A One Day Intensive Seminar Designed to Drill Down into the Practical Application and Nuances of the Final Rule

1. American Conference Institute's conference on:
The AMP Final Rule
A One­Day Intensive Seminar Designed to Drill Down into
the Practical Application and Nuances of the Final Rule
When: May 23, 2016
Where: New York, NY
The Carlton Hotel
Registration Begins: 8AM
AGENDA
AT-A-GLANCE
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The program is still being finalized so reserve
your seat early!

2. 9:15 The AMP Final Rule Recap: Operationalities, Legalities, Realities and
Practicalities
8:00 Registration and Continental Breakfast
9:00 Co­Chairs’ Opening Remarks
10:15 Networking Break
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On January 21, 2015, CMS issued an advance copy of the long awaited
and long overdue AMP Final Rule, which consumed over 650 pages. For
the first time in five years, the Final Rule provides comprehensive guidance
to address the calculation of Average Manufacturer’s Price. This session
will provide an overview of the Final Rule and lay the ground work for
subsequent sessions where we will dive deeper into certain key elements
of the Final Rule as well as their practical application.

3. This session will explore the areas of the Final Rule that still present the greatest
challenges to the industry in that they leave the most ambiguity for lawyers and price
reporting professionals to work through.
Points of discussion will include:
10:30 The Dark Side of the Final AMP Rule: Uncertainties,
Ambiguities, Unanswered Questions and Lingering Concerns
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The meaning of “original NDA”
The “not generally dispensed” standard under 5i AMP
Non­5i drugs not generally dispensed through a retail community pharmacy
The definition of “covered outpatient drug”, including its application to
radiopharmaceuticals
The treatment of “returns”
The handling of intercompany sales
The lack of supportive guidance for value based contracting
Specific areas where CMS may be vulnerable to litigation from manufacturers

4. CMS declined to finalize its proposed definition of “line extension” in the AMP Final Rule
and instead requested additional comments and stated that it “may” address the issue in
future rulemaking. The Agency directed manufacturers to rely on the statutory definition
and to use reasonable assumptions. This session will explore how manufacturers should
address this challenge.
Points of discussion will include:
11:30 Line Extensions: Making Reasonable
Assumptions in the Absence of Guidance
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Examining the statutory definition
What assumptions are considered reasonable
Benchmarking best practices for making reasonable assumptions
12:15 Networking Luncheon

5. “Bona fide service fees” has been an important concept since it was originally introduced,
in the calculation of ASP, and continues to be a focus in the AMP Final Rule. This
session will cover, among other topics:
1:30 Drilling Down on Bona Fide Service Fees: FMV, Price
Appreciation Credits, and More
Revisions made to the concept from the Proposed Rule
Revisions to the “no pass through” prong of the four­part test
The persistence of no additional guidance on determining fair market value
The discussion surrounding “price appreciation credits”
2:15 Turning Back the Clock with Authorized Generics?
In the AMP Final Rule, CMS largely finalized its proposed regulations regarding the
treatment of authorized generics in the calculation of AMP and best price of the branded
drug. While the regulatory text appears relatively straight forward, the Final Rule includes
a significant amount of commentary from CMS, which creates a muddled picture, similar
to the prior AMP Final Rule, for the treatment of authorized generics in the AMP of the
branded drug. This session will:
Discuss the guidance relevant to authorized generics in the Final Rule
Analyze when and where the guidance permits authorized generics to be included
in AMP
Explore how this guidance may be interpreted in light of the statutory language
3:00 Afternoon Break
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6. 3:15 Overcoming Operational Challenges to Implementation
Including Territory Inclusion, Data Collection, and Class of
Trade Designations
How to handle the treatment of sales to territories that operate with price controls
and request a waiver
The timing to include territories for purposes of calculations, smoothing, and
rebate payments
For international companies, if these sales are booked to a separate legal
entity/GL, how are those transactions to be treated
How to validate rebates
Estimating the rebate liability for accrual purposes
The impact on ASP
4:15 Best Practices for Auditing and Monitoring Pricing Practices
to Ensure Continued Compliance with the New Guidelines
Overall best practices for government pricing
Areas where reasonable assumptions may need to be made and appropriate
documentation
When and how manufacturers should communicate with government agencies
5:15 One Day Seminar Concludes
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