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:
Civil monetary penalties for manufacturers – to be published Spring 2015
Manufacturer and administrative dispute resolution – to be published Fall 2015
An omnibus guidance (also called the mega-guidance, or even the Mega-G) to be published June 2015
If you remember last year, there was a lot of anxiety caused by the announcement of a mega-regulation (mega-reg), and the ever pending mega-reg, and then finally the slow fizzle of the mega-reg, which soon became the mega-mess after PhRMA challenged HRSA on the Orphan Drug Rule. So now we have “Guidances” in certain 340B areas on how HRSA thinks the program ought to be conducted but they aren't necessarily enforceable by law.
After the recap of 2014, the Mega-Guidance, of course, was the main focus of the presentation. This guidance will be subject to a comment period and will provide lots to discuss between now and the next 340B Coalition meeting in D.C.
Areas expected to be included in this guidance are:
contract pharmacies
recertification
duplicate discounts, including Medicaid managed care (Cmdr. Pedley stated that they would be working closely with CMS and will provide Medicaid managed care guidance)
process for credits and refunds by manufacturers to covered entities
manufacturer limited distribution plans
HRSA seems to have regrouped with compliance and audits at the top of its list of priorities. Commander Pedley specifically stated, “…program integrity is our highest priority.” Self-auditing and constant preparation for audits was strongly encouraged along with regular internal and external audits to help provide positive audit results. She discussed addressing audit findings and the fact that you really only get one shot to argue your case. Submitting as much evidence and documentation that you can to support those arguments was crucial and she stated that HRSA is very unlikely to reverse their decision unless you do.
Other best practices mentioned by Commander Pedley were:
working with Apexus
attending 340B University
participating in peer-to-peer calls
obtain resources and information on OPA and Apexus websites
What this all boils down to and we can’t harp on it enough – PROGRAM INTEGRITY IS IMPERATIVE in this ever-changing 340B world and routine self-audits (internal and external) must be a pillar in your 340B program.
If you would like to view Commander Pedley’s 340B Winter Coalition address please click HERE.
We’ve got more to write on the 340B Drug Pricing Program in general including 340B external audits, 340B compliance reviews, 340B program requirements, 340B audit results, etc. Don’t miss out on future articles delving deeper into the 340B program!
