To Be or Not to 340B Blog

Legal Updates on the 340B Program

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By: Quarles & Brady LLP

Blog Authors

Alyce Katayama
Brenda Shafer
Caroline Hennessy
Elizabeth Gebarski
Jaya White
Richard Davis

Latest from To Be or Not to 340B Blog

It’s been a roller coaster two years for the 340B Program, and we are now back to review some of the major developments and program changes during this time. On the highest level, despite a flurry of proposed legislative action, the 340B Program remains largely unchanged from where it stood prior to 2017. As covered in more detail below, the notable exception to this is the significant Medicare Part B reimbursement reductions for certain categories…
The proposed 340B Drug Pricing Program Omnibus Guidance that was issued in August 2015 and promised to turn the 340B world on its head was withdrawn on January 30, 2017. Not that most covered entities are upset. The proposed 340B Drug Pricing Program Omnibus Guidance proposed a host of changes to the 340B Drug Pricing Program, a law that requires drug manufacturers to provide discounts on “covered outpatient drugs” to “covered entities,” when those “covered…
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 340B Coalition Conference (hosted by 340B Health) many CEs we interacted with had already experienced the Health Resources and Services Administration (“HRSA”) audit process.…
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 of it all, each had the same underlying education of stakeholders so that covered entities (“CEs”) can continue stretching “scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.”…
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 340B Prime Vendor, Apexus. The 340B Coalition Conference, on the other hand, charges a fee and is organized by 340B Health, a membership organization that advocates for covered entities (CEs). In this post, we disclose…
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”) will be paid come January 1, 2017. This change could have a substantial impact on 340B Program child site eligibility.…
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 drug is used. To make a very long story short, in 2010, the Patient Protection and Affordable Care Act (PPACA) made several changes to the 340B Program.  In part, it added several new CEs (e.g.,…
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 to do but sit back and wait. This post will focus on an aspect of the 340B Program that could undergo significant changes under the proposed Guidance – child sites. What are we talking about here? …
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 340B Program, including covered entity (“CE”) eligibility; the patient definition; Group Purchasing Organization prohibitions; contract pharmacies; duplicate discounts; and CE audits. It also includes enhanced program integrity requirements for CEs, contract pharmacies, and pharmaceutical manufacturers…
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 or before October 27, 2015. The proposed Guidelines aim to “add clarity in the marketplace for all 340B Program stakeholders and strengthen the [U.S. Department of Health and Human Services’] HHS’s ability to administer the 340B…