Changes to the Medicaid Drug Rebate and Section 340B Discount Drug Programs: A Practical Approach to Understanding What Health Reform Means, What to Do and by When


On March 23, 2010, President Obama signed H.R. 3590, the "Patient Protection and Affordable Care Act," (PPACA) into law. This legislation, as subsequently amended by H.R. 4872, the "Health Care and Education Reconciliation Act of 2010," includes significant revisions to the Medicaid Drug Rebate Program (MDRP) and to the 340B Drug Discount Program (340B Program).

The Health Care and Life Sciences practice group will present a 90-minute webinar designed to assist pharmaceutical and biotech manufacturers in understanding the practical impact of this legislation with respect to the MDRP and the 340B Drug Discount Program. Epstein Becker Green attorneys are well-versed in government program prescription drug pricing issues and have considerable experience in counseling manufacturers regarding their compliance obligations and with defending manufacturers in government investigations.

Key themes to be addressed:  

Changes in pricing metrics under each Program

  • How is the "basic" rebate changing? 
  • How will the new AMP calculation compare to the calculation under the DRA Final Rule?  
  • How will Best Price be calculated to account for changes implemented by PPACA? 
  • Is my product a "line extension" and, if so, what does that mean to rebate liability?
  • Will my product's AMP be public? (If so, when?) 
  • What are the changes to the Federal Upper Limits?

Changes in the scope of each Program

  • How will the FUL changes affect Medicaid reimbursement? What might this mean for Medicaid utilization? 
  • How will Medicaid managed care plans utilization be included in the state invoices (and when?)
  • How might state Medicaid drug coverage expand under Health Reform? 
  • Will Medicaid utilization increase (and when is the Medicaid program expansion effective)? 
  • Who are the "new" 340B Program covered entities and how are they different from the current covered entities?  
  • Will I need to make 340B covered drugs available for inpatient purchases?

Changes in manufacturers' obligations under each Program

  • What new reporting obligations will my company have? 
  • How will the changes to the MDRP impact my company's rebate obligations? 
  • Can I recalculate my baseline AMP?
  • How will the changes to the MDRP impact my 340B financial obligations?
  • What is the so-called "must sell" provision and what does it mean to my company?
  • How will 340B "integrity" provisions impact my company?
  • When do I need to comply with the MDRP and 340B changes and what should I be doing now?

The speakers will also leave time at the end of the webinar for questions (including those last minute 1Q10 implementation questions!).

For more information, contact Kristi Swanson at (202) 861.4186 or [email protected].