National Medical Policy Subject: Colonoscopy Policy Number: NMP105 Effective Date: February 2004 Updated: February 2014 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate Medicaid Manuals for coverage guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use X X Source National Coverage Determination (NCD) National Coverage Manual Citation Local Coverage Determination (LCD)* Reference/Website Link Colorectal Cancer Screening Tests: http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx Colonoscopy and Sigmoidoscopy-Diagnostic; Diagnostic Colonoscopy: http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx X Article (Local)* Other Medicare Claims Processing Manual, Chapter 18 Preventive and Screening Services: https://www.cms.gov/manuals/downloads/clm104c18 .pdf Medicare Learning Matters Network. Medicare Guide to Preventive Services. March 2011: http://www.cms.gov/Outreach-andEducation/Medicare-Learning-NetworkMLN/MLNProducts/downloads/mps_guide_web061305.pdf Medicare Learning Matters Network. MLN Matters Colonoscopy Feb 14 1 Number: MM7012 Revised. Related Change Request (CR) #: 7012. Release Date: March 2, 2011. Waiver of Coinsurance and Deductible for Preventive Services, Section 4104 of The Affordable Care Act, Removal of Barriers to Preventive Services in Medicare: http://www.cms.gov/Outreach-andEducation/Medicare-Learning-NetworkMLN/MLNMattersArticles/downloads/mm7012.pdf Medicare Learning Matters Network. MLN Matters Number: SE0613. Updated October 2012. Colorectal Cancer: Preventable, Treatable, and Beatable: Medicare Coverage and Billing for Colorectal Cancer Screening: http://www.cms.gov/Outreach-andEducation/Medicare-Learning-NetworkMLN/MLNMattersArticles/downloads/SE0613.pdf None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under “Reference/Website” and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Health Net, Inc. considers colonoscopy medically necessary according to the revised guidelines set forth by the American Gastroenterological Association, the American Society of Colon & Rectal Surgeons, the American Cancer Society, the U.S. MultiSociety Task Force on Colorectal Cancer, the American College of Radiology, the National Comprehensive Cancer Network, the American College of Gastroenterology, and the American Society for Gastrointestinal Endoscopy for patients who meet any of the following indications: Diagnostic Colonoscopy 1. Evaluation of an abnormality on barium enema or other imaging study, which is likely to be clinically significant, such as a filling defect or stricture. 2. Evaluation of unexplained gastrointestinal bleeding, such as: Hematochezia not thought to be from rectum or perianal source, especially if the patient is > 40 years old. Colonoscopy Feb 14 2 Melena of unknown origin after an upper GI source has been excluded. Presence of fecal occult blood. 3. Unexplained iron deficiency anemia. 4. Chronic inflammatory bowel disease of the colon if more precise diagnosis or determination of the extent of activity of disease will influence immediate management. 5. Clinically significant diarrhea of unexplained origin with additional symptoms (e.g., dehydration, weight loss). 6. Evaluation of acute colonic ischemia/ischemic bowel disease. 7. Evaluation of cytomegaloviral colitis in a patient with HIV infection 8. Evaluation of patient with Streptococcus bovis endocarditis. 9. Intraoperative identification of the site of a lesion that cannot be detected by palpation or gross inspection at surgery (e.g., polypectomy site or location of a bleeding source). 10. Marking a neoplasm for surgical localization. 11. Constipation with involuntary weight loss of > 10 lbs within 12 weeks, or continued constipation following 2 weeks of treatment with fiber, hyperosmotic agents or stool softeners. Therapeutic Colonoscopy 1. Excision of colonic polyp(s). 2. Treatment of bleeding from such lesions as vascular malformation, ulceration, neoplasia, and polypectomy site (e.g., electrocoagulation, heater probe, laser or injection therapy). 3. Foreign body removal. 4. Decompression of pseudo-obstruction of the colon (Ogilvie's syndrome). 5. Decompression of acute nontoxic megacolon. 6. Treatment of sigmoid volvulus. 7. Balloon dilation of stenotic lesions (e.g., anastomotic strictures). 8. Palliative treatment of stenosing or bleeding neoplasms (e.g., laser, electrocoagulation, stenting). Screening Colonoscopy Initial screening for colorectal cancer at 50 years of age for asymptomatic, average risk men and women with follow-up colonoscopy every 10 years if the exam is normal. Note: Screening may begin age 45 for African Americans because of the higher incidence of colorectal cancer. Surveillance Colonoscopy Colonoscopy Feb 14 3 Low-risk Patients With No Family History of Colorectal Cancer Treatments Removal of small, hyperplastic polyps would be considered normal colonoscopy. Subsequent colonoscopy is recommended at 10 years. Complete removal of 1 or 2 small tubular adenomas (< 1 cm) in low risk patients with no family history of colorectal cancer. Colonoscopy in 5 years after the initial polypectomy - if the next exam is normal, then the colonoscopy will be in 5-10 years, the patient can thereafter be screened as per average risk guidelines. High-risk Patients with a Personal History of Colorectal Cancer Treatments This refers to patients with colon or rectal cancer that has been resected with curative intent. These patients should undergo high quality perioperative clearing. Colonoscopy should be done around the time of initial diagnosis to rule out synchronous* neoplasms, or synchronous disease. At the time of diagnosis of colon cancer Presurgical evaluation for additional synchronous cancer or neoplastic polyps – if not possible due to obstruction from the carcinoma or for other technical reasons, options include intraoperative colonoscopy or colonoscopy within 3 - 6 months of resection. If abnormal repeat in 1 year. Post treatment surveillance: For stage I disease, colonoscopy at 1 year. Repeat at 3 years, and then at 5 years thereafter, unless advanced adenoma (villous polyp, polyp >1 cm or high-grade dysplasia) is found. In this case, repeat colonoscopy in 1 year. After resection of colorectal cancer or neoplastic polyp Post treatment surveillance stage II/III disease with no known residual disease, colonoscopy 1 year after resection, or 3-6 months post resection if not performed preoperatively due to obstructing lesion. Repeat in 3 years and then every 5 years thereafter, follow-up colonoscopy indicated advanced adenoma (villous polyp, polyp >1 cm or high-grade dysplasia) is found. In this case, repeat colonoscopy in 1 year. More frequent colonoscopies may be indicated in patients with colon cancer before 50 years of age. Colonoscopy Feb 14 4 Low anterior resection of rectal cancer Colonoscopy usually done within 3-6 month intervals for the first 2-3 years, to identify local recurrence. NCCN: every 3-6 mo for 2 yrs following LAR then every 6months for a total of 5 yrs Pedunculated polyp containing invasive carcinoma Colonoscopic removal is adequate treatment in the uniform presence of favorable prognostic indicators.** A followup examination within 3 months is mandatory to confirm the presence or absence of residual or recurrent disease Note* - Synchronous neoplasms refers to two or more abnormal growths of tissue occurring simultaneously and presumed to be of separate origin. The neoplasms may be histologically the same or different, and may be found in the same or different sites. Preoperative or intraoperative diagnosis of the presence of synchronous colorectal carcinomas is very important because once they are over looked, they present as early metachronous carcinomas with advanced stages and usually require re-operation. Synchronous adenocarcinomas from large bowel could metastasize to the liver. Note** - Favorable prognostic indicators include all of the following: Complete excision No vascular or lymphatic invasion Clear margins Well-differentiated histology (Grade I or II). High-risk Patients Treatments Individuals with 3 or more adenomas (3-10) 3 years after initial polypectomy, subsequent surveillance are recommended within 5 years, depending on colonoscopic findings. Longer intrvals are recommended for persons with normal follow-up colonoscopies. Patients with >10 adenomas on a single examination <3 years after initial polypectomy. Consider the possibility of familial polyposis syndrome. Individual with a personal history of attenuated familial adenomatous polyposis (AFAP) Varies depending on the individual’s age and adenoma burden. For young patients under the age of 21 with small adenoma burden, colonoscopy and polypectomy are recommended every 1-2 years with appropriate surgical evaluation and counseling. Age 21 and older with small adenomatous polyp burden, colectomy and IRA are alternative treatment options to colonoscopy and polypectomy. When polposis is too significant to be managed by polypectomy, (i.e., polyps >20 at any Colonoscopy Feb 14 5 individual exam or when polyp >1 cm in diameter or advanced histology is identified), surgery is recommended. Piece meal resection of a large sessile adenoma Colonoscopy at 2 - 6 month intervals until complete polyp removal is verified.* After one negative result examination, standard surveillance is performed as for patients with benign adenomas. Crohn's colitis and chronic ulcerative pancolitis Screening every 1-2 years should be initiated 8-10 years at onset of symptoms of pancolitis or 12 years after onset of leftsided colitis Note* - Surgical resection is recommended for residual abnormal tissue at the polypectomy site after two or three attempts at colonoscopic removal. High-risk Patients With Significant Family History Advanced, large adenomas (>1cm), or multiple adenomas (>3) of any size, or adenomas with villous histology, high-grade dysplasia or a family history of colorectal cancer. Genetic diagnosis of familial adenomatous polyposis (FAP)/ attenuated familial adenomatous polyposis (AFAP), or are at risk of having FAP but genetic testing has not been performed or is not feasible Treatments Colonoscopy at 3 years after the initial polypectomy - if normal, repeat in 3 years if normal then, repeat colonoscopy in 5 years. The patient can thereafter be screened as per average risk guidelines. Family history of Classical FAP/Genetic testing done: If an individual at risk is found not to carry APC gene mutation responsible for FAP, screen as an average risk individual. If positive for APC gene mutation, flexible sigmoidoscopy or colonocscopy every 12 months, beginning at 10-15 years of age. Once adenomas develop, surgical options should be reviewed. If no genetic testing has been done, offer annual flexible sigmoidoscopy or colonoscopy beginning at age 10 -15 years until the age of 24. Then if results continues to be negative, screening is scaled down to every 2 years until age 34, every 3 years until age 44 and every 3-5 years thereafter. Consider substituting colonoscopy every 5 years beginning at age 20 for a chance that an individual may have attenuated familial adenomatous polyposis (AFAP). Family history of AFAP: Similar genetic counseling, testing and surveillance considerations for individuals with FAP apply to patients with AFAP, except for the endoscopy approach. Colonoscopy Feb 14 6 Individuals with AFAP may not present until a later age and may have fewer polyps than those with classical FAP. In the absence of a true negative genetic test, an individual with a family history of AFAP, should begin colonoscopy screening in late teens, with repeat exam every 2-3 years. Genetic or clinical diagnosis of Hereditary Non-polyposis Colon Cancer (HNPCC)/Lynch Syndrome or who are at increased risk for HNPCC Colonoscopy every 1 - 2 years beginning at age 20 - 25 years, or 2-5 years younger than the youngest diagnosis age in the family, whichever comes first, to be repeated every 1-2 years. A 1st degree relative (parent, sibling, or child) with sporadic colorectal cancer or adenomatous polyps diagnosed at age < 60 years or 2 or more 1st degree relatives diagnosed with colorectal cancer at any age *Screening colonoscopy starting at age 40 years or 10 years younger than the earliest diagnosis in their family, whichever comes first, and repeated every 5 years if negative. A first-degree relative ≥age 60 years or 2 second-degree relatives with either colorectal cancer or adenomatous polyps. Colonoscopy should be done at age 40 years. Screening options at intervals recommended for average-risk individuals after this initial colonoscopy. Note* - Colorectal cancer in relatives more distant than first-degree does not increase risk substantially above the average risk group. Health Net, Inc. considers colonoscopy not medically necessary for any of the following circumstances: 1. Chronic, stable, irritable bowel syndrome or chronic abdominal pain; there are unusual exceptions in which colonoscopy may be done once to rule out disease, especially if symptoms are unresponsive to therapy. 2. Acute limited diarrhea. 3. Hemorrhoids. 4. Bright red rectal bleeding in patients with a convincing anorectal source on sigmoidoscopy and no other symptoms suggestive of a more proximal bleeding source 5. Metastatic adenocarcinoma of unknown primary site in the absence of colonic signs or symptoms when it will not influence management. 6. Routine follow-up of inflammatory bowel disease (except for cancer surveillance in chronic ulcerative colitis and Crohn's colitis). 7. Upper GI bleeding or melena with a demonstrated upper GI source. 8. Routine examination of the colon in patients about to undergo elective abdominal surgery for non-colonic disease. Relative contraindications to colonoscopy are Colonoscopy Feb 14 7 1. Toxic megacolon and fulminant colitis. 2. Peritonitis 3. Known or suspected colonic necrosis. 4. Documented acute severe diverticulitis / diverticular abscess. 5. Possible perforated viscus. 6. Severe coagulopathy, severe thrombocytopenia, severe neutropenia 7. History of radiation therapy for abdominal or pelvic cancer 8. History of abdominal or pelvic malignancy 9. Extensive adhesions from prior abdominal surgery 10. Pregnancy * Note* - Colonoscopy is currently contraindicated during pregnancy because of inadequate data on safety but may be strongly considered for severe life-threatening colonic conditions such as suspected colon cancer, evaluation of a right-sided colonic mass, and uncontrolled severe right-colonic hemorrhage, and to guide segmental colectomy for urgent colonic surgery. Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2014, the ICD-9 code sets used to report medical diagnoses and inpatient procedures will be replaced by ICD-10 code sets. Health Net National Medical Policies will now include the preliminary ICD-10 codes in preparation for this transition. Please note that these may not be the final versions of the codes and that will not be accepted for billing or payment purposes until the October 1, 2014 implementation date. ICD-9 Codes V10.00 V10.05 V10.06 V12.70 V12.72 V16.0 V18.51 V76.51 009.0 009.1 009.2 009.3 153.1-153.9 154.0-154.8 195.3 196.2 Colonoscopy Feb 14 Personal history of malignant neoplasm, gastrointestinal, tract, unspecified Personal history of malignant neoplasm, large intestine Personal history of malignant neoplasm, rectum, rectosigmoid junction, and anus Personal history of unspecified digestive disease Personal history of colonic polyps Family history of malignant neoplasm, gastrointestinal tract Family history of colonic polyps Special screening for malignant neoplasms of colon Infectious colitis, enteritis and gastroenteritis Colitis, enteritis, and gastroenteritis of presumed infectious origin Infectious diarrhea Diarrhea of presumed infectious origin Malignant neoplasm of colon Malignant neoplasm of rectum, rectosigmoid junction, and anus Malignant neoplasm of the pelvic region Secondary and unspecified malignant neoplasm of intraabdominal lymph nodes 8 197.5 197.6 197.7 199.0 211.3 211.4 230.3 230.4 230.5 230.6 235.2 235.5 280.0 280.9 285.1 421.0 555.0-555.9 556.0-556.9 557.0 557.1 557.9 558.1 558.2 558.9 560.0 560.1 560.2 560.81 560.89 560.9 562.10 562.12 562.13 564.4 564.5 564.7 564.81 564.89 569.0 569.3 569.41 569.81 569.82 569.83 569.84 569.85 569.86 569.89 578.1 578.9 Colonoscopy Feb 14 Secondary malignant neoplasm of large intestine and rectum Secondary malignant neoplasm of the retroperitoneum and peritoneum Secondary malignant neoplasm of liver, specified as secondary Disseminated malignant neoplasm without specification of site Benign neoplasm of colon Benign neoplasm of rectum and anal canal Carcinoma in situ of colon Carcinoma in situ of rectum Carcinoma in situ of anal canal Carcinoma in situ of anus, unspecified Neoplasm of uncertain behavior of stomach, intestines and rectum Other and unspecified neoplasm of digestive organs Iron deficiency anemia secondary to blood loss (chronic) Iron deficiency anemia, unspecified Acute posthemorrhagic anemia Acute and subacute bacterial endocarditis Regional enteritis Ulcerative colitis Acute vascular insufficiency of intestine Chronic vascular insufficiency of intestine Unspecified vascular insufficiency of intestine Gastroenteritis and colitis due to radiation Toxic gastroenteritis and colitis Other and unspecified noninfectious gastroenteritis and colitis Intussusception Paralytic ileus Volvulus Intestinal or peritoneal adhesions with obstruction (postoperative) (postinfection) Other specified intestinal obstruction, Other Unspecified intestinal obstruction Diverticulosis of colon (without mention of hemorrhage) Diverticulosis of colon with hemorrhage Diverticulitis of colon with hemorrhage Other postoperative functional disorders Functional diarrhea Megacolon, other than Hirschsprung's Neurogenic bowel Other functional disorders of intestine Anal and rectal polyp Hemorrhage of rectum and anus Ulcer of anus and rectum Fistula of intestine, excluding rectum and anus Ulceration of intestine Perforation of intestine Angiodysplasia of intestine (without mention of hemorrhage) Angiodysplasia of intestine with hemorrhage Dieulafoy lesion (hemorrhagic) of intestine Other specified disorder of intestine, Other Blood in stool Hemorrhage of gastrointestinal tract, unspecified 9 787.9 787.99 792.1 793.4 936 Diarrhea Other symptoms involving digestive system, Nonspecific abnormal findings in stool contents Nonspecific abnormal findings on radiological and other examination; gastrointestinal tract Foreign body in intestine and colon ICD -10 Codes AØ9 C17-C21.8 C76.3 C77.2 D01.0-D01.49 D12.Ø D12.6 D5Ø.Ø-D50.9 D62 I33.Ø-I33.9 K50-K50.919 K51-K51.319 K51.4-K51.419 K51.5-K519 K51.8-K51.919 K52-K52.9 K55-K55.9 K56-K56.7 K57-K57.93 K58-K58.9 K59-K59.9 K62-K62.9 K63-K63.9 K63.5 K91.8-K91.89 K92-K92.9 R19.4 R19.5 R93.3 T18.3XXA T18.4XXA Z12.I-Z12.3 Z12.11 Z8Ø.Ø Z83.71 Z85.00 Z86.Ø1Ø Colonoscopy Feb 14 Infectious gastroenteritis and colitis, unspecified Malignant neoplasm of small intestine, colon, rectosigmoid junction, rectum, anus and anal canal Malignant neoplasm of pelvis Secondary and unspecified malignant neoplasm of intraabdominal lymph nodes Carcinoma in situ of colon, rectosigmoid junction, rectum, anal canal and anus and intestine Benign neoplasm of cecum Benign neoplasm of colon, unspecified Iron deficiency anemia secondary to blood loss (chronic) Acute posthemorrhagic anemia Acute and subacute infective endocarditis Crohn’s disease Ulcerative colitis Inflammatory polyps of colon Left sided colitis Ulcerative colitis, unspecified Other and unspecified noninfective gastroenteritis and colitis Vascular disorders of intestine Paralytic ileus Diverticular disease of intestine Irritable bowel syndrome Other functional disorders Other diseases of anus and rectum Other diseases of intestine Polyp of colon Other intraoperative and postprocedural complications and disorders of digestive system Other diseases of digestive system Change in bowel habits Other fecal abnormalities Abnormal findings on diagnostic imaging of other parts of digestive tract Foreign body in small intestine, initial encounter Foreign body in colon, initial encounter Encounter for screening for malignant neoplasm of intestinal tract Encounter for screening for malignant neoplasm of colon Family history of malignant neoplasm of digestive organs Family history of colonic polyps Personal history of malignant neoplasm of unspecified digestive organ Personal history of colonic polyps 10 Z87.19 Z85.03-Z85.048 Z85.06-Z85.068 Personal history of other diseases of the digestive system Personal history of malignant neoplasm of large intestine, rectum, rectosigmoid junction and anus Personal history of malignant neoplasm of small intestine CPT Codes 44388 44389 44390 44391 44392 44393 44394 44397 45355 45378 45379 45380 45381 45382 45383 45384 45385 45386 45387 Colonoscopy through stoma; diagnostic, with or without collection of specimen(s) by brushing or washing ; with biopsy, single or multiple ; with removal of foreign body ; with control of bleeding (e.g., injection, bipolar cautery, unipolar cautery, laser, heater probe, stapler. plasma coagulator) ; with removal of tumor(s), polyp(s), or other lesion(s) by hot biopsy forceps or bipolar cautery ; with ablation of tumor(s), polyp(s), other lesion(s) not amenable to removal by hot biopsy forceps, bipolar cautery or snare technique ; with removal of tumor(s), poly(s), or other lesion(s) by snare technique ;with transendoscopic stent placement (includes predilation) Colonoscopy, rigid or flexible, transabdominal via colotomy, single or multiple Colonoscopy, flexible, proximal to splenic flexure; diagnostic, with or without collection of specimen(s) by brushing or washing, with or without colon depression ; with removal of foreign body ; with biopsy, single or multiple ;with directed submucosal injection(s), any substance ; with control of bleeding (e.g., injection, bipolar cautery, unipolar cautery, laser, heater probe, stapler. plasma coagulator) ; with ablation of tumor(s), polyp(s), or other lesion(s) not amendable to removal; by hot biopsy forceps, bipolar cautery or snare technique ; with removal of tumor(s), polyp(s), or other lesion(s) by hot biopsy forceps or bipolar cautery ; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique ;with dilation by balloon, 1 or more strictures ;with transendoscopic stent placement (includes predilation) HCPCS Codes G0105 G0121 Colorectal cancer screening; colonoscopy on individual at high risk Colorectal cancer screening; colonoscopy on individual not meeting criteria for high risk Scientific Rationale – Update February 2013 2012 recommendations for colonoscopic surveillance after screening and polypectomy from the US Multi-Society Task Force on Colorectal Cancer, include the following: Colonoscopy Feb 14 11 1. Baseline examination: no adenomas or polyps. Next exam recommended in 10 years. There is now stronger evidence to support the 10-year interval after negative findings on baseline colonoscopy for average-risk individuals, assuming that the baseline colon examination is complete with a good bowel preparation. 2. Baseline examination: no adenomas; distal small (<10 mm) hyperplastic polyps. Next exam recommended in 10 years. Prior and current evidence suggests that distal hyperplastic polyps (HPs) <10 mm are benign and non-neoplastic. If the most advanced lesions at baseline colonoscopy are distal HPs <10 mm, the interval for colonoscopic follow-up should be 10 years. 3. Baseline examination: 1–2 tubular adenomas <10 mm. Next exam recommended is recommended at 5-10 year intervals. Data published since 2006 endorse the assessment that patients with 1–2 tubular adenomas with low-grade dysplasia <10 mm represent a low-risk group. Three new studies suggest that this group may have only a small, nonsignificant increase in risk of advanced neoplasia within 5 years compared with individuals with no baseline neoplasia. The evidence supports a surveillance interval of longer than 5 years for most patients 4. Baseline examination: 3–10 adenomas. Recommendation for next exam at 3 year intervals Two new studies reported outcomes in patients with multiple adenomas. The NCI Pooling Project analysis found that with each additional adenoma, there is a linear increase in risk for both advanced and nonadvanced neoplasia. The VA study (which contributed data to the pooling project) also provided a second referent group: patients with no baseline neoplasia. The risk of advanced neoplasia at 5 years was 2.4% in the nonneoplasia referent group, 4.6% if patients had 1–2 tubular adenomas <10 mm (RR, 1.92; 95% CI, 0.83–4.42), and 11.9% if they had 3 or more tubular adenomas <10 mm (RR, 5.01; 95% CI, 2.10–11.96). The VA study shows that even if all of the adenomas are <10 mm, there is increased risk of advanced neoplasia with multiplicity of adenomas. The new information from the VA study and the NCI Pooling Project support the previous recommendation that patients with 3 or more adenomas have a level of risk for advanced neoplasia similar to other patients with advanced neoplasia (adenoma >10 mm, adenoma with HGD) 5. Baseline examination: >10 adenomas. Recommendation for next exam is <3 year interval. The NCI Pooling Project notes a marked increased risk of advanced neoplasia among patients with 5 or more adenomas at baseline. 6. Baseline examination: one or more tubular adenomas ≥10 mm. Recommendation for next exam is at 3 year intervals. Colonoscopy Feb 14 12 New information provides additional data showing that patients with one or more adenomas ≥10 mm have an increased risk of advanced neoplasia during surveillance compared with those with no neoplasia or small (<10 mm) adenomas. This recommendation assumes that the examination was of high quality and complete removal of neoplastic tissue occurred at baseline. This group represents a small proportion of all patients with adenomas. If there is question about complete removal (ie, piecemeal resection), early follow-up colonoscopy is warranted. 7. Baseline examination: one or more adenomas with villous features of any size. Recommendation for next exam at 3 year intervals New information provides additional data showing that patients with one or more adenomas with villous histology have an increased risk of advanced neoplasia during surveillance compared with those with no neoplasia or small (<10 mm) tubular adenomas. 8. Baseline examination: one or more adenomas with HGD. Recommendation for next examination at 3-year interval. The presence of an adenoma with HGD is an important risk factor for development of advanced neoplasia and CRC during surveillance. 9. Baseline examination: serrated polyps. No follow up recommendations. The clinical implications of serrated polyps are uncertain. The current evidence suggests that size (>10 mm), histology (a sessile serrated polyp is a more significant lesion than an HP; a sessile serrated polyp with cytological dysplasia is more advanced than a sessile serrated polyp without dysplasia), and location (proximal to the sigmoid colon) are risk factors that might be associated with higher risk of CRC. A sessile serrated polyp ≥10 mm and a sessile serrated polyp with cytological dysplasia should be managed like high risk adenoma (HRA). Serrated polyps that are <10 mm and do not have cytological dysplasia may have lower risk and can be managed like Low risk adenoma (LRA). Note: HRA is defined as 3 or more adenomas, tubular adenoma ≥10 mm, adenoma with villous histology, or HGD. LRA is defined as 1–2 tubular adenomas <10 mm. The National Comprehensive Care Network (NCCN) states, “Surveillance colonoscopies are primarily aimed at identifying and removing metachronous polyps because data show that patients with a history of colorectal cancer have an increased risk of developing second cancers, particularly in the first 2 years after resection. Furthermore, use of post-treatment surveillance colonoscopy has not been shown to improve survival through the early detection of recurrence of the original colorectal cancer. The recommended frequency of post- treatment surveillance is higher for patients with Lynch Syndrome.” Scientific Rationale - Update May 2013 According to the National Cancer Institute, colorectal cancer is the third most commonly diagnosed cancer in the African American population. Over 18,000 new cases of colorectal cancer are diagnosed in African Americans annually. Though the overall CRC rates are declining in the United States, the rates for African Americans Colonoscopy Feb 14 13 are decreasing more slowly than the rates for white Americans. African Americans are also more likely to be diagnosed when colorectal cancer is advanced and, therefore, less treatable. Between 2002 and 2008, the likelihood of surviving 5 years after a diagnosis of colorectal cancer was only 57 percent for African Americans, compared with 65 percent for white Americans. The difference between African Americans and whites in colorectal cancer death rates has actually widened over the years. The American College of Gastroenterology and the Institute for Clinical Systems Improvement recommends that screening for colorectal cancer (CRC) in African Americans may begin at age 45. The rationale is based on high incidence of CRC and a greater prevalence of proximal or right-sided polyps and cancerous lesions in this population. Scientific Rationale – Update April 2009 Updated Guidelines for Detection of Adenomatous Polyps and Colorectal Cancer Screening in Asymptomatic Average-Risk Adults and Guidelines from the American Gastroenterological Association, the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer, the American College of Radiology Colon Cancer Committee, the National Comprehensive Cancer Network and the Canadian Association of Gastroenterology are very similar and state: Patients with small rectal hyperplastic polyps should have colonoscopy or other screening options at intervals recommended for average-risk individuals. (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); Patients with 1 or 2 small tubular adenomas with low-grade dysplasia should have colonoscopy 5 –10 years after the initial polypectomy. 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); [The American Gastroenterological Association notes 5 years for follow-up exam for low-risk patients]. Patients with 3 to 10 adenomas or 1 adenoma >1 cm or any adenoma with villous features or high-grade dysplasia should have colonoscopy 3 years after the initial polypectomy. Adenomas must have been completely removed. (If the follow-up colonoscopy is normal or shows only 1 or 2 small, tubular adenomas with low-grade dysplasia, then the interval for the subsequent examination should be 5 years); [The American Society of Colon & Rectal Surgeons feel that patients who have advanced or multiple adenomas should have their first followup colonoscopy at 5 years. They do not note the exact # of polyps. However, they do state that numerous adenomas, a malignant adenoma with invasive cancer or a large sessile adenoma should have a short interval follow-up colonoscopy based on clinical judgement]. [2008- American Journal of Gastroenterology recommend screening in this scenario, should be the same as individuals who are at average-risk (colonoscopy every 10 years beginning at age 50 years)]. Patients with >10 adenomas on a single examination should have colonoscopy <3 years after the initial polypectomy. (Consider the possibility of an underlying familial syndrome); Colonoscopy Feb 14 14 Patients with sessile adenomas that are removed piecemeal should have colonoscopy 2 to 6 months to verify complete removal. (Once complete removal has been established, subsequent surveillance needs to be individualized based on the physician’s judgment. Completeness of removal should be based on both endoscopic and pathologic assessments); Patients with colon and rectal cancer should undergo high quality perioperative clearing with colonoscopy recommended 3 to 6 months after cancer resection, if no unresectable metastases are found during surgery; alternatively, colonoscopy can be performed intraoperatively. (In the case of nonobstructing tumors, this can be done by preoperative colonoscopy. In the case of obstructing colon cancers, computed tomographic colonography [CTC] with intravenous contrast or double-contrast barium enema [DCBE] can be used to detect neoplasms in the proximal colon); Patients undergoing curative resection for colon or rectal cancer should have 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. 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. Following the examination at 1 year, the intervals before subsequent examinations may be shortened if there is evidence of HNPCC or if adenoma findings warrant earlier colonoscopy. 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 American Society of Colon & Rectal Surgeons state that colonoscopy should be done 6 months postoperative and if this is normal, subsequent colonoscopy should be done after 3 years, and if this is normal, every 5 years]. Either colorectal cancer or adenomatous polyps in a first-degree relative before age 60 years or in 2 or more first-degree relatives at any age, colonoscopy should be done at age 40 years or 10 years before the youngest case in the immediate family. Colonoscopy should then be repeated every 5 years; [2008American Journal of Gastroenterology recommend screening as the same as average risk (colonoscopy every 10 years beginning at age 50 years]. Either colorectal cancer or adenomatous polyps in a first-degree relative ≥age 60 years or in 2 second-degree relatives with colorectal cancer, colonoscopy should be done at age 40 years. Screening options at intervals recommended for average-risk individuals. (Screening should begin at an earlier age, but individuals may choose to be screened with any recommended form of testing); Genetic diagnosis of familial adenomatous polyposis (FAP) or suspected FAP without genetic testing evidence, colonoscopy should be done at age 10 to 12 years. Annual flexible sigmoidoscopy (FSIG) to determine if the individual is expressing the genetic abnormality and counseling to consider genetic testing. If the genetic test is positive, colectomy should be considered; Colonoscopy Feb 14 15 Genetic or clinical diagnosis of hereditary nonpolyposis colon cancer (HNPCC) or individuals at increased risk of HNPCC. Colonoscopy aged 20 to 25 years or 10 years before the youngest case in the immediate family. Colonoscopy every 1 to 2 years and counseling to consider genetic testing. Genetic testing for HNPCC should be offered to first-degree relatives of persons with a known inherited mismatch repair (MMR) gene mutation. It should also be offered when the family mutation is not already known, but 1 of the first 3 of the modified Bethesda Criteria is present; Inflammatory bowel disease, chronic ulcerative colitis, and Crohn’s colitis. Cancer risk begins to be significant 8 years after the onset of pancolitis or 12 to 15 years after the onset of left sided colitis. Colonoscopies with biopsy are recommended every 1 to 2 years for dysplasia. These patients are best referred to a center with experience in the surveillance and management of inflammatory bowel disease. Colonic Polyps Colonic polyps, or adenomas, are benign epithelial neoplasms that arise from the epithelial cells lining the colon. Colonic polyps are traditionally divided into 3 groups, hyperplastic polyps, adenomas, and polyposis syndromes. Hyperplastic Polyps Hyperplastic polyps are now recognized to possess some malignant potential in the setting of hyperplastic polyposis syndrome. Patients who are affected have an occurrence of hyperplastic polyps proximal to the sigmoid colon, with two or more that are greater than 10 mm in diameter, a total of more than 30 polyps, or a firstdegree relative with the syndrome. The polyps in this syndrome may have adenomatous components, display a serrated, saw-tooth surface epithelium, and harbor methylation of specific target genes, including mismatch repair genes. Adenomatous Polyps Adenomas comprise approximately 10% of polyps. Approximately 90% of adenomas are small, usually less than 1 cm in diameter, and have a small potential for malignancy. The remaining 10% of adenomas are larger than 1 cm and approach a 10% chance of containing invasive cancer. The risk of progression to carcinoma is related to both the size and the histology of the adenoma. Adenomas that are greater than 1 cm, contain a substantial (>25%) villous component, or have high-grade dysplasia are commonly referred to as advanced neoplasms and carry an increased cancer risk. First, the pathway for migration of invasive cells from the tumor into submucosal and more distant structures is shorter. Second, the complete endoscopic removal is more challenging and more difficult to ascertain. Adenomas are traditionally divided by histology into the following three types: tubular, tubulovillous, and villous. Tubular adenomas are the most common of the 3 types and can be found anywhere in the colon. Villous adenomas most commonly occur in the rectal area; tend to be larger than the other two types; and tend to be nonpedunculated, velvety, or cauliflowerlike in appearance. Villous adenomas are associated with the highest morbidity and mortality rates of all polyps. They can cause hypersecretory syndromes characterized by hypokalemia and profuse mucous discharge and can harbor carcinoma in situ or invasive carcinoma more frequently than other adenomas. Colonoscopy Feb 14 16 The shape or gross structure of the polyp is also clinically significant. Those polyps with a stalk are called pedunculated. Those polyps without a stalk are called sessile. Sessile polyps are more concerning than large pedunculated polyps for two reasons. First, the pathway for migration of invasive cells from the tumor into submucosal and more distant structures is shorter. Second, the complete endoscopic removal is more challenging and more difficult to ascertain. Some premalignant neoplasia is now recognized to be flat, rather than protuberant. Such nonpolypoid neoplasia is more common in the setting of chronic colitis and may be detected more readily by nontraditional endoscopic imaging methods, such as narrow-band width imaging or mucosal staining. Polyposis Syndromes Polyposis syndromes are hereditary conditions that include familial adenomatous polyposis (FAP), hereditary nonpolyposis (a misnomer) colorectal cancer (HNPCC)/Lynch syndrome, Gardner syndrome, Turcot syndrome, Peutz-Jeghers syndrome, Cowden disease, familial juvenile polyposis, and hyperplastic polyposis. Progress has been made in understanding some of the genetic factors contributing to the development of these syndromes. Some of the syndromes have extraintestinal features that help differentiate one syndrome from the other. For example, FAP is best understood in terms of the genetic basis and subsequent pathological and genetic events leading to carcinoma. Two other types of benign polyps are hamartomatous polyps, which contain a mixture of normal tissues, and inflammatory polyps, which contain an inflammatory epithelial reaction and are typically found in the context of colitis. Summary Although colonoscopy is considered to be the reference standard against which the sensitivity of other colorectal cancer screening tests are compared, it is not perfect. The relative sensitivity and specificity of the different colorectal screening tests with adequate data to assess cancer detection such as colonoscopy, flexible sigmoidoscopy, and fecal tests—can be depicted as follows: Sensitivity: Hemoccult II < fecal immunochemical tests Hemoccult SENSA flexible sigmoidoscopy < colonoscopy Specificity: Hemoccult SENSA < fecal immunochemical tests Hemoccult II < flexible sigmoidoscopy = colonoscopy For the operator-dependent tests such as flexible sigmoidoscopy, CT colonography, and colonoscopy, better operator training and more experience have a high likelihood of improving sensitivity. Assurance of performance of high-quality endoscopy should be part of all screening programs. Screening for colorectal cancer reduces mortality through detection and treatment of early-stage cancers and detection and removal of adenomatous polyps. The degree to which each of these mechanisms contributes to a reduction in mortality is unknown, although it is likely that the largest reduction in colorectal cancer mortality during the 10 years after initial screening comes from the detection and removal of early-stage cancers. Colonoscopy is a necessary step in any screening program that reduces mortality from colorectal cancer. Colonoscopy Feb 14 17 There is adequate evidence that the benefits of detection and early intervention decline after age 75. There is a substantial lead-time between the detection and treatment of colorectal neoplasia and a mortality benefit, and competing causes of mortality make it progressively less likely that this benefit will be realized with advancing age. In March 2008, the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology jointly recommended screening for colorectal cancer beginning at 50 years of age by high-sensitivity fecal occult blood test (FOBT) or fecal immunochemical testing annually, flexible sigmoidoscopy every 5 years, double-contrast barium enema every 5 years, CT colonography (virtual colonoscopy) every 5 years, colonoscopy every 10 years, or fecal DNA at an unspecified interval. (2008) American College of Gastroenterology states: “The evidence that colonoscopy prevents incident colorectal cancer and reduces the consequent mortality from colorectal cancer is indirect but substantial. No prospective randomized controlled trials comparing colonoscopy with no screening, have been completed. However, major advantages of colonoscopy as a screening test include that it is widely available, examines the entire colon, allows single-session diagnosis and treatment, is comfortable when carried out with sedation, and is the only test recommended at 10-year intervals for average-risk persons. The incremental benefit of colonoscopy over sigmoidoscopy is the detection of patients with proximal colon neoplasia (particularly advanced adenomas), as well as large hyperplastic polyps that are not associated with distal neoplasia”. In summary, there are no prospective randomized controlled trials of screening colonoscopy for the reduction in incidence or mortality of colorectal cancer. However, because colonoscopy and polypectomy is used to evaluate other positive screening tests, there is evidence to indicate that these procedures result in incidence reductions in randomized controlled trials of other screening tests. The evidence base to support screening colonoscopy, though indirect, is substantial. Scientific Rationale – Update November 2008 Winauer et al. (2003) Patients who have had one or more adenomatous polyps removed at colonoscopy should be managed according to the findings on that colonoscopy. Patients who have had numerous adenomas, a malignant adenoma (with invasive cancer), a large sessile adenoma, or an incomplete colonoscopy should have a short interval follow-up colonoscopy based on clinical judgment. Screening for colonoscopy for patients with significant personal history is noted below: Patients who have advanced or multiple adenomas (>3) should have their first follow-up colonoscopy in 3 years. Patients who have 1 or 2 small (<1 cm) tubular adenomas should have their first follow-up colonoscopy at 5 years. It is not unreasonable, given available evidence, to choose even longer intervals. However, the evidence is still evolving. Future evidence may clarify the intervals more precisely. Colonoscopy Feb 14 18 The timing of the subsequent colonoscopy should depend on the pathology and number of adenomas detected at follow-up colonoscopy. For example, if the first follow-up colonoscopy is normal or only 1 or 2 small (<1 cm) tubular adenomas are found, the next colonoscopy can be in 5 years. Patients with 3-10 adenomas or any adenoma or any adenoma >1cm or any adenoma with villous features or high-grade dysplasia should have colonoscopy every 3 years. Patients with >10 adenomas should have colonoscopy more frequently than every 3 years, determined by clinical judgment. Patients with Sessile adenomas that are removed piecemeal should be offered a colonoscopy at 2-6 months to verify complete removal. Colon Cancer Screening for those with Family History of Colon Cancer is noted below: First degree relative with colon cancer or adenomatous polyps on biopsy age >60 or two 1st degree relatives diagnosed with colorectal cancer at any age Colonoscopy at age 40 or 10 years earlier than the earliest dx in their family, whichever comes first Repeat colonoscopy every 5 yrs First degree relative with colon ca or adenomatous polyp dx age >60 or two 2nd degree relatives with colon cancer Screen like average risk patients but start at age 40 Scientific Rationale – Initial Colorectal cancer is a major American health problem, ranking as the second leading cause of cancer death, after lung cancer, in the United States. About 129,400 new cases are diagnosed each year, and 56,600 Americans die annually from this disorder. The etiology of colorectal cancer is heterogeneous, with environment or genetics playing varying key roles in different patients. About 80% of patients with colorectal cancer seem to have sporadic disease with no evidence of having inherited the disorder. In the remaining 20%, there seems to be a potentially definable genetic component. Colorectal polyps are classified histologically as neoplastic or non-neoplastic. Most colorectal cancers arise from neoplastic adenomatous polyps (adenomas). Adenomas are monoclonal derivatives of a mutated epithelial stem cell. Scientific studies now conclusively show that resecting adenomatous polyps prevents colorectal cancer. Colonoscopy is a visual examination of the mucosa of the large intestine with a flexible video or fiberoptic endoscope. The colonoscope is inserted through the anus, a stoma or transabdominally and is advanced through the large intestine under direct vision. Standard diagnostic functions include inspection, biopsy, photography and video recording. Diagnostic observations are made concerning focal benign or malignant lesions, diffuse mucosal changes, luminal obstruction, motility, and extrinsic compression by contiguous structures. The most common therapeutic endoscopic procedures include polypectomy, dilatation of strictures, removal of foreign bodies and treatment of gastrointestinal bleeding with coagulation. Colonoscopy Feb 14 19 Colonoscopy is the most sensitive and specific test for detecting cancer and large polyps but is associated with higher risks than other screening tests for colorectal cancer. These include a small risk of bleeding and risk of perforation, primarily associated with removal of polyps or biopsies performed during screening. Potential screening options for colorectal cancer include home fecal occult blood test (FOBT), flexible sigmoidoscopy, the combination of home FOBT and flexible sigmoidoscopy, colonoscopy, and double-contrast barium enema. Each option has advantages and disadvantages that may vary for individual patients and practice settings. The American Cancer Society recommends screening people at average risk for colorectal cancer beginning at 50 years of age by (1) FOBT annually; (2) flexible sigmoidoscopy every five years; (3) annual FOBT plus flexible sigmoidoscopy every five years; (4) double-contrast barium enema every five years; or (5) colonoscopy every 10 years. A 10-year interval has been recommended for colonoscopy on the basis of evidence regarding the natural history of adenomatous polyps. Shorter intervals (five years) have been recommended for flexible sigmoidoscopy and double-contrast barium enema because of their lower sensitivity, but there is no direct evidence with which to determine the optimal interval for tests other than FOBT. The US Preventive Services Task Force (USPSTF) recommends initiating screening at 50 years of age for men and women at average risk for colorectal cancer, based on the incidence of cancer above this age in the general population. In persons at higher risk (for example, those with a first-degree relative who receives a diagnosis of colorectal cancer before 60 years of age), initiating screening at an earlier age is reasonable. Expert guidelines exist for screening very high-risk patients, including those with a history suggestive of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer HNPCC), or those with a personal history of ulcerative colitis. Similar recommendations are issued by the American College of Surgeons, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians. As a general rule, complete colonoscopy should be done at the time of initial polypectomy to detect and resect all synchronous adenomas. Most patients with polyps detected by barium enema or flexible sigmoidoscopy, especially if the polyps are multiple or large, should undergo colonoscopy to excise the polyp and search for additional neoplasms. As simple small (< 1 cm) tubular adenomas are extremely common and the risk of subsequent cancer in these patients is approximately equal to that of the general population (0.1%), the decision whether to perform colonoscopy must be individualized depending on the patient's age, comorbidity, and past or family history of colorectal neoplasia. Current recommendations for follow-up surveillance colonoscopy assume that the initial clearing colonoscopy was complete to the cecum with adequate preparation and removal of all visualized polyps. If, because of multiple adenomas or other technical reasons, the colonoscopist is not reasonably confident that all adenomas have been found and resected, clearance should be verified at one year or sooner. If only a single tubular adenoma < 1 cm in size is found, the first subsequent examination can be in five years. If a subsequent colonoscopy is negative, further examination can be performed at an interval of five years. After a complete clearing colonoscopy has been accomplished after an initial polypectomy, repeat colonoscopy to check for metachronous adenomas should be performed in 3 years for patients at high risk for developing metachronous advanced adenomas. This includes those who at baseline examination have multiple (> 2) adenomas, a large (> 1 cm) adenoma, an adenoma with villous histology or high-grade dysplasia, or have a family history Colonoscopy Feb 14 20 of colorectal cancer. Efforts to control colon cancer now focus mainly on strategies to reliably detect and resect advanced adenomas before they become malignant. Patients with large (> 2 cm) sessile adenomas, especially if removed in piecemeal fashion, should have additional clearing examinations at 3 - 6 month intervals until complete polyp removal is verified. If residual polyp is present, it should be resected and the completeness of resection documented in 3 months. After one negative follow-up examination, care can revert to standard surveillance as performed for patients with benign adenomas. If complete resection is not possible after two or three examinations, the good-risk patient should usually be referred for surgical therapy. At the time of diagnosis of colon cancer, it is important to evaluate the remaining colon for additional neoplastic lesions prior to surgery. If this is not possible due to obstruction from the carcinoma or for other technical reasons, alternative options include intraoperative colonoscopy or colonoscopy within three to six months of resection. Once additional neoplasms have been excluded or removed, surveillance colonoscopy to detect metachronous neoplasia should be carried out three years after resection. If this examination is negative, subsequent colonoscopy may be carried out at 3 to 5 year intervals. In patients with rectosigmoid cancer resected for cure by low anterior resection, sigmoidoscopy may be considered every three to six months for two years to evaluate possible suture line recurrence. Because the risk for local recurrence or for lymph node metastasis from invasive carcinoma in a colonoscopically resected polyp is less than the risk for death from colonic surgery, no further treatment is indicated after colonoscopic resection of a malignant polyp (an adenomatous polyp with cancer invading the submucosa) if the endoscopic and pathological criteria listed below are fulfilled: The polyp is considered to be completely excised by the endoscopist and is submitted in toto for pathological examination. In the pathology laboratory, the polyp is fixed and sectioned so that it is possible to accurately determine the depth of invasion, grade of differentiation, and completeness of excision of the carcinoma. The cancer is not poorly differentiated. There is no vascular or lymphatic involvement. The margin of excision is not involved. Invasion of the stalk of a pedunculated polyp, by itself, is not an unfavorable prognostic finding, as long as the cancer does not extend to the margin of stalk resection. When a patient's malignant polyp has poor prognostic features, the relative risks of surgical resection should be weighed against the risk of death from metastatic cancer. The patient at high risk for morbidity and mortality from surgery probably should not have surgical resection. If a malignant polyp is located in that part of the lower rectum that would require an abdominal-perineal resection, local excision rather than a standard cancer resection usually is justified. Rectal ultrasound studies may assist in determining correct treatment. During colonoscopic excision of a large sessile polyp that may require subsequent surgical resection, it may be useful to mark the polypectomy site with India ink. There are groups that have a high incidence of colorectal cancer. These include those with hereditary conditions, such FAP and HNPCC. Together they account for no more than 6% of colorectal cancers. More common conditions associated with an increased risk include: a personal history of colorectal cancer or adenomas, first degree relative Colonoscopy Feb 14 21 with colorectal cancer at any age, first degree relative with adenomas diagnosed before 60 years of age, a personal history of ovarian, endometrial, or breast cancer, and a personal history of long-standing chronic ulcerative colitis or Crohn’s colitis. These high-risk groups account for only about a quarter of all colorectal cancers, so limiting screening or early cancer detection to only these high-risk groups would miss the majority of colorectal cancers. Review History February 2004 April 2006 November 2008 April 2009 February 2012 February 2013 May 2013 February 2014 Medical Advisory Council initial approval Update – no revisions Added the word ‘Treatment’ above the second column for Highrisk Patients with Significant Personal History and Significant Family History. Update. Revised Grid on Surveillance Colonoscopy. Codes reviewed. Update – no revisions Update – no revisions. Added Coding updates. Added constipation as an indication, added that screening for African Americans may begin at 45 Update – Several revisions to policy statement regarding surveillance colonoscopy for high risk individuals based on recommendations from NCCN (2.2013 Colorectal cancer screening and 2.2014 Colon cancer) This policy is based on the following evidenced-based guidelines: 1. 2. 3. 4. 5. 6. 7. 8. National Comprehensive Cancer Network (NCCN). Colorectal Cancer Screening. Practice Guidelines in Oncology 2009. Rex DK, Johnson DA, Anderson JC, et al. American College of Gastroenterology Guidelines for Colorectal Cancer Screening 2008. Clinical Guidelines. Screening for Colorectal Cancer: U.S. Preventive Services Task Force Recommendation Statement. U.S. Preventive Services Task Force. 4 November 2008 | Volume 149 Issue 9. Levin B, Lieberman DA, McFarland B, et al. Screening and Surveillance for the Early Detection of Colorectal Cancer and Adenomatous Polyps, 2008. A Joint Guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. CA Cancer J Clin 2008; 58:130-160. 2008 American Cancer Society. American Society of Colon and Rectal Surgeons. Colorectal Cancer Screening and Surveillance: Clinical Guidelines and Rationale. 2003. Available at: http://www.fascrs.org/physicians/practice_parameters/colorectal_cancer_screen ing_surveilance/ McFarland EG, Levin B, Lieberman DA, et al. Revised Colorectal Screening Guidelines: Joint Effort of the American Cancer Society, U.S. Multisociety Task Force on Colorectal Cancer, and American College of Radiology. 2008. Radiology. DOI: 10.1148/radiol.2483080842. Colorectal Cancer Screening and Surveillance: Clinical Guidelines and Rationale – Update Based on New Evidence. General Recommendations. American Society of Colon & Rectal Surgeons. 2003. Available at: http://www.fascrs.org/physicians/practice_parameters/colorectal_cancer_screen ing_surveilance/ Lieberman DA, Rex DK, Winawer SJ, et al. Guidelines for colonoscopy surveillance after screening and polypectomy: a consensus update by the US Colonoscopy Feb 14 22 Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2012 Sep;143(3):844-57. Available at: http://www.gastrojournal.org/article/S00165085(12)00812-8/fulltext#sec2.2 9. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. Colorectal Cancer Screening. Version 2.2013 10. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. Colon Cancer. 2.2014 References – Update February 2014 1. 2. 3. 4. Cone MM, Beck DE, Hicks TE, et al. Timing of colonoscopy after resection for colorectal cancer: are we looking too soon? Dis Colon Rectum. 2013. Nov;56(11):1233-6. Cooper GS, Kou TD, Barnholtz Sloan JS, et al. Use of colonoscopy for polyp surveillance in Medicare beneficiaries. Cancer. 2013 May 15;119(10):1800-7. Hassan C, Quintero E, Dumonceau JM, et al. Post-polypectomy colonoscopy surveillance: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2013 Oct;45(10):842-51 Leddin D, Enns R, Hilsden R, et al. Colorectal cancer surveillance after index colonoscopy: guidance from the Canadian Association of Gastroenterology. Can J Gastroenterol. 2013 Apr;27(4):224-8. References – Update May 2013 1. 2. 3. Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM; American College of Gastroenterology. American College of Gastroenterology guidelines for colorectal cancer screening 2009. Erratum in Am J Gastroenterol. 2009 Jun;104(6):1613. Agrawal J, Syngal S. Colon cancer screening strategies. Curr Opin Gastroenterol. 2005;21(1):59-63. Agrawal S, Bhupinderjit A, Bhutani MS, et al. Colorectal cancer in African Americans. Am J Gastroenterol. 2005;100(3):515-523. References – Update February 2013 1. 2. 3. 4. Chokshi RV, Hovis CE, Hollander T, et al. Prevalence of missed adenomas in patients with inadequate bowel preparation on screening colonoscopy. Gastrointest Endosc 2012; 75:1197. Lee L, Saltzman JR. Overview of colonoscopy in adults. UpToDate. January 2, 2013. Lee TJ, Blanks RG, Rees CJ, et al. Longer mean colonoscopy withdrawal time is associated with increased adenoma detection: evidence from the Bowel Cancer Screening Programme in England. Endoscopy 2013; 45:20. Moritz V, Bretthauer M, Ruud HK, et al. Withdrawal time as a quality indicator for colonoscopy - a nationwide analysis. Endoscopy 2012; 44:476. References – Update February 2012 1. 2. Cappell MS. Risks versus benefits of gastrointestinal endoscopy during pregnancy. Nat Rev Gastroenterol Hepatol. 2011 Oct 4;8(11):610-34. Hassan C, Di Giulio E, Marmo R, et al. Appropriateness of the indication for colonoscopy: systematic review and meta-analysis. J Gastrointestin Liver Dis. 2011 Sep;20(3):279-86 References – Update April 2009 1. Enders GH, El-Deiry WS. Colonic Polyps: Follow-up. EMedicine. August 22, 2008. Colonoscopy Feb 14 23 2. Lieberman D, Nadel M, Smith RA, et al. Standardized colonoscopy reporting and data system: report of the Quality Assurance Task Group of the National Colorectal Cancer Roundtable. Gastrointest Endosc 2007;65:757–766. 3. Maciosek MV, Solberg LI, Coffield AB, et al. Colorectal cancer screening: health impact and cost effectiveness. Am J Prev Med. 2006; 31:80-9. 4. Rex DK, Kahi CJ, Levin B, et al. Guidelines for colonoscopy surveillance after cancer resection: a consensus update by the American Cancer Society and the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology 2006; 130:1865–1871. 5. Regula J, Rupinski M, Kraszewska E, et al. Colonoscopy in colorectal-cancer screening for detection of advanced neoplasia. N Engl J Med 2006;355:1863– 1872. 6. Smith RA, Cokkinides V, Eyre HJ. American Cancer Society Guidelines for the Early Detection of Cancer, CA Cancer J Clin 2005; 55:31-44. 7. Leddin D, Hunt R, Champion M, et al. Canadian Association of Gastroenterology and the Canadian Digestive Health Foundation:Guidelines on colon cancer screening. 2004. 8. Winawer S, Fletcher R, Rex D, et al. Colorectal Cancer Screening and Surveillance: Clinical Guidelines and Rationale - Update Based on New Evidence. American Gastroenterological Association. 2003 9. Trowbridge B, Burt RW. Colorectal cancer screening. Surgical Clinics of North America - Volume 82, Issue 5 (October 2002), MD Consult. References – Update November 2008 1. 2. 3. 4. 5. Lieberman DA, Weiss DG, Harford§ WV, et al. Five-Year Colon Surveillance After Screening Colonoscopy. Gastroenterology. Volume 133, Issue 4, October 2007, Pages 1077-1085. Singerman J. Gastroenterology and Hepatology Board Review. June 13, 2007 Saini SD, Kim HM, Schoenfeld P. Incidence of advanced adenomas at surveillance colonoscopy in patients with a personal history of colon adenomas: a meta-analysis and systematic review. Gastrointestinal Endoscopy. Volume 64, Issue 4, October 2006, Pages 614-626. Available at: http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WFY-4M9BT2XV&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050 221&_version=1&_urlVersion=0&_userid=10&md5=7d2283d1fd066e41da7a575 bcf9fab78 New Zealand Guidelines Group (NZGG). Surveillance and management of groups at increased risk of colorectal cancer. Wellington (NZ): New Zealand Guidelines Group (NZGG); 2004 May. 84 p. Winawer S, Fletcher R, Rex D, et al. Gastrointestinal Consortium Panel. Colorectal cancer screening and surveillance: clinical guidelines and rationale. Update based on new evidence. Gastroenterology 2003 Feb;124(2):544-60. References – Initial 1. American College of Gastroenterology, American College of Physicians, American Gastroenterological Association and American Society for Gastrointestinal Endoscopy. Colorectal cancer screening and surveillance: Clinical guidelines and rationale - update based on new evidence. 1997 Feb (revised 2003 Feb). Gastroenterology February 2003;124(2). 2. American Society for Gastrointestinal Endoscopy: Diagnostic and Therapeutic Procedures. Colonoscopy Feb 14 24 3. Johnson DA, Lieberman DA, et al. ACG recommendations on colorectal cancer screening for average and higher risk patients in clinical practice. Amer Journ of Gastroenterology. 2000 April;95(4):868-877. 4. Winawer SJ. Colorectal Cancer: The Importance of Early Dectection. 1999. 5. Colorectal cancer screening: Recommendation statement from the Canadian Task Force on Preventive Health Care. CMAJ • July 24, 2001; 165 (2) Accessed at: http://www.cmaj.ca/cgi/content/full/165/2/206 6. National Guideline Clearinghouse (NGC) Guideline Synthesis. Screening for Colorectal Cancer. 2000. 7. Bond JH. Polyp Guideline: Diagnosis, Treatment, and Surveillance for Patients With Colorectal Polyps. American Journal of Gastroenterology November 2000;95(11): 3053-3063. 8. Zuckerman GR, Prakash C, Askin MP, Lewis BS. AGA technical review on the evaluation and management of occult and obscure gastrointestinal bleeding. Gastroenterology. 2000 Jan;118(1):201-21. 9. Brandt LJ, Boley SJ. AGA technical review on intestinal ischemia. Gastroenterology. 2000 May;118(5):954-68. 10. American Gastroenterological Association medical position statement: guidelines for the evaluation and management of chronic diarrhea. Gastroenterology 1999 Jun;116(6):1461-3. 11. American Society of Colon and Rectal Surgeons. Practice parameters for the detection of colorectal neoplasms. Diseases of the Colon & Rectum 1999;42(9):1123-1129. 12. Pignone M, Rich M, Teutsch SM, Berg AO, Lohr KN. Screening for colorectal cancer in adults at average risk: a summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med 2002;137:132-41. 13. Pignone M, Rich M, Teutsch SM, Berg AO, Lohr KN. Screening for colorectal cancer in adults. Systematic Evidence Review no. 7. Prepared by the Research Triangle Institute-University of North Carolina Evidence-based Practice Center under Contract No. 290-97-0011. AHRQ Publication no. 02-S003. Rockville, Md.: Agency for Healthcare Research and Quality, June 2002. 14. Screening for colorectal cancer: recommendations and rationale. Ann Intern Med 2002;137:129-31. 15. Appropriate use of gastrointestinal endoscopy. American Society for Gastrointestinal Endoscopy. Gastrointest Endosc 2000; 52(6): 831-7. 16. Primary and preventive care: periodic assessments. American College of Obstetricians and Gynecologists. ACOG Committee Opinion 246. Washington, D.C.: ACOG, 2000. 17. Winawer SJ, Stewart ET, Zauber AG, Bond JH, et al. A comparison of colonoscopy and double-contrast barium enema for surveillance after polypectomy. N Engl J Med 2000;342:1766-72. 18. Winawer SJ, Fletcher RH, Miller L, et al. Colorectal cancer screening: clinical guidelines and rationale. Gastroenterol 1997;112:594-642. 19. Itzkowitz SH. Inflammatory bowel disease and cancer. Gastroenterol Clin North Am 1997; 26:129-139. 20. Byers T, Levin B, Rothenberger D, et al: American Cancer Society Guidelines for Screening and Surveillance for Early Detection of Colorectal Polyps and Cancer: Update 1997. Ca Cancer J Clin 1997;47:154-60. 21. Beresentes K, Fennerty MB, Sampliner RE. Lack of spontaneous regression of tubular adenomas in two years of follow-up. Am J Gastroenterol 1997;92:111720. 22. Rex DK, Cutler CS, Lemmel GT, et al. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology 1997;112:24-8. Colonoscopy Feb 14 25 23. Bernstein D, Rogers A. Malignancy in Crohn's disease. Am J Gastroenterol 1996; 91:434-440. 24. Petersen GM, Knowledge of the adenomatous polyposis cold gene and its clinical application. Ann Med 1994, 26:205-208. 25. Bond JH. Polyp guideline: diagnosis, treatment and surveillance for patients with nonfamilial colorectal polyps. Ann Intern Med 1993, 119(8):836-43. 26. Burt RW. Colonoscopic surveillance for the patient with a family history of colorectal cancer. Gastrointestinal Endoscopy Clin NA 1993, 3:715-24. 27. Bond JH for the Practice Parameters Committee of the American College of Gastroenterology. Polyp guideline: Diagnosis, treatment, and surveillance for patients with nonfamilial colorectal polyps. Ann Intern Med 1993;119:836-43. 28. Hamilton SR. The molecular genetics of colorectal neoplasia. Gastroenterology 1993;105:3-7. 29. Schrock TR. Colonoscopy versus barium enema in the diagnosis of colorectal cancer and polyps. Gastrointest Endosc Clin North Am 1993;3:585-610. 30. Kronborg D. Screening guidelines for colorectal cancer. Scand J Gastroenterol 1992 Suppl:123-9. 31. Guillem JG, Forde KA, Treat MR et al. Colonoscopic screening for neoplasms in asymptomatic first-degree relatives of colon cancer patients. Dis. Colon Rectum 1992, 35:523-9. 32. Levin B. Lennard-Jones J. Riddell et al. Surveillance of patients with chronic ulcerative colitis. Bulletin of the World Health Organization 1991, 69:121-9. 33. Hixson LJ, Fennerty MB, Sampliner RE, et al. Prospective blinded trial of the colonoscopic miss-rate of large colorectal polyps. Gastrointest Endosc 1991;37:125-7. 34. Waye JD, Bashkoff E. Total colonoscopy: Is it always possible? Gastrointest Endosc 1991;37:152-4. 35. Eddy DM. Screening for colorectal cancer. Ann Intern Med 1990, 113:373-84. 36. O'Brien MJ, Winawer SJ, Zauber AG, et al. The National Polyp Study: Patient and polyp characteristics associated with high-grade dysplasia in colorectal adenomas. Gastroenterology 1990;98:371-9. 37. Fleischer DE, Goldberg SB, Browning TH et al. Detection and surveillance of colorectal cancer. JAMA 1989, 261:580-4. Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net’s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this " Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member’s benefits, nor is it intended to dictate to providers how to practice medicine. Colonoscopy Feb 14 26 Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Patients. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to patients. Patients should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Patients and providers should refer to the Patient contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Patient’s Contract Controls Coverage Determinations. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the patient’s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Patient’s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Patient’s contract shall govern. Coverage decisions are the result of the terms and conditions of the Patient’s benefit contract. The Policies do not replace or amend the Patient’s contract. If there is a discrepancy between the Policies and the Patient’s contract, the Patient’s contract shall govern. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid patients shall not be construed to apply to any other Health Net plans and patients. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid patients by law and regulation. Colonoscopy Feb 14 27
© Copyright 2024