It takes a real grown-up government agency to admit when it has bungled the job, or maybe it just takes a good thrashing in the court of public opinion. Of course, there are government agencies that simply mumble into their coffee mugs about "fixing the problem," assuming they acknowledge their stumbles in the first place. Let's take a moment to look at two rather peculiar stories about government agencies that have appeared recently in Medical Device Daily.
CMS walks back from the precipice
We all remember the story about a recent decision by a Medicare administrative contractor (MAC) to not cover lower-limb prostheses, and that became quite the story, indeed. Device makers might experience more angst over things like the outpatient prospective payment system, but let's acknowledge that nobody ever marched on Washington over the OPPS.
NHIC was the MAC stuck with the unenviable task of making a coverage decision about lower-limb prosthetics, which drew fire from a former U.S. senator, prompted a march on a government building in DC, and drove a petition to the White House website that easily drew the requisite number of signatures to trigger a response from the Obama administration.
This was definitely a Buster Keaton moment for CMS as it now has to convene a working group to address this and related issues. Don't expect any quick changes, though, as this working group will be charged with determining what kind of evidence the agency will need in order to cover these prosthetics.
In other words, the more things change...
DoJ: Doctors play, hospitals pay
Remember all the fuss and bother about the purportedly unnecessary volume of implants of cardioverter defibrillators? So does the Dept. of Justice, which announced the other day that it will fine the heck out of a bunch of hospitals over the matter despite letting doctors entirely off the hook.
It's perhaps too tempting to hang physicians out to dry about this, but they've been pushing the envelope for quite some time despite a very keen awareness of the risks they ran. Device makers haven't been able and/or willing to generate enough evidence from trials and registries to prompt CMS to expand its coverage of ICDs for sudden cardiac arrest, so maybe these companies deserve some of the blame for this mess.
Either way, let's assume for a moment that all these patients really needed these devices. If those wacky, fun-loving attorneys at DoJ can let docs off the hook, how can they hit the hospitals for the same thing? Are we really expected to believe a hospital administrator is in a position to seize a cardiologist by the lapels and tell him or her not to implant this device?
If that's your view of the situation, all I can say is good luck with your next used car purchase. All it would take to relieve that administrator of his or her job is one dead grandmother on the street along with a leak of how this soulless profiteer refused that poor patient her device, and then it's back to the Wild, Wild West ... in other words, right back to where we'd have been, anyway.
To those of us who paddle through life with nothing more than undergraduate degrees, this sounds like another bunch of government prosecutors (i.e., law school zealots) out to prove they've done something constructive. The reality is this: All they've done is reroute taxpayer dollars back into the Treasury's cash register, where another agency will undoubtedly ensure (cough) it's money well spent.
It's all too much, isn't it? Still, even I have to admit it could be worse.