Screening & Surveillance Guidelines

Chapter 2 Screening & Surveillance Guidelines I. Eligibility Coloradans ages 50 and older (average risk) or under 50 at elevated risk for colon cancer (personal or family history) that meet the following five criteria*: 1. Patient of a participating clinic: This is determined by administrators and medical staff of the participating clinics, using their usual, internal definition of clinic patient 2. Income at or below 250% of the Federal Poverty Level: This is determined by participating clinics based on the information in Figure 2-1 3. Need for colorectal screening: This is determined by participating clinics based on adherence to screening guidelines issued by the American Cancer Society (Figure 2-2) Persons who have had a colonoscopy in the past 10 years (without adenomas being detected) are not eligible Persons who have had a sigmoidoscopy or a barium enema in the past 5 years are not eligible for a sigmoidoscopy or barium enema, but they are eligible for a colonoscopy A positive or negative fecal occult blood test (FOBT) test, regardless of how recent the test was, does not affect eligibility for a sigmoidoscopy or colonoscopy through the Program The Colorectal Screening Referral Form (Figure 2-3) must be completed and signed by the patient s primary care provider prior to screening and a copy must remain in the chart 4. Have no health insurance or have an insurance plan that does not cover any cost for endoscopic colorectal screening: This criteria is to be determined by each clinic, based on patient reports. Patients who have insurance plans that cover any of the cost for endoscopic colorectal screening are not eligible for the Program, regardless of the cost of the co-pay or deductible of the plan. Patients covered by insurance plans which do not cover any costs for endoscopic colorectal screening, as well those who are uninsured, are eligible for the Program 5. Must be lawfully present in the United States: See Chapter 3 for requirements of lawful presence *Participating clinics are responsible for documenting eligibility information including lack of coverage of endoscopic colorectal screening, and will be asked to present this information at the time of chart audit by the Program Clinic Enrollment Protocol Clinics and Hospitals enrolled in the Colorado Colorectal Screening Program shall provide primary care services to patients who are referred to the Program for endoscopic colorectal screening. The majority of clinics and hospitals enrolled can be referred to as the safety net for primary care and include members of the Colorado Community Health Network (CCHN), Colorado Rural Health Center (CRHC), and Clinic Net (CN). Rev.5.2013 2-1

Clinics and Hospitals not under the umbrella of CCHN, CRHC, or CN who wish to enroll as a Program partner will be considered on a case-by-case basis. Inclusion criteria may be based on one or more of the following conditions: 1. Clinics and Hospitals must provide primary care to clients who are eligible and referred to the Program 2. Clinics and Hospitals provide care to the medically underserved in geographical regions and communities where a CCHN, CRHC or CN system is not currently established 3. Clinic and Hospitals are serving special populations who are in need of medical care but do not have access to or are not permitted to be a client of CCHN, CRHC, or CN 4. Clinic and Hospital systems who provide endoscopic screening services within their system, agree to partner with other participating health clinics to provide screening when capacity is available and the need is identified The Program Director will make the final decision about Clinic or Hospital inclusion into the Program. Figure 2-1: 250% of Federal Poverty Guidelines The Colorado Colorectal Screening Program uses poverty guidelines to determine eligibility based on number of persons in the family unit. The Program allows for an income at or below 250% of the Federal Poverty Level (FPL). The poverty level is established by the Department of Health and Human Services, 250% is 2.5 times the amount of the poverty level. The Program will allow inclusion of patients who have no income to those who have an income up to 250% of the FPL. Table 2-1 should be used as a guide to understand income levels. Clinics should use existing methodologies for verification of patient income to establish income level. Poverty guidelines are updated annually by the federal government, and are usually released by mid February of that year. You can find the current poverty guidelines with calculated percentages at http://aspe.hhs.gov/poverty/index.shtml. Rev.5.2013 2-2

II. Screening Methods This Program supports informed decision making in screening, a process that each patient with his/her provider needs to complete. The Program will reimburse near the Medicare Allowable Reimbursement Rate for associated screening services in the age and risk eligible populations. All rates will be negotiated on an individual basis. Screening Methods Covered The endoscopic screening sections of the American Cancer Society guidelines (Figure 2-2) serve to guide the Program. These are the same endoscopic screening guidelines currently endorsed by the Colorado Clinical Guidelines Collaborative. Flexible Sigmoidoscopy is a direct visualization of the inside of the lower half of the colorectum, often to the point of the splenic flexure, through a flexible sigmoidoscope. This procedure is reimbursed by the Program. Biopsy during flexible sigmoidoscopy should be performed for any polyp smaller than 1 cm since hyperplastic polyps seen by flexible sigmoidoscopy are not an indication for full colonoscopy. Patients with histologically proven adenoma or with polyps greater than 1 cm in size (which are nearly always adenomas) should be referred for colonoscopy. Colonoscopy is the direct examination of the entire length of the colon via a colonoscope. All costs associated with a colonoscopy (provider, facility, anesthesia and pathology) are reimbursed by the Program. Colonoscopy is a screening test, but it is often also a diagnostic test and/or a treatment procedure when lesions are identified, biopsied and/or removed. The goal during a colonoscopy is that all lesions identified as cancer or polyps (sessile or pedunculated) be excised or, if too large for excision, biopsied, and sent for pathologic examination. An exception is when numerous (over 10-20) small (< 5mm) polyps are encountered in the rectum and distal colon; since these are typically hyperplastic polyps, representative biopsies of 5-10 can be obtained. Pathologic evaluation of colonic polyps is critical to determine the individual s risk category for CRC, the first degree relatives risk of CRC, and the proper interval for repeat CRC testing. An adequate colonoscopy is one that reaches the cecum and visualized over 90% of the colonic mucosal surface. Double Contrast Barium Enema (DCBE) is less sensitive than colonoscopy for colorectal neoplasms. Therefore, it is rarely elected as a primary screening method, though it can be reimbursed by the Program. Its use should be reserved for situations in which a patient and provider determine that a screening DCBE is the best screening option. Rev.5.2013 2-3

Support for Systems Change The Program is able to provide support for clinics to implement sustainable systems for comprehensive cancer screening to include the following screening methods: High Sensitivity Fecal Occult Blood Tests (FOBT) High Sensitivity Fecal immunochemical tests (FIT) The Program offers training on implementing systems changes to increase colorectal cancer screening rates in your practice. These include a written office policy, an office reminder system and a high quality stool blood screening test in addition to endoscopy screening. Additionally, the Program is partnering with community health centers and local public health to implement Flu-FOBT clinics during annual flu seasons. The Program is able to offer no cost colonoscopies for patients with a positive FOBT/FIT who meet eligibility guidelines. Screening Methods NOT Covered Stool DNA test (sdna) CT Colonography (Virtual Colonoscopy) Digital Rectal Exam (DRE) should be performed at the time of colonoscopy or sigmoidoscopy. This test is NOT reimbursed separately by the Program. Rev.5.2013 2-4

Figure 2-2: ACS Colorectal Screening Guidelines (03/2008) Beginning at age 50, both men and women at average risk for developing colorectal cancer should use one of the screening tests below. The tests that are designed to find both early cancer and polyps are preferred if these tests are available and an individual is willing to have one of these more invasive tests. Tests that find polyps and cancer Flexible sigmoidoscopy every 5 years* Colonoscopy every 10 years Double contrast barium enema every 5 years* CT colonography (virtual colonoscopy) every 5 years* Tests that mainly find cancer High sensitivity fecal occult blood test (FOBT) every year*,** Fecal immunochemical test (FIT) every year*,** *Colonoscopy should be done if test results are positive **For FOBT or FIT used as a screening test, the take-home multiple sample method should be used. A FOBT or FIT done during a digital rectal exam in the doctor's office is not adequate for screening People should talk to their doctor about starting colorectal cancer screening earlier and/or being screened more often if they have any of the following colorectal cancer risk factors: A personal history of colorectal cancer or adenomatous polyps A personal history of chronic inflammatory bowel disease (Crohn s disease or ulcerative colitis) A strong family history of colorectal cancer or polyps (cancer or polyps in a firstdegree relative [parent, sibling, or child] younger than 60 or in 2 or more first-degree relatives of any age) A known family history of hereditary colorectal cancer syndromes such as familial adenomatous polyposis (FAP) or hereditary non-polyposis colon cancer (HNPCC) Rev.5.2013 2-5

Figure 2-3: PCP Referral Form Rev.5.2013 2-6

III. Screening & Surveillance Guidelines Figure 2-4: Reimbursable Screening Guidelines for Average, Increased, and High Risk Patients (10/2006) Risk Category Age to Begin Reimbursable Screening Recommendation Average Risk Asymptomatic individuals who are not in the categories below (including those with a previous hyperplastic polyp as their most advanced lesion) 50 years Age to stop screening: 85 Note: Cormorbidity should be considered for those between 75-85 Colonoscopy every 10 years OR Flexible Sigmoidoscopy or DCBE every 5 years Increased Risk Individual age 45 and older with blood in the stool or a positive FOBT are eligible for endoscopic evaluation through CCSP Either colorectal cancer or adenomatous polyps, in any first-degree relative before age 60, or in two or more first-degree relatives at any age (if not a hereditary syndrome) On previous endoscopic screening, individual with one or two small (<1 cm), adenomatous polyps with only low-grade dysplasia and/or sessile serrated polyp without dysplasia On previous endoscopic screening, individual with any of the following: - 3 to 10 adenomas or - one large ( 1 cm) adenomatous polyp or - any sessile serrated polyp with cytologic dysplasia On previous endoscopic screening, individual with more than 10 adenomas at one examination Personal history of curative-intent resection of colorectal cancer 45 with symptoms Colonoscopy Age 40 or 10 years before the youngest colon cancer / adenoma in the family, whichever is earlier At initial time of polyp diagnosis At initial time of polyp diagnosis At initial time of polyp diagnosis One year after diagnosis Colonoscopy every 5-10 years Colorectal cancer in relatives more distant than first-degree does not increase risk substantially above the average-risk group Colonoscopy 5 years after initial polyp removal. If that exam is normal, then colonoscopy every 5 10 years thereafter. Colonoscopy 3 years (providing that piecemeal removal has not been done & the adenoma(s) are completely removed) If the follow-up exam is normal or shows only one or two small tubular adenomas with lowgrade dysplasia, then colonoscopy every 5 years thereafter. < 3 years interval established by clinical judgment Colonoscopy one year after resection. If normal, then the interval before next subsequent exam should be 3 years. If normal, then the interval before next subsequent exam should be 5 years. High Risk Individual with family history of Familial Adenomatous Polyposis (FAP) Individual with family history of hereditary nonpolyposis colon cancer (HNPCC) Puberty Age 21 to 25 years Sigmoidoscopy (or colonoscopy) and genetic testing. If polyposis is confirmed by endoscopy and/or if genetic testing is positive, then refer patient to a center with experience in managing FAP. Colonoscopy and genetic testing*. If genetic test is normal, screen as per average risk. Rev.5.2013 2-7

Personal history of inflammatory bowel disease: (Chronic Ulcerative colitis or Crohn s disease) Cancer risk begins to be significant 8 years after the onset of pancolitis OR 12 15 years after the onset of left sided colitis If genetic test is positive or patient has not had genetic testing, then refer patient to a center with experience in managing HNPCC. Colonoscopy with multiple biopsies every 1 2 years, and refer patient to a center with experience in surveillance and management of IBD Important Note: The Program can only cover the costs of colorectal cancer screening in patients with established, long standing disease (>8 years) and not for the diagnosis or symptomatic evaluation of patients with IBD. Patients with signs or symptoms of colorectal cancer need to be managed individually with a diagnostic work up. In some cases, endoscopic evaluation of patients with signs and symptoms can be reimbursed through this Program. In addition, patients with hematochezia or a positive FOBT between ages 45-50 will be considered eligible for endoscopic evaluation under this Program. Genetic testing may be recommended but is not a reimbursable item through the Program. Guidelines for Colonoscopy Surveillance after Polypectomy: A Consensus Update by the U.S. Multi-Society Task Force on Colorectal Cancer and the American Cancer Society Full Article - CA Cancer J Clin 2006;56:143-159 A. Surveillance Recommendations 1. Patients with small rectal hyperplastic polyps should be considered to have normal colonoscopies, and therefore the interval before subsequent colonoscopy should be 10 years. An exception is patients with a hyperplastic polyposis syndrome. They are at increased risk for adenomas and colorectal cancer and need to be identified for more intensive follow up. 2. Patients with only one or two small (< 1 cm) tubular adenomas with only low-grade dysplasia should have their next follow-up colonoscopy in 5 to 10 years. The precise timing within this interval should be based on other clinical factors (such as prior colonoscopy findings, family history, and the preferences of the patient and judgment of the physician). 3. Patients with 3 to 10 adenomas, or any adenoma > 1 cm, or any adenoma with villous features, or high-grade dysplasia should have their next follow-up colonoscopy in 3 years providing that piecemeal removal has not been done and the adenoma(s) are completely removed. If the follow-up colonoscopy is normal or shows only one or two small tubular adenomas with low-grade dysplasia, then the interval for the subsequent examination should be 5 years. 4. Patients who have more than 10 adenomas at one examination should be examined at a shorter (< 3 years) interval established by clinical judgment, and the clinician should consider the possibility of an underlying familial syndrome. Rev.5.2013 2-8

5. Patients with sessile adenomas that are removed piecemeal should be considered for follow up at short intervals (2 to 6 months) to verify complete removal. Once complete removal has been established, subsequent surveillance needs to be individualized based on the endoscopist s judgment. Completeness of removal should be based on both endoscopic and pathologic assessments. 6. More intensive surveillance is indicated when the family history is suggestive of any of the familial colon cancer syndromes. B. Additional Surveillance Considerations 1. The present recommendations assume that colonoscopy is complete to the cecum and that bowel preparation is adequate. A repeat examination should be done if the bowel preparation is not adequate before planning a long-term surveillance program. 2. There is clear evidence that the quality of examination is highly variable. A continuous quality improvement process is critical to the effective application of colonoscopy in colorectal cancer prevention. 3. A repeat examination is warranted if there is a concern that the polyp is incompletely removed, particularly if it shows high-grade dysplasia. 4. Endoscopists should make clear recommendations to primary care providers about when the next colonoscopy is indicated. 5. Given the evolving nature of guidelines, it is important that physicians and patients should remain in contact so that surveillance recommendations reflect changes in guidelines. 6. Pending further investigation, performance of fecal occult blood test is discouraged in patients undergoing colonoscopic surveillance. 7. Discontinuation of surveillance colonoscopy should be considered in persons with serious comorbidities with less than 10 years of life expectancy, according to the clinician s judgment. 8. The application of evolving technologies such as chromoendoscopy, magnification endoscopy, narrow-band imaging, and computed tomography colonography are not established for postpolypectomy surveillance at this time. Guidelines for Colonoscopy Surveillance after Cancer Resection: A consensus Updated by the American Cancer Society and the U.S. Multi-Society Task Force on Colorectal Cancer Full Article - CA Cancer J Clin 2006:56-160-167 A. Post-Cancer Resection Surveillance Colonoscopy Recommendations 1. Patients with colon and rectal cancer should undergo high quality perioperative clearing. In the case of nonobstructing tumors, this can be done by preoperative colonoscopy. In the case of obstructing colon cancers, computed tomography colonography with intravenous contrast or double contrast barium enema can be used to detect neoplasms in the proximal colon. In these cases, a colonoscopy to clear the Rev.5.2013 2-9

colon of synchronous disease should be considered 3 to 6 months after the resection if no unresectable metastases are found during surgery. Alternatively, colonoscopy can be performed intraoperatively. 2. Patients undergoing curative resection for colon or rectal cancer should undergo a colonoscopy 1 year after the resection (or 1 year following the performance of the colonoscopy that was performed to clear the colon of synchronous disease). This colonoscopy at 1 year is in addition to the perioperative colonoscopy for synchronous tumors. 3. If the examination performed at 1 year is normal, then the interval before the next subsequent examination should be 3 years. If that colonoscopy is normal, then the interval before the next subsequent examination should be 5 years. 4. Following the examination at 1 year, the intervals before subsequent examinations may be shortened if there is evidence of hereditary nonpolyposis colorectal cancer or if adenoma findings warrant earlier colonoscopy. 5. Periodic examination of the rectum for the purpose of identifying local recurrence, usually performed at 3 to 6 month intervals for the first 2 or 3 years, may be considered after low anterior resection of rectal cancer. The techniques utilized are typically rigid proctoscopy, flexible proctoscopy, or rectal ultrasound. These examinations are independent of the colonoscopic examinations described above for detection of metachronous disease. B. Additional Recommendations Regarding Post-Cancer Resection Surveillance Colonoscopy 1. These recommendations assume that colonoscopy is complete to the cecum and that bowel preparation is adequate. 2. There is clear evidence that the quality of examinations is highly variable. A continuous quality improvement process is critical to the effective application of colonoscopy in colorectal cancer prevention. 3. Endoscopists should make clear recommendations to primary care physicians about when the next colonoscopy is indicated. 4. Performance of fecal occult blood test is discouraged in patients undergoing colonoscopic surveillance. 5. Discontinuation of surveillance colonoscopy should be considered in persons with advanced age or comorbidities (with less than 10 years of life expectancy), according to the clinician s judgment. 6. Surveillance guidelines are intended for asymptomatic people. New symptoms may need diagnostic workup. 7. Chromoendoscopy (dye-spraying) and magnification endoscopy are potentially helpful but not established as essential to screening or surveillance. Rev.5.2013 2-10