Well, big news out yesterday. As of 1/30/2017, the 340B Omnibus Guidance is officially withdrawn.
Where does that leave us?
Well, that brings be to my second topic, the 340B Winter Coalition Conference. I am in my seat on our airplane to San Francisco. I am excited for this conference, as the legislative sessions will be very hot topics. We, Turnkey, are taking 7 staff to the conference, and have our booth (come visit us at booth 57 if you are attending). In the event you are not attending, we will share some of the follow-up to what the discussion is around the post-Omnibus withdrawal 340B landscape. My personal thought is that HRSA may be waiting for rule making authority to formally write more specific rules and guidance on the 340B program. Especially around the 340B patient definition. Of course, this would require legislation, which is why I am excited to hear from 340B Health about all the bills in the senate and house. We also have to worry about the current ACA repeal potential and how that might affect our ACA covered entities (i.e., CAH, RRC, SCH, and CAN). Stay tuned my friends!
HRSA 340B Audits: We have already attended two HRSA audits this year, and have a third one coming up. We feel the Bizzell HRSA auditors have been fair, however, we are seeing auditors with more 340B operational experience. This means they understand 340B programs in more detail and therefore the need for 340B covered entities to remain compliant is even more important (if that is even possible).
One last note, I wanted to thank all of the covered entities we work with who responded on the 340B Health exchange question that asked for recommendations for external 340B auditors. It was so nice to see so many people put our name out there, it kind of made me a little teary eyed. I think we have the privilege of working with the best covered entities in the program. I look forward to seeing many of you this week at the conference.