The general public might think of FDA and CMS as ingredients in the government’s alphabet soup, but there are times when things seem to move too slowly for a mere broth to be the medium. Here are two stories that are taking a lot of time to achieve the required viscosity.
First, let’s tackle some of the blowback attached to FDA’s latest attempt to finesse the First Amendment on the point of off-label use. Off-label device use has been the bane of FDA for years, and worse yet in the agency’s view is when device makers talk about off-label use. This latest attempt at a guidance on how device makers should (not) exercise freedom of speech raised the hackles at the Washington Legal Foundation (WLF), an outfit FDA knows all too well.
The reader might remember the 1999 case in which WLF persuaded a judge to enjoin some of the agency’s restrictions per the Food and Drug Administration Modernization Act of 1997. WLF’s response to the latest draft claims that the draft “appears to violate the terms of [the] permanent injunction” the association obtained in WLF v. Henney. WLF argued further in a recent statement that the draft’s limitation of appropriate materials to those that address “adequate and well-controlled clinical investigations” constitutes a standard “that would virtually eliminate dissemination.”
Richard Samp is the chief counsel at WLF, and if you ever met him, you’d think there’s no more mild-mannered denizen of DC. On the other hand, he works for WLF, and I have to assume he likes a good scrum as much as the next JD.
In other words, this is far from over.
CMS says “CED” to the MitraClip
The Centers for Medicare & Medicaid Services recently proposed to pay for the MitraClip via the coverage with evidence development (CED) mechanism, but it was interesting to see how the agency arrived at CED with this device. Abbott Vascular had requested a new technology add-on payment last year, which CMS declined, and then the company asked the agency earlier this year to shift the procedure between diagnostic-related groups because the default DRGs were too miserly.
So why CED?
CMS declined last year to cover the MitraClip because FDA had not at the time approved the device, but CMS never staked out a position in the FY 2014 proposal for the inpatient prospective payment system (IPPS) as to whether the MitraClip met the cost criterion for a new technology add-on. So it’s tough to say just where the agency stands on this score.
The IPPS proposal for 2015 tackled the question of the device’s DRG classification, but here again, CMS declined, this time based on what the agency saw as a problem with the company’s claims regarding resource utilization. Still, physician societies backed Abbott on the resource question, leading one to wonder whether CMS wasn’t intent on a CED approach from the outset.
We can speculate endlessly about whether CMS has issues with the device, but it might be more informative to speculate about the approach to these novel and expensive cardiology devices generally. After all, TAVR devices got the same treatment, but when was the last time anyone saw a national CED determination for an orthopedic device? I can’t recall any of recent vintage off the top of my head (but that could change as all those bum-kneed Baby Boomers hit retirement).
Sponsors of left atrial appendage (LAA) closure devices might want to take note on two scores. One is that CED is a pretty sure bet for their devices, and the second is that a registry requirement is almost certainly in the offing. Sponsors of the TAVR registry had already carved out a spot for mitral valve repair devices, but where might an LAA closure registry find a home?
ICYMI: Uncle Sugar is poised to plow another $200 million into the Healthcare.gov website, which will bring the grand total to more than a billion bucks. And some people wonder why some taxpayers dislike big government. If you don’t get it by now, forget it. You never will.