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From Regulation To Reimbursement: Ex-FDA Chief Says CMS Needs New Reimbursement Frameworks

Following his recent talk at the National Press Club on reimbursement issues, former US FDA Commissioner Scott Gottlieb told Medtech Insight a new breakthrough device rule proposed by the Medicare agency CMS is good but will still be economically unfeasible for many hospitals. Instead, he says new frameworks need to be developed for the new kinds of technologies coming to market.

Scott Gottlieb

Industry insiders hope a new rule on breakthrough devices from the Centers for Medicare and Medicaid Services is a first step to expanding coverage for all new devices. While praising the proposal, Scott Gottlieb, former commissioner of the US Food and Drug Administration, said he doesn’t believe that will happen without a complete rethink of reimbursement pathways at the CMS.

“I’d be surprised if they extended [the reimbursement rule] to all devices,” Gottlieb said in an interview with Medtech Insight. “My guess is they will want to apply some kind...

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