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

FDA Plans For Private-Payer Meetings Ahead, But Roadblocks Remain

This article was originally published in The Gray Sheet

Executive Summary

FDA’s device center is recruiting private payers to meet with manufacturers during the pre-submission process to hasten reimbursement. But some experts believe the effort may be hobbled by a lack of common interests.

You may also be interested in...



Medicare Will Look To Informal Pathways For Faster Medtech Reimbursement

The US Centers for Medicare and Medicaid Services has withdrawn efforts on a proposed rule to offer faster Medicare reimbursement to novel devices, but the agency still plans to work on different approaches to provide "timely patient access" to device innovations, a spokeswoman said. AdvaMed says it is disappointed by CMS's decision to withdraw the rule after a 10-month review by the Office of Management and Budget.

Payers Want Access To US FDA's Pre-Submission Meetings

As sponsors push for more access to physicians, payers hope to be able to gather more pre-approval information about drugs – like they now can with devices – for budgeting and patient access.

Bringing Private Payers To The Regulatory Table: FDA Reaches Out To Insurers

The agency's device center put out a request to health insurers to make themselves available to participate in FDA pre-submission meetings so that device firms, particularly start-ups, can better understand data expectations for coverage while companies are still designing studies to support FDA approval.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT034863

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