Medtech Insight is part of the Business Intelligence Division 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

Breakthrough Reimbursement Proposals Percolate From FDA, Industry

This article was originally published in The Gray Sheet

Executive Summary

As industry continues to nudge CMS to follow FDA's lead in making reforms that streamline the path to market for innovative new devices, the agencies are themselves floating solutions. All sides are thinking up strategies to rely on FDA's determination that a device meets certain "breakthrough" standards to trigger a streamlined path to data-conditioned reimbursement. But some in industry are concerned about an overemphasis on national, rather than local, coverage, and, in particular, the Medicare coverage-with-evidence-development process.

Advertisement

Related Content

Despite Only Two Parallel Review Success Stories, CMS Touts Better Coordination
Medicare Will Look To Informal Pathways For Faster Medtech Reimbursement
FDA, CMS Heads Press For 'Single Front Door' For Real-World Evidence
Next AdvaMed Chief Is BIO Exec Scott Whitaker
Things Are Looking Up On The US Regulatory/Policy Front
In Case You Missed It: Top 10 "Gray Sheet" Stories In October
Parallel Reviews Should Lead To Local Coverage, Coding Decisions, Firms Say

Topics

Advertisement
UsernamePublicRestriction

Register

MT034274

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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