Interagency coordination at the Department of Health and Human Services is purported to be a routine fact of life nowadays, but there are signs that outside forces are pushing FDA into activity that could have a big effect on another important agency.

This might be strictly a problem of perception rather than reality, but its tough to avoid the conclusion that all the emphasis on speed at FDA might run up against a rather large obstacle elsewhere at HHS.

Breaking through to nowhere

AdvaMed held its annual policy briefing earlier this month, during which the association advocated mandatory Medicare coverage of pivotal clinical trials for any device FDA designates a breakthrough device. This is part of the congressional 21st Century Cures initiative and not necessarily an idea of AdvaMed’s provenance (though it could be), but there is an understandable lack of detail as to how CMS will be involved.

Parallel review is one obvious vector for this kind of collaboration, but one has to wonder whether this is really a game-changer for more than the occasional PMA. If a device is that important to CMS, it’d want to be involved in any event. If device makers have been wary of parallel review up to now because of the additional requirements for such a trial, will they suddenly jump on board now?

They might. Coverage of a pivotal trial might be pretty irresistible (even if the reimbursement proves miserly), but it’s still tough to imagine this kind of thing will suddenly give parallel review a handful of applications each year when it has produced only two applications over the past five years. At any rate, one has to imagine CMS will be very choosy about which applications it will sign on to cover.

The imprecision of precision medicine

The second issue in this FDA/CMS context falls under the President’s Precision Medicine initiative, and deals with those massively parallel genomic sequencing machines. FDA wants to make use of existing and yet-to-surface data repositories to ease its review of next-gen sequencing applications, but this seems to reintroduce us to the analytical-versus-clinical validity quandary.

A massively parallel machine can fly around the genomic space at warp speed all it wants, but development of clinical evidence sounds like more of a subsonic flight proposition to the untutored ear. Not to criticize FDA for trying to amp up its informatics game, but how is CMS not the rate-limiting step (pardon the cliché) here?

Alzheimer’s again out in the cold

I know I’ve ground this axe before, but you just have to love the Precision Medicine Initiative for its same-old/same-old approach. It offers $70 million for cancer and squadoosh for neurodegenerative states, which will cost the American economy twice as much as cancer in the decades to come. How’s that for responsible stewardship of the taxpayer’s dollar?

The more things stay the same, the more they stay the same.