#GPSummit14: More from day 2

Our live coverage from IIR's 6th Annual Government Programs Summit has been provided by Katie Lapins, Director, Huron Consulting Group and Lori Greene, Manager, Huron Consulting Group . 

The theme around the afternoon sessions at this year’s GPSummit was documentation, documentation, documentation!!  The operational complexities when the Final Rule is published can be minimized tremendously if you have good documentation around your assumptions and processes.  One panel, led by Michael Panicaro from Revitas, focused on how manufacturers should be addressing their internal business objectives while developing an approach to identify the potential impacts of the Final Rule.  This session provided thoughtful insight as to how manufacturers should be preparing for the Final Rule and regardless of an organization’s size, how many products are currently marketed, or what is in the pipeline, every manufacturer will be affected.

Based on input from the conference attendees, most manufacturers have begun looking at what the Proposed Rule means to their organization, but few had gone as far as pulling data for modeling “what if” scenarios or advising other departments that could be impacted by the changes.  Most attendees expressed the opinion that CMS would issue the Final Rule by the end of May 2014, but a few others felt that it might be later in 2014.    As always there are going to be differences between what is in the Proposed Rule versus the Final Rule and interpretations and assumptions, especially before any additional guidance is issued, should always be documented.  Another point raised was that it is important that any assumptions or interpretations be consistent.  And of course, manufacturers should contact vendors to ensure that any system that provides data for the GP calculations, or performs the GP calculations, will be able to comply with the necessary changes and within the requisite time period. 

Food for thought…. One company in attendance has broken out the Proposed Rule into buckets.  For instance, with the possible expanded definition of “States” to include US Territories, which were previously excluded from the calculation of AMP and Best Price, the company located all of the data, entered it into their GP system, and analyzed the impact of the change to their numbers.  The biggest challenge for this company was locating where all of the data resided.

Tomorrow is another packed day focused on the 340B Program.  Of special note is the session with Commander Krista Pedley who oversees the Program.