This year’s med tech conference was a lot like previous years’ events, but the heat of the moment is always telling, isn’t it? Following are a few developments that were part of the conference by design or by chance, but the task of sorting out which will and will not leave a mark, as it were, is no mean feat.
Lab test fee or a test of labs’ patience?
The draft clinical lab fee schedule blew up just in time for the conference with a publication date of Sept. 22, which was also just in time to ruin plenty of otherwise perfectly serviceable weekends, a fact of timing that was not lost on anyone in attendance at MedTechCon 2017.
The bottom line is that the Centers for Medicare & Medicaid Services came up with a lab fee schedule for CY 2018 that took test makers and clinical labs quite by surprise, or at least that’s what the reactions would seem to suggest. Among the more intensely engaged in this debate is the American Clinical Laboratory Association, which vowed to take the fight to the courts if necessary. Those of us without a JD might assume that means the U.S. District Court for the District of Columbia, which is notoriously friendly to government. What is less clear to those of us without a JD is what basis the ACLA would use to sue. CMS is certainly within its statutory right – indeed, it’s the agency’s obligation – to set lab rates, but one supposes we’ll see what the legal pretext is, should it come to that.
There were some documented issues with reporting of private payer rates, including one outlier that resulted in a figure that was more than 42,000 times the amount CMS is allowed to pay for the test in question, but CMS's position is probably going to be that it has little reason to change the proposed fee schedule, given that it's modeling to account for more participation by several types of labs resulted in the same level of reduced payment. The irony is that industry has for some time been highly annoyed by how the agency prices new tests, which drove a lot of the push for a new lab fee paradigm, but CMS rejected its own advisory panel recommendations for 50 out of 83 crosswalk and gapfill procedures for new tests, which might be the real reason everyone is so dyspeptic about this draft fee schedule for 2018.
This is another stay-tuned moment, but one gets the feeling that CMS can’t dither as it has yet to publish CY 2018 Part B premiums for its beneficiaries, and it would be a big help if the lab fee mess were sorted out quickly.
‘La volta’ at CDRH
There seems to be a debate over whether the late Medieval dance known as la volta led to the development of the waltz, but the name in more or less colloquial terms means “the turning,” and hasn’t the tenor of conversation coming out of the FDA’s device center turned dramatically in the past seven years?
When Jeff Shuren took the job as CDRH chief at the end of 2009, regulatory review was not necessarily worse than obtaining Medicare coverage, but that dynamic flipped in fairly short order. In the two or three years following, device makers were revolting against what they saw as inordinate demands for additional evidence in premarket reviews and lots of general foot-dragging at the Office of Device Evaluation.
In response, industry availed itself of a lot of traction on Capitol Hill, as can be seen in the various features of the two most recent device user fee agreements, and now the agency has the temerity to refer to real-world evidence as valid scientific evidence. This does not sit well with some in the Twitterverse, who seem on the verge of taking torch and pitchfork to the streets to push back against the purportedly inflated virtues of RWE and registries, abominations of a graceless, Gothic sort, which they see as nothing more than the hyperbolically charged aggregations of otherwise unrelated body parts. One gets the feeling that even Peter Boyle couldn’t tap dance his way into their hearts!
To mix our metaphors, we might note that la volta was seen as a monstrosity when it first bubbled up into plain view of polite society in Renaissance Europe, although its purported stepchild, the waltz, eventually gained quite a bit of respectability, particularly in the salons of Vienna. But it didn’t happen overnight.
Will RWE and the turning at CDRH gain a similar respectability? By some accounts, only if you’re distracted by neck bolts and garish folk dances, but it won’t take a lot of adverse events for some to cry foul.
Hail to the SG
A widely unreported story, and one that seems to have provoked little angst in the life science industries, is the appointment of Noel Francisco to the position of Solicitor General. The problem with reporting this story is that Francisco, late of Jones Day, is a black box where patent law and PMA preemption are concerned.
Francisco clerked for the late Antonin Scalia, which may or may not be dispositive (if you’ll pardon the expression) regarding Francisco’s views on preemption. Scalia voted in favor of preemption in Riegel v.Medtronic, but so did everyone else on the bench (including Stevens and Breyer) with the exception of Justice Ruth Bader Ginsburg, so there are somewhere between few and no tea leaves to read into that.
I asked around when the news broke, and one IP association said they had nothing on Francisco where patent law is concerned. Among the IP blogs that also have nothing to say on Francisco is Patently O, which is one of the better quality patent blogs in the business. Ergo, we’re left to guess how Francisco would have treated cases like Mayo and Myriad (I drew essentially the same blank responses from the tort bar, just in case you were wondering).
It’s tough to ignore this development given that the Solicitor General’s remarks to the Supreme Court carry a lot of heft with the nine black robes, but in the absence of anything more compelling than mere speculation…