Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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.

You may also be interested in...



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.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT030627

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel