[caption id="attachment_3560" align="alignleft" width="231"]Yellow brick roads don't always go where you want[/caption]
Sometimes when I think about policy and regulatory matters in the world of med tech, I feel like I’m no longer in Kansas. Here are three stories of interest to device makers that might make one wonder who’s behind the curtain, and an icon of sorts for each.
Jobs legislation; the Cowardly Lion
The U.S. House of Representatives has passed H.R. 4, a bill that deals principally with jobs, but carries with it a repeal of the 2.3% medical device tax. So why is this bill a problem for the Senate?
Besides the repeated opposition to a device tax repeal voiced by the Obama administration, we have two nay votes by Reps. Nancy Pelosi and Henry Waxman, both of whom have served as proxies to the administration’s views on lots of legislation. If they’re opposed to H.R. 4, what are the chances it’ll pass in the Senate?
There’s no need to ask what the Senate vote count would be. Senate majority leader Harry Reid is not going to let it come up for a vote, I guarantee it. Thus the King of the Senate jungle does what he does best, which is to prevent votes that could embarrass his party.
The new CED; the Munchkins
The Centers for Medicare & Medicaid Services has been looking at an overhaul of the coverage with evidence development program since November 2011 and held a public meeting in 2012, turning out a draft guidance for the program in November that year. But there has been nothing since then.
Just like the Munchkins, there are a lot of moving parts to the CED draft, and there are a lot of stakeholders. There are thousands of drug and device makers, and more than 800,000 doctors and hospitals. And there are those 535 Medicare micromanagers on the Hill who want to tell CMS what to do about specific coverage decisions.
Is it just too much trouble to get all those adorable Munchkins to work together?
The only thing we can say for certain is that the draft CED is out there somewhere and that it’s tough to spot. Maybe there’s a wicked witch cruising around overhead on her broom, and that’s why it’s still hiding.
The Watchman device; Dorothy
They say there’s no place like home, and Boston Scientific might believe the FDA circulatory systems advisory committee is a second home for the Watchman left atrial appendage device. The device will appear a third time at an advisory committee Oct. 8, and who knows what will happen? FDA is concerned about ischemic stroke numbers, so it’s anyone’s guess. How ironic that one of the trials used to support the application returned better-than-expected numbers for those on medical management.
When in doubt, just click your heels three times, little Watchman. It might not get you and Toto back to Natick, Massachusetts, but it couldn’t hurt.
[caption id="attachment_3529" align="alignleft" width="300"]Old-school technology: Boring, perhaps, but maybe smarter?[/caption]
If you want to hear some fairly outlandish remarks, just bring several thousand people under one roof and talk about medical devices. That’s usually more than enough to bring out the best and the worst in all of us, not to mention a few qualities in between.
Below are two examples of the rhetoric at TCT 2014. Does the rhetoric capture reality? I’ll let you decide.
Reinhardt makes a splash
One of the rather interesting discussions on Saturday the 13th was provided by noted economist Uwe Reinhardt, who is never bashful about telling us all how he thinks it is.
Reinhardt had little nice to say about Wall Street, characterizing its inhabitants as being "so destructive in their financial pursuits." The problem with the antipathy toward Wall Street is that it does not bear all the burden for the financial meltdown of 2008. Our federal government had a lot to do with the loosening of standards for home ownership over the preceding three decades, and a lot of individuals took out mortgages they knew they couldn't afford if anything went awry in their lives. So it wasn’t just adventurous lenders that caused the economy to crater.
Besides, if you want an economy that accounts for nearly a quarter of global GDP with only 5% of the world's population doing it, you have to accept that there'll be problems. Anyone who wants the U.S. economy to look like Europe's has to ask what would happen to all those drugs and devices that are currently available. If the U.S. financial system looked like Europe's, a lot of those drugs and devices would just go away.
To his credit, though, Reinhardt did blast the Obama administration for its repeated claims that the lower rate of healthcare and Medicare inflation is all due to the Affordable Care Act. It's nice to know I'm not the only one willing to say so.
To resorb or not to resorb?
Abbott released one-year data from its bioresorbable vascular scaffold (or stent depending on your preference) at TCT this year, and the buzz was more than just palpable. The company put on a full-court media press to clarify some of the issues associated with the device, but Boston Scientific sounded off, too.
In the unlikely case you missed it, the data comparing the BVS to the firm's Xience drug-eluting stent suggested a higher incidence of thrombosis, with two confirmed cases out of more than 330 while the Xience returned zero incidents out of slightly less than 170 patients. To the untutored ear, the data didn't sound bad at all for a first randomized trial for a first-of-a-kind device, especially since you had double the patients on the experimental device and far less operator experience with the BVS, which everyone at TCT has acknowledged is more difficult to implant than the Xience.
The thing I find most compelling about a bioresorbable is that there is no risk of stent fracture or deformation after the device resorbs, which doesn't take very long. Stent fracture has not emerged as some sort of public health tsunami the way thrombosis was for first-generation drug-eluting stents, but these metallic devices are no longer just for the very old and frail. They're making their way into younger patients who will live longer and be more active, and thus some sort of risk might emerge over time. Besides, as this article suggests, there is an existing metric for rates of stent fracture.
Your friendly neighborhood med tech reporter talked to several people about this trial, and one of them said the general attraction of a bioresorbable stent/scaffold is aesthetic. If a broken metal stent poking out into the artery is someone's idea of aesthetics, what does it take to qualify as a medical need?
[caption id="attachment_3489" align="alignleft" width="320"]Whiff: Reggie hit a lot of homers, but had nearly 2,600 strikeouts.[/caption]
Baseball analogies are definitely overused, and now it’s my turn to abuse the privilege. Following are three stories in which somebody failed to reach base.
Definition of a device
One of the more interesting developments of late is the recall of a huge number of convenience kits assembled by Customed of Puerto Rico. FDA recently announced a recall of more than 200 of these so-called “devices,” but there’s something a little misleading about characterizing this as a medical device recall.
So a convenience kit is a medical device? The Center for Devices and Radiological Health also regulates laser pointers used during public presentations. Does that make laser pointers medical devices?
When most people think of medical devices, they think about pacemakers, CT units, and infusion pumps. A convenience kit is described as a medical device only because FDA has deemed it as such for regulatory purposes. There is nothing about a convenience kit that qualifies it as a medical device. It’s just not even close.
Drinking the healthcare Kool-Aid
You have to love the propensity of the defenders of the Affordable Care Act to wax euphorically over the recent news regarding healthcare spending growth. The latest news is that healthcare spending growth is expected to top out at 5.7% per annum over the next decade or so. Is this good news?
Well, a lot of pundits seem to think so, based on the notion that this pace will outstrip GDP growth by a mere 1.5%. The problem is that this calls on the economy to grow at 4.2% annually over that time. Is that a realistic expectation?
The data suggest nothing even remotely resembling that kind of GDP growth has happened in the past three-plus decades, as this report makes clear. The average growth of GDP between 1981 and 2000 was in the neighborhood of 3.5%. I’ll give the supporters of the Affordable Care Act a pass on the numbers since 2008 because of this protracted recession, but the numbers just do not add up even if you discount the past six years.
Pioneer ACOs voting with their feet
The news is out that Sharp Healthcare of San Diego just exited the Pioneer accountable care organization plan, but Sharp is not the first Pioneer ACO to dump the program by any means.
It’s tough to extrapolate this to other organizations because one imagines the participants in the Pioneer program were already “doing it right,” so perhaps they had less to gain than others. Still, one has to wonder if the ACO program isn’t in competition with other Medicare programs, such as the bundled payment program, which CMS discussed earlier this year.
We’ve all heard at least informally that the Centers for Medicare & Medicaid Services has more healthcare reform programs in the works than providers can digest. Could these two programs (and others) be cannibalizing each other?