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

Medicare 'Coverage With Evidence' May Rise With FDA Postmarket Emphasis

This article was originally published in The Gray Sheet

Executive Summary

As FDA touts plans to shift clinical data requirements when possible to the postmarket phase, a top CMS official highlights the importance of the Medicare coverage with evidence development policy.

You may also be interested in...



Breakthrough Device Route, Registries On Wish List At Senate Hearing

Industry stakeholders listed their priorities to improve the medical regulatory process and research during a second hearing at the Senate Health, Education, Labor and Pensions Committee which is working on its own version of the House's 21st Century Cures bill.

Planning Board Proposes Postmarket Device Surveillance Timeline

A planning board created to develop a framework for a new U.S. medical device surveillance system has proposed a seven year plan on how to get the system up and running, which will include creating incentive systems for stakeholders as well as reducing the burden of recording and managing device data.

Local Coverage With Evidence Development Is Legit, CMS Says; But It May Be Rare

CMS issued its final guidance on the coverage-with-evidence-development program, two years following a draft. It is explicit that local Medicare contractors can employ CED in setting coverage policies in their jurisdictions, but it is not clear that the language will encourage significant use at the local level. The guidance also revises its approach on ending CED policies compared to what was stated in the 2012 draft guidance.

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

MT033725

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