Medicare is removing a major barrier to allowing people with diabetes (PWDs) to access and use continuous glucose monitor (CGM) devices, the most powerful technology for regulating blood sugar levels currently available.
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.
The new Medicare policy announced in June 2021 does away with the Centers for Medicare & Medicaid Services (CMS) 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.
“It was about time to make this stupid barrier 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.
The new policy also allows Medicare members with diabetes access to a newer form of fast-acting inhalable insulin, which was previously not covered.
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.
With the new policy taking effect on July 18, 2021, Medicare is no longer enforcing that 4-fingerstick requirement for those with type 1 (T1D) and type 2 diabetes (T2D) who use insulin.
All the details of putting this new policy into place are laid out for their 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 four-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 its decision, CMS says it analyzed available studies to determine if the four-times-a-day 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.
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. — has now 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.”
This rule change also takes effect on July 18, 2021.
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 not considered medically necessary. CGM also didn’t fall under the Durable Medical Equipment (DME) category that covers other diabetes devices and supplies at the time, making it technically ineligible for Medicare coverage.
Then in 2017, the agency made a change allowing 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” indication.
A year later in 2018, Medicare began also covering smartphone use with CGMs — something its previous policy change didn’t address, but it still left Medicare beneficiaries unable to access the latest CGM devices with smartphone connectivity as part of their core function.
As of October 2020, all CGM devices on the market with the exception of those from Medtronic Diabetes are covered by Medicare. These include the Dexcom G6, the Abbott FreeStyle Libre 1 and 2, and the implantable Eversense CGM from Senseonics.
These are all considered “therapeutic CGMs” that can be used without fingerstick backup tests, except for the Medtronic Minimed CGM, which is why it is not covered.
When CMS announced the proposed rule in late 2020, type 1 diabetes advocacy group JDRF praised the move as 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 longtime 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.”
That proposed rule change was originally set to begin April 1, 2021, and would have allowed for coverage of the “non-adjunctive” Medtronic CGM, but that has not yet been realized — due to the change of administration. A CMS spokesperson told DiabetesMine in July 2021 that the proposal was part of the annual budget process and had not been finalized or cleared in order to take effect.
While Medicare is still finalizing a decision on whether it cover every FDA-cleared CGM going forward, the pricing for Medicare members would also 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 (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 require a sensor scan in order to see an actual glucose result: $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,” then-CMS Administrator Seema Verma said in a statement at the time this was announced in 2020.
“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.”
Even with this latest change, many see a need for more Medicare reform across the board. With the COVID-19 pandemic beginning 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.
But those revisions weren’t permanent and may go away before too long as the urgency of the pandemic fades.
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
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.”
From the medical professional perspective, Grunberger is another who believes more change is needed for those on Medicare who want to use CGM technology.
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 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 hypoclycemia 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.”