[caption id="attachment_4301" align="alignleft" width="256"]In this corner: Medicare v. CGMs[/caption]
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.
[caption id="attachment_4253" align="alignleft" width="222"] Read all about it yet again?[/caption]
It seems almost tragic that the acronym "SGR" has disappeared from the news, but there are still lots of stories that never get old. Even the ones that don't age well tend to pop up without warning, though, including questions about the viability of China as a med tech market and a new twist on interoperability.
Asian dragon or a snake in the grass?
Sometimes paper is just paper, a comment that might aptly be directed at mainland China's yuan. Some saw the recent move to pull down the yuan's value as a way to prop up exports, but there appears to be a copycat movement afoot that is already creating serious ripple effects.
We examined the underpinnings of China's economic present and future last year, asking among other things how long Beijing could sustain its monetary three-ring circus. The latest currency manipulation has not helped the Shanghai index, which has shed roughly 40% in the past two months, part of the reason the Dow lost more than 1,700 points between Aug. 10 and Aug. 24.
Granted the U.S. economy is propped up by the Federal Reserve's use of a zero federal funds rate, but consider the impact on demand – and the concomitant hit China's economy would take – if Janet Yellen & Co. decided to start pushing rates up again.
All of this leads one to wonder if med tech is smartly invested in an economy with a banking system that's still based on some pretty rotten timbers. That's not exactly news, but what is more obvious now than in August of last year is that China's computer-based piracy is by some accounts tantamount to a declaration of IT war.
The cavalry is all tied up
Several major med tech firms rely on China for a noticeable percentage of their sales, and some analysts believe that any slowdown of business in China in the second half of this calendar year is likely to be modest. But the Eurozone still struggles with the anemic Mediterranean economies, and oil prices of $40 per barrel aren't doing much for the economies of Russia, Mexico and a number of nations in the Middle East.
So is John Wayne about to ride over the hill and save the world? Probably not. There was a time when the U.S. economy was massive enough to pull up the rest of the world, but that's a faint hope for what has become a ridiculously over-regulated American economy.
FDA jumps into the interop quagmire
Just tweet "interoperability" to physicians on Twitter and you'll get a downright visceral reaction, but the push for a national medical device surveillance system has introduced this concept into the wider world of med tech. FDA's latest report on this notion discusses how registries and other sources of data might be linked to forge such a system, but the document acknowledges that linking these data sources will create interoperability issues.
Much ado about nothing? Maybe, but vendors of electronic health record software knew about the need for interoperability quite some time ago. Former HHS Secretary Mike Leavitt started talking about EHR interoperability no later than in 2006, and here we are nine years later. The operators of these registries probably heard next to nothing about it until relatively recently.
As was the case with "doc fix," we scribblers are going to get a lot of mileage out of interoperability, and our keyboards might get more mileage out of it than the 18 years of wear and tear the S, G and R keys endured.
Five years ago during Cleveland Clinic's 2010 Medical Innovation Summit, a panel audience was asked, by a show of hands, if they considered obesity a disease. Only about half the audience raised their hand. The other half raised their hand when asked if obesity was a lifestyle choice.
Keep in mind, this was a well-educated audience comprised of healthcare executives, clinicians, and investors. And yet, only about half of them were willing, at that time, to call obesity a disease. If the same audience was polled on the topic again today, I'd like to think the outcome would be different.
Debating the legitimacy of obesity as a disease does nothing to solve the epidemic. Instead, that kind of thinking only feeds the stigma that keeps people from seeking weight-loss treatment. It's also the kind of thinking that helped stifle innovation in the U.S. obesity market for nearly three decades as companies have struggled to gain regulatory approval and reimbursement for new weight loss technology.
Fortunately, the tide seems to be changing and a plethora of new weight loss devices have been introduced just in the past three months.
Since May, the FDA has approved two different balloon-based weight loss devices (Apollo Endosurgery's Orbera and Reshape Medical's dual balloon system) and a neuromodulation device that blocks signals between the brain and the stomach (the Maestro system from Enteromedics). The agency also cleared a new gastric sleeve product that Medtronic inherited from its Covidien acquisition. Other devices are in the pipeline and could enter the U.S. market next year.
The reality is obesity is both a disease and a lifestyle issue. That's why companies like Apollo and Reshape and several others in the space have built a support program around the therapy to help patients learn how to modify their behavior and, in theory, maintain a healthy weight after the procedure. And it is not a problem that will be solved overnight or even in five years. But with so many new minimally-invasive treatment options finally reaching the U.S. market, and hopefully a reduced stigma about what obesity actually is, I am optimistic that more patients will seek help before they reach the point where an invasive surgery is their only option.