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HHS Formally Withdraws 340B Rebate Pilot, Agrees to New Guardrails for Any Future Rebate Efforts

February 6, 2026 William Newton, Associate Editor/Senior Writer 340B Report Views

The U.S. Department of Health and Human Services asked a federal district court to vacate its 340B rebate pilot.

The U.S. Department of Health and Human Services (HHS) on Thursday formally withdrew its controversial 340B rebate pilot proposal and [...]

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Providers Raise Concerns Over Manufacturer Handling of 340B Claims Under the IRA

February 3, 2026 William Newton, Associate Editor/Senior Writer 340B Report Views

Some providers have voiced transparency concerns about the handling of 340B claims data under the IRA.

Providers navigating the Inflation Reduction Act’s (IRA) rollout say they are growing concerned about the lack of transparency into how [...]

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Lilly Defends 340B In-House Pharmacy Claims Data Requirements, 340B Health and Other Providers Push Back

February 3, 2026 Luke Zarzecki 340B Report Views

Eli Lilly defended its policy requiring covered entities to report 340B claims data for in-house pharmacy utilization in a late-January letter to HRSA.

Drugmaker Eli Lilly defended its newly implemented policy requiring covered entities to report 340B claims data for in-house pharmacy utilization [...]

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OPA Staff on Furlough as Congress Looks to Pass HHS Funding Package, End Partial Shutdown

February 3, 2026 Shannon Young, Associate Editor/Senior Writer 340B Report Views

HRSA announced furloughs on its Office of Pharmacy Affairs Information System website after Congress failed to meet its Jan. 30 federal funding deadline.

The Health Resources and Services Administration (HRSA) informed 340B stakeholders this week that the staff in its Office of Pharmacy [...]

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Health Systems, HRSA Argue Over 340B Child Site Registration Policy at January Hearing

February 3, 2026 Shannon Young, Associate Editor/Senior Writer 340B Report Views

Attorneys representing health systems and HRSA squared off over a contentious federal 340B hospital offsite clinic registration policy at an early January, Washington, D.C. federal court hearing.

Attorneys representing 44 health systems and the Health Resources and Services Administration (HRSA) squared off over a contentious federal 340B [...]

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Cassidy Extends Senate HELP Committee’s 340B Investigation to 340B Prime Vendor Apexus

February 2, 2026 William Newton, Associate Editor/Senior Writer 340B Report Views

Sen. Bill Cassidy (R-La.) sent 340B prime vendor Apexus a letter as part of his yearslong investigation into the 340B program.

An influential U.S. Senate Republican and longtime 340B critic has expanded his yearslong inquiry into the 340B program to include [...]

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CMS Selects Drugs for Next Round of Medicare Negotiations; This Time Including Part B Products

January 29, 2026 Shannon Young, Associate Editor/Senior Writer 340B Report Views

A screenshot of CMS' fact sheet on the 2028b IPAY drugs.

CMS announced the latest round of high-cost prescription drugs covered under Medicare Part D—and for the first time—Part B chosen for price negotiations under the IRA.

The Trump administration on Tuesday announced the latest round of high-cost prescription drugs covered under Medicare Part D—and for the [...]

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HHS Releases New Guidance for Direct-to-Consumer Drug Sales

January 29, 2026 Shannon Young, Associate Editor/Senior Writer 340B Report Views

A screenshot of the HHS OIG's Jan. 27 bulletin on direct-to-consumer sales.

The HHS Office of Inspector General published a Jan. 27 bulletin detailing how drugmakers can take advantage of direct-to-consumer sales to patients with federal health care coverage.

Pharmaceutical manufacturers can sell prescription drugs directly to patients—including Medicare and Medicaid enrollees—who choose to pay with cash as long [...]

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Large Hospital Group Asks HRSA to Immediately Block Lilly’s 340B In-House Pharmacy Claims Data Policy

January 27, 2026 William Newton, Associate Editor/Senior Writer 340B Report Views

A screenshot of AHA's Jan. 26 letter to HRSA

The American Hospital Association urged HRSA to take enforcement action against Eli Lilly's new 340B claims data policy.

The American Hospital Association (AHA) on Monday asked federal regulators to “take any and all available enforcement action” to halt [...]

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Three Drugmakers To Refund 340B Covered Entities for Overcharges, Two Announce NDC Changes

January 27, 2026 340B Report Staff 340B Report Views

A screenshot of the manufacturer notices on the Health Resources and Services Administration’s Office of Pharmacy Affairs website.

UCB, Johnson & Johnson and Baxter notified covered entities of refunds, while Baxter and Amgen announced new National Drug Codes for certain products.

Three drugmakers recently announced refunds to 340B covered entities that purchased certain medications between 2008 and 2023, while two unveiled [...]

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