It’s a new year with a host of new possibilities, not to mention a few hangovers from 2014. So what will 2015 bring to the world of med tech? Let’s find out.
Administration says “revenue-neutral”
Will Rogers is credited with having said, “the only difference between death and taxes is that death doesn't get worse every time Congress meets.” This year might prove the exception where corporate tax reform is concerned. I say that because Secretary of Commerce Penny Pritzker is now on record as saying the Obama administration is on board with revenue-neutral tax reform (See Pritzker’s remarks at 2:45). That doesn’t mean tax reform is going to happen this year, but it’s not a bad start.
Incidentally, this might also be a signal to the Business Round Table and the U.S. Chamber of Commerce to get their member ducks in a row unless they’re prepared to wait until 2017 to start this whole thing all over again, and it’s not a slam-dunk that the 115th Congress will be more amenable to tax reform than the current Congress.
FDA and LDT regs: good idea or no?
It’s all a question of whose ox is getting gored, but the two-day FDA meeting on the agency’s proposal to regulate lab-developed tests was actually pretty interesting. One of the speakers was Girish Putcha, director of lab science at Palmetto GBA, which handles a lot of requests for diagnostic coverage on behalf of the Centers for Medicare & Medicaid Services.
Putcha said among other things that the statute does no rule out the possibility that CMS can require that a test be checked for clinical validation and instrument and software validation, but he advised FDA avoid asking too much for design controls and other such features of the quality systems regulations.
The common expectation is that FDA regulation of clinical labs will drive some tests out of labs, which of course will dry up some revenues. I have a problem choking down this business of citing the latest FDA-approved BRCA test by Myriad as an example of an LDT as at all suggestive of the future for labs, though. I strongly suspect Myriad paid the tab for that effort, not the lab.
There’s a saying that if you want less of something, tax it. Same goes for regulations. It’ll be interesting to see what the clinical lab business looks like five years from now.
Fun with comparative ineffectiveness
It’s always amusing to watch those who are unfamiliar with the world of med tech attempt to impose their will on this continually churning sector of life science. The January Journal of the American College of Cardiology offered a comparative effectiveness report on coronary artery bypass and PCI for stable ischemic heart disease, and the authors concluded that at four years or longer, patients undergoing bypass "had better outcomes but at higher costs than those undergoing PCI."
But as the song says, that’s [not] where the fun is. This study drew on Medicare data for patients treated between 2004 and 2008, and of course the data are obsolete. The authors said as much, remarking, that most interventionalists "now have at least four types of DES available," and thus the question facing policymakers now is whether these outcomes would hold "if second-generation DES were to be implanted" in such a population.