News Alert

Novartis is Fifth Drugmaker to Sue HRSA to Implement Controversial 340B Rebate Model

Novartis is suing HRSA to impose a controversial 340B rebate model that the agency has not authorized.
Novartis this week became the fifth manufacturer to sue the Health Resources and Services Administration (HRSA) to implement a 340B [...]

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NYT Investigative Article Sparks Both Scrutiny and Support for 340B Prime Vendor Apexus

The New York Times published a Jan. 15 investigative article about the 340B prime vendor.
Yesterday’s New York Times investigative article alleging that the 340B prime vendor, Apexus, profited by driving 340B program expansion has [...]

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HRSA Terminates 20 ‘Ineligible’ 340B Sites from STD Clinic; Clinic Rejects Allegations and Vows to Fight Back

HRSA has terminated 20 Sagebrush Health sites from the 340B program for allegedly violating program eligibility requirements.
The Health Resources and Services Administration (HRSA) has terminated the 340B status of 20 sites affiliated with the Nevada-based STD [...]

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Heron, Dr. Reddy’s, Organon, CooperSurgical Issue NDC Changes 

Four drugmakers have notified 340B covered entities of changes to certain national drug codes (NDC) for their products over the past three weeks.
Four drugmakers have notified 340B covered entities of changes to certain national drug codes (NDC) for their products over the [...]

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Drugmaker Lawsuit Targets 340B Eligibility of In-Kind STD Clinics; STD Grantee Denies Allegations

Three drugmakers sued HRSA in federal court over 340B eligibility for certain STD clinics, including Sagebrush Health.
Three large drugmakers are suing the federal government for allegedly allowing certain STD clinics to unlawfully participate in the 340B [...]

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AHA Urges CMS to Block Drugmaker 340B Rebate Models, Improve Medicare Transaction Facilitator

The AHA raised concerns that October 2024 federal guidance on Medicare drug price negotiations may allow drugmakers to “wrongly justify fundamental changes to the 340B program.”
A major hospital advocacy group recently warned that October 2024 agency guidance on Medicare drug price negotiations may allow drugmakers [...]

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IRA Rollout, Regulatory Gaps May Drive Major 340B Reforms in 2025, Says Adam Fein of Drug Channels

Adam Fein, Ph.D, president of Drug Channels Institute, predicted the IRA's implementation could drive major 340B changes during a Dec. 13 webinar.
Emerging regulatory conflicts between the Inflation Reduction Act (IRA) and the 340B program may soon force policymakers to enact major [...]

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Breaking News

Sanofi Pauses 340B Rebate Proposal, Sues HRSA to Impose Controversial Model

Sanofi sued HRSA on Dec. 16 in a federal district court in an effort to implement its controversial 340B rebate model.
French pharmaceutical giant Sanofi late yesterday announced it would pause the implementation of its contested 340B rebate plan and become [...]

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Breaking News

HRSA Threatens to Remove Sanofi from 340B Program Over ‘Unapproved’ 340B Rebate Proposal

HRSA threatened to take significant enforcement actions against Sanofi over the drugmaker's proposed 340B rebate model.
The federal department that oversees the 340B program told Sanofi late Friday afternoon that it must cease implementation of its [...]

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Exclusive

It’s Not Just Arkansas Anymore: West Virginia Becomes Second State to Start Enforcing Its Contract Pharmacy Access Law

The West Virginia Board of Pharmacy ended its self-imposed stay on alleged violations to the state's 340B contract pharmacy access law at its Dec. 8 meeting.
The West Virginia Board of Pharmacy is beginning to act on its growing backlog of alleged violations to the state’s [...]

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