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

Accelerated Approval For Medicare Coverage? FDA Model Could Be Useful For Value-Based Agreements

Executive Summary

Centers for Medicare & Medicaid Innovation could enable outcomes-based contracting for novel, 'curative' therapies follow something like the FDA’s Accelerated Approval model, former top HHS official suggests.

You may also be interested in...



HHS Safe Harbor For Value-Based Drug Contracts May Be On Horizon

US proposed rule establishing new safe harbors from anti-kickback rules for value-based and outcomes-based contracts limits protections to clinicians, providers and certain other groups and expressly excludes pharmaceutical manufacturers. But HHS suggests a separate safe harbor for prescription drug contracts may be forthcoming.

Value-Based Contracts: Medicaid Best Price Concerns Could Be Eased With CMS Guidance

Absent any legislative remedy, an administrative fix could provide manufacturers with confidence that value-based arrangements won’t trigger a new best price, Duke Margolis policy experts propose.

Beyond The "Blueprint": The Next Stage For US HHS Drug Price Policy

Upcoming transition in HHS drug pricing policy staff reinforces the Trump Administration's shift away from the 2018 "Blueprint” and towards engaging with bipartisan Congressional legislation – and spotlighting executive action as coming from the White House in the context of the upcoming Presidential campaign.

Topics

UsernamePublicRestriction

Register

LL1126230

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