Southwest Consulting Associates Blog

The 340B program’s major compliance focus has historically been targeted at covered entities and whether those covered entities are in full compliance with program requirements, but there are also requirements for drug manufacturers that seem to be underexamined, and in many cases, do not receive near the scrutiny of the covered entity compliance requirements. Manufacturer’s 340B compliance is just as important and this year, Health Resources and Services Administration (HRSA) appears to be moving forward on drafting guidance for manufacturers as well as increasing manufacturer audits and imposing civil monetary penalties for overcharging providers.

The 340B Congressional Hearing that was scheduled for March 5th, and cancelled due to a snowstorm, was rescheduled and held yesterday March 24th at 10am EST.  Ms. Diana Espinosa from HRSA, Ms. Ann Maxwell from the OIG, and Dr. Debra Draper from the GAO appeared as witnesses at the hearing and were asked to give a 5 minute summary of their submitted written testimony.  The subcommittee members then moved on to a Q&A session to further understand the functionality of the 340B program and its current impact.  While there were a few members that questioned the actions of HRSA and the 340B program with skepticism and derision, the overall hearing proved to be positive, enlightening, and educational for house members.

In our last post, we focused on HRSA’s 2015 agenda item to complete at least 200 340B audits and listed several risk factors that could increase the likelihood of a 340B entity being selected for an audit.  There is no way to be certain if an audit for your 340B entity is on the horizon, but here are some things you may want to do to get your facility ready, just to be on the safe side.  Que The Temptations’ “Get Ready” in the background...

Last year, and then again at the 340B Winter Coalition, HRSA announced that they planned on performing at least 200 340B audits by the end of 2015.  According to the latest data, they had completed 33 as of January 13th.  And according to Commander Pedley’s 340B Winter Coalition address (see highlights HERE), program integrity is OPA’s highest priority.  So, if you haven’t received your 340B audit notification letter yet, be on the lookout.  

On Thursday February 5th, 2015, at the 340B Winter Coalition, Commander Krista Pedley (Director of Office of Pharmacy Affairs) gave a presentation addressing the 340B Drug Pricing Program.  In this presentation, although many things were covered, the main take-a-ways were what to expect from HRSA in 2015 including:

It’s registration time again.  That’s right.  All aboard the 340B train.  All those that qualified in October are now eligible and those that missed the deadline in October have until the 15th of January to register.  Let me tell you, the word is out.  October 2014’s registration had 4,158 CE’s and CP’s that registered.  Well, it is a great program.  And there are some great benefits for the covered entities as well as the contracted pharmacies, as long as you follow the guidelines, the rules set in place and you watch your back.  Between the HRSA regulations, the wholesalers, the manufacturers and the software vendors, it’s a tricky cup of tea out there.  

So, for those of you that have decided to join in on the fun, a few words of advice….