For many medical devices, clearance from the U.S. Food and Drug Administration is only the first step. Decisions by Medicare to reimburse purchases of the product - decisions often followed by private insurers - can be critical for a device's success.

That's why the FDA and the Centers for Medicare and Medicaid Services are considering reviewing products at the same time to speed up reimbursement decisions.

"This process will serve the public interest by reducing the time between FDA marketing approval or clearance decisions and CMS national coverage determinations," the agencies wrote in a notice posted in the Federal Register on Friday.

But not all industry-watchers think friendly collaboration is a good thing. For one, they say that evidence required for FDA clearance might not be enough to convince CMS to vote for coverage. More importantly, they fear that CMS' economic analyses could creep into FDA decision-making.

"The intrusion of cost-benefit considerations into the regulatory approval equation has for some time defined industry's worst nightmare and the fear - despite very clear, long-established and strong legal prohibitions against consideration of cost by either FDA or CMS - is that free communication between FDA and CMS would open the door to using cost as a market approval consideration," wrote Edward Berger, founder of Larchmont Strategic Advisors, in a blog post for MassDevice News.

A public comment period on the proposed rule, which follows a memorandum of understanding between the two agencies inked in June, lasts until Dec. 16.

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