Local Coverage Article Response to Comments

Response to Comments: Colon Capsule Endoscopy (CCE)


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Response to Comments: Colon Capsule Endoscopy (CCE)
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Response to Comments
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As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.
We would like to thank those who suggested changes to the draft of the Colon Capsule Endoscopy (CCE) LCD.
The official notice period for the final LCD begins on 02/25/2021 and the final determination will become effective on 04/15/2021.

Response To Comments


The commenter (the manufacturer Medtronic) is pleased that the proposed LCD is largely in alignment with the FDA approved indications for PillCam COLON 2. The criteria for CCE as a primary procedure for patients with major risks for OC or moderate sedation includes the requirement of either Fecal Occult Blood Test (FOBT) positive (guaiac or immunochemical) or Multitarget Stool DNA (sDNA) Test positive. The FDA cleared indication for PillCam Colon does not define "evidence of lower GI bleeding." The commenter agrees that FOBT and sDNA tests would help identify those patients with occult GI bleeding. However, hemodynamically stable patients with overt GI bleeding, such as those with scant intermittent melena or hematochezia, may be candidates for PillCam and may not necessarily undergo a stool test given presumed positivity of the test. Therefore, requiring a positive stool test in these patients seems unnecessary. Therefore, the commenter proposes the addition of a third bullet point, "OR other evidence of lower GI bleeding." The commenter also requests additional ICD-10-CM codes K92.1 (melena) and K92.2 (gastrointestinal hemorrhage, unspecified) be added to the Local Coverage Article: Billing and Coding: Colon Capsule Endoscopy (CCE).

The commenter indicates under the proposed LCD, CCE is covered as a secondary procedure for the surveillance of colon polyp(s) if the 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. This proposed language would allow CCE as a secondary procedure after incomplete OC only in the setting of previously diagnosed pathology, whether it be polyps or positive stool test. However, the FDA cleared indication for CCE allows the device to be used for the detection of colon polyps after incomplete OC with adequate prep, regardless of history of colon polyps or positive stool tests. The commenter is concerned that the proposed use of CCE after incomplete colonoscopy is limited to patients with a history of polyps or positive stool tests. When a colonoscopy is incomplete, the proximal colon may not be completely evaluated, potentially missing relevant polyps or other colonic findings. Under the proposed policy, a patient is required to have a prior polyp identified or a positive stool test before CCE is medically necessary. This restriction limits the use of CCE in an important subset of patients that may have a polyp or other colonic findings in the proximal colon, however it was never detected because the proximal colon was not accessible by the colonoscope. The commenter suggests the following alternative phrasing for secondary procedures: "Secondary procedure for the detection or surveillance of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible."

We have revised the indications for primary and secondary procedures to include "other evidence of lower GI bleeding in hemodynamically stable patients" as a third bullet. We have added diagnosis codes K92.1 (melena) and K92.2 (gastrointestinal hemorrhage, unspecified) as codes that support medical necessity. We have revised the secondary procedure wording to state "for the detection or surveillance of colon polyp(s).”


The commenter requests consideration to slightly change the language in the History/Background and/or General Information section to read: "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." The commenter also requests the following language for consideration to the Coverage Indications, Limitations and/or Medical Necessity section: "CCE devices are covered when the device has received Food and Drug Administration (FDA) market clearance for that device's FDA-approved indication or is used in a CMS approved clinical trial that meets all of the conditions specified." The commenter suggests the following change to the limitations number 2. Patients with a cardiac pacemaker or another implanted-electro-medical device. The commenter indicates the current issue with patients who have an electro-medical device is because the currently approved colon capsule endoscopy device emits a radiofrequency signal. Devices in development do not and therefore, patients with an implanted electro-medical device would be able to have a procedure if it were performed with such a device when it is cleared for marketing by the U.S. Food and Drug Administration. The commenter suggests that the language be updated to read: " 2. Patients with a cardiac pacemaker of another implanted electro-medical device if the CCE device is contraindicated due to emission of a radiofrequency signal or other interfering signal."

We have revised the History/background and/or General Information section as suggested and have reworded limitation #2.

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