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.

Please see full alert below for more information.

LOADING PDF: If there are any problems, click here to download the file.

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.

© Baker Donelson | Attorney Advertising

Written by:


Baker Donelson on:

Popular Topics
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.