Continuous glucose monitors have been around for a few years, but the Centers for Medicare & Medicaid Services has had little to say about them to date. NHIC, a Medicare administrative contractor that seems to serve as the agency's point for durable medical equipment, has declared that CGMs are not coverable, and the coverage debate is getting noisier every day.

Some argue that nearly all private carriers cover CGMs for Type 1 diabetes, but it would appear that the evidence in support of coverage seems less than overwhelmingly convincing, a fact that device makers might be in a unique position to change.

Approved indications unsupportive; ditto the data

CGMs are novel and thus a highly iterative technology, and DexCom, for instance, has vowed to come up with even smaller and less intrusive offerings. The company's president said recently that to thrive in this space, "you have to have new thing after new thing after new thing that enhances the patient experience," but there is this nagging question of what these devices would do for the taxpayer's experience.

First, let's take a look at the indications for use statement for the Medtronic MiniMed. If you scroll to page 2, you'll see that FDA approved the device not to prevent or treat hypoglycemia, but to suspend delivery of insulin when the user is unable to manage the situation. It's tough to find an FDA-approved device that isn't described as an adjunct or otherwise secondary approach to glucose management.

The most recent meta-analysis of CGM use I can locate does not address Type 1 adult patients, but this study does little to support the proposition in Type 1 pediatric patients. And this is far from being the only analysis of trials to lend lukewarm support at best to the proposition, including this evaluation conducted by the Cochrane Collaboration, which does evaluate Type 1 adults. It doesn't help that acetaminophen completely mangles a CGM's ability to accurately read glucose levels, either.

The key body of evidence for Medicare coverage often comes from the Agency for Healthcare Research and Quality, which financed a comparative effectiveness study for CGMs the agency published in 2012. The data for Type 1 adults suggest that HbA1c was better managed with a CGM, but the report states that the strength of evidence for this conclusion was low and was "heavily influenced by one study."

No firewall between Medicare, Medicaid?

If you do a search of the term "cost of continuous glucose monitoring," one of the first 10 hits is an article in Diabetes Care, a journal of the American Diabetes Association. What's interesting about this article is that the authors claim that long-term projections indicate that CGM use in Type 1 patients is cost effective, but they base that on a quality-adjusted life year of $100,000.

Granted the article is five years old, but my impression is that the cost-effectiveness threshold probably hasn't moved much since 2010. I'm also under the impression that the default number for a QALY is about $50,000, a position some appear to still agree with, although there is some dispute on that score. A QALY of four times that sum, a position the authors of the NEJM piece advocate, is a little adventuresome, to be polite. I'm not sure what set point AHRQ and CMS use, but is a QALY set point of even $100,000 fiscally realistic?

By the way, some endocrinologists are saying CGMs should be covered for Type 2 patients who are on multiple insulin injections a day, but advocates of coverage are arguing that not even all Type 1 patients would need these devices. Talk about mixed messages.

Incidentally, anyone who thinks this is just a Medicare discussion might want to reconsider, as a recent analysis of the incidence of diabetes among Medicaid enrollees makes clear the pressure for Medicaid coverage will pop up immediately when Medicare coverage happens.

Judge to NHIC; silence is consent

The latest news is that the courts have jumped in via Whitcomb v. Burwell, a decision that includes a rather interesting passage. The judge points to the fact that NHIC declined to cover because FDA's approval language means a device's use is precautionary in nature, but the judge also said that a failure of national and local coverage documents to explicitly non-cover CGMs "is not a matter the court can overlook."

Maybe it's just me, but is it really rational to infer that a failure to explicitly non-cover a device is a justification for forcing Medicare to cover that device? That's nothing but an invitation to pandemonium and bankruptcy. There is legislation in the works that would force CMS's hand, but it has zero chances of flying this year. It is, however, just the kind of feel-good story that elected officials hanker for in even-numbered years, so we'll see.

I get that private payers have to deal with allegations that they're soulless profiteers, so one might imagine they're more likely than public payers to succumb to patient pressure. The optics for CMS are not quite the same, though, and it's not at all clear that this is a bad thing – at least not where CGMs are concerned.