Continuous Glucose Monitors: The Long and Winding Road To Acceptance, Coverage

At first patients didn’t care that much. Then the monitors improved, and studies showed improved outcomes. But CMS wouldn’t cover them unless they had a ‘nonadjunctive’ indication. Now some envision a time when fingersticks will be a thing of the past for many people with diabetes.

Howard Wolinsky

Continuous glucose monitors provide patients with readings on what their glucose levels are at the moment and typically whether they are trending into the territory of hypoglycemia, a dangerous drop in sugar that can lead to a serious medical emergency. These technological marvels, about the size of mobile phones, also track blood-sugar spikes so that people with diabetes can avoid the harm caused by hyperglycemia.

But in American health care, technological advances will sit on the shelf gathering dust unless private and public payers agree to cover them. For standalone continuous glucose monitors, insurance coverage has been a long and bumpy road.

“Insurers were slow to approve the technology, and Medicare was even slower,” says Cynthia Rice, a senior vice president for advocacy and policy at JDRF (formerly the Juvenile Diabetes Research Foundation), the New York City charity that raises funds for research and advocates for patients with type 1 diabetes.

There is some play in these numbers, but experts consider virtually all of the American children and adults with type 1 diabetes to be candidates for continuous glucose monitors (roughly 1.2 million people), along with perhaps as many as 5% of Americans with type 2 diabetes (roughly 1.7 million people). The type 2 candidates are people whose disease needs to be intensely managed.

Layer of safety

Early versions of the glucose monitors were uncomfortable, inaccurate, and hard to use, so patients and their doctors weren’t exactly clamoring for access or coverage. That started to change as the devices began to improve in accuracy and comfort and as studies began to show that the monitors didn’t just measure blood glucose but also improved health outcomes. Professional groups began to include the monitors in their guidelines as the standard of care. A study published in the New England Journal of Medicine in 2008 helped JDRF and other advocates make a case for coverage.

“We engaged with the largest dozen health plans to encourage the coverage of CGM [continuous glucose monitors] and they did. And then others followed,” says Rice.

JDRF also made an economic case that the monitors resulted in fewer costly emergency room visits and hospitalizations for hypoglycemia and reduced rates of complications. Over time, high glucose levels can lead to deadly heart and kidney disease as well as nerve damage, amputation, and blindness. Today, she says, virtually all insurers cover CGMs.

Tomas Walker, the senior U.S. medical director for Dexcom, a continuous glucose monitor manufacturer in San Diego, says a common problem for people who have had diabetes for a long time is “hypoglycemic unawareness”—they start to lose the ability to recognize when their blood sugar is heading toward dangerously low levels. He says the monitoring devices can spot declines in blood sugar and notify patients in time to get their levels up by drinking fruit juice or eating some candy.

“These devices act as a safety layer,” says Walker. “They warn you that, ‘hey, maybe you don’t feel it, but your blood sugar is dropping low.’ When we’ve gone out and done patient surveys, that’s one of the things they commonly tell us—that this technology catches the low often before I feel it.” Walker notes that a single hypoglycemic incident can cost an insurer tens of thousands of dollars.

Medicare late to the party

Medicare often leads the way in covering new technology, with commercial insurers following suit. But that hasn’t been the case with glucose monitors.

For years, CMS classified continuous glucose monitors in a category that prevented coverage. A spokesman for Dexcom explains that the monitors were approved by the FDA as “adjunctive therapy” to be used in combination with conventional fingerstick measurement of blood glucose levels. But Medicare wouldn’t cover the monitors unless they had a nonadjunctive indication. That conflict ended in December 2016 when the FDA changed the label for the Dexcom monitor to indicate that they could be used independently of fingersticks.

Until then, patients who aged out of commercial insurance coverage and moved into Medicare had to return to glucometers, pay out of pocket for a continuous monitor, or appeal the Medicare decision, Rice says.

Subsequently, CMS approved reimbursement for qualified monitors and recognized them as durable medical equipment.

But, Rice notes, unlike commercial plans, Medicare hasn’t been covering the smartphone apps that work with the continuous glucose monitors. That’s partly because smartphones did not meet Medicare’s definition of durable equipment. As a result, Medicare beneficiaries who wanted coverage had to get a dedicated reader that reads output from the sensors.

However, that seems to be changing. Last month, acccording to Dexcom, CMS approved coverage for a G5 device smartphone app. The FDA requires the system to always be shipped with the reader, but once a person has the system, they can choose whether to use the reader or the app.

Katrina Koller

More research is needed on how type 2 diabetes patients might benefit from continuous glucose monitors, says Katrina Koller of the University of Illinois–Chicago.

Medicaid coverage is another priority for monitor manufacturers and patient advocates. Currently, about half of the state programs cover continuous glucose monitors.

End of the fingerstick era

For many people with diabetes, frequent fingersticks are as much a part of the disease as watching what you eat and taking medication. Continuous glucose monitors could make the fingerstick a thing of the past.

Katrina Koller, a dietitian and diabetes program coordinator at the University of Illinois–Chicago, says more research is needed on the monitors and the type 2 patients who might benefit. “Still, all patients can benefit from CGM,” she says. “The direction in the future is going to be more toward CGM over standard sticks. It’s just a matter of money really.” Glenn Johnson, an Abbott executive, says his son has diabetes. “I can only hope that more patients will have access to CGMs. I can see fingersticks being replaced. It’s going to take some time but that’s the vision of the future.”

Howard Wolinsky is a freelance medical writer based in Chicago.