LCD Reference Article Response To Comments Article

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

A58342

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
National Government Services, Inc.	MAC - Part A	06101 - MAC A	J - 06	Illinois
National Government Services, Inc.	MAC - Part B	06102 - MAC B	J - 06	Illinois
National Government Services, Inc.	MAC - Part A	06201 - MAC A	J - 06	Minnesota
National Government Services, Inc.	MAC - Part B	06202 - MAC B	J - 06	Minnesota
National Government Services, Inc.	MAC - Part A	06301 - MAC A	J - 06	Wisconsin
National Government Services, Inc.	MAC - Part B	06302 - MAC B	J - 06	Wisconsin
National Government Services, Inc.	A and B and HHH MAC	13101 - MAC A	J - K	Connecticut
National Government Services, Inc.	A and B and HHH MAC	13102 - MAC B	J - K	Connecticut
National Government Services, Inc.	A and B and HHH MAC	13201 - MAC A	J - K	New York - Entire State
National Government Services, Inc.	A and B and HHH MAC	13202 - MAC B	J - K	New York - Downstate
National Government Services, Inc.	A and B and HHH MAC	13282 - MAC B	J - K	New York - Upstate
National Government Services, Inc.	A and B and HHH MAC	13292 - MAC B	J - K	New York - Queens
National Government Services, Inc.	A and B and HHH MAC	14111 - MAC A	J - K	Maine
National Government Services, Inc.	A and B and HHH MAC	14112 - MAC B	J - K	Maine
National Government Services, Inc.	A and B and HHH MAC	14211 - MAC A	J - K	Massachusetts
National Government Services, Inc.	A and B and HHH MAC	14212 - MAC B	J - K	Massachusetts
National Government Services, Inc.	A and B and HHH MAC	14311 - MAC A	J - K	New Hampshire
National Government Services, Inc.	A and B and HHH MAC	14312 - MAC B	J - K	New Hampshire
National Government Services, Inc.	A and B and HHH MAC	14411 - MAC A	J - K	Rhode Island
National Government Services, Inc.	A and B and HHH MAC	14412 - MAC B	J - K	Rhode Island
National Government Services, Inc.	A and B and HHH MAC	14511 - MAC A	J - K	Vermont
National Government Services, Inc.	A and B and HHH MAC	14512 - MAC B	J - K	Vermont

Article Information

General Information

Article ID
A58342

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

Article Type
Response to Comments

Original Effective Date
12/01/2020

Retirement Date
N/A

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Article Guidance

Article Text

As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from the members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the LCD for Implantable Continuous Glucose Monitors (I-CGM). The official notice period for the final LCD begins on 10/15/2020, and the final determination will become effective on 12/1/2020.

Response To Comments

Number	Comment	Response
1	Multiple comments were received asking that the frequent blood glucose monitoring (BGM) testing requirement 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 fingersticks”, 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	One commenter stated that if diabetes mellitus (DM) is not controlled the resulting consequences will be very expensive to treat and carry very high risk for the society to take care of the disabled diabetic population which is 1/3 of the total disabled.	We appreciate your comment, the policy is designed to ensure beneficiaries have access to services that help them manage their diabetes.
3	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 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.
4	One comment was received recommending modification of the wording relating to insulin treatment to eliminate the word “injections” as there is an 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 policy.
5	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, NGS 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 fingerstick 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 NGS 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 the comment. We disagree with your assertion that the current evidence for implantable glucose monitors is not generalizable to the Medicare population. Coverage of therapeutic continuous glucose monitors is already provided as a DME benefit for the same patients. CGM use as a DME benefit is not restricted based on age or disability. This device is categorized by the FDA as a therapeutic continuous glucose monitor, the difference being that the sensor is implanted rather than external. The objective data is similar to external CGMs and there is no reason to doubt that the performance of this device going forward will deviate from current data, regardless of age. Furthermore, there were patients in the Medicare aged population in the studies, though few. However, there is no clinical reason why the data is not generalizable to patients in the Medicare population. With 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.
6	One commenter indicates the uncertainty regarding re-approvals will make it impractical and burdensome preparations and suggests Medicare look at the data online for individual patients and make the determination without the provider having to get involved. If Medicare determines the service is not covered, Medicare can let the physician know the reason for the denial since the data is available online.	We thank you for your comment; however, it is the providers responsibility to prescribe this service and will not, at this time, be replaced by data monitoring that replaces prescribing responsibility.

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

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