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Category: Regulatory

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188 Bipartisan House Members Urge HHS Action Against J&J’s ‘Unlawful’ 340B Rebate Proposal

William Newton, Associate Editor/Senior Writer Views
A bipartisan group of 188 House members sent HHS a letter urging action against J&J's 340B rebate proposal.
A bipartisan group of 188 House lawmakers urged the federal government Friday to “use every enforcement tool” at its disposal [...]

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Breaking News

HRSA to J&J: End 340B Rebate by Monday or Lose Access to Key Government Health Insurance Markets

William Newton, Associate Editor/Senior Writer Views
HHS and HRSA sent J&J a Sept. 27 letter that again threatened tough enforcement action against the drugmaker's 340B rebate proposal.
The federal agency overseeing the 340B program has doubled down on its threat to terminate Johnson & Johnson’s (J&J’s) access [...]

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Exclusive

High-Ranking HRSA Official Talks Genesis Decision, Drugmaker Audits During Rare Unscripted Q&A at Industry Conference

William Newton, Associate Editor/Senior Writer Views
Lisa Scholz interviewed HRSA's OPA Director Chantelle Britton at the MDRP Summit in Chicago.
A high-ranking federal regulator addressed the 340B patient definition and manufacturer audits during an unscripted Q&A session after a speech [...]

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Sanofi Imposes New 340B Contract Pharmacy Rule in Arkansas Following Legal Deal with State

William Newton, Associate Editor/Senior Writer Views
Sanofi Arkansas 340B
Sanofi implemented a new 340B contract pharmacy rule for certain Arkansas hospitals.
Sanofi is requiring Arkansas hospitals to prove they legally own 340B-priced drugs until they are dispensed at contract pharmacies after [...]

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CMS Publishes Final Rule on Medicaid Rebates with Significant 340B Implications

William Newton, Associate Editor/Senior Writer Views
CMS released a final rule for Medicaid rebates with new identifiers and definitions that impact the 340B program.
Federal regulators last Friday finalized a highly anticipated rule for the Medicaid Drug Rebate Program (MDRP) with new identifiers and [...]

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PhRMA, HHS Seek Continued Pause on 340B ADR Lawsuit

William Newton, Associate Editor/Senior Writer Views
HHS and PhRMA will continue to pause a lawsuit challenging the government's 340B ADR process.
A major drug industry trade group and the federal government have asked a federal judge to continue to pause litigation [...]

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Column: CMS Should Heed the Advice of 340B Community on Medicare Negotiations

Ted Slafsky, Publisher & CEO Views
Ted Slafsky, publisher and CEO of 340B Report, writes about Medicare drug price negotiations and the 340B program.
The Biden administration deserves credit for playing a key role in passing the first law in history to allow the [...]

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HRSA’s Enforcement Threats Against J&J’s 340B Rebate Proposal Could Face Drugmaker Challenge

William Newton, Associate Editor/Senior Writer Views
Attorneys are mixed on the strength of J&J's legal case if it chooses to challenge HRSA's opposition to its 340B rebate proposal in court.
The federal government’s recent threat to penalize Johnson & Johnson (J&J) for its unapproved 340B rebate model could spark a [...]

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Federal Judge Upholds Four Drugmakers’ 2021 Contract Pharmacy Restrictions—Without Addressing ‘40-Mile Radius’ Rule

William Newton, Associate Editor/Senior Writer Views
A federal district judge upheld four drugmakers' contract pharmacy restrictions as implemented in 2021.
A federal district judge ruled that four drugmakers’ 340B contract pharmacy restrictions—as implemented in 2021—do not violate the 340B statute, [...]

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Breaking News

HHS to J&J: End 340B Rebate Proposal Immediately or ‘Face Potential Consequences’—Including Termination from Federal Health Insurance Programs

William Newton, Associate Editor/Senior Writer Views
HHS sent J&J a Sept. 17 letter demanding the drugmaker "immediately" cease its plan to implement a 340B rebate model.
The federal agency that oversees the 340B program today formally warned Johnson & Johnson (J&J) that it must “cease implementation [...]

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