1. Clinical Solutions for Lung Cancer Screening (LCS)
Tom Tynes
Oncology Solutions
May 2015

2. Invivo Clinical Solutions
More than just boxes

3. Lung Cancer Huge Problem, Fragmented Solutions
Lung cancer is the number 1 cancer killer globally
Life expectancy: 1.1 years after diagnosis
1.3M deaths/year worldwide; more than breast, colon, prostate, pancreatic cancers combined
US: 160,000 deaths and 220,000 new cases/year
Emerging Markets burden even greater (China: 390,000 deaths and 490,000 new cases /year)
NLST demonstrated significant benefits, USPTF recommended CT lung screening for long-term smokers
‘Private’ cash-pay programs continue to expand
ACA requirements for private payors effective January 1, 2015
CMS reimbursement expected this year
Increase in hospitals/centers offering comprehensive lung cancer programs to more effectively manage disease
Screening, diagnostics, staging, multi-modality therapy (surgery, radiation oncology, interventional therapy)
Benefits: improved survival, reduced long tern costs (high cost to treat advanced disease)
Early diagnosis, accurate staging and timely treatment is critical to better clinical outcome
65-70% Stage III or IV
Only 15%
will survive
5 years
Stage
0, I, & II

4. Lung Cancer Screening (LCS) Program
Extensive product & service offering for successful implementation of a comprehensive CT lung screening program throughout the continuum of patient care
This is our overall value proposition and setting us up to help enable a high quality clinically relevant CT Lung Screening Program

5. CT Lung Cancer Screening (LCS) Solution Intelligent Integration throughout the Continuum of Patient Care
Education and awareness programs for physicians and at-risk patients
Local connections to patient advocacy groups
Assistance with reimbursement landscape
Marketing and public relations materials
Consultative Services
Patient & Data Management
Radiology Workflow
Computer-Aided Detection
Education Resources
Structured online education courses
Measured performance against large clinical database
Helps ensure and document proficiency
Education resources for new physicians
Standard clinical protocols (ACR Lung-RADS)
Automated, real-time 360° patient status
Integrated IT interfaces (HIS, RIS, PACS, EMR)
Reminder letters & program KPIs
Auto-detection of suspicious nodules
Second reader for added confidence
Workflow integrated
Proven clinical performance
Vendor-neutral chest CT review
Automated temporal comparison
Integrated Lung-RADS reporting
Results synced with patient manager

6. CT Lung Cancer Screening Reimbursement
A brief, recent history
June, 2011 NLST releases initial findings for CT lung cancer screening for high-risk individuals
February, 2015 CMS issues a final national coverage determination that provides for Medicare coverage of Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)
December, 2013 USPSTF gives low-dose CT lung cancer screening “B” recommendation
2011
2013
2015
2014
April, 2014 MEDCAC recommends against Medicare coverage for lung screening
June, 2013 USPSTF releases draft recommendation
What USPSTF “B” Recommendation Means for Lung Screening Programs
A grade “B” by the USPSTF means that the USPSTF recommends the service and that there is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial
The Affordable Care Act requires that all new private health insurance plans cover all preventative services that are rated at a grade “B” or higher by the USPSTF
Source: "Screening for Lung Cancer, U.S. Preventative Services Task Force Recommendation Statement,” USPSTF Final Recommendation Statement, Dec. 2013; Oncology Roundtable interviews and analysis

7. Primary Care Physician Radiology Imaging Facility
CMS Lung Cancer Decision Memo
Participants
Age: 55 – 77
30 Pack-years smoking and less than 15 years since quitting
No signs or symptoms of lung cancer
Marketing Services
Primary Care Physician
Shared Decision Making Visit – Benefits/Harms of Screening,
Follow-up diagnostics tests, over-diagnosis, FP rate, radiation exposure.
Counseling on adherence to the screening program and smoking cessation
Marketing Services
Radiologist
Board Certified, Training in diagnostic radiology and radiation safety
Supervision and interpretation of 300 chest CTs in past 3 years
CME to ACR standards
Radiology Imaging Facility
LDCT with CTDIvol < 3.0mGy for standard patients
Utilizes a standardized lung nodule classification and reporting system
Collects and submits data to a CMS-approved registry