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

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

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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Eli Lilly and Amgen Announce Refunds, Amgen Issues NDC Change

Eli Lilly and Amgen announced refunds for 340B covered entities that purchased certain drugs in 2021.
Two drugmakers recently announced that they will refund 340B covered entities that purchased certain medications following adjustments to their ceiling [...]

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HRSA Adds Louisiana to Eligible States for Immediate 340B Enrollment Due to Hurricane Francine 

HHS declared a Public Health Emergency for Louisiana following Hurricane Francine.
Louisiana providers can enroll in the 340B program outside of the formal enrollment period amid disaster relief efforts following Hurricane [...]

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News Alert

340B Covered Entities Threaten Action Against Drugmakers Over New Reporting Requirements

Second Sight Solutions updated 340B ESP's terms of use on Oct. 4.
A law firm representing hospitals and other 340B covered entities across the U.S. has called on more than two dozen [...]

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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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Exclusive

Arkansas Plans to Challenge J&J’s Contested 340B Rebate Proposal for Violation of State Law

J&J said its 340B rebate proposal will apply to Arkansas covered entities.
Arkansas plans to challenge Johnson & Johnson’s (J&J’s) 340B rebate proposal for violating the state’s law barring drugmaker contract pharmacy [...]

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