Tuesday, May 6, 2014

Q&A with Miree Lee of M. Lee Consulting, LLC - A Speaker at IIR's Gross-To-Net Accounting Forum

At the 2nd Annual Gross-To-Net Accounting Forum, Miree Lee will be leading a workshop on the Impact of the MDRP AMP Final Rule on Accruals. With the CMS AMP Final Rule scheduled to be released in May, attendees of this workshop will learn about the many variables within the rule that alter government payer forecasting, gross-to-net and accrual calculations. Different types of manufacturers must also consider how their products and their distribution model are specifically impacted.

Key considerations of the final rule, impact for each:
  • Pharmaceutical Price Points (AMP, BP, ASP, NFAMP, 340B, etc.)
  • Overview of Various Government Programs
  • Requirements under Medicaid Drug Rebate Program
  • What is AMP?
  • What are the inclusion and exclusion filters?
  • How is AMP used?
  • What is BP?
  • What are the inclusion and exclusion filters?
  • How is BP used?
  • What is the URA?
  • What are some potential changes in AMP, BP and URA?
  • How do companies accrue?
  • How does Medicaid expansion impact accruals?
  • Managed Care Medicaid and Duplicate Discounts
  • Other changes in Medicaid that may impact accruals


1. How feasible is collaboration between managed markets, commercial, government programs and Finance?  

Collaboration takes on different forms for different companies.  There isn't a "one size fits all" methodology except that the core principle of collaboration is a critical necessity for government pricing/program compliance.  Some companies identify and memorialize the collaboration process via formal process methodology document which outlines the tactical activities of collaboration (e.g. roles, responsibilities, timelines, specific reports and data, meeting schedule, etc.).  Other companies may adopt a less formal process whereby key persons of each department are involved in providing the proper information to the pricing department or responsible individual to ensure government pricing/program compliance.  Depending upon the size, structure, product mix, complexity of business and various other factors, cross functional collaboration may look different company-to-company. 

2. Key questions to ask before investing and building an automated GTN or GP system? 

Number of products, number of NDCs, annual sales, number of direct and indirect customers, classes of trade for direct and indirect customers, number and types of discount contracts, rebate or chargeback, tiered or market share based contracts, volume based contracts, formulary status requirements, bundles, stacked discounts, types of fees - bona fide or not. 

3. How to accrue and forecast patient/ payer related items? What critical/ essential information is required and what aspects you can’t afford to overlook.
  • Intimate knowledge of the competitive market
  • Shifts in market share and causes for the shifts (pricing, special contracts, supply, reimbursement)
  • Thorough understanding of payers and changes in payor reimbursement
  • Changes in payor coverage and patient population (e.g. Medicaid expansion, shifts in payor mix)
  • Changes in mandatory discount/rebate liability (e.g. Medicaid URA increases substantially or 340B or FSS price decreases substantially)
  • Price protection and how price protection is calculated

To hear more from Miree, please join us at the Gross-To-Net Accounting Forum, June 17-18 in Philadelphia, PA. 

Register now and save an additional $100 off the current rate when using the code: XP1911BLOG

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