The new year is underway and a few things of interest to med tech firms have already cropped up. Here are three of the more interesting developments in the world of medical devices (and it’s only for the month of January).
Duval files petition to stay substantial equivalence guidance
I’ve never filed a citizen’s petition, but something tells me it entails more work than making a cup of coffee, so I’ll assume that regulatory consultant Mark Duval thought he was on to something in filing a petition to have FDA stay its 2011 guidance on substantial equivalence.
Duval indicated that stage-gated reviews of 510(k) applications have morphed into a mechanism for forcing applicants into the de novo route, but Duval also told me that while managers at CDRH seem to have struck a more realistic tone in their approach to the device clearance process, many of the staff at the Office of Device Evaluation are acting as though they didn’t get the flyer.
Duval explained that stage-gated reviews have turned into an excuse for administratively determining a device not substantially equivalent, a determination that is supposed to be made only upon a review of the merits of the application.
One presumes there will always be at least some conflict between regulator and regulated, but it appears the conflict has ebbed only mildly since the change in administration at CDRH in 2009. We’ll see how this develops going forward.
OIG signs off on single-vendor agreement
Device makers are not always fond of group purchasing organizations (GPOs), but agreements between doctors and hospitals that restrict the range of devices available in the cath lab are not eyed benignly by industry, either. Still, the decision by the Office of Inspector General to step aside and allow a group of interventional cardiologists to sign just such an agreement with a hospital does not seem to have provoked much response from device makers, at least none that is audible.
As described in the Jan. 10 edition of Medical Device Daily, the cath lab in question would be stocked with drug-eluting stents provided via only a single vendor, which probably means a GPO has just shouldered aside at least one new entrant to the DES market. Less surprising is that the cardiologists have agreed to implement “certain measures to reduce costs attributable to lab procedures,” which purportedly accounts for 60% of the pay-for-performance compensation program in the agreement.
With all the emphasis on cost containment, however, this may a blueprint for how things are done going forward. Have device makers concluded this is no longer a fight worth fighting?
Stage 3 meaningful use: Providers cry Uncle
Both doctors and hospitals pleaded with the Centers for Medicare & Medicaid Services not to jam more meaningful use standards down their throats until the meaning of stage 2 meaningful use standards emerges.
A representative of the Federation of American Hospitals told me that not only have providers not had time to fully digest the utility of stage 2 meaningful use, they’re also feeling the camel’s back sag under the aggregation of quality initiatives coming out of CMS for the past decade or so. Quality might usually trump quantity, but it appears that a certain quantity of quality … oh, nevermind.
Suffice it to say that stage 3 meaningful use is not going to come into force this year.
Looking forward, it does not appear that the Supreme Court has scheduled the hearing of the Myriad gene patenting case. One assumes they’ll hear arguments this term, but as of now, the Court has published its schedule to the end of March, and there’s no mention of Myriad.