LCD Reference Article Response To Comments Article

Response to Comments: DL38664 Implantable Continuous Glucose Monitors (I-CGM)

A58408

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
First Coast Service Options, Inc.	A and B MAC	09101 - MAC A	J - N	Florida
First Coast Service Options, Inc.	A and B MAC	09102 - MAC B	J - N	Florida
First Coast Service Options, Inc.	A and B MAC	09201 - MAC A	J - N	Puerto Rico Virgin Islands
First Coast Service Options, Inc.	A and B MAC	09202 - MAC B	J - N	Puerto Rico
First Coast Service Options, Inc.	A and B MAC	09302 - MAC B	J - N	Virgin Islands

Article Information

General Information

Article ID
A58408

Article Title
Response to Comments: DL38664 Implantable Continuous Glucose Monitors (I-CGM)

Article Type
Response to Comments

Original Effective Date
10/11/2020

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The following are the comment summaries and contractor responses for First Coast Service Options Proposed Local Coverage Determination (LCD) DL38664 Implantable Continuous Glucose Monitors (I-CGM) which was posted for comment on April 30, 2020, and presented at the May 13, 2020 Open Meeting. All comments were reviewed and incorporated into the final LCD where applicable.

Response To Comments

Number	Comment	Response
1	Multiple comments were received asking that the blood glucose monitoring (BGM) requirement for frequent testing be removed for various reasons. These reasons included “the requirement seems unfair and not realistic”, “Durable medical equipment (DME) providers are reluctant or refuse to provide 4 or more test strips per day”, “there is insufficient data to support a specific number of self-monitoring of blood glucose tests that should be performed to predict the effectiveness of CGM”, “patients who currently use older style CGMs may not be testing as frequently given these devices are now labelled to replace finger sticks”, and “data suggests such frequent monitoring is not required and would be considered excessive”.	We thank you for your comments, after further consideration and review, this criteria is completely removed from the policy.
2	Multiple comments were received asking that we clarify that some beneficiaries may choose to transition to an implantable CGM from another CGM technology and would therefore, not have been performing finger stick testing using a blood glucose monitor.	We appreciate your comments, after further consideration and review, the policy is revised to include an exception statement in the limitations section of the LCD 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	An international firm that stated, “We represent a number of clients who develop, manufacture, and market technologies for use by patients with diabetes, as well as other healthcare stakeholders” provided this comment. The client list of those whom this firm represents was not provided. The Medicare program should not make duplicative payment for glucose monitoring supplies. If an I-CGM is used to monitor a patient’s glucose, the billing entity should also be responsible for supplying any blood glucose monitor (“BGM”) supplies necessary for I-CGM use. A closer review of the evidence for I-CGM should be conducted to determine whether this device and related service are reasonable and necessary for Medicare beneficiaries. The Draft LCD does not discuss any published evidence demonstrating improved clinical outcomes conferred on Medicare beneficiaries by I-CGMs. In establishing coverage and payment for I-CGMs and associated supplies, First Coast should ensure that the Medicare program does not double-pay for glucose monitoring supplies. As noted in the Draft LCD, I-CGM, like therapeutic CGMs, “are designed to replace finger stick blood glucose testing”. Consistent with this intended use, the Glucose Monitors LCD (L33822) confirms that claims for standard BGM and related supplies will be denied if the patient is already receiving a therapeutic CGM for glucose monitoring. The Draft LCD does not recognize that I-CGMs are intended to substitute for standard BGM (and their associated supplies). The Draft LCD should be revised to make clear that Medicare will not provide separate payment for BGM supplies in connection with beneficiaries who receive I-CGM. Instead, the billing entity that receives payment for I-CGMs should be responsible for supplying the patient with the required BGM supplies needed to operate the device (such as test strips, lancets, lancing device, and calibration solutions). This approach would mirror the approach for the supply allowance for therapeutic CGMs (K0553). Otherwise, the Medicare program would be double-paying for glucose monitoring supplies that are neither reasonable nor necessary for beneficiaries who receive an I-CGM. The commenter indicates they noted that there does not appear to be a discussion of published evidence supporting the reasonable and necessary use for I-CGMs in the Medicare population. Medicare policies require that a service must, among other things, be furnished in accordance with accepted standards of medical practice, meet but not exceed the patient’s medical need, and is at least as beneficial as an existing and available medically appropriate alternative. The commenter indicates the Draft LCD does not discuss evidence that demonstrates I-CGMs improve clinical outcomes for Medicare beneficiaries, such as through reductions in HbA1C, hypoglycemic events, or other endpoints that show the device results in a clinical benefit for patients. The Draft LCD also noted that these pivotal trials featured “few patients…in the Medicare aged population”, further calling into question the current evidence as fulfilling Medicare coverage requirements. With respect to whether I-CGM is consistent with accepted standards of medical practice, the professional society recommendations and consensus statements cited in the Draft LCD are not actually based on an assessment of I-CGMs. Rather, these recommendations and statements were made following consideration of the evidence supporting CGMs that use an external sensor and monitor, devices that do have published data demonstrating their impact on clinical outcomes. Rather than requiring I-CGMs to demonstrate their own ability to improve outcomes, it seems that all of the evidence cited in favor of the clinical benefits was derived from studies of external sensor CGMs. This evidence relates to an entirely different product category covered under a separate Medicare benefit. As a result, the commenter strongly urges First Coast to reassess the evidence in support of I-CGMs to determine if this separate and independent device and service meet the appropriate standard for Medicare coverage.	Thank you for your comments. Evidence exists that demonstrates the use of implantable glucose monitors in the Medicare population. The objective data is similar to external continuous glucose monitors (“CGMs”) and the current data indicates that this device has clinical efficacy regardless of age. In addition, this device is categorized by the Food and Drug Administration (FDA) as a therapeutic CGM. At present, the use of external CGMs is a covered DME benefit for non-Medicare as well as Medicare patients. While few, there are patients in the Medicare aged population in the studies; demonstrating strong indication that the data is generalized to patients in the Medicare population. In regards to your recommendation indicating the Draft LCD should be revised to make clear that Medicare will not provide separate payment for BGM supplies in connection with beneficiaries who receive I-CGM, this issue is outside the scope of this LCD.
4	The commenter has concern with criterion #6 where the LCD states, “…every six months following initial prescription of I-CGM, the treating practitioner has an in-person visit…” Given implantable CGM requires a health care professional (HCP) to insert the device, isn’t this criterion already met? According to the commenter this is redundant and not necessarily a requirement that makes sense in the context of an implantable device. The commenter has a concern about criterion #2 where a patient must be performing four times a day testing to become eligible for an implantable CGM. After the adoption of CGM, few of these patients use a blood glucose meter four times per day. If this language is part of the criteria, this may preclude patients to transition over to implantable CGM if it is medically necessary.	We thank you for your comment and for bringing to our attention that this may be an unnecessary burden for the patient and provider. The requirement was intended to encourage routine follow-up patient care. This requirement is removed from the policy and replaced with “recommended follow-up care is expected”. In regards to criterion # 2, after further consideration and review, the decision was made to remove this requirement from the LCD.
5	A commenter has requested that the coverage for Eversense CGM in the Medicare population be fast-tracked, especially at this time of uncertainty in our country’s ability to provide medical care to individuals with diabetes. There have been patients that have had issues obtaining supplies for the other CGM devices either due to inability to go to the pharmacy to get supplies or distribution issues with stores closing or distribution centers understaffed. The commenter would also like to disagree with the coverage criteria requiring a patient test four times a day as setting a number on the test required per day to make the patient eligible for any CGM device counters the ADA recommendations for treating people with diabetes. To the commenter’s knowledge, there is no data source that supports the predictive capability with CGM based on historical use of a Blood Glucose Meter.	We thank you for your comment. In regards to fast tracking the CGM coverage for the Medicare population, the development of a new local coverage determinations (LCD) and associated local coverage articles (LCA) must follow the process and guidelines that have been outlined in the CMS Internet-Only Manuals (IOMs) Publication 100-08 Medical Program Integrity Manual, Chapter 13 Local Coverage Determinations. Also, in regards to the coverage criterion of testing four times a day, after further consideration and review, the decision was made to remove this requirement from the LCD.
6	One comment was received recommending modification of the wording relating to insulin treatment to eliminate the word “injections” as there is inhaled insulin used by some patients. To accommodate that reality, the wording should reflect “multiple daily administrations” with insulin, not “injections”. The commenter further 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, after further consideration and review, the statement related to insulin treatment and the elimination of the word “injections”, is revised and the statement “injections of insulin” is replaced with multiple daily “administrations of insulin” taking into account the other forms of insulin. Regarding the permanent adoption of the temporary waiver under COVID-19, a waiver of this type of requirement is beyond the scope of this LCD.
7	A commenter requests that “CPT III code 0447T will be included in the accompanying LCD Article to ensure providers understand that this code may be used for individuals who may need removal of the sensor only. We support the discussion around adding 0447T to the paragraph, but do not tie in specific diagnosis codes to the use of that code as there may be other circumstances that require removal irrespective of diagnosis”.	Thank you for your comment. CPT III code 0447T has been added to the billing and coding article indicating that diagnosis code limitations will not be applied at this time.

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Response to Comments: DL38664 Implantable Continuous Glucose Monitors (I-CGM)

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