Viatris, Amgen, GSK Announce 340B Refunds; Amgen Issues NDC Change

Viatris and two other drugmakers recently issued notices to 340B covered entities.
Three drugmakers recently announced refunds for 340B covered entities that were overcharged when buying certain drugs. Viatris, Amgen and GSK [...]

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Breaking News

Federal Judge Upholds HHS’ Right to Pre-Approve 340B Rebates, Tosses Four of Five Drugmaker Lawsuits

Judge Dabney Friedrich of the U.S. District Court for the District of Columbia largely sided with HHS and against the drug industry in multiple 340B rebate lawsuits.
A federal district judge has upheld the federal government’s authority to require agency approval of drugmaker 340B rebate models, dealing [...]

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Breaking News

HHS Secretary RFK Jr. Weighs in on 340B Program Publicly for 1st Time

HHS Secretary. Robert F. Kennedy Jr. told House lawmakers Wednesday that he could not confirm reports that HHS is seeking to shift 340B to CMS due to a “court order."
Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. provided his first public remarks on the 340B program Wednesday [...]

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Drugmakers Press Federal Judge to Quickly Rule on 340B Rebates, Argue HHS’ Plan for Guidance ‘Commits to Nothing’

Drugmakers are urging a D.C. federal district judge to "expeditiously" rule on their motions seeking to implement controversial 340B rebate models.
Four major drugmakers and an industry vendor are urging a federal judge not to delay ruling on their 340B rebate [...]

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340B Antitrust Lawsuit Against Insulin Drugmakers Could Have New Life After Federal Appeals Court Hearing 

A panel of judges heard arguments in a case against four major insulin manufacturers at the U.S. 2nd Circuit Court of Appeals in New York City.
Federal appeals court judges on Friday questioned whether four major insulin manufacturers could have imposed similar 340B contract pharmacy restrictions [...]

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Hospital Group Warns that Medicare Drug Price Negotiation Payment Process Undermines 340B

The American Hospital Association recently took issue with Biden administration IRA Medicare drug price negotiation guidance.
A key national hospital advocacy group recently urged the Trump administration to modify the retrospective payment process under the Inflation [...]

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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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