Legal Update, September 2022

Legal Update

Really, Truly: Only Eligible Patients Can Receive 340B Drugs
by Elizabeth “Issie” Karan, Legal Counsel

The 340B Discount Drug Program grants eligibility to many types of federal grantees and specially designated hospitals, along with Hemophilia Treatment Centers (HTCs). Sometimes these entities may be part of the same health system and/or corporate structure. However, regardless of close relationships or even shared ownership among different 340B covered entities, products purchased under the 340B Program can only be transferred to eligible patients. As a result, the government takes the position that transfer among different covered entities of products purchased under the 340B Program constitutes diversion. Apexus provides the following FAQ on this issue on their website:

FAQ ID: 1349
Last Modified: 08/02/2022
Q: Can a 340B covered entity transfer 340B drugs to another 340B covered entity site, if both are part of the same healthcare system?
A: No. A 340B covered entity is prohibited from transferring 340B drugs to anyone other than a patient of that covered entity. Accordingly, one 340B covered entity cannot transfer a 340B drug to patients of a different covered entity. Under the statute, health care delivery systems to which an eligible 340B covered entity may belong are not included in the statute as eligible entities. For more information, please review OPA Accountable Care Organizations Policy Release, 2012-02, available at:

Most commonly this question comes up in the context of expiring product. If HTCs are in this situation, we recommend contacting the manufacturers to determine if options for buy-backs, exchange, or transfer exist. If you have additional question, please reach out to the Hemophilia Alliance team!

Also in this Issue…

Notes from Joe
· Supporting Partners Across the Community

Alliance Update
· Join us for the New HTC Staff Meeting!

Washington Update

Payer Update
· Know Your Patients and Their Insurance

Notes from the Community
· HTC Considerations for 2023 DSCSA Requirements

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