Clinical Policy Title: Lung cancer screening

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1 Clinical Policy Title: Lung cancer screening Clinical Policy Number: Effective Date: July 1, 2016 Initial Review Date: April 27, 2016 Most Recent Review Date: March 6, 2018 Next Review Date: March 2019 Policy contains: Lung cancer screening. Low-dose computed tomography. Related policies: None. ABOUT THIS POLICY: Select Health of South Carolina has developed clinical policies to assist with making coverage determinations. Select Health of South Carolina s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peerreviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by Select Health of South Carolina when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Select Health of South Carolina s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Select Health of South Carolina s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Select Health of South Carolina will update its clinical policies as necessary. Select Health of South Carolina s clinical policies are not guarantees of payment. Coverage policy Select Health of South Carolina considers the use of lung cancer screening with low-dose computed tomography scanning, also known as spiral CT or helical CT scanning, to be clinically proven and, therefore, medically necessary when all of the following criteria are met: Annual screening for lung cancer with low-dose CT scan criteria: - Ages years. - Asymptomatic (no signs or symptoms of lung disease). - Tobacco-smoking history of at least 30 pack-years (one pack-year = smoking one pack per day for one year; one pack = 20 cigarettes). - Current smoker or one who has quit smoking within the past 15 years. - A written order for low-dose CT scan lung cancer screening. - For the initial low-dose CT scan lung cancer screening service, a written order must be provided during a lung cancer screening counseling visit. - For subsequent low-dose CT scan lung cancer screenings, a written order may be provided during any appropriate visit (Moyer, 2014). Limitations: 1

2 All other indications for lung cancer screening with low-dose CT scanning are not medically necessary. Chest X-rays should not be used for cancer screening (Wender, 2013). Positron emission tomography is considered experimental and investigational for lung cancer screening because its effectiveness for this indication has not been established. Alternative covered services: Monitoring by treating provider. Smoking cessation program. Background Lung cancer is the second most common cancer and the leading cause of cancer death in the United States, with 224,390 cases and 158,080 deaths in Of Americans diagnosed with the disease in , 18.7 percent survived five years, and 10.2 percent survived 10 years; these figures are much lower for advanced lung cancer (Howlader, 2016). The most important risk factor for lung cancer is smoking, which is observed in approximately 85 percent of all U.S. lung cancer cases. A 2012 survey found that 18.1 percent of Americans ages 18 and older currently smoke, which accounts for 45.0 percent of ever-smokers (Agaku, 2014). Most lung cancer cases are non-small-cell lung cancer, and most screening programs focus on the detection and treatment of early-stage non-small-cell lung cancer. Although chest radiography and sputum cytologic evaluation have been used to screen for lung cancer, low-dose CT scanning has greater sensitivity for detecting early-stage cancer. The major risks of low-dose CT scanning, include radiation exposure, high false-positive rates, and over-diagnosis (Aberle, 2013). Although lung cancer screening is not an alternative to smoking cessation, the U.S. Preventive Services Task Force (USPSTF) found adequate evidence that annual screening for lung cancer with low-dose CT scanning in a defined population of high-risk persons can prevent a substantial number of lung cancerrelated deaths. Direct evidence from a large, well-conducted, randomized, controlled trial provides moderate certainty of the benefit of lung cancer screening with low-dose CT scanning in this population. The magnitude of benefit to the person depends on that person's risk for lung cancer because those who are at highest risk are most likely to benefit. Screening cannot prevent most lung cancer-related deaths, nor can it prevent smoking cessation. Combination therapy with counseling and medications is more effective at increasing cessation rates than either component alone. The U.S. Food and Drug Administration has approved several forms of nicotine replacement therapy (gum, lozenge, transdermal patch, inhaler, and nasal spray), as well as bupropion and varenicline (Moyer, 2014). The USPSTF recommends annual screening for lung cancer with low-dose CT scanning in adults ages 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 2

3 health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery (Moyer, 2014). The American Cancer Society guideline is similar to that of the USPSTF, except it recommends screening from ages 55 to 74 (Wender, 2013), as does the guideline from the American College of Chest Physicians (Detterbeck, 2013), and the American Thoracic Society/American College of Chest Physicians (Wiener, 2015). A panel of European experts concurs that a low-dose CT scan-based system, stratified by risk, can be effective in screening for lung cancer (Oudkerk, 2017). Searches Select Health of South Carolina searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on January 30, Search terms were: lung cancer screening and mortality. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings A systematic review that identified eight guidelines on lung cancer screening found consistent agreement supporting lung cancer screening of high-risk individuals using low-dose CT scanning (Li, 2016). Perhaps the largest study of lung cancer screening efficacy included 53,454 high-risk persons enrolled from by the National Lung Screening Trial. Subjects underwent three annual screenings with either low-dose CT scanning or single-view chest radiography; 90 percent screening adherence was reported. By the end of 2009, the rates of positive screening tests were 24.2 and 6.9 percent for lowdose CT scanning and radiography. Incidence of lung cancer was higher in the CT group (1,060 to 941 cases), and mortality from the disease was 20 percent lower (247 to 309 deaths), a significant difference. All-cause mortality was 6.7 percent lower (NLSTRT, 2011). An update of the study confirmed 3

4 the 20 percent reduction (i.e., 356 versus 443 deaths; Bach, 2012). Four other trials did not result in significant decreases of disease-specific and all-cause mortality with low-dose CT scan screening compared to chest X-rays (Coureau, 2016). The National Lung Screening Trial also found that low-dose CT scanning detected 54 percent more lung cancer cases than did chest X-rays (292 versus 190); and 115 percent more Stage I cases (158 versus 70). The sensitivity for low-dose CT scanning was higher (93.8 versus 73.5 percent), but specificity was lower (73.4 versus 91.3 percent) (NLSTRT, 2013). A 2013 Cochrane review of nine trials (eight were randomized) of 453,965 subjects updated earlier Cochrane reviews in 1999, 2004, and When smokers and non-smokers were combined in a screening program using radiography, there was just a one percent reduction in lung cancer mortality. More frequent chest X-rays were linked with an 11 percent higher lung cancer mortality. Combining sputum cytology with chest X-rays resulted in a 12 percent lung cancer mortality reduction, close to achieving statistical significance, but is not recommended (Manser, 2013). An estimated 8.6 million Americans would be included in the high-risk lung cancer category as defined in guidelines (CMS, 2014). If all were screened, 12,250 lung cancer deaths would be averted each year, although the cost-effectiveness of such a program needs further analysis (Ma, 2013). A systematic review of 34 studies found that low-dose CT scanning (compared with CXRs) in lung cancer screening was associated with an over-diagnosis of to percent; a median false positive estimate of percent for once-only screening, and percent for multiple rounds; a median of deaths and patients with major complications per 1,000 screened undergoing invasive follow-up procedures; and a median of 9.74 and 5.28 individuals per 1,000 screened with benign conditions with minor and major invasive follow-up procedures (Usman Ali, 2016). A European study of 247,354 persons approached for screening resulted in 4,055 assigned either to the screening or control group. Lung cancer was detected in a total of 42 (2.1 percent) of subjects. Of these, 36 were stage 1-2, and nearly all (35) underwent surgery as a first-line treatment. Although mortality was not reported for these groups, authors conclude that screening was effective (Field, 2016). Spiral CT scans have also been used to screen for lung cancer. A trial of 2472 subjects showed that among patients randomized to undergo yearly spiral CT for four years, 28 lung cancers were detected, compared to just 13 visible in baseline chest X-rays. The number of Stage I cancers were four-fold greater (16 versus four) in the CT group (Infante, 2008). This study was updated to 6549 subjects, followed over eight years, finding a 16.3 percent lower mortality rate from all causes (299 versus 357 per 100,000 person-years) in those undergoing CT scans (Infante, 2017). Several large trials did not find results supporting screening for persons at high risk for lung cancer. One, conducted in Denmark, randomized a total of 4,104 subjects to five annual low-dose CT scans or no screening. More lung cancers were diagnosed in the screening group (69 versus 24, p<.001). At the end 4

5 of the screening period, total deaths were higher in the screening group, and of borderline significance (61 versus 42, p<.059); 15 screened and 11 non-screened persons died of lung cancer, a difference not significant at p=.428 (Saghir, 2012). Another trial, conducted in Italy, randomized 4,099 participants to a control group (1723), to biennial low-dose CT screening (1,186), or to annual low-dose CT screening (1,190). Cumulative five-year lung cancer incidence was higher in the annual screening group (620 per 100,000, compared to 457 in the biennial group and 311 in the control group). Lung cancer mortality was higher in the annual screening group (216 versus 109 and 109, p=.21) as was total mortality (558 versus 363 and 310, p=.13) (Pastorino, 2012). Policy updates: A total of three clinical guidelines/other and five peer-reviewed reference were added to, and one clinical guideline/other and one peer-reviewed reference were removed from this policy in January Summary of clinical evidence: Citation Usman Ali (2016) Risks of various modes of lung cancer screening Manser (2013) Content, Methods, Recommendations Key points: Systematic review of 34 studies on lung cancer screening for high-risk individuals. LDCT and CXRs compared, median follow-up of 6.5 years. LDCT versus CXRs associated with over-diagnosis of 10.99% to 25.83%. Key points: LDCT versus CXRs associated with deaths and major complications per 1,000 undergoing invasive follow-up procedures. LDCT versus CXRs had median false positives of 25.53% for baseline/once-only screening, and 23.28% for multiple rounds of screening. LDCT versus CXRs had 9.74 and 5.28 minor and major invasive follow-up procedures for benign conditions. LDCT screening reduces lung cancer mortality, but standardized screening practices are warranted to maximize accuracy and minimize potential harms. Effect of lung screening using LDCT, CXRs, and sputum cytology Systematic review of nine trials (n = 453,965), updating 1999, 2004, and 2010 Cochrane reviews on lung cancer screening. One study that combined smokers and non-smokers had an insignificant 1% reduction in lung cancer mortality. Frequent versus non-frequent screening with CXRs increased lung cancer mortality by 11% (significant). Combining CXRs and sputum cytology to CXR alone reduced lung cancer mortality by 12% (borderline significant). 5

6 Citation NLSTRT (2013) Comparison of LDCT and CXRs for lung cancer screening NLSTRT (2011) Effects of CT versus CXRs screening on lung cancer incidence and mortality Content, Methods, Recommendations Key points: Current evidence does not support screening for lung cancer with CXRs or sputum cytology. Study of 53,439 high-risk individuals screened for lung cancer, enrolled , followed for three years; half given LDCT, half given CXRs. LDCT group had higher positive screening result (27.3% versus 9.2%). LCDT group had higher number of lung cancer diagnoses (292 versus 190). LCDT group had higher number of Stage 1 cancers diagnosed (158 versus 70). Sensitivity and specificity 93.8% and 73.4% for LDCT, 73.5% and 91.3% for CXRs. Key points: Study of 53,454 high-risk individuals screened for lung cancer, enrolled , followed until end of 2009; half given LDCT, half given CXRs. Adherence to screening exceeded 90%. Positive screening results were mostly false positives (96.4% for LDCT, 94.5% for CXRs). Higher incidence of lung cancer for LDCT (1,060 versus 941 cases). 20% fewer lung cancer deaths for LDCT (247 versus 309 per 100,000 person-years). 6.7% fewer deaths from all causes for LDCT group. References Professional society guidelines/other: Agaku IT, King BA, Dube SR. Current cigarette smoking among adults United States, Morbidity and Mortality Weekly Report (MMWR). January 17, Atlanta GA: U.S. Centers for Disease Control and Prevention. Accessed January 29, Detterbeck FC, Mazzone PJ, Naidich DP, Bach PB. Screening for lung cancer: diagnosis and management of lung cancer, 3 rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5 Suppl):e78s e 92s. Howlader N, Noone AM, Krapcho M, et al. SEER Cancer Statistics Review, April, Bethesda MD: National Cancer Institute. Accessed January 30, Humphrey L, Deffebach M, Pappas M, et al. Screening for lung cancer: systematic review to update the U.S. Preventive Services Task Force recommendation statement. Rockville MD: Agency for Healthcare 6

7 Research and Quality (US); Report No EF-1. Accessed January 29, 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 Thor Cardiovas Surg. 2012;144(1): 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(5): Moyer VA; U.S. Preventive Services Task Force. Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012;157(2): Oudkerk M, Devarai A, Vliegenthart R, et al. European position statement on lung cancer screening. Lancet Oncol. 2017;18(12)e754 e766. U.S. Centers for Medicare and Medicaid Services (CMS). Decision memo for screening for lung cancer with low-dose computed tomography (LDCT). February 5, Accessed January 29, U.S. Preventive Services Task Force (USPSTF). Final Recommendation Statement. Lung Cancer: Screening. December 31, Accessed January 29, Wiener RS, Gould MK, Arenberg DA, et al. An official American Thoracic Society/American College of Chest Physicians policy statement: implementation of low-dose computed tomography lung cancer screening programs in clinical practice. Am J Respir Crit Care Med. 2015;192(7): Wender R, Fontham ET, Barrera E Jr, et al. American Cancer Society lung cancer screening guidelines. CA Cancer J Clin. 2013;63(2): Peer-reviewed references: Aberle DR, Adams AM, Berg CD, et al. National Lung Screening Trial Research Team. Reduced lungcancer mortality with low-dose computed tomographic screening. New Engl J Med. 2011;365(5): Aberle DR, Abtin F, Brown K. Computed tomography screening for lung cancer: has it finally arrived? Implications of the national lung screening trial. J Clin Oncol. 2013;31(8): Bach PB, Mirkin JN, Oliver TK, et al. Benefits and harms of CT screening for lung cancer: a systematic 7

8 review. JAMA. 2012;307(22): Church TR, Black WC, Aberle DR, et al. National Lung Screening Trial Research Team. Results of initial low-dose computed tomographic screening for lung cancer. New Engl J Med. 2013;368(21): Coureau G, Salmi LR, Etard C, Sancho-Garnier H, Sauvaget C, Mathoulin-Pelissier S. Low-dose computed tomography screening for lung cancer in populations highly exposed to tobacco: a systematic methodological appraisal of published randomized controlled trials. Eur J Cancer. 2016;61: Field JK, Duffy SW, Baldwin DR, et al. The UK Lung Cancer Screening Trial: a pilot randomised controlled trial of low-dose computed tomography screening for the early detection of lung cancer. Health Technol Assess. 2016;20(40): Hayes Inc., Hayes Medical Technology Report. Low-Dose Computed Tomography for Lung Cancer Screening in the Elderly: Higher Detection and False-Positive Rates. Lansdale, PA. Hayes Inc.; February Humphrey LL, Deffebach M, Pappas M, et al. Screening for lung cancer with low-dose computed tomography: a systematic review to update the U.S. Preventive Services Task Force recommendation. Ann Intern Med. 2013;159: Infante M, Lutman FR, Cavuto S, et al. Lung cancer screening with spiral CT: baseline results of the randomized DANTE trial. Lung Cancer. 2008;59(3): Infante M, Sestini S, Galeone C, et al. Lung cancer screening with low-dose spiral computed tomography: evidence from a pooled analysis of two Italian randomized trials. Eur J Cancer Prev. 2017;26(4): Li ZY, Luo L, Hu YH, et al. Lung cancer screening: a systematic review of clinical practice guidelines. Int J Clin Pract. 2016;70(1): Ma J, Ward EM, Smith R, Jemal A. Annual number of lung cancer deaths potentially avertable by screening in the United States. Cancer. 2013;119(7): Manser R, Lethaby A, Irving LB, et al. Screening for lung cancer. Cochrane Database Syst Rev. 2013;(6):CD Doi: / CD pub3. National Lung Screening Trial Research Team, Aberle DR, Adams AM, Berg CD, et al (NLSTRT). Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011;365(5): National Lung Screening Trial Research Team, Church TR, Black WC, Aberle DR, et al (NLSTRT). Results of 8

9 initial low-dose computed tomographic screening for lung cancer. N Engl J Med. 2013;368(21): Pastorino U, Rossi M, Rosato V, et al. Annual of biennial CT screening versus observation ni nheavy smokers: 5-year results of the MILK trial. Eur J Cancer Prev. 2012;21(3): Saghir Z, Dirksen A, Ashraf H, et al. CT screening for lung cancer brings forward early disease. The randomized Danish Lung Cancer Screening Trial: status after five annual screening rounds with low-dose CT. Thorax. 2012;67(4): Usman Ali M, Miller J, Peirson L, et al. Screening for lung cancer: a systematic review and meta-analysis. Prev Med. 2016;89: Veronesi G, Bellomi M, Scanagatta P, et al. Difficulties encountered managing nodules detected during a computed tomography lung cancer screening program. J Thorac Cardiovasc Surg. 2008;136(3): CMS National Coverage Determinations (NCDs): Lung Cancer Screening with Low Dose Computed Tomography (LDCT). Effective February 5, Covers annual screening for high-risk patients ages 55 to 77. CMS Medicare Coverage Database website. KeyWord=lung+cancer+screening&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAACAAAA AA&. Accessed January 30, Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comments N/A ICD-10 CM Code Description F Nicotine dependence, unspecified, uncomplicated F Nicotine dependence, unspecified, in remission Comments 9

10 ICD-10 CM Code Description F Nicotine dependence, cigarettes, uncomplicated Z12.2 Encounter for screening for malignant neoplasm of respiratory organs Z72.0 Tobacco use Z Personal history of nicotine dependence Comments HCPCS Level II Code G0297 Description Low-dose computed tomography for lung cancer screening Comments 10