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The Future of the 340B Program: 2023 Key Decisions

Critical decisions are pending before courts and legislators in 2023 that promise to shape the future of the 340B Drug Pricing Program (340B Program), which provides discounts on outpatient drugs for certain health care...more

Omnibus 340B Guidance Raises New Issues for Covered Entities

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

HRSA Proposes Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

The Health Resources and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking impacting the 340B Drug Pricing Program (340B Program) on June...more

OIG Publishes Report Identifying Issues With 340B Contract Pharmacy Arrangements

On February 5, 2014, the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) published a report (OIG Report) describing the results of a survey it had conducted of the use of contract...more

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