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?