LCD Reference Article Response To Comments Article

Response to Comments: Implantable Continuous Glucose Monitors (I-CGM)

A58340

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Source Article ID
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Article ID
A58340
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Implantable Continuous Glucose Monitors (I-CGM)
Article Type
Response to Comments
Original Effective Date
11/02/2020
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The Comment period for the Implantable Continuous Glucose Monitors (I-CGM) L38657 began on 05/21/2020 and ended on 07/06/2020.  Comments were received from the provider community. The notice period begins on 09/17/2020 and ends 11/01/2020. The LCD becomes final on 11/02/2020.

All comments provided within the open comment period have been reviewed. Those comments covering similar topics were collectively gathered and responded to as demonstrated by these examples below.

Response To Comments

Number Comment Response
1

We urge that you change the blood glucose self-testing requirement for I-CGMs to at least three (3) times per day, consistent with Medicare coverage policy for test strips and current scientific understanding and clinical recommendations from the experts in diabetes care. While it is possible to secure coverage for four or more test strips per day, it involves more paperwork and administrative hurdles for patients, providers and DME suppliers.

Thank you for your comments. Noridian has eliminated this requirement from the final LCD.

2

We would like to see language added to the coverage criteria to account for patients who have adopted other CGM systems and may have had trouble complying, managing them, and cases when the CGM might not be appropriate anymore in light of other CGM options, like I-CGM.

Thank you for your comments. An exception statement will be added to the LCD allowing transition to an I-CGM in instances where a beneficiary has previously met coverage criteria for a non-implantable continuous glucose monitor and subsequently chooses to switch to an implantable device. This will require the treating provider’s cooperation and involvement as a small procedure is required to implant the I-CGM sensor.

3

Since it is required that the implantable continuous glucose monitor sensor be replaced every 90 days, the criterion regarding the beneficiary requiring an in-person visit with the treating practitioner every 6 months is unnecessary and may add to confusion.

Thank you for your comments. Noridian agrees that this requirement may appear redundant. Therefore, this requirement will be removed from the LCD.

4

We also recommend modification of the wording related to insulin treatment to eliminate the word “injections.” There is an inhaled insulin on the market used by some patients. To accommodate that reality, the wording should reflect “multiple daily administrations” with insulin, not “injections.”

Thank you for your comments. Noridian agrees that because there is another option for insulin therapy that comes in a non-injectable form, the verbiage will be changed to “insulin administrations” rather than “injections”.

5

We ask that you strongly consider permanent adoption of the temporary waiver CMS issued under the COVID-19 Public Health Emergency that permits face-to-face office visit requirements for Medicare coverage of certain services to be performed by telehealth.

Thank you for your comments. This subject matter is beyond the scope of this LCD.

6

We ask that Noridian delay establishing Medicare coverage for Implantable CGMs until published evidence demonstrates the ability of Implantable CGMs to improve clinical outcomes in Medicare beneficiaries with diabetes on insulin therapy. The differences in patient adherence, product design, and use between Implantable and external sensor CGM devices weigh against Noridian adopting this Draft LCD that concludes Implantable CGMs will confer clinical benefits on Medicare patients.

Consistent application of the Medicare coverage criteria is critical to ensure Medicare beneficiaries receive the most appropriate items and services to diagnose and treat their clinical conditions. At this time, we do not believe the published evidence related to Implantable CGMs supports a conclusion that Implantable CGMs are reasonable and necessary for use by diabetic Medicare beneficiaries.

Thank you for your comments. Noridian respectfully disagrees with commenters and believes that evidence is sufficient to provide coverage for a therapeutic implantable continuous glucose monitor if coverage criteria is met. Although different in product design, the concept of an implantable sensor device is a reasonable and necessary option for Medicare beneficiaries as they work in partnership with their treating provider to achieve optimal control of their diabetes.

7

We would also like to comment around this renewed look at how Category III CPT codes are being viewed by the Medicare Administrative Contractors as historically this has been a very difficult and potentially short-sighted process in developing access to new medical technologies. Given most new technology must first utilize a Category III CPT code to establish market uptake it has been difficult to deliver that market uptake in the face of non-coverage. The establishment of an LCD for I-CGM proves that newer innovation can be supported by clinical evidence such that the scientific community can agree on its impact on health outcomes, irrespective of its current coding status. We ask that the Contractors continue to evaluate new technology based on its current evidence and potential impact on health outcomes versus categorically denying their coverage merely because of the code that supports that technology.

Thank you for your comments. However, the review of category III CPT codes is not within the scope of this LCD.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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