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HRSA Proposes Changes to STD Clinics and Other 340B Covered Entities’ Recertification and Enrollment Requirements; Extends Date for Rebate Comments

HRSA included updated 340B program enrollment and recertification requirements for covered entities in an Aug. 7 Federal Register notice.
Sexually transmitted disease (STD) clinics and other 340B covered entities must submit new or more complete information to enroll in [...]

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In Unanimous Decision, Fed Appeals Court Reverses Lower Court Ruling and Allows 340B Antitrust Lawsuit Against Insulin Drugmakers to Advance

The U.S. 2nd Circuit Court of Appeals' 3-0 decision reversed a lower court’s 2024 ruling that had denied health centers' antitrust claims against four drug manufacturers that have placed contract pharmacy restrictions.
A federal appeals court ruled unanimously Wednesday that an antitrust class action lawsuit, in which two health clinics alleged four [...]

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HHS Touts 340B Rebate Pilot Proposal to Appeals Court, Hospitals File Amicus Brief Urging Court to Reject Rebates

HHS highlighted its proposed 340B rebate pilot in an Aug. 1 brief filed with the U.S. Court of Appeals for the District of Columbia Circuit.
The U.S. Department of Health and Human Services (HHS) touted the agency’s recently announced plan to pilot a 340B rebate [...]

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The Compliance Arms Race: Can Smaller Covered Entities Keep Up?

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The 340B program has morphed into a battlefield of rules, audits, and reporting. For smaller covered entities (CEs), especially rural hospitals and community clinics, keeping pace feels like a losing race. While large health systems deploy entire

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Judge Rejects HHS’ Partial Motion to Dismiss in Drugmakers’ Lawsuit Challenging STD Site Recertifications

The U.S. District Court for the District of Columbia, denied HHS’ partial motion to dismiss drugmakers’ claims in a lawsuit alleging that the federal government allowed certain STD clinics to unlawfully participate in the 340B program.
A Washington D.C. federal court this week rejected the Department of Health and Human Services’ (HHS) request to partially dismiss [...]

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Trump Calls on Drugmakers to Implement ‘Most Favored Nation’ Pricing, Resurrects Idea to Extend MFN to all Medicaid Patients

President Donald Trump sent a July 31 letter to 17 major drugmakers to begin implementing his proposed “most-favored nation” model for prescription drugs.
President Donald Trump is urging more than a dozen leading pharmaceutical manufacturers to begin implementing his proposed “most-favored nation” (MFN) [...]

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Plenful

Q: Tell us some interesting details about your company’s history.

Plenful was founded with a clear mission: to transform healthcare operations from the inside out. Our Founder

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Expert Tip from Visante

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TIP: When a covered entity participates with 340B ESP™ to obtain 340B pricing restoration, it is critical to monitor manufacturer policies, ESP eligibility,

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Senate HELP Committee Chairman Again Criticizes 340B Hospitals and Calls for Reforms at Hearing

Senate HELP Committee Chairman Bill Cassidy (R-La.) pointed to 340B program reforms as one potential way to address health care costs at a July 31 hearing.
A key Senate Republican and outspoken 340B critic recently argued that any comprehensive efforts to address healthcare affordability in Congress [...]

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Liquidia Tightens 340B Contract Pharmacy Restrictions; Biogen, Sanofi Exempt New States

Liquidia announced that as of Aug. 1, it will only ship 340B purchases of Yutrepia to covered entities with a contract pharmacy in its limited distribution network.
A North Carolina-based drugmaker recently tightened its 340B contract pharmacy restrictions to limit distribution of a pulmonary arterial hypertension treatment—just [...]

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