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Federal Court’s Ruling Against 340B Hospital Drug Purchasing Restrictions Policy Sparks Uncertainty

Shannon Young, Associate Editor/Senior Writer 340B Report Views
An exterior shot of Premier's offices.
A D.C. federal court's March 31 ruling against a 2013 340B hospital drug purchasing restrictions policy has sparked uncertainty among some 340B hospitals, stakeholders said.
A late-March federal court decision striking down a 2013 Health Resources and Services Administration (HRSA) policy that restricted how certain [...]

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Biocon Pharma to Refund 340B Covered Entities for Overcharges, Amgen Introduces New NDCs

Shannon Young, Associate Editor/Senior Writer 340B Report Views
HRSA website screenshot.
Biocon Pharma and Amgen recently notified covered entities of refunds and new NDCs in notices posted to HRSA's website.
An Indian drugmaker recently announced refunds to 340B covered entities that purchased certain medications between 2022 and 2025, while a [...]

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Most Stakeholder Comments on 340B Rebate RFI So Far Are Duplicates Linked to Pharma-Funded Patient Group’s Template

William Newton, Associate Editor/Senior Writer 340B Report Views
A side-by-side of a Patients Rising template and an RFI comment.
More than half of early comments on HRSA’s 340B rebate RFI were identical submissions closely mirroring language from a Patients Rising template.
The Health Resources and Services Administration (HRSA) has published the first batch of stakeholder comments on its latest 340B rebate [...]

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Stakeholders Say Trump’s Renewed Push to Move 340B to CMS, Increase Program Funding Could Signal New Focus on Program

Shannon Young, Associate Editor/Senior Writer 340B Report Views
Stakeholders said the 340B shakeup proposed in the Trump administration’s FY 27 HHS budget could suggest a new focus on 340B activity.
The Trump administration’s revamped plan to move 340B oversight from the Health Resources and Services Administration (HRSA) to the Centers [...]

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White House Announces Tariffs on Drugmakers That Do Not Negotiate MFN Prices, U.S. Manufacturing Commitments

Luke Zarzecki, National Correspondent 340B Report Views
A screenshot of the presidential proclamation announcing the tariffs
The Trump administration announced on April 2 that pharmaceutical manufacturers will face new tariffs unless they negotiate a "most favored nation" price and begin to onshore their production of drugs.
The White House unveiled plans last week to set 100% tariffs on brand-name imported drugs with a number of exceptions, [...]

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News Alert

Trump’s FY 27 HHS Budget Again Looks to Move 340B from HRSA to CMS, Calls for Major OPA Funding Increase

Shannon Young, Associate Editor/Senior Writer 340B Report Views
The Trump administration’s FY 27 HHS budget released Friday calls for moving the 340B program from HRSA to CMS, as well as an $8.3 million funding increase for program oversight.
President Donald Trump’s administration has revived its plan to move the 340B program from its longtime home at the Health [...]

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News Alert

Federal Court Strikes Down HRSA’s 340B Hospital Drug Purchasing Restrictions Policy

Shannon Young, Associate Editor/Senior Writer 340B Report Views
Premier logo.
A Washington D.C. federal district judge ruled March 31 in favor of Premier, a GPO which had challenged a 2013 HRSA policy that prohibited certain hospitals from using either 340B discounts or GPO-negotiated discounts for initial drug inventory purchases.
A Washington D.C. federal court on Tuesday struck down a 13-year-old Health Resources and Services Administration (HRSA) policy that restricts [...]

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Tennessee Attorney General’s Office Warns Novo Nordisk that In-House 340B Claims Data Requirements Violate State Law

Luke Zarzecki, National Correspondent 340B Report Views
The Tennessee Attorney General's Office warned Novo Nordisk in a March 30 letter that its new in-house claims data requirements violated state law.
The Tennessee Attorney General’s office this week urged a Danish drugmaker against implementing new in-house claims data requirements that the [...]

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Drug Industry Lauds Appeals Court’s Ruling Against West Virginia’s 340B Contract Pharmacy Law, AG ‘Reviewing’ Options

Shannon Young, Associate Editor/Senior Writer 340B Report Views
Exterior shot of 4th Circuit Appeals Court.
The 4th Circuit Court of Appeals' ruling against West Virginia's 340B contract pharmacy law drew mixed reaction from drugmakers and providers and sparked questions about a potential U.S. Supreme Court review.
The drug industry this week celebrated its first federal appeals court victory against a state 340B contract pharmacy access law—a [...]

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Organon to Move to Truzo, Becomes 3rd Drugmaker to Use Kalderos’ Platform for 340B Contract Pharmacy Restrictions

Shannon Young, Associate Editor/Senior Writer 340B Report Views
Organon logo.
Organon announced that it will move its 340B contract pharmacy claims review and policy oversight duties to Kalderos’ Truzo platform as of May 1.
The New Jersey-based spin-off of pharmaceutical giant Merck announced Wednesday that it will become the third drugmaker to utilize a [...]

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