Coverage Policy Manual
Policy #: 2002020
Category: Radiology
Initiated: October 2002
Last Review: July 2018
  Virtual Colonoscopy/CT Colonography

Description:
Computed tomography colonography (CTC), commonly referred to as virtual colonoscopy, is a minimally invasive alternative to standard methods of diagnosing and screening for colorectal polyps and cancer that simulates the endoluminal view seen at colonoscopy.  It is an imaging technique involving thin-section helical  computed tomography to generate high-resolution two-dimensional axial images of the colon.  Three-dimensional images are then constructed off-line.  While virtual colonoscopy requires a full bowel preparation, similar to conventional colonoscopy, no sedation is required and the exam is less time consuming.  However, gas insufflations of the intestine that may be uncomfortable for the patient is required.  Interpretation of the images is described as difficult and time consuming.
 
Validation of virtual colonoscopy as an alternative screening test for colon cancer requires prospective studies focusing on its diagnostic performance  compared to the gold standard, either sigmoidoscopy or colonoscopy.  The sensitivity of virtual colonoscopy in high risk patients has been reported in several studies to be in the range of 91% for polyps measuring more than 10 mm in diameter, 82% for polyps measuring 6-9 mm and 55% for polyps measuring less than 5 mm.  When polyps are identified on virtual colonoscopy it is presumed the patient will then undergo conventional colonoscopy requiring another bowel prep.  The diagnostic performance of virtual colonoscopy in average risk patients has not been studied in prospective studies.
 
Coding
 
There are category I CPT codes for this procedure:
 
74261 Computed tomographic (CT) colonography, diagnostic, including image post-processing; without
contrast material
74262 with contrast material(s) including non-contrast images, if performed
74263 Computed tomographic (CT) colonography, screening, including image post-processing.
 

Policy/
Coverage:
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Screening virtual colonoscopy/CT colonography meets primary coverage criteria for effectiveness and is covered:
 
    • Once every 5 years, for patients 50 years of age or older who are unable, due to an accompanying medical condition, to undergo screening optical colonoscopy, or who have had a failed optical colonoscopy;   
    • Once every 5 years, for patients less than 50 years of age who are at increased risk for colorectal cancer or polyps (i.e., 1) a strong family history of colorectal cancer or polyps in a first degree relative [parent, sibling, or child] younger than 60, or in two or more first degree relatives of any age; or 2) a known family history of colorectal cancer syndromes such as familial adenomatous polyposis [FAP] or hereditary nonpolyposis colon cancer [HNPCC] who are unable, due to an accompanying medical condition, to undergo screening optical colonoscopy, or who have had a failed optical colonoscopy;   
 
Diagnostic virtual colonoscopy/CT colonography meets primary coverage criteria for effectiveness and is covered only:
 
    • for patients with known colonic disease who have had a failed colonoscopy because of intrinsic colonic disease, or
    • the patient has known/suspected colonic disease but also has a cardiac, pulmonary, or neuromuscular medical condition which prevents the performance of colonoscopy.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
All other uses of virtual colonoscopy/CT colonography do not meet member benefit certificate primary coverage criteria.
 
For members with contracts without primary coverage criteria, all other uses of virtual colonoscopy/CT colonography are considered not medically necessary. Services considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 

Rationale:
2002 Update
Validation of virtual colonoscopy as an alternative screening test for colon cancer requires prospective studies focusing on its diagnostic performance compared to the gold standard, i.e., either sigmoidoscopy or colonoscopy, in both low-, average-, and high-risk patient populations. Fenlon and colleagues performed a study of 100 patients at high risk of colon cancer who underwent virtual colonoscopy followed by conventional colonoscopy.  Patients were considered at high risk if they were 50 years or older AND had 1 or more of the following: history of adenomatous polyps, recent sigmoidoscopic evidence of 1 or more polyps, a positive finding on fecal occult-blood testing, or a history of colorectal cancer in 1 or more first-degree relatives. The results of virtual colonoscopy were analyzed on a per polyp basis. For a true positive result, the lesion identified on virtual colonoscopy had to have been matched according to location, size, and morphologic features to a lesion found on conventional colonoscopy. On conventional colonoscopy, 115 polyps and 3 carcinomas were found in 49 of the 51 patients. A total of 33 polyps were not identified on virtual colonoscopy, the majority of which (73%) were small, measuring between 1 and 5 mm in diameter. The sensitivity of virtual colonoscopy was 91% for large polyps greater than 10 mm in diameter, 82% for those measuring 6 to 9 mm, and 55% for small polyps measuring less than 5 mm. Other studies have reported similar lower sensitivities.
 
It is unclear whether a sensitivity of 91% in high-risk patients would be clinically acceptable.  Some have suggested that the speed and relative ease of virtual colonoscopy might enhance patient compliance with screening recommendations; at the present time only about 40% of eligible patients undergo screening for colon cancer with either fecal occult blood testing, sigmoidoscopy , barium enema, or colonoscopy. Increased compliance may thus outweigh the decreased sensitivity of virtual colonoscopy compared to conventional colonoscopy.  However, bowel preparation and air insufflation may be barriers to acceptance. In addition, when polyps are detected with virtual colonoscopy, patients would presumably undergo subsequent endoscopic colonoscopy, typically requiring another bowel preparation. Akerkar and colleagues reported on a case series of 221 patients who underwent both conventional and virtual colonoscopy.  Patients completed a questionnaire regarding both tests prior to discharge. Patients reported more pain and discomfort after the virtual colonoscopy procedure.
 
Finally, the diagnostic performance of virtual colonoscopy in average-risk patients has not been studied in prospective studies.
 
2003 Update
A search of the medical literature based on MEDLINE database was performed for the periods of August 15, 2001, to December 3, 2002. Findings in the recent literature do not alter the above conclusion on CT colography screening; therefore, the policy statement is unchanged.
 
The recent literature contains articles on the evolving technical characteristics of the procedure; comparative results of computer-assisted CT colonography to unaided radiologists’ interpretation, and the use of CT colonography in selected clinical scenarios such as in the management of suspected or known cancer, and where colonoscopy is not feasible.
 
Several recent studies continue to examine the sensitivity and specificity of CT colography in colon lesions of varying sizes relative to colonoscopy for colorectal cancer screening. Studies continue to note lower sensitivity and specificity with CT colography for lesions less than 6 mm in diameter. Sensitivity and specificity with CT colography improve as lesions approach 10 mm.
 
The possible role of CT colography in an overall population-based colon cancer screening strategy that currently employs multiple modalities (e.g., fecal occult blood, sigmoidoscopy, and colonoscopy) has not been clearly defined and not shown to be cost effective.
 
The third U.S. Preventive Services Task Force (2000-2002) provided updated recommendations on screening for colorectal cancer.  The Task Force report concluded the following regarding CT colography:
Effectiveness — No studies have evaluated the effectiveness of CT colography in reducing morbidity or mortality from colorectal cancer.
Accuracy — Several studies conducted in research settings among highly skilled radiologists have evaluated the accuracy of CT colography compared with that of colonoscopy.. Initially reported sensitivity and specificity values for cancers and large polyps were in the range of 85% to 90%, but recent reports have suggested lower levels of accuracy for less experienced examiners. Small and flat polyps are less well visualized on CT colography than are cancers and large polyps.
Adverse Effects — The data are currently insufficient to measure the frequency of complications with CT colography.
Acceptability — The acceptability and feasibility of CT colography have not been examined.
 
2005 Update
The 2005 Arkansas Legislature mandated insurance plan coverage of several procedures for screening for colorectal cancer, effective August 2005.  Virtual colonoscopy/CT colonography was not one of the mandated procedures.
 
2006 Update
In a 2006 position statement the American Gastroenterological Association (AGA) stated peer-reviewed published data suggest that CT colonography is only indicated as a diagnostic tool for patients who have undergone incomplete colonoscopies for limited indications.  
 
2008 Update
The National CT Colonography Trial of the American College of Radiology Imaging Network was reported in September 2008 (Johnson, 2008).  This study of 2,531 participants out of 2,600 asymptomatic individuals who were recruited, evaluated CT colonography compared to screening colonoscopy.  CT colonography identified 90% of patients with asymptomatic large colorectal adenomas or cancers, but failed to detect a lesion measuring 10 mm or more in diameter detected by optical colonoscopy in 10% of patients.  The detection of polyps smaller than 10 mm was considerably less, but whether detecting polyps of less than 10 mm in size is medically important is unknown.  It must be recognized that CT colonography does not differentiate between benign and malignant polyps.  If a polyp is identified, colonoscopy is indicated for pathological study and possible removal.  One other caveat from the study: Seventeen percent (17%) had a finding on CT colonography that was positive for one or more polyps 1 cm or larger, and approximately 1 in 4 of these patients actually had polyps (Fletcher, 2008).
 
Prior to September 2008, virtual colonoscopy/CT colonography was excluded based on member benefit certificate exclusion of services that are under study to determine effectiveness.  The conclusion of ACR Imaging Network Trial removes CT colonography from coverage exclusion, and limited coverage has been established.
 
2012 Update
There is no additional scientific literature identified that would prompt a change in the coverage statement.
 
2013 Update
This policy is being updated with a literature review through January 2013. There was no new information that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
 
There is no direct evidence that evaluates the impact of CT colonography on health outcomes compared to optical colonoscopy. Modeling studies, generally done as part of cost-effectiveness analyses, can provide some insights into the health outcome benefits of CT colonography, as well as provide relevant data on cost-effectiveness.
 
Given the chain of logic and other underlying evidence that supports the practice of accepted colon cancer screening techniques such as optical colonoscopy, a 90% sensitivity of CT colonography for detection of polyps 10 mm or larger is consistent with an improvement in health outcomes. The 86% specificity of CT colonography would result in some false-positive tests, which, in turn, would result in some unnecessary follow-up colonoscopies. However, compared with optical colonoscopy, there are several other types of health outcomes that may differ in terms of convenience, cost, detection of unrelated health problems, and radiation exposure. These are difficult to quantify, and are probably small in magnitude compared to the health benefit of identifying and removing cancer precursors.
 
Two studies completely simulated assumptions that are consistent with current diagnostic capability of CT colonography and recommended practice guidelines (Scherer, 2008; Zauber, 2009). In the study by Zauber et al., (Zauber, 2009) colonoscopy was slightly more effective and was less expensive than CT colonography. This was based on a model using 1,000 individuals who were 65 years old. In spite of a somewhat lower per procedure cost, the strategy using CT colonography was found to be more expensive because CT colonography was performed every 5 years (compared to every 10 years for optical colonography), and patients with polyps 6 mm or larger were referred for optical colonoscopy for polyp removal. In this model, the payment for colonoscopy without polypectomy was $500 and for CT colonography was $488. In the study by Scherer et al., the model was based on 1,000 individuals aged 50 years (Scherer, 2008). In this analysis, the only model for CT colonography that was more effective than every 10-year optical colonoscopy was CT colonography every 5 years, with removal of polyps 6 mm or larger. Using these assumptions, this CT colonography approach saved 118.5 lives compared to 116.8 for every 10-year optical colonoscopy; the costs of the two approaches were $2.95 million and $1.86 million, respectively. In this analysis, the costs of each procedure were comparable, $523 for CT colonography compared to $522 for optical colonoscopy without polypectomy. Thus, the outcomes using CT colonography were comparable to optical colonoscopy, yet the CT colonography strategy was more costly. In this study, a sensitivity analysis showed that when the cost of CT colonography was 0.36 that of colonoscopy, CT colonography became less expensive. .
 
A published cost-effectiveness analysis (Pickhardt, 2009) performed by the same authors as a previously published analysis (Hassan, 2008) but applied to a simulated Medicare age population 65 years and older reached similar conclusions as the previously published analysis, which also incorporates the benefits of aortic aneurysm screening. Another cost-effectiveness analysis of several colon cancer screening techniques by Heitman et al. compared several colon cancer screening techniques (Heitman, 2010). This review reported that CT colonography was similar in effectiveness to several other established screening techniques, but was more expensive and was therefore a dominated, or unpreferred strategy.
 
Lansdorp-Vogelaar et al. conducted a systematic review of cost-effectiveness studies of colon cancer screening techniques and found 55 publications relating to 32 unique cost-effectiveness models (Lansdorp-Vogelaar, 2011).. CT colonography was evaluated in 8 models. Although CT colonography was deemed cost-effective compared with no screening, it was dominated (i.e., both more expensive and less effective) by established screening strategies in 5 of the analyses. They found one study in which CT colonography would be the recommended screening strategy at a cost per life-year gained of less than $50,000.
 
In general, in these cost-effectiveness analyses, colonoscopy was the more effective screening test. CT colonography was a dominant option (more effective and less costly) only in the 1 study that added CT colonography’s benefit of detection of aortic aneurysm and extracolonic cancers (Hassan, 2008). This study also incorporated long-term radiation effects (Hassan, 2008). This benefit of detecting extra-colonic disease was calculated to account for up to 20% of the total health benefit achieved. Most of the benefit was estimated to be from early detection of aortic aneurysms. Screening for aneurysm using ultrasound has been demonstrated to be effective in older (i.e., age 65 or older) men and has been recommended for older male smokers. Screening for the other cancers assumed to be detected has not been shown to be effective. Further research is needed to bolster the data supporting considerable benefit of CT colonography regarding aortic aneurysm, especially in older individuals, and extracolonic cancer detection, as well as the costs and potential health risks of false-positive findings.
 
Due to differing assumptions, current studies vary in their evaluation of the comparative costs and effects of CT colonography and colonoscopy with currently available data and practice guidelines. Overall benefit without consideration of costs appears to be similar between the two tests regarding colon cancer prevention. Most studies did not consider the potential benefits of aortic aneurysm detection and extracolonic cancer detection. CT colonography was generally more expensive and in many studies less effective as a screening strategy than colonoscopy, and in other studies only slightly more effective.
 
There are no long-term comparative studies that directly report on outcomes of CT colonography compared to optical colonoscopy. The determination of comparative outcomes of CT colonography and optical colonoscopy is complex, due to the differing patterns of follow-up associated with each strategy. Studies of cost-effectiveness have modeled outcomes of the two procedures, and generally conclude that outcomes are similar, or that optical colonoscopy results in better outcomes. These analyses assume equal participation rates between the two strategies.
 
2014 Update
This policy is updated with a literature search through June 2014. The key identified literature is included below.
 
One prospective non-randomized study assessing the diagnostic accuracy of CT colonography for colorectal cancer screening was identified. This non-randomized study did not prompt a change in the coverage statement. At present, there is no direct evidence that evaluates the impact of CT colonography on health outcomes compared with optical colonoscopy.
 
In 2014, Fini et al reported results from a study of the diagnostic accuracy of CT colonography for clinically relevant colorectal lesions, defined as polyps or masses 6 mm or larger among first-degree relatives of patients with colorectal cancer (Fini, 2014). CT colonography was undertaken following a noncathartic bowel preparation among 344 patients, with optical colonoscopy undertaken on the following day. Sensitivity and specificity for lesions 6 mm or larger were 77% (95% confidence interval [CI], 59% to 95%) and 99% (95% CI, 97% to 100%), respectively.
 
Colon cancer diagnosis in patients with symptoms or risk factors
Several studies have evaluated the role of CT colonography in the diagnosis of colon cancer in patients who have had symptoms or positive findings on other screening modalities (ie, fecal occult blood testing [FOBT]).
 
In 2014, Plumb et al published findings from a systematic review and meta-analysis of studies evaluating the performance of CT colonography for the diagnosis of colon cancer among subjects with positive FOBT (Plumb, 2014). FOBT is a recommended screening technique for colorectal cancer; positive tests are typically followed up with colonoscopy. In this meta-analysis, the authors included only studies that used CT colonography in the evaluation of patients who had had a positive FOBT and compared colonography results with a reference test, either conventional colonoscopy, segmental unblinded colonoscopy, or surgery with subsequent histopathology. Five articles were included in the authors’ analysis, representing 4 studies with 622 patients. Pooled per-patient sensitivity and specificity for adenomas 6 mm or larger or colorectal cancer were 88.8% (95% CI, 83.6% to 92.5%) and 75.4% (95% CI, 58.6% to 86.8%), respectively.
 
The Plumb meta-analysis focused on patients with positive FOBT testing, but several additional studies have evaluated the role of CT colonography for patients with symptoms of colorectal cancer. In 2013, Atkin et al reported results from an RCT comparing colonoscopy and CT colonography in the evaluation of patients with symptoms suggestive of colorectal cancer (Atkin, 2013). Given the challenges of conducting a study that would be adequately powered to detect small differences between CT colonography and colonoscopy in colorectal cancer and large polyp detection, the authors used rates of the need for additional evaluation after CT colonography as a primary outcome, with the assumption that such rates would strongly affect the evaluation of the benefits and costs of the procedure. The study randomly allocated patients aged 55 or older with symptoms suggestive of colorectal cancer in a 2:1 fashion to either colonoscopy or CT colonography. The study was not blinded. Both colonoscopy and CT colonography procedures were conducted with a full bowel preparation. The study’s primary outcome was the proportion of patients who had additional colonic investigation, defined as any subsequent examination of the colon until diagnosis (usually histologic confirmation of a cancer or polyp) or until a patient was referred back to his or her family doctor. Additional diagnostic evaluation of the colon was required in 160 of 533 (30.0%) of those assigned to CT colonography, compared with 86 of 1047 (8.2%) of those assigned to colonoscopy (p<0.001). The overall detection rate for colorectal cancer or large polyps did not differ between the groups (relative risk [RR], 0.95; 95% CI, 0.70 to 1.27; p=0.69). The authors comment that the high referral rate for additional procedures could potentially be mitigated with wider implementation of CT colonography, radiologist training, and standardized protocols.
 
Simons et al evaluated the miss rate (false negative rate) and sensitivity of colorectal cancer on CT colonography among patients who presented with symptoms of colorectal cancer (Simons, 2013). The authors included 1855 consecutive patients who underwent CT colonography at a single center. These data were linked to a comprehensive population-based cancer registry to determine if patients were diagnosed with colorectal cancer in the 2 years after their CT colonography. Fifty-three patients were diagnosed with colorectal cancer, of whom 40 patients had had colorectal cancer suspected, 5 diagnosed with large polyps that appeared malignant on histology, and 5 diagnosed with an indeterminate mass on CT colonography. Two patients who developed cancer had not been diagnosed on CT colonography, and 1 patient who developed cancer had had an incomplete colonography, for an overall sensitivity of CT colonography of 94.3% (95% CI, 88% to 100%).
 
Diverticulitis/Diverticulosis
Chabok et al reported results of a prospective study comparing CT colonography with optical colonoscopy for follow up of acute diverticulitis (Chabok, 2013). One hundred eight patients presenting for follow-up of episode of acute diverticulitis underwent evaluation with both CT colonography and optical colonoscopy. At 1 study site, half of patients were examined by colonoscopy first and then by CT colonography, and the other half were examined by CT colonography first. At the second study site, patients were evaluated alternately by CT colonography or colonoscopy as the first study. The evaluating radiologist and endoscopist interpreting the tests were blinded to the results of the second test. Patients reported their impressions on the procedure by a visual analog scale. Compared with colonoscopy, CT colonography had a sensitivity and specificity for the diagnosis of diverticular disease of 99% and 67%, respectively. Patients reported the colonoscopy was more painful and uncomfortable.
 
Practice Guidelines and Position Statements
In 2012, the American College of Physicians (ACP) released updated guidelines for colorectal cancer screening (Qaseem, 2012).  ACP’s guideline development process involves the assessment of existing guidelines via the Appraisal of Guidelines for Research and Evaluation II instrument. ACP makes the following recommendations regarding colon cancer screening:
 
“ACP recommends using a stool based test, flexible sigmoidoscopy, or optical colonoscopy as a screening test in patients who are at average risk. ACP recommends using optical colonoscopy as a screening test in patients who are at high risk. Clinicians should select the test based on the benefits and harms of the screening test, availability of the screening test, and patient preferences.”
 
The guidelines further note that CT colonography is an option for screening in average-risk patients older than 50 years and is supported by some guidelines.
 
In 2008, the American College of Gastroenterology issued guidelines for colorectal cancer screening. They recommend colonoscopy every 10 years beginning at age 50 as the preferred screening strategy for the general population. Patients who decline colonoscopy or for whom colonoscopy is not feasible should be offered other screenings such as flexible sigmoidoscopy every 5 to 10 years, CT colonography every 5 years, and an annual fecal immunochemical test (American College of Gastroenterology, 2008).
 
2015 Update
A literature search conducted through June 2015 did not identify any new literature that would prompt a change in the coverage statement. The following is a summary of the key identified.
 
Ulcerative Colitis
Patients with ulcerative colitis may require frequent monitoring of their colon with colonoscopy to evaluate for pathology, and CTC has been evaluated as an alternative in this population. Prabhakar et al evaluated the diagnostic accuracy of CTC, compared with optical colonoscopy, among 20 patients with biopsy-confirmed ulcerative colitis, in clinical remission (Prabhakar, 2015). For the detection of a granular appearance on colonoscopy, CTC had a sensitivity and specificity of 81.0% and 73.8%, respectively. For the detection of pseudopolyps, CTC had a sensitivity and specificity of 82.1% and 84.5%, respectively. Seventy-five percent of patients reported preferring CTC for follow-up examinations, while 25% expressed no definitive opinion. The results of this small study do not prompt a change in the coverage statement.
 
CTC in Patients With Contraindications to Optical Colonoscopy
CTC may also be indicated in patients who have contraindications to conventional colonoscopy or in patients who have incomplete conventional colonoscopy because of colonic obstruction or stenosis. A case series by Yucel et al (Yucel, 2008) reported on 42 patients older than 60 years (mean, 71 years; range, 60-87 years) referred for CTC because of contraindications to the conventional procedure (n=12) or incomplete colonoscopy (n=30). Contraindications included anticoagulation therapy (n=8), increased anesthesia risk (n=3), or poor tolerance for colonoscopy preparation (n=1). The most common reasons for incomplete colonoscopy included diverticular disease, colonic redundancy, adhesions, and residual colonic content. Optimal distension of the entire colon was achieved in 38 patients (90%), and 39 (93%) of the patients had abnormal findings. Extracolonic findings potentially requiring further evaluation or treatment were observed in 26 patients (62%).
 
Plumb et al retrospectively compared results from CTC and optical colonoscopy for patients evaluated at a single center who were indicated for CRC screening because of a positive FOBT (Plumb, 2014). Based on the institutional protocol, optical colonoscopy was preferred for individuals with positive FOBT, but CTC substituted if the subject was unable to safely complete colonoscopic bowel preparation, was too frail or immobile to undergo colonoscopy, although potentially fit for necessary treatment, had another contraindication to colonoscopy, or had an incomplete colonoscopy. The study analyzed 2731 FOBTpositive patients screened with CTC as their first screening test. Of these, 1027 had CRC or polyps suspected (37.6%; 95% CI, 33.8% to 41.4%), and 911 underwent confirmatory testing. One hundred
twenty-four were found to have CRC (4.5%) and 533 (19.5%) were found to have polyps, for an overall CRC- or polyp-detection rate of 24.1% (95% CI, 21.5% to 24.1%). The positive predictive value for CRC or polyps was 72.1% (95% CI, 66.6% to 77.6%). Colonoscopy data were available for 72,817 FOBTpositive patients who underwent colonoscopy as an initial screening test, among whom 9.0% had CRC and 50.6% had polyps. The authors attribute the difference in CRC and polyp rates between the groups to underlying differences in risk between those referred for CT colonoscopy and potential biases in the interpretation of screening guidelines.
 
Ongoing and Unpublished Clinical Trials
NCT01739608 - Assessment of the Participation Rate and the Diagnostic Accuracy of a Colorectal Cancer Screening Program: CT Colonography Versus Flexible Sigmoidoscopy. Evaluation of a New Model Based on Telediagnosis. There is a planned enrollment of 20,000 subjects. The estimated completion date is December 2015.
 
NCT01651624 -  Comparison Between Faecal Occult Blood Test (FOBT), Computed Tomographic Colonography (CTC) With Computer Aided Diagnosis (CAD) and Colonoscopy as a Primary Screening Test for Colorectal Cancer. The trial is listed as having a planned enrollment of 14,000 subjects. The estimated completion date is listed as December 2018.
 
Practice Guidelines and Position Statements
 
American College of Gastroenterology
In 2012, the American College of Gastroenterology (ACG), along with the American Gastroenterological Association Institute and the American Society for Gastrointestinal Endoscopy, updated the 2006 guidelines on colonoscopy surveillance after polypectomy (Lieberman, 2008). This guideline makes the following statement on CTC and other newer colonic imaging technologies: “The role of new endoscopic technologies has not been studied in surveillance cohorts, although there are ongoing studies of CT colonography.... At this point, these technologies technology do not have an impact on surveillance intervals.”
 
European Society of Gastrointestinal Endoscopy and European Society of Gastrointestinal and Abdominal Radiology
In 2014, the European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastrointestinal and Abdominal Radiology (ESGAR) issued guidelines for the use of CTC (Spada, 2014).
 
These guidelines recommend CTC in the following cases:
 
    • As the radiologic examination of choice for the diagnosis of colorectal neoplasia. ESGE/ESGAR do not recommend barium enema in this setting (strong recommendation, high quality evidence).
    • If colonoscopy is incomplete (preferably the same or next day). Delay of CTC should be considered following endoscopic resection. In the case of obstructing colorectal cancer, preoperative contrast-enhanced CTC may also allow location or staging of malignant lesions (strong recommendation, moderate quality evidence).
    • As an acceptable and equally sensitive alternative when endoscopy is contraindicated or not possible for patients with symptoms suggestive of colorectal cancer (strong recommendation, high quality evidence.)
 
ESGE/ESGAR do not recommend CTC as a primary test for population screening or in individuals with a positive first-degree family history of CRC. However, it may be proposed as a CRC screening test on an individual basis providing the screenee is adequately informed about test characteristics, benefits, and risks (weak recommendation, moderate quality evidence).
 
American College of Radiology
In 2014, ACR published updated appropriateness criteria for imaging tests for CRC screening, which includes the following guidelines related to CTC (Yee, 2014):
    • In an average-risk individual, age greater than or equal to 50 years, CTC every 5 years after a negative screen has a rating of 9 (usually appropriate).
    • In an average-risk individual after positive fecal occult blood test (FOBT), CTC has a rating of 9 (usually appropriate).
    • In an average-, moderate-, or high-risk individual after incomplete colonoscopy, CTC has a rating of 9 (usually appropriate).
    • In a moderate-risk individual (personal history of adenoma or carcinoma or first-degree family history of cancer or adenoma), CTC has a rating of 9 (usually appropriate).
    • In a high-risk individual (hereditary nonpolyposis colorectal cancer), CTC has a rating of 3 (usually not appropriate; colonoscopy is the preferred procedure).
    • In a high-risk individual (ulcerative colitis or Crohn colitis), CTC has a rating of 3 (usually not appropriate; colonoscopy is the preferred procedure).
   
2017 Update
A literature search conducted through May 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Several subsequent systematic reviews of studies on CTC in a colorectal cancer (CRC) screening setting have been published. Most recently, in 2016, Lin and colleagues published a systematic review and meta-analysis of literature on CRC screening, conducted for the U.S. Preventive Services Task Force (USPSTF) on CRC screening (Lin, 2016). The investigators identified 9 prospective diagnostic accuracy studies on CTC (total N=6497 patients). Seven studies involved CTC with bowel preparation and 2 involved CTC without bowel preparation. Five studies, including both without bowel preparation, were rated by USPSTF as good quality and the remaining 4 were considered fair quality. In 4 studies of CTC with bowel preparation, the sensitivity to detect adenomas 6mm or larger ranged from 73% to 98% and specificity ranged from 89% to 91%. The sensitivity of CTC to detect adenomas 10 mm or larger (7 studies) ranged from 67% to 94% and the specificity ranged from 96% to 98%. Four of the 9 studies (n=481) also provided data on colonoscopy. The sensitivity for adenomas 6 mm or larger ranged from 75% to 93%, and the sensitivity to detect adenomas 10 mm and larger ranged from 89% to 98%.
 
In addition, the Lin systematic review evaluated evidence on harms and extracolonic findings associated with CTC. Eleven fair or good quality prospective studies (total N=10,272 patients) suggested little or no risk of serious adverse effects such as perforation. In contrast, Lin and colleagues estimated that, with optical colonoscopy, the risk of perforation was 4 in 10,000 procedures (95% confidence interval [CI], 2 to 5 in 10,000) and the risk of major bleeding was 8 in 10,000 procedures (95% CI, 5 to 14 in 10,000). Radiation exposure is a potential harm of CTC and many of the studies did not report the extent of exposure to radiation. Using data from 4 studies, Lin estimated that the radiation dose of a full-screening CTC examination was about 4.5 to 7 mSv [milliSieverts]. However, in more recent studies (ie, published in 2004 to 2008), the estimated radiation dose was lower, about 1 to 5 mSv. Among studies reporting this outcome, extracolonic findings occurred in 27% to 69% of CTC examinations. Approximately 1% to 11% underwent diagnostic evaluation and 3% required treatment. Extracolonic cancers occurred in about 0.5% of individuals undergoing CTC examinations.
 
Martin-Lopez and collegues published a meta-analysis that included 9 studies of CRC screening (Martin-Lopez, 214). Studies conducted for the diagnosis of CRC or in elderly, high-risk, or symptomatic patients were excluded. The overall per patient pooled sensitivity and specificity of CTC was 66.8% (95% CI, 62.7% to 70.8%) and 80.3% (95% CI, 77.7% to 82.8%), respectively. For colonoscopy, the pooled sensitivity was 92.5% (95% CI, 89.0% to 95%) and pooled specificity was 73.2% (95% CI, 67.7% to 78.1%). In the subgroup of larger lesions, the diagnostic accuracy of the 2 approaches was more similar. For lesions 10mm or larger, CTC had a pooled sensitivity of 91.2% (95% CI, 86.5% to 94.6%) and the specificity of 87.3% (95% CI, 86.2% to 88.3%). The pooled sensitivity of colonoscopy for lesions 10 mm or larger was 92.9% (95% CI, 86.0% to 97.1%) and specificity was 91.3% (95% CI, 89.9% to 92.5%).
 
Johnson and colleagues published one of the largest studies of a screening population, the American College of Radiology Imaging Network (ACRIN) trial (Johnson, 2008). Patients underwent CTC prior to standard colonoscopy. The study used 16- to 64-row detector CT scanners, stool-tagging techniques, and minimum training standards for interpreters of the test. A total of 2600 individuals were enrolled, and data were available for 2531 (97%) of them. The results of this study showed 90% sensitivity of CTC for polyps 10 mm or larger and 86% specificity; positive and negative predictive values were 23% and 99%, respectively. In a follow-up analysis of the ACRIN trial, Fidler and colleagues demonstrated that CTC had similar sensitivity and specificity in the detection of nonpolypoid adenomas (Fidler, 2014).
 
More recently, several large RCTs have been published comparing the diagnostic accuracy of CTC to different method of CRC screening. In the Ijspeert and colleagues study, 8844 individuals were invited to be screened and 2258 (26%) agreed to participate (Ijspeert, 2016). This included 982 (34%) of 2920 randomized to CTC and 1276 (22%) of 5924 randomized to standard colonoscopy. The analysis focused on detection of high-risk sessile serrated polyps (SSPs). SSPs were detected significantly more often in colonoscopy examinations (n=55 [4.3%]) than CTC examinations (n=8 [0.8%]). For the outcome of all SSPs (high and low risk), significantly more were detected with colonoscopy (n=83 [6.5%]) than with CTC (n=21 [2.1%]; p<0.001). Adverse events were not discussed.
 
Regge and colleagues sigmoidoscopy (n=2738) (Regge, 2016). The detection rate for advanced adenomas did not differ significantly between groups (p=0.52). Detection rates were 133 (5.1%) in the CTC group and 127 (4.7%) in the flexible sigmoidoscopy group. Ten CRCs were identified in the CTC group and 9 in the flexible sigmoidoscopy group. No serious adverse events were reported.
 
2018 Update
A literature search was conducted through June 2018.  There was no new information identified that would prompt a change in the coverage statement.  

CPT/HCPCS:
74261Computed tomographic (CT) colonography, diagnostic, including image postprocessing; without contrast material
74262Computed tomographic (CT) colonography, diagnostic, including image postprocessing; with contrast material(s) including non-contrast images, if performed
74263Computed tomographic (CT) colonography, screening, including image postprocessing

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