IEHP UM Subcommittee Approved Authorization Guidelines CT Screening (Low Dose) for Lung Cancer

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1 CT Screening (Low Dose) for Lung Cancer Policy: There is currently adequate evidence that using low dose computed tomography (LDCT) to screen asymptomatic individuals who are at risk for lung cancer improves patient outcomes. The National Lung Screening Trial (NLST) showed evidence that LDCT lowers mortality by 20% as compared to screening for lung cancer with chest x-ray (Aberle, ). Therefore, the IEHP Utilization Subcommittee adopts LDCT as an annual screening modality for lung cancer at this time when all the following criteria are met: 1. Age years 2. Tobacco smoking history of at least 30 pack-years 3. Current smoker or one who has quit smoking within the last 15 years 4. Asymptomatic (no signs or symptoms of lung cancer; e.g. weight loss, hemoptysis) 5. Documentation of a recent visit with a doctor that states the risks and benefits of proceeding with the LDCT for lung cancer screening have been discussed and agreed upon. An optional tool for doctors to use to counsel patients is available at (see Appendix B) 6. The LDCT for lung cancer screening is to be performed at an American College of Radiology (ACR) Lung Cancer Screening Center Designated site (see Appendix A) CPT Code for LDCT: S8032 Centers for Medicare and Medicaid Services (CMS): Decision Memo CAG-00439N, February 5, : The Center for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to add a lung cancer screening counseling and shared decision making visit, and for appropriate beneficiaries, annual screening for lung cancer with low dose computed tomography (LDCT), as an additional preventive service benefit under the Medicare program only if all of the following criteria are met: Sixth St, Suite 120, Rancho Cucamonga, CA Tel (909) Fax (909) Visit our web site at: A Public Entity

2 Page 2 of 11 Age years Asymptomatic (no signs or symptoms of lung cancer; e.g. weight loss, hemoptysis) Tobacco smoking history of at least 30 pack years Current smoker or one who has quit smoking within the last 15 years Radiology Imaging Facility Eligibility Requirements: 1. Performs LDCT with volumetric CT dose index of <= 3.0 mgy for standard size patients (5 7 and approximately 155 pounds) with adjustments for smaller and larger patients 2. Utilizes standardized lung nodule identification, classification and reporting system 3. Makes available smoking cessation interventions for current smokers 4. Collects and submits data to a CMS-approved registry for each LDCT lung cancer screening test performed Medi-Cal: Medi-Cal Benefit Manual, Radiology: Diagnostic, page 3, February : 1. Current or former smokers to 74 years of age 3. A smoking history of at least 30 pack years 4. No history of lung cancer The U.S. Preventive Services Task Force (USPSTF) (December ): Grade B. The USPSTF recommends annual screening for lung cancer with low-dose computed tomography (LDCT) 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. American College of Chest Physicians and American Thoracic Society Policy Statement Components Necessary for High Quality Lung Cancer Screening, Mazzone, et al., Chest Oct : The authors presented a joint position statement endorsed by the American College of Chest Physicians, American Thoracic Society, American Association of Thoracic Surgery, American Cancer Society, and American Society of Preventive Oncology: Lung cancer screening with a low dose chest CT scan can result in more benefit than harm when performed in settings committed to developing and maintaining high quality programs. This project aimed to identify the components of screening that should be a part of all lung cancer screening programs. To do so, committees with expertise in lung cancer screening were assembled by the Thoracic Oncology Network of the ACCP and the Thoracic Oncology Assembly of the ATS. Lung cancer program components were derived from evidence-based reviews of lung cancer screening, and supplemented by expert opinion. Nine essential components of a lung cancer screening program were identified.

3 Page 3 of Who is offered lung cancer screening 2. How often, and for how long, to screen 3. How the CT is performed 4. Lung nodule identification 5. Structured reporting 6. Lung nodule management algorithms 7. Smoking cessation 8. Patient and provider education 9. Data collection American Cancer Society (February 6, ) The American Cancer Society has thoroughly reviewed the subject of lung cancer screening and issued guidelines that are aimed at doctors and other health care providers: Patients should be asked about their smoking history. Patients who meet ALL of the following criteria may be candidates for lung cancer screening: 55 to 74 years old In fairly good health Have at least a 30 pack-year smoking history Are either still smoking or have quit smoking within the last 15 years The American College of Radiology (November 20, ) The ACR strongly supports the use of LDCT for lung cancer screening and believes that the ability of this technique to reduce mortality depends on appropriate patient selection, the performance of high-quality, low radiation exposure LDCT exams interpreted by qualified physicians in a structured reporting and management system for quality reporting and outcomes monitoring. American College of Radiology (ACR) Lung Cancer Screening Designation Radiology facilities that have the following criteria have been designated ACR Lung Cancer Screening sites: 1. Definition of eligible and appropriate screening population 2. Incorporation of smoking cessation 3. Physician qualification of at least 200 chest CT exams in prior 36 months 4. Structured reporting and management tool, such as Lung-RADS 5. Multi-detector, helical (spiral) scanner; low-dose CT protocol must have a CT dose index volume of <=3 mgy for a standard-size patient (5 7, 154 lb) 6. Exposure techniques must be adjusted for patient size 7. Participation in the ACR Dose Index Registry is recommended (scheduled to go live May 2015 with planned back entries to January 2015) 8. Use and submit a low-dose CT protocol that meets the criteria outlined in the ACR- Society of Thoracic Radiology Practice Parameter for the Performance and Reporting of Lung Cancer Screening Thoracic CT

4 Page 4 of 11 Aetna (April 10, ) Aetna considers annual low-dose computed tomography (LDCT) scanning for lung cancer screening medically necessary. Cigna (February 15, ) Cigna covers annual screening for lung cancer with low-dose computed tomography (LDCT) as medically necessary. Anthem (April 7, ) The use of low-dose, non-contrast spiral (helical) multi-detector CT imaging as a screening technique for lung cancer is considered medically necessary. Randomized Clinical Studies: Reference # of Patients Treatment Results Conclusions Presented in the Penderson et al NELSON, 2009 Saghir et al, DLCST, , for this study LDCT vs. usual care 4104 LDCT vs. usual care Prevalence data after 2yrs: At baseline 179 persons showed noncalcified nodules larger than 5 mm, and most were rescanned after 3 months: The rate of false-positive diagnoses was 7.9%, and 17 individuals (0.8%) turned out to have lung cancer. Ten of these had stage I disease. Eleven of 17 lung cancers at baseline were treated surgically, eight of these by video assisted thoracic surgery resection. Lung cancer detection rate was 0.83% at baseline and mean 001), and more were low stage (48 vs. 21 stage I annual detection rate was 0.67% at incidence rounds (p=0.535). More lung cancers were diagnosed in the screening group (69 vs. 24, p<0. IIB nonsmall cell lung cancer (NSCLC) and limited stage small cell lung cancer (SCLC), p=0.002), whereas frequencies of high-stage lung cancer were the same (21. vs 16 stage IIIA IV NSCLC and extensive stage SCLC, p=0.509). At the end of screening, 61 patients died in the screening group and 42 in the control group (p=0.059). Fifteen and 11 died Abstract Screening may facilitate minimal invasive treatment and can be performed with a relatively low rate of falsepositive screen results compared with previous studies on lung cancer screening. (Study to be completed in 2015.) CT screening for lung cancer brings forward early disease, and at this point no stage shift or reduction in mortality was observed. More lung cancers were diagnosed in the screening group, indicating some degree of

5 Page 5 of 11 ITALUNG, 2009 Pegna et al DANTE, 2009 Infante et al NLST, 2011 Aberle et al 3206 LDCT vs. usual care 2472 LDCT vs. usual care 53,454 LDCT vs. CXR of lung cancer, respectively (p=0.428). 207 (12.8%) subjects did not undergo CT after randomization. The baseline screening test was positive in 426 (30.3%) of 1406 subjects. Twenty-one lung cancers (prevalence1.5%) were found in 20 subjects: 18 non-small cell lung cancer (NSCLC), 2 small cell lung cancer (SCLC) and a case of typical carcinoid. Ten NSCLC (47.6%) were in Stage I. Sixteen fine needle aspirations were performed in 15 lung cancers, with a positive result in 12 (75%) cases. One biopsy only (6.3%) was performed on a benign lesion. Seventeen lung cancers (81%) were treated with surgical resection in 16 subjects. One subject underwent surgery for a benign lesion (5.5% of all surgical resections). After a median follow-up of 33 months, lung cancer was detected in 60 (4.7%) patients receiving LDCT and 34 (2.8%) control subjects (P = 0.016). Resectability rates were similar in both groups. More patients with stage I disease were detected by LDCT (54 vs. 34%; P = 0.06) and fewer cases were detected in the screening arm due to intercurrent symptoms. However, the number of advanced lung cancer cases was the same as in the control arm. Twenty patients in the LDCT group (1.6%) and 20 controls (1.7%) died of lung cancer, whereas 26 and 25 died of other causes, respectively. Relative reduction in mortality from lung CA with LDCT screening was 20% overdiagnosis and need for longer follow-up. Results of the baseline screening test in the active arm of the ITALUNG trial are substantially in line with those of RCT and observational studies. The mortality benefit from lung cancer screening by LDCT might be far smaller than anticipated. Screening with LDCT reduces mortality from lung CA. Background: Lung cancer is the third most common cancer and the leading cause of cancer deaths in the United States. Cancer of the lung and bronchus accounted for over 150,000 deaths in 2013 (more than the total number of deaths from colon, breast, and prostate cancer combined) with a median age at death of 72 years 13. Mortality rates for lung and bronchus cancer have decreased only

6 Page 6 of 11 slightly over the past decade. The majority of cases are still diagnosed at a later stage with a low five year relative survival rate. Given the burden of lung cancer on the US population, a suitable screening test for lung cancer has been sought for many years. Initial studies used sputum cytology and/or chest radiography. These failed to conclusively demonstrate improvements. In 2011, the results of the NCIsponsored National Lung Screening Trial (NLST) were published 24. The NLST showed that people aged years with a history of heavy smoking are 20% less likely to die from lung cancer if they are screened with low dose helical CT (LDCT) as compared to chest x-rays. LDCT minimizes radiation exposure compared to a standard chest CT. While LDCT reduces radiation exposure, the image quality is also reduced which in turn may influence readability. The NLST identified risks as well as benefits. For example, people screened with low dose helical CT had a higher overall rate of false-positive results, leading to a higher rate of invasive procedures and serious complications from those procedures. The results of the NLST study led to multiple professional societies endorsement of the use of LDCT for lung cancer screening. These include the American Cancer Society, the American College of Radiology, the American College of Chest Physicians, and the American Thoracic Society. To optimize the benefits of the use of LDCT for lung cancer screening, these professional societies acknowledge a careful implementation of its use; one with careful patient selection that balances the risks, harms, and benefits, while ensuring appropriate access to these services in centers of proven expertise in chest radiology, pulmonary thoracic surgery, and medical and radiation oncology. The centers should provide multidisciplinary and coordinated care with registry management of findings and follow up. In 2014, the USPSTF recommended annual screening for lung cancer with low-dose computed tomography in adults aged 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 a curative lung surgery (B recommendation). Effective Date: May 27, 2007 Reviewed Annually: November 11, 2015 Revised: May 8, 2013 May 20, 2015

7 Page 7 of 11 Appendix A As of May 15, 2015, the following sites in the Inland Empire have received the ACR Lung Cancer Screening Center Designation: 1. Eisenhower Imaging Center, Luci Curci Cancer Center, Bob Hope Drive, Rancho Mirage, CA a. Not contracted; would require member LOA for Medicare and Medi-Cal 2. San Antonio Community Hospital, 999 San Bernardino Road, Upland, CA a. Contracted for Medicare and blanket LOA for Medi-Cal 3. San Antonio Medical Plaza East, 685 North 13 th Ave., Upland, CA a. Not contracted; would require member LOA for Medicare and Medi-Cal 4. Imaging Healthcare Specialists, Temecula Valley, Hancock Ave., Ste. 105, Murrieta, CA a. Contracted for Medicare and Medi-Cal 5. Arrowhead Regional Medical Center, 400 N. Pepper, Colton, CA a. Contracted for Medicare and Medi-Cal Appendix B Patient and Physician Guide: National Lung Screening Trial (NLST)

8 Page 8 of 11 Bibliography: 1. Aberle DR, Adams AM, Berg CD, et al.: Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med 365(5): , Aetna Clinical Policy Bulletin: Lung Cancer Screening, Number 0380, April 10, Available at: Accessed May 15, American Cancer Society guidelines for lung cancer screening, Feb. 6, 2015, Available at: Accessed May 20, American College of Radiology, ACR Designated Lung Cancer Screening Center. Available at: Accessed May 15, American Lung Association. Providing Guidance on Lung Cancer Screening To Patients and Physicians. April 23, Available at SmallCell/DetailedGuide/non-small-cell-lung-cancer-detection. Accessed on April 15, Anthem Medical Policy, Computed Tomography Scans with or without Computer Assisted Detection (CAD) for Lung Cancer Screening, RAD.00043, April 7, Available at: Accessed on May 15, Bach, et al. Benefits and harms of CT screening for lung cancer: a systematic review. JAMA Jun 13; 307(22): Baldwin D, Duffy S, Wald N, Page R, Hansell D, Field J. UK Lung Screen (UKLS) nodule management protocol: modelling of a single screen randomised controlled trial of low-dose CT screening for lung cancer. Thorax 2011;66: Becker N, Delorme S, Kauczor H-U. LUSI: the German component of the European trial on the efficacy of multislice-ct for the early detection of lung cancer. Onkologie 2008;31:130 (PO320) 10. California Technology Assessment Forum (CTAF). Low Dose Spiral Computerized Tomography (LDSCT) Screening for Lung Cancer. October 19, Available at Accessed on April 15, Centers for Disease Control and Prevention. Lung Cancer Statistics. Available at: Accessed on 04/15/ Cigna Medical Coverage Policy: Computed Tomography, Low-Dose for Lung Cancer Screening, Policy Number 0007, February 15, Available at: eria_spiral_ct_for_lung_cancer_screening.pdf. Accessed May 15, Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG N); Centers for Medicare & Medicaid Services (CMS); February 5, 2015; Available at: Accessed on May 15, Field JK, Baldwin D, Brain K, et al; UKLS Team. CT screening for lung cancer in the UK: Position statement by UKLS investigators following the NLST report. Thorax. 2011;66(8): Gopal M, Abdullah SE, Grady JJ, Goodwin JS. Screening for lung cancer with low-dose computed tomography: a systematic review and meta-analysis of the baseline findings of randomized controlled trials. J Thorac Oncol Aug;5(8): Humphrey, et al. Screening for lung cancer with low-dose computed tomography: a systematic review to update the US Preventive Services Task Force recommendation. Ann Intern Med Sep 17; 159(6): Infante M, Cavuto S, Lutman F, et al. A randomized study of lung cancer screening with spiral computed tomography: three-year results from the DANTE trial. American Journal of Respiratory and Critical Care Medicine 2009;180: Jaklitsch MT, Jacobson FL, Austin JH, Field JK, Jett FR, Keshavjee S, 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 Throac Cardiovasc Surg Jul;144(1): Jett JR, Midthun DE. Screening for lung cancer: For patients at increased risk for lung cancer, it works. Ann Intern Med. 2011;155(8):

9 Page 9 of Lung Cancer Alliance, Screen for Lung Cancer. Where do I go? Available at Accessed on April 14, Manser, et al, Screening for lung cancer. Cochrane Database Syst Rev Jun 21;6:CD Mazzone, et al., Components Necessary for High Quality Lung Cancer Screening, Chest Oct National Cancer Institute: PDQ Lung Cancer Screening. Bethesda, MD: National Cancer Institute. Date last modified 03/01/2013. Available at: Accessed on 04/15/ National Cancer Institute: Lung Cancer Screening Saves Lives: The National Lung Screening Trial, July 31, Available at: Accessed on May 15, National Comprehensive Cancer Network (NCCN). NCCN GUIDELINES Clinical Guidelines in Oncology. National Comprehensive Cancer Network, Inc 2012, All Rights Reserved. Lung Cancer Screening v Available at: Accessed on April 15, Pedersen J, Ashraf H, Dirksen A, et al. The Danish Randomized Lung Cancer CT Screening Trial overall design and results of the prevalence round. Journal of Thoracic Oncology 2009;4: Pegna L, Picozzi G, Mascalchi M, et al. Design, recruitment and baseline results of the ITALUNG trial for lung cancer screening with low-dose CT. Lung Cancer 2009;64: Prosch H, Schaefer-Prokop C. Screening for lung cancer. Curr Opin Oncol Mar; 26(2): Saghir Z, Dirksen A, Ashraf H, Bach KS, Brodersen J, Clementsen PF, 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. Throax Apr;67(4): Silvestri G. Screening for lung cancer: It works, but does it really work? Ann Intern Med. 2011;155(8) The Wall Street Journal, December 1, Wellpoint to Cover Lung CT Scans for Heavy Smokers. By Anna Wilde Mathews. Available at: Accessed on 04/15/ United States Preventive Services Task Force, Lung Cancer Screening Recommendation Statement, December Available at: Accessed May 15, Updated Requirements for Lung Cancer Screening with Low-Dose CT, Medi-Cal Benefit Manual, Radiology: Diagnostic, page 3, February 2, van den Bergh K, Essink-Blot M, Borsboom G, et al. Short-term health-related quality of life consequences in a lung cancer CT screening trial (NELSON). British Journal of Cancer 2010;102: Wender et al, American Cancer Society Lung Cancer Screening Guidelines. CA Cancer J Clin 2013;63: Disclaimer IEHP Clinical Authorization Guidelines (CAG) are developed to assist in administering plan benefits, they do not constitute a description of plan benefits. The Clinical Authorization Guidelines (CAG) express IEHP's determination of whether certain services or supplies are medically necessary, experimental and investigational, or cosmetic. IEHP has reached these conclusions based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). IEHP makes no representations and accepts no liability with respect to the content of any external information cited or relied upon in the Clinical Authorization Guidelines (CAG). IEHP expressly and solely reserves the right to revise the Clinical Authorization Guidelines (CAG), as clinical information changes.

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