Tag Archives: compliance

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”) will be paid come January 1, 2017. This change could have a substantial impact on … 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

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, email, or US Mail by August 17, 2015. Keep in mind, all submitted comments will be … Continue Reading

The Message Is Clear from OPA Director Pedley

Covered entities should be constantly preparing for  audit.  That  was the message, loud and clear, from Office of Pharmacy Affairs Director, Cmdr. Krista Pedly, who spoke by webcast  at the recent Winter Conference of the 340B Coalition in San Francisco.  That preparation, she said, should include making use of the compliance tools available through Apexus … Continue Reading

340B Program Participants: It’s Time to Ramp Up Compliance

340B covered entities need to revisit and perhaps ramp up their compliance efforts.  The director of the Health Resources and Services Administration’s Office of Pharmacy Affairs has been very open in touting the fact that HRSA has invested in program integrity to make sure that manufacturers and covered entities remain compliant and that benefits for … Continue Reading