Category Archives: Guidance

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Notice to Covered Entities: Manufacturer Seeking 340B Claims Data

While we addressed recent wins for 340B covered entities concerning manufacturer transparency in a previous article, Merck Sharpe & Dohme Corp. (“Merck” or “Manufacturer”) now appears to seek its own access to 340B covered entity data in a different fashion. Specifically, over the past few weeks, Merck has sent letters to numerous 340B covered entities … Continue Reading

GAO Report Suggests Increased Oversight of 340B Program

On January 10, 2020, the Government Accountability Office (GAO) released a report which “found weaknesses in the Health Resources and Services Administration’s (HRSA) oversight [of the 340B Program] that may result in some hospitals receiving discounts for which they are not eligible.” The GAO report primarily focused on the extent to which HRSA is monitoring and reviewing nongovernmental … Continue Reading

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 of it all, each had the same underlying education of stakeholders so that covered entities … Continue Reading

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 340B Prime Vendor, Apexus. The 340B Coalition Conference, on the other hand, charges a fee … Continue Reading

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 drug is used. To make a very long story short, in 2010, the Patient Protection … Continue Reading

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 to do but sit back and wait. This post will focus on an aspect of … Continue Reading

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 340B Program, including covered entity (“CE”) eligibility; the patient definition; Group Purchasing Organization prohibitions; contract … Continue Reading
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