New Registration Process for 340B Entities — Another Sign of Changes in the Program


Over the past year, the Office of Pharmacy Affairs (OPA), the agency within HHS’ Health Resources and Services Administration (HRSA) that administers the 340B Drug Discount Program (340B Program), has implemented significant changes that affect covered entities that participate in the 340B Program. Largely in response to direction from the Government Accountability Office (GAO) and pressure from certain Republican members of Congress, OPA has taken numerous steps that affect covered entities — particularly those participating as Disproportionate Share Hospitals (DSH).

These changes to the 340B Program reflect a clear focus on compliance, probably the most significant attention to compliance by OPA in the history of the 340B Program. In addition to the various actions taken by OPA in the past year, which include auditing selected DSH hospitals and creating a new program-integrity oath for hospitals re-certifying in the 340B Program, the OPA has recently created a new website which was launched on October 5. The theme and tone of the new website clearly demonstrate an emphasis on compliance.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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