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 Drug Coverage Could Be Driven By Commercial Plan Decisions Under Proposal

Executive Summary

Proposed rule would also clarify standard for determining whether coverage of a drug, device, or biologic is ‘reasonable and necessary.’

You may also be interested in...



Medicare Final CAR-T Policy Eases Coverage Requirements

Product developers and researchers applaud the changes, including dropping "coverage with evidence development" approach.

New York State To Conduct Its Own Review Of COVID-19 Vaccines In Another Blow To FDA’s Reputation

Governor Cuomo will establish two panels, one examining safety and efficacy and another considering distribution and pricing, to advise the state on how to approach use of coronavirus vaccines once one is approved.

Off-Label Use: US FDA Backs Away From ‘Totality Of Evidence’ Standard In Proposed Reg

New proposed rule says a manufacturer’s knowledge of the unapproved use of a product does not alone determine intended use. Former FDA lawyer says rule could set off fireworks over the scope of what the agency considers evidence of off-label use.

Topics

UsernamePublicRestriction

Register

SC081785

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