LCD L38571: Colon Capsule Endoscopy (CCE)

Diagnostic and/or surveillance* (performed for signs/symptoms of disease) colon capsule colonoscopy (CCE) is medically necessary for the detection of colon polyps when EITHER of the following criteria are met:

• Secondary procedure after an incomplete diagnostic optical colonoscopy (OC) with adequate preparation, and a complete evaluation of the colon was not technically possible (1,2) when EITHER of the following criteria are met

• Detection or surveillance of colon polyp(s) OR

• Diagnostic procedure when ANY of the following criteria are met (3):

• Fecal Occult Blood Test (FOBT) positive (guaiac or immunochemical) OR

• Multitarget Stool DNA (sDNA) Test positive OR

• Other evidence of lower GI bleed in hemodynamically stable patients

• Primary procedure in patients with major risks for OC or moderate sedation as indicated from an evaluation of the patient by a board certified or board eligible gastroenterologist, a surgeon trained in endoscopy, or a physician with equivalent endoscopic training when EITHER of the following criteria are met:

• Surveillance of colon polyp(s) in previously diagnosed patients OR

• Diagnostic procedure when ANY of the following criteria are met (3):

• Fecal Occult Blood Test (FOBT) positive (guaiac or immunochemical) OR

• Multitarget Stool DNA (sDNA) Test positive OR

• Other evidence of lower GI bleed in hemodynamically stable patients

Exclusion Criteria (NONE of the below are allowed)

• Known or suspected gastrointestinal obstruction, stricture, or fistula

• Cardiac pacemaker or another implanted electro-medical device if the CCE device is contraindicated due to emission of a radiofrequency or other interfering signal

• Swallowing disorder

• Known contraindication or allergy to any medication or preparation agent used before or during the procedure

• May not be done in conjunction with CT Colonography (CTC)

• CCE is not a Medicare Benefit for colorectal cancer screening, regardless of family history or other risk factors for the development of colonic disease

* Cancer Diagnostic strategies refer to the measures taken to investigate persons with symptoms suspicious for malignancy or as a result of positive screening tests. Cancer Surveillance refers to the interval utilization of diagnostic strategies in people with previously detected cancerous or pre-cancerous lesions. Cancer Screening strategies refer to those measures taken to diagnose cancerous and pre-cancerous lesions in asymptomatic people with no previous history of such.

CCE is a noninvasive procedure that does not require air inflation or sedation and allows for minimally invasive and painless colonic evaluation. CCE utilizes a tiny wireless camera that takes pictures of the gastrointestinal tract. The wireless camera is housed inside a vitamin-size capsule that is swallowed with water. As the capsule travels through the digestive tract, the camera takes pictures that are transmitted to a recorder worn by the patient. The images are then transmitted to a computer with special software where the images are strung together to create a video. The provider reviews the video to look for any abnormalities within the gastrointestinal tract.

The first-generation device had a low sensitivity and specificity for polyps in the colon, however a second-generation device received FDA clearance January 2014 and expanded use in January 2016 (1,2). The improved design is slightly bigger with two cameras and increased angle of view allowing nearly 360-degree coverage of the colon. The capsule battery last 10 hours with a slower frame rate. Improvements in software allow estimation of polyp size and improved mucosal surface evaluation. Unless indicated, reference to CCE is specific to the second-generation device. Both FDA indications are specific to colon polyp detection, but whereas the original restricted to use as a secondary procedure after failed OC, the expanded indication included use as a primary procedure in patients at major risk for colonoscopy or moderate sedation, and with evidence of lower GI bleeding. See Table 1 for details of the following studies.

The pivotal trial that led to FDA clearance was a prospective blinded study of 884 asymptomatic patients classified as average colorectal cancer (CRC) risk (4). Technical failures (short transit time plus poor preparation) occurred in 9% of patients. The authors conclude based on polyp detection sensitivity and specificity data that: “capsule performance seems adequate for patients who cannot undergo colonoscopy or who had incomplete colonoscopies.”

Two studies comparing CCE to CTC demonstrated at least non-inferiority in terms of sensitivity and specificity (5,6). One found improved sensitivity and specificity for CCE, but both studies had methodological flaws with low quality evidence. Advantages to CTC include the ability to use when obstruction or stricture is a concern and to obtain visualization of other abdominal structures. Advantages to CCE are the lack of radiation exposure and direct visualization of colorectal mucosa. Patient preference and availability of the technology also may play a role in test selection.