Colon Capsule Endoscopy (CCE)

Jurisdiction: J15 MAC Part B. States: Kentucky, Ohio. 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-size 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. Definitions (U.S. Multisociety Taskforce) Cancer Screening strategies refer to those measures taken to diagnose cancerous and pre-cancerous lesions in asymptomatic people with no previous history of such. 1 Cancer Diagnostic strategies refer to the measures taken to investigate persons with symptoms suspicious for malignancy or as a result of positive screening tests. 1 Cancer Surveillance refers to the interval utilization of diagnostic strategies in people with previously detected cancerous or pre-cancerous lesions. 1 Covered Indications For diagnostic and/or surveillance purposes, Colon capsule endoscopy (CCE) is medically necessary when EITHER of the following criteria are met: Primary 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 and EITHER of the following criteria are met 2 : Fecal Occult Blood Test (FOBT) positive (guaiac or immunochemical) OR Multitarget Stool DNA (sDNA) Test positive OR Blood-based biomarker colorectal cancer screening test (CRC) positive OR Other evidence of lower GI bleeding in hemodynamically stable patients Secondary 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 Blood-based biomarker colorectal cancer screening test (CRC) 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 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 May not be performed 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. Please refer to NCD 210.3 for colorectal cancer screening coverage. 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 national coverage determinations, 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.