News Alert

HHS to Issue Guidance on 340B Rebates, IRA Interaction Within 30 Days

HHS plans to release stakeholder guidance on 340B rebates in 30 days.
The U.S. Department of Health and Human Services (HHS) plans to release guidance within 30 days on 340B rebate models [...]

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Sumitomo Exempts Four More States From 340B Contract Pharmacy Restrictions, GSK Exempts Nebraska, Utah

Sumitomo Pharma America has announced exemptions to its contract pharmacy restrictions for 340B covered entities in Nebraska, North Dakota, South Dakota and Utah.
Two major drug manufacturers are loosening their 340B contract pharmacy restrictions for states that have passed contract pharmacy access laws [...]

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News Alert

Federal Judge Grills Both Sides in Key Hearing on 340B Rebate Dispute

A hearing on five drug industry 340B rebate lawsuits took place April 29 in the U.S. District Court for the District of Columbia.
A federal judge today in Washington, D.C. scrutinized arguments from both manufacturers and the government in a closely watched hearing [...]

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Federal Judge Holds High-Stakes Hearings Today on Five Drug Industry 340B Rebate Lawsuits

U.S. District Judge Dabney Friedrich of the District of Columbia is presiding over five April 29 hearings over drugmaker 340B rebate lawsuits. She previously largely sided with Novartis and United Therapeutics in a separate case on drugmaker contract pharmacy restrictions.
A federal judge in Washington, D.C., is holding high-stakes hearings today on five drug industry lawsuits challenging the government’s opposition [...]

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HRSA Audits Find Two Drugmakers Overcharged for 340B Drugs, Driving Calls for More Drug Industry Oversight 

HRSA released the results of its first two drugmaker audits of 2025 this month.
Recent Health Resources and Services Administration (HRSA) audits found that two drugmakers overcharged covered entities for their 340B drugs, fueling [...]

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Takeda Tightens 340B Contract Pharmacy Restrictions, Biogen Exempts Nebraska From Its Restrictions Policy

Japanese pharmaceutical giant Takeda recently announced changes to its 340B contract pharmacy restrictions.
A Japanese pharmaceutical giant and Massachusetts biotechnology company recently announced changes to their respective 340B contract pharmacy restrictions. Tokyo-based Takeda [...]

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HHS Continues to Oppose Unapproved Drugmaker 340B Rebate Models in New Legal Filings

HHS has again urged a federal district court to reject multiple drug industry lawsuits seeking to implement 340B rebate models.
The U.S. Department of Health and Human Services (HHS) is continuing its pushback against drugmaker attempts to unilaterally convert upfront [...]

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Minnesota Finalizes Expanded 340B Provider Reporting Requirements, Extends Submission Deadline to May 30

The Minnesota Department of Health issued updated reporting guidance last week for 340B providers.
Minnesota covered entities will have additional 340B reporting requirements this year, but an extended deadline to submit that data, according [...]

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News Alert

Leaked HHS Budget Document Details Plans to Move 340B Program to CMS

The Trump administration appears to detail its plans to move the 340B program from HRSA to CMS in a reportedly leaked internal budget document.
President Donald Trump’s (R) preliminary budget appears to call for “new authority to regulate all aspects of the 340B program,” [...]

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Hospitals, Health Centers Criticize Trump’s Executive Order Over Controversial 340B Rule, Possible Medicare Payment Cuts

President Donald Trump (R) issued a wide-ranging April 15 executive order on drug pricing policy.
Hospital and health center leaders are pushing back against President Donald Trump’s (R) new executive order, criticizing its controversial 340B [...]

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