Free Lung Cancer Screening Proposal - BTMed.org

Free Lung Cancer Screening Proposal - BTMed.org

Andrea McKee, M.D. Chairman Department Radiation Oncology Sophia Gordon Cancer Center Lahey Clinic May 15, 2012 www.Lahey.org/LungScreening 1-855-CT-CHEST Disclosures None www.Lahey.org/LungScreening 1-855-CT-CHEST Outline Lung Cancer Background Incidence/Mortality National Lung Screening Trial (NLST) National Comprehensive Cancer Network (NCCN) Lung Cancer Screening at Lahey Clinic

Program Structure Structured Reporting LUNG-RADS Classification System Challenges Rescue Lung, Rescue Life www.Lahey.org/LungScreening 1-855-CT-CHEST Lung Cancer Incidence/Mortality: US Number one cause of cancer-related death in the US and World Kills more women than Breast, Ovarian, and Uterus Cancer Combined 200K new cases/yr 160K deaths/yr

www.Lahey.org/LungScreening 1-855-CT-CHEST Risk Factors? www.Lahey.org/LungScreening 1-855-CT-CHEST Tobacco Trends History of tobacco use <20% in 2006 42% in 1965 Demonization campaign Higher prevalence Military (1 in 3) vs (1 in 5) Less educated Higher risk Rescue workers

Occupational exposure www.Lahey.org/LungScreening 1-855-CT-CHEST Tobacco Trends Competition has been tough - tobacco industry, Hollywood, press Guard against withholding of health care services or advocacy based on social history slippery slope www.Lahey.org/LungScreening 1-855-CT-CHEST Lung Cancer Incidence/Mortality: US Primary Prevention (Smoking Cessation) Success Decreased number of overall lung cancer deaths in US Despite success 160K still die every year from lung cancer Most people who die from lung cancer now are FORMER SMOKERS

www.Lahey.org/LungScreening 1-855-CT-CHEST Lung Cancer Incidence/Mortality: US Primary Prevention (Smoking Cessation) Success Decreased number of overall lung cancer deaths in US Despite success 160K still die every year from lung cancer Most people who die from lung cancer now are FORMER SMOKERS 35% of Lung Cancer Diagnosis Current Smokers 50% of Lung Cancer Diagnosis Former Smokers 15% of Lung Cancer Diagnosis Never Smokers Lung Cancer 5-Year Overall Survival Remains Unchanged 1975 12%, Current 15% www.Lahey.org/LungScreening 1-855-CT-CHEST Lung Cancer Incidence/Mortality: US

Primary Prevention (Smoking Cessation) Success Decreased number of overall lung cancer deaths in US Despite success 160K still die every year from lung cancer Most people who die from lung cancer now are FORMER SMOKERS Lung Cancer 5-Year Overall Survival 1975 12%, Current 15% Stagnant survival result of absent Secondary Prevention FORMER SMOKERS cannot benefit from PRIMARY PREVENTION Secondary Prevention = LUNG SCREENING LUNG SCREENING Find disease at early more treatable stage LUNG SCREENING GOAL Decrease Mortality not Incidence www.Lahey.org/LungScreening 1-855-CT-CHEST

Lung Cancer Screening Data to support screening been around awhile NEJM October 2006 31,567 patients baseline screened with low dose CT from 1993-2005 484 lung cancers detected (85% clinical stage I) 10 year survival 92% for those having surgery 8 patients refusing therapy died within 5 years of diagnosis www.Lahey.org/LungScreening 1-855-CT-CHEST Lung Cancer Treatment NSCLC: Unscreened Population NSCLC Stage I, II, IIIA Potential Cure Surgical resection

Radiotherapy Chemotherapy Stage IIIB/IV Palliative Goldstraw P, Crowley J, Chansky K, et al. (2007) The IASLC Lung Cancer Staging Project: proposals for the revision of the TNM stage groupings in the forthcoming (seventh) edition of the TNM Classification of malignant tumours. J Thorac Oncol 2:706714. www.Lahey.org/LungScreening 1-855-CT-CHEST National Lung Screening Trial Results: Stage Shift www.Lahey.org/LungScreening 1-855-CT-CHEST Stage IV NSCLC

<1% = 5 year OS www.Lahey.org/LungScreening 1-855-CT-CHEST Incidental Finding on CXR Stage T1BN0 58% 5-year Overall Survival Goldstraw P, Crowley J, Chansky K, et al. (2007) The IASLC Lung Cancer Staging Project: proposals for the revision of the TNM stage groupings in the forthcoming (seventh) edition of the TNM Classification of malignant tumours. J Thorac Oncol 2:706714. www.Lahey.org/LungScreening 1-855-CT-CHEST Annals of Internal Medicine October 2011 62 year-old female with a history of well-controlled hypertension presents for routine follow-up. She is

asymptomatic and feels well. She has jogged 3 miles 3 times weekly for years with no recent change in exercise tolerance. She has a 30 pack-year history of tobacco use but quit 10 years ago. Normal physical exam. She read a recent study that found a benefit to screening with LDCT and inquires if this is appropriate for her? What should you recommend? www.Lahey.org/LungScreening 1-855-CT-CHEST Secondary Prevention Preclinical Diagnosis: Screening Awareness 5mm nodule 6 month fu diagnostic CT recommended 7mm NSCLC treated with lobectomy and nodal evaluation

T1aN0 (screened) What is this patients 5-year overall survival? www.Lahey.org/LungScreening 1-855-CT-CHEST Secondary Prevention Preclinical Diagnosis: Screening Awareness 92% = 5 year OS www.Lahey.org/LungScreening 1-855-CT-CHEST Secondary Prevention Preclinical Diagnosis: Screening Awareness 85% of patients in screened population have stage I lung cancer Asymptomatic 58% 5-year OS Screening Stage I

92% 10-year OS Symptomatic Stage IV 1% 5-year OS www.Lahey.org/LungScreening 1-855-CT-CHEST US Cancer Mortality Rates Secondary Prevention www.Lahey.org/LungScreening 1-855-CT-CHEST U.S. Cancer Statistics Working Group. United States Cancer Statistics: 19992007 Incidence and Mortality Web-based Report. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute; 2010. Available at: www.cdc.gov/uscs.

US Cancer Mortality Rates Secondary Prevention PSA Mammography Colonoscopy www.Lahey.org/LungScreening 1-855-CT-CHEST U.S. Cancer Statistics Working Group. United States Cancer Statistics: 19992007 Incidence and Mortality Web-based Report. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute; 2010. Available at: www.cdc.gov/uscs. National Lung Screening Trial (NLST): 6/29/2011 National Lung Screening Trial Research Team (2011) Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med 365(5):395409.

www.Lahey.org/LungScreening 1-855-CT-CHEST National Lung Screening Trial Design Overview Multicenter Randomized Controlled Trial Sponsor: NCI Division of Cancer Treatment and Diagnosis 33 US Screening Centers NCI Division of Cancer Prevention (LSS) American College of Radiology Imaging Network (ACRIN) $300,000,000 + www.Lahey.org/LungScreening 1-855-CT-CHEST National Lung Screening Trial Design Overview 53,456 participants Exclusions

Enrolled 2002 2004 Metallic implants chest or back Treatment or evidence of cancer in previous 5 Ages 55-74 Greater than 30 pack-year smoking history years

History of lung cancer Prior lung resection except needle biopsy Home O2 requirement Symptoms: Hemoptysis, weight loss, treated respiratory infection within past 12 weeks Chest CT within previous 18 months Participation in other cancer screening/prevention trial Unable to lie on back with arms above head Active or quit < 15 years National Lung Screening Trial Research Team (2011) Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med 365(5):395409. www.Lahey.org/LungScreening 1-855-CT-CHEST National Lung Screening Trial Design Overview Treatment Arms: Low Dose Chest CT (1.5 mSv)

PA Chest Radiograph (0.02 mSv) Screening Intervals: T0: Baseline prevalence screen T1: Year 1 incidence screen T2: Year 2 incidence screen Positive Test Non-calcified nodule greater than 4mm in mean diameter Other findings suspicious for lung cancer (adenopathy, effusion) Workup of positives determined by PCPs not NLST www.Lahey.org/LungScreening NLST reading radiologist recommendation available 1-855-CT-CHEST National Lung Screening Trial Results: Mortality Lung cancer specific mortality 20% reduction in lung cancer specific mortality LDCT = 356 deaths, CXR = 443 deaths

Median follow-up 6.5 years Overall mortality 6.6% reduction in overall mortality LDCT = 1877 deaths, CXR = 2000 deaths Not statistically significant when lung cancer deaths excluded National Lung Screening Trial Research Team (2011) Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med 365(5):395409. www.Lahey.org/LungScreening 1-855-CT-CHEST National Lung Screening Trial Results: Other Lung cancer prevalence: 1% 1 in 100 at risk patients have cancer Lung cancer annual incidence: 0.5 0.8% Decrease in # of late stage cancers in CT group vs CXR

Real stage shift not just overdiagnosis Small cell lung cancer Not detected at earlier stage Overrepresented as interval cancers Number Needed to Screen (NNS) is 320 National Lung Screening Trial Research Team (2011) Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med 365(5):395409. www.Lahey.org/LungScreening 1-855-CT-CHEST National Lung Screening Trial Results: Rate of Positive ScreeningsAq CT (24.2%) > 3x more sensitive than CXR (6.9%) T0 & T1 Rate: 27-28% T2 Rate:

16.8% 2 year stability benign (Fleischner Guidelines) Expected rate for ongoing LDCT screening At least one positive result (3 screens): Significant incidental finding: 39.1% 7.5% Not screening everyone highly selected group (3%) National Lung Screening Trial Research Team (2011) Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med 365(5):395409. www.Lahey.org/LungScreening 1-855-CT-CHEST National Lung Screening Trial Results: Positive Workup/Adverse Events False Positives Most have noninvasive imaging follow-up

CXR: 14.4% Chest CT: 49.8% PET/CT: 8.3% Invasive diagnostic procedures: Complication rate: 1.4% Major complication rate: 0.06% 2.6 % True Positives Invasive procedure major complication: 11.2% Surgical resection mortality: 1% www.Lahey.org/LungScreening 1-855-CT-CHEST NLST Results: False Positive Workup/Adverse Events False Positive Rate: 20-25%: Chance you will end up with a false positive

~10-12% for Mammography (Call back) False Discovery Rate (1-PPV): 96%: Chance if you are positive you do not have cancer Same as mammography False Positive Biopsy Rate 0.4-2.4%: Chance if screened you will have an unnecessary invasive procedure (LDCT) 7-15%: Chance if you end up having a biopsy it will be negative (mammography). www.Lahey.org/LungScreening 1-855-CT-CHEST NLST NEJM 6/29/2011 NCCN 10/26/2011 NLST Summary

20% lung cancer mortality benefit 7% overall mortality benefit 1 in 100 has lung cancer NNT = 320 Opportunity to save 30,000 lives/yr NCCN Considerations Prolonged debate Cost to Society Patient anxiety

Radiation exposure False positives/informed consent Operational concerns www.Lahey.org/LungScreening 1-855-CT-CHEST National Comprehensive Cancer Network (NCCN): 10/26/2011 NCCN Guidelines for Lung Cancer Screening (V.1.2012) www.nccn.org www.Lahey.org/LungScreening 1-855-CT-CHEST NCCN Recommendation Categories NCCN Guidelines for Lung Cancer Screening (V.1.2012) www.nccn.org

www.Lahey.org/LungScreening 1-855-CT-CHEST NCCN Recommendation Categories NCCN Guidelines for Lung Cancer Screening (V.1.2012) www.nccn.org www.Lahey.org/LungScreening 1-855-CT-CHEST NCCN High-Risk Groups www.Lahey.org/LungScreening 1-855-CT-CHEST NCCN High-Risk Group 2 Risk Factors Personal Cancer History

Lung, lymphoma, smoking related cancers Family History Lung Cancer in 1st Degree Relative Chronic Lung Disease Emphysema Pulmonary Fibrosis Carcinogen Exposure Arsenic, asbestos, cadmium, chromium, diesel fumes, nickel, radon, silica www.Lahey.org/LungScreening 1-855-CT-CHEST NCCN Guidelines Solid or Part Solid Nodules Follow-up NCCN Guidelines for Lung Cancer Screening (V.1.2012) www.nccn.org www.Lahey.org/LungScreening 1-855-CT-CHEST

Lung Cancer Screening Risks and Benefits (NCCN) NCCN Guidelines for Lung Cancer Screening (V.1.2012) www.nccn.org www.Lahey.org/LungScreening 1-855-CT-CHEST Overdiagnosis, Survival, Mortality Survival Diagnosis www.Lahey.org/LungScreening 1-855-CT-CHEST Death Overdiagnosis, Survival, Mortality Survival

Mortality Diagnosis www.Lahey.org/LungScreening 1-855-CT-CHEST Death Lung Cancer Mortality Survival Mortality 365 Death due to lung cancer = 20% 443 Diagnosis

www.Lahey.org/LungScreening 1-855-CT-CHEST Death Overall Mortality Survival Mortality 1877 2000 Diagnosis www.Lahey.org/LungScreening 1-855-CT-CHEST Death due to any cause across

entire group= 6.6% Death Overall Survival Benefit 7% Adjuvant Therapy Reduces Risk Breast cancer ACT chemotherapy 5 years anti-estrogen therapy Post-mastectomy RT Prostate Cancer Post prostatectomy RT Head and Neck cancer Post-operative chemoRT Cervix Cancer Post-operative chemoRT

Medical-legal consequences www.Lahey.org/LungScreening 1-855-CT-CHEST Overdiagnosis Determine time and cause of death in those patients diagnosed and treated for lung cancer Mortality Diagnosis www.Lahey.org/LungScreening 1-855-CT-CHEST Death CT Lung Cancer Screening Morbidity Radiation exposure MDCT resolution allows for dose reduction LDCT <1mSv, Mammography 0.7mSv

1 mSv www.Lahey.org/LungScreening 1-855-CT-CHEST 10 mSv Radiation Exposure LDCT <1 mSv Years of annual lung screening Mammogram Lumbar Spine Films Diagnostic Chest CT Triphasic CT AB/P Background Exposure

Colorado Occupational Exposure Transatlantic Flight .7 mSv 2 mSv 10 mSv 25 mSv 3 mSv/year 4.5 mSv/year 50 mSv/year .1 mSv 2 10 25 3 4.5 50 7 flights = 1 LDCT

10 -30 year latency period to develop secondary malignancies from RT exposure Average age of patients in screening trials is 62 www.Lahey.org/LungScreening 1-855-CT-CHEST LUNG-RADS Overview Purpose: Establish a standardized quality assurance tool to mirror the tool widely utilized in Mammography (BI-RADS). Objectives: Standardize terminology Organized reporting and assessment structure Data collection tool to facilitate outcome monitoring www.Lahey.org/LungScreening 1-855-CT-CHEST LUNG RADS Lung Number Category

S Category Category 1: Negative (12mo) Positive for extra-pulmonary Category 2: Negative with finding not suspicious for benign pulmonary findings lung cancer but requiring (12mo) clinical follow-up Category 3: Positive/likely Thyroid mass Aneurysm benign (follow-up per NCCN Kidney Mass guidelines) Category 4: Positive/suspicious for malignancy Category 5: Known cancer www.Lahey.org/LungScreening 1-855-CT-CHEST

LUNG RADS Lung Number Category Category 1: Negative (12mo) Category 2: Negative with benign pulmonary findings (12mo) Category 3: Positive/likely benign (FU per NCCN guidelines) Category 4: Positive/suspicious for malignancy Category 5: Known cancer

S Category Positive for extra-pulmonary finding not suspicious for lung cancer but requiring clinical follow-up www.Lahey.org/LungScreening 1-855-CT-CHEST Thyroid mass Aneurysm Kidney Mass Fracture An Actuarial Analysis Shows That Offering Lung Cancer Screening As An Insurance Benefit Would Save Lives At Relatively Low Cost

Cost per life-year saved would be below $19,000 www.Lahey.org/LungScreening 1-855-CT-CHEST Pyenson et al, Health Affairs 31, No.4 770779: April 2012 Cost-Effectiveness Private Insurance Coverage 11/2011 Anthem California 12/2011 Wellpoint www.Lahey.org/LungScreening 1-855-CT-CHEST Productivity Loss due to Cancer www.Lahey.org/LungScreening 1-855-CT-CHEST

Who Is Screening? MDACC Oncology Round Table Brigham and Womens Hospital Survey 3/2012 Georgetown University 32% Currently screening (n=104) Thomas Jefferson University

77% Starting screening program Hospital (n=77) UCSF Most CT lung screening programs have been launched in the past 9 Cedars-Sinai Medical Center months Yale University Cancer Center Mean # of patients screened in Mayo Clinic 2011 = 70 John Hopkins Medical Center 88% of patients pay out of pocket Memorial Sloan Kettering Cancer Center Lahey Clinic The Advisory Board Company 3/12 Self pay rate $170 to $1000 www.Lahey.org/LungScreening (Average $230)

1-855-CT-CHEST The Advisory Board Company 3/12 www.Lahey.org/LungScreening 1-855-CT-CHEST Barriers to Screening Applicability to patients outside study group? Duration of screening? Education/awareness/endorsement Access to care in the absence of established reimbursement Rescue Lung, Rescue Life www.Lahey.org/LungScreening 1-855-CT-CHEST Lung Cancer Screening Practices of Primary Care Physicians: Results From a National Survey 962 family physicians, general practitioners and general internists surveyed in 2006-2007

38% no test 55% CXR 22% LDCT <5% sputum cytology Multivariate modeling: Lung cancer screening endorsed by expert groups Screening shown to be effective Patients ask about screening www.Lahey.org/LungScreening 1-855-CT-CHEST Klabunde, PhD et al: Annals of Family Medicine Vol. 10, No.2 March/April 2012 Lung Cancer Screening Practices of Primary Care Physicians: Results From a National Survey

To date, because of a lack of evidence from rigorous studies, major expert groups have not recommended screening asymptomatic individuals, even those with heavy or longterm smoking histories, for lung cancer US Preventative Services Task Force American Cancer Society 2009 guidelines American College of Chest Physicians www.Lahey.org/LungScreening 1-855-CT-CHEST Klabunde, PhD et al: Annals of Family Medicine Vol. 10, No.2 March/April 2012 Screening Endorsements NCCN Category I recommendation to screen high-risk patients October 2011 American Lung Association April 2012

Best way to prevent lung cancer is to never smoke or quit LDCT for NLST group (does not give parameters on frequency) Do not screen with CXR LDCT not for everyone ALA to develop public health materials to educate patients Call to action to hospitals and screening centers to screen responsibly www.Lahey.org/LungScreening 1-855-CT-CHEST James Mulshine, MD, associate provost and vice president for research at Rush University Medical Center "With this positive trial result, we have the opportunity to realize the greatest single reduction of cancer mortality in the history of

the war on cancer. www.Lahey.org/LungScreening 1-855-CT-CHEST Why Free? Ethical Make lung screening available for all socioeconomic groups until CMS reimburses Power of Free Human Motivation Few people screened when charge Helping to Raise Awareness

Multidisciplinary centers may not need to charge (TBD) Seize Opportunities to fulfill Hospital Mission Save Lives, Growth, Innovation, Sustainability, Teamwork www.Lahey.org/LungScreening 1-855-CT-CHEST How Free? Existing Infrastructure Pilot Use existing time in CT schedule (30 slots on PET/CT per week) 1-855-CTCHEST Use downtime on installed CT Scanners M F: 6PM-9PM (12 scans per shift) Additional capacity exists at LCN and Burlington Sat/Sun: 12Hrs x 2

IT - build/manage database of findings January 9th started free lung screening www.Lahey.org/LungScreening 1-855-CT-CHEST LDCT Lung Screening Patient Calls (855-CT-CHEST) Patient Flow Intake Staff Evaluate Eligibility FAQ Given PCP Order www.Lahey.org/LungScreening 1-855-CT-CHEST

LDCT Lung Screening Patient Flow Patient Calls (855-CT-CHEST) Group 3 Dont Qualify (Refer to PCP) Intake Staff Evaluate Eligibility FAQ Given PCP Order www.Lahey.org/LungScreening 1-855-CT-CHEST

LDCT Lung Screening Patient Flow Patient Calls (855-CT-CHEST) Group 3 (Refer to PCP) Dont Qualify Dont Qualify Intake Staff Evaluate Eligibility FAQ Given Call Back May

Qualify (Cancer History, Risk Factors) PCP Order www.Lahey.org/LungScreening 1-855-CT-CHEST LDCT Lung Screening Patient Flow Patient Calls (855-CT-CHEST) Group 3 (Refer to PCP) Dont Qualify

Dont Qualify Intake Staff Call Back May Qualify Evaluate Eligibility FAQ given Do Qualify PCP Order (Cancer History, Risk Factors) Do Qualify Group 1 & Group 2

1. Record PCP 2. Assign Lahey PCP if no PCP 3. Schedule Appointment 4. Asymptomatic Disclosure www.Lahey.org/LungScreening 1-855-CT-CHEST LDCT Lung Screening Patient Flow Patient Calls (855-CT-CHEST) Group 3 (Refer to PCP) Dont Qualify Dont

Qualify Intake Staff Call Back May Qualify Evaluate Eligibility FAQ Given Do Qualify PCP Order (Cancer History, Risk Factors) Do Qualify Group 1 & Group 2 1. Record PCP

2. Assign Lahey PCP if no PCP 3. Schedule Appointment 4. Asymptomatic Disclosure Obtain PCP Order Appt Reminder Call (48 hrs before exam) Screen Patient 1. No IV 2. No changing 3. Scan < 10 sec www.Lahey.org/LungScreening 1-855-CT-CHEST LDCT Lung Screening Patient Flow Patient Calls (855-CT-CHEST)

Group 3 (Refer to PCP) Dont Qualify Dont Qualify Intake Staff Call Back May Qualify Evaluate Eligibility FAQ Given Do Qualify PCP Order

(Cancer History, Risk Factors) Do Qualify Group 1 & Group 2 1. Record PCP 2. Assign Lahey PCP if no PCP 3. Schedule Appointment 4. Asymptomatic Disclosure Obtain PCP Order Appt Reminder Call (48 hrs before exam) Screen Patient 1. No IV 2. No changing 3. Scan < 10 sec www.Lahey.org/LungScreening 1-855-CT-CHEST

Credentialed Radiologist Interpretation LDCT Lung Screening Patient Flow Patient Calls (855-CT-CHEST) Group 3 (Refer to PCP) Dont Qualify Dont Qualify Intake Staff

Call Back May Qualify Evaluate Eligibility FAQ Given Do Qualify PCP Order Schedule Rescreen (<74y) S Negative & Lung-Rads 1, 2 (2/3 Screenings) (Cancer History, Risk Factors)

Do Qualify Group 1 & Group 2 1. Record PCP 2. Assign Lahey PCP if no PCP 3. Schedule Appointment 4. Asymptomatic Disclosure Obtain PCP Order Appt Reminder Call (48 hrs before exam) Screen Patient 1. No IV 2. No changing 3. Scan < 10 sec www.Lahey.org/LungScreening 1-855-CT-CHEST Credentialed

Radiologist Interpretation LDCT Lung Screening Patient Flow Patient Calls (855-CT-CHEST) Group 3 (Refer to PCP) Dont Qualify Dont Qualify Intake Staff Call Back

May Qualify Evaluate Eligibility FAQ Given Do Qualify PCP Order Schedule Rescreen (<74y) S Negative & Lung-Rads 1, 2 (2/3 Screenings) (Cancer History, Risk Factors) Do Qualify

Group 1 & Group 2 1. Record PCP 2. Assign Lahey PCP if no PCP 3. Schedule Appointment 4. Asymptomatic Disclosure Obtain PCP Order Credentialed Radiologist Interpretation S Positive or Lung Rads 3, 4, 5 (1/3 Screenings) Follow NCCN Guidelines Appt Reminder Call

(48 hrs before exam) Screen Patient 1. No IV 2. No changing 3. Scan < 10 sec www.Lahey.org/LungScreening 1-855-CT-CHEST CT Lung Screen Pilot Statistics As of the week of 2/24/12 Patients verbally screened Patients scheduled Patients scanned* Lahey patients* Non Lahey Patients* * percentage of Patients Scheduled www.Lahey.org/LungScreening 1-855-CT-CHEST

209 179 85% 105 59% 156 87% 23 13% Patient Survey www.Lahey.org/LungScreening 1-855-CT-CHEST Statistical Correlation to the NLST Study Lahey Pilot Finalized cases Negative (cat 1,2) 70 Positive (cat 3,4,) Incidentals (S pos) Lahey PCP assigned 101

31 3 NLST study Total Screened26,000 Negative 72.7% Positive 27.3% Incidentals 7.5% Cancers found 1% 1 www.Lahey.org/LungScreening 1-855-CT-CHEST How did you start? Multidisciplinary

coordinated effort Steering Committee Evidence based Business plan Legal Compliance Education and CME Concerns Informed consent Involvement of PCP Education regarding screening as process Enticement or hidden cost Uninsured Volume overload of radiology, PCPs, and specialists Perception of outside hospitals and clinicians How long before

reimbursement is established? www.Lahey.org/LungScreening 1-855-CT-CHEST Rescue Lung, Rescue Life Movement Steering Committee: Radiology Oncology

Pulmonary Richard Guarino Jeffery OBrien Samuel Skura Patricia Grady Patricia Doyle Angela Tambini Marketing Erika Clapp GIM Guy Napolitana, MD Brendan Connell, MD

Administration Brady McKee, MD Sebastian Flacke, MD Robert French, MD Christoph Wald, MD Andrea McKee, MD Paul Hesketh, MD

Finance Kevin Bennett Andrew Villanueva,MD Anthony Campagna, MD Jeffrey Klenz, MD www.Lahey.org/LungScreening Carla Lamb, MD 1-855-CT-CHEST Business Development Robert Toporoff Philanthropy Elizabeth Garvin Volume Reassurance

Mammography LDCT Screen US Population 60,000,000 9,000,000 (high-risk) Lahey 30,000 4500 100 screenings per week www.Lahey.org/LungScreening 1-855-CT-CHEST

Volume Reassurance Mammography LDCT Screen US Population 60,000,000 9,000,000 (high-risk) Lahey 30,000 4500 1 cancer per week 100 screenings per week

www.Lahey.org/LungScreening 1-855-CT-CHEST Volume Reassurance Mammography LDCT Screen US Population 60,000,000 9,000,000 (high-risk) Lahey 30,000 4500 1 cancer per week

100 screenings per week 27 positives www.Lahey.org/LungScreening 1-855-CT-CHEST Volume Reassurance Mammography LDCT Screen US Population 60,000,000 9,000,000 (high-risk) Lahey

30,000 4500 1 cancer per week 100 screenings per week 27 positives 7 potentially significant findings www.Lahey.org/LungScreening 1-855-CT-CHEST Volume Reassurance Mammography LDCT Screen US Population

60,000,000 9,000,000 (high-risk) Lahey 30,000 4500 1 cancer per week 100 screenings per week 27 positives 7 potentially significant findings After 2 years we will save 1 life every 3 weeks www.Lahey.org/LungScreening

1-855-CT-CHEST Volume Reassurance Example Individual PCP: 2500 Patient Panel ~75 patients: Qualify for lung screening (NCCN high-risk) ~20 patients: Positive for a lung nodule ~5 patients: Potentially significant incidental findings 1 cancer per week Clinic 100 screenings per week 27 positives 7 potentially significant findings After 2 years we will save 1 life every 3 weeks www.Lahey.org/LungScreening 1-855-CT-CHEST When Will CMS Reimburse? Lung vs Breast Screening

Lung Cancer Breast Cancer 5 Yr Overall Survival 1975 12% 75% 5 Yr Overall Survival 2007 15% 89% Screening Modality LDCT Mammogram

Annual Annual/Biannual 30PY, 55-74y Females 40-80y 9,000,000 60,000,000 Cost of Exam $300 $100 Per Year Cost of 1 Screen

$2.1 B $6 B Radiation Exposure 0.5-1.7 mSv 0.7 mSv Mortality Reduction 20% 10-35% NNS 320 1250 (40-49y)

Overdiagnosis < 17% vs CXR* 5-50% False Positive Rate ~35%/ 3 years 30-35%/10 years (annual) < $50,000 $38K - 58K (40-80y) Screening Frequency Patient Population Patient Number Estimates

Cost/QALY www.Lahey.org/LungScreening 1-855-CT-CHEST Risks of Free Screening States where health insurance is not required by law Massachusetts >98% insured US Population statistics ~ <4% of high-risk patients will not have insurance Operational endeavor Instructional CD Potential for patient harm - Lung Cancer Alliance National Framework For Excellence www.Lahey.org/LungScreening 1-855-CT-CHEST Rescue Lung, Rescue Life Movement Mission: Save lives through the early detection of lung cancer with responsible CT lung screening

Encourage the government to establish reimbursement for CT lung screening Encourage other centers of excellence in the treatment of lung cancer to offer FREE CT lung screening until CMS establishes reimbursement Break down barriers and prejudice faced by those at risk for lung cancer Raise public awareness of the power of CT lung screening to save lives www.Lahey.org/LungScreening 1-855-CT-CHEST Thank You www.Lahey.org/LungScreening 1-855-CT-CHEST

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