Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Exact Sciences Colon Cancer Test Gets Quick Results From CMS

This article was originally published in The Gray Sheet

Executive Summary

CMS granted the company a broad-based national coverage policy at breakneck speed and a positive preliminary payment decision to boot for the Cologuard DNA stool test. It is the first national coverage determination resulting from the FDA-CMS parallel review pilot.

You may also be interested in...



Pacts In Medtech, July/August 2018

Derived from Strategic Transactions, Informa's premium source for tracking life-sciences deals, the bimonthly Pacts In Medtech highlights notable technology alliances, R&D partnerships and commercial collaborations. In this edition, we look at industry pacts that were sealed in July and August 2018.

FDA Extends Parallel Review Program ‘Indefinitely’

The program, which allows select manufacturers to have their products reviewed simultaneously for FDA approval and Medicare coverage, has been in the pilot stage since 2011. Now it is formally in full implementation mode and the agencies are looking for more manufacturers to participate.

FDA-CMS Parallel Review Pilot Will Be Extended; Drugs Not The Focus

CMS remains open to the idea of using parallel review (or, less formal parallel advice) for prescription drugs, but the current and future focus of the pilot program is likely to stay on devices and diagnostics.

Related Content

Related Companies

UsernamePublicRestriction

Register

OM017175

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