Pink Sheet 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

CMS Offers Two Paths To “Coverage With Evidence” In Revised Guidance

This article was originally published in The Pink Sheet Daily

Executive Summary

The agency aims to clarify its rationale and solidify the legal basis for requiring data collection as a condition of national Medicare coverage in guidelines issued July 12.

You may also be interested in...



Quality Of Biomarkers Questioned Again; Lancet Report Calls For Better Evidence

As personalized medicine shifts from theory to practice, concerns are mounting about whether the evidence behind many biomarkers is sufficient to make pharmacogenomic testing worthwhile – suggesting sponsors should pay careful attention to providing evidence to support use of companion diagnostics.

Quality Of Biomarkers Questioned Again; Lancet Report Calls For Better Evidence

As personalized medicine shifts from theory to practice, concerns are mounting about whether the evidence behind many biomarkers is sufficient to make pharmacogenomic testing worthwhile – suggesting sponsors should pay careful attention to providing evidence to support use of companion diagnostics.

Costs Are “Valid” Selection Factor In Medicare “Coverage With Evidence Development” Option – NIH Bioethicists

Medicare CED policy does not compromise ethical standards for medical research, they conclude in JAMA commentary.

Topics

UsernamePublicRestriction

Register

ID020288

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