LCD Reference Article Response To Comments Article

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

A59614

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Article ID
A59614
Original ICD-9 Article ID
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Article Title
Response to Comments: Implantable Continuous Glucose Monitors (I-CGM)
Article Type
Response to Comments
Original Effective Date
01/11/2024
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The comment period for the Implantable Continuous Glucose Monitors (I-CGM) DL38743 Local Coverage Determination (LCD) began on 10/5/23 and ended on 11/18/23. The notice period for L38743 begins on 1/11/24 and will become effective on 2/25/24. The comments below were received from the provider community. All comments provided within the open comment period have been reviewed. Those comments covering similar topics were collectively gathered and responded to.

Response To Comments

Number Comment Response
1

Several commenters expressed their support for the proposed I-CGM coverage criteria revisions which include coverage for persons with diabetes who require basal insulin as well as non-insulin users that have significant problematic hypoglycemia.

Palmetto GBA Medical Directors would like to thank the individuals and/or associations representing and advocating for persons with diabetes. We agree that technologies like I-CGM have transformed the diabetes management landscape with the goal of improving outcomes and quality of life for those living with this disease.

2

Several commenters expressed their support for removal of what they believed to be too stringent of coverage criteria that restricted access to I-CGM only to insulin treated persons with diabetes requiring 3 or more daily administrations of insulin or use of a subcutaneous insulin infusion pump who must further demonstrate frequent adjustments in dosing on the basis of blood glucose monitor results. Thus, preventing some persons with diabetes equal access to what is considered standard of care in diabetes management.

Palmetto GBA Medical Directors would like to thank the individuals and/or associations representing and advocating for persons with diabetes. We agree that technologies like I-CGM have transformed the diabetes management landscape and that a patient with diabetes should, along with their healthcare provider, have equal access to blood glucose monitoring capabilities based on the patient’s specific needs, preferences, and skill level.

3

Several commenters expressed their support of this LCD’s alignment with the continuous glucose monitoring coverage criteria in the Medicare DME LCD on Glucose Monitors. However, to ensure parity across all coverage policies, commenters are further requesting the addition of all ICD-10 diagnoses codes included in the DME billing and coding article to be included in the I-CGM billing and coding article.

Palmetto GBA Medical Directors agree that it is best to align coverage criteria with that of the Medicare DME Policy whenever possible, so as to avoid confusion. However, we reiterate that this policy pertains only to the subject of implanted continuous glucose monitors, unlike the DME policy which addresses continuous glucose monitors more broadly. As to certain unspecified diabetes diagnosis codes not included in the billing and coding article, we remind commenters that it is a Medicare requirement as well as the responsibility of the healthcare provider to use diagnosis codes to the highest level of specificity. Consequently, this MAC views these codes as lacking specificity and therefore will not be added to the article.

4

One commenter expressed their support of allowing a Medicare-approved telehealth visit, rather than a face to face visit every 6 months to document adherence to a beneficiary’s CGM regimen and diabetes treatment plan. Especially, in light of any persons with diabetes who may be dealing with access to care disparities.

Palmetto GBA Medical Directors understand that there are some Medicare beneficiaries, who may have access to care issues. It is our belief that close follow-up is important in ensuring appropriate management of persons with diabetes. Which also aligns with the Medicare DME Policy. Consequently, we agree that although not replacing an initial face to face visit, follow-up visits utilizing telehealth technology may be warranted and thus considered reasonable in certain circumstances.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L38743 - Implantable Continuous Glucose Monitors (I-CGM)
Related National Coverage Documents
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SAD Process URL 1
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Public Versions
Updated On Effective Dates Status
01/05/2024 01/11/2024 - N/A Currently in Effect You are here

Keywords

  • Implantable Continuous Glucose Monitors
  • I-CGM