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Point and Counterpoint |

POINT: Should Lung Cancer Screening by Chest CT Scan Be a Covered Benefit? YesCover Lung Cancer Screening? Yes FREE TO VIEW

David F. Yankelevitz, MD
Author and Funding Information

From the Icahn School of Medicine at Mount Sinai.

CORRESPONDENCE TO: David F. Yankelevitz, MD, Icahn School of Medicine at Mount Sinai, 1428 Madison Ave, New York, NY 10029; e-mail: david.yankelevitz@mountsinai.org


FINANCIAL/NONFINANCIAL DISCLOSURES: The author has reported to CHEST the following conflicts of interest: Cornell University has had a licensing agreement with General Electric related to intellectual property on lung nodule analysis since 2006, and as a faculty member, Dr Yankelevitz was entitled to a share of the monies. He also is involved in research funded by the Flight Attendant Medical Research Institute through Mount Sinai regarding screening and risks of second-hand tobacco smoke. Dr Yankelevitz is director of the Lung Biopsy Service at the Icahn School of Medicine at Mount Sinai and an I-ELCAP Investigator.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2015;147(2):287-289. doi:10.1378/chest.14-2812
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Based on the US Preventive Services Task Force (USPSTF) grade B recommendation for lung cancer screening,1 commercial insurers operating through Affordable Care Act exchanges, with the exception of certain grandfathered plans, must cover individuals aged < 65 years who meet the USPSTF criteria for CT scan screening without copayments before the end of 2015.2 Thus, for these insurers, the question regarding coverage is settled; all that might be considered is whether the law is reasonable or whether the USPSTF made an improper recommendation. With regard to the Centers for Medicare & Medicaid Services (CMS), the decision will be based on whether they determine the test has a proven benefit to the covered population.3 In making this determination, it is necessary to understand the benefit in terms of potential lives saved compared with potential harms. With lung cancer being the leading cause of cancer death in the Medicare population, the stakes are high. However, should CMS decide not to provide this coverage, the incongruous result would be that those younger and at lower risk would be covered, whereas those at higher risk would not. In a somewhat analogous manner it would also allow for those aged > 65 years with means to pay on their own the opportunity to be screened, whereas poor and probably higher-risk populations would not have access.

These issues of policy aside, of greater concern are some of the prevailing views on lung cancer screening, even among eminent guideline organizations, that have quite seriously underestimated the potential number of lives saved and exaggerated the harms. The source of error regarding lives saved relates to a serious misinterpretation of the results of the National Lung Screening Trial (NLST). As its core result, NLST demonstrated a 20% mortality reduction in the CT scan screened arm of the trial compared with the chest radiograph control arm.4 This result has been mistakenly interpreted to mean that only 20% of those with potentially fatal lung cancer will be cured as a consequence of the screening. For example, in a joint statement from the American College of Chest Physicians and the American Society of Clinical Oncology based on that NLST result, the authors state the following to be included in a discussion between a physician and the person considering being screened: “4 out of 5 people who are going to die of lung cancer will die of it even if they are screened. Screening prevents one in five deaths from lung cancer.”5 The NLST result, however, is by no means a measure of the extent of lives that can be saved in the context of a sustained screening program. Instead, it was designed as a test of hypothesis about whether lives can be saved, and even more specifically, its primary intent was to determine whether there was an advantage to finding and treating smaller lung cancers diagnosed under CT scan screening compared with larger cancers diagnosed under chest radiography screening.6 As a test of that hypothesis, the NLST was successful; however, there has now been a misguided effort to transform that result into a measure of the magnitude of the benefit. Yankelevitz and Smith7 reported the two primary reasons inherent in stop-screen design trials, such as NLST, that cause the outcome measure of mortality reduction to be lower than the actual full magnitude of the benefit. The main point is that when addressing the magnitude of reduction in fatal outcomes of lung cancer that results from diagnosing the cancer earlier under screening, it is incorrect to equate this with the mortality reduction seen in a trial such as NLST with limited rounds of screening and limited length of follow-up. The mortality reduction within the NLST would have been very different with more screening rounds and different lengths of follow-up. In fact, there is nothing inherently incompatible between the 20% reduction in mortality reported in the NLST and the much higher estimates of cure rates for lung cancers diagnosed under screening, say even 70% to 80% as estimated by International Early Lung Cancer Action Program (I-ELCAP).8 Understanding this difference is critical to any decision-making process regarding coverage, and even more so in terms of providing information to a person interested in being screened. Therefore, these societies are obliged to correct their misrepresentation of this core result of the NLST.

Understanding this misrepresentation of the NLST result should be a critical concern for decision-makers at CMS, but there are indications that those providing guidance to them have similarly misinterpreted its meaning. As part of the process for determining benefit, a set of questions was set forth to be addressed by an advisory panel. One of these questions was, “How confident are you that there is adequate evidence to determine that annual screening beyond 3 annual LDCT [low-dose CT] screens improves health outcomes?”9 The implication is that NLST only demonstrated benefit associated with three rounds of screening but not more (or for that matter less), again, a serious misunderstanding of what the designers of the NLST sought to demonstrate. As hypothesized prior to the trial, the NLST demonstrated a life-saving benefit to finding and treating early lung cancer diagnosed under CT scan screening in that high-risk population. The three rounds of screening was simply a design parameter to keep the cost of the study within reason while still reasonably testing the hypothesis. The result should be viewed as showing that each round of screening was beneficial and that there is no reason to believe that this would be limited to three rounds. The USPSTF clearly agreed with these later points as demonstrated by their recommendation for continued annual screening in the high-risk group beyond three rounds.1

In regard to the issue of harms, these have also been seriously misunderstood. One important example can be seen in the systematic review endorsed by several guideline organizations where the critical distinction in rate of false-positive nodules found on the baseline round and subsequent rounds is not emphasized.5 False-positive findings are far fewer in annual repeat rounds, and ultimately, the rate in the repeat round becomes the dominant consideration because the baseline round occurs only once, whereas annual repeat screenings would continue up to age 80 according to the USPSTF recommendations. Aside from this important distinction, the size chosen to define a positive result was also not fully appreciated, and the evidence now clearly shows that the false-positive rates can be dramatically decreased in the baseline round by changing the size threshold such that it is in the range of 10% (with the additional workup typically another low-dose scan) and even lower in subsequent rounds.10 These findings, some made subsequent to publication of NLST results, have already been endorsed by several guideline organizations.11,12

The concern about radiation dose has also been overstated.13 There has been debate about the extent of any potential harm, with the extent assumed to be directly related to dose. There is no debate that lowering the dose while maintaining image quality is clearly advantageous and that the potential harms, if any, are even lower for the older age population and actually not realistic because they would occur, if ever, some 20 years later. Considerations for coverage should, therefore, be made on what is now considered routinely achievable. Tremendous advances in technology have been made in the decade since the screening portion of the NLST was completed. Scans can now be routinely performed with doses < 1 mSv, where there is virtually no evidence that harm even exists.14,15 Other areas of potential harms, such as surgical mortality and complications, in the context of screening have now been shown to be quite low in both the NLST and the I-ELCAP,4,16 and data continue to accumulate that issues related to quality of life and anxiety can be successfully managed.17,18 The extent to which these potential harms can be minimized will continue to improve as both technology and knowledge continue to accumulate.

Screening has a large potential benefit, and harms associated with it can be minimized and will continue to decrease. Issues of implementation, results tracking, and setting standards are important considerations, but there is strong precedent that they can be managed effectively as, for example, with mammography. Organizations such as the American College of Radiology, with assistance and endorsement from other appropriate partners, are well poised to provide this input. An effective policy on lung cancer screening could have the greatest impact on reducing cancer death than any other intervention for the foreseeable future. The challenge will be careful and considered implementation.

Abbreviations

CMS

Centers for Medicare & Medicaid Services

CXR

chest radiography

LDCT

low-dose CT

NLST

National Lung Screening Trial

RCT

randomized clinical trial

USPSTF

US Preventive Services Task Force

Lung cancer: screening. US Preventive Services Task Force website. http://www.uspreventiveservicestaskforce.org/uspstf/uspslung.htm. Accessed September 25, 2014.
 
Centers for Medicare & Medicaid Services; Center for Consumer Information & Insurance Oversight. Affordable Care Act implementation FAQs - set 18. Centers for Medicare & Medicaid website. http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs18.html. Accessed September 25, 2014.
 
Medicare program; revised process for making Medicare National coverage determinations. Fed Regist. 2003;68(187):55634-55641.
 
Aberle DR, Adams AM, Berg CD, et al; National Lung Screening Trial Research Team. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011;365(5):395-409. [CrossRef] [PubMed]
 
Bach PB, Mirkin JN, Oliver TK, et al. Benefits and harms of CT screening for lung cancer: a systematic review [published correction appears in JAMA2012;308:1324.]. JAMA. 2012;307(22):2418-2429. [CrossRef] [PubMed]
 
ACRIN #6654. Contemporary screening for the detection of lung cancer. American College of Radiology Imaging Network website. http://www.acrin.org/Portals/0/Protocols/6654/Protocol-ACRIN%206654%20Amendment%2010,%2011.1.04.pdf. Accessed September 25, 2014.
 
Yankelevitz DF, Smith JP. Understanding the core result of the National Lung Screening Trial [published correction appears inN Engl J Med. 2013;368(18):1757]. N Engl J Med. 2013;368(15):1460-1461. [CrossRef] [PubMed]
 
Henschke CI, Yankelevitz DF, Libby DM, Pasmantier MW, Smith JP, Miettinen OS; International Early Lung Cancer Action Program Investigators. Survival of patients with stage I lung cancer detected on CT screening. N Engl J Med. 2006;355(17):1763-1771. [CrossRef] [PubMed]
 
MEDCAC meeting 4/30/2014 - lung cancer screening with low dose computed tomography. Centers for Medicare & Medicaid Service website. http://www.cms.gov/medicare-coverage-database/details/medcac-meeting-details.aspx?MEDCACId=68#questions. Accessed September 25, 2014.
 
Henschke CI, Yip R, Yankelevitz DF, Smith JP; International Early Lung Cancer Action Program Investigators. Definition of a positive test result in computed tomography screening for lung cancer: a cohort study. Ann Intern Med. 2013;158(4):246-252. [CrossRef] [PubMed]
 
NCCN guidelines for patients: lung cancer screening. National Comprehensive Cancer Network website. http://www.nccn.org/patients/guidelines/lung_screening/#16. Accessed September 25, 2014.
 
LungRADS, version 1.0 assessment categories. American College of Radiology website. http://www.acr.org/∼/media/ACR/Documents/PDF/QualitySafety/Resources/LungRADS/AssessmentCategories.pdf. Accessed September 25, 2014.
 
American Association of Physicists in Medicine. AAPM position statement on radiation risks from medical imaging procedures. American Association of Physicists in Medicine website. https://www.aapm.org/org/policies/details.asp?id=318&type=PP&current=true. Accessed September 25, 2014.
 
Frank L, Christodoulou E, Kazerooni EA. Radiation risk of lung cancer screening. Semin Respir Crit Care Med. 2013;34(6):738-747. [CrossRef] [PubMed]
 
McCollough CH, Chen GH, Kalender W, et al. Achieving routine submillisievert CT scanning: report from the summit on management of radiation dose in CT. Radiology. 2012;264(2):567-580. [CrossRef] [PubMed]
 
Flores R, Bauer T, Aye R, et al; I-ELCAP Investigators. Balancing curability and unnecessary surgery in the context of computed tomography screening for lung cancer. J Thorac Cardiovasc Surg. 2014;147(5):1619-1626. [CrossRef] [PubMed]
 
van den Bergh KA, Essink-Bot ML, Borsboom GJ, et al. Short-term health-related quality of life consequences in a lung cancer CT screening trial (NELSON). Br J Cancer. 2010;102(1):27-34. [CrossRef] [PubMed]
 
Gareen IF, Duan F, Greco EM, et al. Impact of lung cancer screening results on participant health-related quality of life and state anxiety in the National Lung Screening Trial. Cancer. 2014;120(21):3401-3409. [CrossRef] [PubMed]
 

Figures

Tables

References

Lung cancer: screening. US Preventive Services Task Force website. http://www.uspreventiveservicestaskforce.org/uspstf/uspslung.htm. Accessed September 25, 2014.
 
Centers for Medicare & Medicaid Services; Center for Consumer Information & Insurance Oversight. Affordable Care Act implementation FAQs - set 18. Centers for Medicare & Medicaid website. http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs18.html. Accessed September 25, 2014.
 
Medicare program; revised process for making Medicare National coverage determinations. Fed Regist. 2003;68(187):55634-55641.
 
Aberle DR, Adams AM, Berg CD, et al; National Lung Screening Trial Research Team. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011;365(5):395-409. [CrossRef] [PubMed]
 
Bach PB, Mirkin JN, Oliver TK, et al. Benefits and harms of CT screening for lung cancer: a systematic review [published correction appears in JAMA2012;308:1324.]. JAMA. 2012;307(22):2418-2429. [CrossRef] [PubMed]
 
ACRIN #6654. Contemporary screening for the detection of lung cancer. American College of Radiology Imaging Network website. http://www.acrin.org/Portals/0/Protocols/6654/Protocol-ACRIN%206654%20Amendment%2010,%2011.1.04.pdf. Accessed September 25, 2014.
 
Yankelevitz DF, Smith JP. Understanding the core result of the National Lung Screening Trial [published correction appears inN Engl J Med. 2013;368(18):1757]. N Engl J Med. 2013;368(15):1460-1461. [CrossRef] [PubMed]
 
Henschke CI, Yankelevitz DF, Libby DM, Pasmantier MW, Smith JP, Miettinen OS; International Early Lung Cancer Action Program Investigators. Survival of patients with stage I lung cancer detected on CT screening. N Engl J Med. 2006;355(17):1763-1771. [CrossRef] [PubMed]
 
MEDCAC meeting 4/30/2014 - lung cancer screening with low dose computed tomography. Centers for Medicare & Medicaid Service website. http://www.cms.gov/medicare-coverage-database/details/medcac-meeting-details.aspx?MEDCACId=68#questions. Accessed September 25, 2014.
 
Henschke CI, Yip R, Yankelevitz DF, Smith JP; International Early Lung Cancer Action Program Investigators. Definition of a positive test result in computed tomography screening for lung cancer: a cohort study. Ann Intern Med. 2013;158(4):246-252. [CrossRef] [PubMed]
 
NCCN guidelines for patients: lung cancer screening. National Comprehensive Cancer Network website. http://www.nccn.org/patients/guidelines/lung_screening/#16. Accessed September 25, 2014.
 
LungRADS, version 1.0 assessment categories. American College of Radiology website. http://www.acr.org/∼/media/ACR/Documents/PDF/QualitySafety/Resources/LungRADS/AssessmentCategories.pdf. Accessed September 25, 2014.
 
American Association of Physicists in Medicine. AAPM position statement on radiation risks from medical imaging procedures. American Association of Physicists in Medicine website. https://www.aapm.org/org/policies/details.asp?id=318&type=PP&current=true. Accessed September 25, 2014.
 
Frank L, Christodoulou E, Kazerooni EA. Radiation risk of lung cancer screening. Semin Respir Crit Care Med. 2013;34(6):738-747. [CrossRef] [PubMed]
 
McCollough CH, Chen GH, Kalender W, et al. Achieving routine submillisievert CT scanning: report from the summit on management of radiation dose in CT. Radiology. 2012;264(2):567-580. [CrossRef] [PubMed]
 
Flores R, Bauer T, Aye R, et al; I-ELCAP Investigators. Balancing curability and unnecessary surgery in the context of computed tomography screening for lung cancer. J Thorac Cardiovasc Surg. 2014;147(5):1619-1626. [CrossRef] [PubMed]
 
van den Bergh KA, Essink-Bot ML, Borsboom GJ, et al. Short-term health-related quality of life consequences in a lung cancer CT screening trial (NELSON). Br J Cancer. 2010;102(1):27-34. [CrossRef] [PubMed]
 
Gareen IF, Duan F, Greco EM, et al. Impact of lung cancer screening results on participant health-related quality of life and state anxiety in the National Lung Screening Trial. Cancer. 2014;120(21):3401-3409. [CrossRef] [PubMed]
 
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