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The Medtronic Guardian 3 CGM may soon be covered by Medicare.

All continuous glucose monitors (CGMs) may soon be covered by Medicare, if a new proposed federal rule is approved and takes effect. This means people with diabetes covered by Medicare will have more choice in the type of diabetes technology they are able to use.

The Centers for Medicare and Medicaid Services (CMS) announced the proposed rule change on Oct. 27, 2020, and it was published the following week in the federal register. If finalized into policy, it would take effect in April 2021 at the earliest.

Public comments are now being accepted, and once that comment period ends, the federal agency will work toward finalizing and publishing the precise language of the rule before it goes into effect.

This is a big-ticket item, given that one-third of Medicare beneficiaries live with diabetes and more are being directed to CGM technology as a way to help manage their condition.

With access and affordability often the biggest hurdle to achieving better health outcomes, Medicare coverage is an important topic — especially since Medicare leads the way on what policies are adopted by private health insurers.

Type 1 diabetes advocacy organization JDRF praised this move; it’s a policy change the org has been pushing toward for years.

“CGM technology has and will continue to advance and mature, and it is important that regulations remain flexible to be able to accommodate these future advances,” said JDRF CEO Dr. Aaron Kowalski, who lives with T1D and is a long-time CGM user himself. “Broadening Medicare coverage in this way will be better able to accommodate for the future of this important technology for people with T1D.”

Up until early 2017, CMS did not cover CGM use because the agency considered it to be “precautionary,” meaning CGMs were classified as a supplemental type of device that were not considered medically necessary. CGM also didn’t fall under the “durable medical equipment” category that covers other diabetes devices and supplies, therefore it wasn’t eligible for Medicare coverage.

That longstanding policy changed when the agency allowed for certain CGMs to be covered if they were deemed “therapeutic” — or cleared by the Food and Drug Administration (FDA) as accurate enough for use in treatment and dosing decisions, without a requirement for patients to take a fingerstick glucose test for confirmation. That was referred to as a “non-adjunctive” designation.

A year later in 2018, Medicare began also covering smartphone use with CGMs — something its previous policy change didn’t address, but left Medicare beneficiaries unable to access the latest CGM devices with smartphone connectivity as part of their core function.

To date, all CGM devices on the market with the exception of those from Medtronic Diabetes are covered by Medicare. These include the Dexcom G5 and G6 models, the Abbott FreeStyle Libre 1 and 2, and the implantable Eversense CGM from Senseonics.

However, the Medtronic Guardian 3 sensor, used as a stand-alone CGM and also in conjunction with the Minimed 670G Hybrid Closed Loop system, have not been deemed accurate enough to be used for insulin dosing and treatment. This means they did not qualify for the coveted “non-adjunctive” label required by Medicare to approve coverage.

The new proposed rule, if enacted, would replace the 2017 policy. Practically speaking, the only major change would be now covering the Medtronic CGM, the only only CGM that hasn’t previously obtained the “non-adjunctive” designation that all of its competitors already have.

CMS admits that it really is just embracing what’s going on in the real world. The fact is that patients are indeed using the Medtronic Guardian 3 sensor to make treatment decisions.

In the rule proposal, CMS specifically points out that several courts have disagreed with the federal agency’s standing policy stating that Medtronic’s current CGM is not being used to serve a medical purpose.

“Beneficiaries are continuing to use adjunctive or ‘non-therapeutic’ CGMs to help manage their diabetes, and claims submitted for this equipment and its related supplies and accessories are being denied,” the CMS proposal states. “We believe classification of CGMs in general is an important issue to address again… in rule-making.”

Regardless of the FDA’s view whether a product requires calibration with a fingerstick test, CMS sees the technology’s ability to alert patients to dangerous high or low glucose levels as critical — especially during sleeping hours, when patients are generally unable to do a fingerstick test.

As such, both adjunctive and non-adjunctive CGMs would be considered Durable Medical Equipment and thus covered by Medicare.

Medtronic praised this new policy proposal in a statement.

“We strongly believe this proposal puts patients first and empowers them to choose the therapies that best meet their diabetes management needs,” Medtronic Diabetes lead Sean Salmon stated. “Importantly, the proposed rule, if finalized, could enable continuity of therapy for people on certain Medtronic insulin pump systems transitioning into Medicare — including Medtronic hybrid closed loop systems which automatically adjust insulin delivery based on readings from the integrated CGM.”

While Medicare would allow for coverage on any FDA-cleared CGM going forward, the pricing for Medicare members would be adjusted based on the adjunctive / non-adjuctive categorization.

Three payment categories for CGM are being proposed:

  • Dexcom and Eversense XL CGMs, with their non-adjunctive status (no fingerstick) approval, would be the most expensive at $222.77 for the Dexcom G6 and $259.20 for the Eversense CGM supplies each month.
  • Medtronic CGM (still requiring fingerstick confirmations) would cost $198.77 per month for supplies, which factors in necessary test strips and subtracts the cost of those strips from what’s reimbursed for CGM supplies.
  • The FreeStyle Libre 1 and Libre 2, considered “Flash Glucose Monitors” (FGM) that don’t display real-time glucose readings and do require a fingerstick for confirmation, would be: $46.86 for Libre 2 sensors and batteries, and $52.01 a month for the Libre 1 supplies.

This new pricing plan is still subject to Congressional approval in the federal budget for 2021, and exact amounts may vary depending on specific details put in place by Medicare plan vendors. As always, it’s important to triple-check the details of your own insurance plan.

No doubt, the biggest issue for CGM users on Medicare will be the number of CGM sensors allotted each month, as this has been a big issue in the past, with people struggling to get coverage for the full amount they need.

But any expansion of Medicare coverage for CGM is a positive step forward, according to authorities. Among other things, it sends a signal that new technologies are welcome.

“With the policies outlined in this proposed rule, innovators have a much more predictable path to understanding the kinds of products that Medicare will pay for,” CMS Administrator Seema Verma said in a statement.

“For manufacturers, bringing a new product to market will mean they can get a Medicare payment amount and billing code right off the bat, resulting in quicker access for Medicare beneficiaries to the latest technological advances and the most cutting-edge devices available.”