CMS Finalizes Next Medicare Drug Negotiation Guidance Without Resolving Key Concerns of 340B Stakeholders

CMS has issued final guidance on the next round of Medicare drug price negotiations under the IRA.
Federal regulators issued final guidance for the next round of Medicare drug price negotiations yesterday but did not propose remedies [...]

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340B Provider Groups, Key Federal Lawmaker Praise HRSA for Pressuring J&J to Drop 340B Rebate Proposal

U.S. Rep. Abigail Spanberger (D-Va.) and multiple 340B provider groups applauded HRSA for its response on J&J's 340B rebate proposal.
Multiple 340B provider groups have applauded the federal government for threatening “strong” enforcement actions that led Johnson & Johnson (J&J) [...]

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Kalderos Launches New Drug Discount Platform with 340B Rebate Capabilities as Lawsuit with HHS Remains Paused

Kalderos announced a new drug discount platform that supports 340B rebate capabilities.
Drug industry vendor Kalderos last week launched a new drug discount platform with 340B rebate capabilities as its prior lawsuit [...]

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Breaking News

J&J Abandons 340B Rebate Due to HRSA’s Enforcement Threats But Defends Model in Letter to Agency

J&J announced it will "forgo implementation" of its 340B rebate proposal due to enforcement threats from HRSA.
Johnson & Johnson (J&J) notified the Health Resources and Services Department (HRSA) this morning that it will drop its 340B [...]

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Breaking News

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

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

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

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

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

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

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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