New Frontiers to Cancer Care Symposium. Lung Cancer Screening Update: Pros, Cons, and Understanding the CMS Requirements

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1 Thursday October 15, 2015 New Frontiers to Cancer Care Symposium Lung Cancer Screening Update: Pros, Cons, and Understanding the CMS Requirements Mark S. Parker, M.D., F.A.C.R. Professor, Diagnostic Radiology and Internal Medicine Director, Thoracic Imaging Division Director, Lung Cancer Screening Program

2 Learning Objectives 1. Understand the False positive rates False negative rates Over-diagnosis rates Radiation doses associated LCS Cost effectiveness relative to other commonly used screens 2. Know the requirements mandated by CMS Appropriately order a LCS Necessary to receive reimbursement

3 Epidemiology 1, 2 1. What is non-small cell lung cancer? Accessed 21 August American Cancer Society: Cancer Facts and Figures 2015: Accessed 21 August 2015.

4 USA: 2015 Statistics 1, 2 New Lung Cancer Diagnoses ~221, ,610 in men 105,590 in women Lung Cancer Deaths ~158,040 86,380 in men 71,660 in women Lung cancer alone accounts for 27% of all cancer-related deaths 1. What is non-small cell lung cancer? Accessed 21 August American Cancer Society: Cancer Facts and Figures 2015: Accessed 21 August 2015.

5 Background 1, 2 Among the top four deadliest cancers in the U.S. (lung, prostate, breast and colorectal), lung cancer historically was the only cancer not subject to routine screening. Fig. 1. Screening digital mammogram revealing a spiculated upper quadrant lesion. Fig. 2. Transrectal ultrasound shows an indeterminate prostate lesion (arrows). Fig. 3. Virtual colonoscopy depicts a distal colonic polyploid lesion (arrow).

6 Background 3 Historically, this reflected no screening test (e.g. chest radiography, sputum cytology) had reduced lung-cancer specific mortality Dramatically changed with the National Lung Screening Trial (NLST) results release in November 2011 Randomized control trial showed that high-risk persons who received a baseline and 2 subsequent annual low-dose helical CT (LDCT) scans had a 20% lower risk of death from lung cancer compared to those screened with chest radiographs 3. National Lung Screening Trial Research Team, Aberle DR, Adams AM, Berg CD, Black WC, et al. Reduced Lung Cancer Mortality Rate with Low-Dose Computed Tomography. N Engl J Med 2011; 365(5):

7 Society / Organizational Endorsements 4-10 ~ 40 major medical societies and organizations have endorsed LDCT American Lung Association (ALA) American College of Chest Physicians (ACCP) American Society of Clinical Oncology (ASCO) National Comprehensive Cancer Network (NCCN) American Cancer Society (ACS) Lung Cancer Alliance (LCA) American Association of Thoracic Surgery (AATS) 4. American Lung Association. American Lung Association provides guidance on lung cancer screening. Available at: guidelines/. Accessed August 21, New lung cancer guidelines recommends offering screening to high-risk individuals. Available at: News/Press-Releases/2013/05/New-Lung-Cancer-Guidelines- Recommends-Establishment-of-Screening- Programs. Accessed August 21, Lung cancer guidelines. Available at: guidelines/lung-cancer. Accessed August 21, National Comprehensive Cancer Network. Available at: = nccn.org /professionals / physician_gls/pdf/lung _screening.pdf. Accessed August 21, American Cancer Society new lung cancer screening guidelines for heavy smokers. Available at: cancer/news/new-lung-cancer-screening-guidelines-for-heavy- smokers. Accessed August 21, Lung Cancer Alliance. National Framework for Excellence in Lung Cancer Screening and Continuum of Care: uniting the at-risk public with responsible medical care now. Available at: national-framework-for-lung-screening-excellence.html. Accessed August 21, 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;144:33 38.

8 United States Preventive Services Task Force 11 December Issued its final recommendation statement and awarded LDCT a B grade (equivalent to screening mammography) B grade - High certainty the net benefit is moderate or there is moderate certainty the net benefit is moderate to substantial Affordable Health Care Act (ACA) - Private insurers MUST cover without copay all medical procedures receiving a grade B or higher from the USPSTF 11 uspreventiveservicestaskforce.org/uspstf13/lungcan/lungcanfact. pdf). Accessed 21 August 2015.

9 Centers for Medicare and Medicaid Services 12 February 2015 CMS issued its final decision to approve reimbursement for LDCT lung screening for Qualified Medicare Beneficiaries Who is Eligible for Screening? Age years Asymptomatic Current cigarette smoker at least 30 pack-year history Former smoker quit within the last 15-years

10 Centers for Medicare and Medicaid Services 12 Mandates PCP or other qualified healthcare provider both counsel and document mutual participation in a shared decision-making visit prior to submitting a written order for lung cancer screening

11 Centers for Medicare and Medicaid Services 12 Mandates PCP or other qualified healthcare provider both counsel and document mutual participation in a shared decision-making visit prior to submitting a written order for lung cancer screening Pros (benefits) and Cons (harms) of screening Over-diagnosis rate False positive and negative rates Radiation exposure

12 Pros (Benefits) and Cons (Harms) 2, 3, 13, 14 Cons Lung cancer is often insidious Producing minimal or no clinical symptoms until it is far advanced and no longer curable by surgical resection Most patients already have locally advanced or metastatic disease at their 1st clinical presentation Only 15-25% of patients have potentially resectable, earlystage disease confined to the chest at presentation If a lung cancer is not resectable when first discovered, most affected patients will die within the next 9 months Despite surgical and chemo-radiation therapy advances, 5-year survival rate for all newly diagnosed lung cancers of all stages remains a dismal 16% (1 in 7) Pros NLST: 412 pts. (85%) diagnosed clinical Stage I lung cancer Estimated 10-year survival rate in this subgroup 88% Among 302 participants with clinical Stage I cancer who underwent surgical resection within 1 month after diagnosis, the survival rate: 92% 2. American Cancer Society: Cancer Facts and Figures 2015: ment/acspc pdf. Accessed 21 August National Lung Screening Trial Research Team, Aberle DR, Adams AM, Berg CD, Black WC, et al. Reduced Lung Cancer Mortality Rate with Low-Dose Computed Tomography. N Engl J Med 2011; 365(5): Ellis PM, Vandermeer R. Delays in diagnosis of lung cancer. J Thorac Dis. 2011;3: Henschke CI, Yankelevitz DF, Libby DM. Survival of patients with stage I lung cancer detected on CT screening. N Engl J Med 2006; 17:

13 Over-Diagnosis Detect lung cancers patient may die with rather than die from Over-treatment: Unnecessary tests / invasive procedures / therapies Not unique to LCS Intrinsic to cancer screening in general 15. Parker MS, Groves RC, Fowler AA, Shepherd RW, Cassano AD, et al. Lung Cancer Screening With Low-dose Computed Tomography: An Analysis of the MEDCAC Decision. J Thorac Imag: 30(1); 15-23, January Alvarado M, Ozanne E, Esserman L. Overdiagnosis and overtreatment of breast cancer. Am Soc Clin Oncol Educ Book. 2012;e40 e45. DOI: /EdBook_AM e Gøtzsche PC, Jørgensen KJ. Screening for breast cancer with mammography. Cochrane Database Syst Rev. 2013;6: CD

14 Over-Diagnosis Example: Screening Mammography Detection of DCIS has increased markedly in recent years secondary to widespread use of screening mammography: Now accounts for 25-40% of mammographically detected cancers May detect cancers / cases of non-invasive DCIS that warrant treatment Alternatively, we may also detect cancers or other cases of DCIS that will never cause symptoms or threaten the individual s life Since we cannot distinguish those cases of DCIS that do and do not require treatment all lesions are similarly treated Results in an over-diagnosis of breast cancer Results in over treatment exposing women to unnecessary additional imaging, biopsy, surgery, potentially chemotherapy and radiation therapy 15. Parker MS, Groves RC, Fowler AA, Shepherd RW, Cassano AD, et al. Lung Cancer Screening With Low-dose Computed Tomography: An Analysis of the MEDCAC Decision. J Thorac Imag: 30(1); 15-23, January Alvarado M, Ozanne E, Esserman L. Overdiagnosis and overtreatment of breast cancer. Am Soc Clin Oncol Educ Book. 2012;e40 e45. DOI: /EdBook_AM e Gøtzsche PC, Jørgensen KJ. Screening for breast cancer with mammography. Cochrane Database Syst Rev. 2013;6: CD Harris AT. Case 41: Ductal carcinoma in situ. Radiology. 2001;221 (3): Conant EF, Brennecke CM. Breast imaging, case review. Mosby Inc. (2006) ISBN: Yamada T, Mori N, Watanabe M et-al. Radiologic-pathologic correlation of ductal carcinoma in situ. RadioGraphics. 2010;30 (5):

15 Over-Diagnosis 3, 21, 22 Analogously, in the NLST, investigators found ~18% (about 1 in 5) detected cancers were likely indolent NLST also stressed this over-diagnosis rate would diminish as experience with LCS increased and this estimate was an upper limit of the potential over-diagnosis rate Atypical Adenomatous Hyperplasia Adenocarcinoma In Situ Supporting this hypothesis, the USPSTF modeling studies estimate that only 10-12% of screen-detected lung cancer cases would not otherwise be detected in a patient s lifetime Early Invasive Adenocarcinoma 3. National Lung Screening Trial Research Team, Aberle DR, Adams AM, Berg CD, Black WC, et al. Reduced Lung Cancer Mortality Rate with Low-Dose Computed Tomography. N Engl J Med 2011; 365(5): Patz EF Jr, Pinsky P, Gatsonis C, et al. Overdiagnosis in low- dose computed tomography screening for lung cancer. JAMA Intern Med. 2014;174: USPSTF: screen high-risk smokers for lung cancer. Available at: Cancer/ Accessed July 8, 2014.

16 False Negative Rate 15, studies: Lung Cancer Screening CT Sensitivity Range: % (most often >90%) with a resultant False-negative rate: 0-20% 15. Parker MS, Groves RC, Fowler AA, Shepherd RW, Cassano AD, et al. Lung Cancer Screening With Low-dose Computed Tomography: An Analysis of the MEDCAC Decision. J Thorac Imag: 30(1); 15-23, January Menezes RJ, Roberts HC, Paul NS, et al. Lung cancer screening using low-dose computed tomography in at-risk individuals: the Toronto experience. Lung Cancer. 2010; 67: Swensen SJ, Jett JR, Hartman TE, et al. CT screening for lung cancer: five-year prospective experience. Radiology. 2005; 235: Toyoda Y, Nakayama T, Kusunoki Y, et al. Sensitivity and specificity of lung cancer screening using chest low-dose computed tomography. Br J Cancer. 2008;98: Tsushima K, Sone S, Hanaoka T, et al. Radiological diagnosis of small pulmonary nodules detected on low-dose screening computed tomography. Respirology Nov;13(6): van Klaveren RJ, Oudkerk M, Prokop M, et al. Management of lung nodules detected by volume CT scanning. N Engl J Med. 2009;361: Veronesi G, Bellomi M, Mulshine JL, et al. Lung cancer screening with low-dose computed tomography: a non-invasive diagnostic protocol for baseline lung nodules. Lung Cancer. 2008;61: 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: ;13:

17 False Negative Rate 15, 22, 23, Contrast these false-negative rates with that of other commonly employed and accepted screening exams Data supports Lung Cancer Screening CT is a more efficacious screening test False-Negative Rates of Commonly Accepted Screens Contrasted with LCS-CT: Screening Test False-Negative Rate (%) Lung Cancer Screening-LDCT 0-20% Mammography 20% Flexible Sigmoidoscopy Colonoscopy 15. Parker MS, Groves RC, Fowler AA, Shepherd RW, Cassano AD, et al. Lung Cancer Screening With Low-dose Computed Tomography: An Analysis of the MEDCAC Decision. J Thorac Imag: 30(1); 15-23, January USPSTF: screen high-risk smokers for lung cancer. Available at: Cancer/ Accessed July 8, Menezes RJ, Roberts HC, Paul NS, et al. Lung cancer screening using low-dose computed tomography in at-risk individuals: the Toronto experience. Lung Cancer. 2010; 67: 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: ;13: National Cancer Institute Fact Sheet: Mammograms. Avail- able at: mammograms. Accessed June 25, Elmore JG, Barton MB, Moceri VM, et al. Ten-year risk of false positive screening mammograms and clinical breast examinations. N Engl J Med. 1998;338: Hubbard RA, Kerlikowske K, Flowers CI, et al. Cumulative probability of false-positive recall or biopsy recommendation after 10 years of screening mammography: a cohort study. Ann Intern Med. 2011;155: Schoen RE, Oinsky PF, Weissfeld JL, et al. Colorectal cancers not detected by screening flexible sigmoidoscopy in the prostate, lung, colorectal and ovarian cancer screening trial. Gastrointest Endosc. 2012;75: Singh H, Turner D, Xue L, et al. Risk of Developing Colorectal Cancer Following a Negative Colonoscopy Examination Evidence for a 10-Year Interval Between Colonoscopies. JAMA 2006; 295(20): % 28-47%

18 False Positive Rate 3, 15 NLST: Defined Positive Screen as one in which a noncalcified nodule at least 4mm in diameter was detected Across the baseline and 2 annual rounds of screens 96% of the positive CT screens and 95% of the positive chest x-ray screens were falsely positive Suspicious imaging finding(s) did NOT represent a true lung cancer 3. National Lung Screening Trial Research Team, Aberle DR, Adams AM, Berg CD, Black WC, et al. Reduced Lung Cancer Mortality Rate with Low-Dose Computed Tomography. N Engl J Med 2011; 365(5): Parker MS, Groves RC, Fowler AA, Shepherd RW, Cassano AD, et al. Lung Cancer Screening With Low-dose Computed Tomography: An Analysis of the MEDCAC Decision. J Thorac Imag: 30(1); 15-23, January

19 False Positive Rate 15, 36 Caveat: Simply detecting a nodule invasive procedure Value of low-dose CT screening: Program is built on repeat low-dose CT scans, not invasive procedures 96% of false-positive findings are sorted out with repeat LDCT imaging not biopsy or surgery, but imaging Baseline 3 months latter: Course of Steroids Organizing Pneumonia 15. Parker MS, Groves RC, Fowler AA, Shepherd RW, Cassano AD, et al. Lung Cancer Screening With Low-dose Computed Tomography: An Analysis of the MEDCAC Decision. J Thorac Imag: 30(1); 15-23, January Caution advised for lung cancer screening in older adults. Available at: Accessed August 25, 2014.

20 False Positive Rate 15, 37, 38 American College of Radiology - Lung-RADS system for specific reporting, follow-up, and management of both (-) and (+) screens Lung-RADS classification scheme similar to Bi-Rads system for screening mammography dictated largely by lesion size and morphology Lung-RADS increased the size threshold actionable nodule from 4 to 6mm based of a large amount of supporting data Further substantially reduce the number of false positive studies compared with NLST Markedly reduce the need to workup positive studies and stratify the pertinent imaging findings over the NLST 15. Parker MS, Groves RC, Fowler AA, Shepherd RW, Cassano AD, et al. Lung Cancer Screening With Low-dose Computed Tomography: An Analysis of the MEDCAC Decision. J Thorac Imag: 30(1); 15-23, January Medicare panel raises doubts about CT lung cancer screening. Available at: Accessed June 14, Lung CT screening reporting and data system (Lung-RADS). Available at: LungRADS. Accessed 25 June 2014.

21 False Positive Rate 15, 22, By applying the Lung-RADS system, it is estimated that only 1 in 10 individuals with a Positive Lung Cancer CT Screen would require a biopsy Lung Cancer Screening CT actually proves more efficacious than commonly accepted and widely utilized screening tests False (+) Rates of Other Accepted Screens versus LDCT Screening Test False (+) Results Over 10 Annual Screens (%) Cancer Deaths Prevented Mammography 50-60% 1 per 1905 screens Flexible Sigmoidoscopy 30.3 (men) / 19.3 (women) 1 per 871 screens Lung Cancer CT 96% 1 per 320 screens 15. Parker MS, Groves RC, Fowler AA, Shepherd RW, Cassano AD, et al. Lung Cancer Screening With Low-dose Computed Tomography: An Analysis of the MEDCAC Decision. J Thorac Imag: 30(1); 15-23, January USPSTF: screen high-risk smokers for lung cancer. Available at: Cancer/ Accessed July 8, Medicare panel raises doubts about CT lung cancer screening. Available at: Accessed June 14, Lung CT screening reporting and data system (Lung-RADS). Available at: LungRADS. Accessed 25 June National Cancer Institute Fact Sheet: Mammograms. Available at: mammograms. Accessed June 25, Elmore JG, Barton MB, Moceri VM, et al. Ten-year risk of false positive screening mammograms and clinical breast examinations. N Engl J Med. 1998;338: Hubbard RA, Kerlikowske K, Flowers CI, et al. Cumulative probability of false-positive recall or biopsy recommendation after 10 years of screening mammography: a cohort study. Ann Intern Med. 2011;155: Croswell JM, Kramer BS, Kreimer AR, et al. Cumulative incidence of false-positive results in repeated, multimodal cancer screening. Ann Fam Med. 2009;7: DOI: /afm.942.

22 Measuring Radiation Exposure Millisievert (msv) Dose is ~ 6 months of normal background exposure Modality Natural Background ½ PPD Smoker PA and Lateral Chest V/Q Lung Scan Standard Chest CT MDCTPA Abdominal-Pelvic CT PET-CT Scan Coronary Angiogram Effective Radiation Dose (msv) 3.6 msv/year (add 1.5 msv Colorado / New Mexico 0.18 msv 0.1 msv 2.2 msv 3 msv 5 msv 8-10 msv 14.0 msv 7.0 msv Cardiac Stress Test Lung Cancer Screen 9 msv 1.5 msv Encyclopedia of Science: Atomic and Nuclear Physics; accessed 06 February Accessed 15 September Accessed 15 September 2015.

23 Cost 15, 54, 55 Many concerns have been raised as to whether the health care system can afford the projected costs of a national lung cancer screening program Joshua A. Roth, PhD, MHA (Postdoctoral Research Fellow at the Fred Hutchinson Cancer Research Center in Seattle, Washington) recently showed adding LDCT screening to the Medicare Program could result in diagnosis ~ 54,900 earlier-stage and more treatable lung cancers over a 5-year period Postulated ~$5.6 billion would be spent on an estimated 11.2 million additional LDCT scans alone $1.1 billion on diagnostic workups $2.6 billion on cancer care Total cost of $9.3 billion to Medicare Total 5-year expenditure equivalent in premiums per Medicare member only a $3.00 / mos. increase 15. Parker MS, Groves RC, RW, Cassano AD, et al. Lung Cancer Screening With Low-dose Computed Tomography: An Analysis of the MEDCAC Decision. J Thorac Imag: 30(1); 15-23, January CT lung cancer screening would cost Medicare $9 billion. Available at: Accessed September 3, Roth JA, Sullivan SD, Ravelo A, et al. Low-dose computed tomography lung cancer screening in the Medicare program: projected clinical, resource, and budget impact [abstract 6501]. J Clin Oncol. 2014;32(suppl):5s.

24 Cost 15, 56, 57 Pyenson et al found: Lung Cancer Screening in high-risk Medicare-aged persons is more cost-effective than screening for cervical and breast cancer and comparable to colorectal cancer screening Determined 4.9 million Medicare beneficiaries would be eligible for screening (USPSTF) If all 4.9 million beneficiaries were screened and treated consistently beginning at age 55 ~358,000 additional people with current or prior lung cancer would still be alive Estimated total cost of a life-year saved with Lung Cancer Screening $18,452 / estimated average annual cost of $241 per person screened Cost of treating late stage lung cancer 2X that of finding and curing early stage lung cancer 15. Parker MS, Groves RC, RW, Cassano AD, et al. Lung Cancer Screening With Low-dose Computed Tomography: An Analysis of the MEDCAC Decision. J Thorac Imag: 30(1); 15-23, January CT PyensonBS,HenschkeCI,YankelevitzDF.Offeringlungcancer screening to high-risk Medicare beneficiaries saves lives and is cost effective: an actuarial analysis. Am Health Drug Benefits. 2014;7: Lung cancer screening guidelines updated: guidelines/ /1. accessed 14 October 2012.

25 Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG N) 58 February 5, 2015: CMS issued a National Coverage Decision Memo Announced LDCT Screening as a new benefit for Eligible Beneficiaries Effective Immediately To date, have not released Reimbursement Instructions Current Recommendations: Document / Hold all Medicare Claims 58.

26 CMS Requirements from the PCP 58 Beneficiary MUST receive written order for Lung Cancer Screening CT Follow Lung Cancer Screening Counseling and Shared Decision-Making Visit Who does the counseling and is involved in the shared-making decision: Furnished by a Physician or Qualified Non-Physician Practitioner (e.g. physician assistant, nurse practitioner, or clinical registered nurse) 58.

27 CMS Requirements from the PCP Role of Patient Navigator-Facilitator 58, 59 I. Order Entry: Determination of Beneficiary Eligibility for Lung Cancer Screen CT Age Date of Birth Documentation of the absence of symptoms of lung cancer Specific calculation of smoking history in pack-years Former smokers: number of years since quitting cords.pdf. Accessed 23 September 2015.

28 CMS Requirements from the PCP Role of Patient Navigator-Facilitator II. Documentation of a Shared decision includes: Benefits and Potential Harms of Screening Over-diagnosis False positive rate Radiation exposure Counseling on the importance of adherence to annual LDCT screens Follow-up diagnostic testing 58, rds.pdf. Accessed 23 September 2015

29 CMS Requirements from the PCP 58 Role of Patient Navigator-Facilitator III. Counseling on abstinence if former smoker IV. Counseling current smokers on various smoking cessation programs and interventions and furnishing needed materials and resources QUIT-NOW ( ) Quit Now Virginia- free, telephone-based help line with smoking cessation coaches and educational materials to help persons quit American Lung Association (1-800-LUNGUSA) American Cancer Society ( ) V. Counseling on the impact of patient-specific comorbidities and their ability or willingness to undergo diagnostic testing and curative surgical resection 58.

30 CMS Requirements from the PCP 58 Role of Patient Navigator-Facilitator VI. NPN of ordering physician on baseline and follow-up screens VII. Follow-up and communication of abnormal results / diagnostic tests VIII. Annual follow-up reminders for LungRADS 1 and LungRADS 2 patients IX. Enter data into and maintain LCS data into the ACR Lung Cancer Screening Registry (approved by CMS) Screening-Registry 58.

31 Multi-Disciplinary Team Thoracic Radiologists Primary Care Physicians Pulmonologists Interventional Radiologists Nuclear PET- CT Physicians Medical Oncologists Surgical Oncologists Thoracic Surgeons Patient Navigator /Smoking Counselor

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