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

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.

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.

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.

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.

One commenter stated “Criterion #6 is confusing to me. If I am implanting the sensor in the patient every 90 days or perhaps in the future where the technology could expand to a longer sensor life, I will need to see the patient every six months? This is an implantable device; the patient will have to see me to continue using CGM”. “The nature of an implanted device will automatically stimulate another patient-health care professional engagement and to me is unwarranted language. I propose that Novitas remove this criterion as it is confusing and does not really make sense in the context of an implanted device that can only be offered by an HCP”.

We thank you for your comment and for bringing this to our attention that this may be an unnecessary burden for the patient and provider. The requirement was intended to encourage routine follow-up care. This requirement is removed from the policy and replaced with “recommended follow-up care is expected”.

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, Novitas 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 Novitas 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 were patients in the Medicare aged population in the studies; demonstrating strong indication that the data is generalizable 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.

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.