Colon Capsule Endoscopy (CCE)

Jurisdiction: JJ Part B. States: Alabama, Georgia, Tennessee. Type: Active LCD

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits. History/Background and/or General Information Colon capsule endoscopy (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-sized capsule that is swallowed with water. As the capsule travels through the digestive tract, the camera system takes pictures. 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. Covered Indications Diagnostic/surveillance, when performed for signs and symptoms of disease CCE, is medically necessary when EITHER of the following criteria are met: 1. P rimary procedure in patients with major risks for Optical Colonoscopy (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 3 : Fecal Occult Blood Test (FOBT) positive (guaiac or immunochemical); OR M ultitarget Stool DNA (sDNA) Test positive; OR Other evidence of lower GI bleeding in hemodynamically stable patients 2. S econdary procedure: For the detection or surveillance of colon polyp(s) if the diagnostic OC was incomplete OR When an incomplete diagnostic OC was performed for either: Fecal Occult Blood Test (FOBT) positive (guaiac or immunochemical) OR Multitarget Stool DNA (sDNA) Test positive OR Other evidence of lower GI bleeding in hemodynamically stable patients Limitations The following are considered not medically reasonable and necessary: Patients with known or suspected gastrointestinal obstruction, stricture, or fistula Patients with a cardiac pacemaker or another implanted electro-medical device that emits a radiofrequency or other interfering signal Patients with swallowing disorder(s) Patients with a known contraindication or allergy to any medication or preparation agent used before or during the procedure CCE performed in conjunction with Computed Tomographic Colonography (CTC) CCE performed for screening, regardless of family history or other risk factors for the development of colonic disease Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS NCDs, and all Medicare payment rules. The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.