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Calling All Innovators: FDA And CMS Seek Candidates For Parallel Review Pilot

This article was originally published in The Gray Sheet

Executive Summary

FDA and CMS are seeking device companies with innovative technologies to participate in the first test of "parallel," or simultaneous, pre-market approval and Medicare coverage reviews.

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CDRH Preps New Program To Streamline Approval-To-Reimbursement Path

The device center is in the very early stages of launching the “CDRH Reimbursement Program,” planning to go beyond its current parallel-review collaboration with CMS to work with device firms, CMS and private payers to streamline the pathway from market approval to reimbursement.

CMS Administrator Tavenner Emphasizes CMS And FDA Collaboration

While speaking Sept. 24 at the 2013 AdvaMed conference, CMS Administrator Marilyn Tavenner outlined CMS’ priorities over the next three years, focusing on access, quality and cost with a specific emphasis on CMS collaborations with FDA.

CMS Restricts Coverage For Devices More Than Drugs, Study Finds

Discrepancies between FDA-approved labeling and national Medicare coverage decisions are frequent, particularly for medical devices, where CMS tends to be more restrictive than FDA, researchers reported in Health Affairs. The findings have implications for the parallel review program.

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