Learning and Earning with Gateway Professional Education CME/CEU Webinar Series

Learning and Earning with Gateway Professional Education CME/CEU Webinar Series Best Practices for Colorectal Cancer Screening March 14, 2018 12:00pm 1:00pm Robert A. Smith, PhD Vice President, Cancer Screening American Cancer Society Joe Mastalski Manager, Quality Improvement Gateway Health SM

Learning and Earning with Gateway Professional Education CME/CEU Webinar Series To receive CME/CEU credit for today s webinar: Call xxx-xxx-xxxx from the cell phone number you provided when you enrolled in the webinar series Enter code: **code would have been provided at time of live webinar** You MUST call by the end of the day today to receive credit! Next webinar: April 4, 2018 HPV and Cervical Cancer Forgot to enroll? Enroll today to get CME credit for attending our next webinar at https://www.surveymonkey.com/r/nzjydf7 Questions? Email us at ProviderEngagementTeam@GatewayHealthPlan.com This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Allegheny General Hospital and Gateway Health Plan. Allegheny General Hospital is accredited by the ACCME to provide continuing medical education for physicians. Allegheny General Hospital designates this live webinar activity for a maximum of 1.0 AMA PRA Category 1 Credit TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity. 2

Shout Out! Washington Health System Washington, PA CTC: Carol Rhodes To arrange for a group viewing and lunch at your practice for a future webinar, please contact your Gateway Clinical Transformation Consultant (CTC). 3

Today s Presenters: Robert A. Smith PhD Vice President, Cancer Screening Joe Mastalski Manager, Quality Improvement American Cancer Society Quality Improvement Gateway Health SM 4

Screening for Colorectal Cancer Robert A. Smith, PhD Vice President, Cancer Screening, American Cancer Society Adjunct Professor of Epidemiology Emory University Rollins School of Public Health

Disclosures I have no financial disclosures or conflicts of interest to declare

Outline of Today s Presentation Recent trends Screening guidelines The screening tests, including strengths, limitations, and quality issues Strategies to increase screening rates Resources

Colorectal cancer screening reduces CRC mortality by finding cancer early, and by detecting and removing precursor lesions 1. Prevention Find and remove polyps to prevent cancer 2. Early Detection Find cancer in the early stages, when best chance for a cure

CRC Statistics Trends in Disease Rates & Screening Rates

Long-Term Trends in Colorectal Cancer Incidence (1975-2013) and Mortality (1930-2014) Rates* by Sex, United States. The dramatic declines in colorectal cancer incidence & mortality over the past decade have been attributed to the widespread uptake of colonoscopy screening, which increased from 19% in 2000 to 63% in 2015 among adults aged 50 to 75 years. Siegel RL, et al. CA Cancer J Clin 2017;67:177-193. 10

Trend in Colorectal Cancer Mortality: Age-standardized Rate vs. Number of Deaths, United States, 1975-2014 The decline in death rates accelerated beginning around 2000, and notably has been of sufficient magnitude to overcome the aging and growth of the population Siegel RL, et al. CA Cancer J Clin 2017;67:177-193.

Decline in CRC Incidence and Mortality Decline due to: Screening earlier cancer detection improved survival Improvements in treatment Survival Rates by Disease Stage* 5-yr Survival 100 90 80 70 60 50 40 30 20 10 0 90.3% 70.4% 12.5% Local Regional Distant Stage of Detection

Colorectal Cancer Screening (%), Adults Ages 50 Years or Older, United States, 2015 Siegel RL, et al. CA Cancer J Clin 2017;67:177-193.

American Cancer Society and United States Preventive Services Task Force Guidelines for CRC Screening, 2008 15

CRC Screening in Average Risk Adults: 2008 Recommendation ACS, USMSTF, ACR Stool Testing gfobt FIT mtsdna Flexible sigmoidoscopy Annual screening with high sensitivity (HS) gfobt or FIT, or Mt-sDNA every 3 years Low sensitivity gfobt not recommended Screening every 5 years Screening every 5 years, with annual gfobt or FIT is an option Colonoscopy Screening every 10 years CT Colonography Screening every 5 years

On June 20, 2016, the USPSTF released update CRC screening recommendations, providing an update of their 2008 recommendations The recommendations covered colorectal cancer screening with FOBT (gfobt, FIT, and FIT-DNA), endoscopy (colonoscopy and flexible sigmoidoscopy), and CT colonography Two tests not endorsed in the draft recommendations released in 2015 (FIT-DNA and CT colonography) were endorsed in the 2016 final recommendations. JAMA June 21, 2016 Volume 315, Number 23

USPSTF CRC Screening Recommendation Statement In the current recommendation, instead of emphasizing specific screening approaches, the USPSTF has instead chosen to highlight that there is convincing evidence that colorectal cancer screening substantially reduces deaths from the disease among adults aged 50 to 75 years and that not enough adults in the United States are using this effective preventive intervention. JAMA June 21, 2016 Volume 315, Number 23

USPSTF CRC Screening Recommendations, 2016 How does these changes compare with the 2008 ACS guideline? ACS endorses screening Q 3 yrs. Same ACS does not emphasize combined FSIG/FOBT JAMA June 21, 2016 Volume 315, Number 23

Screening for Colorectal Cancer Test Performance & Clinical Considerations

Stool Test: Guaiac (gfobt) Most common type of FOBT Best evidence (3 RCT s) 30 year f/u (NEJM Oct 2013) Need specimens from 3 bowel movements Non-specific Results influenced by foods and medications Older forms (Hemoccult II) not recommended! Better sensitivity with newer versions (Hemoccult Sensa)

Minnesota Colon Cancer Control Study 33,020 participants, with 30 years of follow-up Rehydrated guaiac based FOBT Screening reduced colorectal-cancer mortality Relative risk for annual screening: 0.68; (95% CI, 0.56 to 0.82) Relative risk for biennial screening: 0.78; (95% CI, 0.65 to 0.93) Conclusion: After 30 years of follow-up, an invitation to annual FOBT screening was associated with 32% fewer CRC deaths, and a biennial invitation was associated with 22% fewer deaths

Minnesota FOBT Trial Comparative Incidence in the Invited & Control Group Screening with FOBT is associated with a reduction in incidence of colorectal cancer 18 yrs. after randomization, there was 20% lower CRC incidence in the annual screening group Annual group = 32/1,000 Control group = 39/1,000 In the Minnesota Trial, there was a high colonoscopy referral rate due to the use of rehydrated FOBT

Single Test Performance Characteristics of gfobt Variants: Hemoccult & Hemoccult II Low test sensitivity (vs. program sensitivity) Sensitivity improved with rehydration, but specificity suffers Dietary restrictions reduce patient adherence Interpretation of test results is subjective Lower patient completion compared with FIT NOT RECOMMENDED BY ACS or USPSTF FOR CRC SCREENING Study with One-Time Testing Collins, et al. AIM, 2005 Lieberman, et al. NEJM, 2001 Imperiale, et al. NEJM, 2004 Allison, et al. NEJM, 1996 Sensitivity for Cancer 9.5% [ In Office, Single Panel gfobt] 50% (w/rehydration) Specificity 97.5% 93.8% 14.1% 95.2% 37.1% 97.7%

Single Panel FOBT Following Digital Rectal Exam In-Office FOBT is common CRC screening strategy Reasons to STOP single sample FOBT Not recommended by any CRC screening guideline Not recommended by the manufacturer of any test Lowest sensitivity of all CRC screening tests, i.e., less than 5% for advanced neoplasia

Stool Test: Immunochemical (FIT) Slightly more costly than guaiac tests Higher sensitivity for cancer & adenomas than guaiac-based FOBT Specific for human blood and for lower GI bleeding Results not influenced by foods or medications Most types require only 1 or 2 stool specimens Patients prefer FIT to gfobt Test Completion Rate is Higher!!

Meta-analysis of FIT vs. Hemoccult Sensa FIT Hemoccult Sensa Sensitivity: 73-89% 64-80% Specificity: 92-95% 87-90% Two Key Points: 1. Only high sensitivity stool tests are recommended for screening 2. FIT is a superior option for annual stool testing. Lee, JK et. al. Ann Intern Med. 2014 160 (3): 171

Adherence with FIT is consistently better than with guaiac-based stool tests Adherence Study FIT Guaiac Hoffman (2010) 61.4% 50.5% Hol (2010) 61.5% 49.5% Van Rossum (2008) 59.6% 49.6% Cole (2003) 39.6% 23.4% Source: TR Levin, MD

Multi-Target Stool DNA Test Only one test currently available (Cologuard) Combines tests for stool DNA markers associated with cancers and adenomas plus an FIT

NEJM 2014

Cologuard Guidelines & Coverage FDA has cleared it for marketing as CRC screening test Q 3 years CMS has agreed to cover Cologuard for average risk Medicare beneficiaries age 50 85 yrs Medicare will reimburse ~ $500 Q 3 yrs. for the test (price includes navigation component) Private insurance coverage limited All positive tests must be evaluated by colonoscopy Included in current ACS guidelines, and USPSTF recommendations

Colonoscopy Allows direct visualization of entire colon lumen Screening, diagnostic and therapeutic 10 yr. interval The most common screening test in US (>80%)

Colonoscopy Polypectomy prevents colorectal cancer The National Polyp Study observed a 76-90% reduction in CRC incidence after polypectomy Winawer et al, NEJM 1993

Long-Term Colorectal-Cancer incidence and Mortality after Lower Endoscopy Data from two prospective cohort studies: the Nurses Health Study, which included 121,700 U.S. female nurses, 30 to 55 years of age at enrollment in 1976; the Health Professionals Follow-up Study, which included 51,529 U.S. male health professionals, 40 to 75 years of age at enrollment in 1986. Examined the association between lower endoscopy (1988-2008) and colorectal cancer incidence and mortality through June 2012.

Long-Term Colorectal-Cancer incidence and Mortality after Lower Endoscopy NEJM, 2013, vol. 369 no. 12

Quality Issues with Colonoscopy Poor pre-procedure documentation Poor prep Failure to reach the cecum Rapid withdrawal time Adverse events Highly variable adenoma detection rate Interval cancers Over and under utilization of the procedure Highly variable reports Poor feedback Most endoscopists are unaware of their numbers, since most facilities do not track their data.

What do the quality data on colonoscopy reveal? Adenoma detection rate (ADR) is highly variable. In one large series, ADR varied from 7% - 52% 8% interval cancer rate ADR inversely associated with the interval cancer rate ADR inversely associated with colorectal cancer death

Variability in the Adenoma Detection Rate is 10 fold, and is Associated with Withdrawal Time Barclay et al. NEJM;2006;355:2533

Adenoma Detection Rate and Risk of CRC Incidence, Interval Cancer, and Death Setting: Kaiser Permanente of Northern California 264,972 Colonoscopies among 223,842 patients were eligible for assessment 927,523 person-years of follow-up and detection of 712 interval CRCs) Outcome: Risk of CRC 6 months to 10 years after colonoscopy

Hazard ratios for ADR and risk of advanced stage CRC, and fatal CRC Advance Stage CRC Fatal CRC

Key Quality Indicators Adenoma Detection Rate (ADR) Entire Unit and Individual Endoscopists Improvement plans are initiated if ADR rate is not 25% for men and 15% for women, or > 20% overall Cecal Intubation Rate (CIR) Improvement plans are initiated if complete colonoscopy is not accomplished in > 90% of all patients and > 95% of those undergoing screening and surveillance procedures, for both the unit as a whole and for each individual endoscopist Quality of Preparation Improvement plans are initiated if prep quality is not adequate for detection of all polyps > 5 mm in > 90% of patients.

Key Quality Indicators Complete Procedure Documentation Patient demographics ASA Score (assessment of procedural risk) Procedure Indications (screening, surveillance, symptoms, etc.) Procedural Technical Description (medications, extent of exam, adequacy of preparation, ease and tolerance, retroflexion, other maneuvers) Colonoscopic Findings Diagnosis and Assessment Unplanned Events Follow-up Plan Incomplete unit or endoscopist documentation shall initiate improvement plan

Recommended, But Less Common CRC Screening Tests 44

Flexible Sigmoidoscopy The scope on the right is a 60 cm flexible scope. Others include smaller 35 cm flexible scope, and the 25 cm rigid scope.

Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial 14 UK centers 170,432 eligible men and women 57,237 to the intervention group, of which 71% underwent a single flexible sigmoidoscopy Outcomes of interest: Colorectal cancer incidence Colorectal cancer mortality Findings: 23% reduced incidence 31% reduced mortality

Radiographic CRC Screening Tests Double Contrast Barium Enema CT Colonography, aka Virtual Colonoscopy

Results: For all samples, sensitivity of Plasma Septin9 for CRC detection was 73.3%, and 68.0% for FIT. Specificity of the Plasma Septin9 test was 81.5% compared with 97.4% for FIT. When test results for Plasma Septin9 and FIT were combined, CRC detection was 88.7% at a specificity of 78.8%. Conclusions: At a sensitivity of 72%, the Plasma Septin9 test is non- inferior to FIT for CRC detection, although at a lower specificity. PLOS ONE www.plosone.org 1 June 2014 Volume 9 Issue 6 e98238

Improving Colorectal Cancer Screening Rates Offer Your Patients the Option of Colonoscopy OR FOBT

Colonoscopy should be regarded as an effective screening test, not the best screening test for all adults While colonoscopy is viewed as the best screening test, many patients face barriers or are not willing to undergo colonoscopy Often recommended despite access or other challenges Focus on colonoscopy associated with low screening rates in a number of studies Patient preferences rarely solicited

Primary Care Provider Perceptions of Screening Tests FOBT/FIT used, but: Effectiveness questioned by many clinicians Lack of knowledge re: performance of new vs. older forms of stool tests, other quality issues

Benefits, Harms, and Burdens of Recommended Screening Strategies Over a Lifetime Source: CISNET, 2015

Many Patients Prefer FOBT Randomized clinical trial in which 997 patients in the San Francisco PH care system received different recommendations for screening: Recommended Test Colonoscopy 38% FOBT 67% Colonoscopy or FOBT 69% Completed Screening Many patients will forgo screening if they are not offered an alternative to colonoscopy. (Inadomi et al. 2012)

Many Patients Prefer FOBT/FIT Diverse sample of 323 adults given detailed side-by-side description of FOBT and colonoscopy (DeBourcy et al. 2007) 53% preferred FOBT 212 patients at 4 health centers rated different screening options with different attributes (Hawley et al. 2008) 37% preferred colonoscopy 31% preferred FOBT Nationally representative sample of 2068 VA patients given brief descriptions of each screening mode (Powell et al. 2009) 37% preferred colonoscopy 29% preferred FOBT

Summary--Advantages of Stool Tests Newer tests are very accurate Preferred by a significant % of patients Less expensive No bowel preparation. Done in privacy at home. No need for time off work or assistance getting home after the procedure. Non-invasive no risk of pain, bleeding, perforation Limits need for colonoscopies required only if stool blood testing is abnormal.

Improving Colorectal Cancer Screening Rates Take Advantage of Checkups to Refer for CRC Screening

Cancer Screening & the Periodic Preventive Health Exam Retrospective cohort study 64,288 adults ages 52-78 in a managed care plan Outcomes focused on completion of: CRC screening Breast cancer screening Prostate cancer screening

Adjusted Incidence of 3 Cancer Screening Tests by Receipt of Preventive Health Exam (PHE) CRC Screening Mammography PSA Testing Received PHE Did Not Receive PHE Approximately 50% of adults who had received a PHE completed CRC screening within 5 annual visits

Improving Colorectal Cancer Screening Rates Expand Opportunities for CRC Screening During the Delivery of Other Preventive Care

Flu-FIT is an intervention designed to use the opportunity when adults are receiving flu shots to promote colorectal cancer screening

CRC Screening Outreach During Annual Flu Shot Activities Potential Benefits of Flu-FOBT or Flu-FIT Programs: Reaches patients at a time each year when they are already thinking about prevention Creates a seasonal focus on cancer screening that may add to other screening efforts Time-efficient way to involve non-physician staff in screening activities Educates patients that just like a flu shot, you need FOBT/FIT every year Slide courtesy of M. Potter, MD

San Francisco General Hospital Randomized Trial (Flu shot clinic attendees randomized to Flu Only vs. Flu + FOBT on different dates included telephone follow-up for FOBT recipients) FLU Only FLU + FOBT (N=268) (N= 246) Up-to-Date Before Flu 52.9% 54.5% Season Up-to-Date After Flu Season 57.3% 84.3% Change: (p<0.001) +4.4 % +29.8 % Ann Fam Med, 2009

Improving Colorectal Cancer Screening Rates Make CRC Screening a Practice Priority and Implement Evidence-Based Interventions to Improve Screening Rates

Action Plan Toolkit Version This 8 page guide introduces clinicians and staff to concepts and tools provided in the full Toolkit Contains links to the full Toolkit, tools and resources Not colorectal-specific; practical, action-oriented assistance that can be used in the office to improve screening rates for multiple cancer sites (colorectal, breast and cervical) Available at http://nccrt.org/about/provider-education/crc-clinician-guide/

Communication

Clinician Reminder Systems Are Essential!! Chart Prompts Problem lists Screening schedules Integrated summaries Alerts Flags placed in chart Follow-Up Reminders Tickler System Logs and Tracking Electronic Reminder Systems

Colorectal Cancer Screening Uptake among Patients Receiving Usual Care in the Systems of Support to Increase Colorectal Cancer Screening Trial, by Exposure to a Patient-Centered Medical Home Patients in PCMHs 8 months or longer were 29% more likely to receive CRC screening than patients with fewer months in the PCMH

What is State of the Art Colorectal Cancer Screening? Take and regularly update family history Include maternal and paternal sides for 3 generations Counsel your patients about signs and symptoms of colorectal cancer Follow ACS or USPSTF guidelines, with particular attention to adherence Offer your patients colonoscopy AND a high sensitivity FOBT, preferably FIT Identify a screening services with gastroenterologists who track their performance

www.cancer.org/colonmd www.cancer.org/professionals

High Quality Stool Testing Clinicians Reference: FOBT One page document designed to educate clinicians about important elements of colorectal cancer screening using fecal occult blood tests (FOBT). Provides state-of-the-science information about guaiac and immunochemical FOBT, test performance and characteristics of high quality screening programs. Available at www.cancer.org/colonmd

NCCRT Tools, Resources and Publications Available at: nccrt.org

www.nccrt.org

http://www.cdc.gov/cancer/colorectal/quality/index.htm

Thank you

Colorectal Cancer Screening Initiatives Joseph Mastalski, Manager, Quality Improvement 1 DATE PRESENTED BY:

HEDIS Measure Looks at the percentage of Medicare members who are up to date with screening Target Population Men and women Ages 50-75 years No history of colorectal cancer or total colectomy 76 DATE PRESENTED BY:

HEDIS Measure There are currently 5 acceptable tests for screening: Fecal Occult Blood Test (FOBT) Every year Flexible Sigmoidoscopy Every 5 years Colonoscopy Every 10 years CT Colonography* - Every 5 years FIT-DNA Test Every 3 years *CT Colonography is not currently covered by Gateway Health 77 DATE PRESENTED BY:

Member Outreach and Education Interactive Voice Response (IVR)/ Email/ SMS campaigns focused around education, screening reminders and appointment scheduling Cobranded letter with the American Cancer Society Social media posts and newsletter articles Annual ifobt campaign 78 DATE PRESENTED BY:

Provider Initiatives Practice reference guide with HEDIS specifications and helpful tips Clinical Transformation Consultant support Gateway to Practitioner Excellence (GPE ) provider incentive 79 DATE PRESENTED BY:

2017 GPE Program* Follows the HEDIS specification: Members ages 50-75 years of age who receive an appropriate screening No history of colorectal cancer or total colectomy $10 per member per year for submission of a CPT/HCPCS code for screening The CPT/HCPCS codes do not need to be submitted by the PCP. Credit is given for getting the member screened. *2018 program is currently being developed 80 DATE PRESENTED BY:

Applicable Codes for GPE Definition CPT Category I HCPCS Colonoscopy G0105, G0121 Flexible Sigmoidoscopy G0104 FOBT 82270, 82274 G0328 FIT-DNA Test 81528 G0464 81 DATE PRESENTED BY:

Slides will be posted at www.gatewayhealthplan.com/provider/provider-resources/educational-tools (CME credit only for enrolled participants in live webinar) 83