Stool DNA Testing for Colorectal Cancer Screening Physician

Stool DNA Testing for Colorectal Cancer Screening Physician Orientation Henry Ford EPIC Users October 2017 For More Information Visit: Cologuard. Test. com 1

Topics • Scientific Overview • Stool Collection Process • EPIC Order Process • HFHS Result Entry Process • Reimbursement and Billing • FAQs 2

*OC FIT-CHEK, Polymedco, Inc. Source: 1. Ahlquist. DA et al. , Cancer (1989) 3

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NEJM published prospective study conducted across 90 sites 1 92% Cancer sensitivity 94% Early stage cancer sensitivity 87% Specificity Head-to-head superiority to FIT* for cancer and precancer detection versus a leading fecal blood test (FIT) FIT is recommended annually and has a specificity of 95%; Cologuard is recommended every 3 years and has specificity of 87% 5 Note: The performance of Cologuard has been established in a cross sectional study. Programmatic performance of Cologuard has not been studied. Performance has not been 5 evaluated in adults who have been previously tested with Cologuard. Source: 1. Imperiale TF et al. , N Engl J Med (2014)

Sensitivity Results Optical Colonoscopy 100% Optical Colonscopy Range 94% - 97% 97% 92. 3% 80% 73. 8% Cologuard FIT+ Optical Colonoscopy Range 94% - 97% 69. 2% 60% 46. 2% 42. 4% 40% 23. 8% 20% 0% Cancer Sensitivity +Polymedco. OC-CHEK FIT. Imperiale. TF et al. N Engl. J Med. 2014; 370(14): 1287 -1297. High Grade Dysplasia Sensitivity Advanced Adenoma Sensitivity 6

*If a result cannot be obtained due to insufficient sample size, low DNA capture, etc. , the lab will automatically request a second sample, at no additional cost to the patient. ESL Patient Report. 2016. 7

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Conducted by Exact Sciences Staff 67% Compliance* Cologuard’s patient compliance rate is derived from the number of completed tests reported divided by the number of collection kits shipped to patients during the 12 -month period ending 60 days prior to December 31, 2016. 12

Ordering Cologuard in Epic 13

Ordering Cologuard in Epic 14

Ordering Cologuard in Epic 15

What happens when the Cologuard Order is Signed? ü An order is automatically faxed directly to Exact Sciences 16

What happens when the Cologuard Order is Signed? Cont. ü A Patient Instructions report is printed automatically and should be given to patient as a reminder 17

AVS Smart. Phrase. COLOGUARD AVS when. COLOGUARD Smart. Phrase is used 18

In Summary, 2 Items Should Be Given to Patient 1. AVS and 2. Cologuard Patient Instructions Automatic Order faxed to Exact Sciences Automatic Patient Instructions sheet printed on clinic printer Provider Driven Use Smart. Phrase to add Cologuard to AVS Note: provider will not receive notification directly in Epic Patient should be given sheet before leaving office Patient should be given AVS before leaving office 19

Notification of Result • Population Health Coder will retrieve the result from the Exact Sciences portal • Result will be entered into Original Order and Updated to Final Result • Quality Assurance protocols integrated into process • A hardcopy of the result will be placed in the Media Tab • Result will be sent to Provider’s In. Basket in Epic • Provider to assess whether patient is a My. Chart user ◦ If yes, patient will automatically receive My. Chart message with result ◦ If no, provider should utilize standard processes to ensure letter is sent to patient with result 20

Cologuard Outcomes Negative • Result sent to provider In. Basket • Patient notified through My. Chart or by letter • Repeat screening at appropriate interval Positive • Result sent to provider In. Basket • Patient notified through My. Chart or by letter • Provider orders Diagnostic Colonoscopy Canceled • Reason for cancellation sent to provider In. Basket • Cancelled result not posted in My. Chart • Provider takes appropriate actions (re-order or alternative screening method advised) Cologuard Satisfies Health Maintenance Screening Interval Set at 3 Years Interval modified by Gastroenterology or PCP pending colonoscopy results Health Maintenance Not Met 21

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Payor Coverage $0. 00 co-pay and $0. 00 deductible Medicare FFS and MA BCBSM – PPO United Health. Care Aetna BCN $0. 00 co-pay and $0. 00 deductible HAP – all members *effective 1/1/2017 Vast majority have $0. 00 co-pay and $0. 00 deductible Highly variable ($0. 00 - $649. 00) Note: All patients are advised to call their insurance provider directly to confirm potential out-of-pocket costs. The figures above are for informational purposes only and may not reflect current contract status. 24

FAQs Q. Does my patient really have to call their insurance company? A. Yes, all patients are advised to call their insurance company. While we believe most insurance companies in southeast Michigan provide coverage, we can not guarantee $0 co-pay and deductibles. Q. What happens if the order does not have one of the two z-codes (z 12. 11 and z 12. 22)? A. The Population Health Coder will be notified by Exact Sciences and will cancel the order and send an In. Basket message to provider. Provider is asked to evaluate appropriate use of Cologuard and either 1) select alternative screening method or 2) re-order test with correct z-code(s) Q. What happens if my patient does not return the collection kit? A. Neither the patient or the insurance provider will be charged 25

FAQs Q. What happens if the test kit can not be processed; is there anything I need to do? A. Exact Sciences will reach out to your patient directly and explain why the kit could not be processed. They will ask permission to re-send the kit. • If patient answers yes, the kit is re-shipped. • If patient answers no, the order is cancelled. You will receive an In. Basket message indicating a new screening method is advised. Q. Who bills for the Cologuard Test? A. Exact Sciences bills for the Cologuard test Q. Who should I contact with questions about the Epic Order? A. Open a helios helpdesk ticket and it will be routed appropriately. For administrative questions contact Emily Nerreter, Manager of Coding Quality and Education. 26