Diabetes device development is ramping up but reimbursement looms large

Many companies are working to reduce the amount of work patients must do to manage their diabetes, but lack of CMS coverage for patch pumps may dissuade innovators from working in that space.

Diabetes management has historically meant constant vigilance—including pricking one’s finger several times a day to keep blood glucose levels in check. Diabetes device makers are looking to change this by providing them with tools that “recede into the background.”

At least, that’s what Chris Thomas, a research fellow and director of biosensor technology in Abbott’s diabetes care unit, says. Abbott—as well as a proliferation of other players, including medtech titan Medtronic and a number of startups—is aiming to simplify diabetes management, reducing its burden on the patient.

Diabetes device development seems to have hit its stride in 2017—Medtronic launched the world’s first “artificial pancreas” system and the FDA approved the consumer version of Abbott’s mostly fingerstick-free continuous glucose monitor.

Other companies—Roche, Senseonics, Dexcom, Tandem and Insulet—are working to improve artificial pancreas technology, while companies like Glooko, Voluntis and Livongo offer digital health tools to aid in diabetes management.

RELATED: Bigfoot raises $37M to trial AI-enabled insulin delivery devices

The FDA is changing the way it thinks about reviewing and approving medtech. For example, the agency rolled out a program geared toward creating a more suitable regulatory path for digital health software that poses a lower risk than traditional medical devices.

But, traditional device or software, regulatory approval means nothing if companies can’t get their products to patients. And that means securing reimbursement.

The Centers for Medicare & Medicaid Services covers traditional insulin pumps, which administer insulin through a catheter, as “durable medical equipment.” And while “almost every” private insurer covers Insulet's Omnipod, which comprises a handheld device and a disposable insulin-delivering “pod” that a patient sticks to his or her body, CMS does not.

“The government has told us it’s not a cost issue. It is a policy issue,” said Insulet CEO Patrick Sullivan. A traditional system has a durable pump, but disposable tubes. In the case of a patch pump, the pump body itself is disposable. The upfront cost of a tubed pump is higher but its disposables are cheaper, while a patch pump has a low upfront cost and pricier disposables. And, Sullivan says, the total cost of either system over four years is “about the same.”

RELATED: Lilly makes big push into devices to protect diabetes sales

CMS’ argument is that “Disposable drug delivery systems, including elastomeric infusion pumps (A4305, A4306, A9274) are non-covered devices because they do not meet the Medicare definition of durable medical equipment.”

But patients, physicians and advocates, including Cynthia Rice, senior vice president of advocacy and policy at JDRF, the diabetes research nonprofit, don’t see why the agency doesn’t find another route.

“We think that Medicare has the authority under current law to cover patch pumps,” Rice said. If it doesn’t meet their definition of durable medical equipment, they could cover it under the Medicare Part D drug benefit, which includes supplies associated with delivering insulin into the body, she said.

“In terms of insulin pumps, Medicare should cover all types, no matter what the form factor is,” Rice said. “This includes patch pumps. It doesn’t make any sense to us that people turning 65 and joining Medicare should lose access to technology they’ve used for years.”

Bill Gregory, now retired, is one of those patients. He started using Insulet’s patch pump at 61 and, now he’s aged into Medicare, pays for his device out of pocket.

“Luckily, Insulet gives us a little price break. But it’s costing about $300 a month just for the ‘pod’ and I have to pay for the insulin as well,” he said. He once estimated the cost for his device and insulin to be around $600 a month.

RELATED: Medicare unveils coverage criteria for Dexcom G5 continuous glucose monitor

Patients who prefer to use—and whose physicians prefer them to use—a patch pump, but cannot afford it, must switch to a Medicare-covered device, namely, a traditional tubed pump.

“Such an injustice is, quite frankly, infuriating,” Sullivan said.

Of course, this impedes Insulet’s ability to reach a subset of patients—the company is still not profitable and Sullivan says it plans to be next year—but CMS’ decision has wider implications.

“This is an issue not only of access for people with diabetes, but also an issue of innovation,” Rice said. JDRF has engaged with private health plans, as well as with Medicare on new technologies—including the “artificial pancreas”—to make sure they are getting coverage.

The current situation, she said, is stifling innovation for the next generation of diabetes technology.

Insulet isn’t the only company with a patch pump. But innovators may shy away from developing new, better patch pumps—and systems, such as “artificial pancreas” devices based around these pumps—if the path to reimbursement is absent or unclear.