Well, FDA and the Centers for Medicare & Medicaid Services are at it again with parallel review, but this time they've tacitly acknowledged what everyone knew all along; that it would never be willingly adopted by more than a very few device makers. In the Federal Register notice of Oct. 11, the two agencies state that the two-year pilot for parallel review won't accommodate more than five applications per year.
When FDA and CMS initially tried to drum up interest in the idea, a number of observers told me industry would never flock to the idea in any numbers greater than that. However, it's also worth pointing out that the timing for coverage analysis is no different under parallel review if a device maker can't apply for parallel review until the device appears at an advisory committee hearing. Ditto the timing of disclosure.
Another peculiarity is that the notice states that CMS will have the option of using coverage with evidence development as a potential reimbursement outcome in parallel review. No point in stopping the presses for that one, is there?
The net result is that you're probably safe if you bet the cost of your kid's braces that parallel review will never attract industry in droves. In fact, if you can find someone foolish enough to take that bet, by all means take it.
Fans of conspiracy theory might smell cost containment in parallel review. After all, the FR notice does not say CMS can't inject itself into the device approval process before that device goes to advisory. Furthermore, the two agencies signed an MOU in 2010 regarding data sharing that does nothing to limit CMS's use of FDA's data. What better way for CMS to get its camel's nose in the tent?
That last part is admittedly speculative, but what's the alternative explanation? “We just wanna know” isn't it. Does CMS want to help FDA foster innovation? Sure, that's it.
Think I'm paranoid? Then describe the net benefit to industry if parallel review is of little (or no) help to five or fewer applications each year. Let's not forget that relatively inexpensive510(k) devices are ineligible, or about all the budget pressure in Washington. If there's one mantra regarding Medicare these days in this town, it's “cut costs.”
Of course it's possible that this whole thing will fizzle and become nothing more than a curiosity for future generations of med-tech policy geeks. Or maybe the only place it'll fly is on that topsy-turvy mess known to comic book fans as Bizarro World. In that case I'll eat a plate of crow, preferably with a dollop of bearnaise, please.
Still, I have to ask: Could parallel review as a screening mechanism for those really expensive PMA devices take root in our normal, non-Bizarro little corner of the Universe, where we drive on the parkway and park on the driveway?
Not a chance. Right?