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

Stakeholder Advice To Add-On Aspirants: Meet With CMS Prior To Approval

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers seeking new-technology "add-on" payments under CMS' inpatient prospective payment system should meet with the agency well before a product gains premarket approval, according to Hospital & Ambulatory Group Director Liz Richter

You may also be interested in...



CMS New Tech Add-On Interpretation Contested By Industry Reps

Medtronic will attempt to persuade CMS that the firm's Kinetra deep-brain stimulation device marks a substantial clinical improvement over its predecessor - the dual-implant Soletra - and therefore qualifies for a new technology "add-on" payment

Xbrane Assembles The Troops As FDA Says No To Lucentis Biosimilar

Xbrane Biopharma was riding the crest of a wave with the EU launch of its biosimilar to Lucentis, following years of toil and investment. However, plans to roll out the product in the US will have to be pushed back – likely – into the middle of 2025, following a US FDA complete response letter.

Latest Headlines
See All
UsernamePublicRestriction

Register

MT020254

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