Overcoming the Challenges Stemming from the CMS Proposed Medicaid Rebate Rule

Pharmaceutical Pricing Litigation
Developing cutting-edge litigation strategies in response to a new wave of pricing cases in AWP, AMP, BP, and more

Theories and causes of action in pharmaceutical pricing cases are becoming more complex and creative, as the tried and true standard pricing methodology of AWP is waning.  Examine the cutting edge trends and shape a litigation strategy that will prepare you for the new wave of pricing cases.

• Develop defense responses to AWP litigation despite the lack of a statutory definition of "average"
• Bolster your trial strategy to mitigate exposure in litigation over AMP calculations in light of proposed changes from CMS
• Understand the current CMS position, as they try to clarify the complex set of best price rules and guidance from the early 2000s
• Shape defense strategy in response to the increase of qui tam and whistleblower cases proceeding to trial
• Distinguish between pricing FCA cases and off-label cases to improve litigation tactics
• Adjust trial strategy to account for cases litigated by state-appointed private outside counsel
• Overcome the challenges stemming from the CMS proposed Medicaid rebate rule
• Creating a plan of action for litigation with pricing rules still up in the air
• Responding to proposed rules changes and "clarifications"
• How will manufacturers handle the proposed Medicaid rebate rules if they are enacted as-is?
• Healthcare reform and 340B