It’s the most wonderful time of the year! That’s right, MDRP Summit has kicked
off at The Palmer House Hilton in Chicago and, despite the fact that the
conference doesn’t officially kick off until Wednesday, the industry’s premier
subject matter experts wasted no time providing their most valuable insights to
the GP community. After four years of
waiting for the AMP Final Rule, and countless presentations urging us to be
ready for it, we finally have some definitive language to review. For those of us who have (obviously) read
every word of the final rule, but want to make sure that we implemented all the
key changes, the Track C: Full Day Symposium
on The AMP Final Rule: Application, Implementation and Impact of the Final Rule
provided the perfect prelude to the Summit.
Joe Birdsall of Dohmen Life Science Services kicked off the
day by introducing a panel discussion on Deconstructing
the AMP Final Rule: A Step by Step Analysis of the Key Implications of the
Final Rule, moderated by Kristin Hicks of Arnold & Porter, with
panelists Frank Prybeck (Celgene), Josh O’Harra (Eli Lilly), and Kave Niksefat
(Amgen). I always enjoy panel discussions
because they give us a sense not just of the regulations, but of the day to day
operational challenges manufacturers might face when implementing them. Panelists discussed the pain of identifying
Mail Order and Specialty Pharmacies, which might require a thorough review of
contract language, or even picking up the phone to ask the entities what products
and services they provide. The
participants also stressed the importance of establishing consistent processes,
whether you are assigning class of trade or identifying 5i products, to ensure
determinations are consistent and unbiased.
Next up was Christopher Schott of Hogan Lovells, with an
excellent presentation on Identification
& Alternate Rebate Formula for Line Extensions. I was particularly excited for this session
because I promised one of my clients, who was unfortunately unable to attend the
Summit this year, that I would explain everything he need to know about
calculating AMP for line extensions when I got back. I was able to catch up with Chris after the session,
and I will be posting a more thorough recap of his presentation and this topic after
the conference for our readers at home.
John Shakow of King & Spalding was up next, expounding
on everything we should know about 5i AMP,
Eligibility, Calculations & Implications. This is another area that has been a hot
topic among my clients, as many manufacturers are acquiring new products, and
may be identifying 5i products, performing the 70/30 determination, and calculating
5i AMP for the first time. John
demystified the calculation, providing a background on the genesis of 5i AMP,
and reminding us that it’s really just a matter of inclusions and
exclusions. Oh, and there’s the pesky,
monthly requirement to calculate when 5i eligible products are considered not
generally dispensed through a retail community pharmacy. Although some in the room disagreed, John suggested
that manufacturers not back out their government sales when performing the
70/30 calculations, a position supported by language in the AMP Final Rule, to
identify an accurate percentage of “not generally dispensed” sales.
The next two sessions, Bundling
by John Gould of Arnold & Porter, and Impact
of the Final Rule on COT with Jesse Mendelsohn and Dhirendra Jena of Model
N, provided helpful insights for those responsible for GP within their
organizations. Perhaps more importantly,
they identified other covered employees within pharmaceutical organizations who
should be aware of the impact their contracting and operations decisions have
on the company’s GP calculations. It
might not be a bad idea to review these presentations with your shared services
groups to give them an idea of how their work impacts you.
Finally, King & Spalding and EY partnered up to close
the Pre-Conference Day with Service Fees:
Bona Fide or Constructive Price Concession?
They walked us through the four (seven?) part test for determining
whether fees to wholesalers and other AMP, BP, and ASP eligible entities can be
considered bona fide. This is another
presentation you might want to pass on to your colleagues after the Summit,
particularly those in Managed Markets and Commercial Contracting – if they don’t
modify their contracting strategies, you can at least be aware of what to expect. As always, document your methodologies and
reasonable assumptions to ensure that your results are consistent and
transparent, and don’t be shy about soliciting advice and industry data from
legal counsel and FMV consultants.
After we filled our brains with all the GP information we
could handle, IIR officially welcomed us to Chicago with the Grand Opening
Reception in the 4th floor exhibit hall. As I made my way through the room catching up
with old friends and colleagues, I couldn’t help but laugh at how far the
booths have come since I began my career; it seems like just yesterday that I was
awkwardly slapping Velcro panels to an un-structurally sound frame, but now the
booths look seamlessly professional (some are even complete with interactive
iPads!). What hasn’t changed is the
quality of the SMEs in the booths (and those roaming the room), who are ready
to answer your questions and offer solutions to your most pressing problems.
That’s all for today, kids.
Stay tuned for live blog updates throughout the 2016 MDRP Summit, from
your friendly neighborhood Government Pricing Specialists!
About the Author:
Dana Z. Collins has worked in the Government Pricing space for almost a decade,
as both a consultant and an in-house compliance professional. As a GP consultant, Dana’s areas of primary focus
are audits/assessments, training, ongoing calculations, Medicaid rebate
processing, and policies/procedures – oh, and blogging. After working with Katie Lapins, Principal/Owner
of Government Pricing Specialists (GPS), on and off over the years, Dana joined
GPS in 2016 and has never looked back.
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