The 340B Coalition. The super bowl of 340B events. All the 340B all-stars in one place at one time. The energy is palpable and the excitement is giddy. I expected to see Maureen Testoni do her touchdown dance at any moment and I awaited with baited breath.
This coalition was no exception and the topics were spot on in regards to several of the issues we see with our clients. HRSA audits and Medicaid were the half time show and they did not disappoint. Commentary provided by 340B Health and Apexus kept us all apprised of what is happening in the 340B arena. If you were not able to make the show I will recap the highlights. So now you can be a 340B fan, and WOW at the watercooler on Monday morning.
The first play began with Captain Krista Pedley of Office of Pharmacy Affairs (OPA). She spent a conscious effort moving up the line by discussing HRSA audits. The surprise to fans came when she informed us that the audit process will be moved to the OPA. The OPA office will now be fulfilling the audit role. She made certain to reiterate that this will not change the audit process nor will it affect the covered entities in any way. The audit process will continue the same as always. She also reminded fans that manufacturers can limit drugs provided to the 340B program as well as limit distribution in specialty items. However, with communication to manufacturers and including HRSA in any challenges the covered entity encounter, HRSA can help resolve the ‘roughing the passer’ call.
Recertification was the second play. Covered entities must be registered in the 340B program in order to participate. A ‘time out’ from HRSA was the reminder to ensure everything is compliant within your entity. Material breach was also discussed and should be disclosed to HRSA based on entity policy and procedure. Manufacturers also need to be informed of material breach and communication initiated.
Orphan drugs finished up the third play with a touchdown! Captain Pedley reminded the ‘water boy’ (which includes everyone that can’t purchase Orphan drugs) that you are free to purchase Orphan drugs outside of the 340B plan and encouraged you to find these drugs at other discounted prices. In the words of Bobby Boucher “Now that’s what I call high quality H2O.”
QB Chris Hatwig stepped on the field to introduce Apexus’ 340B Operations Certificate Program. This is where I pulled out my hot pink No. 1 foam finger. The Operations certificate is beneficial for any individual who would like to pursue specialized training in 340B knowledge. This is not a free program, but offered at a discounted rate for individuals in a 340B covered entity.
Chris also introduced a new service provided by Apexus that will help covered entities find orphan drug contracting. Apexus will also incentivize manufacturers by waiving their fees if they offer orphan drugs at a discount.
A major ‘foul’ was called by Apexus to some manufacturers who are sending “inquiries” to covered entities that imply they are working with HRSA. These “inquiries” have been sent to HRSA and they are false. Manufacturers will not be sending communication to covered entities on behalf of HRSA. First step if you receive one of these is communication. Contact the manufacturer immediately and if needed, contact HRSA.
Lastly, Medicaid, the ‘goodyear blimp’ that hovers over the 340B playfield. They reminded covered entities that duplicate discounts, fee-for-service, and managed care are all resources involved with Medicaid. It is up to the covered entities to make sure they are correctly billing Medicaid. Medicaid will not take the ‘ignorant’ plea. The covered entity needs to know what their state is billing and what constitutes a duplicate discount.
Touchdown!! Apexus is working on a master database that will include Medicaid policies for reimbursement from all states for duplicate discount prevention. The fans go wild!!!
340B fans, I cannot believe it, I cannot believe it, this will go down as the best 340B coalition in history. This wraps up the highlights from day 1- Live from Washington DC. Goodnight.
– Jenn Cook