News Alert

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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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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AbbVie, Novartis Sue Oregon Over New 340B Contract Pharmacy Access Law

Drugmakers AbbVie and Novartis recently filed separate federal lawsuits challenging Oregon's new 340B contract pharmacy access law.
AbbVie and Novartis recently became the first drugmakers to file lawsuits challenging Oregon’s new law prohibiting 340B contract pharmacy restrictions. [...]

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State Contract Pharmacy Lawsuit Roundup: Hearing in Utah; Updates in Colorado, Nebraska, Oklahoma

Key hearings and briefs occurred in ongoing litigation on 340B contract pharmacy access laws in Utah, Colorado, Nebraska and Oklahoma.
Editor’s Note: With 340B-related litigation heating up in several states following the enactment of new contract pharmacy access laws, 340B [...]

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News Alert

340B Providers, Drug Industry Raise Concerns Over HRSA’s 340B Rebate Model Pilot Proposal 

340B provider groups and drugmakers raised concerns Thursday over HRSA's proposed 340B rebate guidance.
340B covered entities and drugmakers offered competing criticisms Thursday of the Health Resources and Services Administration’s (HRSA) newly released 340B [...]

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Breaking News

HRSA Proposes 340B Rebate Model Pilot for Narrow Set of Drugs Under Strict Conditions

The Health Resources and Services Administration published its highly-anticipated proposed 340B rebate guidance this morning, proposing a narrowly-scoped pilot program.
The Health Resources and Services Administration unveiled its highly anticipated proposed 340B rebate guidance on the morning of July 31.
The Health Resources and Services Administration (HRSA) today unveiled its highly anticipated 340B rebate guidance, proposing a pilot program that [...]

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Patient Groups Back Drugmakers in 340B Rebate Appeal, Without Disclosing Drug Industry Funding or Missed Compliance Deadline

Three patient groups recently told a federal appeals court that a 340B rebate model “is essential to the effort to bring transparency to 340B.” One of those groups did not disclose its financial ties to drugmakers, and another is out of compliance with state public reporting laws.
Three patient groups are urging a federal appeals court to back drugmaker 340B rebate models they argue would bring transparency [...]

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Record Turnout for Fourth Annual ‘Defend 340B’ March on Capitol Hill

340B advocates marched on Capitol Hill to "defend 340B" for the fourth straight summer. (Credit: Community Voices for 340B)
Nearly 80 advocates marched toward Capitol Hill yesterday in a record turnout for the fourth annual “Defend 340B March” in [...]

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