As the saying goes, "A joy that's shared is a joy made double." And that may now be the case via more coordinated FDA and CMS actions.
A June 23 memorandum of understanding on data sharing (signed by FDA Commissioner Peggy Hamburg and CMS Acting Administrator Marilyn Tavenner), could serve as a first step toward parallel reviews by FDA and CMS. CDRH Health Director Jeff Shuren announced the pact at a June 24 public workshop on device innovation.
The memorandum "will allow for the first time routine and timely sharing of information and expertise between our two agencies to strengthen our ability to achieve our respective missions," commented Shuren.
As part of the new effort, the two agencies are "seriously exploring the ability to start, at a manufacturer's request, a Medicare national coverage determination process while the medical device is still under pre-market review at FDA," for example, Shuren explained at the meeting. "Such an approach could reduce the time from FDA approval to CMS coverage and payment for some devices."
He also noted that the agencies may eventually consider defining certain circumstances when an FDA determination on safety and effectiveness is adequate for CMS to pay for a new technology "without additional evidence."
Shuren stressed, however, that only expanded information sharing has been agreed upon at this point. Parallel review is "not a done deal," he said
CMS' coverage-with-evidence-development policies, for instance, could help with FDA post-market data collection, he explained. FDA is already exploring use of Medicare claims data as a post-market surveillance tool as part of its Sentinel initiative.
