Setting new standards in information exchange for the pharmaceutical and biotech industry


According to our advisors, the Department of Health and Human Services has not yet cleared the AMP Rule for final review by the Office of Management and Budget (OMB). Since OMB reviews can take upwards of 90 days, inside sources say that the Final Rule is not likely to come out until late summer or fall. We are happy to continue to offer this much anticipated program to help answer all your operational, policy, financial, systems and compliance questions from CMS’s Covered Outpatient Drug Rule AMP Final Rule. We will announce new dates for the Fall asap.

The much anticipated final rule revises requirements for Medicaid reimbursement for covered outpatient drugs to implement provisions of the Affordable Care Act (ACA). This program brings together GP and MDRP experts to address significant administrative and compliance challenges and answer questions that impact your bottom line.

Covered Topics:

  • Medicaid Drug Rebate Average Manufacturer Price regulation: AMP methodology for covered outpatient drugs
  • Class of Trade COT: Clear COT definition and the impact on sales through specialty pharmacies, home infusion and PBM owned pharmacies
  • Identification of 5i drugs: How to handle related calculations
  • Definitions of Innovator Multiple Source Drug and Single Source Drug: Ensure proper calculations
  • Best Price exemption on 340B prices: Understand changes relative to the orphan drug rule
  • Restatement of base AMP and Best Price BP: Should you and can you do it?
  • Bona Fide Service Fees: Understand methodology for documenting and defining including price appreciation credits
  • Bundling: How to determine discounts in a bundled arrangement
  • Line extensions: Understand new definition and rebate formula
  • US Territory Expansion Decision: How to obtain data and rebates for US Territories
  • Authorized Generics Sales inclusion in Primary manufacturer’s AMP


How AMP Final Rule affects 340B Program:

  • Definition of “covered outpatient drug”
  • State Medicaid plans’ provisions regarding reimbursement of 340B drugs
  • 340B drugs for Medicaid managed care patients
  • How manufacturers are to treat orphan drugs sold to new covered entities types for purposes of calculating Medicaid best price


At this Summit you will learn:

  • How to revise your processes and SOPs to reflect the changes
  • How and when restatements should be performed
  • What questions other manufacturers have and identify the questions you to need to ask internally
  • Understand how other departments such as contracting, legal, compliance and commercial contracting are impacted by the changes
  • Devise workarounds and manual solutions for systems changes
  • And much more…


Please note if the Mega Rule is published before July, we will also address:

340B Drug Pricing Program Proposed Regulation (Mega Rule) Overview

  • 340b Hot Topics: Defining eligible patient, understand compliance requirements, and new program integrity initiatives
  • Understand the Orphan Drug Rule challenge and Implications for the Mega-Rule
  • HRSA Audits of Covered Entities
  • OIG Contract Pharmacy Audit
  • Duplicate Discount Prohibition and Medicaid MCOs
  • AIDS Drug Assistance Programs Proposed Rule Status (ADAP) Rebates for Cost-Sharing Expenditures
  • Status of HRSA Audits of manufacturers


Speaking Faculty

Don Bell
SVP & General Counsel, National Association of Chain Drug Stores (NACDS)

Kathleen Black
Director Government Strategy, Pfizer

Paula Grist
Director, Government Reporting, Hospira

George Kenny
Senior Account Manager, 340B, Managed Care and Customer Operations, Genentech, Inc.

Perry Elizabeth Knight
Senior Counsel Law Department, Johnson & Johnson

Miree Lee, MS, MBA
Bio-Pharma Pricing & Contracts Consultant, M. Lee Consulting, LLC

Paula Martins
Director, Government Contracts, Daiichi Sankyo

Edward McAdam
Senior Director of Contracting, Pricing & Analytics, Daiichi Sankyo

Jay McKinley
Senior Director, Government Pricing and Commercial Operation, Dendreon

Lorraine Moccio, Director
Government Contracting & Pricing Compliance Officer, Johnson & Johnson International

Josh O’Harra
Assistant General Counsel, Eli Lilly and Company

Invited CMS Speakers

Tamara Bruce
Technical Director, Division of Pharmacy,  Disabled, & Elderly Health Programs Group, Center for Medicaid and CHIP Services, CMS

Dona Coffman
Technical Director, Division of Pharmacy, Disabled, & Elderly Health Programs Group, Center for Medicaid and CHIP Services, CMS

Kimberly Howell
Acting Director, Division of Pharmacy, Disabled, & Elderly Health Programs Group, DHHS, Center for Medicaid and CHIP Services, CMS