LCD Reference Article Response To Comments Article

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

A58382

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Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

Document Note

Posted: 9/24/2020
Correction: A58382 is effective beginning 9/17/2020

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Source Article ID
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Article ID
A58382
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
11/13/2020
Revision Effective Date
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Revision Ending Date
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Article Text

The following are the comment summaries and contractor responses for CGS Proposed Local Coverage Determination (LCD): Implantable Continuous Glucose Monitors (I-CGM) DL38662 which posted for comment on May 28, 2020 through July 12, 2020 and presented at the May 2020 Contractor Advisory Committee (CAC) Meeting. All comments were reviewed and incorporated into the final LCD where applicable.

 

Response To Comments

Number Comment Response
1

Comments from the Endocrine Society, Senseonics, Medical Device Manufacturer’s Association (MDMA), JDRF, American Association of Clinical Endocrinologists (AACE), Tri-County Endocrinology & Nuclear Medicine, P.C., Advanced Medical Technology Association, and American Diabetes Association were received requesting modification and/or removal of the blood glucose monitoring (BGM) 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. CGS has eliminated this requirement from the final LCD.

2

Comments from Senseonics, Endocrine Society, JDRF, American Association of Clinical Endocrinologists (AACE), and the Tri-County Endocrinology & Nuclear Medicine, P.C. were received requesting the addition of language to the coverage criteria to account for patients who have adopted other CGM systems. These patients may have had trouble complying, managing them, and cases when the CGM might not be appropriate anymore considering other CGM options, like I-CGM.

We appreciate your comments, after further consideration and review, the policy is revised to include an exception statement for those beneficiaries who have previously met the coverage criteria for a non-implantable continuous glucose monitor and subsequently choose to switch to an implantable device.

 

3

The American Diabetes Association requests the consideration to permanently adopt 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. Utilizing telehealth for the required biannual office visit to maintain CGM coverage will continue to be an important new safety protocol for people with diabetes and providers will reduce the administrative and resource burdens associated with a face-to-face in-office visit that can be just as effectively performed by telehealth.

 

Thank you for your comment. The permanent adoption of the temporary waiver under COVID-19 is beyond the scope of this LCD.

4

Two comments were received from JDRF and American Diabetes Association recommending a modification to the language relating to insulin treatment by eliminating the “injections” as there is at least one form of inhaled insulin on the market. To accommodate that reality, it was suggested to modify the wording in the LCD to require “administrations” of insulin.

 

Thank you for your comment. CGS 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

Two commenters, Senseonics and JDRF, stated the importance of the inclusion of the CPT III codes 0446T, 0447T and 0448T in the accompanying LCD article. The importance of including 0447T in the accompanying LCD Article to assist the providers understanding of the code for “removal of the sensor only” and further state they “support adding 0447T” but request the diagnosis codes to be removed because “there may be other circumstances that require removal irrespective of diagnosis.”

It was further stated, ”we believe that payment for implantable CGMs as a physician service is appropriate and are pleased to see that this technology has been included in that benefit category.”

Thank you for your comments. 0447T has been added.

6

A comment was received from Latham & Watkins, an international firm, requesting CGS to “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 CGS 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 comment. CGS respectfully disagrees and believes there is adequate evidence to support coverage for a therapeutic implantable continuous glucose monitor if coverage criteria are met. Although different in product design, the concept of an implantable sensor device is a reasonable and necessary option for Medicare beneficiaries.

7

Two comments were received from JDRF and an Endocrinologist from the Fairview Hospital of Cleveland Clinic requesting language modification regarding the beneficiary requiring an in-person visit with the treating practitioner every 6 months stating “the 6-month requirement to see patients seems unnecessary” and should take place more frequently only in cases “if the provider and patient determine it necessary to do so.”

Thank you for your comments. CGS agrees and the requirement will be removed from the 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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Updated On Effective Dates Status
08/31/2020 11/13/2020 - N/A Currently in Effect You are here

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