Colon Capsule Endoscopy (CCE) Open Public Meeting - November 05, 2020 - JE Part B

JOCELYN FERNANDEZ:
Hi, everyone.

Let's begin the meeting.

Good afternoon, and welcome members of the public to the Open meeting for the proposed LCD Colon Capsule Endoscopy. LCD number, D like in David L38824 for Jurisdiction E, and DL38826 for Jurisdiction F.

The meeting will be recorded.

The audio recording and written transcript will be posted on our website following today's meeting.

All lines are currently being muted by our system and will remain muted throughout the meeting. Only registered commenters will be allowed to comment during today's meeting. For the commenters, you are being allotted 15 minutes to make comments. Your line will be opened when it is your turn to speak. Make sure you are not on mute within your system or we will not be able to hear your comments. You should be prepared to begin your comments immediately when called upon and will hear the moderator’s voice when one minute remains.

By signing in today, you are giving consent to the use of your recorded voice and your comments.

Please, be mindful of sharing any personal health information in your verbal comments. We ask that all comments made today also be submitted in writing.

While only registered speakers will be commenting today, anyone in attendance may submit written comments.

I will now turn the meeting over to Dr. Ann Marie Sun for comments on the proposed LCD.DR.

ANN MARIE SUN:
Hello and welcome to our discussion of the Colon Capsule Endoscopy LCD.

I just wanted to throw out some clarifications as well as just quickly summarize and kind of remind folks of what the LCD criteria entails. So, if we go ahead and go to the next slide.

So, some definitions that I want to make sure are clear as they do affect the interpretation of the LCD is to define three main categories. When it comes to cancer screening strategies, this refers to those measures taken to diagnose cancerous and pre-cancerous lesions in asymptomatic people with no previous history of such. So those folks who have no symptoms, whatsoever, or signs, and no history of such and they're just being tested with no specific reasoning, except more of a preventative measure at this point, that is called a cancer screening. A Cancer Diagnostics strategy is one where measures are taken to investigate someone who has symptoms that are suspicious for malignancy, or as a result of some positive screening testing.

And lastly, cancer surveillance strategies refer to the interval utilization of diagnostic strategies or testing and people with previously detected cancerous or pre-cancerous lesions.

So, surveillance is more periodically checking to see the status of the patient’s cancer or treatment related to such. So these types of definitions do come from the U.S. Multi-Society Taskforce and is very important and the interpretation of the LCD. OK, next slide, please.

In regards to what colon capsule endoscopy is, at the very basic level, this is a non-invasive procedure, unlike what many folks may know as and what's called an optical colonoscopy, which is a more invasive procedure that has been traditionally and commonly used to look for any type of colon cancer.

This particular diagnostic strategy is non-invasive, and it consists of a tiny wireless camera that's housed inside a vitamin sized capsule. This capsule is swallowed and as it goes down through the digestive system. There's a camera that takes with multiple angles, takes pictures within the digestive tract and then these pictures are transmitted to a recorder that's worn by the patient.

These images are also transmitted to computer where there are some special software that takes these images, string them together to create a video, and then the video of the images is reviewed by a provider who's trained in this to look for any abnormalities within the GI tract. So that is kind of the concept of what Colon Capsule Endoscopy is. Next slide, please.

So, in regards to our LCD, I wanted to be very clear that the indications are only for diagnostic and surveillance purposes only. They are not or they are not indicated at this point for any screening type strategies so when we discuss the colon capsule endoscopy and the coverage criteria, this is for diagnostic and surveillance cancer strategies at this time. For colon capsule endoscopy, it is considered medically necessary when either of the following criteria are met. As a primary procedure, so, first line procedure in patients who are deemed to have major risk for Optical Colonoscopy, or at a major risk for any type of moderate sedation that is often used during a normal optical colonoscopy procedure. This major risk, though, has to be identified and documented by a board certified or board eligible gastroenterologist, or a surgeon trained in endoscopy, or a physician with equivalent endoscopic training.

Now, along with this, the patient that we're discussing where this would meet criteria would be one that already has had some sort of positive screening exams such as a fecal occult blood test or a multi-target stool DNA test. As a secondary procedure for surveillance of colon polyps, if you'd have an incomplete optical colonoscopy where you weren't able to successfully complete, the optical colonoscopy, the colon capsule endoscopy could be your second line testing, if needed, when it comes to surveillance purposes.

When it comes to the initial use of a diagnostic optical colonoscopy test, or testing, and for some reason, you're unable to complete the test, then, it is potentially, approvable are indicated as a secondary option, should be diagnostic, optical colonoscopy, fail in some sort of fashion either.

There's an inability to visualize all that's needed, or some other reason why you would have to stop the optical colonoscopy because it was not completed. So, in this situation, though, remember that the patient has to have had some sort of positive screening previously for this to be deemed diagnostics. So, in the diagnostic surveillance purposes only will the colon capsule endoscopy be covered. Next slide, please.

Now, there are some limitations to having this done. Including if the patient is known to have some sort of GI tract, obstruction, stricture, fistula, where anatomically it would be difficult for this capsule to pass. For those patients with a cardiac pacemaker or another implanted electromechanical device, patients with swallowing disorders or a known contraindication or allergy to any medication or colon prep that will be used before or during the procedure.

Also, it is not reasonable if it was to be used in conjunction with the CT Colonography. Next slide, please.

Lastly, and just to clarify, again, that the Colon Capsule Endoscopy is not a Medicare benefit for colorectal cancer screening, regardless of family history, or other risk factors for the development of chronic disease. When we talk colorectal cancer screening, CMS has a national coverage determination available to review, which is NCD number 210.3, which does go into what is considered applicable colorectal cancer screening strategies that Medicare recognizes and will reimburse. So for those purposes, I would refer to the NCD.

Next slide, please.

At this point in time, I will let Jocelyn takeover again. Thank you.

JOCELYN FERNANDEZ:
Thank you, Dr. Sun.

We have only one commenter today, Dr. Francesca Rancati.

Dr. Rancati, your line is open.

DR. FRANCESCA RANCATI:
Thank you, can you hear me, first of all?

JOCELYN FERNANDEZ:
I can.

DR. FRANCESCA RANCATI:
Perfect. Thank you very much and good afternoon everyone. Thank you for this kind invitation to the meeting.

My name is Francesca Rancati.

I have been working with Medtronic GIH as Medical Affairs Director since 2015 and I hold a PhD in Biotechnology from the University of Milan. So today I'm going to represent Medtronic in this meeting.

On behalf of this company, can you go to the next slide.

I would like to highlight that Medtronic appreciates the effort that went into the development of this policy for colon cancer endoscopy.

We appreciate in particular that Noridian has recognized PillCam Colon 2 as a device that qualifies for Medicare coverage as a diagnostic test that is safe and effective and reasonable and necessary for the defined patient population.

The defined patient population as being described prescribed previously by [inaudible], the FDA approved indications listed in the slides in the last bullet points, so you can see the detection of colon polyps in patients after incomplete colonoscopy, despite the non liquid prep, when the complete an evaluation of the colon was not technically possible. And also, it is indicated for the detection of colon polyps in patients that have a higher risk for colonoscopy or moderate sedation for example patients that have a risk for GI bleeding in lower GI tract.

This applies only to patients with major risks for colonoscopy or moderate sedation but they could tolerate colonoscopy, moderation sedation when identified some colon abnormalities which require again, another inspection of the colon. So the proposed so the indicates as previously described that Colon Capsule Endoscopy is not a Medicare benefit for colorectal cancer screening. Despite the fact that the patients might carry risk factors for development of colorectal cancer such as family history. Medtronic recognize and supports limitations according to [inaudible] is not FDA approved for colorectal cancer screening. Therefore, Medtronic respectfully requests Noridian to move forward with the coverage for Colon Capsule Endoscopy based on FDA approved indications.

Thank you very much and let me know if you have any questions.

JOCELYN FERNANDEZ:
Thank you, Dr. Rancati, for your comments.

This concludes the comment portion of today's Open meeting.

In closing, we would like to communicate the next steps in the policy development process.

The comment period for the proposed LCD will remain open until November 21st, 2020. As noted earlier, all comments to be considered by our medical directors for the proposed LCD must be submitted in writing. Written comments can be e-mailed to policydraft@noridian.com, or mailed to the address on your screen. Comment information for our proposed LCDs are located on our website at noridianmedicare.com. Upon review of the comments, our Medical Directors will either finalize or retire the proposed LCD. Please monitor our website or register for listserv notifications to be informed of actions taken to implement or retire our proposed LCD.

Before we end, Dr. Sun, do you have any final comments you would like to make?

DR. ANN MARIE SUN:
No, thank you so much. I just wanted to thank everybody for joining. Thank you.

JOCELYN FERNANDEZ:
OK, this concludes our meeting for today. Thank you everyone for attending. Enjoy the rest of your day!