Friday, September 17, 2010

MDRP 2010 Conference - 340B Pricing Structure and True-Up Operational Challenges and Compliance Strategies to Comply with New Enforcement Rules

Christopher Hatwig – Apexus/340B Prime Vendor Program
Lisa Scholz – Health Resources and Services Administration (HRSA), Pharmacy Services Support Center (PSSC)
LCDR Devin Williams – Office of Pharmacy Affairs (OPA)
CDR Krista Pedley - Office of Pharmacy Affairs (OPA)

The Office of Pharmacy Affairs is working diligently to get the new provisions of the healthcare reform bills implemented. Section 7102 is complete and will be up on the website for public comments starting on Monday. This section deals with the civil monetary penalties and the dispute resolution process. They are asking that everyone please log on, read through the proposals, and comment up to November 19th. This is the first time that the OPA has ever had regulations in their program and is very anxious to get feedback and work in partnership.

They are still working on Section 7101 and have 260 sites enrolled since August 2nd. The new sites will be posted weekly until September 30th at which time it will go back to quarterly posting. The OPA did not receive any funding to implement the new regulations and they are having some of the same problems with the provisions (e.g., orphan drugs) that manufacturers are having. Having said that, they are working hard on these issues while wanting to maintain high customer service and integrity in the program and ask for our help, feedback, and patience.

Another way that the departments are trying to reach out and make the 340B program better is by starting the 340BIQ group. This group works with entities in ways to develop more access to the drugs and to the utilization, while they focus on the outcomes, quality, and efficiency of the entity and the program.

Apexus is working to integrate the refund process into the system due to the new provisions. They have found that there are small entities that are unable to cash a check, and that it is costing manufacturers more to process the check than the amount of the check. One process is for electronic credits – including re-bills if the changes are being made within six months of original bill date. The OPA/HRSA/340B Prime Vendor groups are all working on this and encourage manufactures to contact them if they need assistance; they will work with you and the OIG for solutions.

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