Medical Policy

Subject: Wireless Capsule Endoscopy for Gastrointestinal Imaging and the Patency Capsule
Document #: RAD.00030 Current Effective Date:    06/28/2017
Status: Revised Last Review Date:    05/04/2017


This document addresses the use of wireless capsule endoscopy (WCE or video capsule endoscopy [VCE]) devices which have been developed for imaging the esophagus, small bowel and colon and the patency capsule which is intended to ensure that there are no strictures in the digestive tract to impede passage of the wireless endoscopy capsule.

WCE is accomplished by encasing video, illumination and transmission modules inside a capsule the size of a large vitamin pill. When swallowed, peristalsis moves the capsule along the esophagus and gastrointestinal tract. The encapsulated camera records images and then transmits the data to an external receiver worn by the person being tested. The receiver can download the data to a computer workstation for interpretation.

Note: Please see the following related document for additional information:

Position Statement

Medically Necessary:

Wireless capsule endoscopy of the small bowel is considered medically necessary as a diagnostic imaging tool,in adults or children 2 years of age and older, in the following clinical circumstances:

  1. To investigate obscure gastrointestinal bleeding, suspected to be of small bowel origin, after appropriate evaluation (at a minimum upper and lower endoscopy) has excluded a source of bleeding in the upper gastrointestinal tract or colon; or
  2. For the initial evaluation of individuals with suspected Crohn's disease when small bowel follow-through (SBFT) or enteroclysis, including CT enteroclysis and upper and lower endoscopy are non-diagnostic AND there is no suspected or confirmed gastrointestinal obstruction, stricture, or fistulae; or
  3. Suspected small intestinal tumors; or
  4. For individuals beginning at age 35 or greater with Lynch syndrome or polyposis syndromes; or
  5. For diagnostic re-evaluation of individuals with known Crohn's disease who remain symptomatic after appropriate treatment has occurred and there is no suspected or confirmed gastrointestinal obstruction, stricture, or fistulae; or
  6. Refractory undiagnosed malabs orptive syndromes with prior history of negative small bowel biopsy (for example, suspected celiac disease with prior negative biopsy); or
  7. To investigate anemia with concomitant iron deficiency, suspected to be of small bowel origin, after appropriate evaluation (at a minimum upper and lower endoscopy) has excluded a source of anemia from the upper GI tract and colon. 

Investigational and Not Medically Necessary:

Other indications for wireless capsule endoscopy for small bowel disease are considered investigational and not medically necessary, including, but not limited to, abdominal pain in the absence of gastrointestinal bleeding.

Wireless capsule endoscopy is considered investigational and not medically necessary for individuals with known or suspected gastrointestinal obstruction, stricture, or fistulae.

Wireless capsule endoscopy for esophageal disease is considered investigational and not medically necessary.

Wireless capsule endoscopy is considered investigational and not medically necessary as a means to perform colorectal cancer screening or identify colon disease.

Use of a patency capsule is considered investigational and not medically necessary.


Wireless Capsule Endoscopy for Obscure GI Bleeding
The following are examples of two small bowel WCE devices with 510k clearance. The PillCam SB® (Given Imaging, Inc., Duluth, GA) received U.S. Food and Drug Administration (FDA) 510k clearance in 2004. The EndoCapsule® (Olympus America Inc., Center Valley, PA) received 510k clearance in 2007.

Two published studies compared the results of WCE and push enteroscopy (PE) in individuals with obscure gastrointestinal bleeding. Both reported that capsule endoscopy revealed additional information not provided by PE and rarely missed lesions detected by PE. The results were consistent across these two studies reporting additional diagnostic yield from WCE in 25 to 50% of the cases. For example, in one study of 20 individuals with obscure digestive tract bleeding, WCE found a bleeding site in 11 out of 20 (55%) of those studied and provided additional information not detected by PE in 5 out of 20 cases (25%). All of the lesions detected by WCE were distal to the region examined during PE (Lewis, 2002).

The second comparative study was conducted on 32 subjects in Germany (Ell, 2002). Overall, this study found that WCE identified a definite source of bleeding in 21 out of 32 subjects (66%) studied and provided additional information not detected by PE in 16 of 32 cases (50%). No significant complications from WCE were reported in these studies.

A meta-analysis compared WCE with other approaches (including small bowel barium radiography and PE) in identifying small bowel pathology in individuals with obscure gastrointestinal bleeding (Triester, 2005). The researchers extracted their findings from pooled data from studies which involved more than 500 participants. When WCE was compared with PE for obscure gastrointestinal bleeding, WCE resulted in a yield of 63% and enteroscopy 28%. With regards to clinically significant findings, WCE accounted for 56% and PE 26%. When WCE was compared with small bowel barium radiography, the yield for any findings was 67% and 8%, respectively. Clinically significant findings accounted for 42% and 6%, respectively.

Mylonaki and colleagues (2003) investigated the clinical efficacy and technical performance of capsule endoscopy and PE in a series of 50 subjects with colonoscopy and gastroscopy negative gastrointestinal bleeding. The source of bleeding was discovered in the small intestine in 34 of 50 subjects. The yield of WCE was superior to PE in evaluating the source of obscure bleeding in the small intestine (68% vs. 32% respectively). No complications were encountered with PE; however, several technical difficulties were encountered with WCE. The capsule was retained in the esophagus of 1 individual, and in 7 subjects the capsule passed into the pylorus and returned to the stomach. The battery stopped working in 16 (28%) and in 3 there was a temporary loss of images due to an electrical disconnection. A total of 49 of the 50 subjects preferred capsule endoscopy to PE while 2 found the capsule difficult to swallow.

Practice guidelines on the diagnosis and management of small bowel bleeding, published by the American College of Gastroenterology (ACG) support the use of WCE "as a first-line procedure for small bowel (SB) evaluation after upper and lower GI sources have been excluded, including second-look endoscopy when indicated". The ACG guidelines also indicate that in the diagnosis of small bowel bleeding, provided that the VCE in not contraindicated, "VCE should be performed before deep enteroscopy to increase diagnostic yield" (Gerson, 2015).

In its guidelines on the role of endoscopy in the management of suspected small-bowel bleeding, the American Society of Gastrointestinal Endoscopy (ASGE) indicates that "given its high diagnostic yield, VCE is considered the test of choice in the evaluation of small-bowel bleeding after unrevealing standard endoscopic examinations". However, in its formal recommendations, the ASGE states that WCE should be used as the initial test for individuals with overt or occult small bowel bleeding and stipulates that positive WCE results should be followed with push enteroscopy if within reach or device-assisted enteroscopy. The authors note that these recommendations are based on low quality evidence (ASGE, 2017).

Wireless Capsule Endoscopy for Crohn's Disease
Dionisio and colleagues (2010) used a meta-analysis to evaluate the diagnostic yield of WCE compared with other modalities in individuals with suspected and established Crohn's disease (CD). The other modalities included PE, colonoscopy with ileoscopy (C+IL), small bowel radiography (SBR), computed tomography enterography (CTE), and magnetic resonance enterography (MRE). Data on the diagnostic yield of the various modalities were extracted, pooled, and analyzed. Data on individuals with suspected and established CD were analyzed separately. Weighted incremental yield (diagnostic yield of WCE-diagnostic yield of comparative modality) and 95% confidence intervals (CIs) of WCE over comparative modalities were calculated. A total of 12 trials (n=428) compared the yield of WCE with SBR in individuals with CD. Eight trials (n=236) compared WCE with C+IL; four trials (n=119) compared WCE with CTE; two trials (n=102) compared WCE with PE; and four trials (n=123) compared WCE with MRE. For the suspected CD subgroup, several comparisons met statistical significance. The researchers concluded that WCE is superior to SBR, CTE, and C+IL in the evaluation of individuals with suspected CD. The researchers also concluded that WCE is also a more effective diagnostic tool in established CD individuals compared with SBR, CTE, and PE.

A meta-analysis compared the yield of WCE with other modalities in symptomatic individuals with suspected or confirmed nonstricturing CD (Triester, 2006). The researchers examined the data of 11 prospective controlled trials, involving a total of 309 participants. The results suggested that WCE is superior to small bowel barium radiography (63% and 23% respectively), colonoscopy with ileoscopy (61% and 46% respectively), CT enterography/ CT enteroclysis (69% and 30% respectively) and PE (46% and 8% respectively) for diagnosing nonstricturing small bowel CD. While diagnostic yield of WCE was higher than that of small bowel MRI (72% and 50% respectively); the analysis relied on data from only one study with 18 subjects.

In another small study (n=43), subjects with or without known CD who were suspected to have small-bowel CD were prospectively evaluated with PE, enteroclysis, and WCE. Group 1 consisted of 22 individuals known to have CD, while Group 2 consisted of 21 individuals suspected of having small bowel CD. In Group 1, WCE detected more erosions than the other two investigations (p<0.001). In Group 2, a new diagnosis of CD was made in 2 subjects, but there was no significant difference in yield compared with the other two investigations. The referring physicians rated the usefulness of WCE as 4.4 on a scale of 5. The findings of WCE resulted in a change in the management of 30 participants (70%). The authors concluded that WCE has a higher yield than PE and enteroclysis in individuals with known CD when small-bowel mucosal disease is suspected, and this leads to a change in management in the majority of these individuals (Chong, 2005).

Albert and colleagues (2005) compared the diagnostic accuracy of WCE with MRI and enteroclysis in 52 subjects with suspected CD or with previously established non-small bowel CD. Thirty-nine (39) females and 13 males were investigated by MRI, fluoroscopy and, if bowel obstruction could be excluded, by WCE. CD was newly suspected in 25 of the individuals while the diagnosis of CD (non-small bowel) had been previously established in 27 individuals. Small bowel CD was diagnosed in 41 of the 52 participants (79%). WCE was not accomplished in 14 individuals due to bowel strictures. Of the remaining 27 participants, WCE, MRI, and fluoroscopy detected small bowel CD in 25 (93%), 21 (78%), and 7 (33%) of 21cases, respectively. WCE was the only diagnostic tool used in 4 individuals. WCE was slightly more sensitive than MRI (12 versus 10 of 13 individuals with suspected CD and 13 versus 11 of 14 individuals with established CD). The researchers concluded that WCE and MRI are complementary methods for diagnosing small bowel CD. WCE is capable of detecting limited mucosal lesions that may be missed by MRI, but awareness of bowel obstruction is mandatory. In contrast, MRI is helpful in identifying transmural CD and extraluminal lesions, and may exclude strictures.

Dubcenco and colleagues (2005) reported on capsule endoscopy findings in individuals with established and suspected small-bowel CD correlated with radiologic, endoscopic, and histologic findings. Symptomatic eligible individuals had ileocolonoscopy and biopsies from the terminal ileum, followed by small-bowel radiologic studies before WCE. Endoscopic, radiologic, WCE, and histologic findings were compared. Histology (terminal ileum biopsy specimens or a tissue sample after small-bowel resection) served as the gold standard. Data were analyzed for 39 individuals. All study participants had histologic evaluation of the small bowel. A final diagnosis of active small-intestine CD was made in 29/39 participants (74.4%). When calculated, WCE yielded a sensitivity and specificity of 89.6% and 100.0%, respectively, and a positive predictive value and negative predictive value of 100.0% and 76.9%, respectively, whereas small-bowel series were 27.6% and 100.0% and 100.0% and 32.3% respectively. The researchers concluded that WCE is more accurate in detecting small-bowel inflammatory changes suggestive of CD than conventional studies. WCE when combined with ileocolonoscopy may be proposed as a first-line investigation of the small intestine in cases of uncomplicated known or suspected CD.

The ASGE points out that WCE has been weighed against other radiologic studies for the diagnosis of Crohn's disease with somewhat disparate results:

Overall, most studies suggest that WCE has a superior sensitivity for the detection of small bowel Crohn's disease compared with other radiologic studies, with variable specificity. Significant limitations of WCE in the diagnosis of Crohn's disease are the lack of validated capsule criteria and the inability to obtain biopsy specimens for confirmation of the diagnosis. This is particularly relevant with concurrent use of NSAIDs, which is also associated with small-intestine ulcers and strictures. Furthermore, up to 13.8% of asymptomatic healthy volunteers not taking NSAIDs can have mucosal breaks and other lesions seen on WCE which are not related to Crohn's disease (ASGE, 2013).

The European Society of Gastrointestinal Endoscopy (ESGE) recommendations on the clinical use of VCE to investigate small-bowel, esophageal and colonic diseases (Ladas, 2010) state the following: 

The main reasons for a VCE procedure in Crohn's disease are to establish the diagnosis, to assess disease prognosis, disease activity, and mucosal healing post therapy, and to define the extent and severity of disease. VCE examination may be particularly important before medication dosage is changed, and for follow-up after immunomodulators and biologics have been given. VCE may permit confirmation of the diagnosis when Crohn's disease is suspected on clinical grounds, without a definite diagnosis from another modality.

In a more recent publication, the ESGE indicates CE is not an appropriate first-tier test to diagnose Crohn's disease but may be an appropriate tool in individuals with suspected Crohn's disease and negative ileocolonoscopy findings (Pennazio, 2015).

Wireless Capsule Endoscopy for Familial Syndromes
WCE is also being investigated as a means to carry out surveillance of the small bowel in individuals with Lynch syndrome (hereditary non-polyposis colorectal cancer [HNPCC]) or inherited polyposis syndromes including familial adenomatous polyposis (FAP). These conditions have a high risk for benign small-bowel polyps and cancer.

The ESGE (Ladas, 2010) recommends that based on the available published data, VCE may replace enteroclysis for surveillance in individuals with Peutz–Jeghers syndrome. The guideline also states that VCE "is indicated in FAP patients with duodenal polyps, because these patients may develop small-bowel polyps." The guideline acknowledges that:

Although capsule endoscopy allows better visualization of the small intestine than other noninvasive diagnostic methods, it has low sensitivity for identifying the major papilla and does not seem accurate in distinguishing the ampullary from the periampullary region. Therefore, the use of side-view duodenoscopy for staging duodenal disease is mandatory.

The ASGE Technology Status Evaluation Report on Wireless Capsule Endoscopy (Mishkin, 2006) concluded that WCE is a relatively new technology for assessment of the digestive tract. Small intestinal applications are the most extensively studied, and it has quickly become a first-line test for visualizing the mucosa of the small intestine. The most common applications include evaluation for "suspected small intestinal tumors and surveillance in patients with polyposis syndromes."

Wireless Capsule Endoscopy for Iron Deficiency Anemia
WCE has been proposed to investigate unexplained iron deficiency anemia (IDA) when upper and lower endoscopic gastrointestinal evaluation is negative. Apostolopoulos and colleagues (2006) studied 253 consecutive individuals diagnosed with unexplained IDA. Of this group, 51 had negative endoscopic workups. WCE was performed on these individuals. Following the WCE, air double-contrast enteroclysis was also performed on this group. WCE identified one or more small bowel lesions considered to be a likely cause of IDA in 29 of the 51 participants while enteroclysis identified abnormalities in only 6 of the 51 participants. WCE also identified all 6 of the radiographic findings.

In a retrospective case series, Muhammad and colleagues (2009) studied 424 individuals with IDA and negative standard endoscopic evaluations with or without obscure gastrointestinal bleeding (OGIB). The groups were further divided by age: those less than 50 years (group 1); 50-64 years (group 2); 65-85 years (group 3); and greater than 85 years old (group 4). In all groups, WCE identified small bowel erosion/ulceration and angiodysplasia. The highest percentage of these findings occurred in group 3 (65-85 years) and group 4 (greater than 85 years) in the IDA individuals with and without OGIB. The authors concluded that WCE is a valuable diagnostic tool for small bowel evaluation when standard endoscopic evaluations are negative. Further, they concluded that diagnostic yield of WCE in the evaluation of IDA progressively increases as age advances.

Wireless Capsule Endoscopy for Esophageal Disease
The PillCam ESO® (Given Imaging, Inc., Duluth, GA) received 510k clearance by the FDA in 2007 for imaging the esophagus.

WCE has been proposed as a diagnostic tool in the detection of Barrett's esophagus and other esophageal disorders. Unlike the small intestine, which in many cases cannot be directly visualized with PE, the esophagus can be directly visualized with an upper gastrointestinal endoscopy (EGD). For example, an EGD with or without a biopsy, is the standard technique to evaluate Barrett's esophagus in individuals with gastroesophageal reflux disease (GERD). If WCE is used as an alternative to EGD, those with a negative study could potentially forgo a conventional endoscopy. However, individuals with findings suggestive of Barrett's esophagus would require a confirmatory EGD with biopsy. Therefore the role of WCE requires consideration of specific selection criteria to establish the most efficient imaging hierarchy for evaluating the esophagus. 

At the present time, there is limited published literature addressing these issues. In 2004, Eliakim compared WCE to conventional upper endoscopy for detection of esophageal pathologies. Endoscopy identified esophageal pathology in 12 of the 17 subjects. WCE identified esophageal pathology in all 12 and an additional pathology in 1 individual that was missed during endoscopy. The positive predictive value of the WCE for esophageal pathology was 92%; the negative predictive value was 100%. WCE specificity was 80% and sensitivity 100%. The authors concluded that while this study demonstrated that WCE is an accurate, convenient, safe and well-tolerated method to screen for esophageal disorders, additional large-scale studies are necessary to more fully assess this diagnostic tool. Other studies have examined modifications of WCE, such as attaching a string to the capsule which allowed the operator to manually control the movement of the capsule through the esophagus. In the first study, 30 subjects with clinical liver cirrhosis were enrolled; 19 for surveillance and 11 for screening purposes (Pennazio, 2004). Fifty individuals with Barrett's esophagus were enrolled in the second study (Ramirez, 2003). This modified procedure proved to be safe (no capsules were lost and no strings were disrupted) in both studies.

WCE for esophageal disorders is an emerging technology with diagnostic potential. However, the limited data currently available are too preliminary to establish its role in the evaluation of the esophagus.

Wireless Capsule Endoscopy for Colonic Disease 
Obtaining images of the colon is one of the newest applications being explored for WCE. WCE of the colon is particularly appealing when compared to the conventional means of bowel exploration (colonoscopy) because it is non-invasive, does not require sedation, intubation, insufflation, or radiation and no serious adverse effects have been reported. Researchers are exploring the use of WCE as an alternative method of colorectal cancer screening and as a substitute to conventional colonoscopy in the diagnosis of colonic diseases. Several studies have assessed the accuracy of WCE for the detection of colorectal disease.

Schoofs and colleagues (2006) reported the results of a pilot evaluation in humans of the safety, feasibility, and performance of colon capsule endoscopy compared with conventional colonoscopy. The study included 36 participants who were referred for screening colonoscopy or for suspicion of polyps or colorectal cancer. In the detection of any polyp, the sensitivity, specificity, PPV and NPV of conventional colonoscopy compared to WCE were 76%, 64%, 83%, and 54%, respectively. For the detection of three polyps or more, the sensitivity, specificity, PPV and NPV of WCE were 63%, 68%, 36%, and 86%, respectively. The authors concluded that results of WCE were encouraging but additional larger trials are needed.

Eliakim and colleagues (2006) conducted a prospective, multicenter study which evaluated 84 individuals who were referred for colonoscopy as part of colorectal cancer screening (43%), postpolypectomy surveillance (26%), and lower gastrointestinal signs and symptoms (31%). After undergoing colon preparation, the participants ingested the capsule on the morning of the examination, followed by conventional colonoscopy on the same day. The PillCam Colon capsule (PCC) findings were reviewed by three experts in capsule endoscopy who were blinded to the findings on conventional colonoscopy. Of the 84 participants, 20 (24%) had at least one polyp of 6 mm or more in size, or three or more polyps of any size: 14/20 (70%) were identified with capsule endoscopy and 16/20 (80%) were identified by conventional colonoscopy. Polyps of any size were found in 45 participants; 34/45 (76%) were detected by capsule endoscopy and 36/45 (80%) by conventional colonoscopy. With regards to any polyp thought to be significant (any polyp larger than 6 mm), the first reading of the capsule demonstrated a sensitivity, specificity, PPV and NPV of 50%, 83%, 40%, and 88%, respectively. All of these statistics were higher when a second reading of the capsule video was performed (a practice that is not commonly performed with small-bowel capsule endoscopy). In comparison with conventional colonoscopy, false-positive findings using the PCC were recorded in 15/45 cases (33%). There were no adverse events related to the capsule endoscopy.

Sieg and colleagues (2009) evaluated the feasibility and performance of WCE in comparison with special attention to a short colon transit time. WCE was prospectively tested in ambulatory subjects enrolled for colonoscopy who presented for screening or with positive fecal occult blood test. Study participants underwent colon preparation and ingested the capsule in the morning. Colonoscopy was performed after excretion of the capsule. Colonoscopy and WCE were performed by independent physicians who were blinded to the results. A total of 38 subjects were included in the study, but results were reported for the 36 individuals who successfully completed WCE and the conventional colonoscopy examination. One participant was excluded because the capsule remained in the stomach during the entire period of examination. Another participant had limited time and the procedure had to be stopped when the capsule was still in the transverse colon. The capsule was excreted within 6 hours in 84% of the participants (median transit time 4.5 hours). If oral sodium phosphate was excluded from the preparation, the colon transit time increased to a median of 8.25 hours. In total, 7/11 polyps less than 6 mm detected by colonoscopy were identified by WCE. One polyp (less than 6 mm) detected by WCE was not identified by colonoscopy. No large polyps were found. One case of colorectal cancer (CRC) was detected by both methods. The mean rates of colon cleanliness (range from 1=excellent to 4=poor) in the cecum (2.1), transverse colon (1.6), and in the descending colon (1.5) were significantly better than in the rectosigmoid colon (2.6), and the overall mean rate during colonoscopy was significantly better than during WCE. No adverse effects occurred. The authors concluded that WCE appears to be a promising new modality for colonic evaluation and may increase compliance with CRC screening. To achieve a short colon transit time, sodium phosphate seems to be a necessary adjunct during preparation. The short transit time is a prerequisite to avoid the delay mode of the capsule. With an undelayed PCC, a "pan-enteric" examination of the gastrointestinal tract would be feasible. The authors further concluded that additional studies are needed to improve the cleanliness, especially in the rectum and to evaluate the method as a potential screening tool.

Triantafyllou and colleagues (2009) evaluated if PCC endoscopy can complete colon examination after failure of conventional colonoscopy to visualize the cecum. The study included 12 participants who had incomplete colonoscopy – 6 cases had an obstructing tumor of the left side of the colon; and in 6 cases, there were technical difficulties to complete colonoscopy. The PCC endoscopy was able to visualize the rectum in one case. The capsule did not reach the site where colonoscopy stopped in 6 of the 12 cases (3 left-sided tumors and 3 with technical difficulties). In one of the three cases in which the capsule passed the site where colonoscopy stopped, poor bowel preparation precluded the accurate examination of the colon. A total of 4 participants underwent a third colon examination (three barium enemas and one virtual CT colonoscopy). There were no adverse events related to PCC endoscopy. The authors concluded that in subjects with incomplete colonoscopy, PCC endoscopy did not always satisfactorily examine the colon.

Van Gossum and colleagues (2009) conducted a prospective, multicenter study comparing WCE with optical colonoscopy for the detection of colorectal polyps and cancer. In this cohort of 328 participants, the subjects underwent an adapted colon preparation, and colon cleanliness was graded from poor to excellent. The sensitivity and specificity of WCE to detect polyps greater than or equal to 6 mm in size were 64% (95% CI, 59 to 72) and 84% (95% CI, 81 to 87), respectively. The sensitivity and specificity of WCE to detect advanced adenoma were 73% (95% CI, 61 to 83) and 79% (95% CI, 77 to 81), respectively. Of 19 cancers discovered by colonoscopy, 14 were identified by WCE (sensitivity, 74%; 95% CI, 52 to 88). For all lesions, the sensitivity of WCE was higher in subjects with good or excellent colon cleanliness than in those with fair or poor colon cleanliness. Mild-to-moderate symptoms (abdominal discomfort, nausea, vomiting and headache) were reported in 26 (7.9%) of the 328 participants who completed the study and resolved within 48 hours. The authors concluded that the use of WCE of the colon allows visualization of the colonic mucosa in most individuals, but its sensitivity for identifying colonic lesions is low when compared with the use of optical colonoscopy.

Pilz and colleagues (2010) reported the results of a prospective study comparing WCE to conventional colonoscopy as the gold standard. A total of 59 individuals were included in the study and results were evaluable in 56 participants. Polyp detection rate for significant polyps was 11% on colonoscopy and 27% on WCE. Conventional colonoscopy detected 6/56 (11%) subjects with polyps which were not identified by WCE. For polyps of any size, the sensitivity of WCE was 79% (95% CI, 61 to 90), specificity was 54% (95% CI, 35 to 70), PPV was 63% and NPV was 71%. The authors concluded that "in comparison to the gold standard, the sensitivity of WCE for detection of relevant polyps is low; however, the high NPV supports its role as a possible screening tool." 

In a prospective study, Rex and colleagues (2015) enrolled 884 individuals at average risk for colon cancer.  All participants underwent WCE followed by conventional optical colonoscopy several weeks later. The conventional colonoscopy was conducted by an endoscopist blinded to capsule results. An unblinded colonoscopy was carried out on participants found to have lesions 6 mm or larger by capsule but not conventional colonoscopy. A total of 189 (21%) individuals were excluded from analysis due to inadequate cleansing, rapid colon transit time (less than 40 minutes), site termination and individuals lost to follow-up. Capsule endoscopy detected polyps 6mm or larger with 81% sensitivity (95% CI, 77% to 84%) and 93% specificity (95% CI, 91% to 95%). WCE detected polyps 10mm or larger with 80% sensitivity (95% CI, 76% to 84%) and the specificity was 97% (95% CI, 96% to 98%). Capsule colonoscopy identified subjects with 1 or more conventional adenomas 6 mm or larger with 88% sensitivity (95% CI, 82%93) and 82% specificity (95% CI, 80%–83%), and 10 mm or larger with 92% sensitivity (95% CI, 82%–97%) and 95% specificity (95% CI, 94%–95%). Sessile serrated polyps and hyperplastic polyps accounted for 26% and 37%, respectively, of false-negative findings from capsule analyses.

Spada and colleagues (2010) performed a systematic review and meta-analysis to assess the accuracy of WCE in detecting colorectal polyps. A total of 8 studies providing data on 837 subjects demonstrated WCE sensitivity for polyps of any size and significant findings (polyps greater than or equal to 6 mm in size or more than three in number) were 71% and 68%, respectively. The specificity of WCE for polyps of any size and significant findings were 75% and 82%, respectively.

Researchers are also exploring the use of WCE as an alternative method for assessing the extent and severity of ulcerative colitis. Sung and colleagues (2012) evaluated 100 individuals with suspected or known ulcerative colitis by performing WCE and colonoscopy on the same day. The authors reported WCE sensitivity and specificity to detect active colonic inflammation was 89% (95% CI, 80 to 95) and 75% (95% CI, 51 to 90), respectively. The PPV and NPV were 93% (95% CI, 84 to 97) and 65% (95% CI, 43 to 83), respectively. The researchers concluded that while WCE is a safe procedure to monitor mucosal healing in ulcerative colitis, at this stage, it cannot be recommended to replace conventional colonoscopy in the management of this condition.

Oliva and colleagues (2014) assessed the diagnostic accuracy of a second-generation WCE (WCE-2) device in evaluating the disease activity of ulcerative colitis in a pediatric cohort. Colonoscopy was used as a gold standard and disease extent, tolerability, interobserver agreement and safety were measured. The 30 consecutive pediatric participants with ulcerative colitis who were prospectively enrolled in the study initially underwent WCE-2 which was followed by colonoscopy later on the same or the following day. The blinded procedures were performed and the diagnostic accuracy of WCE-2 to identify disease activity was determined using a modified Matts score, which classified the participants as either normal (Matts score ≤ 6) or with active inflammation (Matts score > 6). Interobserver agreement was determined using the kappa statistic. One participant, who was unable to swallow the capsule was excluded, leaving 29 subjects available for analysis. The sensitivity of WCE-2 for disease activity was 96% (95% CI, 79-99) and the specificity was 100% (95% CI, 61-100). The positive and negative predictive values of WCE-2 were 100% (95% CI, 85-100) and 85% (95% CI, 49-97), respectively. The authors reported no serious adverse events. Overall, the WCE-2 had a higher tolerability than colonoscopy (p<0.05). In all cases, the interobserver agreement was excellent (κ>0.86). The investigators concluded using a modified Matts score, CCE-2 was accurate in evaluating significant mucosal inflammation in pediatric subjects with ulcerative colitis. 

The report of the Canadian Agency for Drugs and Technologies in Health (CADTH) on capsule colonoscopy/PillCam Colon concluded that there is limited evidence on WCE in imaging the colon. Larger, multi-center trials that compare WCE with colonoscopy are needed. The evidence to support the use of WCE in screening for colorectal cancer is also lacking (Tran, 2007).

The ASGE emerging technology report (2008), which provides scientific reviews solely for educational and informational purposes, highlights several areas in which additional research is needed for colonic WCE, including but not limited to the following:

The European guidelines for quality assurance in colorectal cancer screening and diagnosis indicate WCE is not recommended for colorectal cancer screening and provide the following conclusions with regards to the diagnostic performance of WCE:

Capsule endoscopy bears promise as an alternative to colonoscopy, because the examination can be realised without intubation, insufflation, pain, sedation or radiation; no serious adverse effects have been reported. However, accuracy data show inferior performance compared to colonoscopy (III). Better diagnostic performance results from large multicentre prospective trials in the average-risk population are required before capsule endoscopy can be recommended for screening (VI - A). (Lansdorp-Vogelaar, 2012).

In 2014, the FDA approved the PillCam® COLON 2 (Given Imaging Ltd. [Yoqneam, Israel]) as a de novo Class II device that may be marketed and used as predicates for future 510(k) submissions. The FDA de novo approval letter indicates the PillCam COLON 2 is a new modality "intended to be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible." According to information in the FDA Decision Summary, clearance was based on a clinical trial comparing WCE with optical colonoscopy based on the presence or absence of at least one finding of a polyp ranging in size from 6 mm to 10 mm on optical colonoscopy. Candidates for the study were individuals between the age of 50 and 75 years, at average risk for colorectal cancer. At the time of this review, the results of this study were not found in the peer-reviewed, scientific literature. Also, information specifically addressing contraindications to the PillCam COLON 2 device were not found on the FDA or manufacturer's web site, however, the PillCam Colon device (which predicated the Colon 2 device) is contraindicated in individuals with: (1) known or suspected GI obstruction, strictures or fistulas based on the clinical picture or pre-procedure testing and profile; (2) cardiac pacemakers or other implanted electro-medical devices; and (3) swallowing disorders.

Most of the studies evaluating the effectiveness of WCE to detect colonic lesions have been done on individuals with a clinical indication for colonoscopy rather than for use as a screening tool for the general population. Based on the available literature, WCE has not been proven to be of equal or greater value than colonoscopy as a tool to detect conditions in the colon. Current limitations of WCE are its requirement for highly effective bowel preparation because the colon is not well visualized with WCE when stool obscures observation of the colonic mucosa. Visualization of the colonic mucosa is also more difficult in the colon versus the small intestines because the colon is larger in diameter and transit time is slower in the colon. It is possible that WCE may miss suspicious areas of the colon because the camera is pointed in the wrong direction as it passes the suspect area. There is also insufficient evidence at this time demonstrating that WCE results in improved clinical utility when compared to conventional colonoscopy.

Wireless Capsule Endoscopy for Other Applications
At this time there are inadequate data regarding other applications of WCE including, but not limited to, evaluation of irritable bowel syndrome, celiac disease, small intestinal diverticula and intussusception. Culliford and colleagues (2005) describe 47 individuals in whom capsule endoscopy was used to evaluate complicated celiac disease. The study results were consistent with celiac disease in 87% of the cases, but also resulted in the some unexpected findings, including one case of intussusception. In another study by Anato and colleagues (2007), an unsuspected case of intussusception was diagnosed as researchers evaluated the efficacy and clinical impact of WCE in 37 children (over 3 years [2002-2005]). Thomson and colleagues (2007) had a similar experience when they investigated 28 consecutive children with suspected small bowel disease and inadvertently discovered a case of an intussusception of the upper jejunum.  Xue and colleagues (2015) reported the results of a systematic review evaluating WCE for unexplained chronic abdominal pain. A total of 1520 participants from 21 studies were included. The pooled diagnostic yield of small bowel WCE was 20.9% (95% CI, 15.9% to 25.9%). Inflammatory lesions were identified most often (78.3%), followed by tumors (9.0%). The authors acknowledge that limitations of the study included its retrospective design, the various types of examinations prior to small bowel capsule endoscopy and the dissimilar durations of abdominal pain.

Patency Capsule
In 2006 the FDA granted 510(k) clearance for the Agile™ Patency System (Given Imaging, Inc., Duluth, GA). According to the FDA approval letter:

The Agile™ Patency System is an accessory to the PillCam SB video capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam SB video capsule in patients with known or suspected strictures in adults and children from two years of age.

A few small studies have reported on the use of a patency capsule prior to WCE in individuals suspected of having intestinal strictures potentially resulting in retention of an endoscopy capsule (Boivin, 2005; Delvaux, 2005; Signorelli, 2006; Spada, 2005, 2007a, 2007b). The size of the patency capsule is similar to the WCE capsule but it is made of lactose with barium and is designed to dissolve within 30-100 hours of entering the intestinal tract. It carries a radiofrequency tag that can be detected by a scanning device. Excretion of the intact capsule within a given time period without symptoms of abdominal pain or obstruction suggests that a subsequent endoscopy capsule can be safely passed. The published studies mostly involved individuals with known CD, and asymptomatic passage of an intact patency capsule was associated with a subsequent uncomplicated WCE. The onset of symptoms or delay in passage with disintegration of the capsule resulted in the cancellation of the subsequent WCE. Nevertheless the patency capsule produced abdominal pain and obstructive symptoms in a number of individuals, with occasional need for emergency hospitalization or surgical intervention. It is also unclear whether those who were denied WCE based on the patency capsule outcome would have in fact experienced complications related to the endoscopy capsule.

Zhang and colleagues (2014) conducted a meta-analysis to estimate the diagnostic value of the patency capsule based on the existing trials. The researchers used PubMed, CENTRAL and EMBASE to search for studies that included individuals with suspected small bowel stricture who were evaluated by both the patency capsule and a reference standard (following capsule endoscopy and/or surgical pathology and/or endoscopic findings). The quality of the eligible studies was evaluated using the Quality Assessment for Diagnostic Accuracy Studies-2 criteria. Calculations were carried out to determine the sensitivity, specificity, likelihood ratios and the area under the receiver operating characteristic curve (AUROC). A total of five studies (203 subjects) met the eligibility criteria. The pooled data demonstrated a PC sensitivity of 97% (95% CI, 93-99%) and a specificity of 83% (95% CI, 65-94%). The AUROC was 0.9557. The researchers concluded the patency capsule may be of diagnostic value in confirming the patency of the GI tract prior to capsule endoscopy.

Larger, randomized studies are needed to validate the role of the patency capsule in preventing adverse outcomes compared to established methods of evaluation in individuals being considered for WCE. 


Wireless Capsule Endoscopy for Small Bowel Disease
The standard methods of detecting abnormalities in the intestines have been through direct visualization using endoscopic techniques such as colonoscopy and upper endoscopy. Limitations of endoscopy include incomplete visualization of the entire small intestine, individual discomfort, risk of perforation and the need to sedate the individual. One advantage of endoscopy is the ability to biopsy suspicious lesions. 

Radiologic techniques provide indirect visualization and include a variety of barium studies. The individual drinks barium to coat the lining of the small intestine before X-rays are taken. The barium appears white on X-ray film, revealing inflammation or abnormalities in the intestine. Barium studies are typically used to diagnose CD, ulcerative colitis and peptic ulcers. While the single contrast study is simple, a more accurate method is the double contrast small bowel follow-through (SBFT) or enteroclysis. In this examination, a very dense preparation of barium is injected into the small intestine. The barium covers only the surface of the intestine, revealing a better view of the organ. Drawbacks to this procedure include exposure to X-rays, individual discomfort, limited capability to make a diagnosis (only gross abnormalities are observable), and diarrhea.

WCE of the small bowel is performed using a camera device that directly visualizes the inside of the small intestine to detect polyps, cancer, or causes of bleeding and anemia. The device comes in capsule form approximately the size of a large vitamin, and contains a camera, lights, transmitter and batteries. The capsule has a clear end that allows the camera to view the lining of the small intestine. Abdominal sensors are attached to the individual to track the progression of the device via the digestive tract. Prior to being swallowed, the capsule is activated by removing it from a magnetic holder. Once swallowed, the natural muscular waves of the digestive tract propel the capsule forward through the stomach, into the small intestine, through the large intestine, and then out in the stool. The indwelling camera takes images at a rate of two frames per second and uses wireless radio transmission to send the images to a recording device that the individual wears around the waist. The stored data is transferred to a computer for processing and analysis by a gastroenterologist. The device software allows the physician to view both streaming video images and image-by-image, whichever the doctor prefers.

WCE does not require sedation and is usually well tolerated. It has been used most frequently as a technique to identify the source of obscure intestinal bleeding. Recently, there has been interest in exploring its use in individuals with inflammatory bowel disease, small bowel neoplasms, small intestinal diverticula, and evaluation of malabsorptive syndromes such as celiac disease.

Potential harms associated with WCE include undergoing unnecessary or inappropriate treatment if the test falsely suggests a small-bowel lesion, incorrectly characterizes the extent of disease, or inaccurately represents the response to treatment. In addition, entrapment of the capsule during transit within strictures or diverticuli that are not accessible by flexible endoscopy has occurred in as much as 1% of the cases studied, but could be potentially higher among individuals with a tendency for stricture formation such as occurs in CD or nonsteroidal anti-inflammatory drug (NSAID) induced strictures. Failure of the capsule to advance through the intestinal tract has the potential to cause complications that could result in the need for endoscopic or surgical retrieval of an entrapped capsule. Therefore, prior to initiation of the procedure, patency of the gastrointestinal tract should be confirmed. The standard of care in the medical community for determining the patency of the gastrointestinal tract is an X-ray examination of the small bowel although the patency capsule has been proposed as an alternate means to gather this information.

Wireless Capsule Endoscopy for Esophageal Disease
WCE of the esophagus is similar to WCE of the small bowel with some exceptions. When WCE is performed for esophageal disorders, the individual is fitted with three thoracic sensors which are attached to the data recorder in order to track the movement of the capsule. The individual ingests a small amount of water and simethicone while standing and then swallows the activated capsule while lying down. The individual is then gradually raised in a series of inclinations over a total of 5 minutes. Contraindications for WCE of the esophagus are the same as those for WCE of the small intestine.

WCE has been proposed as an alternative to upper gastrointestinal endoscopy (EGD) for direct visualization of the lining of the esophagus to rule out disorders such as esophagitis, ulcers, and upper gastrointestinal bleeding. The major advantage of EGD over the imaging system is the ability to obtain biopsies of the esophageal tissue during the procedure. EGD is considered the gold standard for esophageal visualization. Determination of the diagnostic value of WCE requires that it be compared against conventional EGD. 

Wireless Capsule Endoscopy for Colonic Disease
Colon capsule endoscopy has been proposed as a safe, non-invasive procedure for visualizing the colon without the need of sedation, intubation, air-sufflation or radiation. Researchers are exploring the use of these devices as an alternative method to conventional colonoscopy in colorectal cancer screening and the detection of diseases of the colon. One of the major advantages of conventional colonoscopy over WCE of the colon is the ability to obtain biopsies during the procedure. Conventional colonoscopy is the gold standard for visualization of the colon and rectum.

The PillCam COLON 1 device measures 11 x 31 mm and has two cameras that acquire video images from both ends with a frame rate of 4 images per second. The COLON 1 device has an angle of view of 154 degrees and can operate for approximately 10 hours. The newer device, the PillCam COLON 2 device is slightly larger, measuring 11.6 x 31.5 mm, has two cameras that acquire video images from both ends of the capsule and has an angle of view of 174 degrees. The COLON 2 device captures 4 images per second when the capsule is stationary and 35 images per second when the capsule is in motion. The Data Recorder on the COLON 2 device is able to recognize the location of the capsule (stomach, small intestine) and how long it has been there. The RAPID software is able to provide graphic data for estimating the size of polyps (Singeap, 2012).  


Anemia with iron deficiency: A condition when available iron is insufficient to support normal red blood cell production. This can be caused by overt or obscure chronic blood loss, notional deficiency or malabsorption of iron in the gastrointestinal tract. 

Barrett's esophagus: A premalignant condition associated with gastroesophageal reflux disease (GERD).

Celiac disease: A genetic disorder where eating certain types of protein, called gluten, sets off an autoimmune response that causes damage to the small intestine; this, in turn, causes the small intestine to lose its ability to absorb the nutrients found in food which may lead to significant disorders of malnutrition.

Crohn's disease: Inflammation in the small intestine; Crohn's disease usually occurs in the lower part of the small intestine, called the ileum, but it can affect any part of the digestive tract, from the mouth to the anus; the inflammation extends deep into the lining of the affected organ.

Deep enteroscopy: A procedure which involves the advancement of a long endoscope into the small intestine for both diagnostic and therapeutic purposes; also known as balloon assisted enterosocopy.

Enteroclysis: A radiologic examination of the small intestine carried out by infusing radiocontrast through a tube inserted through the nose or throat to the duodenum, or jejunum. Images are taken in real time as the contrast moves through the digestive tract, aided by administration of methyl cellulose. CT enteroclysis is also now available which combines the advantages of CT and conventional enteroclysis.

Intussusception: A disorder in which a part of the intestine folds itself telescopically into another section of the intestine.

Obscure GI bleeding: A positive fecal occult blood test or visible GI bleeding with no bleeding source identified. 

Zenkers diverticulum: Herniation of the mucosa of the esophagus through a defect in the wall of the esophagus; the location is usually in the upper one-third of the esophagus.


The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

91110 Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), esophagus through ileum, with interpretation and report
ICD-10 Diagnosis  
C17.0-C17.9 Malignant neoplasm of small intestine
C18.0-C18.9 Malignant neoplasm of colon
C19 Malignant neoplasm of rectosigmoid junction
C20 Malignant neoplasm of rectum
C7A.010-C7A.019 Malignant carcinoid tumors of the small intestine
D13.2 Benign neoplasm of duodenum
D13.30-D13.39 Benign neoplasm of other and unspecified parts of small intestine
D37.2 Neoplasm of uncertain behavior of small intestine
D50.0-D50.9 Iron deficiency anemia
K50.00-K50.919 Crohn's disease (regional enteritis)
K90.0-K90.9 Intestinal malabsorption
K92.0 Hematemesis
K92.1 Melena
K92.2 Gastrointestinal hemorrhage, unspecified
Z86.010 Personal history of colonic polyps

When services are Investigational and Not Medically Necessary:
For the procedure and diagnosis codes listed above when criteria are not met; for all other diagnoses, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

When services are also Investigational and Not Medically Necessary:

91111 Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), esophagus, with interpretation and report
91299 Unlisted diagnostic gastroenterology procedure [when specified as use of patency capsule]
0355T Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), colon, with interpretation and report
ICD-10 Diagnosis  
  All diagnoses

Peer Reviewed Publications:

  1. Albert JG, Martiny F, Krummenerl A, et al. Diagnosis of small bowel Crohn's disease: a prospective comparison of capsule endoscopy with magnetic resonance imaging and fluoroscopic enteroclysis. Gut. 2005; 54(12):1721-1727.
  2. Antao B, Bishop J, Shawis R, Thomson M. Clinical application and diagnostic yield of wireless capsule endoscopy in children. J Laparoendosc Adv Surg Tech. A. 2007; 17(3):364-370.
  3. Apostolopoulos P, Liatsos C, Gralnek IM, et al. The role of wireless capsule endoscopy in investigating unexplained iron deficiency anemia after negative endoscopic evaluation of the upper and lower gastrointestinal tract. Endoscopy. 2006; 38(11):1127-1132.
  4. Boivin ML, Lochs H, Voderholzer WA. Does passage of a patency capsule indicate small-bowel patency? A prospective clinical trial? Endoscopy. 2005; 37(9):808-815.
  5. Chong AK, Taylor A, Miller A, et al. Capsule endoscopy vs. push enteroscopy and enteroclysis in suspected small-bowel Crohn's disease. Gastrointest Endosc. 2005; 61(2):255-261.
  6. Cohen SA, Klevens AI. Use of capsule endoscopy in diagnosis and management of pediatric patients, based on meta-analysis. Clin Gastroenterol Hepatol. 2011; 9(6):490-496.
  7. Culliford A, Daly J, Diamond B, et al. The value of wireless capsule endoscopy in patients with complicated celiac disease. Gastrointest Endosc. 2005; 62(1):55-61.
  8. Delvaux M, Ben Soussan E, Laurent V, et al. Clinical evaluation of the use of the M2A patency capsule system before a capsule endoscopy procedure, in patients with known or suspected intestinal stenosis. Endoscopy. 2005; 37(9):801-807.
  9. Dionisio PM, Gurudu SR, Leighton JA, et al. Capsule endoscopy has a significantly higher diagnostic yield in patients with suspected and established small-bowel Crohn's disease: a meta-analysis. Am J Gastroenterol. 2010; 105(6):1240-1248.
  10. Dubcenco E, Jeejeebhoy KN, Petroniene R, et al. Capsule endoscopy findings in patients with established and suspected small-bowel Crohn's disease: correlation with radiologic, endoscopic, and histologic findings. Gastrointest Endosc. 2005; 62(4):538-544.
  11. Eliakim R, Yassin K, Shlomi I, et al. A novel diagnostic tool for detecting oesophageal pathology: the Pillcam oesophageal video capsule. Aliment Pharmacol Ther. 2004; 20(10):1083-1089.
  12. Eliakim R, Fireman Z, Gralnek IM et al. Evaluation of the PillCam Colon capsule in the detection of colonic pathology: results of the first multicenter, prospective, comparative study. Endoscopy. 2006; 38(10):963-970.
  13. Ell C, Remke S, May A, et al. The first prospective controlled trial controlling wireless capsule endoscopy with push enteroscopy in chronic gastrointestinal bleeding. Endoscopy. 2002; 34(9):685-689.
  14. Koornstra JJ, Kleibeuker JH, Vasen HF. Small-bowel cancer in Lynch syndrome: is it time for surveillance? Lancet Oncol. 2008; 9(9):901-905.
  15. Lewis BS, Swain P. Capsule endoscopy in the evaluation of patients with suspected small intestinal bleeding: Results of a pilot study. Gastrointest Endosc. 2002; 56(3):349-353.
  16. Long MD, Barnes E, Isaacs K, et al. Impact of capsule endoscopy on management of inflammatory bowel disease: A single tertiary care center experience. Inflamm Bowel Dis. 2011; 17(9):1855-1862.
  17. Muhammad A, Pitchumoni CS. Evaluation of iron deficiency anemia in older adults: the role of wireless capsule endoscopy. J Clin Gastroenterol. 2009; 43(7):627-631.
  18. Mylonaki M, Fritscher-Ravens A, Swain P, et al. Wireless capsule endoscopy; a comparison with push enteroscopy in patients with gastroscopy and colonoscopy negative gastrointestinal bleeding. Gut. 2003; 52(8):1122-1126.
  19. Oliva S, Di Nardo G, Hassan C, et al. Second-generation colon capsule endoscopy vs. colonoscopy in pediatric ulcerative colitis: a pilot study. Endoscopy. 2014; 46(6):485-492.
  20. Pennazio M. Capsule endoscopy: Where are we after 6 years of clinical use? Dig Liver Dis. 2006; 38(12):867-878.
  21. Pennazio M, Santucci R, Rondonotti E, et al. Outcome of patients with obscure gastrointestinal bleeding after capsule endoscopy: report of 100 consecutive cases. Gastroenterology. 2004; 126(3):643-653.
  22. Pilz JB, Portmann S, Peter S, et al. Colon Capsule Endoscopy compared to Conventional Colonoscopy under routine screening conditions. BMC Gastroenterol. 2010; 10:66.
  23. Ramirez FC, Shaukat MS, Young MA, et al. Feasibility and safety of string, wireless capsule endoscopy in the diagnosis of Barrett's esophagus. Gastrointest Endosc. 2003; 61(6):741-746.
  24. Rex DK, Adler SN, Aisenberg J, et al. Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population. Gastroenterology. 2015; 148(5):948-957.
  25. Riccioni ME, Urgesi R, Spada C, et al. Unexplained iron deficiency anaemia: Is it worthwhile to perform capsule endoscopy? Dig Liver Dis. 2010; 42(8):560-566. 
  26. Schoofs N, Deviere J, Van Gossum A. PillCam colon capsule endoscopy compared with colonoscopy for colorectal tumor diagnosis: a prospective pilot study. Endoscopy. 2006; 38(10):971-977.
  27. Sieg A, Friedrich K, Sieg U. Is PillCam COLON capsule endoscopy ready for colorectal cancer screening? A prospective feasibility study in a community gastroenterology practice. Am J Gastroenterol. 2009; 104(4):848-854.
  28. Signorelli C, Rondonotti E, Villa F, et al. Use of the Given Patency System for the screening of patients at high risk for capsule retention. Dig Liver Dis. 2006; 38(5):326-330.
  29. Singeap AM, Trifan A, Cojocariu C, Stanciu C. Colon capsule endoscopy compared to colonoscopy for colorectal neoplasms diagnosis: an initial experience and a brief review of the literature. Rev Med Chir Soc Med Nat Iasi. 2012; 116(1):145-149.
  30. Spada C, Hassan C, Marmo R, et al. Meta-analysis shows colon capsule endoscopy is effective in detecting colorectal polyps. Clin Gastroenterol Hepatol. 2010; 8(6):516-522.
  31. Spada C, Riccioni ME, Costamagna G. Patients with known small bowel stricture or with symptoms of small bowel obstruction secondary to Crohn's disease should not perform video capsule endoscopy without being previously tested for small bowel patency. Am J Gastroenterol. 2007b; 102(7):1542-1543.
  32. Spada C, Shah SK, Riccioni ME, et al. Video capsule endoscopy in patients with known or suspected small bowel stricture previously tested with the dissolving patency capsule. J Clin Gastroenterol. 2007a; 41(6):576-582.
  33. Spada C, Spera G, Riccioni M, et al. A novel diagnostic tool for detecting functional patency of the small bowel: the Given patency capsule. Endoscopy. 2005; 37(9):793-800.
  34. Sung J, Ho KY, Chiu HM et al. The use of Pillcam Colon in assessing mucosal inflammation in ulcerative colitis: a multicenter study. Endoscopy. 2012; 44(8):754-758.
  35. Thomson M, Fritscher-Ravens A, Mylonaki M, et al. Wireless capsule endoscopy in children: a study to assess diagnostic yield in small bowel disease in paediatric patients. J Pediatr Gastroenterol Nutr. 2007; 44(2):192-197.
  36. Triantafyllou K, Tsibouris P, Kalantzis C, et al. PillCam Colon capsule endoscopy does not always complement incomplete colonoscopy. Gastrointest Endosc. 2009; 69(3 Pt 1):572-576.
  37. Triester SL, Leighton JA, Leontiadis GI, et al. A meta-analysis of the yield of capsule endoscopy compared to other diagnostic modalities in patients with non-stricturing small bowel Crohn's disease. Am J Gastroenterol. 2006; 101(5):954-964.
  38. Triester SL, Leighton JA, Leontiadis GI, et al. A meta-analysis of the yield of capsule endoscopy compared to other diagnostic modalities in patients with obscure gastrointestinal bleeding. Am J Gastroenterol. 2005; 11(11):2407-2418.
  39. Van Gossum A, Munoz-Navas M, Fernandez-Urien I, et al. Capsule endoscopy versus colonoscopy for the detection of polyps and cancer. N Engl J Med. 2009; 361(3):264-270.
  40. Xue M, Chen X, Shi L, et al. Small-bowel capsule endoscopy in patients with unexplained chronic abdominal pain: a systematic review. Gastrointest Endosc. 2015; 81(1):186-193.
  41. Zhang W, Han ZL, Cheng Y, et al. Value of the patency capsule in pre-evaluation for capsule endoscopy in cases of intestinal obstruction. J Dig Dis. 2014; 15(7):345-351.

Government Agency, Medical Society, and other Authoritative Publications:

  1. ASGE Technology Committee, Adler DG, Chand B, et al. Capsule endoscopy of the colon. Gastrointest Endosc. 2008; 68(4):621-623.
  2. ASGE Technology Committee, Wang A, Banerjee S, et al. Wireless capsule endoscopy. Gastrointest Endosc. 2013; 78(6):805-815.
  3. Blue Cross Blue Shield Association. Wireless capsule endoscopy. TEC Assessment, 2003; 17(21).
  4. Blue Cross Blue Shield Association. Wireless capsule endoscopy for small-bowel diseases other than obscure GI bleeding. TEC Assessment, 2003; 18(18).
  5. California Technology Assessment Forum (CTAF). Capsule Endoscopy in the Evaluation of Established and Suspected Crohn's Disease. October 2006. Available at: Accessed on April 6, 2017.
  6. Centers for Medicare and Medicaid Services. National Coverage Determination for Endoscopy. NCD #100.2. Effective date not posted. Available at: Accessed on April 6, 2017.
  7. Gerson LB, Fidler JL, Cave DR, et al. ACG Clinical Guideline: Diagnosis and Management of Small Bowel Bleeding. Am J Gastroenterol 2015; 110:1265–1287.
  8. Gurudu SR, Bruining DH, Acosta RD, et al. The role of endoscopy in the management of suspected small-bowel bleeding. Gastrointest Endosc. 2017; 85(1):22-31.
  9. Ladas SD, Triantafyllou K, Spada C. European Society of Gastrointestinal Endoscopy (ESGE): recommendations (2009) on clinical use of video capsule endoscopy to investigate small-bowel, esophageal and colonic diseases. Endoscopy. 2010; 42(3):220-227
  10. Lansdorp-Vogelaar I, von Karsa L, International Agency for Research on Cancer. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition--Introduction. Endoscopy. 2012; 44 Suppl 3:SE15-E30.
  11. Lee KK, Anderson MA, Baron TH, et al. Modifications in endoscopic practice for pediatric patients. Gastrointest Endosc. 2008; 67(1):1-9.
  12. Levin B, Brooks D, Smith RA, Stone A. Emerging technologies in screening for colorectal cancer: CT colonography, immunochemical fecal occult blood tests, and stool screening using molecular markers. CA Cancer J Clin. 2003; 53:44-55. 
  13. Lichtenstein GR, Hanauer SB, Sandborn WJ. Practice Parameters Committee of American College of Gastroenterology. Management of Crohn's disease in adults. Am J Gastroenterol. 2009; 104(2):465-483.
  14. Mishkin DS, Chuttani R, Croffie J, et al. ASGE Technology Status Evaluation Report: wireless capsule endoscopy. Gastrointest Endosc. 2006; 63(4):539-545.
  15. Pennazio M, Spada C, Eliakim R, et al. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2015; 47(4):352-386.
  16. Shamir R, Hino B, Hartman C, et al. Wireless video capsule in pediatric patients with functional abdominal pain. J Pediatr Gastroenterol Nutr. 2007; 44(1):45-50.
  17. Thomson M, Fritscher-Ravens A, Mylonaki, et al. Wireless capsule endoscopy in children: a study to assess diagnostic yield in small bowel disease in paediatric patients. J Pediatr Gastroenterol Nutr. 2007; 44(2):192-197.
  18. Tran K. Capsule colonoscopy: PillCam Colon. Issues Emerg Health Technol. 2007; (106):1-4.
  19. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Oympus Capsule Endoscope System. No. K063259. Silver Spring, MD: FDA. September 14, 2007. Available at: Accessed on April 6, 2017.
  20. U.S. Food and Drug Administration 510(k) Premarket Notification Database. PillCam COLON 2 Capsule Endoscopy System. K153466. Available at: Accessed on April 6, 2017.
  21. U.S. Food and Drug Administration 510(k) Summary. Given PillCam® Platform with PillCam® SB Capsules Given® AGILE Patency System. No. K090557. Silver Spring, MD: FDA. September 28, 2009. Available at: Accessed on April 6, 2017.
  22. U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health. New device approval letter. January 29, 2014. PillCam COLON 2 Capsule Endoscopy System. K123666. Available at: Accessed on April 6, 2017. 
  23. U.S. Food and Drug Administration de novo Summary. PillCam COLON 2 Capsule Endoscopy System. No. K123666. Silver Spring, MD: FDA. December 12, 2012. Available at: Accessed on April 6, 2017.

Agile Patency System
Camera Pill
Capsule Endoscopy
Olympus EndoCapsule
Patency Capsule
PillCam COLON 1
PillCam COLON 2
PillCam ESO
PillCam SB
Video Capsule Endoscopy
Wireless Capsule Endoscopy

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History
Status Date Action
Revised 05/04/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Updated the Rationale, References and History sections. In the 6th bullet of the Medically Necessary criteria, change the word "e.g" to "for example". Updated formatting in Position Statement section.
Reviewed 05/05/2016 MPTAC review. Updated the Rationale, Definitions, References and History sections. Removed ICD-9 codes from Coding section.
Revised 05/07/2015 MPTAC review. In medically necessary position statement, the word "two" was changed to "2". Updated review date, Rationale, References and History sections.
Revised 05/15/2014 MPTAC review. Changed title to: "Wireless Capsule Endoscopy for Gastrointestinal Imaging and the Patency Capsule." In the position statement, added language to clarify the medically necessary criteria applies to the small bowel only. Revised second bullet in med nec statement to include "CT enteroclysis." Last bullet in med nec section revised to include the word "concomitant." Added new position statement indicating WCE is considered investigational and not medically necessary as a means to perform colorectal cancer screening or identify colorectal disease. Updated Description/Scope, Rationale, Background/Overview, References, and History sections. Updated Coding section with 07/01/2014 CPT changes.
Revised 02/13/2014 MPTAC review. In the Position Statement, removed criteria for GU assessment prior to performing wireless capsule endoscopy to investigate iron deficiency anemia. Updated review date, Rationale, References, and History sections.
Reviewed 02/14/2013 MPTAC review.  Updated review date, References and History sections.
Revised 02/16/2012 MPTAC review.  Revised the medically necessary criteria to include enteroclysis as an appropriate diagnostic test for Crohn's disease.  Updated review date, Definitions, References and History sections.
Revised 11/17/2011 MPTAC review.  Revised the medically necessary criteria for WCE as a diagnostic tool in individuals with Lynch syndrome or polyposis syndromes.  Added medically necessary criteria for WCE when used in the diagnostic re-evaluation of individuals with known Crohn's disease. Updated review date, Description/Scope, Rationale, Coding, References and History sections.
Revised 11/18/2010 MPTAC review. Added medically necessary criteria for IDA. Revised first bullet in medically necessary position statement to include upper and lower endoscopy as examples of appropriate tests. Revised second bullet of medically necessary position statement to read "For the initial evaluation of individuals with suspected Crohn's disease when small bowel follow-through (SBFT), upper and lower endoscopy are non-diagnostic AND there is no suspected or confirmed gastrointestinal obstruction, stricture, or fistulae." Updated Description, Rationale, Background, Coding and References.
Revised 11/19/2009 MPTAC review. Changed medically necessary position statement to indicate that wireless capsule endoscopy is considered medically necessary, as a diagnostic imaging tool in adults or children two years of age and older. Updated review date, Rationale, Background/Overview, References and History sections.
Reviewed 11/20/2008 MPTAC review. Updated review date, rationale, references and history sections.
Reviewed 08/28/2008 MPTAC review. Updated review date, References and History sections. Grammatical corrections made to rationale and background/overview sections.
  02/21/2008 The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.
Revised 08/23/2007 MPTAC review. Title, description, position statement, rationale and background/overview sections of the document updated to specifically address the patency capsule which is considered investigational/not medically necessary. 
Revised 09/14/2006 MPTAC review. Title, Description, Position Statement, Rationale and Background/Overview sections of the document updated to specifically address wireless capsule endoscopy for esophageal disorders. Medical Necessity criteria expanded to address intestinal tumors and periodic surveillance for polyposis syndromes and suspected or refractory malabsorptive syndromes. References and Coding updated.
Reviewed 03/23/2006 MPTAC review. A review of the peer reviewed scientific literature from 06/01/2005 to 02/23/2006 did not yield information that would result in a modification to the current document. Rationale section and References updated. 
  11/18/2005 Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).
Revised 07/14/2005 MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Policy Harmonization. 
Pre-Merger Organizations Last Review Date Document Number Title
Anthem, Inc. 04/28/2005 RAD.00030 Wireless Capsule Endoscopy
WellPoint Health Networks, Inc. 04/28/2005 2.06.17 Wireless Capsule Endoscopy