysema on unenhanced CT chest scan and
• optimised treatment for other comorbidities.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Emphysema, Endobronchial valve, IBV valves, Emphasys, Zephyr endobronchial valve system, bronchial valve, Spiration Valve System

APPROVED BY GOVERNING BODIES:

In October 2008, the “IBV® Valve System” (Spiration, Inc, Redmond, WA) was approved by the FDA under the Humanitarian Device Exemption 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 (LVRS). An air leak present on postoperative day seven is considered prolonged unless present only during forced exhalation or cough. An air leak present on day five should be considered for treatment if it is: (1) continuous, (2) present during normal inhalation phase of inspiration, or (3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. IBV Valve System use is limited to six weeks per prolonged air leak.

Currently, 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. 

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply. Refer to member’s benefit plan. 

CURRENT CODING: 

CPT Codes:

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	Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with removal of bronchial valve(s), initial lobe
31649	Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with removal of bronchial valve(s), each additional lobe (List separately in addition to code for primary procedure)
31651	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), each additional lobe (List separately in addition to code for primary procedure[s])

REFERENCES:

1. Buttery SC, Banya W, Bilancia R, et al. Lung volume reduction surgery versus endobronchial valves: a randomised controlled trial. Eur Respir J. Apr 2023; 61(4).
2. Centers for Disease Control and Prevention. Chronic Obstructive Pulmonary Disease (COPD). Data and Statistics. 2022. www.cdc.gov/copd/data.html.
3. 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.
4. Criner GJ, Mallea JM, Abu-Hijleh M, et al. Sustained Clinical Benefits of Spiration Valve System in Patients with Severe Emphysema: 24-Month Follow-Up of EMPROVE. Ann Am Thorac Soc. Feb 2024; 21(2): 251-260.
5. 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.
6. 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):1066-1073.
7. 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 trial): study design and rationale. Thorax. Mar 2014.
8. Dransfield MT, Garner JL, Bhatt SP, et al. Effect of Zephyr Endobronchial Valves on Dyspnea, Activity Levels and Quality of Life at One Year. Ann Am Thorac Soc. Mar 30 2020.
9. 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.
10. Du Rand IA, Barber PV, Goldring J et al. Summary of the British Thoracic Society Guidelines for advanced diagnostic and therapeutic flexible bronchoscopy in adults. Thorax 2011; 66(11):1014-1015.
11. Eberhardt R, Slebos DJ, Herth FJF, et al. Endobronchial Valve (Zephyr) Treatment in Homogeneous Emphysema: One-Year Results from the IMPACT Randomized Clinical Trial. Respiration. NA 2021; 100(12): 1174-1185.
12. 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.
13. Gillespie CT, Sterman DH, Cerfolio RJ, et al. Endobronchial valve treatment for prolonged air leaks of the lung: case series.  Ann Thorac Surg 2011; 91(1):270-273.
14. Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2023 Global Strategy for Prevention, Diagnosis, and Management of COPD.goldcopd.org/2023-gold-report-2/. 
15. 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.
16. Hartman JE, Welling JBA, Klooster K, Carpaij OA, Augustijn SWS, Slebos DJ. Survival in COPD patients treated with bronchoscopic lung volume reduction. Respir Med. 2022 May;196:106825. doi: 10.1016/j.rmed.2022.106825. Epub 2022 Mar 16. 
17. 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.
18. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
19. 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. 
20. Klooster, KK, ten Hacken, NN, Hartman, JJ, Kerstjens, HH, van Rikxoort, EE, Slebos, DD. Endobronchial Valves for Emphysema without Interlobar Collateral Ventilation.. N. Engl. J. Med., 2015 Dec 10;373(24).
21. 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.
22. 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.
23. Li, SS, Wang, GG, Wang, CC, Gao, XX, Jin, FF, Yang, HH, Han, BB, Zhou, RR, Chen, CC, Chen, LL, Bai, CC, Shen, HH, Herth, FF, Zhong, NN. The REACH Trial: A Randomized Controlled Trial Assessing the Safety and Effectiveness of the Spiration® Valve System in the Treatment of Severe Emphysema. Respiration, 2018 Dec 17;1-12:1-12. 
24. National Institute for Health and Care Excellence. Chronic obstructive pulmonary disease in over 16s: Diagnosis and management. Available at: www.nice.org.uk/guidance/ng115/chapter/Recommendations#managing-stable-copd.
25. National Institute for Health and Care Excellence. Endobronchial valve insertion to reduce lung volume in emphysema. Available at: www.nice.org.uk/guidance/IPG600/chapter/1-Recommendations.
26. Ninane V, Geltner C, Bezzi M, et al. Multicentre European study for the treatment of advanced emphysema with bronchial valves. Eur Respir J. Jun 2012;39(6):1319-1325.
27. U.S. Food & Drug Administration. Spiration Valve System Approval Letter. December 3, 2018. Available at: www.accessdata.fda.gov/cdrh_docs/pdf18/P180007A.pdf.
28. U.S. Food & Drug Administration. Spiration Valve System. Summary of Safety and Effectiveness Data. Available at: www.accessdata.fda.gov/cdrh_docs/pdf18/P180007B.pdf.
29.  U.S. Food & Drug Administration. Zephyr Endobronchial Valve Approval Letter. June 29, 2018. Available at: www.accessdata.fda.gov/cdrh_docs/pdf18/P180002a.pdf.
30. Valipour A, Herth FJ, Burghuber OC et al. Target lobe volume reduction and COPD outcome measures after endobronchial valve therapy. Eur Respir J. Feb 2014;43(2):387-396.
31. Valipour, AA, Slebos, DD, Herth, FF, Darwiche, KK, Wagner, MM, Ficker, JJ, Petermann, CC, Hubner, RR,Stanzel, FF, Eberhardt, RR. Endobronchial Valve Therapy in Patients with Homogeneous Emphysema. Results from the IMPACT Study.. Am. J. Respir. Crit. Care Med., 2016 Nov 1;194(9).
32. 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.
33. van der Molen MC, Hartman JE, Vanfleteren LEGW, Kerstjens HAM, van Melle JP, Willems TP, Slebos DJ. Reduction of Lung Hyperinflation Improves Cardiac Preload, Contractility, and Output in Emphysema: A Prospective Cardiac Magnetic Resonance Study in Patients Who Received Endobronchial Valves. Am J Respir Crit Care Med. 2022 May 18. doi: 10.1164/rccm.202201-0214OC. Epub ahead of print.
34. van Geffen, WW, Slebos, DD, Herth, FF, Kemp, SS, Weder, WW, Shah, PP. Surgical and endoscopic interventions that reduce lung volume for emphysema: a systemic review and meta-analysis. Lancet Respir Med, 2019 Feb 13;7(4). 
35. 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): 288-297.
36. Xu JQ, Murphy SL, Kochanek KD, Arias E. Mortality in the United States, 2018. NCHS Data Brief, Number 355. Hyattsville, MD: National Center for Health Statistics; 2020. www.cdc.gov/nchs/data/databriefs/db355-h.pdf.
37. Zarrabian B, Mirsaeidi M. A Trend Analysis of Chronic Obstructive Pulmonary Disease Mortality in the United States by Race and Sex. Ann Am Thorac Soc. Jul 2021; 18(7): 1138-1146.

POLICY HISTORY:

Medical Policy Group, November 2010

Medical Policy Administration Committee, December 2010

Available for comment December 2, 2010 through January 16, 2011

Medical Policy Group, May 2011: Updated Key Points and References

Medical Policy Group, March 2012 (2): 2012 Update – Key Points & References

Medical Policy Group, November 2012: 2013 Coding Update – Added Codes 31647, 31648, 31649, & 31651; Deleted Codes 0250T, 0251T, & 0252T; all effective 1/1/13.

Medical Policy Panel, February 2013

Medical Policy Group, February 2013 (2):  2013 Updates to Key Points & References; no change in policy statement (reformatted policy statement only)

Medical Policy Group, October 2013 (2): Removed ICD-9 and 10 Diagnosis/Procedure codes; no change to policy statement.

Medical Policy Panel, February 2014

Medical Policy Group, February 2014 (1): Update to Key Points and References; no change to policy statement

Medical Policy Panel, March 2015

Medical Policy Group, March 2015 (2): Updates to Key Points and References; no change to policy statement

Medical Policy Panel, June 2016

Medical Policy Group, June 2016 (7): Updates to Key Points, Key Words; Approved by Governing Bodies and References. Code 31651 was corrected, previous typing error listed 36151; Previous coding section removed (codes 0250T, 0251T, & 0252T deleted 12/31/2012). No change to policy statement.

Medical Policy Panel, June 2017

Medical Policy Group, June 2017 (7): Updates to Title, Key Points, Key Words; Approved by Governing Bodies and References. Policy statement clarified- removed “endo”. No change in intent.

Medical Policy Panel, June 2018

Medical Policy Group, June 2018 (7): Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, August 2019

Medical Policy Group, August 2019 (5): Updates to Description, Key Points, Approved by Governing Bodies, and References. No changes to Policy Statement.

Medical Policy Panel, June 2020

Medical Policy Group, June 2020 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, Approved by Governing Bodies, and References. No changes to Policy Statement.

Medical Policy Panel, June 2021

Medical Policy Group, June 2021 (5): Updates to Description, Key Points, and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Panel, June 2022

Medical Policy Group, June 2022 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, June 2023

Medical Policy Group, June 2023 (5): Updates to Description, Key Points, Benefit Application, and References. No change to Policy Statement.

Medical Policy Panel, June 2024

Medical Policy Group, July 2024 (5): Updates to Key Points and References. No change to Policy Statement.

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.