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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Delaware Enacts 340B-PBM Payment Law Without Contract Pharmacy Provisions from Original Version

Delaware enacted a law prohibiting PBMs from limiting payments to healthcare providers based on their 340B status.
Delaware Gov. John Carney (D) late last week signed into law a bill to prohibit “discrimination against 340B entities by [...]

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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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Breaking News

Senator Cassidy Extends 340B Inquiry to Two Major Pharmaceutical Manufacturers

Sen. Bill Cassidy (R-La.) has extended an ongoing 340B probe to two major drug manufacturers.
An influential Republican senator this morning requested detailed information from Eli Lilly and Amgen on their 340B programs, including the [...]

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

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

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

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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Fourth Hospital Sues HRSA for Alleged ‘Unlawful’ Authorization of J&J 340B Program Audits

Children’s National Medical Center sued HRSA for approving a drugmaker's 340B audit request.
A Washington, D.C.-based children’s hospital has sued the federal government for authorizing drugmaker Johnson & Johnson (J&J) to perform “unlawful” [...]

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Diabetes Drugmakers Urge Federal Appeals Court to Dismiss Health Centers’ 340B Antitrust Lawsuit

Sanofi and three other diabetes drugmakers are urging a federal district court to dismiss 340B antitrust allegations against them.
Four diabetes drugmakers are urging a federal appeals court to uphold a lower court’s decision to dismiss 340B antitrust claims [...]

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HHS Concessions in Contract Pharmacy Lawsuits Unlikely to Signal Shift in 340B Rebate Stance, Attorneys Say

The federal government is moving to resolve four contract pharmacy lawsuits, but may continue fighting Kalderos' 340B rebate model in court.
The federal government is likely to continue opposing 340B rebate models even as it moves to resolve four separate contract [...]

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