Hemo Alliance Newsletters

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: https://www.hrsa.gov/sites/default/files/hrsa/opa/accountable-care-05-23-2012.pdf

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

Team Alliance Contact Information

We work for you! Please don’t hesitate to contact any of us with any questions or concerns:

Name Email Phone
Jeff Blake jeff@hemoalliance.org 317-657-5913
Jennifer Borrillo, MSW, LCSW, MBA borrillo@hemoalliance.org 504-376-5282
Heidi Lane, PT, DPT, PCS heidi@hemoalliance.org 435-659-1230
Jeff Amond amond@hemoalliance.org 608-206-3132
Jennifer Anders jennifer@hemoalliance.org 954-218-8509
Angela Blue, MBA angela@hemoalliance.org 651-308-3902
Karen Bowe-Hause karen@hemoalliance.org 717-571-0266
Zack Duffy zack@hemoalliance.org 503-804-2581
Michael B. Glomb MGlomb@ftlf.com 202-466-8960
Johanna Gray, MPA jgray@artemispolicygroup.com 703-304-8111
Kiet Huynh kiet@hemoalliance.org 917-362-1382
Elizabeth Karan elizabeth@karanlegalgroup.com 612-202-3240
Kollet Koulianos, MBA kollet@hemoalliance.org 309-397-8431
Roland P. Lamy, Jr. roland@hemoalliance.org 603-491-0853
Dr. George L. Oestreich, Pharm.D., MPA george@gloetal.com 573-230-7075
Theresa Parker theresa@hemoalliance.org 727-688-2568
Mark Plencner mark@hemoalliance.org 701-318-2910
Ellen Riker eriker@artemispolicygroup.com 202-257-6670