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HRSA › Regulatory Requirements › Proposed Rules

Baker Donelson

HHS Previews Guidance Addressing Implementation of 340B Rebate System

Baker Donelson on

In the fall of 2024, several pharmaceutical companies reacted to HRSA's decision to prevent them from implementing a rebate model for their respective 340B Programs by filing lawsuits against HHS and HRSA claiming that the...more

Hogan Lovells

340B program: Proposed rule would accelerate the effective date of the CMP Final Rule from July 1, 2019, to January 1, 2019

Hogan Lovells on

This week, the Health Resources and Services Administration (HRSA) issued a Proposed Rule (Proposed Rule) to cease any further delay of the 340B Ceiling Price and Civil Monetary Penalties regulation (CMP Final Rule) and...more

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