J&J’s Contested 340B Rebate Proposal Would Further Limit Contract Pharmacies, Give Drugmaker More Control of Program, Attorneys Say

J&J's plans to convert certain 340B discounts to a rebate model would reshape the 340B program.
Johnson & Johnson’s (J&J’s) proposed 340B rebate model, which has not received government approval, would give the drugmaker significantly more [...]

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Kedrion Posts 340B Refund Notice; Mylan Issue NDC Changes

Kedrion was one of two drugmakers to issue recent notices to covered entities on a federal government agency website.
Drugmaker Kedrion Biopharma has posted a refund notice to 340B providers, and Mylan notified covered entities of National Drug Code [...]

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News Alert

HRSA Says Johnson & Johnson’s New 340B Rebate Model Did Not Receive Agency Approval, Is ‘Inconsistent’ with 340B Statute

HRSA did not approve J&J's newly proposed 340B rebate model, an agency spokesperson told 340B Report.
The federal agency that oversees the 340B program did not approve drugmaker Johnson & Johnson’s (J&J’s) proposal to convert certain [...]

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Breaking News

J&J Announces Plans to Shift Certain 340B Discounts to Rebate Model, Prompting Fierce Backlash from Providers, Regulators

Johnson & Johnson announced it will convert two 340B drugs to a rebate model for hospitals.
In a move that would fundamentally alter the 340B program, pharmaceutical giant Johnson & Johnson (J&J) told hospitals this morning [...]

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Sanofi Asks 340B Hospitals for Information on Purchases of Its Top-Selling Drug

Sanofi is reportedly asking hospitals for data relating to 340B purchases of Dupixent.
French drugmaker Sanofi has reportedly asked some hospitals for data relating to 340B purchases of a popular drug used to [...]

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Hospital Groups ask Supreme Court to Reverse Ruling that Impacts 340B Eligibility

Hospital groups are urging the Supreme Court to correct what they called HHS' misinterpretation of DSH percentage calculations.
Six national hospital associations recently urged the Supreme Court to correct what they called the Department of Health and Human [...]

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Federal Court Grants Texas Hospitals’ Request to Temporarily Block DSH Calculation Changes

A federal court sided with a group of Texas hospitals’ efforts to block an HHS rule.
A federal court last week sided with a group of Texas hospitals’ efforts to block—at least temporarily—a Department of Health [...]

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AHA Raises ‘Serious Concerns’ with MedPAC’s Direction on 340B

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AHA officials penned a Medical Economics op-ed on “the truth behind growth of the 340B prescription drug program.”
A major hospital advocacy group recently urged congressional advisers to “carefully consider” the potential negative consequences of any new efforts [...]

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Former Pfizer Exec. Slams 340B, Says IRA Will Worsen Program in New Op-Ed 

Kirsten Axelsen, a consultant and former Pfizer executive, cautioned that the 340B program “will be even worse” under the IRA in an Aug. 13 op-ed.
A former Pfizer executive and current biopharmaceutical consultant took aim this week at what she called the “poorly managed” 340B [...]

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HRSA Seeks Public Comment On ADR Process and Required Administrative Load

HRSA is seeking stakeholder comments on the administrative burden of the updated 340B ADR process.
The Health Resources and Services Administration (HRSA) has requested public comment on how petitioners file their initial claims in the [...]

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