Implantable Continuous Glucose Monitors (I-CGM) Open Public Meeting - November 2, 2023 - JE Part B

Kari DuPreez:
Good afternoon. Welcome to the open public meeting for the proposed LCD, Implantable Continuous Glucose Monitors, I-CGM DL38657 for JE and DL38659 for JF.

Before we begin the meeting, I would like to make the following announcements.

This meeting will be recorded. The recording and written transcript will be posted on our website following today's meeting. All lines are currently being muted and will remain muted throughout the meeting. Only those who have registered to present will be allowed to comment on the proposed LCD today.

For the presenters, you are being allotted 10 minutes to make comments. Your line will be opened when it is your turn to speak. Please 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 presentation immediately when called upon and will hear the moderators 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 during your presentation.

In addition to comments that are made today, all comments should also be submitted in writing. All written comments received will be recorded in the Response to Comments article.

I will now turn the meeting over to Dr. Ann Marie Sun. Dr. Sun, you may begin.

Dr. Sun:
Hello and thank you everybody for attending. Just briefly, what I wanted to do right now was to update everyone, listening in about what we did as far as updating our previously or I would say already existing Implantable Continuous Glucose Monitor Local Coverage Determination. One of the main reasons we did update this I-CGM LCD was in response to some reconsideration requests that we took into account, especially the question and request regarding the previous but yet recent update that the DME contractors with their Glucose Monitor DME policy with their LCD update.

Requesting some sort of, I would say update to be similar in aspect when it comes to the Continuous Glucose Monitoring devices.

We did take that into account, and we also wanted to do an updated evidentiary review on the devices available, you know research and studies available, so we also included in our new updated LCD updated research as well, and that is available on a summary of evidentiary analysis.

As far as the criteria for an implantable continuous glucose monitor, we did update our criteria not only using the DME policy as guidance I would say but based on the evidentiary analysis, we felt it was appropriate to change the and update the LCD criteria to match their continuous glucose monitoring portion of their DME. I will remind folks that the DME LCD policy is for glucose monitors, so it does entail different types and so, if there's any question, please note that this is related to implantable and it's related to the Continuous Glucose Monitoring, which is similar to the subcutaneous version, that's in the DME policy. So, all the criteria will be similar. I do want to note that the main changes include, if you can go to let's see, OK, this this portion here, the first three criteria, basically setting up the fact that obviously the patient has to have some sort of applicable diabetes mellitus diagnosis. We did update the billing and coding article and included some additional diagnosis codes that we felt were relevant to this updated policy. Also included, of course, the important information to indicate that a treating practitioner is monitoring the patient's overall condition and use of this monitor. Can you go to the next slide, please?

Most importantly, criteria or covered indication number four, we changed and updated the LCD criteria to be beneficiary being insulin treated, or the beneficiary has a history of problematic hypoglycemia and then with documentation of at least one of the following, so there's two options there, I won't read it to you but it does match the DME LCD policy. Next slide, please.

And, of course, we find it very important to continue constant contact collaboration with the beneficiary and the treating practitioner. So, we still require at least every six months some sort of follow-up regarding how the patient's diabetes is controlled utilizing the implantable device. Next slide.

The limitations remain the same and so this part has not changed from our previous LCD policy.

Next slide.

And, as mentioned, you can see on the updated draft of the billing and coding article, we did expand the list of potentially payable ICD-10 diagnosis codes.

And with that I will now introduce our first speaker.

Our first and only speaker, I think, at this time.

Dr. Kaufman.

Dr. Kaufman:
Hello, can you hear me?

Dr. Ann Marie Sun:
Yes.

Dr. Kaufman:
OK, great, thank you. My name is Dr. Francine Kaufman. I'm the Chief Medical Officer at Senseonics.

Next slide, please.

I also am a Professor Emeritus of Pediatrics, past President of the American Diabetes Association, a Member of the National Academy of Medicine, and I continue to see patients and I appreciate this opportunity to talk to about the Noridian Implantable Continuous Glucose Monitor, I-CGM, DL38657 and DL38659.

Next slide, please.

I've already stated my conflict of interest as the Chief Medical Officer Senseonics.

Next slide.

Just briefly to talk about the Eversence E3 CGM system, that has a duration of functional use of 180 days, this is the only implantable CGM system that's approved by the FDA at this point in time.

It consists of three components a fully unplanted, very small sensor that's placed under the skin and in the subcutaneous tissue in the arm and it measures glucose in the interstitial fluid.

Above this sensor lies a Smart transmitter that is removable, rechargeable and held in place with a mild silicone adhesive patch.

The transmitter takes the raw glucose data, calculates the glucose value and then sends it to an app on the smartphone.

The glucose data is updated every five minutes and as well, alerts can be elicited that are visual as well as auditory, and on the transmitter, itself is a vibratory alert.

We measure glucose in the interstitial fluid with a fluorescent technology, and we are approved since February of 2022, indicated for adults only, and the insertion and removal of the system is performed by trained and certified health care providers.

Next slide.

So, we are in approval for the removal of the requirement that the beneficiary be insulin-treated with three or more daily administrations of insulin, and absolutely, in agreement with any insulin treatment at all.

And also appreciative of adding a history of problematic hypoglycemia to the criteria for the beneficiaries.

So, this updated criteria for coverage of the Implantable CGM better reflects the current clinical evidence and standards for the reasonable and necessary use of a CGM.

And there is a robust body of evidence and medical literature supporting this position.

There are a number of important randomized controlled trials that show the benefit of using CGM in type 2 diabetes patients who use basal insulin only.

There are three systematic reviews with meta analyzes that showed CGM use in patients with type 2 diabetes, compared to finger stick glucose management was associated with significant reduction in hemoglobin A1c values.

And there are two prospective clinical trials that showed that clinically significant episodes of hypoglycemia go undetected, without CGM in type 2 patients, either using insulin or being treated with non-insulin regimens.

In addition, the major professional diabetes associations in the United States have made favorable recommendations for the use of CGM, in particular, for patients with type 2 diabetes and basal insulin only.

Next slide, please.

So, Senseonics supports the draft LCD, the changes in coverage are in concert with the medical literature and positions of the major professional diabetes associations.

The updated coverage criteria provides parity two coverage criteria across all CGM systems.

However, we do, respectively request that Noridian add all the relevant ICD-10 diagnoses to DA58133 and DA58138 so that both DME CGM LCD and Noridian Part B Implantable CGM have parity with the ICD-10 diagnoses. Next slide.

So, in our official comment submission we have provided a list of 81 ICD-10 diagnoses codes currently not Included but are included in the DME CGM LCD.

So, this creates some confusion amongst providers who are looking for consistency across cover diagnoses. We do feel that is essential that the following more commonly used ICD-10 diagnosis be added.

These include the code for diabetes due to underlying condition with unspecified complications, type 1 diabetes mellitus with unspecified complications, type 2 diabetes with unspecified complications, and other specified diabetes with unspecified complications. Next slide.

So, in summary, Senseonics appreciates Noridian's timely review of the ICGM LCD to bring coverage criteria parity across all CGM systems. We support the updated coverage criteria included in the proposed LCD DL38657 and DL38659for the implantable CGM and we request that the draft coding article include the requested ICD-10 codes to ensure parity across CGM systems.

And I thank you very much for your attention.

Kari DuPreez:
Alright, thank you, Dr. Kaufman, we appreciate your comments. Dr. Sun, do you have any comments you'd like to make before we go into the closing and next steps?

Dr. Sun:
No. I'm OK. Thank you very much.

Kari DuPreez:
All right.

With the closing and next steps, the comment period for the proposed LCD will remain open until November 4th, 2023. 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 LCD is located on our website, at www.noridianmedicare.com.

Upon review of the comments, our medical directors will either finalize or retire the proposed LCD. Responses to comments will be viewable in the Response to Comments article.

Please monitor our website or register for listserv notifications to be informed of actions taken on our proposed LCD.

And, again, Dr. Sun, anything else you'd like to add before we end the meeting today?

Dr. Sun:
No, but I appreciate everybody's attendance. Thank you so much.

Kari DuPreez:
All right. Perfect, then this does conclude our meeting. We want to thank you for attending the Noridian Open Public Meeting today.