LCD Reference Article Response To Comments Article

Response to Comments: Colon Capsule Endoscopy (CCE) (DL38837)

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A58624
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Article Title
Response to Comments: Colon Capsule Endoscopy (CCE) (DL38837)
Article Type
Response to Comments
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03/28/2021
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The following are the comment summaries and contractor responses for WPS Proposed Local Coverage Determination (LCD) DL38837 Colon Capsule Endoscopy (CCE), which was posted for comment on 10/01/2020, and presented at the Open Meeting on 10/14/2020. All comments were reviewed and incorporated into the final LCD where applicable. Thank you for the comments.

Response To Comments

Number Comment Response
1

The commenter writes in support of the proposed colon capsule endoscopy (CCE) coverage. The commenter is in agreement with the proposed indications for CCE utilization based on the present FDA approved indications. The commenter provided several points in support of the indications and feels the proposed coverage for CCE will enhance the care for the small subset of patients who have been referred for colonoscopy but were unable to have a technically complete study or were felt to be too high risk medically to undergo the procedure. The commenter is in full support in the approval of this coverage.

Thank you for your comment; we appreciate your support in the proposed coverage for CCE.

2

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."

Thank you for your comments. We have revised the History/background and/or General Information section as suggested and have reworded limitation #2.

3

The commenter is pleased that the proposed LCD is largely in alignment with the FDA approved indications for PillCam COLON 2. The commenter has some concerns with the Covered Indications in the proposed LCD. The commenter appreciates the inclusion of medical necessity criteria for CCE as a primary procedure for patients with major risks for Optical Colonoscopy (OC) or moderate sedation as indicated from an evaluation of the patient by the physician. The commenter strongly believes these decisions are best left to the patient's physician to determine based on the patient's clinical presentation or history. Any additional requirements to this criterion could create unnecessary barriers to CCE as a diagnostic option; thus, potentially negatively impacting the continuum of care or early diagnosis and patient prognosis.

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 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.

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 states the importance of visualizing the proximal colon to the cecum is well supported in the literature. Intubation of the cecum is of critical importance because interval cancers are often located in the proximal colon and the development of interval cancers is more frequent after an incomplete exam.

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."

Thank you for your comments. 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) if the diagnostic OC was incomplete OR…."

4

The commenter is in support of the decision for local coverage decision for PillCam COLON. The commenter indicates PillCam COLON as a noninvasive means to evaluate the colon of individuals who cannot undergo colonoscopy due to other medical conditions or fear of the procedure is an instrumental tool that can help patients.

Thank you for your comment; we appreciate your support in the proposed coverage for CCE.

5

The commenter is pleased the policy is being updated but indicates the covered indications as a primary procedure lists two indications that may invite a deviation from the standard of care. The current standard of care is to proceed with colonoscopy in the event of positive FOBT or stool DNA. The term "major risk for colonoscopy or moderate sedation" is open to broad interpretation. The commenter suggests using ASA class 3 or greater and after the clinical assessment of the endoscopist performing the procedure.

The commenter recommends removing item 2 under limitations regarding pacemakers. The commenter indicates it is well established now and nearly 20 years after FDA approval and in after extensive clinical use that CE can be safely done in patients with implantable devices. While the package insert lists these devices as a contraindication, there is extensive clinical use demonstrating safety and efficacy.

The commenter suggests removing limitation 4 regarding contraindication or allergy to any medication or preparation agent used before or during the procedure. The commenter indicates it is not the purview or responsibility for LCDs to advise on the prep. The way it is written, any allergy to any prep solution would be a contraindication even if it is not used.

The commenter recommends adding that MRI should not be done in patients undergoing CCE and a flat plate of the abdomen ordered if there is concern for capsule retention after study completion.

Regarding the clinical literature, the commenter indicates in reference to Rex et al. study; 26% false negative findings for SSA polyps is unacceptably high. This was a sentinel study and it should be recognized that CCE is inferior to well performed colonoscopy in detecting these lesions.

The commenter recommends dropping the Kobaek-Larsen 2018 study as a reference as there are significant methodologic flaws in the study the least of which was the study design used colonoscopy as the standard against which to measure CCE and they concluded that CCE was superior. Statistical fundamentals apply; the best that one can conclude in the study design is non-inferiority. While peer reviewed, it was not published in a top tier journal.

In the systematic reviews, the declaration by 2018 Emergency Care Research Institute as "somewhat favorable" is a weak endorsement.

In the analysis of evidence, the commenter disagrees with the word "suitable" in and recommends rephrasing as "…CCE is an alternative to OC…" and "In addition, CCE is a secondary procedure…"

Thank you for your comments. No changes will be made to the "major risk for colonoscopy or moderate sedation" at this time. We have revised the wording to limitation #2 to state "patients with a cardiac pacemaker or another implanted electro-medical device that emits a radiofrequency or other interfering signal." No changes will be made with regards to limitation #4 at this time. We do not feel a need to state "MRI should not be done in patients undergoing CCE and a flat plate of the abdomen ordered if there is concern for capsule retention after study completion" at this time. With regards to the Rex et al. and Kobaek-Larsen clinical literature, no changes will be made as we do not recognize them as superior. With regards to the analysis of evidence section and the word "suitable", the wording had been revised as suggested.

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Associated Documents

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