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CIGNA HEALTHCARE COVERAGE POSITIONColorectal Cancer Screening and SurveillanceINSTRUCTIONS FOR USE Coverage Positions are intended to supplement certain standard CIGNA HealthCare benefit plans. Please note, the terms of a participants particular benefit plan document Group Service Agreement (GSA), Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document may differ significantly from the standard benefit plans upon which these Coverage Positions are based. For example, a participants benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Position. In the event of a conflict, a participants benefit plan document always supercedes the information in the Coverage Positions. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable group benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Positions and; 4) the specific facts of the particular situation. 2005 CIGNA Health Corporation Coverage Position Colorectal cancer screening may be subject to the terms, conditions and limitations of a preventive services benefit. Please refer to the applicable CIGNA HealthCare benefit plan document to determine benefit availability and the terms and conditions of coverage. If coverage for colorectal cancer screening is available, the following conditions apply. CIGNA HealthCare covers the following colorectal cancer tests as medically necessary for both men and women age 50 and over who are at average risk: yearly fecal occult blood (FOBT) or immunochemical test flexible sigmoidoscopy every five years double contrast barium enema (DCBE) every five years colonoscopy every ten years CIGNA HealthCare covers colorectal cancer screening as medically necessary for increased-or high-risk women and men who have any ONE of the following risk factors: a first-degree relative (sibling, parent, child) who has had colorectal cancer or an adenomatous polyp; screening should begin at age 40 family history of familial adenomatous polyposis (FAP); screening should begin at puberty: sigmoidoscopy annually, beginning at age 10-12 colonoscopy every five years family history of hereditary nonpolyposis colorectal cancer (HNPCC); screening should begin at age 21: sigmoidoscopy annually, beginning at age 10-12 colonoscopy every one to two years, beginning at age 20-25 or 10 years younger than the earliest case in the family, whichever comes first CIGNA HealthCare covers colorectal cancer surveillance for individuals with a personal history as follows: personal history of adenomatous polyps: one or more adenomatous polyps removed at the time of the colonoscopy; screening should be managed according to the pathological findings numerous adenomas, a malignant adenoma (with invasive cancer), a large sessile adenoma, or an incomplete colonoscopy; should have a short interval follow-up, based on pathological findings advanced or multiple adenomas (equal to or greater than three); first follow-up colonoscopy should occur in three years one or two small (less than one centimeter) tubular adenomas; first follow-up colonoscopy should occur at five years on-going surveillance after first follow-up colonoscopy; if the colonoscopy is normal or only one or two small (less than one centimeter) tubular adenomas are found, the next colonoscopy can be in five years personal history of colorectal cancer: surveillance after colon resection, with curative intent, then approximately six months after the surgery OR surveillance after colorectal cancer; if the colonoscopy performed at six months or a complete preoperative examination is normal, subsequent colonoscopy should be repeated at three years and then, if normal, every five years personal history of inflammatory bowel disease: for surveillance oevery one to two years after an eight-year history of the disease with pancolitis OR oevery one to two years after 15 years history of left-sided colitis surveillance for all patients beginning with 8-10 years of disease to document the extent of the disease CIGNA HealthCare does not cover fecal occult deoxyribonucleic acid (DNA) testing for the screening of colorectal cancer, as it is considered experimental, investigational or unproven. CIGNA HealthCare does not cover the use of a virtual colonoscopy for screening or surveillance of colorectal cancer as it is considered experimental, investigational or unproven. General Background Colorectal cancer (CRC) is the third most common malignant neoplasm worldwide, and the second leading cause of deaths in the United States. It is estimated that there will be 145,290 new cases diagnosed in the United States in 2005 and 56,290 deaths due to this disease. Between 1973 and 1995, mortality from colorectal cancer declined by 20.5% and incidence declined by 7.4% in the United States. The incidence is higher in men than in women. It ranges from 49.8 per 100,000 per year in Hispanic men to 72.4 in African American men. In women it ranges from 32.9 in Hispanics to 56.2 in African Americans per 100,000 per year. The age-adjusted mortality rates for men and women are 26.3 in men and 18.5 in women. About 5% of Americans are expected to develop the disease within their lifetime. Age-specific incidence and mortality rates show that most cases are diagnosed in individuals over age 50 (National Cancer Institute, NCI, 2005). There are specified groups of individuals reported to have a higher incidence of colorectal cancer than the general population. These include those with certain hereditary conditions, such as familial adenomatous polyposis (FAP) and hereditary nonpolyposis colorectal cancer (HNPCC) inherited in an autosomal dominant manner. 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 colorectal adenomas; first-degree relative with colorectal cancer; 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 Crohns colitis. These high-risk groups account for about 25% of all colorectal cancers. Research is focusing on measures that can be taken to reduce the incidence and prevalence of adenomas that may result in a subsequent decrease in the risk of colorectal cancer. Researchers now believe that adenomatous polyps (adenomas) are precursors for the vast majority of colorectal cancers due to inherited susceptibility and environmental or lifestyle factors. Numerous medical societies endorse the need for screening and surveillance for colorectal cancer. The American Cancer Society (ACS, 2003) and the American Gastroenterological Association (AGA, 2003) stratify the population into three risk categories for the potential development of colorectal cancer: average risk: people age 50 or older not otherwise defined as being at increased risk increased risk: people with single, small (less than 1 cm) adenomatous polyps; people with a large (1 cm+) adenoma, multiple adenomas, or adenomas with high-grade dysplasia or villous change; personal history of curative-intent resection of colorectal cancer; colorectal cancer or adenomatous polyps in a first-degree relative younger than age 60 or in two or more first-degree relatives of any age (if not a hereditary syndrome) high risk: people with a family history of familial adenomatous polyposis; people with a family history of hereditary non-polyposis colon cancer; people with inflammatory bowel disease, chronic ulcerative colitis, or Crohns colitis (cancer risk is similar in both ulcerative and Crohns colitis) The American Cancer Society (ACS) Guidelines The ACS Guidelines for Colorectal Cancer Screening and Surveillance for the early detection of colorectal adenomas and cancer are as follows for average risk women and men age 50 and older: o fecal occult blood test (FOBT) or fecal immunochemical test (FIT) every year o flexible sigmoidoscopy (FSIG) every five years* o annual FOBT or FIT and flexible sigmoidoscopy every five years* o double-contrast barium enema every five years o colonoscopy every 10 years *The FOBT or FIT test should be done at home following manufacturers recommendations and not in the physicians office. The ACS recommends against in-office stool-based testing due to its very low accuracy rates. *Combined testing is preferred over either annual FOBT or FIT, or FSIG every five years, alone. There is no justification for repeating FOBT or FIT in response to an initial positive finding, as all positive tests should be followed up with a colonoscopy (ACS, 2003). The ACS and the AGA recommend the following colorectal cancer screening and surveillance for women and men at increased- or high-risk due to one or more of the following risk factors: a first-degree relative (sibling, parent, child) who has had colorectal cancer or an adenomatous polyposis; screening should begin at age 40 family history of familial adenomatous polyposis (FAP); screening should begin at puberty family history of hereditary nonpolyposis colorectal cancer (HNPCC); screening should begin at age 21 a first-degree relative (sibling, parent, child) who has had colorectal cancer or an adenomatous polyposis; screening should begin at age 40 family history of familial adenomatous polyposis (FAP); screening should begin at puberty: sigmoidoscopy annually, beginning at age 10-12 colonoscopy every five years family history of hereditary nonpolyposis colorectal cancer (HNPCC); screening should begin at age 21: sigmoidoscopy annually, beginning at age 10-12 colonoscopy every one to two years, beginning at age 20-25 or 10 years younger than the earliest case in the family, whichever comes first personal history of adenomatous polyps: one or more adenomatous polyps removed at the time of the colonoscopy; screening should be managed according to the pathological findings numerous adenomas, a malignant adenoma (with invasive cancer), a large sessile adenoma, or an incomplete colonoscopy; should have a short interval follow-up, based on pathological findings advanced or multiple adenomas (equal to or greater than three); first follow-up colonoscopy should occur in three years one or two small (less than one centimeter) tubular adenomas; first follow-up colonoscopy should occur at five years on-going surveillance after first follow-up colonoscopy, if the colonoscopy is normal or only one or two small (less than once centimeter) tubular adenomas are found, the next colonoscopy can be in five years personal history of colorectal cancer: surveillance after colon resection, with curative intent, then approximately six months after the surgery OR surveillance after colorectal cancer, if the colonoscopy performed at six months or a complete preoperative examination is normal, subsequent colonoscopy should be repeated at three years and then if normal, every five years personal history of inflammatory bowel disease: for surveillance, every one to two years after an eight-year history of the disease with pancolitis OR every one to two years after 15 years history of left-sided colitis or surveillance for all patients beginning with 8-10 years of disease to document the extent of the disease The National Cancer Institute (NCI) The NCI (2005) supports the use of screening for CRC with: Fecal Occult Blood Testing: Guaiac-based fecal occult blood testing either annually or biennially using rehydrated or nonrehydrated stool specimens in people age 50-80 decreases mortality from colorectal cancer. Potential harms include false-positive and false-negative results. Colonoscopy: Often used to follow up a positive fecal occult blood test, colonoscopy is associated with uncommon but serious complications, including: colonic perforation resulting in sepsis, need for surgical repair procedures, or death. Hemorrhage resulting from colonoscopic polypectomy may require blood transfusion, hospitalization, or surgical intervention.Sigmoidoscopy: Regular screening by sigmoidoscopy in people over age 50 may decrease mortality from colorectal cancer. There is insufficient evidence to determine the optimal interval for such screening. The American Gastroenterology Association (AGA) The AGA (2000) recommends colorectal screening in all men and women at average risk, starting at age 50. This screening can be by ANY of the following methods: fecal occult blood: annually flexible sigmoidoscopy: every five years double contrast barium enema: every five years double contrast barium enema and flexible sigmoidoscopy: every five years colonoscopy: every 10 years The American Academy of Family Physicians (AAFP) The AAFP (2000) recommends any of the following as screening methods appropriate for individuals age 50 and over, as colorectal cancer is more common in older people: fecal occult blood testing every year flexible sigmoidoscopy every five years fecal occult blood testing every year and flexible sigmoidoscopy every five years double-contrast barium enema every 5-10 years colonoscopy every 10 years American Society of Colon and Rectal Surgeons (ASCRS) The (2003) recommends the following screening guidelines for screening individuals age 50 and over: digital rectal exam and fecal occult blood testing every year flexible sigmoidoscopy: every five years total colon exam (colonoscopy or double contrast barium enema and proctosigmoidoscopy: every 5-10 years For Moderate Risk individuals: History of colorectal cancer in first-degree relative, age 55 or younger, or two or more first degree relatives of any age: oColonoscopy: At age 40 or 10 years before the youngest case in the family, whichever is earlier. Procedure should be repeated every 5 years. History of colorectal cancer in a first-degree relative over the age of 55: oColonoscopy: At age 50, or 10 years before the age of the case, whichever is earlier. Procedure should be repeated every 5 to 10 years. Personal history of large (1cm) or multiple colorectal polyps of any size: oColonoscopy: One year after polypectomy. Procedure should be repeated if recurrent polyps in 1 year or with no recurrence in 5 years. Personal history of colorectal malignancy-surveillance after resection for curative intent: oColonoscopy: 1 year after resection, then if normal repeat in 3 years, then if still normal every 5 years. For High Risk individuals: Family history of hereditary adenomatous polyposis: oFlexible sigmoidoscopy: at 12 to 14 years of age or puberty, repeat every 1 to 2 years. Consider genetic counseling, consider genetic testing. Family history of hereditary nonpolyposis colon cancer: o Colonscopy: age 21-40 every 2 years. Age 40 then annually. Consider genetic counseling, consider genetic testing. Inflammatory Bowel Disease: oLeft-sided colitis: Colonoscopy, after 15 years of disease history, then every 1 to 2 years oPancolitis: Colonoscopy, after 8 years of disease history, then every 1 to 2 years The Agency of Healthcare Research and Quality (AHRQ) and the U S Preventative Services Taskforce (USPSTF) The AHRQ along with the USPSTF (2002) strongly recommend that screening for colorectal cancer should begin at age 50 for individuals at average risk. This recommendation was based on fair to good evidence that showed an effective impact on reducing mortality from colorectal cancer. The USPSTF concluded that the benefits from screening substantially outweigh potential harms, although the quality of evidence, magnitude of benefit, and potential harms vary with each method. They did not find direct evidence that screening colonscopy is effective in reducing colorectal cancer mortality; efficacy of colonoscopy is supported by its integral role in trials of FOBT, extrapolation from sigmoidoscopy studies, limited case-control evidence, and the ability of colonoscopy to inspect the proximal colon. Average Risk Screening and Surveillance Fecal Occult Blood Testing: Diagnostic screening with fecal occult blood testing (FOBT) has been reported to have a sensitivity and specificity of 26-92% and 90-99% respectively, for the detection of colorectal cancer in asymptomatic persons. Positive reactions on guaiac-impregnated cards, the most common form of FOBT testing, can signal the presence of bleeding from premalignant adenomas and early-stage colorectal cancers; however, this test can also report false-positives caused by the ingestion of foods containing peroxidases, gastric irritants such as salicylates and other anti-inflammatory agents. Small adenomas and colorectal malignancies that bleed only intermittently, or not at all, can also be missed. The ACS and the USPSTF strongly recommend the annual screening of patients using the standard take-home multiple sample FOBT. The repeated use of this test as a screening method in a properly-implemented screening program has proven its effectiveness. Collins et al. (2004) conducted a prospective cohort study, from February 1994 to January 1997, at 13 Veterans Affairs medical centers to study the sensitivity and specificity of digital FOBT versus the 6sample at-home FOBT, followed by a complete colonoscopy. The study enrolled a total of 3121 asymptomatic patients aged 50-75 and predominately male. Some of the patients recruited

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