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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HRSA Seeks Dismissal of Two Health Systems’ Lawsuits Over J&J 340B Audits

HRSA filed motions to dismiss two health systems' lawsuits over J&J 340B audit approvals in the U.S. District Court for the District of Columbia.
The Health Resources and Services Administration (HRSA) is urging a federal court to dismiss two health systems’ lawsuits alleging the [...]

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Safety-Net Hospital Group Urges HRSA to Block Sanofi 340B Rebate, Calling It More Harmful than J&J Model

Bruce Siegel, president and CEO of America's Essential Hospitals, strongly opposed Sanofi's 340B rebate model in a letter to HRSA.
A major hospital group is urging the Health Resources and Services Administration (HRSA) to intervene immediately against Sanofi’s proposed 340B [...]

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Health Systems Temporarily Avoid HRSA 340B Termination Threats as They Fight J&J Audits in Court

HRSA filed joint stipulations with five health systems in separate cases before the U.S. District Court for the District of Columbia.
The federal government has agreed to temporarily delay any enforcement action against five health systems for their refusal to comply [...]

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Sanofi Escalates Legal Fight for HRSA 340B Contract Pharmacy Records Amid Controversial Rebate Push

Sanofi is suing HRSA in federal court to release thousands of 340B contract pharmacy agreements.
Pharmaceutical giant Sanofi has intensified its legal battle seeking the release of extensive 340B contract pharmacy records after announcing plans [...]

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News Alert

Fourth Large Manufacturer Fights to Establish Contested 340B Rebate Model

BMS sued the federal government Nov. 26 to unilaterally establish a 340B rebate model.
Pharmaceutical giant Bristol-Myers Squibb (BMS) sued the federal government late Tuesday to establish a 340B rebate model, joining at least [...]

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340B Providers Slam Sanofi’s New 340B Rebate Model for Hospitals and Health Centers

Sanofi announced plans on Nov. 22 to begin implementing a 340B rebate model for certain hospitals and health centers.
Provider groups have strongly denounced Sanofi’s new 340B rebate model for hospitals and health centers as a costly and harmful [...]

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