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Drug Pricing CMMI Pharmaceutical Industry

Jones Day

Medicare's Innovation Center Charts New Direction: Part 3 – Drugs, Devices, and Data

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The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...more

Latham & Watkins LLP

Healthcare & Life Sciences Drug Pricing Digest - April 2025

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The Latham drug pricing and market access team invites you to read this digest of recent developments on healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more

McGuireWoods LLP

Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies

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The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval Program, including a focus on product withdrawal and requirements for ongoing confirmatory...more

McDermott+

McDermottPlus Check-Up: September 8, 2023

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CONGRESS - House Republicans Release Healthcare Package. On September 6, House Republicans unveiled the Lower Costs, More Transparency Act, a draft package of healthcare transparency provisions, pharmacy benefit manager...more

Goodwin

HHS to Create New Potential Medicare Pricing Models for Cell and Gene Therapy, Drugs Subject to Accelerated FDA Approval, and...

Goodwin on

On February 14, 2023, the U.S. Department of Health and Human Services (HHS) published a report identifying three models that the Center for Medicare & Medicaid Services’ (CMS) Center for Medicare & Medicaid Innovation (CMMI)...more

Faegre Drinker Biddle & Reath LLP

Three New Prescription Drug Innovation Models Latest Action on Drug Pricing

As the Biden administration moves ahead to implement provisions of the Inflation Reduction Act (IRA), including those related to drug negotiation and inflationary rebate, the administration announced three Medicare and...more

Holland & Knight LLP

Healthcare Law Update: May 2018

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Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

Mintz - Health Care Viewpoints

What the Administration Actually Can Do on Drug Pricing

The President’s budget makes clear for all to see that the Administration wants to do something related to drug pricing. Unfortunately for the Administration, most of their proposals require Congressional authority that have...more

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