News & Analysis as of September 25, 2024

Biologics › MedPAC

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Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
[IP Hot Topics Podcast] Innovation Conversations: Dr. Claire Fraser
Nota Bene Episode 71: Shifting Regulatory Landscapes at the FDA: Cannabis, Vaping and Intelligent Medical Devices with Allison Fulton
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Podcast: Non-binding Guidance: Expedited Review Programs for Drugs and Biologics
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
A changing competitive landscape: the role of the ITC in the biosimilars space

CMS Adopts Important "Site-Neutral" Changes to Payment Rules

Baker Donelson on 12/14/2018

CMS took another step in its campaign to impose "site neutrality" on hospital outpatient payments with its recently published final Medicare hospital Outpatient Prospective Payment System (OPPS) rule for CY 2019. The final...more

CMS Proposed Rule Reduces Drug Payments & Requires Implementation of Value-Based Purchasing Tools

Foley & Lardner LLP on 3/15/2016

Proposed Rule - Recently, CMS published a Proposed Rule seeking to test a new model for how Medicare pays for drugs and biologicals paid under the Medicare Part B program. With the goals of determining whether...more

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Biologics › MedPAC

CMS Adopts Important "Site-Neutral" Changes to Payment Rules

CMS Proposed Rule Reduces Drug Payments & Requires Implementation of Value-Based Purchasing Tools

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