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Medicare has expanded access and removed major barriers to allowing people with diabetes (PWDs) to use continuous glucose monitor (CGM) devices, the most powerful technology currently available for regulating blood sugar levels.

This is a big-ticket item, given that one-third of Medicare’s roughly 62 million beneficiaries live with diabetes and more are being directed to CGM as a way to help manage their condition better than with traditional fingerstick tests, that only take a single reading at a time.

Beginning Feb. 28, 2022, those using a Medtronic CGM integrated with the company’s MiniMed insulin pumps will be able to get Medicare coverage for their transmitters, sensors and supplies. The Centers for Medicare & Medicaid Services (CMS) announced a new final rule on this in December 2021, finalizing a proposal first pitched a year earlier in 2020.

This latest rule follows a new Medicare policy that took effect in July 2021, doing away with a longstanding requirement that before any beneficiary could get approved for a CGM, they would need to provide a blood sugar log showing 4 or more tests a day using a traditional fingerstick glucose meter. The new policy also allows Medicare members to get coverage for both CGM use as well as a newer form of inhaled insulin called Afrezza, changing the wording from “injection” to “administration” to allow for coverage of this insulin to be included.

“It was about time to make these stupid barriers go away permanently, after it was sort of suspended due to the pandemic,” said Dr. George Grunberger, a well-known endocrinologist and healthcare advocate in Michigan.

With access and affordability often the biggest hurdle to achieving better health outcomes, Medicare policy changes are key, as the federal insurance program typically leads the way on what coverage will be provided by private health insurers.

Up until now, Medtronic has been the only CGM company without Medicare coverage.

The other CGM products available — Dexcom G5 and G6, Abbott FreeStyle Libre 2, and the implantable Eversense CGM from Senseonics and Ascensia — have been covered for years. But Medtronic is the only company that did not get a “non-adjunctive” designation, which would’ve allowed the CGM to be used for insulin dosing and treatment decisions without a need for confirmatory fingersticks.

That so-called “dosing claim” was a new category created by the Food and Drug Administration (FDA), its first attempt to distinguish the different levels of CGM technology that existed at that time in 2017. The Dexcom G5 was the first to obtain that status and be known as a therapeutic CGM, followed by the Abbott FreeStyle Libre and then Eversense 90-day implantable CGM.

To date, Medtronic’s Guardian CGM remains the only one that requires fingerstick calibrations and doesn’t have Medicare coverage.

But CMS is now changing that, lumping Medtronic’s device into the same category as the “non-adjunctive” devices so that they are all covered by Medicare.

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Importantly, the new Medicare policy does not include Medtronic’s stand-alone Guardian Connect CGM system. Instead, it only allows for Medicare coverage of the Medtronic CGM when it is combined with the company’s MiniMed insulin pumps.

This is because Medtronic’s stand-alone Guardian Connect only uses a smartphone app, and does not have a handheld receiver or a separate display device, which can be provided by the insulin pump. As a result, CMS does not see this as meeting their definition of “durable medical equipment,” and the smartphone can’t be covered by Medicare because a phone can of course be used for other purposes beyond just the diabetes technology. That means if you’re using a stand-alone CGM from Medtronic, the needed sensors and transmitters will not be covered by Medicare at this time.

The issue of smartphone use with a CGM has been a longstanding concern for Medicare policy-makers. In 2018, a policy change first allowed limited smartphone use with a CGM device for data-sharing and display. But it stopped short of opening the door to coverage for CGM technology that is controlled solely by a smartphone and isn’t already deemed “FDA-cleared” for treatment decisions by itself.

A company spokesperson tells DiabetesMine, “You are correct that this new rule does not cover our Guardian Connect standalone CGM as it does not have a DME durable receiver. Medicare or Medicaid patients who use Guardian Connect and do not have coverage are eligible for the CGM Access Discount program, which offers patients transmitters and sensors at a lower cost. Medtronic will continue to work with CMS to continue expanding coverage for more patients.”

As of July 18, 2021, Medicare is no longer enforcing the 4-fingerstick requirement for those with type 1 (T1D) and type 2 diabetes (T2D) who use insulin and want to use a CGM.

All the details of putting that new policy into place were laid out for Medicare contract companies in a comprehensive Local Coverage Determination document.

Medicare has often been criticized for its CGM prerequisite rules, because they aren’t based on any scientific data or sound medical reasoning tied to A1C reduction or even better CGM use. Instead, the long-viewed reason for that requirement was Medicare simply wanting “proof” that someone was invested in their diabetes care enough to use CGM technology, illustrated by gathering enough documentation to show that they tracked their glucose levels regularly.

What’s ironic is that even with the 4-times-a-day requirement, Medicare only reimbursed beneficiaries for 3 test strips a day — meaning that to comply with their rule to get a CGM, its beneficiaries would have to spend some of their own money to buy costly test strips.

In making the change, CMS says it analyzed available studies to determine if the 4x/day fingerstick testing requirement was linked to any improved health outcomes for those with T1D or T2D using insulin. The agency found no evidence that more fingerstick checks led to better health outcomes, compared with lower frequency testing. The agency also pointed out that diabetes organizations like the American Diabetes Association (ADA), Endocrine Society and others internationally do not have any minimum testing frequency as part of their CGM use guidance.

The ADA praised the Medicare policy change removing the 4-fingerstick rule, describing it a “big win” for the Diabetes Community.

“The removal of this criterion has been an effort long-led by the ADA, on which we have been actively engaged with CMS,” the organization tweeted. “People with diabetes on Medicare will now be able to more easily access this critical piece of technology, leading to better diabetes management and better health outcomes.”

Along with this recent CGM policy change, Medicare has also expanded coverage for inhaled insulin Afrezza.

Afrezza inhaled insulin

Originally, Medicare would not pay for both Afrezza and CGM technology, meaning that someone wanting to use either of these for their diabetes management would have to choose.

The restriction was in the fine print. Medicare documentation previously defined “insulin users” only as people using either multiple daily injections (aka MDI) or using an insulin pump. But this policy change — requested by Afrezza-maker MannKind Corp. — amended the definition to include someone taking an inhaled insulin as an alternative.

“This is a win-win for Medicare patients and providers that serve those patients,” said Dr. Stella Ilyayeva, an endocrinologist in New York. “In 2020, almost two-thirds of T1D Afrezza patients were utilizing a CGM concomitantly. I anticipate this change will open up more doors for the population of Afrezza users.”

CMS had originally proposed three different categories of payment for those using the different types of CGM technology. The logic was that some didn’t require fingersticks so users wouldn’t need reimbursement for test strips, as would other systems that still require calibration (i.e. Medtronic). It also viewed the FreeStyle Libre “flash glucose monitoring” a bit differently than other tech, like Dexcom and Eversense. So it proposed different reimbursements for those varying styles of tech.

However, CMS has re-thought that move after public outcry. In its new December 2021 rule comments, the agency noted this:

“After consideration of public comments, CMS does not believe it is necessary at this time to further stratify the types of CGMs beyond the two categories of non-adjunctive and adjunctive CGMs.”

Even with these latest changes, many see a need for more Medicare reform across the board.

When the COVID-19 pandemic began in 2020, CMS eased some of their coverage restrictions temporarily — including a push toward telehealth as shelter-in-place orders forced PWDs across the globe to stay at home rather than travel to clinics or doctor’s offices. Those revisions were extended through 2021 and have become more established.

Yet, the cost and access barriers for CGM use remain a significant burden for most PWDs, and Communities of Color who are already disproportionately hit by diabetes are even more likely to be hit by these barriers.

This is important, given that studies show how much more effective CGMs are than traditional fingerstick glucose meters in reducing hypoglycemia (dangerous low blood sugar) and decreasing high-cost hospital visits resulting from diabetes.

Longtime diabetes advocate George Huntley, who lives with T1D himself and serves as CEO of the Diabetes Leadership Council, told DiabetesMine: “We applaud this decision, but it is only the first step. CMS needs to fully review its eligibility policies in order to reduce remaining barriers to CGM access.”

He points out that this new policy change only applies to people with T1D or T2D who use insulin. It doesn’t remove restrictions or expand eligibility for those with T2D who are not using insulin, even if they are using non-insulin glucose-lowering medications — which is the majority of people with diabetes on Medicare. With many doctors prescribing CGM for non-insulin medications like GLP-1s or SGLT2 inhibitors, many are discouraged from also prescribing mealtime insulin along with that.

As a result, the Medicare-covered T2Ds who are not already on multiple injections of insulin, or are only using 1 or 2 background basal injections per day, remain ineligible for CGM coverage.

Clinical research from 2020 shows that CGM improves diabetes management, including reduced hypoglycemia episodes, in those not only with T1D but also for those with less intensive insulin therapy and those with T2D not using insulin.

“I see minimal change, unfortunately, until reason prevails,” Grunberger told DiabetesMine. “One would have thought that by now, being on [any] insulin and over 65 should be a sufficient reason for CGM coverage. Oh well, may hope spring eternal…”

Advocates are also urging Medicare policy-makers to streamline and simplify the paperwork and documentation requirements for CGM access.

“Current requirements place an unwarranted burden on doctors and office staff to gather and submit substantial documentation on behalf of their patients,” Huntley said. “With time constraints, many clinicians are unwilling or unable to assist patients with this submission. We urge CMS to modify the CGM eligibility requirements and streamline administrative processes to enable all who would benefit from access to this technology, especially our most vulnerable communities that are least likely to overcome unnecessary barriers to care.”