Yep. Audits. They are happening. And, chances are, if your covered entity (“CE”) hasn’t experienced one yet, it is coming to you sometime soon. At both 340B University (hosted by Apexus, the prime vendor for the 340B Drug Pricing Program) and the
To Be or Not to 340B Blog
Legal Updates on the 340B Program
The "To Be or Not to 340B Blog," published by Quarles & Brady LLP, focuses on legal and regulatory developments related to the 340B Drug Pricing Program. The blog covers topics such as manufacturer rebate models, contract pharmacy restrictions, dispute resolution processes, and federal and state legislative changes impacting 340B covered entities. It analyzes the implications of policy shifts, litigation, and administrative rules on hospitals, health systems, and other eligible providers participating in the 340B Program. The blog also discusses enforcement actions, compliance challenges, and the evolving landscape of drug pricing and reimbursement under the 340B statute.
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Comparing 340B University and the 340B Coalition Conference
Maybe it is just us, but we wanted to know whether we would get a different experience at 340B University versus the 340B Coalition Conference. In some ways, these conferences could not have been more different. But, at the heart…
Top Takeaway from 340B University and 340B Coalition Conference
This year we once again had boots on the ground for 340B University and the 340B Winter Coalition Conference for a four-day 340B Drug Pricing Program (340B Program) adventure. 340B University is free of charge and is put on by the…
Site Neutral Payments Put 340B Child Sites in Jeopardy
Just when you thought you understood all the threats facing the 340B Drug Pricing Program (“340B Program”), along comes the Bipartisan Budget Act of 2015 (“BBA 2015). BBA 2015 changes the way in which new off-campus hospital outpatient departments (“HOPDs”)…
PhRMA 2-0 in The Orphan Drug Wars
U.S. Federal District Court Judge for the District of Columbia, Rudolph Contreras, ruled Wednesday, October 14, 2015 that manufacturers need not offer 340B discounts for orphan drugs sold to a specified group of covered entities (CEs), regardless of how the orphan…
Breaking Down the Proposed Omnibus Guidance – Child Sites
It is coming down to the wire – comments are due on the 340B Drug Pricing Program Omnibus Guidance (“Guidance”) in about two weeks! On October 28, 2015 the comment period will be closed and there will be nothing left…
Breaking Down the Proposed Omnibus Guidance – Covered Entity Eligibility, Registration & Termination
As promised, the blog will be taking an in-depth look at discrete topics included in the proposed 340B Drug Pricing Program Omnibus Guidance (“Guidance”), which was published August 28, 2015. The proposed Guidance touches on almost every aspect of the…
The Proposed 340B Drug Pricing Program Omnibus Guidelines Have Landed
It is official: The Health Resources and Services Administration (“HRSA”) has published the long-awaited “Mega Guidance.” The Proposed 340B Drug Pricing Program Omnibus Guidelines (“Guidelines”) were published in the Federal Register on August 28, 2015. Any comments must be submitted on…
Finally! HRSA Proposes Manufacturer Civil Monetary Penalties
On June 17, 2015 the Health Resources and Services Administration (“HRSA”) finally published its much anticipated proposed rule, the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation. Comments must be submitted via the online portal,…
Near Miss on Congressional Overhaul of 340B Program
In just a matter of days, changes to the 340B Program were proposed and then withdrawn from H.R. 6, The 21st Century Cures Act. Had hospitals, health systems, and related lobbying groups not been closely watching the Act, the changes might have quietly gone through when the 21st Century…