Medical Policy



Subject: Computed Tomography Scans for Lung Cancer Screening
Document #: RAD.00043 Current Effective Date:    06/28/2017
Status: Revised Last Review Date:    05/04/2017

Description/Scope

This document addresses computed tomography (CT) scans for lung cancer screening. This document does not address CT scans performed for evaluation of chest-related symptoms or follow-up evaluation of abnormalities previously detected when a CT scan of the chest was performed for a medically necessary reason.

Note: Please see the following document(s) for additional information:

Position Statement

Medically Necessary:

The use of low-dose, non-contrast spiral (helical) multi-detector CT imaging as a screening technique for lung cancer is considered medically necessary when used to screen for lung cancer for certain high-risk individuals when all of the following criteria are met:

  1. Individual has no signs or symptoms suggestive of underlying lung cancer which includes, but is not limited to the following: unexplained cough, hemoptysis, or unexplained weight loss of more than 15 pounds in the past year; and
  2. Individual is between 55-80 years of age; and
  3. There is at least a 30 pack-year history of cigarette smoking; and
  4. If the individual is a former smoker, that individual had quit smoking within the previous 15 years; and
  5. Screening will occur no more often than annually.

Investigational and Not Medically Necessary:

The use of CT scanning as a screening technique for lung cancer in asymptomatic individuals is considered investigational and not medically necessary when the above criteria are not met and for all other indications.

Rationale

Although screening may identify cancer at an earlier stage, an associated improved survival will only result if effective surgical or medical treatment is available. The sensitivity of such a test must be balanced against its specificity, since lack of specificity will result in an increasing number of individuals undergoing unnecessary work-ups due to false positive results. The heterogeneous nature of lung cancer may limit the benefit of screening. For example, some lung cancers are very aggressive such that close surveillance and early detection does not improve outcomes. Some small cancers may also present with metastatic disease as the size of the cancer may not correlate with early stage disease.

In September 2002, the National Cancer Institute launched a study of 50,000 current or former high-risk smokers randomized to screening over 3 consecutive years with either a chest x-ray or spiral CT. Participants included in the study were considered to be at high-risk if they were between the ages of 55-74, had at least a 30 pack-year history of smoking and if participants were former smokers, they had quit within the previous 15 years. Participants were excluded from the study if they had a previous diagnosis of lung cancer, if they had a chest CT in the preceding 18 months, had hemoptysis, or had an unexplained weight loss of at least 15 pounds within the preceding year. A total of 26,722 participants were randomly assigned to have low-dose CT and 26,732 received chest x-ray. For those individuals who received a diagnosis of lung cancer after the first test, subsequent screening tests were not offered. The primary outcome of this 8-year study was lung cancer mortality and a determination of the potential benefits and drawbacks for the two screening methods. Enrollment occurred from August 2002 through April 2004. The screening took place from August 2002 through September 2007. Follow-up continued through December 2009. In 2011 the National Lung Screening Trial (NLST) Research Team released their findings of the National Cancer Institute Study. Comparative interpretations were used to determine the outcome of the screening tests. A positive result was considered for CT scan if there was any non-calcified nodule measuring at least 4 mm in diameter. A result was considered positive for chest x-ray if there was any non-calcified nodule or mass. Other abnormalities such as adenopathy or effusion could also be classified as a positive result. If after the third round of screening, abnormalities suspicious for lung cancer were stable during all three rounds, they could then be classified as a minor abnormality as opposed to a positive result.

Participants completed questionnaires regarding vital status. Those who did not complete questionnaires (that is, those who were lost to follow-up) were checked for in the National Death Index for information about their vital status. For those individuals known to have died, death certificates were checked for cause of death. Adherence rates for the screening were 95% in the low-dose CT group and 93% in the chest x-ray group.

For all three rounds of screening, there were a higher number of positive results with the low-dose CT group when compared to the chest x-ray group. In the low-dose CT group positive results were found in 27.3% after the first screen, 27.9% after the second screen and 16.8% after the third screen. For the chest x-ray group positive results were found in 9.2% after the first screen, 6.2% after the second screen and 5.0% after the third screen. After the first round of screening, more than 90% of the positive tests resulted in further diagnostic evaluation and further imaging tests. Following the three rounds of screening, 96.4% of the positive results in the low-dose CT group and 94.5% of the positive results in the chest x-ray group were determined to be false positive results. A total of 1060 lung cancers were diagnosed in the low-dose CT group and 941 were diagnosed in the chest x-ray group. There were 356 deaths from lung cancer in the low-dose CT group and 443 deaths from lung cancer in the chest x-ray group which resulted in a relative reduction in the rate of death from lung cancer with low-dose CT screening of 20%. Overall there were 1877 deaths in the low-dose CT group and 2000 deaths in the chest x-ray group.

An independent board met every 6 months to review the accumulating data. In October of 2010 the independent board determined that a definitive result had been reached and recommended that the results be reported. There were some limitations to this study including a high rate of false positive results potentially from a "healthy-volunteer" effect, the use of less technologically advanced scanners than are in current use, the trial having been conducted at a variety of medical institutions, including academic centers and community facilities. Overdiagnosis, a source of controversy surrounding low-dose CT screening for lung cancer and radiation-induced cancers, could not be directly measured in this study.

In 2013, the NLST research team released their findings from the initial screening examination (the prevalence screening). Using the cohort from the NLST study, a total of 52,344 participants had their first scheduled screening exam. Of those, 7191 out of 26,309 participants in the low-dose CT screening group had positive results compared to 2387 out of 26,035 in the radiograph group. During baseline follow-up, 292 of 26,309 in the low-dose CT group had a diagnosis of lung cancer versus 190 of 26,035 in the radiograph group. The sensitivity and specificity were 93.8% and 73.4% for low-dose CT and 73.5% and 91.3% for chest radiography. The 1-year and 2-year rounds of incidence screening are reported by Aberle and colleagues (2013). For the first year screen, 24,715 of 26,285 participants in the low-dose CT group and 24,089 of 26,410 in the radiograph group underwent screening. In the low-dose CT group, 6901 of 24,715 participants had a positive screen and 1482 of 24,089 had a positive screen in the radiograph group. A total of 186 participants in the low-dose CT group received a diagnosis of lung cancer at this first screen compared to 133 participants in the radiograph group. The sensitivity of low-dose CT was 94.4%, the specificity was 72.6%. The sensitivity of radiography was 59.6% and the specificity was 94.1%. At the second year screening, 24,102 of 25,942 of low-dose CT participants received screening and 23,346 of 26,110 radiograph group participants received screening. During this second year screen, 4054 of 24,102 low-dose CT participants had a positive result and 1174 of 23,346 participants in the radiograph group had a positive scan. A total of 237 low-dose CT scan participants received a diagnosis of lung cancer and 144 participants received a diagnosis of lung cancer in the radiograph group. The sensitivity of low-dose CT was 93.0%, the specificity was 83.9%. The sensitivity of radiography was 63.9%, the specificity was 95.3%.

Bach et al (2012) report a collaborative (American Cancer Society, American College of Chest Physicians, American Society of Clinical Oncology, and the National Comprehensive Cancer Network) systematic review which addressed the evidence of benefits and harms of low-dose CT screening for lung cancer. Based on 8 randomized controlled trials and 13 cohort studies included in this systematic review, the authors made the following recommendations. The first recommendation is that smokers and former smokers should have annual screening with low-dose chest CT if they are aged 55 to 74 years, have smoked for 30 pack-years or more, and either continue to smoke or have quit within the past 15 years. The second recommendation is that CT screening should not be performed for individuals with severe comorbidities which would preclude potentially curative treatment, limit life expectancy or both. The authors point out that while low-dose chest CT screening for lung cancer appears promising there are several questions yet to be answered:

In 2012, the American Association for Thoracic Surgery (Jaklitsch) released their guidelines for lung cancer screening and they recommend that annual lung cancer screening with low-dose CT should occur for certain individuals age 55-79 years of age. The 2013 American College of Chest Physicians (Detterbeck) clinical practice guidelines for screening for lung cancer also recommend annual screening with low-dose CT for smokers and former smokers who have smoked 30 pack-years or more and either continue to smoke or have quit within the past 15 years. The National Comprehensive Cancer Network® (NCCN) 2017 Lung Cancer Screening Guidelines recommend annual low-dose CT until individuals are no longer candidates for definitive treatment, but also states that uncertainty exists about how long screening should occur and the age when screening is no longer appropriate.

In December 2013, the U.S Preventive Services Task Force (USPSTF) released a revised version of their recommendations for screening for lung cancer. This document stated:

The USPSTF recommends annual screening for lung cancer with low-dose computed tomography in adults aged 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years. Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery (B recommendation).

CT screening raises concern regarding radiation exposure risk (even that deemed as "low-dose"), which some have calculated that if performed over a period of many years, may in itself contribute to an increased cancer risk (Brenner, 2004).

A study by Kovalchik and colleagues (2013) investigated whether the benefits and harms of low-dose CT screening in the NLST participants differed according to the participants' prescreening risk of lung cancer death. The participants were classified into two groups, a CT-screening group and a radiography group, and then into five quintiles for the predicted 5-year risk of death from lung cancer (with quintile 1 having the lowest risk and quintile 5 having the highest risk). The median follow-up was 5.5 years. The number of lung-cancer deaths per 10,000 person-years that were prevented in the CT-screening group when compared to the radiography group increased with risk quintile (0.2 in quintile 1, 3.5 in quintile 2, 1in quintile 3, 11.0 in quintile 4, and 12.0 in quintile 5; P=0.01 for trend). There were decreasing trends in the number of false positive results per screening-prevented lung-cancer death (1648 in quintile 1, 181 in quintile 2, 147 in quintile 3, 64 in quintile 4, and 65 in quintile 5). Subjects with the highest risk for lung-cancer death (quintiles 3 through 5) accounted for 88% of the screening-prevented lung-cancer deaths and for 64% of participants with false positive results. The 20% of participants at lowest risk (quintile 1) accounted for only 1% of prevented lung-cancer deaths. The authors concluded that "Screening with low-dose CT prevented the greatest number of deaths from lung cancer among participants who were at highest risk and prevented very few deaths among those at lowest risk."

A 2017 study by Rampinelli and colleagues reported on the cumulative radiation exposure and lifetime attibutable risk of cancer in those scanned with low-dose CT scans. In this retrospective review, 5203 asymptomatic, high-risk participants underwent annual low-dose CT scan for 10 consecutive years. High-risk status was defined as age greater than 50 years old, smoking history with greater than or equal to 20 pack-years, and no history of cancer in the past 5 years. The numbers of additional cancers cases induced by 10 years of screening was 1.5 lung cancers and 2.4 major cancers, an additional risk of induced major cancers of 0.05% (2.4/5,203). The authors concluded, "Radiation exposure and cancer risk from low dose CT screening for lung cancer, even if non-negligible, can be considered acceptable in light of the substantial mortality reduction associated with screening."

Background/Overview

Lung cancer is the leading cause of cancer death for men and women in the United States. The American Cancer Society estimates in 2017 approximately 222,500 new cases of lung cancer will be diagnosed and 155,870 deaths will occur.

CT scanning is a radiographic imaging technique that can provide high quality three-dimensional images. Due to its sensitivity in detecting small lung lesions, CT scanning has been proposed as a screening test for lung cancer in high-risk individuals (for example, smokers). Some CT scans are able to provide lower radiation exposure during scanning.

Definitions

Asymptomatic: Without obvious signs or symptoms of disease.

Hemoptysis: Coughing up blood.

Lung cancer: A cancerous growth in lung tissue.

Pack-year: A way to measure the amount an individual has smoked over a long period of time, calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met: 

HCPCS    
G0296 Counseling visit to discuss need for lung cancer screening (LDCT) using low dose CT scan (service is for eligibility determination and shared decision making)  
G0297 Low dose CT scan (LDCT) for lung cancer screening  
     
ICD-10 Diagnosis  
  All diagnoses
F17.200-F17.209 Nicotine dependence, unspecified
F17.210-F17.219 Nicotine dependence, cigarettes
Z12.2 Encounter for screening for malignant neoplasm of respiratory organs
Z72.0 Tobacco use
Z87.891 Personal history of nicotine dependence

When services are Investigational and Not Medically Necessary:
For the procedure and diagnosis codes listed above when criteria are not met, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

References

Peer Reviewed Publications:

  1. Aberle DR, DeMello S, Berg CD, et al. Results of the two incidence screenings in the National Lung Screening Trial. N Engl J Med. 2013; 369(10):920-931.
  2. Bach PB, Mirkin JN, Oliver TK, et al. Benefits and harms of CT screening for lung cancer: a systematic review benefits and harms of CT screening for lung cancer. JAMA. 2012; 20:1-12.
  3. Brenner DJ. Radiation risks potentially associated with low-dose CT screening of adult smokers for lung cancer. Radiology. 2004; 231(2):440-445.
  4. Kovalchik SA, Tammemagi M, Berg CD, et al. Targeting of low-dose CT screening according to the risk of lung-cancer death. N Engl J Med. 2013; 369(3):245-254.
  5. Markowitz SB, Miller A, Miller J, et al. Ability of low-dose helical CT to distinguish between benign and malignant noncalcified lung nodules. Chest. 2007; 131(4):1028-1034.
  6. National Lung Screening Trial Research Team, Aberle DR, Adams AM, et al. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011; 365(5):395-409.
  7. National Lung Screening Trial Research Team, Church TR, Black WC, et al. Results of initial low-dose computed tomographic screening for lung cancer. N Engl J Med. 2013; 368(21):1980-1991.
  8. New York Early Lung Cancer Action Project Investigators. CT Screening for lung cancer: diagnoses resulting from the New York Early Lung Cancer Action Project. Radiology. 2007; 243(1):239-249.
  9. Rampinelli C, De Marco P, Origgi D, et al. Exposure to low dose computed tomography for lung cancer screening and risk of cancer: secondary analysis of trial data and risk-benefit analysis. BMJ. 2017; 356:j347.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Cancer Society. Lung cancer. 2017. Available at: https://www.cancer.org/cancer/lung-cancer.html . Accessed on March 31, 2017.
  2. Centers for Medicare and Medicaid Services. National Coverage Determination: Lung Cancer Screening with Low Dose Computerized Tomography. NCD #210.14. Effective February 5, 2015. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on March 31, 2017.
  3. Detterbeck FC, Mazzone PJ, Naidich DP, Bach PB. Screening for lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013; 143(5 Suppl):e78S-e92S.
  4. Jaklitsch MT, Jacobson FL, Austin JH, et al. The American Association for Thoracic Surgery guidelines for lung cancer screening using low-dose computed tomography scans for lung cancer survivors and other high-risk groups. J Thorac Cardiovasc Surg. 2012; 144(1):33-38. Available at: http://aats.org/multimedia/files/Guidelines/Lung-Cancer-Screening-Using-low-dose-computed-tomography-scans.pdf. Accessed on March 31, 2017.
  5. Manser R, Lethaby A, Irving LB, et al. Screening for lung cancer. Cochrane Database Syst Rev. 2013; (6):CD001991.
  6. Moyer VA; U.S. Preventive Services Task Force. Screening for Lung Cancer: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2014; 160:330-338.
  7. NCCN Clinical Practice Guidelines in Oncology™. © 2017 National Comprehensive Cancer Network, Inc. Lung cancer screening. Revised August 10, 2016. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on March 31, 2017.
Websites for Additional Information
  1. National Cancer Institute. Lung Cancer. Available at: http://www.cancer.gov/cancertopics/types/lung. Accessed on March 31, 2017.
  2. National Lung Cancer Screening Trial. Available at: http://www.cancer.gov/nlst. Accessed on March 31, 2017.
Index

Computed Tomography
CT Scans
Lung CT

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History
Status Date Action
Revised 05/04/2017 Medical Policy & Technology Assessment Committee (MPTAC) review.
Revised 05/03/2017 Hematology/Oncology Subcommittee review. Updated Description/Scope, Rationale, Background/Overview, Index, Coding and References sections. Title change. Updated formatting in Position Statement section.
  10/01/2016 Updated Coding section with 10/01/2016 HCPCS changes; removed S8032 deleted 09/30/2016.
Reviewed 05/05/2016 MPTAC review.
Reviewed 05/04/2016 Hematology/Oncology Subcommittee review. Updated Rationale and References sections.
  01/01/2016 Updated Coding section with 01/01/2016 HCPCS changes; removed ICD-9 codes.
Reviewed 05/07/2015 MPTAC review.
Reviewed 05/06/2015 Hematology/Oncology Subcommittee review. Updated Coding section.
Reviewed 02/05/2015 MPTAC review. Updated Description/Scope, Rationale, Definitions, and Reference sections.
  10/01/2014 Updated Coding section with 10/01/2014 HCPCS changes.
Reviewed 05/15/2014 MPTAC review.
Reviewed 05/14/2014 Hematology/Oncology Subcommittee review.
Revised 02/13/2014 MPTAC review. Revised medically necessary upper age limit criteria from age 79 to 80. Updated Rationale and References.
Revised 11/14/2013 MPTAC review. 
Revised 11/13/2013 Hematology/Oncology Subcommittee review. Updated Position Statement to extend age from 74 years to 79 years and that screening will occur no more often than annually. Updated Rationale and References.
Reviewed 11/08/2012 MPTAC review.
Reviewed 11/07/2012 Hematology/Oncology Subcommittee review. Updated References.
Revised 05/10/2012 MPTAC review.
Revised 05/09/2012 Hematology/Oncology Subcommittee review. Addition of "non-contrast" to Position Statement. Updated Rationale and References. Updated Coding section; removed CPT 71260, 71270.
Revised 11/17/2011 MPTAC review.
Revised 11/16/2011 Hematology/Oncology Subcommittee review. Added medically necessary indications to Position Statement. Updated Rationale, Definitions, Coding and References.
Reviewed 11/18/2010 MPTAC review.
Reviewed 11/17/2010 Hematology/Oncology Subcommittee review. Updated Rationale and References.
Reviewed 11/19/2009 MPTAC review.
Reviewed 11/18/2009 Hematology/Oncology Subcommittee review. No change to Position Statement. Updated Rationale and Reference sections.
Reviewed 11/20/2008 MPTAC review. No change to Position Statement.
Reviewed 11/29/2007 MPTAC review. No change to Position Statement. The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary."
Revised 12/07/2006 MPTAC review. Updated Rationale regarding use of spiral/helical CT for lung cancer screening. Updated References.
Revised 09/14/2006 MPTAC review. Added clarification to Position Statement regarding inclusion of helical/spiral CT devices; updated Reference section.
  01/01/2006 Updated Coding section with 01/01/2006 CPT/HCPCS changes.
  11/17/2005 Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).
  Reviewed 09/22/2005 MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.
Pre-Merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc.

 

No prior document  
WellPoint Health Networks, Inc.

09/24/2005

4.11.02 CT Scans with or without Computer Assisted Detection (CAD) for Lung Cancer Screening