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.
