Implantable Continuous Glucose Monitor (I-CGM) Open Public Meeting - June 17, 2020 - JF Part A

Jocelyn
Good afternoon and welcome members of the public to the open meeting for proposed LCD, Implantable Continuous Glucose Monitors. LCD Number: DL38657, Jurisdiction E, and DL38659 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 our commenter, you are being allotted 10 minutes to make comments. Your line will be open. 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 you will hear the commenters voice when one minute remain. By signing in today, you are given consent to the use of your recorded voice and your comment. Please be mindful of sharing any personal health information. We ask that any comments made today also be submitted in writing. Only registered and confirmed speakers will be allowed to comment today. Others 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. Sun
Thank you, Jocelyn.

Hello, everybody, my name is Dr. Ann Marie Sun and I'm one of the Contract Medical Directors here at Noridian. Just a couple of statements I wanted to make at this juncture just to clarify for the purposes of Medicare that continuous glucose monitors that are not implantable fall under the DME benefit categories so, therefore, coverage would fall under their DME MAC LCD which they have one for glucose monitors. In that benefit category, there are specific HCPCS codes assigned to the therapeutic continuous glucose monitor themselves, which are to be billed for reimbursement purposes. So that's all I would really say about that. But just to clarify, and what by definition today, we're talking about implantable devices. This falls under Medicare Part B as a benefit category. So, that is why we have a separate Implantable Continuous Glucose Monitor draft LCD here for you today. As you're most likely aware in Part B for reimbursement purposes, T codes were specifically assigned for the actual implantation and or removal of the device, and that's how Medicare should be billed, and we do note that in our accompanying draft billing and coding article. So, depending on the type of device, whether implantable or not, the concept of Continuous glucose monitoring doesn't change and, therefore, it does require, although there's a DME LCD for glucose monitors, and there's a part B one, we do require close coverage alignment between us and our counterparts. So that draft here today, does indeed reflect that. I just wanted to make those clarifications otherwise, Jocelyn, I’ll give it back to you.

Jocelyn
OK, our first commenter is Dr. Francine Kaufman. Doctor Kaufman, can you hear me?

Dr. Kaufman
Yes, I can. Thank you very much, and I'd like to thank you for this opportunity to present on the Eversense® Continuous Glucose Monitoring system first, long term, Implantable CGM system. My name is Fran Kaufman. I'm the Chief Medical Officer at Senseonics and I'm also a practicing pediatric endocrinologist at the University of Southern California School of Medicine and the Children's Hospital of Los Angeles. I do want to add that a number of my Senseonic colleagues are on this call today, including our President Dr. Tim Goodnow, and my conflict of interest is obvious, and I am an employee and also a member of the Board of Directors of Senseonics.

So, on slide two, there is the Standards of Care for Continuous Glucose Monitoring, or CGM, and it is considered a standard of care for Type one and intensively managed Type two diabetes patients. American Diabetes Association, that amends their standards every year, has recommended CGM as a tool to improve glucose control and mitigate against hypoglycemia. The American Association of Clinical Endocrinologists, or AACE, their standards developed in 2016, and, again, saw the benefits of using CGM to reduce costs and the medical consequences of hypoglycemia and poor glycemic control. The same was for the Endocrine Society also in 2016 essentially stating the same that CGM should be a standard of care to improve diabetes outcomes. Next slide, please.

This slide describes the FDA indications for Eversense® as a therapeutic CGM. It's indicated for adults and used for up to 90 days. This system provides real-time glucose readings, glucose trend information, alerts that can be activated to detect or predict episodes of high and low glucose levels. And the data can be shared with up to five care partners in real time. And the data is also retrievable by both patients and healthcare providers to adjust diabetes regimens and behaviors. This device is used as a non-adjunctive system to replace information from standard home, blood glucose monitoring, and it does require calibration. Next slide.

This slide shows the components of the Eversense® CGM system. There's the center that is fully implanted the smart transmitter that is worn above the sensor on the skin and adhere to in place with a mild silicone based adhesive. The mobile app on the smartphone, and as well as the cloud-based data management system. And again, this system is able to be shared with up to five care partners, so the sensor lasts for up to three months. It's fully implantable. The smart transmitter on the body has a vibratory alert system so one is not holding their smartphone, or within a significant distance of the smartphone, this is an added benefit. Then, the transmitter can be taken on and off. Next slide, please.

This slide describes how the Eversense® system works. The on-body transmitter wirelessly powers the implanted sensor. The antenna on the sensor receives this energy and power as a sensor. The indicator polymer on the sensor fluorescence, when glucose is present in a reversible reaction. The sensor then sends back the raw data to the transmitter that calculates the glucose value. Values then sent to the mobile device where it's displayed, and trends and alerts can be shown. And, again, this can be shared with up to five care partners. Next slide.

This slide shows the ever since insertion and removal procedures all done in a sterile field set up in the healthcare provider's office. For the insertion, a small five mm incision is made after numbing with local anesthesia. A sterile tool is inserted to create a pocket, the sensors placed in that pocket and the skin is then with Steri-Strips and a small bandage is placed on top.

The removal procedure, again, done under sterile conditions, involves anesthetizing the area of a 5 to 6 mm, small incision, inserting the clamp, grasping the sensor and removing it. Then, the incision again as closed with a Steri-Strip and a small bandage on top. Next slide.

I wanted to show you an example of how the system is used by a patient with intensively managed diabetes, this patient turns out to be a 71-year old with longstanding diabetes, and this is the data from her data management system or DMS system. It shows that she wears a transmitter over the sensor powering the sensor, getting data, almost all the time, 93% of the time. Love that, are a series of glucose metrics that show how the data can be displayed. So, there's an average sensor glucose which is excellent for this patient. From that can be derived an estimated A1C value, and I do want to suggest that this has been extremely valuable in the time of COVID, when many patients were either not willing or not able to go to a laboratory to obtain an A1C measurement and the data from the CGM can be used to estimate that A1C. It can then be shared with the healthcare provider and the patient during a virtual health care visit.

Then, the data the glucose data can be displayed by low in target and high values. There are target rages for all of these for the time in the target range of 70 to 180 milligrams per deciliter. The goal is to get above 70%. You can see this patient and marketed improvement over that. Then there's other measures, a coefficient of variation in the standard deviation measures of glycemic variability. Then there's also the display of the ambulatory glucose profile that shows the glucose sensor overlay, the median glucose in ranges of 25 and 75 percentiles.

So, with this during a healthcare encounter, either in person or virtual, a lot can be obtained as to what needs might need to be changed in the patient's diabetes regimen. Next slide, please.

And I just want to do a boost commentary on the coverage criteria so the next slide after that. So, the therapeutic I CGM coverage is shown here. I do want to point out that many beneficiaries of reforming blood glucose monitoring frequently, however, many are not because they're coming from another transcutaneous CGM device, and they're no longer using CGM or at a much lower frequency. Therefore, we feel that this criteria number two, about testing blood glucose values four or more times a day, might not be met, and we're hoping these criteria can be revised.

I'll conclude here and I do want to thank you for your attention, and I'll be more than happy to answer any questions you may have, and again, I want to thank you on behalf of the Eversense® the first long-term, implantable CGM system.

Jocelyn
Thank you, Dr. Kaufman for your comments.

Dr. Kaufman
Yeah, there's an appendix. I don't think we need to go over those, but they are available.

Jocelyn
OK, this concludes a comment portion of today's meeting. In closing, we would like to communicate the next step in the Policy Development process. The comment period for the Proposed LCD will remain open until July 6, 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 www.noridianmedicare.com. Upon review of the comments or medical directors, will either finalized or retire the proposed LCD. Please monitor our website or register for listserv notification to be informed of action taken on our proposed LCD. I will now ask Dr. Sun; do you have any final comments?

Dr. Sun
No, I do not, and thank you. Thank you, Dr. Kaufmann, for your time to present this information to us, and thank you, everybody, for joining us.

Jocelyn
Thank you. This concludes our meeting for today. Have a wonderful day.